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中国药典附录Ⅰ(A-Z)中英文对照
（附录Ⅰ制剂通则） Appendix Ⅰ General Requirements for Prearations （丸剂）Ⅰ A 丸剂 Pills 系指药材细粉或药材提取物加适宜的黏合剂或其他辅料制成的珠形或类球形制剂，分为蜜丸、水蜜九、水丸、糊丸、蜡丸和浓缩丸等类型。 Pills are spherical or spherical-like solid dosage forms made of finely powdered crude drugs or crude drug extracts, proper binders or other excipients. They are classified into honeyed pills, water-honeyed pills, watered pills, pasted pills, concentrated pills waxed pills and concentrated pills etc. 蜜丸 系指药材细粉以蜂蜜为黏合剂制成的丸剂。 其中每丸重量在 0.5g( 含 0.5g)以上的 称大蜜丸，每丸重量在 0.5 以下的称小蜜丸。 Honeyed pills are made of fine powder of crude drugs, using honey as binder. Among them, pills weighing more than 0.5g (including 0.5g) per pill are big honeyed pills, pills weighing less than 0.5g per pill are small honeyed pills. 水蜜丸 系指药材细粉以蜂蜜和水为黏合剂制成的丸剂。 Water-honeyed pills are made of fine powder of crude drugs, using honey and water as binders. 水丸 剂。 Watered pills are made of fine powder of crude drugs, using water (or yellow rice wine, vinegar, dilute medicinal juice, dilute syrup) as binder. 糊丸 系指药材细粉以米粉、米糊或面糊等为黏合资剂制成的丸剂。 Pasted pills are made of fine powder of crude drugs, using rice powder rice-paste or flour-paste as binder. 蜡丸 系指药材细粉以蜂蜡为黏合剂制成的丸剂。 Waxed pills are made of fine powder of crude drugs, using beeswax as binder. 浓缩丸 水蜜丸。 Concentrated pills are made of condensed extract of crude drugs or partial crude drugs, mixing with appropriate excipient or fine powder of other crude drugs, using water, honey or honey and water as binders. They may be classified into concentrated watered pills, 系指药材或部分药材提取浓缩后，与适宜的辅料或其余药材细粉，以水、蜂蜜或 蜂蜜和水为黏合剂制成的丸剂。根据所用黏合剂的不间，分为浓缩水丸、浓缩蜜丸和浓缩 系指药材细粉以水（或根据制法用黄酒、醋、稀药汁、糖液等）为黏合剂制成的丸concentrated honeyed pills and concentrated water-honeyed pills based upon the different binders used in the production. 丸剂在生产与贮藏期间应符合下列有关规定。 The production and storage of pills should comply with the following requirements. 一、除另有规定外，供制丸剂用的药粉应为细粉或最细粉。 1. The powdered drugs for preparing pills are fine or very fine powders, unless specified otherwise. 二、蜜丸所用蜂蜜须经炼制后使用。按炼蜜程度分为嫩蜜、中蜜和老蜜，制备蜜丸时可根 据品种、气候等具体情况选用。除另有规定外，用塑制法制备蜜丸时，炼蜜应趁热加人药 粉中，混合均匀，处方中有树脂类、胶类从含挥发性成分的药味时，炼蜜应在 60℃左右加 人；用泛制法制备水蜜丸时，炼蜜应用沸水稀释后使用。 2. The honey used for honeyed pills production should be processed before using. According to the degree of processing, it can be divided into primary processed honey, secondary processed and tertiary processed honey, which may be selected and used to prepare honeyed pills, depending on the climate and the varieties of honeyed pills. In preparing big and small honeyed pills by rubbing method, the processed honey should be added to the drug powder while hot and mixed well, unless specified otherwise. If resin, gum and volatile drugs are contained in the formulation, the processed honey should be added at about 60℃;in preparing water-honeyed pills by water spray rotating method, the processed honey should be diluted with boiling water before using. 三、浓编丸所用药材提取物应按制法规定，采用一定的方法提取浓缩制成。 3. The extract for preparing concentrated pills should be made by extracting and concentrating according to the certain methods specified under the monograph. 四、除另有规定外，水蜜丸、水丸、浓缩水蜜丸和浓缩水丸均应在 80℃以下干燥；含挥发 性成分或淀粉较多的丸剂（包括糊丸）应在 60℃以下干燥；不宜加热干燥的应采用其他适 宜的方法干燥。 4. Unless specified otherwise, water-honeyed pills watered Pills or concentrated water-honeyed pills, concentrated Watered pills should be dried at a temperature below 80℃; pills containing large amount of volatile constituents or starch (including pasted pills) should be dried at a temperature below 60℃. Thermolabile pills should be dried with other proper methods. 五、制备蜡丸所用的蜂蜡应符合本版药典该药材项下的规定。制备时，将蜂蜡加热熔化，待冷却至 60℃左右按比例加人药粉，混合均匀，趁热按塑制法制丸，并注意保温。 5. Beewax used for producing waxed pills complies with the requirements specified under individual monograph in this pharmacopoeia. In preparing melt beewax by heating, then allow to cool to 60℃ and add drug powders proportionally, mix thoroughly and prepare the waxed pills using the kneading method while the temperature is maintained. 六、凡需包衣和打光的丸剂，应使用各品种制法项下规定的包衣材料进行包衣和打光。 6. For pills need to be coated and polished, coat with the coating materials and polish as specified under individual monograph. 七、丸剂外观应圆整均匀、色泽一致。蜜丸应细腻滋润，软硬适中。蜡丸表面应光滑无裂 纹，丸内不得有蜡点和颗粒。 7. Pills should be round, integrate and uniform in appearance and colour. Big and small honeyed pills should appear fine, smooth and oily-moistened, with proper hardness. Waxed pills should be smooth in apperance without crack, and no drops or granules found inside the pills the pills. 八、除另有规定外，丸剂应密封贮存。蜡丸应密封井Z阴凉干燥处贮存。 8. Unless specified otherwise, Pills should be preserved in tightly closed containers and waxed pills, in tightly closed containers and stored in a dry place. 丸剂应进行以下相应检查。 Following relevant tests should be carried out for pills. 【水分】照水分测定法（附录Ⅸ H)测定。除另有规定外，蜜丸和浓缩蜜丸中所含水分不得 过15. o％；水蜜丸和浓缩水蜜丸不得过12.0％；水丸、糊丸和浓缩水丸不得过9.0％。蜡 丸不检查水分。 Determination of water Carry out the method for the determination of water in general (Appendix Ⅸ H).Unless specified otherwise, big honeyed pills, small honey pills and concentrated honeyed pills contain not more than15.0% of water, water-honeyed pills, concentrated water-honeyed pills not more than l2.O per cent, watered pills, pasted pills and concentrated watered pills not more than 9.0 per cent. No determination of water is required for waxed pills. 【重量差异】除另有规定外，丸剂按丸数服用的照第一法检查，按重量服用的照第二法检 查，均应符合规定。 Weight variation Unless specified otherwise Pills to be taken in pill are examined by Method 1 and pills to be taken by weight examined by Method 2.第一法 以一次服用量最高丸数为 1 份(丸重 1.5g 及 1. 5g 以上的丸剂以 1 丸为 1 份；丸 重 0.015g 以上的丸剂一次服用量最高丸数超过 10 丸的，或丸重 0.015g 及 0.015g 以下的 丸剂一次服用量最高丸数不足 10 丸的，以 10 丸为 1 份），取供试品 10 份,分别称定重量， 再与标示总量（每丸标示重量 X 称取丸数）或标示重量相比较（无标示重量的丸剂，与平 均重量比较），按表 1 的规定，超出重量差异限度的不得多于 2 份，并不得有 1 份超出限 度 1 倍。 Method 1 Take the largest number of pills in single dosage as one part(1 pill as one part for pills weighing 1.5g or more than 1.5 10pills as one part for pills weighing more than 0.015g per pill and with the largest number of pills in single dosage is above 10, or pills weighing 0.015g or less than 0.015g per pill and with the largest number of pills in single dosage is not up to 10).Weigh separately 10 parts and compare with the labelled total weight (labelled weight of each pill X the number of pills weighed)or labelled single weight (if no labelled weight is stated, compare the weight of each pill with the average weight calculated) According to the requirements stated in Table 1. Not more than 2 parts exceed the limit of weight variation and none doubles the limit of weight variation. 