Discussion on Revision，Implementation and Supervision of Regulations on Processing of Decoction Pieces of Chinese Crude Drugs / 中国实验方剂学杂志

ABSTRACT

In recent years, in order to further improve the quality of decoction pieces of Chinese crude drugs, many related basic research work around the processing of decoction pieces of Chinese crude drugs have been carried out by relevant experts. Many opinions and suggestions on the revision of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs were put forward. In order to further improve the preparation of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs, strengthen the guidance on the revision of local processing standards, and clarify issues related to the circulation, use and supervision of decoction pieces, the Department of Drug Registration Management of the National Medical Products Administration and the Chinese Pharmacopoeia Commission have organized experts to discuss these problems. The author only puts forward some suggestions on related issues in order to achieve the purpose of "throwing a brick to attract jade". ①The study of the national regulations on the processing of decoction pieces of Chinese crude drugs should be standardized on the basis of the inheritance for the specific process. ②The revision of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs should be improved on the basis of the existing research results. The regulation of the processing process should not be excessively parameterized, the revision of the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs also should be synchronization to the revision of the Chinese Pharmacopoeia. ③The contents of the Chinese Pharmacopoeia and the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs should have different emphasis. The former should focus on the standard, while the latter should focus on the processing process. ④The revision of local (provincial) processing specifications only collects the pieces that truly have local features and clinical characteristics. ⑤Decoction pieces of local Chinese crude drugs can only be applied at the place of production (province). They are allowed to be produced and distributed in other provinces, municipalities and autonomous regions after through filing. ⑥For the decoction pieces of Chinese crude drugs with large-scale use contained in local processing specifications, they should be included in the National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs as soon as possible, and their quality standards should be included in the Chinese Pharmacopoeia.