Beijing clarifies the work procedures for formulating standards for traditional Chinese medicine formula granules

Medical Network, July 13th.
Recently, the Beijing Municipal Drug Administration issued a notice on the "Beijing Chinese Medicine Formula Granule Standard Formulation Work Procedures and Application Requirements (Trial)" to regulate the research, application and formulation of the standard for Chinese medicine prescription granules
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"Beijing Chinese Medicine Formula Granule Standard Formulation Work Procedures and Application Requirements (Trial)" is divided into four parts: basic principles, basic requirements, working procedures and division of labor, and application materials requirements
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Regarding the basic principles, it is required to adhere to four aspects
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One is to adhere to the theoretical guidance of traditional Chinese medicine to meet clinical needs
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The preparation of decoction pieces used in formula granules should follow the theoretical guidance of traditional Chinese medicine , inherit the experience and technology of traditional decoction pieces processing, and give play to the characteristics and advantages of TCM clinical medicine
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Second, according to adhere to regulations Fan develop
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Standard formulation work should be carried out in accordance with the "Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules", in accordance with the current "Chinese Pharmacopoeia" and "National Pharmaceutical Standards Technical Specifications" format and terminology, to ensure accurate wording, concise language, and logic Be rigorous and avoid misunderstanding and ambiguity
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The third is to persist in inheriting and protecting local characteristics
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Inherit, sort out and excavate local experience and technology to meet the clinical needs of local Chinese medicine, mainly including the "Chinese Pharmacopoeia" and "Beijing Traditional Chinese Medicine Processing Standards" varieties
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The fourth is to insist on scientific and rigorous research
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During the research process, attention should be paid to the whole process investigation of the source of medicinal materials , production transfer, and clinical use.
The factors affecting the quality of formula particles should be fully considered, the standard items and content should be determined in a targeted manner, and specific quality control methods and methods should be studied and established.
Detection indicators
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Regarding the basic requirements, three aspects are involved
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The first is the principle of species collection.
It is required that the species to be included should be those with a clinical history and demand, characteristic processing technology, safe, effective, and controllable quality to meet the clinical needs of Beijing’s traditional Chinese medicine.
In principle, they should be the current Chinese Pharmacopoeia Types of Chinese herbal medicines that have been included in the "Beijing Regulations for the Processing of Chinese Herbal Medicines"
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The second is the basic requirements of the production process, requiring the preparation of traditional Chinese medicine formula granules, except for the molding process, the rest should be basically the same as the traditional decoction; the effective substances of the Chinese medicine formula granules should be basically the same as the standard decoction of traditional Chinese medicine
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The third is the technical requirements for standard formulation, requiring relevant research to be carried out in accordance with the "Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formulation Granules".
The quality control items should be complete and verified by methodology, the indicator components should be selected appropriately, the testing methods should be scientific and the limits should be reasonable.
Satisfy the purpose of controlling the quality of decoction pieces, at least not lower than the corresponding standard of traditional Chinese medicine decoction pieces
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Regarding the work procedures and division of labor, it is required to determine the varieties to be standardized in accordance with the principle of variety inclusion, and based on the progress of national standard formulation, give priority to the development of standards for varieties with high clinical demand, large usage, and research foundation, and the number of varieties should be basically satisfied.
Beijing clinical prescriptions are routinely adjusted and used
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In addition, the notice also clarified the list of requirements for application materials
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