摘要
目的建立香延平痛颗粒的质量标准。方法采用薄层色谱(TLC)法对制剂中的当归、赤芍、续断、陈皮进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中阿魏酸的含量,色谱柱为Agilent Zorbax SB-C_(18)柱(250 mm×4.6 mm,5µm),流动相为乙腈-0.085%磷酸溶液(17∶83,V/V),流速为1.0 mL/min,检测波长为316 nm,柱温为25℃,进样量为5µL。结果当归、赤芍、续断、陈皮的TLC斑点显色清晰,且阴性对照无干扰。阿魏酸的质量浓度在1.09~108.94µg/mL范围内与峰面积线性关系良好(r=1.0000,n=5);精密度、稳定性、重复性试验结果的RSD均小于2%;平均加样回收率为98.52%,RSD为1.43%(n=6)。3批样品中阿魏酸的含量为189.81~208.50µg/g。结论该方法操作简便、专属性强、重复性好、结果准确,可用于香延平痛颗粒的质量控制。
Objective To establish the quality standard of Xiangyanpingtong Granules.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Angelicae Sinensis Radix,Paeoniae Radix Rubra,Dipsaci Radix and Citri Reticulatae Pericarpium in the preparation.High-performance liquid chromatography(HPLC)method was used for the content determination of ferulic acid in the preparation,the chromatographic column was Agilent Zorbax SB-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.085%phosphoric acid solution(17∶83,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 316 nm,the column temperature was 25℃,and the injection volume was 5μL.Results The TLC spots of Angelicae Sinensis Radix,Paeoniae Radix Rubra,Dipsaci Radix and Citri Reticulatae Pericarpium were clear,and the negative control had no interference.The linear range of ferulic acid was 1.09-108.94μg/mL(r=1.0000,n=5).The RSDs of precision,stability,and repeatability test results were all lower than 2%.The average recovery rate of ferulic acid was 98.52%,with an RSD of 1.43%(n=6).The content of ferulic acid in the three batches of samples was in the range of 189.81-208.50μg/g.Conclusion This method is simple,highly specific,reproducible,and accurate,which can be used for the quality control of Xiangyanpingtong Granules.
作者
侯晓丽
辛蓓玮
李婷
李媛
朱秋珍
时扣荣
HOU Xiaoli;XIN Beiwei;LI Ting;LI Yuan;ZHU Qiuzhen;SHI Kourong(The Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine,Shanghai 200137,China)
出处
《中国药业》
2026年第5期96-100,共5页
China Pharmaceuticals
基金
上海市浦东新区卫生健康委员会学科带头人培养计划项目[PWRd2023-14]
上海市浦东新区卫生健康委员会卫生计生科研项目[PW2022A-76]
上海市浦东新区卫生健康委员会学科建设计划项目[PWZxk2022-07]。
