关节乐胶囊质量研究Quality Standard of Guanjiele Capsule
罗海燕,李庆国,关世侠,吴小兵
LUO Hai-yan1,LI Qing-guo2,GUAN Shi-xia2,WU Xiao-bing2(1.School of Basic Medical Science
摘要(Abstract):
目的探讨建立控制关节乐胶囊质量的方法。方法采用薄层色谱法(TLC)对中药川芎和赤芍进行定性鉴别,采用高效液相色谱法(HPLC)对补骨脂素和异补骨脂素进行含量测定。结果 TLC特征斑点明显、专属性强。补骨脂素在0.008 2~0.205 0 mg/m l(r=0.999 8)、异补骨脂素在0.013 0~0.325 0 mg/m l(r=0.999 7)的检测浓度间具有良好的线性关系,平均回收率分别为93.21%(RSD=4.039%,n=6),98.67%(RSD=1.520%,n=6)。结论所建标准可用于关节乐胶囊的质量控制。
Objective To establish the quality standard for Guanjiele capsule.Methods Thin-Layer chromatography(TLC) was employed for the qualitative determination of Rhizoma Chuanxiong and Radix Paeoniae Rubra.High performance liquid chromatography(HPLC) was applied for the determination of Psoralen and Isopsoralen in Guanjiele capsule.Results The characteristic by TLC was obvious and highly specific.The Linear range of Psoralen and Isopsoralen was from 0.008 2~0.205 0 mg/ml(r=0.999 8) and 0.013 0~0.325 0 mg/ml(r=0.999 7).The average recovery was 93.21%(RSD=4.039%,n=6) and 98.67%(RSD=1.520%,n=6),respectively.Conclusion The established standard can be used for the quality control of Guanjiele capsule.
关键词(KeyWords):
关节乐胶囊;质量;薄层色谱;高效液相色谱法
Guanjiele capsule;quality standards;TLC;HPLC
基金项目(Foundation): 广东省自然科学基金课题(编号:815040701000058)
作者(Author):
罗海燕,李庆国,关世侠,吴小兵
LUO Hai-yan1,LI Qing-guo2,GUAN Shi-xia2,WU Xiao-bing2(1.School of Basic Medical Science
参考文献(References):
- [1]潘炎铃,陈斌.天舒软胶囊质量标准的制定及研究[J].人参研究,2005,17(3):25-26.
- [2]黄松,蒋东旭,黄珊珊,等.产后逐瘀胶囊的质量标准研究[J].中药新药与临床药理,2006,17(4):268-270.
- [3]国家药典委员会.中国药典(一部)[M].北京:化学工业出版社,2005.
- [4]阎向东,牛会芬,徐佳曦,等.天冰调督胶囊质量标准研究[J].中成药,2007,29(4):540-542.
- [5]孙栋梁,黄慧成.盆炎净凝胶剂的质量标准研究[J].赣南医学院学报,2008,28(6):801-803.
- [6]徐晓明,徐大勇,邢俊波.HPLC法测定补肾健脑软胶囊中补骨脂素和异补骨脂素的含量[J].中国中医药信息杂志,2008,15(7):47-48.
- [7]高岚,邹中旺.HPLC法测定骨康片中补骨脂素和异补骨脂素的含量[J].现代中药研究与实践,2008,22(2):45-47.