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    Home > Chemicals Industry > Chemical Technology > General Overview of Drug Reference Materials (1)

    General Overview of Drug Reference Materials (1)

    • Last Update: 2022-06-24
    • Source: Internet
    • Author: User
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    Standard materials and analytical testing technology are inseparable.
    Modern analytical testing technology has evolved from classic, single, and simple matrix testing to modern analytical instrument-based, multi-component, trace, and complex matrix testing.
    The difficulty and complexity of the test has increased significantly

    .
    In recent years, with the rapid development of health care and the pharmaceutical industry, the application of medical reference materials has become more and more extensive

    .
    This type of reference material not only has a wide range of varieties and covers a wide range, but also has an increasing number.
    It is essential to ensure the quality of medicines

    .
    Obviously, the drug quality standard is related to the reference material used for analysis and testing.
    In fact, the reference material is the material basis of the quality standard.
    It is a special special measuring tool used to check the quality of medicines.
    It is the benchmark for measuring the quality of medicines.
    As a material standard for calibrating test instruments and methods

    .
    In drug testing, it is a comparison to determine the authenticity of drugs and is necessary to control the quality of drugs

    .

    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
    .
    Therefore, the research and application of medical reference materials is of great significance for promoting the production of medicines, improving the quality of medicines, and ensuring the safety and effectiveness of medicines used by the people

    .

    I.
    Overview

    (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.
    The preparation method, calibration method, calibration fruit, value accuracy, value traceability, stability, and sub-packaging and packaging conditions are subject to comprehensive technical review and approval

    .

    (2) Basic requirements for reference materials

    The drug standard substance is different from the general drug.
    It is a measurement standard product issued by the state.
    It is mainly characterized by the stability, uniformity and accuracy of the characteristic value

    .
    These three characteristics are also the basic requirements of standard materials

    .

    (3) The characteristics of drug reference materials

    Pharmaceutical standard materials should have stability, uniformity and accuracy
    .

    1.
    Stability refers to the ability of a reference material to maintain a stable characteristic value under a specified time and environment;

    2.
    Uniformity refers to the state in which one or several characteristics of a standard substance have the same composition or structure, including the characteristics of the substance itself and certain parameters of the measurement method used (such as precision and sample size);

    3.
    Accuracy means that the standard material has an accurately measured or strictly defined standard value (also called the guaranteed value or the certified value)

    .
    When the standard value is determined by the measurement method, the standard value is the best estimate of the true value of the identified characteristic quantity, and the deviation between the standard value and the true value does not exceed the uncertainty of measurement

    .
    In addition to meeting the above basic requirements, standard materials should also meet the following requirements:

    (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 development history of Chinese medicine reference materials

    The establishment and development of standard materials of traditional Chinese medicine are closely related to the development of the "Chinese Pharmacopoeia".
    The 1985 edition of the "Chinese Pharmacopoeia" included 76 chemical reference substances and reference medicinal materials in the standard for the first time.
    Since then, it has been unstoppably increasing rapidly

    .
    At the same time, the former Ministry of Health and the former National Food and Drug Administration drug standards (standards for preparations of traditional Chinese medicines, standards for new medicines, national standards for traditional Chinese medicine health drugs, local standards to national drug standards, etc.
    ) Significant increase

    .
    In order to ensure the implementation of drug standards, the China Inspection Institute has supplied 76 kinds of Chinese medicine standard materials since 1988, and reached 1,235 kinds of Chinese medicines in the 2011 edition (Table 16-1 and Table 16-2).
    At the same time, it has provided a large number of new medicines for the development of Chinese medicines and scientific research of Chinese medicines.
    The control substance has achieved significant social benefits

    .

    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.
    Classification and use of Chinese medicine reference materials

    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
    .

    Related Links: Safety Inspection of Traditional Chinese Medicine Injections (5)

     

     

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