摘要
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 to establish a method for its quality control. Methods： Fluconazole and baicalin were the main ingredients in the gel, and their contents were determined by ttPLC. Moreover, the drug release in vitro, irritation and stability of the gel were tested. Results： The fluconazole and baicalin had a good linear relationship within the range of 12.5-150.0μg·ml^-1 and 25.0-175.0μg·ml^-1, respectively. The average recovery rate was 99.45% （RSD = 0.40%, n = 9） and 99.31% （RSD =0.31%, n =9）, respectively. The in vitro drug release of the gel was accordance with the first order release equation, and the cumulative release rate of fluconazole and baicalin in 12 h was 87.6% and 80.03% , respectively. The gel was stable without irritation. Conclusion： The formula, preparation technology and stability of compound fluconazole gel are promising and the quality standard is controllable.
出处
《中国药师》
CAS
2016年第9期1682-1685,共4页
China Pharmacist
基金
滨州市科技发展计划项目(编号:2014ZC0141)
关键词
氟康唑
黄芩苷
凝胶
制备
质量控制
Fluconazole
Baicalin
Gel
Preparation
Quality control
