Technical Guidelines for the Expression of Specifications in Traditional Chinese Medicine

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Technical Guidelines for the Expression of Specifications in Traditional Chinese Medicine

1. Overview

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.

The specification is a critical component of the drug package insert. Its wording should provide accurate information on the quantity of active ingredients to facilitate the sale, storage, transport, distribution, and use of the medicine. Although Chinese patent medicines cannot directly state the amount of each constituent ingredient, they can indicate the dosage of medicinal herbs required to produce a single unit formulation. Based on this understanding, the specification for Chinese patent medicines should generally include the theoretical or labeled amount of herbal ingredients (including processed slices, extracts, or active compounds) equivalent to one unit of the finished product.

The specification of traditional Chinese medicine products should be expressed in accordance with this guidance. Given the complexity of traditional Chinese medicines, if strict adherence to this guidance is not feasible in practice, a case-by-case analysis may be conducted, and alternative reasonable methods may be used to indicate the amount of drug contained in each dosage unit.

II. General Principles for Describing Specifications of Chinese Patent Medicines

(I) Principles Corresponding to Prescription Drug Flavors

For preparations of proprietary medicines consisting of medicinal herbs in decoction pieces, the product specification should generally indicate the weight of decoction pieces equivalent to one unit dosage form. For example, for tablets composed of medicinal herbs in decoction pieces, the product specification may be stated as:“Weight per unit**g(equivalent to decoction pieces)**g）”; Liquid preparations, their drug specifications may be labeled as“each1 mlequivalent to decoction pieces**g。

For preparations of prescription drugs where the specification is based on active ingredients or similar components, the drug strength may be stated directly as the indicated amount of such active ingredients per unit preparation. For example, for Elsholtzia ciliata extract drop pills with active ingredients as the formulation, the strength may be labeled as:“Each pill contains 10mg of flavonoids from Erigeron brevipetiolus.4mg。

For prescription drugs in the form of extracts such as crude extracts, fluid extracts, or vegetable oils, the drug specification may be expressed as the theoretical amount of the corresponding medicinal ingredient contained in each dosage unit. For example, if a granule formulation contains**Extracts and decoction pieces may be labeled as: per1 GBequivalent to decoction pieces**g, including**Extract**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:“Each piece is equivalent to a decoction piece.**g, containing extract**mg。

For prescriptions containing chemical drugs or active ingredients, the strength of each must be clearly stated.

Table1 Examples of specification descriptions for different types of medicinal ingredients

Equivalent amounts of decoction pieces corresponding to the same dosage unit of a drug product are generally considered the same specification. For products of the same variety, if the amount of active ingredient per unit volume or weight is identical (excluding injections, metered-dose aerosols, sprays, etc.), they are generally regarded as having the same specification; however, products with different concentrations are generally considered to have different specifications.

Drug specifications generally do not include information about excipients. Formulations equivalent in dosage to the reference product, such as sugar-free granules versus lactose-based granules or film-coated tablets versus sugar-coated tablets due to differences in excipients, are considered the same drug specification. However, due to the unique characteristics of traditional Chinese medicine (TCM) pills, honeyed pills and water-honeyed pills are treated as distinct drug specifications.

(II) Principle of Consistency with Usage and Dosage, and Fill Volume Specifications

The dosage specification of a drug indicates the amount of the drug formulation contained in the smallest packaging unit, such as per strip.12Packs, each bottle contains100 ml, per bag10g, etc. Drug specifications should be consistent with the "Dosage and Administration" and "Packaging" sections of the package insert, including pack sizes.

Specifications should be clear to ensure accurate dosing. Except for pediatric use, phrases like "take once" should generally be avoided.1/3bag (bottle) or1/4such as bags (bottles), etc.

Specifications and related descriptions must align with the "Dosage and Administration" section. For example, when the "Dosage and Administration" for pills is“Oral. One dose.**g..."When, [Specification] can be expressed as“each**Net Weight**g(equivalent to decoction pieces)**g）”, and the fill specification for [packaging] is stated as“Per Bottle**g; when its [Usage and Dosage] is“Oral. One dose.1bag……”When, [Specification] can be expressed as“Each bag is equivalent to a decoction piece.**g, while the quantity specification for [Packaging] is expressed as“Per bag**g; When [Usage and Dosage] is“Oral. One dose.**Maru……”When, [Specification] can be expressed as“each**Net Weight**g(equivalent to decoction pieces)**g）”, and the net quantity specification for "Packaging" is expressed as“Per bottle (bag)**Maru”。

(3) Principle of Standardized Terminology

In TCM product specifications, dose units are translated as follows: - **克 (g)** → **g** - **毫升 (mL)** → **mL**g、machine learningequivalent to, such as each granule being equivalent to a decoction piece**g, each1 mlequivalent to decoction pieces**gOthers. Dosage units such as pills, bags, and granules shall be expressed in Chinese.Over-the-CounterUnits in traditional Chinese medicine specifications, such as grams and milliliters, are also expressed in Chinese.

For prescription drugs in the form of preparations made from decoction pieces, use“equivalent to”Formulation; preparations of prescription drugs containing active ingredients or extracts, use“Include”Statement: For prescription drugs supplied in various forms such as decoction pieces, active ingredients, or extracts, the specification shall be expressed as follows:“equivalent to decoction pieces**g, including……”Expression.

If the drug specification is not an integer, round to no more than two decimal places.ofDecimal.

III. Examples of Terminology for Specifications of Different Dosage Forms of Chinese Patent Medicines

For traditional Chinese medicine compound preparations, dosage forms should generally be specified according to their physical characteristics, such as solid, semi-solid, or liquid. For solid dosage forms like granules, tablets, and capsules, the strength should be expressed as amount per unit (e.g., per tablet, per capsule).1 GB, equivalent to one piece or one granule of the decoction piece**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). Liquid preparations such as mixtures (oral liquids) and washes (excluding injections, metered-dose aerosols, and sprays) may be specified by concentration as per...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 contains2 mland10 mlTwo sizes (eachmachine learningequivalent to the decoction piece dosage1 GB), its drug specification may be indicated as: (1) each2 ml: equivalent to processed slices2GB；（2) each10 ml: equivalent to processed slices10gAlthough both have the same drug concentration, they are still considered different specifications.

The specifications of traditional Chinese medicine pills can be expressed differently depending on the type. For large honeyed pills, the specification is based on each pill being equivalent to...**gGranules, with weight per pill specified. For drop pills, per unitgequivalent 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**gPellets are equivalent to**gDescription of the decoction pieces, with pill weight specified; for dosing by pill count, per**Wan is equivalent to**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:“each10Net Weight0.25g(each1 GBequivalent to decoction pieces0.5g）” “each20Net Weight0.25g(each1 GBequivalent to decoction pieces0.5g）”Both should be considered the same drug specification.

For metered-dose inhalers and sprays, in addition to specifying the fill volume per container and its equivalent theoretical drug content, the amount of theoretical drug delivered per actuation must also be specified. For example, the specification for a certain metered-dose inhaler is:10 ml: equivalent to processed slices6g（0.1gDecoction pieces×60Press). Among them,"10ml"For the fill volume of aerosols,“equivalent to decoction pieces6GFor10 mlEquivalent amount of crude herbs for the aerosol;"0.1g"Decoction pieces”Equivalent amount of decoction pieces per actuation of the aerosol.“60Press”For10 mlNumber of actuations for the aerosol.

See the table for expressions of different dosage forms and specifications.2。

Table2 Examples of dosage specifications for different formulations of Chinese patent medicines^#

#: The drug specifications in the table are illustrated using decoction pieces as an example for all prescription ingredients.