中國藥典附錄Ⅰ(A-Z)中英文對(duì)照

1、精選優(yōu)質(zhì)文檔-傾情為你奉上（附錄制劑通則）Appendix General Requirements for Prearations （丸劑） A Pills丸劑 系指藥材細(xì)粉或藥材提取物加適宜的黏合劑或其他輔料制成的珠形或類球形制劑，分為蜜丸、水蜜九、水丸、糊丸、蠟丸和濃縮丸等類型。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 系指藥材細(xì)粉以蜂蜜為黏合劑制成的丸劑。其中每丸重量在 0.5g( 含 0.5g)以上的稱大蜜丸，每丸重量在0.5以下的稱小蜜丸。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 系指藥材細(xì)粉以蜂蜜和水為黏合劑制成的丸劑。Water-honeyed pills are made of fine powder of crude drugs, using honey and water as binders.水丸 系指藥材細(xì)粉以水（或根據(jù)制法用黃酒、醋、稀藥汁、糖液等）為黏合劑制成的丸劑

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 系指藥材細(xì)粉以米粉、米糊或面糊等為黏合資劑制成的丸劑。Pasted pills are made of fine powder of crude drugs, using rice powder rice-paste or flour-paste as binder.蠟丸 系指藥材細(xì)粉以蜂蠟為黏合劑制

5、成的丸劑。Waxed pills are made of fine powder of crude drugs, using beeswax as binder.濃縮丸 系指藥材或部分藥材提取濃縮后，與適宜的輔料或其余藥材細(xì)粉，以水、蜂蜜或蜂蜜和水為黏合劑制成的丸劑。根據(jù)所用黏合劑的不間，分為濃縮水丸、濃縮蜜丸和濃縮水蜜丸。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.丸劑在生產(chǎn)與貯藏期間應(yīng)符合下列有關(guān)規(guī)定。The production and storage of pi

7、lls should comply with the following requirements.一、除另有規(guī)定外，供制丸劑用的藥粉應(yīng)為細(xì)粉或最細(xì)粉。1. The powdered drugs for preparing pills are fine or very fine powders, unless specified otherwise.二、蜜丸所用蜂蜜須經(jīng)煉制后使用。按煉蜜程度分為嫩蜜、中蜜和老蜜，制備蜜丸時(shí)可根據(jù)品種、氣候等具體情況選用。除另有規(guī)定外，用塑制法制備蜜丸時(shí)，煉蜜應(yīng)趁熱加人藥粉中，混合均勻，處方中有樹脂類、膠類從含揮發(fā)性成分的藥味時(shí)，煉蜜應(yīng)在60左右加人；用泛制法制

8、備水蜜丸時(shí)，煉蜜應(yīng)用沸水稀釋后使用。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、濃編丸所用藥材提取物應(yīng)按制法規(guī)定，采用一定的方法提取濃縮制成。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、除另有規(guī)定外，水蜜丸、水丸、濃縮水蜜丸和濃縮水丸均應(yīng)在80以下干燥；含揮發(fā)性成分或淀粉較多的丸劑（包括糊丸）應(yīng)在60以下干燥；不宜加熱干燥的應(yīng)采用其他適宜的方法干燥。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、制備蠟丸所用的蜂蠟應(yīng)符合本版藥典該藥材項(xiàng)下的規(guī)定。制備時(shí)，將蜂蠟加熱熔化，待冷卻至60左右按比例加人藥粉，混合均勻，趁熱按塑制法制丸，并注意保溫。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劑，應(yīng)使用各品種制法項(xiàng)下規(guī)定的包衣材料進(jìn)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、丸劑外觀應(yīng)圓整均勻、色澤一致。蜜丸應(yīng)細(xì)膩?zhàn)虧?，軟硬適中。蠟丸表面應(yīng)光滑無裂紋，丸內(nèi)不得有蠟點(diǎn)和顆粒。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、除另有規(guī)定外，丸劑應(yīng)密封貯存。蠟丸應(yīng)密封井置陰涼干燥處貯存。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.丸劑應(yīng)進(jìn)行以下相應(yīng)檢查。Following relevant tests should be carried out for pills.【水分】照水分測(cè)定法（附錄 H)測(cè)定。除另有規(guī)定外，蜜丸和濃縮蜜丸中所含水分不得過15. o；水蜜丸和濃縮水蜜丸不得過12.0；水丸、糊丸和濃縮水丸不得過9.0。蠟丸不檢查水分。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.【重量差異】除另有規(guī)定外，丸劑按丸數(shù)服用的照第一法檢查，按重量服用的照第二法檢查，均應(yīng)符合規(guī)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數(shù)為1份(丸重 1.5g及1. 5g以上的丸劑以1丸為1份；丸重0.015g以上的丸劑一次服用量最高丸數(shù)超過10丸的，或丸重0.015g及0.015g以下的丸劑一次服用量最高丸數(shù)不足10丸的，以10丸為1份），取供試品10份,分別稱定重量，再與標(biāo)示總量（每丸標(biāo)示重量X稱取丸數(shù)）或標(biāo)示重量相比較（無標(biāo)示重量的丸劑，與平均重量比較），按表1的規(guī)定，超出重量差異限度的不得多于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標(biāo)示總量或標(biāo)示重量（或平均重量）重量差異限度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 以供試品10丸為1份，取10份，分別稱定重量,再與每份標(biāo)示重量相比較（無標(biāo)示重量的丸劑，與平均重量比較），按表2的規(guī)定，超出重量差異限度的不得

