Preparation and Quality Control of Compound Fluconazole Gel / 中国药师

ABSTRACT

Objective:To prepare compound fluconazole gel and to establish a method for its quality control. Methods: Flucon-azole and baicalin were the main ingredients in the gel, and their contents were determined by HPLC. 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. 0 μg·ml-1 and 25. 0-175. 0 μg·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 e-quation, 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.