复方金蒲片(薄膜衣)定性和定量提升研究

莫敏凤; 蒋小莉; 李吉星; 朱韬; 杨江平; 涂玉; 刘雪年; 苏志恒; 焦爱军

doi:10.16190/j.cnki.45-1211/r.2023.03.027

复方金蒲片(薄膜衣)定性和定量提升研究

Study on qualitative and quantitative improvement of compound Jinpu tablets(film coating)

摘要

摘要: 目的：提升复方金蒲片（薄膜衣）定性和定量标准。方法：采用薄层色谱法（TLC）对制剂中金不换、柴胡、黄芪、丹参进行定性鉴别；采用高效液相色谱法（HPLC）测定制剂中延胡索乙素的含量。结果：建立的TLC鉴别专属性强，且处方药味与对照色谱斑点清晰，分离度良好，重现性强。HPLC 含量测定中延胡索乙素在进样量为0.160～1.605 μg，呈良好线性关系，平均回收率为95.82%，RSD为1.29%（n=6）。结论：建立的TLC和HPLC简便、专属性强、稳定性好、重现性强，能有效评价复方金蒲片（薄膜衣）的定性、定量。

Abstract: Objective: To improve the qualitative and quantitative standards of compound Jinpu tablets (film coating).Methods: Jinbuhuan, bupleurum chinense, astragalus membranaceus and salvia miltiorrhiza in the preparation were qualitatively identified by thin layer chromatography (TLC); the content of tetrahydropalmatine in the preparation was determined by high performance liquid chromatography (HPLC).Results: The established TLC method had strong specificity, clear separation and strong reproducibility between the prescription and the control.In HPLC content determination, tetrahydropalmatine had a good linear relationship in the range of 0.160-1.605 μg, the average recovery was 95.82%, and RSD was 1.29% (n=6).Conclusion: The established TLC and HPLC methods are simple, specific, stable and reproducible, and can effectively evaluate the qualitative and quantitative properties of compound Jinpu tablets(film coating).

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