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    Home > Chemicals Industry > Chemical Technology > Technical requirements for development and calibration of Chinese medicine reference materials (2)

    Technical requirements for development and calibration of Chinese medicine reference materials (2)

    • Last Update: 2022-06-22
    • Source: Internet
    • Author: User
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    2.
    Technical requirements for the development and calibration of reference medicinal materials

    1.
    The reference medicinal material is the physical control used in the inspection of the national drug standard, and it is the national drug standard material, which is based on the "Chinese Pharmacopoeia", the drug standard issued by the former Ministry of Health, the new drug standardization standard, and the drug standard issued by the former State Food and Drug Administration It is stipulated that the control substance used for thin-layer identification test of traditional Chinese medicinal materials and prescription preparations is generally a powder made of pure medicinal materials that have not been burned or chemically extracted

    .
    Reference medicinal materials, as the national statutory reference materials for drug inspection, play an important role in the implementation of national drug standards, the standardization and reproducibility of inspections of medicinal materials, Chinese patent medicines, etc.
    , which cannot be replaced by other substances

    .

    2.
    The reference drug species comprises determining the calibration procedure, the collection and initial inspection of raw materials, feedstock appraisal Pharmacognosy, pulverized raw materials, finished products and other physical and chemical calibration

    .

    (1) Investigation on the acceptance of drug standards

    The research and development varieties of reference medicinal materials are mainly based on the current national drug standards, including: "Chinese Pharmacopoeia" (current edition), the former State Food and Drug Administration National Drug Standards, "New Drug Standardization Standards", and the original State Food and Drug Administration "national standards compilation medicine (medicine local standards rising national standards section)," the former Ministry of health drug standard "Chinese medicine prescription preparations," the former Ministry of health drug standard "drug positive standard" and so on
    .

    (2) Collection and storage of reference medicinal materials

    1.
    The raw materials of reference medicinal materials refer to the pure medicinal materials that are accurate and single in origin for the preparation of reference medicinal materials and whose quality meets the requirements of national or local drug standards

    .

    2.
    The quality of reference medicinal materials In order to ensure the quality of reference medicinal materials and the stability and consistency between batches, the source of the reference medicinal materials should be relatively stable, and the collection location, time, and processing methods should be relatively fixed

    .

    3.
    Key technical indicators Several key technical indicators that should be referred to in the procurement or collection, preparation and calibration of specific varieties of raw materials

    .
    Including: Chinese name, Latin scientific name, origin, customary name of origin, harvest date, processing method of origin, medicinal parts, etc.
    , and attention should be paid to the origin, origin, medicinal part, appearance quality specification grade and previous batch of the variety.
    Consistency of times

    .

    (3) Pharmacognosy identification of reference medicinal materials

    1.
    The reference medicinal materials should have a complete base identification report as far as possible, especially the first batch of raw materials

    .
    For each batch of reference medicinal materials, the source and related information should be recorded in detail as much as possible, such as botanical name, medicinal parts, production environment, harvest location, harvest time, post-harvest treatment process, storage conditions, harvester or unit, etc.
    Information

    .

    2.
    The stacked photos of the entire batch of raw materials try to fully reflect the overall situation of the batch of raw materials from different angles

    .

    3.
    Preliminary inspection should conduct preliminary inspection of raw materials to determine whether the name of the raw materials and medicinal parts meet the standard requirements.
    After confirming that the corresponding standards are correct, the raw materials samples must be inspected and selected (such as: removal of impurities, insects, mold, non- Medicinal parts, etc.
    ), and briefly describe the situation before and after the sample inspection and selection in the experimental record

    .

    4.
    Appraisal results and conclusions shall be inspected according to the technical requirements of drug standards and reference medicinal materials development, and original records shall be made.
    Both character identification and microscopic identification shall be accompanied by pictures of key features, and the character and microscopic identification results and conclusions shall be issued

    .

