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目的:建立吸波面积-HPLC结合法测定白花蛇舌草组分胶囊中整体和个体成分溶出度的方法。方法:以含0.5%十二烷基硫酸钠的p H 6.8磷酸盐缓冲液为溶出介质,转速100 r·min-1,采用紫外-可见分光光度法和HPLC对混合药物及个体成分进行含量测定,比较测定结果的差异。结果:在120 min时,吸波面积法测得整体混合药物的累积溶出率74.72%,HPLC测得槲皮素、齐墩果酸和豆甾醇在同等时间段的累积溶出率分别为77.16%,82.78%,71.70%;吸波面积法与HPLC计算的累积溶出量分别为104.61,102.25 mg。结论:2种方法具有较好的一致性,吸波面积-HPLC结合法可用于白花蛇舌草组分胶囊中整体和个体药物成分溶出度的测试,为其他复方制剂中不同药物成分的溶出度研究提供借鉴。
OBJECTIVE: To establish a method for determining the dissolution of whole and individual components of Hedyotis diffusa Will. By fractional absorption-area-HPLC method. Methods: The contents of mixed drugs and individual components were determined by ultraviolet-visible spectrophotometry and HPLC using p H 6.8 phosphate buffer solution containing 0.5% sodium dodecyl sulfate as dissolution medium at the speed of 100 r · min-1 , Compare the difference between the measurement results. Results: At 120 min, the cumulative dissolution rate of the whole drug mixture was 74.72% by microwave absorption area method. The cumulative dissolution rates of quercetin, oleanolic acid and stigmasterol at the same time were 77.16% 82.78% and 71.70%, respectively. The cumulative elution amounts calculated by absorbance area and HPLC were 104.61 and 102.25 mg, respectively. CONCLUSION: The two methods have good consistency. The area of absorption-HPLC method can be used to test the dissolution of the whole and individual drug components of Hedyotis diffusa Will. The dissolution rate of different drug components in other compound preparations Research to provide reference.