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制备曲安奈德益康唑凝胶,并对其进行了质量研究。选用卡波姆为凝胶基质,液体石蜡、吐温-80、司盘-80、丙二醇和乙醇等为辅料,制备凝胶,并对其性状、pH值和稳定性进行研究。制得的曲安奈德益康唑凝胶pH 4.5—6.5,平均含量硝酸益康唑为100.1%,曲安奈德为99.8%。初步稳定性实验表明,样品在相对湿度(65±5)%,温度(30±2)℃放置3个月,外观、含量无明显改变。该凝胶剂处方设计合理,工艺简单可行,质量控制方法可靠。
Triamcinolone acetonide gel was prepared and its quality studied. The gel was prepared by using carbomer as gel matrix, liquid paraffin, Tween-80, Span-80, propylene glycol and ethanol as excipients, and its properties, pH value and stability were studied. The prepared triamcinolone acetonide gel pH 4.5-6.5, the average content of 100.1% of the econazole nitrate, triamcinolone acetonide 99.8%. The preliminary stability experiments showed that the sample was kept at relative humidity (65 ± 5)%, temperature (30 ± 2) ℃ for 3 months without significant changes in appearance and content. The gelatin prescription design is reasonable, the process is simple and feasible, quality control method is reliable.