微波灭菌对中药汤剂微生物限度的影响

Effect of microwave sterilization on microbial limit of traditional Chinese medicine decoction

目的考察不同微波灭菌参数对汤剂微生物限度的影响,以探讨其应用于汤剂灭菌的可行性。方法选取14组汤剂(普通方、含动物药方、含矿物药方、含后下药方,共四类)煎煮后密封包装,冷却至25℃后使用900W微波炉进行灭菌。以灭菌时间为控制条件分为两组:灭菌60s组与90s组,灭菌后室温储存,于第1,3,7,14,21,30天进行性状观察,并依据《中国药典》(2020版)进行微生物限度检测。结果第1、3天,灭菌后的14组汤剂均合格;第7天,灭菌60s、90s组合格汤剂分别为12组、13组;第14、21天两种灭菌时长下合格汤剂分别为10组、9组;第30天,灭菌60s、90s组合格汤剂分别为7组、8组。灭菌90s组需氧菌含量均显著低于灭菌60s(P<0.05),霉菌和酵母菌含量部分组显著低于灭菌60s组(P<0.05),其余组无显著性差异(P>0.05);相同煎煮、灭菌和储存条件下,不同类别汤剂的含菌量均无显著性差异(P>0.05)。结论经微波灭菌60s、90s置于室温储存30天后分别有50.0%、57.1%的汤剂微生物限度符合药典规定,其具体使用规律有待进一步探讨。

Objective To investigate the effects of different microwave sterilization parameters on the microbial limit of decoction,and to explore the feasibility of its application in the sterilization of decoction.Methods Fourteen groups of decoctions(common prescription,animal-containing prescription,mineral-containing prescription,and post-treatment prescription,a total of four categories)were selected and sealed after decoction.After cooling to 25°C,they were sterilized using a 900w microwave oven.The sterilization time was used as the control condition and divided into two groups:sterilization 60 s group and 90 s group.After sterilization,they were stored at room temperature.The traits were observed on the 1st,3rd,7th,14th,21st and 30th days,and the microbial limit test was carried out according to the'Chinese Pharmacopoeia'(2020 edition).Results On the 1st and 3rd day,the 14 groups of decoctions after sterilization were all qualified;on the 7th day,12 groups and 13 groups were sterilized for 60 s and 90 s respectively.On the 14th and 21st days,the qualified decoctions under the two-sterilization time were 10 groups and 9 groups,respectively.On the 30th day,the combined decoctions of 60 s and 90 s were 7 groups and 8 groups,respectively.The content of aerobic bacteria in the 90 s sterilization group was significantly lower than that in the 60 s sterilization group(P<0.05).The content of mold and yeast in some groups was significantly lower than that in the 60 s sterilization group(P<0.05),and there was no significant difference in the other groups(P>0.05).Under the same decoction,sterilization and storage conditions,there was no significant difference in the bacterial content of different types of decoctions(P>0.05).Conclusion After 60 s and 90 s of microwave sterilization and storage at room temperature for 30 days,50.0%and 57.1%of the microbial limits of the decoction met the requirements of the pharmacopoeia,and the specific use rules needed to be further explored.