表1 标示总量或标示重量（或平均重量） 0.05g 及 0.05g 以下 0.05g 以上至 0.1g 0.1g 以上至 0.3g 0.3g 以上至 1.5g 1.5g 以上至 3g 3g 以上至 6g 6g 以上至 9g 9g 以上 Table 1 Labelled total or single(average weight) 0.05g or less more than 0.05g to 0.1g more than 0.1g to 0.3g more than 0.3g to 1.5g weight variation limit 士 12% 士 11% 士 10% 士 9% 重量差异限度 士 12% 士 11% 士 10% 士 9% 士 8% 士 7% 士 6% 士 5%more than 1.5g to 3g more than 3g to 6g more than 6g to 9g more than 9g士 8% 士 7% 士 6% 士 5%第二法 以供试品 10 丸为 1 份，取 10 份，分别称定重量,再与每份标示重量相比较（无标 示重量的丸剂，与平均重量比较），按表 2 的规定，超出重量差异限度的不得多于 2 份， 并不得有 1 份超出限度 1 倍。 Method 2 Take 10 pills as one part, weigh separately 10 Parts, compare with the labelled weight of each part (if no labelled weight is stated, compart the weight of each pill with the average weight calculated). According to the requirements stated in Table 2. Not more than 2 parts exceed the weight variation limit and none doubles the limit. 表2 每份标示重量或平均重量 0.05g 及 0.05g 以下 0.05g 以上至 0.1g 0.1g 以上至 0.3g 0.3g 以上至 1g 1g 以上至 2g 2g 以上 Table 2 Labelled or Average weight of each part 0.5g or less more than 0.05g to 0.1g more than 0.1g to 0.3g more than 0.3g to 1g more than 1g to 2g more than 2g Weight variation limit 士 12% 士 11% 士 10% 士 8% 士 7% 士 6% 重量差异限度 士 12% 士 11% 士 10% 士 8% 士 7% 士 6%包糖衣丸剂应检查丸芯的重量差异并符合规定，包糖衣后不再检查重量差异，其他包衣丸 刘应在包农后检查重量差异并符合规定，凡进行装量差异检查的单剂量包装丸剂，不再进 行重量差异检查。 Weight variation of sugar-coated pills should be examined before coating, pills are not to be coated until the weight variation of the pill cores complies with the requirements. Theweight variation of pills is no longer examined after sugar-coating, other coated pills should be examined the weight variation after coating and comply W The weight variation is no longer examined for the single dose packed pills, which have been examined according to the filling variation standards. 【装量差异】 单剂量包装的丸剂，照下述方法检查应符合规定。 Filling variation The Filling variation of pills presented in single dose pack should 的重量，每袋（瓶）装量与 comply with the following requirements. 检查法 取供试品 10 袋（瓶?，分别称定每袋（瓶）内容物 （瓶）超出限度 1 倍。 Procedure Take ten packs (or vials) of pills and weigh seperately the content of each pack (or vial), compare with the labelled weight. According to the requirement stated in Table 3.Not more than 2 packs exceed the weight variation limit and none doubles the limit. 表3 标示装量 0.5g 及 0.5g 以下 0.5g 以上至 1g 1g 以上至 2g 2g 以上至 3g 3g 以上至 6g 6g 以上至 9g 9g 以上 Table3 Labelled weight of each pack 0.5g or less more than 0.5g to 1g more than 1g to 2g more than 2g to 3g more than 3g to 6g more than 6g to 9g more than 9g Weight variation limit 士 12% 士 11% 士 10% 士 8% 士 6% 士 5% 士 4% 装量差异限度 士 12% 士 11% 士 10% 士 8% 士 6% 士 5% 士 4% 标示装量相比较，按表 3 的规定，超出装量差异限度的不得多于 2 袋（瓶）并不得有 1 袋【装量】装量以重量标示的多剂量包装丸剂，照最低装量检查法（附录Ⅻ C）检查，应符 合规定。 Filling The Filling variation of multiple doses packed pills of which filling is labelled in weight should comply with the test for Minimum Fill (Appendix Ⅻ C). 【溶散时限】除另有规定外，取供试品 6 丸，选择适当孔径筛网的吊篮（丸剂直径在 2.5mm 以下的用孔径约 0.42mm 的筛网；在 2.5-3.5mm 之间的用孔径约 1.0mm 的筛网；在 3.5mm 以 上的用孔径约 2.0mm 的筛网），照崩解时限检查法?附录Ⅻ A）片剂项下的方法加挡板进 行检查。除另有规定外，小蜜丸、水蜜丸和水丸应在 I 小时内全部溶散；浓缩丸和糊丸应 在 2 小时内全部溶散。操作过程中如供试品黏附挡板妨碍检查时，应另取供试品 6 丸，以 不加挡板进行检查。 Disintegration test Unless specified other wise, Take 6 pills, select a basket with proper porosity of sieve (for pills with the diameter of less than 2.5mm, 2.5-3.5mm or more than 3.5mm,using sieves with pores of 0.42mm,1.0mm or 2.0mm in diameter respectively). Carry out the test as described under the disintegration test (Appendix Ⅻ A) for tablets, using disk. Unless specified otherwise, Small honeyed pills, water-honeyed pills and watered pills should be completely disintegrated within 1 hour, concentrated pills and pasted pills within 2 hours. During procedure, If pills adhere to the disk, thus hindering the determination, take another 6 pills and carry out the determination as described under the disintegration of tablets without disk, pills should be completely disintegrated within the specified time. 上述检查，应在规定时间内全部通过筛网。如有细小颗粒状物未通过筛网，但己软化且无 硬心者可按符合规定论。 In the determination mentioned above, all the pills should pass through the sieve within the specified time. If there are minute granulated masses which cannot pass the sieve but soften without hard core, should be considered to comply with the requirements. 蜡丸照崩解时限检查法（附录 XⅫ A）片剂项下的肠溶衣片检查法检查，应符合规定。 Waxed pills should comply with the requirements stated in monograph for Determination of Disintegration (Appendix Ⅻ A) for enteric-coated tablets. 大蜜丸不检查溶散时限。 No disintegration test is required for big honeyed pills. 【徽生物限度】 照微生物限度检查法（附录 XIII C）检查，应符合规定 Microbial limit test Comply with the requirements stated under Microbial Limit Test(Appendix XIII C).（散剂）Ⅰ B 剂。Powders散剂系指药材或药材提取物经粉碎、均匀混合制成的粉末状制剂，分为内服散剂和外用散 Powders may be defined as mixtures of pulverized crude drugs or extract of crude drugs which are used for oral administration or external application. 散剂在生产与贮藏期间应符合下列有关规定。 The production and storage of powders should comply with the following requirements. 一、供制散剂的药材、药材提取物均应粉碎。除另有规定外，内服散剂应为细粉；儿科用 及外用散剂应为最细粉。 1.The crude drugs or extract of crude drugs for powders production should be Comminuted. Unless specified otherwise, Powders of fine grade am employed for oral administration, and powders of very fine grade, for pediatrics and external application. 二、散剂应干燥、疏松、混合均匀、色泽一致。制备含有毒性药、贵重药或药物剂量小的 散剂时，应采用配研法混匀并过筛。 2.Powders Should be dry, loose, well mixed and uniform in appearance and colour. When preparing powders containing poisonous, or precious drugs, they should be prepared by a compounding and grinding method of isochoric increase by degrees, mixed well and sieved. 三、多剂量包装的散剂应附分剂量的用具；含有毒性药的内服散剂应单剂量包装。 3.Tools for separating dosage should be enclosed in powders presented in
Powders for oral administration containing poisonous drugs should be packed in single dose. 四、除另有规定外，散剂应密闭贮存，含挥发性药物或易吸潮药物的散剂应密封贮存。 4.Unless specified otherwise, Powders should be stored in well closed containers. Powders containing volatile or moisture-absorbing drugs should be stored in tightly closed containers. 散剂应进行以下相应检查。 Following relevant tests should be carried out for powders. 【粒度】用于烧伤或严重创伤的外用散剂，照下述方法检查应符合规定。 Particle size test. 检查法 照粒度测定法（附录Ⅺ B 第二法，单筛分法）测定，除另有规定外，通过六号筛 Powders used for burn or severe trauma should comply with the following的粉末重量，不得少于 95％。 Procedure Carry out the method for the determination of particle size in general (Appendix Ⅺ B, method 2, single particle size-sieve method),unless specified otherwise, the weight of the powders passing through a sieve No.6 should not be less than that of 95 per cent of the powders examined. 【外观均匀度】 取供试品适量，Z光滑纸上，平铺约 5cm2,将其表面压平，在明亮处观察， 应色泽均匀、无花纹与色斑。 Uniformity in appearance Spread evenly a sufficient quantity of powders in an area of about 5 cm2 on a piece of smooth paper, press the surface to be even, observe the powder under a bright light. It should be uniform in colouration without discolourations and stains. 【水分】 照水分测定法（附录Ⅸ H）测定，除另有规定外，不得过 9.0％。 Determination of water specified otherwise. 【装量差异】 单剂量包装的散剂，照下述方法检查应符合规定。 Filling variation Filling variation limit for powders presented in single dose should comply with the requirements stated in the table below. 