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目的:优选痤疮消凝胶的提取工艺,为该制剂的临床应用提供参考。方法:以大黄游离总蒽醌、栀子苷、咖啡酸含量的综合评分为指标,采用均匀设计法考察乙醇体积分数、乙醇用量、提取时间和提取次数对提取工艺的影响。采用HPLC测定大黄游离总蒽醌、栀子苷、咖啡酸含量,流动相分别为甲醇-0.1%磷酸溶液(85∶15),甲醇-水(23∶77),乙腈-0.1%磷酸溶液(10∶90),检测波长依次为254,238,323 nm。结果:最佳提取工艺参数为加12倍量80%乙醇提取3次,每次1 h。大黄游离总蒽醌、栀子苷、咖啡酸质量浓度分别为1 260.33,1 597.56,32.19 mg·L-1。结论:优选的痤疮消凝胶提取工艺合理可行、重复性好,为该制剂生产工艺参数的确定提供实验依据。
Objective: To optimize the extraction process of acne gel to provide reference for the clinical application of the preparation. Methods: The total anthraquinone, geniposide and caffeic acid content of Rhubarb were used as indexes. The uniform design method was used to study the effects of ethanol volume fraction, ethanol dosage, extraction time and extraction times on the extraction process. The content of free anthraquinone, geniposide and caffeic acid in Radix et Rhizoma Rhei was determined by HPLC. The mobile phase consisted of methanol-0.1% phosphoric acid solution (85:15), methanol-water (23:77), acetonitrile-0.1% phosphoric acid solution : 90), the detection wavelength followed by 254,238,323 nm. Results: The optimum extraction parameters were 12 times the amount of 80% ethanol extracted three times, each time 1 h. Rhubarb free total anthraquinone, geniposide, caffeic acid mass concentrations were 1 260.33,1 597.56,32.19 mg · L-1. CONCLUSION: The optimal acne gel removing technology is reasonable and feasible with good repeatability, which provides an experimental basis for the determination of the process parameters of the preparation.