羌归膝舒丸的质量标准研究

Study on the Quality Standard of Qianggui Xishu Pill

羌归膝舒丸是河南省洛阳正骨医院的医院制剂品种,由羌活、独活等14味中药组成的复方制剂。本品为浅褐色至黑褐色的浓缩丸,味苦,微辛。具有舒筋活络、疏肝健脾作用,用于关节病中期,关节屈伸受限,膝部疼痛,以内侧为甚,跛行等症状。该制剂已应用于临床数十年,而且取得了良好的临床疗效,因此它被纳入河南省平乐正骨传统药物的开发与研究项目。本实验旨在建立河南省洛阳正骨医院医院制剂品种"羌归膝舒丸"的质量标准体系。运用薄层色谱鉴别法对处方中的甘草、红花、羌活3味中药材进行鉴别,着重对样品的前处理方法、展开系统、点样体积、显色方法等影响因素进行考察,以期确定简便安全有效的鉴别方法,为完善该制剂的质量标准奠定基础。

Objective Qianggui Xishu pill is hospital pharmaceutical preparations in Luoyang Orthopedic Hospital of Henan Province Orthopedic Hospital of Henan Province, compound preparation composed of 14 traditional Chinese medicines such as angelica,notopterygium. This product is light brown to black brown concentrated pills,bitter taste,micro symplectic. With relax the sinews,Invigorating the liver and invigorating the spleen,for joint disease mid flexion knee pain,limited to the inside of what symptoms of claudication walking. The formulation has been applied in clinic for decades,and have achieved good clinical efficacy,so it is included in the research and development project of Henan Province,Pingle orthopedic traditional medicine. The aim of the experiment was to establish the quality standard system of Qianggui Xishu pill,the hospital preparation variety of Luoyang Bone-setting Hospital in Henan province. The prescription of licorice,safflower,notopterygium 3 herbs were identified in the TLC were investigated emphatically,pretreatment method,the sample expansion system,sample volume,color methods and other factors,in order to determine the identification method is simple,safe and effective,and lay the foundation for the improvement of quality standards the preparation.