检查法 取供试品 10 袋（瓶），分别称定每袋（瓶）内容物的重量，每袋（瓶）装量与标 示装量相比较，按表中的规定，超出装量差异限度的不得多于 2 袋（瓶），并不得有 1 袋 （瓶）超出限度 1 倍。 Procedure Weigh accurately each of ten packs (or vials) of powders and compare the weight of the content of each with the labelled weight. According to the requirements stated in the table, not more than 2 packs should exceed the packing variation limit and none should double the packing variation limit. 标示装量 0.1g 及 0.1g 以下 0.1g 以上至 0.5g 0.5g 以上至 1.5g 1.5g 以上至 6g 6g 以上 装量差异限度 士 15% 士 10% 士 8% 士 7% 士 5% Carry out the method for the determination of water in general (Appendix Ⅸ H). The powders contain not more than 9.0 per cent of water, unlessLabelled weight per pack (or vial) 0.1 g to 0.1 g or less more than 0.1 g to 0.5 g more than 0.5 g to 1.5 g more than 1.5 g to 6 g more than 6 gWeight variation limit 士 15% 士 10% 士 8% 士 7% 士 5%【装量】 多剂量包装的散剂，照最低装量检查法（附录Ⅻ C)检查应符合规定。 Filling Filling variation for powders presented in multiple doses should comply with the test for Minimum Fill (Appendix Ⅻ C). 【无菌】 用于烧伤或严重创伤的外用散剂，照无菌检查法（附录 XIII B)检查，应符合规 定。 Sterility Powders used for burn or severe trauma should comply with the Test for Sterility (Appendix XIII B). 【微生物限度】 除另有规定外，照微生物限度检查法（附录 XIII C)检查，应符合规定。 Microbial limit test Unless otherwise specified, Comply with the requirements stated under Microbial Limit Test (Appendix XIII C).（颗粒剂）Ⅰ CGranules颗粒剂系指药材提取物与适宜的辅料或药材细粉制成具有一定拉度的颗粒状制剂，分为可 溶颗粒、混悬颗粒和泡腾颗粒。 Granules are soluble, suspensible or effervescent preparations in granular form with certain particle size made from drug extracts or finely powdered drug and suitable excipients. 颗粒剂在生产与贮藏期间应符合下列有关规定。 The production and storage of medicinal granules should comply with the following requirements. 一、除另有规定外，药材应按各品种项下规定的方法进行提取、纯化、浓缩成规定相对密 度的清膏、采用适宜的方法干燥，并制成细粉，加适量辅料或药材细粉，混匀并制成颗粒； 也可将清膏加适量辅料或药材细粉，混匀并制成颗粒。应控制辅料用量，一般前者不超过 干膏量的 2 倍,后者不超过清膏量的 5 倍。 1. Unless specified otherwise, the crude drugs should be processed by extraction, purification and concentration to form a thin extract with a required relative density as described under individual monograph, dried by the appropriate methods, and pulverized to fine powder particles, added with a quantity of excipients or finely powdered crude drugs, well mixed and granulate. Also, a quantity of excipients or finely powdered crude drugs may be added into the thin extracts, well mixed and granulated. The amount of excipients added should be controlled, which is not more than 2 times of that of the dried extracts, or not more than 5 times of that of the thin extracts in general. 二、除另有规定外，挥发油应均匀喷人干燥颗粒中，密闭至规定时间或用β环糊精包合后 加人。 2. The volatile oil should be sprayed evenly upon dried granules, stored in well closed containers for the required time, or be added after being wrapped in β -cyclodextrin, unless specified otherwise. 三、制备颗粒剂时可加入矫味剂和劳香剂；为防潮、掩盖药物的不良气味也可包薄膜衣。 必要时，包衣颗粒剂应检查残留溶剂。 3. Correctives and flavoring agents may be added in pre Granules may also be film-coated to prevent moisture absorption, or cover up unpleasant odour. If necessary, solvent residues should be examined for film-coated granules. 四、颗粒剂应干燥、颗粒均匀、色泽一致，无吸潮、结块、潮解等现象。4. Medicinal granules should be dry, uniform in appearance and colour, without moisture absorption, agglomeration, deliquescence and so on. 五、除另有规定外，颗粒剂应密封，在干燥处贮存，防止受潮。 5. Medicinal granules should be stored in tightly closed containers, and in a dry place to prevent moisture absorption, unless specified otherwise. 颗粒剂应进行以下相应检查。 Following relevant tests should be carried out for granules. 【粒度】 除另有规定外，照粒度测定法（附录Ⅺ B 第二法，双筛分法）测定，不能通过 一号筛与能通过五号筛的总和，不得过 15%。 Particle size Unless specified otherwise. Carry out the method for the Determination of Particle Size (Appendix Ⅺ B method 2, double particle size-sieve method), The total which cannot pass through sieve No.1 and pass through sieve No.5 are not more than 15 per cent of granules examined. 【水分】照水分测定法（附录Ⅸ H)测定，除另有规定外，不得过 6.0%. Determination of water Carry out the method for the determination of water (Appendix Ⅸ H). The medicinal granules contain not more than 6.0 per cent of water, unless specified otherwise. 【溶化性】取供试品 1 袋（多剂里包装取 10g），加热水 200m1,搅拌 5 分钟，立即观察， 应全部溶化或呈混悬状。可溶颗粒应全部溶化。允许有轻微浑浊，混悬颗粒应能混悬均匀。 Determination of dispersibility To 1 pack (10 g for granules in multiple doses pack) of medicinal granules, add 200 ml of hot water, stir for 5 minutes, observe immediately, granules should be completely dissolved or in suspension. Solube granules should be dissolved completely and slight
suspensible granules should be suspended uniformly. 泡腾颗粒 取供试品 1 袋，Z盛有 200ml 水的烧杯中，水温为 15-25℃，应能迅速产生气 体而呈泡腾状，5 分钟内颗粒应完全分散或溶解在水中。 Effervescent granules To 1 pack of effervescent granules, put in the beaker filled with 200 ml of water at the temperature between 15℃ and 25℃. Granules should produce bubbles and be in effervescent state immediately, and be dispersed or dissolved in water completely in 5 minutes. 颗粒剂按上述方法检查，均不得有焦屑等。 Examined by the methods above, granules should show no burned charrings etc.【装量差异】 单剂量包装的颗粒剂，照下述方法检查应符合规定。 Filling variation The Filling variation limit of single dose package of medicinal granules should comply with the following requirements. 检查法 取供试品 10 袋，分别称定每袋内容物的重量，每袋装量与标示装量相比较，按表 中的规定，超出装量差异限度的不得多于 2 袋，并不得有 1 袋超出限度 1 倍。 Procedure Take 10 packs of medicinal granules, and weigh individual content of each pack .Compare the calculated weight of each pack with the labelled amount, according to the requirements stated in the table. Not more than 2 packs in filling variation exceed the filling variation limit and none doubles the limit. 标示装量 1g 及 1g 以下 1g 以上至 1.5g 1.5g 以上至 6g 6g 以上 装量差异限度 士 10% 士 8% 士 7% 士 5%Labelled weight per pack 1.0 g or less more than 1 g to 1.5g more than 1.5 g to 6 g more than 6 g FillingFilling variation limit 士 10% 士 8% 士 7% 士 5%【装量】 多剂量包装的颗粒剂，照最低装量检查法（附录Ⅻ C)检查，应符合规定。 Granules presented in multiple doses should comply with the test for Minimum Fill(Appendix Ⅻ C). 【微生物限度】 照微生物限度检查法（附录 XIII C)检查，应符合规定。 Microbial limit test Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).（片剂）Ⅰ DTablets片剂系指药材提取物、药材提取物加药材细粉或药材细粉与适宜辅料混匀压制或用其他适 宜方法制成的国片状或异形片状的制剂有浸膏片、半浸膏片和全粉片。 Tablets are solid preparations of laminal or various shapes compressed to extracts of crude drugs, extracts of crude drugs with finely powdered crude drugs, or finely powdered crude drugs with suitable excipients, including extract tablets, semi-extract tablets and powdered crude drug tablets. 片剂以口服普通片为主，另有含片、咀嚼片、泡腾片、阴道片、阴道泡腾片和肠溶片等。 Tablets are mainly ordinary tablets for oral administration, there are other tablets such as buccal tablets, chewable tablets, effervescent tablets vaginal tablets, vaginal effervescent tablets, enteric coated-tablets and so on. 含片 系指含于口腔中，药物缓慢溶出产生作用的片剂。 Buccal tablets are tablets staying in oral cavity, of which medicaments dissolve slowly and take effects. 咀嚼片 系指于口腔中咀嚼或吮服使片溶化后吞服的片剂。 