附件1
中成药规格表述技术指导原则
一、概述
Drug specifications are typically expressed as the amount of active ingredient per unit dosage form (e.g., per capsule, tablet, gram, milliliter, or pill). However, most Chinese proprietary medicines are compound formulations containing complex ingredients, making it difficult to directly specify the amounts of individual components in the "specifications" section. Currently, specifications for these products are generally described only by weight or volume per unit, which can complicate accurate clinical dosing. To standardize the content and format of specification descriptions for Chinese proprietary medicines, this technical guidance principle is established.
规格是药品说明书内容的重要组成部分，其表述应尽可能提供准确的药物成份量的信息，以便于药品的销售、贮运、分发、使用。中成药的药品规格虽无法直接标明所含药物成份的量，但可以标示出制成单位制剂所需处方药味的剂量。鉴于以上认识，中成药的药品规格标示内容中一般应包含单位制剂中所相当的处方药味（包括饮片、提取物、有效成份等）的理论量（或标示量）。
中成药的药品规格建议参照本指导原则进行规范表述。由于中成药的情况比较复杂，实际工作中难以按本指导原则规范的，可以具体问题具体分析，采用其他合理的方式标示单位制剂中所含药物量的信息。
二、中成药规格表述的一般原则
（一）与处方药味相对应的原则
处方药味为饮片的制剂，其药品规格标示内容一般应包含单位制剂相当于饮片的重量。如处方药味为饮片的片剂，其药品规格可标示为“每片重**g(equivalent to decoction pieces)**g）”；液体制剂，其药品规格可标示为“Every1 mlequivalent to decoction pieces**g。
处方药味为有效成份等的制剂，其药品规格可直接以单位制剂中所含有效成份等的标示量标示。如处方为有效成份的灯盏花素滴丸，其规格可标示为“Each pill contains 10mg of flavonoids from Erigeron brevipetiolus.4mg”。
处方药味为浸膏、流浸膏、植物油脂等提取物的，其药品规格可以单位制剂中所含相应药味的理论量标示。如某颗粒剂处方含**浸膏及饮片，其规格可标示为：每1 GBequivalent to decoction pieces**g，含**浸膏**mg。
Prescription ingredients often consist of multiple dosage forms and should be specified individually whenever possible. If individual specification is impractical, they may be grouped by ingredient type. For example, if a formulation contains several crude herbs and various extracts, the total equivalent amount of crude herbs and the total amount of extracts per unit dose can be calculated separately. The specification would then be stated as:“每片相当于饮片**g, containing extract**mg。
处方含化学药、有效成份的应一一注明标示量。
Table1 Examples of specification descriptions for different types of medicinal ingredients
品名 | 处方药味类型 | Specifications |
板蓝根颗粒 | Decoction pieces | 每袋相当于饮片7g |
Scutellariae Radix Injection | 有效成份 | 每支含灯盏花素4mg |
Gynostemma Pentaphyllum Total Glycoside Drops | 提取物 | Every**Net Weight** GB(each1 GB含绞股蓝总苷6mg） |
复方黄连素片 | 饮片、化学药 | 每片重** GB(equivalent to decoction pieces)0.318g，含盐酸小檗碱30mg） |
Keteling Tablets | 干浸膏、化学药 | 每片重** GB（含小叶榕干浸膏180mgChlorphenamine Maleate0.7mg） |
如同品种单位制剂相当的饮片量等相同，一般视为相同药品规格。同品种单位体积或重量制剂中的药物量相同（注射剂、定量型气雾剂及喷雾剂等除外）的，一般视为相同的药品规格；同品种浓度不同的，一般视为不同的药品规格。
药品规格一般不表述与辅料相关的内容。如同品种单位制剂相当的饮片量等相同，因辅料不同而形成的无糖颗粒与乳糖型颗粒，糖衣片与薄膜衣片等均视为相同的药品规格。由于中药丸剂的特殊性，蜜丸、水蜜丸仍视为不同的药品规格。
（二）与用法用量、装量规格相协调的原则
药品的装量规格主要用于标示最小包装容器内所装药物制剂的量，如每板装12片、每瓶装100ml、每袋装10g，等等。药品规格应与说明书的【用法用量】、【包装】的装量规格等协调。
规格表述应便于准确用药。除儿童用药外，一般不应出现一次服用1/3bag (bottle) or1/4such as bags (bottles), etc.
