口服液体药用塑料瓶微生物污染状况分析及试验方法改进

目的： 通过分析口服液体药用塑料瓶的微生物污染状况，评价其对口服液体制剂质量的贡献。 方法： 参考中国药典2010年版和美国药典36版方法，测定2013年全国评价性抽验中得到的4个品种、9种规格、43家企业的55批口服液体药用塑料瓶的微生物种类和数量。采用薄膜过滤法处理样品提取液，用胰酪大豆胨琼脂培养基进行培养，计数需氧菌总数，用胆盐乳糖增菌液培养，进行控制菌检查。 结果： 每批样品的细菌、霉菌和酵母菌数及大肠埃希菌均符合国家药品包装容器（材料）标准（试行）规定，58%的样品未检出污染微生物，污染有 微生物的样品菌数均未超过7 cfu·瓶^-1，均为环境污染菌芽孢杆菌类及球菌类，且均未检出大肠埃希菌。 结论： 口服液体药用塑料瓶微生物污染未超标。将细菌数、霉菌和酵母菌数统一合并为需氧菌总数测定，可在一张滤膜上同时测定样品的细菌数、霉菌和酵母菌数。改进的检验方法具有省时、方便的特点。

Objective: To analyze the microbial contamination status of medicinal plastic bottles for oral liquid and evaluate the contribution of this analysis to oral liquid preparation quality. Methods: According to Chinese pharmacopoeia (2010 Edition) and the United States Pharmacopoeia (36 Edition),the species and number of microorganisms from the 55 batches of medicinal plastic bottles for oral liquid were determined.The samples included 4 species and 9 specifications from 43 enterprises during the national selective inspection for evaluation in 2013.Sample extracts were treated by membrane filtration,cultured with trypticase soy agar.The amount of aerobic bacterium was counted.Lactose Bile Broth Culture was used to control bacterial examination. Results: The amounts of bacterium,mold,yeast and Escherichia coli of each batch sample met the national drug packaging container (material) standard (Trial Version).58% of the samples did not have contaminating microorganisms according to detection;the amounts of bacterium pollution samples did not exceed 7 cfuper bottle,the microorganisms were environment-contaminating bacteria such as bacillus and coccus.Escherichia coli were not detected in any samples. Conclusion: The situation of microbial contamination of medicinal plastic bottles for oral liquid is satisfactory.Establishment of a determination method for the total number of aerobe bacteria,can detect the number of bacteria,mycete and yeast simultaneously by one filtration membrane.The test method is effective,economical and convenient.

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