    (4) Physical and chemical calibration of reference medicinal materials

    The sample for physical and chemical calibration must be the finished powder that has passed the pharmacognosy identification and crushed the entire batch of raw materials
    .
    Pay attention to uniformity and representativeness when sampling

    .
    The requirements for physical and chemical calibration items are as follows:

    1.
    A brief description of the raw materials.
    There should be at least two conditions for thin-layer identification.
    First, select the test specified in the standard, and then conduct the test with a different extraction method or unfolding condition from the standard according to the composition of the medicinal material

    .
    The tested medicinal materials must have the same chromatographic behavior as the reference medicinal materials or specimens.
    If the main chemical components have known chemical reference materials, they should have consistent chromatographic spots with the chemical reference materials

    .

    2.
    The first batch of reference medicinal materials should be verified by selecting the thin-layer identification conditions of 1 to 3 related Chinese patent medicines according to the situation

    .
    The first batch of reference medicinal materials developed is generally based on accurate and reliable medicinal material specimens or collected plant specimens as a control.
    At the same time, the preparation of the reference medicinal material should be investigated

    .

    (1) Inspection item: Impurities should be removed according to the standard
    .

    (2) Assay items: Assay shall be carried out in accordance with the regulations of medicinal materials standards, and shall comply with the regulations of medicinal materials standards
    .

    (3) Physical and chemical testing of the changed varieties: the first batch of reference medicinal materials must be used as a control, and the monomer Chinese medicine chemical reference materials shall be used as the control at the same time as possible.
    The results of thin-layer chromatography must be consistent with the first batch of chromatograms to ensure the continuity of the reference medicinal materials

    .

    3.
    Technical requirements for the development and calibration of control extracts

    Control extract is a type of non-monomeric component control substance, including medicinal material control extract and volatile oil control substance, used for thin layer chromatography or other chromatographic identification or content determination (labeled content control extract)
    .

    (1) Source, extraction, separation and purification of raw materials

    1.
    The source of the raw materials should be determined according to the types of medicinal materials or proprietary Chinese medicines specified in the national standards.
    The raw materials of the medicinal materials should generally be authentic medicinal materials of mainstream commodities, or cultivated high-quality Chinese medicines that meet the requirements of GAP specifications.
    At the same time, the collection time, location and processing method should be fixed

    .

    2.
    The extraction process should be based on the drug standards and the effective ingredients or effective parts and its physical and chemical properties, and at the same time, according to the extraction principle and experimental analysis results, select the appropriate extraction method, design a reasonable process route, and determine the design basis of the extraction process

    .
    After the preliminary determination of the extraction process route, the factors that may affect the extraction effect should be fully considered, scientific and reasonable experimental design should be carried out, accurate, simple, representative, and quantifiable evaluation indicators and methods should be adopted to optimize the reasonable extraction process conditions

    .

    (2) Separation and purification research

    The separation and purification process includes two aspects: one is to select the corresponding separation method and conditions according to the nature of the crude extract to obtain an effective extraction material; the other is to remove invalid and harmful components, and try to retain the effective ingredients or effective For the part, various purification and refining methods can be used to enrich the target components in a targeted manner
    .

    (3) Physical and chemical inspection

    It mainly includes general physical and chemical identification, chromatographic or spectral identification, and the establishment of fingerprint or characteristic maps
    .

    1.
    Chromatographic identification should be compared with related chemical reference substances, reference medicinal materials or pharmaceutical preparations to determine their consistency

    .
    At the same time, in order to ensure consistency between batches of reference materials, their fingerprint or characteristic maps should be established

    .

    2.
    The inspection items include impurities, moisture, ash, acid-insoluble ash, heavy metals, arsenic salts, pesticide residues, related toxic components and other necessary inspection items

    .
    The corresponding limits shall be specified based on the measurement results of more than three batches of samples

    .

    3.
    Establishment of fingerprint or characteristic pattern.
    For fingerprint or characteristic pattern detection control extract, HPLC or GC method should be used to establish fingerprint pattern or characteristic pattern, and confirm the chromatographic peak with clear structure as much as possible, with fingerprint pattern attached.
    Or feature map

    .

    (4) Fixed value of multi-component components

    For reference extracts, for the main active ingredients or characteristic ingredients and other ingredients with declared value, the method of collaborative calibration should be adopted, and the collaborative unit requires more than 3
    .
    The results of the collaborative calibration are determined after mathematical statistics.
    At the same time, the durability of the control extract after the determination should be investigated, including the analysis and determination conditions, different laboratories, and the determination of related preparations

    .

     

     

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