龙胆泻肝胶囊及软胶囊质量标准研究  

Quality Standard for Longdan Xiegan Capsule and Longdan Xiegan Soft Capsule

作　　者：刘颖[1] 梁洪[2] 祁进[1] 傅欣彤[1] 

机构地区：[1]北京市药品检验所,北京100035 [2]北京市药品监督管理局,北京100035

出　　处：《中国中医药信息杂志》2013年第10期54-59,共6页Chinese Journal of Information on Traditional Chinese Medicine

摘　　要：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=0.999 9),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0.214 4～1.608 mg范围内呈良好的线性关系(r=1.000 0),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。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.

关 键 词：龙胆泻肝胶囊 龙胆泻肝软胶囊 龙胆苦苷 栀子苷 黄芩苷 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]