肉豆蔻饮片微生物计数检查方法研究及其在霉变过程中菌落总数的测定

Validation on Microbiological Counting Test of Myristicae Semen and Determination of Total Number of Colonies in Mildew

目的:研究肉豆蔻饮片微生物限度检查的方法,分析不同霉变程度肉豆蔻饮片需氧菌、霉菌及酵母菌菌落总数的变化趋势。方法:参照2015年版《中国药典》四部"通则1105非无菌产品微生物限度检查:微生物计数法"进行方法的建立和验证,采用建立的方法对霉变过程中的肉豆蔻饮片进行微生物计数。结果:肉豆蔻饮片对方法适应性验证的5种菌均有抑制作用,需采用培养基稀释法进行检验。随着霉变程度加大,肉豆蔻饮片需氧菌、霉菌、酵母菌菌落总数均呈升高趋势,且加速0-6天时增长缓慢,6-9天呈爆发式增长,9-39天匀速增长。结论:该方法可用于肉豆蔻饮片的微生物计数。建议对易霉变药材肉豆蔻增设需氧菌、霉菌、酵母菌总数限值,以保障用药安全。

Objective: To establish the method of microbiological limit test of Myristicae Semen,and to analyze the trend of the total number of aerobic bacteria,molds,and yeast colonies in different levels of mildew.Methods: General Rule1105 Microbial Limit Test for Non-sterile Products: Microbial count in Chinese Pharmacopoeia(2015 edition)was referred and applied to establish and validate the method,which afterwards was used to conduct microbiological counting of the nutmeg cut pieces in the mildew process.Results: The Myristicae Semen had inhibitory effects on the five kinds of bacteria in the method validation.The medium dilution method was used for testing.With the development of moldiness,the total number of aerobic bacteria,molds,and yeast colonies in the moldy decoction pieces showed an increasing trend,and the growth rate was slower at 0 to 6 days,and the explosive growth was observed at 6 to 9 days,and the average increasing rate was 9 to 39 days.Conclusion: This method can be used for microbiological counting of Myristicae Semen.It is recommended to increase the total number of aerobic bacteria,molds,and yeasts in the nutmeg which is quite likely to mildew once in poor or inappropriate storage condition.Therefore,in order to ensure the safety of medication microbiological indexes should be also supervised.