中国药典附录Ⅰ(A-Z)中英文对照

1、精选优质文档-倾情为你奉上（附录制剂通则）Appendix General Requirements for Prearations （丸剂） A Pills丸剂 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

2、 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,

3、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 系指药材细粉以水（或根据制法用黄酒、醋、稀药汁、糖液等）为黏合剂制成的丸剂

4、。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

5、成的丸剂。Waxed pills are made of fine powder of crude drugs, using beeswax as binder.浓缩丸 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、浓缩蜜丸和浓缩水蜜丸。Concentrated pills are made of condensed extract of crude drugs or partial crude drugs, mixing with appropriate excipient or fine powder

6、of other crude drugs, using water, honey or honey and water as binders. They may be classified into concentrated watered pills, 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 pi

7、lls 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

8、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, dependi

9、ng 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 proces

10、sed 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

11、 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 t

12、emperature 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

13、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

14、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 appea

15、rance 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。蜡丸应密封井置阴凉干燥处贮存。8. Unless specified otherwise, Pills s

16、hould 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 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

17、 Carry out the method for the determination of water in general (Appendix 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

18、 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 b

19、y 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 dos

20、age as one part(1 pill as one part for pills weighing 1.5g or more than 1.5g per pill; 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

21、 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)

22、 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）重量差异限度0.05g及0.05g以下士12%0.05g以上至0.1g士11%0.1g以上至0.3g士10%0.3g以上至1.5g士9%1.5g以上至3g士8%3g以上至6g士7%6g以上至9g士6%9g以上士5%Table 1Labelled tot

23、al or single(average weight)weight variation limit0.05g or less士12%more than 0.05g to 0.1g士11%more than 0.1g to 0.3g士10%more than 0.3g to 1.5g士9%more than 1.5g to 3g士8%more than 3g to 6g士7%more than 6g to 9g士6%more than 9g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

24、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

25、 exceed the weight variation limit and none doubles the limit.表2每份标示重量或平均重量重量差异限度0.05g及0.05g以下士12%0.05g以上至0.1g士11%0.1g以上至0.3g士10%0.3g以上至1g士8%1g以上至2g士7%2g以上士6%Table 2 Labelled or Average weight of each partWeight variation limit0.5g or less士12%more than 0.05g to 0.1g士11%more than 0.1g to 0.3g士10%more

26、 than 0.3g to 1g士8%more than 1g to 2g士7%more than 2g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

27、 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 With the requirements; The weight variation is no longer examined for the single dose packed pills, which have been examined

28、 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 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 的重量，每袋（瓶）装量与标示装量相比较，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（瓶）超出限度1倍。Procedure Ta

29、ke 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标示装量装量差异限度0.5g及0.5g以下士12%0.5g以上至1g士11%1g以上至2

30、g士10%2g以上至3g士8%3g以上至6g士6%6g以上至9g士5%9g以上士4%Table3Labelled weight of each packWeight variation limit0.5g or less士12%more than 0.5g to 1g士11%more than 1g to 2g士10%more than 2g to 3g士8%more than 3g to 6g士6%more than 6g to 9g士5%more than 9g士4%【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 C）检查，应符合规定。Filling The Filling

31、 variation of multiple doses packed pills of which filling is labelled in weight should comply with the test for Minimum Fill (Appendix 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 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

32、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 dia

33、meter respectively). Carry out the test as described under the disintegration test (Appendix 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

34、 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

35、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X A）片

36、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 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

37、the requirements stated under Microbial Limit Test (Appendix XIII C).（散剂） B 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剂。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 p

38、roduction 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 administrat

39、ion, 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

40、 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 multiple doses packs; Powders for oral administration containing poisonous drugs should be packed

41、 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

42、 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 Powders used for burn or severe trauma should comply with the following test.检查法 照粒度测定法（附录 B第二法，单筛分法）测定，除另有规定外，通过六号筛的粉末重量，不得少于95。Procedure Carry out the method for the determination of particle size in general (Appendix B, method 2, single parti

43、cle 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，置光滑纸上，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 powder

44、s 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 H）测定，除另有规定外，不得过9.0。Determination of water Carry out the method for the determination of

45、 water in general (Appendix H). The powders contain not more than 9.0 per cent of water, unless 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）

46、，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

47、 the packing variation limit and none should double the packing variation limit.标示装量装量差异限度0.1g及0.1g以下士15%0.1g以上至0.5g士10%0.5g以上至1.5g士8%1.5g以上至6g士7%6g以上士5%Labelled weight per pack (or vial)Weight variation limit0.1 g to 0.1 g or less士15%more than 0.1 g to 0.5 g士10%more than 0.5 g to 1.5 g士8%more than

48、1.5 g to 6 g士7%more than 6 g士5%【装量】 多剂量包装的散剂，照最低装量检查法（附录 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 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 w

49、ith 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） C Granules 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

50、 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

51、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 describe

52、d 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, we

53、ll 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环糊精包合后加人。2. The volatile oil should be sprayed evenly upon drie

54、d granules, stored in well closed containers for the required time, or be added after being wrapped in -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 preparation of granules; Granules may also be f

55、ilm-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, deliq

56、uescence 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 B第二法，双筛分法）测

57、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 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 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 H). The medicinal granules contain not more than 6.0 per cent of wat