CAJ | 학술논문

目的建立龙胆泻肝胶囊及龙胆泻肝软胶囊的质量标准。方法采用薄层色谱法对龙胆、柴胡、黄芩、栀子、泽泻、当归、地黄、甘草进行定性鉴别，并采用高效液相色谱法测定龙胆中龙胆苦苷、栀子中栀子苷、黄芩中黄芩苷的含量。结果薄层色谱斑点清晰。龙胆苦苷在0.0661～0.5951 mg范围内呈良好的线性关系(r＝1.0000)，胶囊剂平均回收率为99.34%(RSD＝1.50%)，软胶囊剂平均回收率为96.62%(RSD＝1.50%)；栀子苷在0.0761～1.3698 mg范围内呈良好的线性关系(r＝0.9999)，胶囊剂平均回收率为101.32%(RSD＝1.70%)，软胶囊剂平均回收率为100.59%(RSD＝0.79%)；黄芩苷在0.2144～1.608 mg 范围内呈良好的线性关系(r＝1.0000)，胶囊剂平均回收率为101.12%(RSD＝1.30%)，软胶囊剂平均回收率为98.07%(RSD＝2.40%)。结论该方法简便易行，重复性好，可用于龙胆泻肝胶囊、龙胆泻肝软胶囊的质量控制。
목적건립룡담사간효낭급룡담사간연효낭적질량표준。방법채용박층색보법대룡담、시호、황금、치자、택사、당귀、지황、감초진행정성감별，병채용고효액상색보법측정룡담중룡담고감、치자중치자감、황금중황금감적함량。결과박층색보반점청석。룡담고감재0.0661～0.5951 mg범위내정량호적선성관계(r＝1.0000)，효낭제평균회수솔위99.34%(RSD＝1.50%)，연효낭제평균회수솔위96.62%(RSD＝1.50%)；치자감재0.0761～1.3698 mg범위내정량호적선성관계(r＝0.9999)，효낭제평균회수솔위101.32%(RSD＝1.70%)，연효낭제평균회수솔위100.59%(RSD＝0.79%)；황금감재0.2144～1.608 mg 범위내정량호적선성관계(r＝1.0000)，효낭제평균회수솔위101.12%(RSD＝1.30%)，연효낭제평균회수솔위98.07%(RSD＝2.40%)。결론해방법간편역행，중복성호，가용우룡담사간효낭、룡담사간연효낭적질량공제。
Objective To establish the quality standards of Longdan Xiegan Capsule and Longdan Xiegan Soft Capsule. Methods Gentianae Radix et Rhizoma, Bupleuri Radix, Scutellariae Radix, Gardeniae Fructus, Alismatis Rhizoma, Angelicae Sinensis Radix, Rehmanniae Radix and Glycyrrhizae Radix et Rhizoma were identified by TLC. Gentiopicrin in Gentianae Radix et Rhizoma, geniposide in Gardeniae Fructus, baicalin in Scutellariae Radix were determined by HPLC. Results The TLC spots developed were clear. Gentiopicrin showed good linear relationship in the range of 0.066 1-0.595 1 mg (r=1.000 0), the average recovery of Capsule was 99.34%(RSD=1.50%), and the average recovery of Soft Capsule was 96.62%(RSD=1.50%). Geniposide showed good linear relationship in the range of 0.076 1-1.369 8 mg (r=0.999 9), the average recovery of Capsule was 101.3% (RSD=1.70%), and the average recovery of Soft Capsule was 100.59%(RSD=0.79%). Baicalin showed good linear relationship in the range of 0.214 4-1.608 mg (r=1.000 0), the average recovery of Capsule was 101.12% (RSD=1.30%), and the average recovery of Soft Capsule was 98.07% (RSD=2.40%). Conclusion The method is simple and reproducible. It can be used to control the quality of Longdan Xiegan Capsule and Longdan Xiegan Soft Capsule.