风湿痹痛胶囊质量标准  

Quality Standard of Fengshi Bitong Capsule

作　　者：黄木土[1] 林兰兰[1] 谢新民[1] 肖俊峰[1] 韩丽萍[1] 

机构地区：[1]广州军区广州总医院药学部,广州510010

出　　处：《医药导报》2017年第7期786-789,共4页Herald of Medicine

基　　金：军队医疗机构制剂标准提高计划-治疗内分泌代谢与老年病非标准制剂质量标准提高研究(14ZJZ15-3);广州市科技计划项目-广州市老年慢病患者合理用药重点实验室(201509010012)

摘　　要：目的建立风湿痹痛胶囊的质量标准。方法采用薄层色谱法对风湿痹痛胶囊中羌活、独活、防风进行定性鉴别;薄层色谱法对黑顺片进行乌头碱限量检查;采用高效液相色谱法测定制剂中羌活主要成分异欧前胡素的含量。结果薄层法色谱鉴别专属性强,斑点清晰,阴性无干扰;乌头碱限量符合《中华人民共和国药典》2010年版要求;异欧前胡素在3.668 96~183.448 00μg·mL^(-1)范围内线性关系良好(r=1),平均加样回收率96.42%,RSD=2.64%。结论该方法专属性强,稳定性好,重复性好,可有效控制风湿痹痛胶囊质量。Objective To establish the quality standard of Fengshi Bitong Capsule. Methods Notopterygh Rhizoma,Angelicae Pubescentis,and Saposhnikoviae Radix were identified by thin layer chromatography（TLC）.Aconitine limit test in this drug also carried out by TLC.The contents of Isoimperatorin in the Notopterygh Rhizoma were determined by high performance liquid chromatography（HPLC）. Results The spots in the TLC were fairly clear and no interference was shown in the blank samples.The aconitine limited in conformity with the 《Chinese Pharmacopoeia》 2010. Isoimperatorin showed a good linear relationship within a range of 3.668 96-183.448 00 μg· mL^-1（r=1）.The average of recovery was 96.42%,RSD=2.64%,respectively. Conclusion The established methods are highly specific,stable and reproducible,which can be used as quality control of fengshi bitong capsule.

关 键 词：风湿痹痛胶囊 羌活 色谱法 薄层 色谱法 高效液相 

分 类 号：R286[医药卫生—中药学] TQ460.1[医药卫生—中医学]