不同剂型通宣理肺类制剂微生物污染状况

Microbial Contamination Degree of Different Dosage Forms of Tongxuelifei Preparations

目的根据2020年山东省药品质量风险监测实施方案,通过对全国10家药品生产企业生产的47批通宣理肺类制剂进行微生物限度检查,分析不同剂型样品微生物污染程度。方法按照《中华人民共和国药典》2015年版四部通则1105、1106进行微生物限度检查。结果需氧菌总数,浓缩丸和胶囊两种剂型小于1.0×10^(2)CFU/g,大蜜丸80%小于1.0×10^(2)CFU/g,霉菌和酵母菌总数,水蜜丸、浓缩丸和胶囊剂小于10 CFU/g,大蜜丸77.1%小于10 CFU/g,大肠埃希菌检查为1 g中未检出,耐胆盐革兰阴性菌为小于10 CFU/g,沙门菌均为10 g中未检出。结论本次药品质量风险监测的47批通宣理肺类制剂微生物限度检查结果总体良好,大蜜丸比其他剂型的微生物污染程度高,胶囊剂的微生物检查各项指标比其他剂型好。

Objective According to the implementation plan of drug quality risk monitoring in Shandong Province in 2020,47 batches of tongxuanlifei preparations produced by 10 drug manufacturers in China were examined for microbial limit,and the levels of microbial contamination of samples of different dosage forms were analyzed.Methods Microbial limit test was carried out according to general rules 1105 and 1106 of Chinese Pharmacopoeia(2015 edition).Results The total number of aerobic bacteria,condensed pills and capsules both formulations were less than 1.0×10^(2)CFU•g^(-1),big honey pill 80%were less than 1.0×10^(2)CFU•g^(-1),the total number of mold and yeast,water-honeyed pills,condensed pills and capsules were less than 10 CFU•g^(-1),big honey pills,77.1%were less than 10 CFU•g^(-1).Escherichia coli check were not detected in 1 g,Bile-Tolerant Gram-Negative Bacteria are less than 10 CFU•g^(-1),Salmonella were not detected in 10 g.Conclusion The microbiological limit test results of 47 batches of tongxuanlifei preparations in this drug quality risk monitoring are generally good,compared with other dosage forms,the big honey pills have a higher degree of microbial contamination.The microbiological index of capsule is better than that of other dosage forms.