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随着科学技术的发展和人们生活质量的提高,药品质量标准应不断地改善提高;新仪器、新科技、新项目等不断地引进到药品质量控制中,使之适应社会的发展和人类的要求。药品的微生物限度检查项,原先均为部颁标准,从1995年版《中国药典》开始,有些剂型和方法已陆续收入《中国药典》中。但笔者认为,尚有测控内涵、指标、范围等方面须改进,特别是中药饮片,尚无微生物项目检查项,笔者就此方面问题浅述己见。 一般认为,中药饮片经煎煮可起到杀菌消毒作用,
With the development of science and technology and the improvement of people’s quality of life, drug quality standards should continue to improve; new instruments, new technologies, new projects, etc., are constantly being introduced into drug quality control to adapt them to the development of society and human needs. . The microbiological limit inspection items of medicines were originally ministerial standards. Starting from the 1995 edition of the “Chinese Pharmacopoeia”, some dosage forms and methods have been successively included in the “Chinese Pharmacopoeia”. However, the author believes that there are still some aspects that need to be improved in terms of measurement and control, indicators, and scope. In particular, there is no microbiological item inspection item for Chinese Herbal Medicine Pieces. The author has a few questions about this aspect. It is generally believed that Chinese Herbal Pieces can be sterilized by boiling.