肤康凝胶微生物限度检查方法适用性试验的研究

Study on applicability test of microbial limit test method for Fukang Gel

目的建立肤康凝胶适宜的微生物限度检查方法。方法按照《中国药典》2015年版4部通则1105、1106、1107,分别采用常规法、培养基稀释法对肤康凝胶进行微生物限度检查方法学验证,以金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉5种试验菌的回收率为指标,考察需氧菌总数、霉菌和酵母菌总数计数方法;建立控制菌金黄色葡萄球菌和铜绿假单胞菌的检查方法。结果常规平皿法需氧菌总数计数显示,金黄色葡萄球菌和铜绿假单胞菌的回收率较低,不在药典规定的0.5~2.0范围内,不符合要求;培养基稀释法需氧菌总数计数显示,金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉的回收率均符合要求。采用平皿法和培养基稀释法霉菌和酵母菌总数计数白色念珠菌和黑曲霉的平均回收率在药典规定的0.5~2.0范围内,均符合要求。采用常规法供试液组和阴性组均未检出两种控制菌,试验组金黄色葡萄球菌未被检出,铜绿假单胞菌能被检出,存在抑菌干扰,方法不可行;采用培养基稀释法试验组铜绿假单胞菌和金黄色葡萄球菌均能被检出,供试液组和阴性对照组两种试验菌均显示阴性,无干扰,方法可行。三批样品验证结果需氧菌总数和霉菌及酵母菌总数均符合标准规定,金黄色葡萄球菌和铜绿假单胞菌均未检出。结论肤康凝胶可用培养基稀释法进行微生物限度检查。

Objective To establish a suitable microbial limit test method for Fukang Gel.Methods According to the 4 general principles 1105,1106,and 1107 of Chinese Pharmacopoeia 2015 edition,routine method and medium dilution method were used respectively to verify the microbial limit test of Fukang Gel.The recovery rates of five test bacteria,Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger were used as indicators,the total number of Aerobic bacteria,Fungi and Yeasts was investigated,and the detection methods of Staphylococcus aureus and Pseudomonas aeruginosa were established.Results The total number of Aerobic bacteria counted by conventional plate method showed that the recovery rates of Staphylococcus aureus and Pseudomonas aeruginosa were low,which were not in the range of 0.5-2.0 stipulated in the Pharmacopoeia and did not meet the requirements.The total number of Aerobic bacteria counted by medium dilution method showed that the recovery rates of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger all met the requirements.The average recoveries of Candida albicans and Aspergillus niger counted by the total number of fungi and yeasts by plate method and medium dilution method were within the range of 0.5-2.0 prescribed in the Pharmacopoeia,which met the requirements.Two kinds of control bacteria were not detected in the test solution group and negative group by routine method.Staphylococcus aureus was not detected in the test group,Pseudomonas aeruginosa could be detected,and there was interference of bacteriostasis,so the method was not feasible.Pseudomonas aeruginosa and Staphylococcus aureus could be detected in the test group by medium dilution method.Both the test solution group and the negative control group showed negative,no interference,and the method was feasible.The results of three batches of samples validation showed that the total number of Aerobic bacteria,Fungi and Yeasts were in accordance with the standard,but Staphylococcus aureus and Pseudomonas aeruginosa were not detected.Conclusion Fukang Gel can be used for microbial limit test by medium dilution method.