Traditional Chinese medicine is an important substance for the prevention and treatment of diseases for thousands of years in China, and its quality is an important factor affecting the curative effect, and the amount of impurities is an important basis for judging the quality of traditional Chinese medicine. Zhang Di, deputy to the National People's Congress and director of the Children's Medical Center of the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, said that in the practice of drug supervision and management in China, cases of "adulteration" of traditional Chinese medicine occur from time to time, based on the current "Drug Administration Law of the People's Republic of China" for traditional Chinese medicine such drugs from "inconsistent ingredient content" (excessive impurities are an important reason) to "inconsistent composition" between the definition, resulting in qualitative difficulties. It is urgent to establish the standard of impurities that are identified as fake and inferior drugs, which is of great significance and role in protecting and promoting the development of traditional Chinese medicine and safeguarding public health.
Zhang Di believes that there are the following problems. First, the definition of impurities in traditional Chinese medicine decoction pieces is unclear; second, the implementation standards for the impurities contained in Chinese herbal medicines and the impurities contained in Chinese herbal decoction pieces are not perfect; third, it is difficult to control impurities in traditional Chinese medicine; Fourth, intentional adulteration occurs from time to time; Fifth, the standards for qualitative Chinese medicine decoction pieces as inferior drugs are not uniform, in addition to the national standards for traditional Chinese medicine decoction pieces, there are also processing specifications promulgated by various provinces, and the punishment standards are different in various places.
To this end, Zhang Di suggested that the identification standards for the identification of fake and inferior drugs in traditional Chinese medicine containing impurities should be formulated, and the relevant requirements should be clarified in the "Drug Administration Law" or the supporting implementation regulations, and the standards for impurities that are identified as fake and inferior drugs should be established, and the classification and amount of fine penalties for inferior drugs should be clarified, so as to achieve the operability and fairness of implementation. In the daily management of the raw materials of Chinese herbal medicines, we can learn from the way of purchasing agricultural and sideline products according to quality pricing, and implement grading pricing procurement management for Chinese herbal medicines. When purchasing medicinal materials from pharmaceutical farmers, we advocate high quality and high price, and the more impurities, the lower the **. The grading standards for decoction pieces of traditional Chinese medicine may be formulated by industry associations and announced to the whole society. Use economic leverage to improve the quality awareness of pharmaceutical farmers and ensure the quality of traditional Chinese medicine decoction pieces from the source. The implementation of the recall system of traditional Chinese medicine decoction pieces, even if the punishment of the second paragraph of Article 117 of the Drug Administration Law is applicable, in addition to the punishment, the manufacturer of the traditional Chinese medicine decoction pieces should also be required to take the initiative to recall, or order the recall of the traditional Chinese medicine decoction pieces involved in the case.
Content**: China Journal of Traditional Chinese Medicine.