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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