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细菌总数、霉菌总数是检测药品染菌量的主要指标,1995年版《中国药典》微生物限度检查法规定细菌总数,霉菌总数检查采用平板法,通过计算各稀释级的平均平板菌落数、按菌数报告规划报告菌数,但作者在检验工作中发现部分药品菌数报告中存在着一些异常情况值得探讨。 在正常的、无抑菌作用的情况下,按10倍比例稀释,各稀释级菌落数测定值应相差有限,级间比值应基本上在1左右变动。但一些中成药或化学药的液体制剂或固体制剂,由于药物本身具有不同程度的抑菌作用,尤其是
The total number of bacteria, the total number of molds is the main indicator of the detection of drug-contaminated bacteria. The 1995 edition of the Chinese Pharmacopoeia limits the total number of bacteria, the total number of molds by plate method, by calculating the average number of plates per dilution level, Report planning report the number of bacteria, but the author found in the inspection report of some drugs in the number of bacteria there are some unusual situations worth exploring. In the normal, no antibacterial effect, according to 10 times the proportion of dilution, the dilution of the measured value of the number of colonies should be a little difference between the level should basically change around 1. However, some proprietary Chinese medicine or chemical liquid liquid preparations or solid preparations, due to the drug itself has varying degrees of antibacterial effect, especially