Chewable tablets are tablets swallowing down after being chewed or sucked to dissolve in oral cavity. 泡腾片 系指含有碳酸氢钠和有机酸，遇水可产生气体而呈泡腾状的片剂。 Effervescent tablets are tablets containing sodium bicarbonate and organic acid, which can produce bubbles and be in effervescent state once meet with water. 阴道片与阴道泡腾片 系指Z于阴道内使用的片剂。 Vaginal tablets and vaginal effervescent tablets are tablets for vaginal cavity use. 肠溶片 系指用肠溶性包衣材料进行包衣的片剂。 Enteric-coated tablets are tablets coated with enteric coating Materials. 片剂在生产与贮藏期间应符合下列有关规定。 The production and storage of tablets should comply with the following requirements. 一、用于制片的药粉（膏）与辅料应混合均匀。含药量小的或含有毒性药的片剂，应根据 药物的性质用适宜的方法使药物分散均匀。 1.The medicinal powders (extracts) for tableting should be mixed with the excipients thoroughly. Tablets containing medicaments toxic in nature or those administered in small dosage should be dispersed uniformly in a way appropriate for the substance concerned.二、凡属挥发性或遇热不稳定的药物在制片过程中应避免受热损失。 2.Tablets containing volatile or thermolabile substances are processed in a way to avoid loss on heating. 三、压片前的颗粒应控制水分，以适应制片工艺的需要，并防止成品在贮存期间发霉、变 质。 3.The moisture content of the granules should be controlled under the processing requirement before tableting, thus to prevent mould contamination, deterioration during storage. 四、片剂根据需要，可加人矫味剂、芳香剂和着色剂等附加剂。 4.If necessary, additives such as correctauts, flavoring agents, colouring agents etc. May be added in the preparation of tablets. 五、为增加稳定性、掩藏药物不良奥味或改善片剂外观等，可对制成的药片包糖衣或薄膜 衣。对一些遇胃液易破坏、刺激胃黏膜或需要在肠道内释放的口服药片，可包肠溶衣。必 要时，薄膜包衣片剂应检查残留溶剂。 5.In order to increase the stability, cover up the unpleasant odour and taste or improve the appearance etc., tablets may be coated with sugar or film. Tablets for oral administration are enteric coated so as to avoid the gastric fluid's destroy, the irritation to the gastric mucosa, thus to obtain a late release in the intestine. If necessary, solvent residues should be examined for film-coated tablets. 六、片剂外观应完整光洁、色泽均匀，有适宜的硬度，以免在包装、贮运过程中发生磨损 或破碎。 6.Tablets should have a clean, smooth and unifor they are sufficiently hard to withstand handling without abrasion or cracking. 七、除另有规定外，片剂应密封贮存。 7.Unless otherwise specified, tablets should be preserved in tightly closed containers. 片剂应进行以下相应检查 Following relevant tests should be carried out for tablets. 【重量差异】 片剂照下述方法检查，应符合规定。 Weight variation Tablets should comply with the following Requirements. 检查法 取供试品 20 片， 精密称定总重量， 求得平均片重后， 再分别精密称定每片的重量， 每片重量与标示片重相比较（无标示片重的片剂，与平均片重比较），按表中的规定，超 出重量差异限度的不得多于 2 片，并不得有 1 片超出限度 1 倍。Procedure Weigh accurately 20 tablets and calculate the average weight, then weigh individually each of the 20 tablets. Compare the weight of each tablet with the labeled tablet weight (if no labelled weight is stated, compare the weight of each tablet with the average weight calculated).According to the requirements stated in the table, not more than 2 of the individual weights exceed the weight variation limit and none doubles the limit. 标示片重或平均片重 0.3g 以下 0.3g 及 0.3g 以上 重量差异限度 士 7.5% 5%labelled or Average weight Less than 0.3g 0.3g or moreWeight variation limit 士 7.5% 5%糖衣片的片芯应检查重量差异并符合烧定，包糖衣后不再检查重量差异。除另有规定外， 其他包衣片应在包衣后检查重量差异并符合规定。 Sugar coated tablets should be tested before sugar coating to show that the tablet cores comply with the requirements. Tablets need not be tested again after sugar coating, unless specified otherwise, other coated tablets should be tested after coating and comply with the requirements. 【崩解时限】 除另有规定外，照崩解时限检查法（附录Ⅻ A）检查，应符合规定。 Disintegration requirements. 阴道片照融变时限检查法（附录Ⅻ B）检查，应符合规定。 Vaginal tablets should comply with the requiremeats under Disintegration Test for Suppositories and Vaginal Tablets (Appendix Ⅻ B). 含片、咀嚼片不检查崩解时限。 No disintegration test is required for buccal tablets and chewable tablets. 【发泡量】 阴道泡腾片照下述方法检查，应符合规定。 Foaming capacity Vaginal effervescent tablets should Comply with the following test. 检查法 除另有规定外，取 25m1 具塞刻度试管（内径 1.5cm)10 支，各精密加水 2ml，Z 37℃士 1℃水浴中 5 分钟后，各管中分别投人供试品 1 片，密塞，20 分钟内观察最大发泡 Unless specified otherwise, Carry out the test as described under the disintegration test (Appendix Ⅻ A).All the tablets should comply with the specified量的体积，平均发泡体积应不少于 6ml,且少于 4ml 的不得超过 2 片. Assay Unless specified otherwise, take 10 25ml-graduated test tubes with piston, add accurately 2 ml of water individually, put in the water bath with the temperature of 37℃士 1℃ for 5 minutes. Put a piece of tablet in each tube, seal up with the piston. Observe the volume of the largest amount of foam. Average volume should not be less than 6 ml, the tablets less than 4 should not be more than 2. 【微生物限度】 照微生物限度检查法（附录 XIII C)检查，应符合规定。 Microbial limit test (Appendix XIII C). Comply with the requirements stated under Microbial Limit Tests（锭剂）ⅠETroches Comply with the requirements stated under Microbial Limit Tests锭剂系指药材细粉与适宜黏合剂（或利用药材本身的黏性）制成不同形状的固体制剂。 Microbial limit test (Appendix XIII C).Troches are solid preparations of various shapes made from fine powders of crude drugs and suitable binders (or using the binding property of crude drugs themselves). 锭剂在生产与贮藏期间应符合下列有关规定。 The production and storage of troches should comply with the following requirements. 一、作为锭剂黏合剂使用的蜂蜜、糯米粉等应按规定方法进行处理。 1.The honey, powder of glutinous rice etc. used for troches should be treated by the specified methods. 二、制备时，应用各品种制法项下规定的黏合剂或利用药材本身的黏性合坨，以模制法或 捏搓法成型，整修，阴干。也可用泛制法制备锭剂。 2.Troches should be prepared with binders or the binding property of crude drugs themselves as described under individual monograph and formed by a moulding or a kneading method, then renovated and dried in the shade. Torches may also be prepared by water spray rotating Method. 三、需包衣或打光的锭剂，应用制法项下规定的包衣材料进行包衣或打光。 3.Troches may be coated or polished, if necessary, using the coating materials stated under the individual monograph of the preparation. 四、锭剂应平整光滑、色泽一致，无皱缩、飞边、裂隙、变形及空心。 4.Troches should be neat, smooth, uniform in colour with no wrinkle, breach, gap, cavity and change in form. 五、除另有规定外，锭剂应密闭，Z阴凉干燥处贮存。 5.Troches should be preserved in well closed containers and stored in a cool and dry place unless specified otherwise. 锭剂应进行以下相应检查。 Following relevant tests should be carried out for troches. 【重量差异】 除另有规定外，照丸剂重量差异项下方法检查，应符合规定。 Weight variation Unless specified otherwise, weight variation for troches complies with the test for Weight variation stated under Pills. 【微生物限度】 照微生物限度检查法（附录 XIII C）检查，应符合规定。Microbial limit test Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).（煎膏剂）Ⅰ FConcentrated Decoctions煎膏剂系指药材用水煎煮，取煎煮液浓缩，加炼蜜或糖（或转化糖）制成的半流体制剂。 Concentrated decoctions are semifluid preparations prepared by decoding the crude drugs in water, concentrating the decoction and adding honey or sugar.(or invertsugar) 煎膏剂在生产与贮藏期间应符合下列有关规定。 The production and storage of concentrated decoctions should comply with the following requirements. 一、药材按各品种项下规定的方法煎煮，滤过，滤液浓缩至规定的相对密度，即得清膏。 