首页|杏苏止咳颗粒质量标准研究

杏苏止咳颗粒质量标准研究

Quality Standard of Xingsu Zhike Granules

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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 C18 柱(250 mm×4.6 mm,5 μm),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 10 μL.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 2.056~51.4 μg/mL范围内与峰面积线性关系良好(r = 0.999 9,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0.071 1~0.218 2 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 C18 column(250 mm×4.6 mm,5 μm),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 10 μ L.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 2.056-51.4 μg/mL(r = 0.999 9,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 0.071 1-0.218 2 mg/g(n = 3).Conclusion The method is simple,reproducible and accurate,which can be used for quality control of Xingsu Zhike Granules.

Xingsu Zhike GranulesTLCHPLCpraeruptorin Aquality standard

姚蓉、于勇、刘代群、陈谢华、罗疆南

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湖南食品药品职业学院,湖南 长沙 410208

湖南省药品检验检测研究院,湖南 长沙 410001

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

湖南省教育厅科研项目(2021)

21C1274

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(7)
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