General Overview of Drug Reference Materials (1)

Standard materials and analytical testing technology are inseparable.

In view of the important status and role of medical reference materials, the content and development status of this work directly reflect the scientific and technological level of China's pharmaceutical industry and health services

I.

(1) Technical review and approval

According to the "Drug Administration Law" and "Administrative Measures for Drug Registration", the China Food and Drug Control Institute (hereinafter referred to as the China National Inspection and Quarantine Institute) is responsible for the calibration and management of national drug standard materials, and is responsible for the selection and management of standard materials.

(2) Basic requirements for reference materials

The drug standard substance is different from the general drug.

(3) The characteristics of drug reference materials

Pharmaceutical standard materials should have stability, uniformity and accuracy

1.

2.

3.

(1) Availability: production enterprises or research institutions should be able to sustainably provide raw materials (materials);

(2) Applicability: It should be consistent with the use requirements and meet the requirements of the corresponding national drug standards

2.

The establishment and development of standard materials of traditional Chinese medicine are closely related to the development of the "Chinese Pharmacopoeia".

Table 16-1 Statistical Table of the Quantity of TCM Standard Substances Contained in the Chinese Pharmacopoeia

Table 16-2 Statistical Table of Quantity in the Supply of TCM Standard Materials from 1988 to 2009

3.

Traditional Chinese medicine standard materials are mainly divided into three categories: Chinese medicine chemical reference substances, reference medicinal materials, and reference extracts

(1) Chinese medicine chemical reference substance

Chinese Chemical Reference, refers to a single component or mixed components for medicines (including Pieces), extract, medicine, and other materials test standard
.

(2) According to the purpose, it is mainly divided into 3 categories

1.
Chinese medicine chemical reference substance for identification is mainly used for thin layer chromatography, gas chromatography and other chromatographic identification items of Chinese medicinal materials, Chinese medicinal pieces, Chinese medicinal extracts and Chinese patent medicines.
The purity should reach more than 95%, and the value is not labeled
.

2.
Chinese medicine chemical reference substance for content determination is used for the determination of Chinese medicinal materials, Chinese medicinal pieces, Chinese medicinal extracts and Chinese patent medicines by ultraviolet spectrophotometry, colorimetry, thin-layer scanning method, liquid chromatography, gas chromatography, etc.
Indicate the value and the processing method before use
.

3.
The chemical reference substance of traditional Chinese medicine for impurity inspection is used for the chromatographic inspection of impurities in Chinese medicinal materials, Chinese medicinal pieces, Chinese medicinal extracts and Chinese patent medicines, and the limit inspection of different medicinal materials or toxic ingredients
.

(1) Traditional Chinese medicine reference medicinal material: It is the original medicinal material powder of the confirmed variety.
It is another type of reference material used for thin-layer identification in China's drug inspection work according to the standard.
It is mainly used for Chinese medicinal materials, Chinese medicinal pieces, Chinese medicinal extracts, etc.
Thin-layer identification of proprietary Chinese medicines
.
Reference medicinal materials, as national drug standard materials, play an important role in the standardization, specificity, and reproducibility of the inspection of Chinese medicinal materials and proprietary Chinese medicines, which cannot be replaced by other substances
.

(2) TCM control extract: extract prepared by means, comprising a plurality of main index components or active ingredients for medicine (including Pieces), for measuring the standard substance extract, medicine and other identification or content
.
Including medicinal material extraction control substance and volatile oil control substance, used for thin-layer chromatography, other chromatographic identification and quantitative determination of labeled content
.
At present, the China Inspection Institute has distributed 20 kinds of varieties: Ginkgo biloba leaf control extract, Dioscorea nigra saponins extract, Panax notoginseng saponins , Panax notoginseng stem and leaf saponins , Ginseng stem and leaf saponins , Huangyao saponins extract, Golden gentian Grass extract, nepeta oil, ginger oil , turmeric oil , star anise oil, houttuynia cordata oil , vitex oil , cumin oil , perilla oil , cinnamon oil , peppermint oil , scented rhododendron oil , evening primrose oil , Job's tears and so on
.

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