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每份標(biāo)示重量或平均重量重量差異限度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%包糖衣丸劑應(yīng)檢查丸芯的重量差異并符合規(guī)定，包糖衣后不再檢查重量差異，其他包衣丸劉應(yīng)在包農(nóng)后檢查重量差異并符合規(guī)定，凡進(jìn)行裝量差異檢查的單劑量包裝丸劑，不再進(jìn)行重量差異檢查。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.【裝量差異】 單劑量包裝的丸劑，照下述方法檢查應(yīng)符合規(guī)定。Filling variation The Filling variation of pills presented in single dose pack should comply with the following requirements.檢查法 取供試品10袋（瓶，分別稱定每袋（瓶）內(nèi)容物 的重量，每袋（瓶）裝量與標(biāo)示裝量相比較，按表3的規(guī)定，超出裝量差異限度的不得多于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標(biāo)示裝量裝量差異限度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%【裝量】裝量以重量標(biāo)示的多劑量包裝丸劑，照最低裝量檢查法（附錄 C）檢查，應(yīng)符合規(guī)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).【溶散時(shí)限】除另有規(guī)定外，取供試品6丸，選擇適當(dāng)孔徑篩網(wǎng)的吊籃（丸劑直徑在2.5mm以下的用孔徑約0.42mm的篩網(wǎng)；在2.5-3.5mm之間的用孔徑約1.0mm的篩網(wǎng)；在3.5mm以上的用孔徑約2.0mm的篩網(wǎng)），照崩解時(shí)限檢查法附錄 A）片劑項(xiàng)下的方法加擋板進(jìn)行檢查。除另有規(guī)定外，小蜜丸、水蜜丸和水丸應(yīng)在I小時(shí)內(nèi)全部

32、溶散；濃縮丸和糊丸應(yīng)在2小時(shí)內(nèi)全部溶散。操作過程中如供試品黏附擋板妨礙檢查時(shí)，應(yīng)另取供試品6丸，以不加擋板進(jìn)行檢查。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.上述檢查，應(yīng)在規(guī)定時(shí)間內(nèi)全部通過篩網(wǎng)。如有細(xì)小顆粒狀

35、物未通過篩網(wǎng)，但己軟化且無硬心者可按符合規(guī)定論。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.蠟丸照崩解時(shí)限檢查法（附錄X A）片

36、劑項(xiàng)下的腸溶衣片檢查法檢查，應(yīng)符合規(guī)定。Waxed pills should comply with the requirements stated in monograph for Determination of Disintegration (Appendix A) for enteric-coated tablets.大蜜丸不檢查溶散時(shí)限。No disintegration test is required for big honeyed pills.【徽生物限度】 照微生物限度檢查法（附錄XIII C）檢查，應(yīng)符合規(guī)定Microbial limit test Comply with

37、the requirements stated under Microbial Limit Test (Appendix XIII C).（散劑） B Powders 散劑系指藥材或藥材提取物經(jīng)粉碎、均勻混合制成的粉末狀制劑，分為內(nèi)服散劑和外用散劑。Powders may be defined as mixtures of pulverized crude drugs or extract of crude drugs which are used for oral administration or external application.散劑在生產(chǎn)與貯藏期間應(yīng)符合下列有關(guān)規(guī)定。The p