l.The crude drugs should be decocted according to the appropriate methods for individual species and filtered. The thin extract is obtained by concentrating the filtrate to a specified relative density. 二、如需加入药粉，除另有规定外，一般应加入细粉。 2.Unless specified otherwise, the fine powder of crude drugs should be added when the powder is needed as required. 三、渭膏按规定量加入炼蜜或糖（或转化糖）收膏；若需加药材细粉，待冷却后加入，搅 拌混匀。除另有规定外，加炼蜜或糖（或转化糖）的量，一般不超过清膏量的 3 倍。 3.The thin extract is concentrated by adding specified quantity of processed honey or sugar (or invert sugar). The fine powder of crude drugs should be added into a cold concentrated decoction, stirred and mixed well. The quantity of honey or sugar (or invert sugar )added is generally not more than 3 times of that of the thin extract, unless specified otherwise. 四、煎膏剂应无焦臭、异味，无糖的结晶析出。 4.Concentrated decoctions should have no burnt or other abnormal odour, and produce no sugar crystal out. 五、除另有规定外，煎膏剂应密封，Z阴凉处贮存。 5.Concentrated decoctions should be preserved in tightly closed containers, stored in a cool place, unless specified otherwise. 煎膏剂应进行以下相应检查。 Following relevent tests should be carried out for concentrated decoctions. 【相对密度】 除另有规定外，取供试品适量，精密称定，加水约 2 倍，精密称定，混匀， 作为供试品溶液。照相对密度测定法（附录Ⅶ A)测定，按下式计算，应符合各品种项下的 有关规定。Relative density Unless specified otherwise, Weigh accurately a sufficient quantity of concentrated decoction being examined, dilute with double quantities of water, weigh accurately and mix well. Carry out the determination of relative density (Appendix Ⅶ A),calculate by the following formula. Should comply with the requirements under individual monograph. 供试品相对密度=W1 ? W1 ? f W2 ? W1 ? fRelative density of-W1-W1×f concentrated decoction-W2-W1×f 式中W1 为比重瓶内供试品溶液的重量，g；Where W 1 is the weight (g) of concentrated decW2 为比重瓶内水的重量，g；W2 is the weight (g) of water in pycnometer. weight of water added inf ? 加入供试品中的水重量 供试品重量? 加入供试品中的水重量f ?weight of water added in concentrat decoction ed weight of concentrat decoction? weight of water added in concentrat decoction ed ed凡加药材细粉的煎膏剂，不检查相对密度。 It is not necessary to examine the relative density when the concentrated decoctions contain fine powder of crude drugs. 【不溶物】 取供试品 5g,加热水 200ml，搅拌使溶化，放Z 3 分钟后观察，不得有焦屑等 异物（微量细小纤维、颗粒不在此限） 。 Insoluble materials To 5g of the concentrated decoction add 200 ml of hot water, stir to dissolve, allow to stand for 3 minutes, and observe. No foreign matters such as scorched masses, etc. should be observed (a small amount of fine fibres and particles are not defined in this limit). 加药材细粉的煎膏剂，应在未加人药粉前检查，符合规定后方可加人药粉。加人药粉后不 再检查不溶物。 The concentrated decoction containing fine powder of crude drugs should be examined before the powder is added. The powder is added if it complies with the requirements. Itis not necessary to examine the insoluble materials after the powder is added. 【装量】 照最低装量检查法（附录Ⅻ C)检查，应符合规定。 Filling Carry out the test for Minimum Fill (Appendix Ⅻ C),it should comply with the specified requirement. 【微生物限度】 照微生物限度检查法（附录 XIII C)检查，应符合规定。 Microbial limit test Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).（胶剂）Ⅰ G 服制剂。Glues胶剂系指动物皮、骨、甲或角用水煎取胶质，浓缩成稠胶状，经干燥后制成的固体块状内 Glues are solid lump preparations intended for internal administration, prepared by decocting animal skin, bone, shell or born with water, concentrating into thick gelatinous mass and then drying. 胶剂在生产与贮藏期间应符合下列有关规定。 The production and storage of glues should comply with the following requirements. 一、胶剂所用原料应用水漂洗或浸漂，除去非药用部分，切成小块或锯成小段，再漂净。 1.Soak and rinse the raw materials for the preparation of glues in water, remove foreign matters or non medicinal parts, cut into small lumps or saw into small pieces, then wash clean. 二、加水煎煮数次至煎煮液清淡为度，合并煎煮液，静Z，滤过，浓缩。浓缩后的胶液在 常温下应能凝固。 2.Decoct with water for several times until the decoction becomes light, combine the decoctions, allow to stand, filter and concentrate the filtrate. The concentrated gelatinous liquid should be able to coagulate under normal temperature. 三、胶凝前，可按各品种制法项下规定加入适量辅料（黄酒、冰糖、食用植物油等） 。 3.Before the glues begin to coagulate, add a suitable amount of excipients (yellow rice wine, crystal sugar, edible vegetable oil, etc.), according to the requirements for processing specified in individual monograph. 四、胶凝后，按规定重量切成块状，阴干。 4.After the glues coagulate, cut into lumps by weight as required and dry in the shade. 五、胶剂应为色泽均匀、无异常臭味的半透明固体。 5.Glues should be translucent, uniform in appearance and colour, without abnormal odour. 六、一般应检查总灰分、重金属、砷盐等。 6.In general, total ash, heavy metals, arsenic salts etc. should be determined 七、胶剂应密闭贮存、防止受潮。 7.Glues should be preserved in well closed containers and protected from moisture. 胶剂应进行以下相应检查。 Following relevant tests should be carried out for glues.【水分】 取供试品 lg，Z扁形称量瓶中，精密称定，加水 2ml,Z水浴上加热使溶解后再 干燥,使厚度不超过 2mm,照水分测定法（附录Ⅸ H 第一法）测定，不得过 15.0％。 Determination of water Put 1g of gules into the flat weighing bottle, weigh accurately, add 2ml of water, then heat it in the water bath to dissolve it, and then dry it. Make sure the thickness is not more than 2 mm. carry out the method for the determination of water (Appendix Ⅸ H, method 1),the glues contain not more than 15.0 per cent of water. 【微生物限度】 照微生物限度检查法（附录 XIII C)检查，应符合规定。 Microbial limit test Comply with the requirements stated under Microbial Limit Test (Appendix XIII C).（糖浆剂）Ⅰ HSyrups糖浆剂系指含有药材提取物的浓蔗糖水溶液。 Syrups are concentrated aqueous solutions of sucrose containing ext 糖浆剂在生产与贮藏期间应符合下列有关规定。 The production and storage of syrups should comply with the following requirements. 一、含蔗糖量应不低于 45％（g/ml） 。 1.Syrups should contain not less than 45per cent (g/ml)of sucrose 二、药材应按各品种项下规定的方法提取、纯化、浓缩至一定体积，或将药物用新煮沸过 的水溶解。加入单糖浆；如直接加入蔗糖配制，则需煮沸，必要时滤过，并自滤器上添加 适量新煮沸过的水至处方规定量。 2.The crude drugs should be extracted, purified and concentrated to a certain volume using the appropriate methods specified under the individual monograph, or drugs are dissolved with freshly boiled water, and then added with simple syrup.If syrups are prepared with solid sucrose, water is added and boiled and filtered, a suitable amount of freshly boiled water may be added to the filtrate to comply with the labelled amount of drugs described in individual monograph, then mixed well. 三、可加入适宜的附加剂。如需加入防腐剂，山梨酸和苯甲酸的用量不得超过 0.3％(其钾 盐、钠盐的用量分别按酸计） ，对羟基苯甲酸酯类的用最不得超过 0.05％，如需加入其他 附加剂，其品种与用量应符合国家标准的有关规定，不影响成品的稳定性，并应避免对检 验产生干扰。必要时可加入适量的乙醇、甘油或其他多元醇。 3.Suitable additives may be added to syrups. If preservatives are needed, the amount of sorbic acid and benzoic acid should not be more than 0.3% (its potassium or sodium salt should be taken by the acid amount),or the amount of p-hydroxybenzoic acid esters, not more than 0.05%. If other additives are added, the varieties and amount used should comply with the requirements involved in national standards and do not interfere with stability and testing of the preparation concerned. Suitable amount of ethanol, glycerin or other poly-alcohols may be added if necessary. 四、除另有规定外，糖浆剂应澄清。在贮存期间不得有发霉、酸败、产生气体或其他变质 现象，允许有少量摇之易散的沉淀。 