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目的:制备复方氟康唑凝胶并建立质量控制方法。方法:以氟康唑配伍黄芩苷制成凝胶,采用HPLC法测定凝胶中氟康唑及黄芩苷的含量,并考查凝胶的刺激性、体外释放度和稳定性。结果:氟康唑及黄芩苷分别在12.5~150.0μg·ml~(-1)、25.0~175.0μg·ml~(-1)浓度范围内线性关系良好,平均回收率分别为99.45%(RSD=0.40%,n=9)、99.31%(RSD=0.31%,n=9)。复方氟康唑凝胶的体外释放符合一级释放方程,氟康唑与黄芩苷在12 h的累积释放度分别为87.6%和80.03%。凝胶稳定性好,无刺激性。结论:复方氟康唑凝胶处方及制备工艺合理,质量稳定可控。
Objective: To prepare compound fluconazole gel and establish quality control method. Methods: Fluconazole with baicalin gel was prepared. The content of fluconazole and baicalin in the gel was determined by HPLC, and the irritation, in vitro release and stability of the gel were examined. Results: Fluconazole and baicalin showed good linearity in the range of 12.5-150.0μg · ml -1 and 25.0-175.0μg · ml -1, with the average recoveries of 99.45% (RSD = 0.40%, n = 9), 99.31% (RSD = 0.31%, n = 9). The in vitro release of compound fluconazole gel followed the first-order release equation. The cumulative release rates of fluconazole and baicalin at 12 h were 87.6% and 80.03%, respectively. Gel stability, non-irritating. Conclusion: The prescription and preparation process of compound fluconazole gel are reasonable and the quality is stable and controllable.