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目的:建立复方参金凝胶的质量控制标准。方法:采用薄层色谱法鉴别了方中黄柏、金银花、蛇床子、苦参、虎杖、冰片;采用高效液相色谱法测定了方中盐酸小檗碱、蛇床子素、绿原酸3个指标成分。结果:薄层鉴别专属性强,斑点清晰,阴性无干扰;盐酸小檗碱、蛇床子素、绿原酸苷分别在0.12~0.60μg(r=0.999 9)、0.056μg~0.28μg(r=0.999 9)、0.08~1.60μg(r=0.999 9)范围内呈良好的线性关系,平均加样回收率(n=6)分别为98.25%、97.04%、98.99%,RSD分别为0.97%、0.71%、0.69%。结论:所建立的定性、定量分析方法简便快速,准确,能够有效控制该制剂的质量。
Objective: To establish the quality control standard of compound ginseng gel. Methods: TLC, HPLC, HPLC, HPLC were used to determine the contents of berberine hydrochloride, osthole and chlorogenic acid in the prescriptions of Cortex Phellodendri, Honeysuckle, Cnidium, Sophora, Polygonum Cuspidatum and Borneol ingredient. Results: The specificity of TLC was clear and the spots were clear and negative without interference. The contents of berberine, osthole and chlorogenic acid were between 0.12 ~ 0.60μg (r = 0.999 9) and 0.056μg ~ 0.28μg (r = 0.999 9) and 0.08-1.60μg (r = 0.999 9). The average recoveries (n = 6) were 98.25%, 97.04% and 98.99%, respectively, with RSDs of 0.97% and 0.71 %, 0.69%. Conclusion: The established qualitative and quantitative analysis method is simple, rapid and accurate, and can effectively control the quality of the preparation.