4.Syrups should be clean, unless specified otherwise. No mold contamination, rancid,gas or other deteriorations are allowed during storage. A small amount of dispersible precipitates are allowed. 五、一般应检查相对密度、pH 值等。 5.In general, relative density, pH value etc. should be determined. 六、除另有规定外，糖浆剂应密封，Z阴凉处贮存。 6.Syrups should be preserved in tightly closed containers. Stored in a cool place, unless specified otherwise. 糖浆剂应进行以下相应检查。 Following relevant tests should be carried out for syrups. 【装量】 单剂量灌装的糖浆剂，照下述方法检查应符合规定。 Filling Syrups packed in a single doe should comply with the following test. 检查法 取供试品 5 支，将内容物分别倒人经校正的干燥量筒内，尽量倾净。在室温下检 视，每支装量与标示装量相比较，少于标示装量的应不得多于 1 支，并不得少于标示装量 的 95%。 Procedure Take 5 bottles of syrup, pour the content separately to the calibrated dry graduated cylinders, remove as completely as possible examine at room temperature. Compare the filling volume of each pack with the labeled amount. Not more than 1 bottle in volume is less than the labelled amount, none is less than 95 per cent of the labeled amount. 多剂量灌装的糖浆剂，照最低装量检查法（附录Ⅻ C)检查，应符合规定。 Syrups packed in multiple doses comply with the requirements stated in Minimum Fill(Appendix Ⅻ C) 【微生物限度】 照微生物限度检查法（附录 XIII C）检查，应符合规定。 Microbial limit test Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).（贴膏剂）Ⅰ ICataplasms贴膏剂系指药材提取物、药材或和化学药物与适宜的基质和基材制成的供皮肤贴敷，可产 生局部或全身性作用的一类片状外用制剂。包括橡胶膏剂、巴布膏剂和贴剂等。 Cataplasms are sheet preparations made of extract of crude drugs, crude drugs or (and) chemical medicaments and appropriate bases, intended for application to skin, may produce local or general effects, including adhesive plasters, babu plasters and sticking plasters etc.. 橡胶膏剂系指药材提取物或和化学药物与橡胶等基质混匀后，涂布于背衬材料上制成的贴 膏剂。橡胶膏剂的制备方法常用的有溶剂法和热压法。常用溶剂为汽油、正已烷，常用基 质有橡胶、热可塑性橡胶、松香、松香衍生物、凡土林、羊毛脂和氧化锌等。也可用其他 适宜溶剂和基质。 Adhesive plasters are cataplasms prepared by mixing the extract of crude drugs or (and) chemical medicaments with bases to the backing materials. The preparation methods of this agent consist of solvents method and hot-pressing method. The commonly used solvents consist of gasoline, n-hexane, and commonly used bases consist of rubber, hot-plastic rubber, rosin, rosin derivatives, vaselin, lanoline and zine oxide etc.. Other appropriate solvents and bases are applicable. Consist of ethylene/vinyl acetate copolymer, silicone rubber and polyethylene glycol etc. 巴布膏剂系指药材提取物、药材或和化学药物与适宜的亲水性基质混匀后，涂布于背衬材 料上制成的贴膏剂。常用基质有聚丙烯酸钠、羧甲基纤维素钠、明胶、甘油和微粉硅胶等。 Babu plasters are cataplasms prepared by well mixing the extract of crude drugs, crude drugs or (and) chemical medicaments with appropriate hydrophilic bases, then spreading to the backing materials. The commonly used bases consist of sodium carboxymethylcellcdose, gelatin, glyce-rine, microniting silica gel and so on. 贴剂系指药材提取物或和化学药物与适宜的高分子材科制成的一种薄片状贴膏剂。主要由 背衬层、药物贮库层、粘胶层以及防粘层组成。常用基质有乙烯-醋酸乙烯共聚物、硅橡胶 和聚乙二醇等。 Sticking plasters are lamellifom cataplasms made of extract of crude drags or (and ) chemical medicaments, and appropriate macromolecular materials mainly composed of backing liner, drug-veserving liner, sticking liner and anti-sticking liner. The commonly used bases consist of ethylene/vinyl acetate copolymer, silicone rubber, and polyethylene glycol etc..贴膏剂常用的背衬材料有棉布、无纺布、纸等；常用的盖衬材料有防粘纸、塑科薄膜、铝 箔-聚乙烯复合膜、硬质纱布等。 The commonly used backing materials for cataplasms consist of calico, non-weaving cloth, commonly used covering materials consist of anti-sticking paper, plastic film, aluminum foil, polyethylene compound film, hard gauze and so on. 贴膏剂在生产与贮藏期间应符合下列有关规定。 Production and storage of cataplasms should comply with the following requirements. 一、药材提取物应按各品种项下规定的方法进行提取。除另有规定外，固体药物应预先粉 碎成细粉或溶于适宜的溶剂中。 1.The extracts of crude drugs are produced using the methods stated under individual monographs. Unless specified otherwise, solid medicament should be finely powdered previously or dissolved in a suitable solvent. 二、贴膏剂必要时可加入透皮促进剂、表面活性剂、保湿剂、防腐剂或抗氧剂等。 2.Transderme promoting agents, surfactants, stabiliyers, hygroscopic agents, preservatives, antioxidants may be added in cataplasms, if necessary. 三、贴膏剂的膏料应涂布均匀，膏面应光洁，色泽一致，无脱膏、失黏现象；背衬面应平 整、洁净、无漏膏现象。涂布中若使用有机溶剂的，必要时应检查残留溶剂。 3.The plasters of cataplasms should be spreaded uniformly, the surface should be smooth and clean, uniform in colour, not u Backing liner should be smooth and clean, no plaster leaked. When organic solvents are used in spreading, solvent residues should be examined if necessary. 四、贴膏剂每片的长度和宽度，按中线部位测量，均不得小于标示尺寸。 4.The length and width of each piece of a cataplasm, measured by the mid-line, are not less than those labeled. 五、除另有规定外，贴膏剂应密封贮存。 5.Unless specified otherwise, Cataplasms should be preserved in tightly closed containers. 贴膏剂应进行以下相应检查。 Following relevant tests should be carried out for cataplasms. 【含膏量】 橡胶膏剂照第一法检查，巴布膏剂照第二法检查。 Extractives in plaster mass Adhesive plasters are tested by Method 1, babu plasters by method 2.第一法 取供试品 2 片（每片面积大于 35cm 的应切取 35cm ),除去盖衬，精密称定，Z于 有盖玻璃容器中加适量有机溶剂（如三氯甲烷、乙醚等）浸渍，并时时振摇，待背衬与膏 料分离后，将背衬取出，用上述溶剂洗涤至背衬无残附膏料，挥去溶剂，在 105℃干燥 30 分钟，移Z干燥器中，冷却 30 分钟。精密称定，减失重量即为膏重，按标示面积换算成 100cm2 的含膏量，应符合各品种项下的有关规定。 Method 1 Take 2 pieces of cataplasm (take 35cm2 for the cataplasms larger than 35cm2 in area),remove the covering liner, weigh accurately and put into a terrarium with cover macerate in suitable quantity of organic solvent (chloroform, aether etc.) and shake over and again until cataplasm separates from the cloth. Take out the cloth and wash with above solvents until no cataplasm remains on it. Remove the solvent and dry the cloth at the temperature of 105℃ for 30 minutes, transfer the cloth to the desiccator. After cooling for 30 minutes, weigh accurately, the cloth. The difference between the weightings is the weight of cataplasm. Calculate the weight per 100 cm2 of the cataplasm by the labelled area. The result should comply with the requirement specified in individual monograph. 第二法 取供试品 1 片，除去盖衬，精密称定，Z烧杯中加适量水，加热煮沸至背衬与膏 体分离后，将背衬取出，用水洗涤至背衬无残留膏体，晾干，在 105℃干燥 30 分钟，移Z 干燥器中，冷却 30 分钟，精密称定，减失重量即为膏重，按标示面积换算成 100cm2 的含 膏量，应符合各品转项下的有关规定。 Method 2 Take one piece of cataplasm, remove the covering liner, weigh accurately and put into a beaker, add suitable quantity of water and heat to boil until cataplasm separates from the liner cloth. Take out the cloth, Wash the cloth with water until no cataplasm remains on cloth. Allow to stand to dry, then put the cloth into an oven with a temperature of 105℃ for 30 minutes, transfer the cloth to a desiccator. After cooling for 30 minutes, weigh accurately the cloth. The difference between the weightings is the weight of cataplasm. Calculate the weight per 100 cm2 of the cataplasm by the labelled area. The result should comply with the requirement specified in individual monograph. 【耐热性】 橡胶膏剂应做耐热性试验。 Heat-resistance Adhesive plasters should be tested for heat-resistance. 试脸方法 除另有规定外，取供试品 2 片，除去盖衬，在 60℃加热 2 小时，放冷后，膏背 面应无渗油现象；膏面应有光泽，用手指触试应仍有黏性。 