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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 ⅠGeneral Requirements for Prearations

(丸剂)Ⅰ 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 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。

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 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 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。蜡丸应密封井臵阴凉干燥处贮存。

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ⅨH)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 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.

【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 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.

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 1

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%

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 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.

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 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%

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 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.

【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 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2g 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%

Table3

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%

【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 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.

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 ⅫA) 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 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 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 multiple doses packs; 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 Powders used for burn or severe trauma should comply with the following 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

的粉末重量,不得少于95%。

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.

【外观均匀度】取供试品适量,臵光滑纸上,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 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.

【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

Weight variation limit

(or vial)

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%

【装量】多剂量包装的散剂,照最低装量检查法(附录ⅫC)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 ⅫC).

【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 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 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 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.

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 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.

【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 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.

泡腾颗粒取供试品1袋,臵盛有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.

标示装量装量差异限度

1g及1g以下士10%

1g以上至1.5g 士8%

1.5g以上至6g 士7%

6g以上士5%

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).

【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 D Tablets

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臵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 uniformly coloured surface; 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重量差异限度

0.3g以下士7.5%

0.3g及0.3g以上〒5%

labelled or Average weight Weight variation limit

Less than 0.3g士7.5%

0.3g or more〒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.

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 ⅫB).

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,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

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 Comply with the requirements stated under Microbial Limit Tests (Appendix XIII C).

(锭剂)ⅠE Troches

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).

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,臵阴凉干燥处贮存。

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。