柏地威湿疹凝胶剂的制备及质量控制方法的研究

Study on the preparation and quality control of Bodiwei gel

研究柏地威凝胶剂成型工艺并确定制剂质量标准。将凝胶剂基质的黏稠度、涂展性、均匀度、透明度、色味、稳定性作为考察指标,筛选凝胶剂基质,制成凝胶剂,采用高效液相色谱法和薄层鉴别法对柏地威凝胶制剂进行测定。结果表明,柏地威凝胶剂基质选用0.75%卡波姆940,1.0%透明质酸,3%甲基纤维素(MC),0.05%凯松,以三乙醇胺调pH 6.0,制成100 g凝胶成型效果最佳。薄层色谱法分离度好,斑点清晰可见,阴性无干扰,含量测定盐酸小檗碱在0.010 4~0.260 0 mg/m L范围内呈良好线性关系,回收率为98.4%~103.4%,RSD为1.87%(n=9)。

The goal exploring optimal molding technology for Bodiwei gel and establish its quality control standard. To determine the ratio in quantity of gel base materials. To establish a method to analyze Amur Corktree Bark,Sophora flavescens,Radix Sanguisorbae and radix clematidis based on qualitative identification by TLC and quantify berberine hydrochloride by HPLC. Results showed that,Bodiwei gel was prepared with the base containing 0. 75% carbopol 940,1. 0% hyaluronic acid,3% methylcellulose,0. 05% Kathon,triethanolamine( as pH 6. 0). The linear correlation of berberine was good in the range of 0. 010 4 ~0. 260 0 mg/m L. The average recovery was 98. 4% ~ 103. 4% and RSD was 1. 87%( n = 9).