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    Home > Chemicals Industry > Chemical Technology > Sub-packaging and supply of Chinese medicine reference materials-sub-packaging, packaging and storage

    Sub-packaging and supply of Chinese medicine reference materials-sub-packaging, packaging and storage

    • Last Update: 2022-06-22
    • Source: Internet
    • Author: User
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    At each stage of the process of sub-packaging and packaging of traditional Chinese medicine reference materials, a stable control procedure that is suitable for the characteristics of the reference material and is beneficial to the characteristics and the value of the characteristics should be established
    .

    Traditional Chinese medicine reference materials should generally be stored in a dry, cool and clean environment.
    For some special storage requirements, special storage measures should be taken, and they should be indicated in the label and instruction manual

    .

    The supply of Chinese medicine reference materials has been mainly based on the China National Inspection Institute (first-level supply) and supplemented by provincial and municipal drug inspection institutes (second-level supply) for many years
    .
    In order to continuously improve the current situation of the supply of drug reference materials, the China Inspection Institute established a reference material supply management information platform in 2010

    .
    At the same time, the platform has established a dynamic management mechanism for subscribing and inventory of secondary supply units, so as to correctly grasp the national demand for each product

    .
    At the same time, the Central China Inspection Institute will
    publish the basic information of the standard material supply on the "standard material" secondary page of the website ( ), including: serial number, product name, batch number, specification, use, storage conditions, whether it is out of stock, price, for batch information
    .
    Through the disclosure of supply information, we will continuously improve service quality and achieve smooth supply of reference materials

    .

    Repacking, packaging and warehousing

    In order to ensure the standardization and uniformity of the preparation and production process of drug reference materials, the standard material packaging work adopts an electronic office management mode, with the help of a special information management system, receiving the packaging card information transmitted by related varieties, and arranging and carrying out the preparation and production work:

    1.
    Sub-assembly requirements

    (1) Sub-packaging of chemical reference substance of traditional Chinese medicine

    Chemical Reference 1.
    The medicine is dispensed in between one hundred thousand purification dispensing, dispensing with on-load between the loaded table, glove box and the like

    .

    2.
    The drugs that are easy to absorb moisture, easy to oxidize (filled with N2 or inert gas), easy to cause allergies, and poisonous and harmful drugs are packed in the glove box

    .

    3.
    The solid powder is mainly divided by hand.
    With the help of a balance, under appropriate packaging conditions (ambient temperature, humidity, dark, oxygen content, and removal of static electricity, etc.
    ), use suitable containers for packaging, mainly using cillin bottles , Screw-top bottle and easy-folding ampoule 3 kinds of containers

    .

    4.
    Solid powder standard materials with large loading and moderate fluidity For solid powder standard materials with large loading and moderate fluidity, a screw-type filling machine is used instead of manual filling

    .

    5.
    Liquid standard materials are divided into liquid distributors, and then uniformly fused and sealed by a fusion-sealing machine

    .

    6.
    For nitrogen-filled or inert gas varieties, online N2 or Ar2 or fusion-sealing methods are used for nitrogen-filled or inert gas varieties

    .

    As the standard substance packaging work is gradually becoming automated, the liquid packaging has also tried to use the peristaltic pump continuous packaging mode, linked to the melting and sealing machine, and continuously improving work efficiency
    .

    (2) Sub-packaging of Chinese medicine reference medicinal materials

    1.
    Traditional Chinese medicine reference materials are usually crushed evenly and then packed.
    The crushing operation needs to be carried out in a dry, non-cross-contamination environment.
    Some reference materials require simple pretreatment

    .

    (1) Direct crushing: After pretreatment, select crushing equipment and methods according to the characteristics of the variety.
    Some Chinese medicines can be crushed directly with crushing equipment

    .

    (2) Frozen crushing: For some oily medicinal materials such as peach kernels, or medicinal materials with high sugar content and high viscosity, such as wolfberry, try to use the method of freezing crushing, vacuuming and nitrogen filling, which greatly reduces This kind of raw material is lost during the crushing process
    .

    (3) Distributed packaging: the crushed raw materials need to be repeatedly mixed by machinery until they are uniform before distributing
    .

    2.
    The packaging conditions of the control medicinal materials are produced in accordance with GMP, and are generally operated in a clean room with constant temperature, humidity, and class D (class 100,000)

    .

    (1) Poisonous and harmful varieties: must be operated in a glove box
    .

    (2) Crushed raw materials: most of them are packed in a closed glove box
    .

    (3) For some raw materials with relatively uniform powder and smaller packaging specifications: a packaging machine should be selected for packaging
    .

    3.
    7ml vials are usually used for the sub-packaging containers of medicinal materials.
    After sub-packaging is completed, cap and seal

    .

    (1) Raw materials with a large capacity: select plastic bottles of different specifications for sub-packaging, and seal with a plastic sealer
    .

    (2) Raw materials with higher volatility: select ampoules for packaging and melt-sealing
    .

    4.
    After clearing the site and sub-packaging, clear the site carefully to prevent cross-contamination between different varieties

    .

    2.
    Packaging requirements

    (1) Packaging of Chinese medicine reference materials

    It is suitable for the quality of pharmaceutical standard materials, and is convenient for storage, transportation and use
    .

    1.
    The label should be labeled packaging, and accompanied by instructions for use, the user provides the following information: name, serial number, lot number, purpose, characteristics values, storage conditions, using methods and precautions

    .

    2.
    The supplier’s certification is usually to meet the requirements of moisture-proof, light-proof and oxidation-proof packaging containers.
    The packaging material supplier shall provide the test results of the moisture permeability test and sealing test of the materials used to prove that the quality is qualified

    .

    3.
    Separate packaging of standard materials.
    At present, most standard materials are mainly divided into brown vials, sealed with rubber stoppers and rolled aluminum caps.
    It is easy to seal and open while meeting the requirements of shading and moisture resistance

    .

    (1) For standard substances that are easily oxidized, brown vials are still used, but they need to be filled with nitrogen or argon to avoid oxidation
    .

    (2) The chemical reference substance that is easy to absorb moisture needs to be packed in Ambe bottles, and the mouth of the bottle is melted and sealed by the linkage sealing machine
    .

    (3) There are also a small number of standard substances with large quantities that are packaged in plastic bottles and sealed with an aluminum foil sealer
    .

    (2) Requirements for the packaging process of Chinese medicine reference materials

    1.
    Before packaging, it mainly includes checking whether the label on the outer packaging is consistent with the product name, batch number, specification and other information before the packaging work starts

    .

    2.
    Workplace packaging is generally in a relatively well-ventilated workplace.
    For toxic and harmful varieties, it must be packaged in a glove box, and protective equipment such as gloves, masks, etc.
    must be worn

    .

    3.
    After the packaging is finished, count the number of packages, destroy the remaining labels, and clean the work site

    .

    Three, storage requirements

    The storage conditions of Chinese medicine reference materials should be suitable for the requirements of the reference materials and be conducive to the stability of the characteristics and the value of the characteristics
    .

    Generally, it should be stored in a dry, cool and clean environment
    .
    For some special storage requirements, special storage measures should be taken and indicated in the label and instruction manual

    .

    Related Links: Technical Review of Drug Development Report

     

     

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