38、roduction and storage of powders should comply with the following requirements.一、供制散劑的藥材、藥材提取物均應(yīng)粉碎。除另有規(guī)定外，內(nèi)服散劑應(yīng)為細(xì)粉；兒科用及外用散劑應(yīng)為最細(xì)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、散劑應(yīng)干燥、疏松、混合均勻、色澤一致。制備含有毒性藥、貴重藥或藥物劑量小的散劑時(shí)，應(yīng)采用配研法混勻并過篩。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、多劑量包裝的散劑應(yīng)附分劑量的用具；含有毒性藥的內(nèi)服散劑應(yīng)單劑量包裝。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、除另有規(guī)定外，散劑應(yīng)密閉貯存，含揮發(fā)性藥物或易吸潮藥物的散劑應(yīng)密封貯存。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.散劑應(yīng)進(jìn)行以下相應(yīng)檢查。Following relevant tests should be carried out for

42、 powders.【粒度】用于燒傷或嚴(yán)重創(chuàng)傷的外用散劑，照下述方法檢查應(yīng)符合規(guī)定。Particle size Powders used for burn or severe trauma should comply with the following test.檢查法 照粒度測(cè)定法（附錄 B第二法，單篩分法）測(cè)定，除另有規(guī)定外，通過六號(hào)篩的粉末重量，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.【外觀均勻度】 取供試品適量，置光滑紙上，平鋪約5cm2,將其表面壓平，在明亮處觀察，應(yīng)色澤均勻、無花紋與色斑。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】 照水分測(cè)定法（附錄 H）測(cè)定，除另有規(guī)定外，不得過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.【裝量差異】 單劑量包裝的散劑，照下述方法檢查應(yīng)符合規(guī)定。Filling variation Filling variation limit for powders presented in single dose should comply with the requirements stated in the table below.檢查法 取供試品10袋（瓶）

46、，分別稱定每袋（瓶）內(nèi)容物的重量，每袋（瓶）裝量與標(biāo)示裝量相比較，按表中的規(guī)定，超出裝量差異限度的不得多于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.標(biāo)示裝量裝量差異限度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%【裝量】 多劑量包裝的散劑，照最低裝量檢查法（附錄 C)檢查應(yīng)符合規(guī)定。Filling Filling variation for powders presented in multiple doses should comply with the test for Minimum Fill (Appendix C).【無菌】 用于燒傷或嚴(yán)重創(chuàng)傷的外用散劑，照無菌檢查法（附錄XIII B)檢查，應(yīng)符合規(guī)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】 除另有規(guī)定外，照微生物限度檢查法（附錄XIII C)檢查，應(yīng)符合規(guī)定。Microbial limit test Unless otherwise specified, Comply with the requirements stated under Microbial Limit Test (Appendix XIII C).（顆粒劑） C Granules 顆粒劑系指藥材提取物與適宜的輔料或藥材細(xì)粉制成具有一定拉度的顆粒狀制劑，分為可溶顆粒、混懸顆粒和泡騰顆粒。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.顆粒劑在生產(chǎn)與貯藏期間應(yīng)符合下列有關(guān)規(guī)定。The production and storage of medicinal granules should comply with the following requirements.一、除另有規(guī)定外，藥材應(yīng)按各品種項(xiàng)

51、下規(guī)定的方法進(jìn)行提取、純化、濃縮成規(guī)定相對(duì)密度的清膏、采用適宜的方法干燥，并制成細(xì)粉，加適量輔料或藥材細(xì)粉，混勻并制成顆粒；也可將清膏加適量輔料或藥材細(xì)粉，混勻并制成顆粒。應(yīng)控制輔料用量，一般前者不超過干膏量的2倍,后者不超過清膏量的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、除另有規(guī)定外，揮發(fā)油應(yīng)均勻噴人干燥顆粒中，密閉至規(guī)定時(shí)間或用環(huán)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、制備顆粒劑時(shí)可加入矯味劑和勞香劑；為防潮、掩蓋藥物的不良?xì)馕兑部砂∧ひ?。必要時(shí)，包衣顆粒劑應(yīng)檢查殘留溶劑。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、顆粒劑應(yīng)干燥、顆粒均勻、色澤一致，無吸潮、結(jié)塊、潮解等現(xiàn)象。4. Medicinal granules should be dry, uniform in appearance and colour, without moisture absorption, agglomeration, deliq

56、uescence and so on.五、除另有規(guī)定外，顆粒劑應(yīng)密封，在干燥處貯存，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.顆粒劑應(yīng)進(jìn)行以下相應(yīng)檢查。Following relevant tests should be carried out for granules.【粒度】 除另有規(guī)定外，照粒度測(cè)定法（附錄 B第二法，雙篩分法）測(cè)

57、定，不能通過一號(hào)篩與能通過五號(hào)篩的總和，不得過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】照水分測(cè)定法（附錄 H)測(cè)定，除另有規(guī)定外，不得過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