中药饮片企业化生产探析

Analysis on the Enterprise Production of Chinese Medicine Pieces

探讨企业化生产中药饮片相关的技术和法规问题。中药炮制是中华医学的宝贵财富,是中华民族同疾病做斗争的产物,是一门传统科学,由于其发展历史悠久,以前多为心口相传,其生产设备和生产方法也多为作坊式生产。中药饮片企业化生产发展历史较短,按照药品生产质量管理规范(Good manufacturing practice,GMP)标准生产的历史更短,中药饮片作为传统行业,如何规范化生产、生产过程如何符合规定,企业规范化生产的操作要点等问题进行了分析和探讨。炮制过程分析,炮制本质分析,法律法规、《中华人民共和国药典》解读,指出企业生产中药饮片应该注意的问题,需要领会炮制的本质、要领及GMP规范要求,才能生产出符合《中华人民共和国药典》、符合中医药临床要求的中药饮片。

The technical and regulatory issues related to the production of Chinese herbal decoction pieces in enterprises were explored.Traditional Chinese medicine processing is the precious wealth of Chinese medicine,the product of the struggle between Chinese democracy and disease,and a traditional science.Because of its long history of development,it has been handed down from heart to mouth before,and its production equipment and methods are mostly workshop production.As a traditional industry,how to standardize the production,how to comply with the rules in the production process and the key points in the operation of standardized production in enterprises are analyzed and discussed.Processing process analysis,processing essence analysis,laws and regulations,interpretation of Pharmacopoeia of the People’s Republic of China,pointed out that enterprises should pay attention to the production of Chinese herbal pieces,conclusions need to understand the essence of processing,essentials and Good manufacturing practice(GMP)specifications,in order to produce Chinese herbal pieces in line with the Pharmacopoeia and clinical requirements of Chinese medicine.