规格等的表述应与用法用量相符。例如，当丸剂的【用法用量】为“Oral. One dose.**g……”when, [Specifications] can be expressed as“Every**Net Weight**g(equivalent to decoction pieces)**g）”, while the quantity specification for [Packaging] is expressed as“Per Bottle**g；当其【用法用量】为“Oral. One dose.1bag……”when, [Specifications] can be expressed as“每袋相当于饮片**g, while the quantity specification for [Packaging] is expressed as“Per bag**g；当【用法用量】为“Oral. One dose.**Pill……”when, [Specifications] can be expressed as“Every**Net Weight**g(equivalent to decoction pieces)**g）”, while the quantity specification for [Packaging] is expressed as“Per bottle (bag)**Pill”。
（三）用语规范的原则
中药规格中的克、毫升等剂量单位分别用英文g、ml等表示，如每粒相当于饮片**g, each1 mlequivalent to decoction pieces**g等。其他丸、袋、粒等剂量单位均用中文表示。Over-the-Counter中药规格中的克、毫升等也均用中文表示。
For prescription drugs in the form of preparations made from decoction pieces, use“相当于”表述；处方药味为有效成份、提取物的制剂，用“Include”表述；处方药味为饮片、有效成份、提取物等多种形式投料的药物，在规格表述中采用“equivalent to decoction pieces**g，含……”表述。
如药品规格不是整数，一般保留不多于两位of小数。
三、不同剂型中成药规格的表述举例
中药复方制剂的药品规格原则上建议按照固体、半固体、液体等的特点分类表述。颗粒剂、片剂、胶囊等固体制剂，其规格可表述为每1 GB、每片或每粒相当于饮片**gFor tablets and capsules, it is recommended to clearly specify the tablet weight or capsule fill amount (e.g., weight per tablet).**g(equivalent to decoction pieces)**g）。合剂（口服液）、洗液等液体制剂（注射剂、定量气雾剂及喷雾剂等除外），其规格可按浓度标示为每1 mlequivalent to decoction pieces**g. Ointments and other semi-solid preparations are labeled as per1 GBequivalent to decoction pieces**g。
Drug specifications for injectables, etc., are indicated by the fill volume in the packaging container and its equivalent theoretical amount of medicinal ingredients. For example, if an injectable contains2ml及10ml两种规格（每ml相当于饮片量1 GB），其药品规格可标示为：（1）每支2ml: equivalent to processed slices2GB；（2）每支10ml: equivalent to processed slices10g。虽然二者药物浓度相同，但仍视为不同药品规格。
中药丸剂的规格可根据丸剂的不同情形分别表述。大蜜丸以每丸相当**g饮片表述，同时标明丸重。滴丸以每gequivalent to dripping pills**gGranule descriptions, with pill weight specified. For honeyed pills, water pills, concentrated pills, etc., the specification is determined based on usage and dosage. When taken by pill weight, the specification is per**g丸剂相当于**gDescription of the decoction pieces, with pill weight specified; for dosing by pill count, per**丸相当于**gThe description of medicinal pieces should be accompanied by the weight of the pills. The pill weight indicated in parentheses serves as a supplementary specification for pill size. Information on pill size can reflect the amount of medicinal pieces contained and may serve as a basis for quality inspection and clinical dosing. For example, the specification description for pills of the same variety is:“Every10Net Weight0.25g(each1 GBequivalent to decoction pieces0.5g）” “Every20Net Weight0.25g(each1 GBequivalent to decoction pieces0.5g）”，二者应视为相同的药品规格。
定量气雾剂及喷雾剂等，在规定包装容器内的装量及其所相当的药味理论量的同时，还应规定每揿所相当的药味理论量。如某定量气雾剂的规格为：10ml: equivalent to processed slices6g（0.1gDecoction pieces×60Press). Among them,“10ml”For the fill volume of aerosols,“equivalent to decoction pieces6g”为10ml气雾剂所相当的饮片量；"0.1g"Decoction pieces”Equivalent amount of decoction pieces per actuation of the aerosol.“60Press”为10ml气雾剂的可揿次数。
不同剂型药品规格的表述参见表2。
