目的:建立银翘蓝芩口服液微生物限度的检查方法。方法:按照《中国兽药典》2010年版一部微生物限度检查法进行银翘蓝芩口服液微生物限度检查。结果:银翘蓝芩口服液无明显的抑菌活性,细菌、霉菌及酵母菌计数采用常规法时其回收率在93.7%~106.8%之间,大于药典要求的70%。控制菌检查选用大肠埃希菌,培养基促生长能力、抑制能力、指示能力和控制菌检查方法均符合中国兽药典要求。采用上述建立的方法,3批银翘蓝芩口服液中细菌、霉菌及酵母菌检查结果均小于1cfu/mL,大肠埃希菌未检出。结论:本研究建立的银翘蓝芩口服液微生物限度检查法简便易行,结果准确,可用于该产品的质量控制。
Objective:Establish Yinqiaolanqin oral liquid microbial limit inspection method. Methods:According to microbial limit test method in Chinese Veterinary Pharmacopoeia (2010 edition, Version I ), the microbial limit test of Yinqiaolanqin oral liquid was performed. Results:Yinqiaolanqin oral liquid had no significant antibacterial activity, when the count of bacteria, molds and yeasts was investigated by conventional method, the recovery rates were between 93. 7% and 106.8%, which were greater than 70%. Escherichia eoli was selected as control bacteria. The growth-promoting ability, inhibition ability, indicating ability of culture medium and the test method of control bacteria were all met the requirements of Chinese Veterinary Medicine. Using the method mentioned above, the results of bacteria, molds and yeasts in three batches were less than 1 cfu/mL, at the same time Escherichia coli could not be detected. Conclusion: The microbial limit test method of Yinqiaolanqin oral liquid was simple and accuracy, which was available for quality control of Yinqiaolanqin oral liquid.