Procedure Unless specified otherwise, take 2 pieces of cataplasm, remove the covering22liner, heat at the temperature of 60℃ for 2 hours, after cooling, the back of cataplasm should be. the surface of the cataplasm Should have patina and still be viscous when touch with finger. 【赋形性】 巴布膏剂应做赋形性试验。 Excipient property Excipient property should be tested for babu plasters. 试验方法 取供试品 1 片，Z 37℃、相对湿度 64％的恒温恒湿箱中 30 分钟、取出，用夹 子将供试品固定在一平整钢板上，钢板与水平面的倾斜角为 600,放Z 24 小时，膏面应无 流淌现象。 Assay Place one piece of cataplasm into the constant T & H chamber with a temperature of 37℃and a relative humidity of 64% for 30 minutes, then take out the piece and fix it to a smooth steel plane using a clip, the steel plane is placed at an angle of 600with the horizontal plane, allow to stand for 24 hours. No moving of the adhesive side occurs. 【黏附性】 除另有规定外，巴布膏剂照贴膏剂黏附力测定法（附录Ⅻ E 第一法） 、橡胶 膏剂照贴膏剂黏附力测定法（附录Ⅻ E 第二法） 、贴剂照贴膏剂黏附力侧定法（附录Ⅻ E 第二、三法）测定，均应符合各品种项下的有关规定。 Adhesive property Unless specified otherwise, babu plasters should comply with the requirements stated under Determination of Cataplasms Adhesion (Appendix Ⅻ E, method 1),adhesive plasters should comply with the requirements stated under Determination of Cataplasms Adhesion (Appendix Ⅻ E, method 2),sticking plasters should comply with the requirements stated under Determination of Cataplasms Adhesion (Appendix Ⅻ E,method2,3). 【重量差异】 贴剂应做重量差异检查，并应符合规定。 Weight variation the requirements. 检查法 除另有规定外，取供试品 20 片，精密称定总重量，求出平均重量，再分别称定每 片的重量，每片重量与平均重量相比较、重量差异限度应在平均重量的5％以内，超出重 量差异限度的不得多于 2 片，并不得有 1 片超出限度 1 倍。 Assay Unless specified otherwise, weigh accurately 20 pieces of cataplasm, and calculate the average weight, then weigh separately each piece of the cataplasm, compare with the average weight. Not more than 2 of the indvidual weights exceed土5% of the average weight and none doubles the limit. Cataplasm should be examined the weight variation and Comply with【微生物限度】 规定。除另有规定外，贴剂照微生物限度检查法（附录 XIII C）检查，应符合 Unless specified otherwise, comply with the requirements statedMicrobial limit testunder Microbial Limit Test (Appendix XIII C).（合剂）Ⅰ JMixtures合剂系指药材用水或其他溶剂，采用适宜方法提取制成的口服液体制剂（单剂量灌装者也 可称“口服液”。 ） Mixtures are liquid preparations intended for oral administration, prepared by extracting the crude drugs with water or other solvents in suitable ways (package of a single dose is also known as &oral liquids&). 合剂在生产与贮藏期间应符合下列有关规定。 The production and storage of mixtures should comply with the following requirements. 一、药材应按各品种项下规定的方法提取、纯化、浓缩至一定体积。除另有规定外，含有 挥发性成分的药材宜先提取挥发性成分，再与余药共同煎煮。 1.The drugs should be extracted, purified and concentrated to a certain volume by the methods as described under individual monograph. Unless specified otherwise The volatile ingredients in crude drugs should be extracted at first, then the remaining crude drugs decocted with the other drugs together. 二、可加人适宜的附加剂。如需加人防腐剂，山梨酸和苯甲酸的用量不得超过 0.3％（其 钾盐、钠盐的用量分别按酸计） ，对羟基苯甲酸酯类的用量不得超过 0.05％，如需加入其 他附加剂，其品种与用量应符合国家标准的有关规定，不影响成品的稳定性，并应避免对 检验产生干扰。必要时可加入适量的乙醇. 2.Suitable additives may by added to mixtures. If preservatives are needed, the amount of sorbic acid and benzoic acid should not be more than 0.3%(its potassium or sodium salt should be taken by the acid amount),or the amount of p-hydroxybenzoic acid esters, not more than 0.05 per cent If another additives are added, The variety and quantity to be used should comply with the requirements of the national standard, and not affect the stability and interfere with the tests for mixtures. If necessary, mixtures could also contain a proper quantity of alcohol 三、合剂若加蔗糖作为附加剂,除另有规定外,含蔗糖量应不高于 20%（g/ml） 。 3.If sucrose is used as an additive in mixtures, unless specified otherwise the content of it is not more than 20 percent (g/g). 四、除另有规定外，合剂应澄清。在贮存期间不得有发霉、酸败、异物、变色、产生气体 或其他变质现象，允许有少量摇之易散的沉淀。 4.Unless specified otherwise, mixtures should be clear, show no evidence of mold contamination, rancidity, foreign matters, colour changing, gas or other deteriorationduring storage, but a small amount of dispelsible precipitates are allowed. 五、一般应检查相对密度、pH 值等。 5.In general, relative density and pH value etc. should be determined. 六、除另有规定外，合剂应密封，Z阴凉处贮存。 6.Mixtures should be preserved in tightly closed containers and stored in a cool place, unless specified otherwise. 合剂应进行以下相应检查。 Following relevant test should be carried out for mixtures. 【装量】 单剂量灌装的合剂，照下述方法检查应符合规定。 Filling variation test. 检查法 取供试品 5 支，将内容物分别倒入经校正的干燥量简内，在室温下检视，每支装 量与标示装量相比较，少于标示装量的不得多于 1 支，并不得少于标示装量的 95%。 Assay Take 5 bottles of a mixture, pour the content separately to the calibrated dry graduated cylinders, examine at room temperature. Compare the filling volume of each pack with the labelled amount, not more than 1 bottle is less than the labelled amount, none is less than 95 per cent of the labelled amount. 多剂量灌装的合剂，照最低装量检查法（附录Ⅻ C)检查，应符合规定。 Mixtures filled in multiple dose should comply with the requirements stated in Minimum Fill(Appendix Ⅻ C). 【微生物限度】 (Appendix XIII C). 照微生物限度检查法（附录 XIII C）检查，应符合规定。 Microbial limit test Comply with the requirements stated under Microbial Limit Tests For mixtures packed in a single dose should comply with the following（滴丸剂）Ⅰ KDripping Pills滴丸剂系指药材经适宜的方法提取、纯化、浓缩并与适宜的基质加热熔融混匀后，滴入不 相混溶的冷凝液中，收缩冷凝而制成的球形或类球形制剂。 Dripping pills are the preparations made by dripping a uniform, melted mixture of medicaments prepared by purify and concentrating extract of crude drugs and appropriate bases into an immiscible cooling liquid and congealing to a spherical or sphare-like. 滴丸剂在生产与贮藏期间应符合下列有关规定。 The manufacture and storage of dripping pills should comply with the following requirements. 一、根据不同品种可选用水溶性基质或非水溶性基质。常用基质有聚乙醇类、泊洛沙姆、 硬脂酸聚烃氢（40)酯、明胶，硬脂酸、单硬脂酸甘油酯、氢化植物油等。 1.Water soluble or water-insoluble bases can be used to suit for different varieties of dripping pills. Commonly used bases consist of polyethylene glycols poloxamer, polyoxy [40] stearate, gelatin and stearic acid, glycerin monosterate, hydrogenated vegetable oils and so on. 二、冷凝液必须安全无害，且与药物不发生作用。常用冷凝液有液状石蜡、植物油、甲基 硅油和水等。 2.The cooling liquid must be innocuous and should not inter liquid paraffin. vegetable oil, methylsilicone oil and water are commonly used for this purpose. 三、滴丸应圈整均匀，色泽一致，无粘连现象，表面无冷凝液黏附。 3.Dripping pills should be round, integrate, uniform in colour and also well shaped without adhesion. No cooling liquid remains on the surface of dripping pills. 四、根据药物的性质与使用、贮藏的要求，在滴制成丸后可包衣。 4.Dripping pills my be coated as required to suit for the properties of the medicaments and for clinical usage and storage. 五、除另有规定外，滴丸剂应密封贮存。 5.Unless specified otherwise, dripping pills should be kept in tightly closed containers. 滴丸剂应进行以下相应检查。 Following relevant test should be carried out for dripping pills. 【重量差异】 除另有规定外，滴丸剂照下述方法检查应符合规定。 Weight variation Unless specified otherwise, the limit of weight variation for drippingpills complies with the following requirements. 检查法 取供试品 20 丸， 精密称定总重量， 求得平均丸重后， 再分别精密称定每丸的重量。 