Table2 Examples of dosage specifications for different formulations of Chinese patent medicines#
No. | 剂型 | 药品规格 | 装量规格 | One dose |
1 | 丸剂（大蜜丸） | Weight per pill** GB(equivalent to decoction pieces)** GB） | 每盒装**Maru | once**Maru |
Pills (small honey pills, water-honey pills, water pills, concentrated pills) | Every**Net Weight** GB (each1 GBequivalent to decoction pieces** GB）； Every**Net Weight** GB (equivalent to decoction pieces)** GB） | Per Bottle** GB； 每盒装**Maru | once** GB； once**Maru | |
Pills (Dripping Pills) | Every**Net Weight** GB (each1 GBequivalent to decoction pieces** GB） | Per Bottle** GB； Per Bottle**Maru | once** GB； once**Maru | |
2 | 颗粒剂 | Every1 GBequivalent to decoction pieces** GB | Per bag** GB | once**bag |
3 | Tablet | 每片重** GB(equivalent to decoction pieces)** GB）； 糖衣片：每片心重** GB(equivalent to decoction pieces)** GB） | Per Bottle**slice | once**slice |
4 | 胶囊剂 | Per capsule** GB(equivalent to decoction pieces)** GB） | Per Bottle**grain | once**grain |
5 | 合剂（口服液） | Every1 mlequivalent to decoction pieces** GB； Each unit is equivalent to one dose of decoction piece.** GB | Per Bottle** ml； Each pack** ml | 一次** ml； once**支 |
6 | 糖浆剂 | Every1 mlequivalent to decoction pieces** GB | Per Bottle** ml (with scale) | once** ml |
7 | 散剂 | Every1 GBequivalent to decoction pieces** GB | Per bag** GB | once** GB |
8 | 注射液 | 每支** ml: equivalent to processed slices** GB | Each pack** ml | once** ml |
9 | Sterile Powder for Injection | per bottle** GB: equivalent to processed slices** GB | Per Bottle** GB | once**瓶 |
10 | 煎膏剂 | Every1 GBequivalent to decoction pieces** GB | Per Bottle** GB | once** GB |
11 | Tinctures | Every1 mlequivalent to decoction pieces** GB | Per Bottle** ml | once** ml |
12 | transdermal patches, medicated plasters, topical application patches | 每贴相当于饮片** GB (Size) | 每盒装**Paste | once1Paste
|
13 | 软膏剂、乳膏剂 | Every1 GBequivalent to decoction pieces** GB | Each pack** GB | once** GB |
14 | 凝胶剂 | Every1 GBequivalent to decoction pieces** GB | Each pack** GB | once** GB |
15 | Suppository | Each granule is equivalent to one dose of the decoction piece.** GB | 每盒装**grain | once**grain |
16 | 流浸膏与浸膏剂 | Every1 GBequivalent to decoction pieces** GB | Per Bottle** GB | once** GB |
17 | Aerosols, Sprays | 定量：** ml: equivalent to processed slices** GB（**mg Decoction pieces×**揿或喷）； 非定量：每1 mlequivalent to decoction pieces** GB | Per Bottle** ml | 定量：一次** ml； 非定量：一次** 揿或喷 |
18 | 滴眼剂 | Every1 mlequivalent to decoction pieces** GB | Per Bottle** ml | once** ml |
19 | 锭剂 | Each ingot is equivalent to a decoction piece.** GB | 每盒装**锭 | once**锭 |
20 | 灸熨剂 | Every1 GBequivalent to decoction pieces** GB | 每盒装**bag | once**bag |
21 | 涂膜剂 | Every1 mlequivalent to decoction pieces** GB | Per Bottle** ml | once** ml |
22 | 膜剂 | 每片相当于饮片** GB (Size) | 每盒装**slice | once**slice |
23 | Tea bags | Every1 GBequivalent to decoction pieces** GB | Per bag** GB | once**bag |
24 | 其他半固体及固体制剂（糊剂、 胶剂等） | Every1 GBequivalent to decoction pieces** GB | Per unit (bag/box)** GB | once** GB
|
25 | 其他液体制剂（露剂、搽剂、灌肠剂、洗剂、灌注液等） | Every1 mlequivalent to decoction pieces** GB | Per Bottle** ml | once** ml |
#：表中药品规格的表述以处方药味均为饮片为例。