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为考察中药蜜丸不同工艺生产的产品及贮存期间的质量是否符合 GMP 要求,我们采用药品卫生检验方法,对制备中药蜜丸的药材、生产过程、包装材料、贮存等环节做了处理前后染菌情况的比较研究,并比较了经~(60)Co 辐射灭菌和未经~(60)Co 辐射灭菌的蜜丸三年后的染菌情况。结果表明,经不同方法处理的蜜丸含菌数明显低于未处理的蜜丸含菌数。保证中药蜜丸卫生质量的关键在于对原料药的处理。
In order to investigate whether the products produced by different methods of Chinese medicine honeyed pills and their quality during storage meet the GMP requirements, we adopted the method of drug hygienic examination to treat the raw materials before and after the preparation of medicine pills, production process, packaging materials and storage of Chinese medicine honey pills. A comparative study of the conditions and comparison of the contamination of three years after the Micra sterilized by ~(60)Co radiation and not sterilized by ~(60)Co radiation. The results showed that the number of bacteria in the honeydew pill treated by different methods was significantly lower than that in the untreated honeydew pill. The key to ensuring the hygienic quality of traditional Chinese medicine pill is the treatment of raw material medicine.