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0.0104~0.2600 mg/mL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 identifica-tion 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/mL.The average recovery was 98.4%~103.4%and RSD was 1.87%(n=9).
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