复方特比萘芬软膏微生物限度检查方法适用性试验研究

陈静; 严佳; 钟桂香; 宋洪涛

doi:10.3969/j.issn.1006-0111.2019.04.014

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复方特比萘芬软膏微生物限度检查方法适用性试验研究

陈静, 严佳, 钟桂香, 宋洪涛

文章导航 > 药学实践与服务 > 2019 > 37(4): 357-360,369

陈静, 严佳, 钟桂香, 宋洪涛. 复方特比萘芬软膏微生物限度检查方法适用性试验研究[J]. 药学实践与服务, 2019, 37(4): 357-360,369. doi: 10.3969/j.issn.1006-0111.2019.04.014

引用本文:

CHEN Jing, ZHONG Guixiang, YAN Jia, SONG Hongtao. Validation of microbial limit test for compound terbinafine gel[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(4): 357-360,369. doi: 10.3969/j.issn.1006-0111.2019.04.014

Citation:

CHEN Jing, ZHONG Guixiang, YAN Jia, SONG Hongtao. Validation of microbial limit test for compound terbinafine gel[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(4): 357-360,369. doi: 10.3969/j.issn.1006-0111.2019.04.014

复方特比萘芬软膏微生物限度检查方法适用性试验研究

doi: 10.3969/j.issn.1006-0111.2019.04.014

中国人民解放军联勤保障部队第九〇〇医院, 福建福州 350025

基金项目: 军队医疗机构制剂标准提高科研专项课题（14ZJZ17）

Validation of microbial limit test for compound terbinafine gel

Department of Pharmacy, Hospital 900 of the Joint Logistics Support Force of PLA, Fuzhou 350025, China

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。
- 复方特比萘芬软膏 /
- 微生物限度检查 /
- 薄膜过滤法 /
- 聚山梨酯80
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.
- compound terbinafine gel /
- microbial limit test /
- membrane filtration /
- polysorbate 80

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复方特比萘芬软膏微生物限度检查方法适用性试验研究

doi: 10.3969/j.issn.1006-0111.2019.04.014

中国人民解放军联勤保障部队第九〇〇医院, 福建福州 350025

基金项目: 军队医疗机构制剂标准提高科研专项课题（14ZJZ17）

收稿日期: 2018-12-27
修回日期: 2019-06-06

关键词:

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。

English Abstract

Validation of microbial limit test for compound terbinafine gel

Department of Pharmacy, Hospital 900 of the Joint Logistics Support Force of PLA, Fuzhou 350025, China

Received Date: 2018-12-27
Rev Recd Date: 2019-06-06

Keywords:

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.

引用本文: