Points of Attention in the Formulation of Provincial Standards for TCM Formula Granules​

5;">On February 10, the State Drug Administration, the State Administration of Traditional Chinese Medicine and other four departments jointly issued the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" (hereinafter referred to as the "Announcement") to end the pilot work of Chinese Medicine Formula Granules.
The release of the "Announcement" marks a new stage in the production and supervision of traditional Chinese medicine formula granules.

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5;">According to the requirements of the "Announcement", qualified manufacturing enterprises can report to the local provincial drug supervision and administration department for the production of traditional Chinese medicine formula granules.

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5;">  The "Announcement" requires that the formulation of provincial standards for traditional Chinese medicine formula granules should be implemented in strict accordance with the "Technical Requirements for Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules".
The formulation of provincial standards for traditional Chinese medicine formula granules should focus on the following points:

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5;">  One is the representativeness of the research samples.
Collect more than 15 batches of raw medicinal material samples of the same base that meet the requirements of the drug standards from different origins, including the local area, main production area, etc.
, on the basis of sufficient production area research, and prepare samples of Chinese medicine decoction pieces for research in accordance with the drug standards or the processing specifications of traditional Chinese medicine decoction pieces.
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5;">  The second is the standardization of standard decoction research.
The standard decoction is a material benchmark for measuring the "consistency" of the traditional Chinese medicine formula granule and the traditional Chinese medicine decoction.
The standardization of the standard decoction covers the authenticity of the decoction pieces (medicinal materials), the consistency of the decoction process, and the rigor of quality control.
Therefore, the preparation of standard decoctions should refer to the "Management Regulations of Traditional Chinese Medicine Decoction Chambers in Medical Institutions" and adopt the traditional decoction mode.
The standard decoction is prepared by decocting and extracting pieces of traditional Chinese medicine, filtering solid-liquid separation, low-temperature concentration, and freeze-drying.
Through 15 batches of standard decoctions’ ointment rate, effective ingredient (or index component) content and content transfer rate, characteristic map and other data, the three basic quality indicators of standard decoctions are analyzed, which are the technological research and development of traditional Chinese medicine formula granules.
Provide basis for the formulation of quality standards.

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5;">  The third is the rationality of process research.
The main evaluation criteria for the rationality of the preparation process of traditional Chinese medicine granules are the three quality indicators of the above-mentioned standard decoction.
Therefore, the determination of extraction time, extraction times, concentration, drying, granulation and other process parameters in process research should be based on the quality indicators of standard decoctions.
The amount of prescription, the total amount of preparation, and specifications should also correspond to the quality indicators of the standard decoction.
The quantity and quality transfer of key quality attributes between Chinese herbal medicines, Chinese herbal medicines, standard decoctions, intermediates, and finished products should be relevant.

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5;">  The fourth is the scientific and rigorous quality standard research.
The formulation of the quality standard of traditional Chinese medicine formula granules should be based on the characteristics of traditional Chinese medicine formula granules.
Since the Chinese medicine decoction pieces have lost the distinguishing characteristics of TCM decoction pieces after being made into granules by decocting in water, special attributes such as characteristic maps or fingerprints should be adopted for overall control.
Method for identification; content determination should select water-soluble active ingredients or exclusive index components as determination indicators, and establish reasonable upper and lower limits based on the content of standard decoction and the range of content transfer rate.
In addition, in order to effectively control the safety of traditional Chinese medicine formula granules, corresponding inspection items should be formulated in accordance with the heavy metals, pesticide residues, and mycotoxin limits stipulated in the quality standards of Chinese herbal medicines and Chinese herbal medicines.
The standards for Chinese herbal medicines and Chinese herbal medicines do not stipulate the above safety.
Corresponding inspections should be conducted on the varieties of sexual inspection items, and control should be determined based on the results of the inspections.

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5;">  Fifth, the importance of quality standard review.
The review of quality standards is an important part of investigating the reproducibility and feasibility of standards.
The quality standards should be reviewed before the draft quality standards are upgraded to official standards.
Provincial drug inspection departments or other qualified inspection agencies should be organized to formulate quality standards.
The draft is reviewed to ensure the feasibility of the standard.

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5;">  The formulation of provincial standards for TCM formula granules is an important work related to the healthy development of the TCM formula granules industry.
It is hoped that all provinces can work together to give full play to the experience of the original pilot enterprises of TCM formula granules and the scientific research advantages of scientific research institutions, and formulate an effective formula as soon as possible.
Provincial standards for controlling the quality of traditional Chinese medicine formula granules.
(Author's unit: Hebei Pharmaceutical and Medical Device Inspection and Research Institute)