Development and stability test of compound ketoconazole ointment

TAO Chun; WU Bo; HUANG Aiwen; WANG Tianyu; WANG Jialin; SONG Hongtao

doi:10.3969/j.issn.1006-0111.2017.06.013

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Objective To prepare compound ketoconazole ointment and perform the stability study. Methods Ketoconazole, mupirocin and mometasone furoate were used as active pharmaceutical ingredients (API). PEG mixture was used as matrix to prepare the ointment.Stability of the API in the ointment was evaluated by the stress tests. Results The optimal ratio of PEG400 to PEG3350 for the ointment matrix was 2:1. Mometasone furoate and mupirocin in the ointment were stable to the high temperature(40℃)while ketoconazole had some degradation. The stability of the API was improved by addition of 0.5% of L-A. During the accelerate test, the ointment had no color change and the API percentages were above 98%. Conclusion The novel compound ketoconazole ointment was successfully prepared and the formulation stability was excellent.

Development and stability test of compound ketoconazole ointment

1. Department of Pharmacy, Fuzhou General Hospital, Fuzhou 350025, China

2. Department of Pharmacy, Fuzhou General Hospital, Fuzhou 350025, China;School of Pharmacy, Fujian Medical University, Fuzhou 350108, China

3. Department of Pharmacy, Fuzhou General Hospital, Fuzhou 350025, China;Medical College, Xiamen University, Xiamen 360000, China

Received Date: 2017-03-08

Rev Recd Date: 2017-07-07

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Abstract: Objective To prepare compound ketoconazole ointment and perform the stability study. Methods Ketoconazole, mupirocin and mometasone furoate were used as active pharmaceutical ingredients (API). PEG mixture was used as matrix to prepare the ointment.Stability of the API in the ointment was evaluated by the stress tests. Results The optimal ratio of PEG400 to PEG3350 for the ointment matrix was 2:1. Mometasone furoate and mupirocin in the ointment were stable to the high temperature(40℃)while ketoconazole had some degradation. The stability of the API was improved by addition of 0.5% of L-A. During the accelerate test, the ointment had no color change and the API percentages were above 98%. Conclusion The novel compound ketoconazole ointment was successfully prepared and the formulation stability was excellent.

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Reference (8)

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[3]	中国中西医结合学会皮肤性病学分会环境与职业性皮肤病学组.糠酸莫米松乳膏临床应用专家共识[J].中国中西医结合皮肤性病学杂志,2017,16(1):88-90.
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[5]	中国医师协会皮肤科分会.皮肤及软组织感染诊断和治疗共识[J].临床皮肤科杂志,2009,38(12):810-812.
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[7]	邢东志,邢晗,宝玲.复方酮康唑软膏的处方设计试验[J].中国现代药物应用,2010,04(16):165-165.
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[1]	刘淮,刘景桢.外用糖皮质激素的适应症与副作用[J].皮肤病与性病,2016,38(1):19-20.
[2]	孟甄,金建玲,刘玉庆,等.细菌耐药性的诱导与消除[J].中国药理学通报,2003,19(9):1047-1051.
[3]	中国中西医结合学会皮肤性病学分会环境与职业性皮肤病学组.糠酸莫米松乳膏临床应用专家共识[J].中国中西医结合皮肤性病学杂志,2017,16(1):88-90.
[4]	谢阳,万苗坚.皮肤科常用糖皮质激素类药物的类型及适应症[J].中国医学文摘(皮肤科学),2015,32(3):283-288.
[5]	中国医师协会皮肤科分会.皮肤及软组织感染诊断和治疗共识[J].临床皮肤科杂志,2009,38(12):810-812.
[6]	朱雷.萘替芬酮康唑乳膏配方筛选及工艺[J].国外医药(抗生素分册),2016,37(3):128-130.
[7]	邢东志,邢晗,宝玲.复方酮康唑软膏的处方设计试验[J].中国现代药物应用,2010,04(16):165-165.
[8]	周月红,张继明,沈鸿.复方酮康唑乳膏中稳定剂的选择[J].医药导报,2004,23(5):331-332.

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Development and stability test of compound ketoconazole ointment

doi: 10.3969/j.issn.1006-0111.2017.06.013

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