Validation of microbial limit test for compound terbinafine gel
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摘要: 目的 建立复方特比萘芬软膏微生物限度检查方法。 方法 根据《中国药典》2015年版四部通则1105、1106、1107具体规则作为检测依据。对薄膜过滤冲洗液体积、供试液稀释级、中和剂的含量等进行考察。 结果 该产品对5种试验菌种均有抑制作用。加入适量聚山梨酯80作为中和剂，同时采用薄膜过滤法可有效去除其抗菌性。需氧菌总数计数采用1∶100稀释级供试液10 ml，冲洗量300 ml。霉菌及酵母菌采用1∶20稀释级供试液10 ml，冲洗量800 ml。5种试验菌株的回收比值均在0.5～2.0之间。控制菌中金黄色葡萄球菌采用1∶10稀释级供试液10 ml （冲洗量1 000 ml/膜）合并培养基稀释法（600 ml）进行检测，铜绿假单胞菌采用1∶10稀释级供试液10 ml/膜（冲洗量300 ml/膜）进行检测。 结论 该方法可作为复方特比萘芬软膏微生物限度的检查方法。Abstract: Objective To establish a microbial limit test method for compound terbinafine gel. Methods The test was carried out according to the requirements of provision 1105,1106 and 1107 of rules of preparation in volume IV of Chinese pharmacopoeia 2015 edition.Experiments were made to observe the volume of rinsing solution,dilution ratio of the test solution and the content of the neutralizing agent. Results Compound terbinafine gel had antimicrobial activities on five tested strains.The method of neutralizing agent polysorbate 80 and film filtration could eliminate the bacteriostatic of the drug.The total number of aerobic bacteria was measured by 10 ml of 1:100 diluted solution and 300 ml washing solution.The total number of molds and yeasts were measured using 10 ml of 1:20 diluted solution and 800 ml washing solution.The recovery ratio of five test bacteria was within a range from 0.5 to 2.0.Staphylococcus aureus of the controlled bacteria was measured by10 ml of 1:10 diluted solution and 1 000 ml washing solution,as well as using increased cultural volume (600 ml).Pseudomonas aeruginosa of the controlled bacteria was measured by 10 ml from 1:10 diluted solution and 300 ml washing solution. Conclusion The method was suitable for the microbial limit test of compound terbinafine gel.
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Key words:
- compound terbinafine gel /
- microbial limit test /
- membrane filtration /
- polysorbate 80
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[1] 尹斌,冉玉平.1%特比萘芬乳膏对常见皮肤癣菌、球形孢子丝菌及裴氏着色真菌的体外抑菌活性研究[J].皮肤病与性病,2015,37(3):130-132. [2] 周琳.莫匹罗星乳膏外用治疗细菌性皮肤病临床疗效观察[J].中华临床医师杂志,2016,10(4):235-236. [3] 国家药典委员会.中华人民共和国药典(2015年版四部)[S].北京:化学工业出版社,2015:136~151. [4] 杨晓莉,李辉,马英英,等.中国药典2015年版非无菌产品微生物限度检查:微生物计数法解读[J].药物分析杂志,2016,36(6):1101-1107. [5] 廖祥茹,陈晨,李旸,等.聚山梨酯80在微生物限度检查中的应用[J].中国药师,2014,17(10):1776-1777. [6] 钱文静,张玫,袁耀佐.盐酸特比萘酚凝胶微生物限度检查方法的验证[J].药物分析杂志,2008,28(12):2135-2139. [7] 张力.特比萘芬片与特比萘芬乳膏治疗皮肤癣菌病的疗效对比[J].中国药业,2013,22(9):69-70. [8] 李辉,杨晓莉,梁泽梅,等.不同剂型硝酸咪康唑微生物限度检查方法适用性研究与评价[J].中国抗生素杂志,2018,43(1):80-84. [9] 汤茜,李瑞莲.盐酸莫西沙星片微生物限度方法适用性研究[J].国外医药抗生素分册,2016,37(4):172-176. [10] 马仕洪,刘鹏,胡昌勤,等.药品微生物限度检查方法适用性试验中加菌方式的实验研究[J].药物分析杂志,2018,38(5):877-872. -
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