杏苏止咳颗粒质量标准研究  

Quality Standard of Xingsu Zhike Granules

作　　者：姚蓉 于勇 刘代群 陈谢华 罗疆南 YAO Rong;YU Yong;LIU Daiqun;CHEN Xiehua;LUO Jiangnan(Hunan Food and Drug Vocational College,Changsha,Hunan,China 410208;Hunan Institute for Drug Control,Changsha,Hunan,China 410001)

机构地区：[1]湖南食品药品职业学院,湖南长沙410208 [2]湖南省药品检验检测研究院,湖南长沙410001

出　　处：《中国药业》2024年第7期65-68,共4页China Pharmaceuticals

基　　金：2021年度湖南省教育厅科学研究项目[21C1274]。

摘　　要：目的提升杏苏止咳颗粒的质量标准。方法采用薄层色谱法对制剂中的前胡、陈皮和桔梗进行定性鉴别;采用高效液相色谱法测定制剂中白花前胡甲素的含量,色谱柱为Shiseido Capcell C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(65∶35,V/V),流速为1.0 mL/min,检测波长为321 nm,柱温为35℃,进样量为10μL。结果前胡、陈皮、桔梗的薄层色谱斑点清晰,分离度好,且阴性对照无干扰。白花前胡甲素的质量浓度在2.056~51.4μg/mL范围内与峰面积线性关系良好(r=0.9999,n=6);精密度、稳定性、重复性试验结果的RSD均小于3.0%(n=6);平均加样回收率为99.21%,RSD为2.01%(n=6)。样品中白花前胡甲素的含量为0.0711~0.2182 mg/g(n=3)。结论该方法操作简便、重复性好、结果准确,可用于杏苏止咳颗粒的质量控制。Objective To improve the quality standard of Xingsu Zhike Granules.Methods Peucedani Radix,Pericarpium Citri Reticulatae and Platycodonis Radix in the preparation were identified qualitatively by the thin-layer chromatography(TLC).The content of praeruptorin A in the preparation was determined by the high-performance liquid chromatography(HPLC),the chromatographic column was Shiseido Capcell C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was methanol-water(65∶35,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 321 nm,the column temperature was 35℃,and the injection volume was 10μL.Results The TLC spots of Peucedani Radix,Pericarpium Citri Reticulatae and Platycodonis Radix were clear and well separated,and the negative control had no interference.The linear range of praeruptorin A was 2.056-51.4μg/mL(r=0.9999,n=6).The RSDs of precision,stability and repeatability tests were lower than 3.0%(n=6).The average recovery of praeruptorin A was 99.21% with an RSD of 2.01%(n=6).The content of praeruptorin A in samples was in the range of 0.0711-0.2182 mg/g(n=3).Conclusion The method is simple,reproducible and accurate,which can be used for quality control of Xingsu Zhike Granules.

关 键 词：杏苏止咳颗粒 薄层色谱法 高效液相色谱法 白花前胡甲素 质量标准 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0