复方黄槐灌肠剂质量标准

Quality Standard of Compound Huanghuai Enema

目的建立复方黄槐灌肠剂质量标准。方法采用薄层色谱法(TLC)对方中大黄、槐花进行定性鉴别;采用高效液相色谱法(HPLC)测定处方中芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚含量。结果大黄、槐花薄层鉴别图谱斑点清晰,阴性对照无干扰;芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚分别在进样量4.26~34.08,17.92~143.36,4.17~33.36,7.31~58.48,2.04~16.36 ng(均r≥0.9997)范围内呈良好的线性关系,平均回收率分别为101.02%,100.06%,99.33%,99.16%,99.60%,RSD值分别为1.57%,0.94%,1.05%,1.29%,2.21%。结论所建立的定性、定量方法简便易行,重复性好,可为复方黄槐灌肠剂提供质量控制方法。

Objective To establish the quality standard for compound Huanghuai enema.Methods Thin layer chromatography(TLC)was adopted for the qualitative identification of Radix et Rhizoma Rhei Palnata and Sophora japonica.The content of aloe-emodin,rhein,emodin,chrysophanol and physcionein were determined by high performance liquid chromatography(HPLC).Results The spots of TLC were distinctived without any interference from the negative references.The determination of aloe-emodin,rhein,emodin,chrysophanol and physcionein showed good linear relation in the range of 4.26-34.08,17.92-143.36,4.17-33.36,7.31-58.48,2.04-16.36 ng,respectively(r≥0.9997).The average recoveries of aloe-emodin,rhein,emodin,chrysophanol and physcionein were 101.02%,100.06%,99.33%,99.16%,99.60%,with RSD 1.57%,0.94%,1.05%,1.29%,2.21%,respectively.Conclusion The TLC and HPLC methods are simple,rapid,accurate and repeatable,which provide the effective methods for the quality control of Compound Huanghuai Enema.