Appendix ⅠGeneral Requirements for Prearations
（丸剂）Ⅰ A Pills
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.
Water-honeyed pills are made of fine powder of crude drugs, using honey and water as binders.
Watered pills are made of fine powder of crude drugs, using water (or yellow rice wine, vinegar, dilute medicinal juice, dilute syrup) as binder.
Pasted pills are made of fine powder of crude drugs, using rice powder rice-paste or flour-paste as binder.
Waxed pills are made of fine powder of crude drugs, using beeswax as binder.
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,
concentrated honeyed pills and concentrated water-honeyed pills based upon the different binders used in the production.
The production and storage of pills should comply with the following requirements.
1. The powdered drugs for preparing pills are fine or very fine powders, unless specified otherwise.
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.
3. The extract for preparing concentrated pills should be made by extracting and concentrating according to the certain methods specified under the monograph.
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.
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.
6. For pills need to be coated and polished, coat with the coating materials and polish as specified under individual monograph.
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.
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.
Following relevant tests should be carried out for pills.
Determination of water Carry out the method for the determination of water in general (Appendix ⅨH).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.
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 1Take the largest number of pills in single dosage as one part(1 pill as one part for pills weighing 1.5g or more than 1.5g 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 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.
Labelled total or single(average weight)weight variation limit
0.05g 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%
Method 2Take 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.
Labelled or Average weight of each part Weight variation limit
0.5g 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 1g 士8%
more than 1g to 2g 士7%
more than 2g 士6%
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 With the requirements; The weight variation is no longer examined for the single dose packed pills, which have been examined according to the filling variation standards.
Filling variation The Filling variation of pills presented in single dose pack should comply with the following requirements.
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.
Labelled weight of each pack Weight variation limit
0.5g 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%
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 ⅫC).
【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 ⅫA) 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.
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 ⅫA) for enteric-coated tablets.
No disintegration test is required for big honeyed pills.
Microbial limit test Comply with the requirements stated under Microbial Limit Test
(Appendix XIII C).
（散剂）Ⅰ B Powders
Powders may be defined as mixtures of pulverized crude drugs or extract of crude drugs which are used for oral administration or external application.
The production and storage of powders should comply with the following requirements.
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.
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 in single dose.
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.
Following relevant tests should be carried out for powders.
Particle size Powders used for burn or severe trauma should comply with the following test.
Procedure Carry out the method for the determination of particle size in general (Appendix ⅪB, 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.
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 Carry out the method for the determination of water in general (Appendix ⅨH). The powders contain not more than 9.0 per cent of water, unless specified otherwise.
Filling variation Filling variation limit for powders presented in single dose should comply with the requirements stated in the table below.
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.
Labelled weight per pack
Weight variation limit
0.1 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 1.5 g to 6 g士7%
more than 6 g士5%
Filling Filling variation for powders presented in multiple doses should comply with the test for Minimum Fill (Appendix ⅫC).
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 C Granules
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.
The production and storage of medicinal granules should comply with the following requirements.
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.
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.
3. Correctives and flavoring agents may be added in preparation of granules; 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.
4. Medicinal granules should be dry, uniform in appearance and colour, without moisture absorption, agglomeration, deliquescence and so on.
5. Medicinal granules should be stored in tightly closed containers, and in a dry place to prevent moisture absorption, unless specified otherwise.
Following relevant tests should be carried out for granules.
Particle size Unless specified otherwise. Carry out the method for the Determination of Particle Size (Appendix ⅪB 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.
Determination of wate r Carry out the method for the determination of water (Appendix ⅨH). 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 turbidity is allowed; suspensible granules should be suspended uniformly.
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.
Examined by the methods above, granules should show no burned charrings etc.
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.
Labelled weight per pack Filling variation limit
1.0 g or less士10%
more than 1 g to 1.5g士8%
more than 1.5 g to 6 g士7%
more than 6 g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。Filling Granules presented in multiple doses should comply with the test for Minimum Fill(Appendix ⅫC).
Microbial limit test Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).
（片剂）Ⅰ D Tablets
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.
Buccal tablets are tablets staying in oral cavity, of which medicaments dissolve slowly and take effects.
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.
Vaginal tablets and vaginal effervescent tablets are tablets for vaginal cavity use.
Enteric-coated tablets are tablets coated with enteric coating Materials.
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.
2.Tablets containing volatile or thermolabile substances are processed in a way to avoid loss on heating.
3.The moisture content of the granules should be controlled under the processing requirement before tableting, thus to prevent mould contamination, deterioration during storage.
4.If necessary, additives such as correctauts, flavoring agents, colouring agents etc. May be added in the preparation of tablets.
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.
6.Tablets should have a clean, smooth and uniformly coloured surface; they are sufficiently hard to withstand handling without abrasion or cracking.
7.Unless otherwise specified, tablets should be preserved in tightly closed containers.
Following relevant tests should be carried out for tablets.
Weight variation Tablets should comply with the following Requirements.
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.
labelled or Average weight Weight variation limit
Less than 0.3g士7.5%
0.3g or more〒5%
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ⅫA）检查，应符合规定。Disintegration Unless specified otherwise, Carry out the test as described under the disintegration test (Appendix ⅫA).All the tablets should comply with the specified requirements.
Vaginal tablets should comply with the requiremeats under Disintegration Test for Suppositories and Vaginal Tablets (Appendix ⅫB).
No disintegration test is required for buccal tablets and chewable tablets.
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，臵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
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.
Microbial limit test Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).
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 Comply with the requirements stated under Microbial Limit Tests (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).
The production and storage of troches should comply with the following requirements.
1.The honey, powder of glutinous rice etc. used for troches should be treated by the specified methods.
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.
3.Troches may be coated or polished, if necessary, using the coating materials stated under the individual monograph of the preparation.
4.Troches should be neat, smooth, uniform in colour with no wrinkle, breach, gap, cavity and change in form.
5.Troches should be preserved in well closed containers and stored in a cool and dry place unless specified otherwise.
Following relevant tests should be carried out for troches.
Weight variation Unless specified otherwise, weight variation for troches complies with the test for Weight variation stated under Pills.