每丸重量与平均丸重相比较，按表中的规定，超出重量差异限度的不得多于 2 丸，并不得 有 1 丸超出限度 1 倍。 procedure Weigh accurately the total weight Of 20 dripping pills, calculate the average weight of each dripping pill.Then weigh accurately each of the 20 dripping pills.Compare the weight of each pill with the average weight. According to the requirements stated in the table, not more than 2 pills deviate outside the limit of weight variation,none deviates outside 1 fold of the limit. 平均丸重 0.03g 及 0.03g 以下 0.03g 以上至 0.1g 0.1g 以上至 0.3g 0.3g 以上 重量差异限度 15% 12% 10% 7.5%Average weight 0.03g or less more than 0.03g or 0.1g mom than 0.1g to 3g more than0.3g 丸应在包衣后检查重量差异并符合规定。Limit of weight variation 15% 12% 10% 7.5%包糖衣滴丸应检查丸芯的重量差异并符合规定，包糖衣后不再检查重量差异。包薄膜衣滴 The weight variation of sugar-coated dripping pills should be examined before coating. Dripping pills are not to be coated until the weight variation of their cores complies with the requirements. The test of weight variation is not required for dripping pills after sugar-coating, but it is needed for dripping pills after film-coating and should comply with the specified requirements. 【崩解时限】 照崩解时限检查法（附录Ⅻ A）检查，除另有规定外，应符合规定。 Disintegration test 【微生物限度】 Carry out the test as described under disintegration test (Appendix Ⅻ A),it should comply with the specified requirements, unless otherwise specified. 照微生物限度检查法（附录 XIII C)检查，应符合规定。 Microbial limit test Comply with the requirements stated under Microbial Limit Tests(Appendix XIII C).(胶囊剂)Ⅰ LCapsules胶囊剂系指将药材用适宜方法加工后，加入适宜辅料填充于空心胶囊或密封于软质囊材中 的制剂，可分为硬胶囊、软胶囊（胶丸）和肠溶胶囊等，主要供口服用。 Capsules are preparations made by mixing crude drugs processed by suitable methods and appropriate excipients, enclosing in capsule shell or sealing in soft capsule. Capsules are classified into hard, soft or enteric shells, mainly for oral administration. 硬胶囊 系指将药材提取物、药材提取物加药材细粉或药材细粉或与适宜辅料制成的均匀 Consist of crude drug extracts, crude drug extracts with fine powders of 粉末、细小颗拉、小丸、半固体或液体，填充于空心胶囊中的胶囊剂。 Hard capsules crude drugs, fine powders of crude drugs or any of the above with appropriate excipients, usually in uniform powder, mini granules, mini pills, semisdids or liquids, enclosed in a capsule shell. 软胶囊 系指将药材提取物、液体药物或与适宜辅料混匀后用滴制法或压制法密封于软质 Prepared by drip-feed or compression method. The extracts of crude 囊材中的胶囊剂。 Soft capsules drugs, liquid medicaments or any of above well mixed with appropriate excipients are sealed in soft capsules. 肠溶胶囊 系指不溶于胃液，但能在肠液中崩解或释放的胶囊剂。 Enteric capsules Enteric capsules are capsules that are insoluble in gastric fluid, but can disintegrate or release the active substance in intestinal fluid. 胶囊剂在生产与贮藏期间应符合下列有关规定。 The production and storage of capsules should comply with the following requirements. 一、药材应按各品种项下规定的方法制成填充物料，其不得引起囊壳变质。 1.Crude drugs should be made into the contents of capsules as specified in the individual monograph and may not result in neither deformation of shells nor in deterioration. 二、小剂量药物应用适宜的稀释剂稀释，并混合均匀。 2.Potent medicaments given in small doses are usually mixed thoroughly with suitable diluents before filling. 三、胶囊剂应整洁，不得有粘结、变形、渗漏或囊壳破裂现象，并应无异臭。 3.Capsules should have a clean, smooth surface and well shaped without adhesion, deformation leakage, breakage or foreign odour. 四、除另有规定外，胶囊剂应密封贮存。4.Capeules should be preserved in tightly closed container, unless specified otherwise. 胶囊剂应进行以下相应检查。 Following relevant tests should be carried out for capsules. 【水分】硬胶囊应做水分检查。取供试品内容物，照水分测定法（附录Ⅸ H)测定，除另有 规定外，不得过 9.0%。硬胶囊内容物为液体或半固体者不检查水分。 Water determination Water determination for hard capsules is required the water content in the contents of hard capsule, is determined by the methods described in Determination of Water (Appendix Ⅸ H). Unless otherwise specified, the water content is not more than 9.0 per cent. Water determination is not required while the contents of hard capsule are liquids or semisolids. 【装量差异】 除另有规定外，取供试品 10 粒。分别精密称定重量，倾出内容物（不得损 失囊壳） ，硬胶囊囊壳用小刷或其他适宜的用具拭净；软胶囊或内容物为半固体或液体的硬 胶囊囊壳用乙醚等易挥发性溶剂洗净，Z通风处使溶剂挥尽，再分别精密称定囊壳重量， 求出每粒内容物的装量。每粒装量与标示装量相比较（无标示装量的胶囊剂，与平均装量 比较） ，装量差异限度应在标示装量（或平均装量）的10％以内，超出装量差异限度的不 得多于 2 粒，并不得有 1 粒超出限度 1 倍。 Filling variation Unless specified otherwise, weigh accurately 10 capsules respectively, remove the content as completely as possible (no loss of capsule shell). For hard capsule. clean the shell with a small brush or oth for soft capsule or hard capsule containing liquids or semisolids, wash the shell with ether or other easily volatile solvents and allow to ventilate until the odour of the solvents is no longer perceptible. Weigh accurately the shell of each capsule. The difference between the weights represents the filling of each capsule. Compare the filling of each capsule with the labelled filling (if no labelled filling is stated, compare the filling of each capsule with the average filling calculated). The filling variation limit should be within 士10%. No more than two of the individual filling deviate outside the limit and none deviates outside 1 fold of the limit. 【崩解时限】 除另有规定外，照崩解时限检查法（附录Ⅻ A)检查，应符合规定。 Disinteugration test otherwise specified. 【微生物限度】 照微生物限度检查法（附录 XIII C)检查，应符合规定。 Carry out the test as described under Determination of Disintegration (Appendix Ⅻ A), it should comply with the specified requirements, unlessMicrobial limit test Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).(酒剂)Ⅰ MMedicinal Wines酒剂系指药材用蒸馏酒提取制成的澄清液体制剂。 Medicinal wines are clear liquid preparations prepared by maceration and extraction of crude drugs with distilled wine. 酒剂在生产与贮藏期间应符合下列有关规定。 The production and storage of medicinal wines should comply with the following requirements. 一、生产酒剂所用的药材，一般应适当加工成片、段、块、丝或粗粉。 1.Generally, the crude drugs for producing medicinal wines should be properly processed into slices, sections, pieces slivers or coarse powders. 二、生产内服酒剂应以谷类酒为原料。 2.Medicinal wines used for oral administration should be prepared with wines made from grains. 三、可用浸渍法、渗漉法或其他运宜方法制备。蒸馏酒的浓度及用量、浸溃温度和时间、 渗漉速度，均应符合各品种制法项下的要求。 3.Medicinal wines my be prepared by maceration, percolation or other suitable methods. The concentration and quantity of distilled wine, temperature and duration for maceration, speed of percolation, should comply with the requirements for preparation described under individual monograph. 四、可加入适量的糖或蜂蜜调味。 4.Medicinal wines may be flavoured by adding a sufficient quantity of sugar or honey as required. 五、配制后的酒剂须静Z澄清，滤过后分装于洁净的容器中。在贮存期间允许有少量摇之 易散的沉淀。 5.Medicinal wines being prepared should be allowed to stand for clarifying then filtered and packed in clean containers. A small amount of dispersibe precipitates during storage are allowed. 六、酒剂应检查乙醇量。 6.Ethanol content should be generally determined for medicinal wines. 七、除另有规定外，酒剂应密封、Z阴凉处贮存。 7.Unless specified otherwise, medicinal wines should be preserved in tightly closed containers and stored in a cool place.酒剂应进行以下相应检查。 Following relevant tests should be carried out for medicinal Wine}