增液承气汤加减直肠栓的质量标准研究

Study on the quality standard of Rectal Suppository of Zengye Chengqi Decoction

目的建立增液承气汤加减直肠栓的质量控制方法。方法采用TLC法对增液承气汤加减直肠栓中的麦冬和大黄药材进行定性鉴别;采用HPLC法对增液承气汤加减直肠栓中的有效成分哈巴苷、哈巴俄苷和梓醇进行定量测定。采用Agilent Eclipse XDB-C_(18)色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈-0.5 mL·L^(-1)磷酸,梯度洗脱;检测波长:210 nm;进样量:10μL;柱温:30℃。结果 TLC法可鉴别麦冬和大黄药材,图谱中斑点显色清晰,阴性对照无干扰;3种成分含量的线性范围分别为12~60,4~20和4~20μg·mL^(-1);平均回收率分别为99.65%,99.58%和99.65%,RSD值均≤0.16%。结论该方法简便、快捷、重复性好,可用于增液承气汤加减直肠栓的质量控制。

Objective To establish a method for the quality control of Rectal Suppository of Zengye Chengqi Decoction.Methods TLC was used to identify Radix ophiopogonis and Radix rhubarb in suppository.The contents of harpagide,harpagoside and catalpol were determined by HPLC.HPLC was performed on an Agilent Eclipse XDB-C 18 column(250 mm×4.6 mm,5μm),with acetonitrile-0.5 mL·L-1 phosphoric acid as the mobile phase for gradient elution.The column temperature was 30℃,the injection volume was 10μL,and the detection wavelength was set at 210 nm.Results The TLC spots of Radix ophiopogonis and Radix rhubarb showed good resolution without interference from the negative samples.The 3 markers reached baseline separation and showed good linearity in the ranges of 12-60,4-20 and 4-20μg·mL-1 respectively.Their recovery rates were 99.65%,99.58%and 99.65%respectively,and RSDs of the 3 compounds were all less than 0.16%.Conclusion The method is simple,accurate and reproducible,which can be used for the quality control of Rectal Suppository of Zengye Chengqi Decoction.