Development and stability test of compound ketoconazole ointment
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摘要: 目的 制备复方酮康唑软膏并考察其稳定性。 方法 以酮康唑、莫匹罗星和糠酸莫米松为主药，以聚乙二醇（PEG）为基质制备软膏；利用影响因素试验考察软膏中药物的稳定性。 结果 PEG400和PEG3350的比例为2：1时，软膏的黏度最佳，易于涂展。制成软膏后，高温下糠酸莫米松和莫匹罗星稳定性良好；酮康唑有少许分解，加入0.5%的抗坏血酸棕榈酸酯（L-A）后，酮康唑的含量明显提高。加速试验发现，放置6个月后软膏的颜色无变化，3种药物的含量均在98%以上。 结论 本实验成功制备了新型复方酮康唑软膏，药物稳定性良好。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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Key words:
- ketoconazole /
- mupirocin /
- mometasone furoate /
- ointment /
- stability
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