The Drug Administration Law stipulates that the processing of Chinese herbal pieces must conform to the provisions of China's Pharmacopoeia or the processing norms formulated by provinces, autonomous regions and municipalities directly under the Central Government. In order to inherit and carry forward the traditional pharmaceutical processing technology of traditional Chinese medicine, improve the quality of decoction pieces, and ensure the characteristics of traditional Chinese medicine and the safety of clinical medication, the relevant administrative departments of the state have formulated corresponding management measures for the production, operation and use of decoction pieces of traditional Chinese medicine.
Quality management of traditional Chinese medicine decoction pieces production
After the founding of the Party, the State Council (83) 160 decided to take the Chinese herbal pieces factory as an independent industrial enterprise, carry out independent accounting and operate independently, and strengthen the scientific production management of Chinese herbal pieces. During the "Seventh Five-Year Plan" period, the state gave key support to the technological transformation of 44 decoction pieces factories, greatly improved the hardware of decoction pieces production, and laid the foundation for the implementation of gmp and the purposeful and planned transformation of existing Chinese herbal pieces production enterprises.
During the "Eighth Five-Year Plan" period, the overall transformation task of 44 key factories was fully completed, and 80 Chinese herbal pieces factories were identified to support the development in the country, so that the production of Chinese herbal pieces gradually realized quality standardization, process standardization, packaging standardization, production mechanization and management modernization. Formulated and issued the General Rules for Infiltration Technology of Chinese Herbal Pieces Industry, the Measures for the Administration of Packaging of Chinese Herbal Pieces and other relevant management regulations for Chinese Herbal Pieces production enterprises. And decided to implement unified planning, rational layout and fixed-point production of toxic Chinese herbal medicine pieces to ensure that the fixed-point enterprises can produce qualified toxic Chinese herbal medicine pieces for national use. These management regulations are of great significance to improve the management level, quality and modernization of Chinese herbal pieces production enterprises.
Quality management of traditional Chinese medicine decoction pieces in medical institutions
Measures for Quality Management of Chinese Herbal Pieces in Medical Institutions (for Trial Implementation) The general rules of this method point out that the quality management of Chinese Herbal Pieces in medical institutions is an important link to ensure the clinical efficacy of Chinese medicine in medical institutions, and it is also an important work to give full play to the advantages of Chinese medicine and serve people's health. All medical institutions must attach great importance to it and establish the concept of quality first. Medical institutions shall formulate strict rules and regulations on the procurement, acceptance, processing, quality inspection, storage and dispensing of Chinese herbal medicines and Chinese herbal pieces, and implement post responsibility system. [Collected by Medical Education Network]
1. Acceptance and procurement management Medical institutions shall employ professional and technical personnel of Chinese medicine who are strict with themselves, abide by laws and regulations, and have experience in identifying the quality of Chinese medicine and decoction pieces. Inspectors must carry out inspection in strict accordance with the Pharmacopoeia of China or the processing specifications of traditional Chinese medicines formulated by the competent departments of provinces, autonomous regions and municipalities directly under the Central Government, and those who fail the inspection will not be accepted.
The quality of the purchased pieces must conform to the general principles of the Quality Standard for Chinese Herbal Pieces (Trial), which requires that: ① impurities such as rhizome, vine, leaf, flower, bark, silt and non-medicinal parts should not exceed 2%; ② Impurities such as fruits, seeds, silt and non-medicinal parts shall not exceed 3%; (3) Non-medicinal parts are not allowed in the whole grass, and impurities such as silt shall not exceed 3%; ④ The impurities such as animals, attachments, carrion and non-medicinal parts shall not exceed 2%; ⑤ Impurities such as minerals, stone inclusions and non-medicinal parts shall not exceed 2%; ⑥ Bacteria and algae, with impurities less than 3%; All landowners resin, impurities shall not exceed 3%; ⑧ No more than 10% of medicinal materials need to be depilated.
2. Management of Processing and Dispensing of Pieces Medical institutions that have the conditions for processing pieces of Chinese herbal medicines and directly purchase Chinese herbal medicines for processing or "temporary processing" should strictly abide by the Pharmacopoeia of China and the Specifications for Processing Chinese Herbal Medicines. Relevant personnel should carefully fill in the processing records and acceptance sheets of decoction pieces. The pieces processed by medical institutions themselves must be accepted by the quality acceptance personnel of medical institutions before they can be put into clinical use.
The medicine barrel in the decoction piece dispensing room has a name label, and the name of the medicine must conform to the correct name adopted by China Pharmacopoeia.
Measuring instruments for dispensing shall be regularly verified by the metrological management unit, and unqualified instruments shall not be used. Dispensing personnel must use measuring instruments to weigh drugs, and may not use hand scales to measure drugs.
The weight error of each dose of decoction pieces should be within 5%. After each dose of medicine is prepared, it can only be distributed to patients after being audited by the auditor. Re-inspection rate requirements 100%.