Validation of microbial limit test for compound terbinafine gel

CHEN Jing; ZHONG Guixiang; YAN Jia; SONG Hongtao

doi:10.3969/j.issn.1006-0111.2019.04.014

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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.

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

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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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Validation of microbial limit test for compound terbinafine gel

doi: 10.3969/j.issn.1006-0111.2019.04.014

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