肾络通胶囊的工艺路线确定及质量标准研究  

Study on the technological line and quality standard of preparation of Shenluotong capsule

作　　者：魏远[1] 焦宁[2] 马华民[2] 杨劼[1] WEI Yuan;JIAO Ning;MA Huamin(Manufacturing Laboratory,The Third Hospital of Hebei Medical University,Hebei,Shijiazhuang 050051,China)

机构地区：[1]河北医科大学第三医院制剂室,石家庄市050051 [2]河北医科大学第三医院药剂科,石家庄市050051

出　　处：《河北医药》2019年第24期3807-3811,共5页Hebei Medical Journal

摘　　要：目的确定肾络通胶囊主要的工艺参数并对其质量标准进行研究。方法以2015版药典为依据,并广泛参考其他相关文献,研究肾络通胶囊的制剂工艺及质量标准。工艺方面通过正交试验,以干浸膏得率为评价指标,优化最佳提取工艺条件,确立制剂工艺。质量标准方面:研究处方中主要药味的定性鉴别、君药黄芪的有效成分含量测定,建立有效、可控的质量标准。结果粉碎工艺:将7/10处方量蝉蜕、1/2处方量僵蚕、1/2处方量乌鞘蛇、1/2处方量地龙烘干研细,过60目筛;提取工艺:提取2次,第1次提取1 h,第2次提取30 min,由于加水倍数对干浸膏得率影响较小,因此第1次提取加水10倍,第2次加水8倍。质量标准研究:建立肾络通胶囊中黄芪、丹参、川芎、地龙、僵蚕五味药的薄层色谱鉴别方法,应用HPLC建立了成品中黄芪甲苷的含量测定方法。结论肾络通胶囊工艺参数明确,制备工艺合理;建立的质量标准能准确地进行定性、定量检测,可对产品质量进行有效控制。Objective To determine the main process parameters of Shenluotong capsule,and to explore its quality standard.Methods The preparation processes and quality standard of Shenluotong capsule were investigated on the basis of pharmacopoeia 2015 and other relevant literatures.The optimum extraction conditions and the preparation process were established by orthogonal test with the paste yield as the evaluation index.The determination of active ingredient in milkvetch root which was the monarch drug in Shenluotong,and the qualitative identification of major herbal medicines in the prescription was used to establish the quality standard of Shenluotong capsule.Results The crushing process included drying and grinding one third prescription of cicada slough,bombyx batryticatus in half prescription,zaocys dhumnade in half prescription and lumbricus in half prescription through a 60-mesh sieve,extracting 1.5 hours for the first time with 10 times of water and 1 hour with 8 times of water for the second time as the extraction process.The quality standard was established by the determination of astragaloside A with TLC identification of milkvetch root,dan-shen root,szechwan lovage rhizome,bombyx batryticatus,and lumbricus in the product.Conclusion The technological parameters of Shenluotong capsule are definite,and the preparation technique is reasonable.The established quality standard is effective and feasible which can be carried out to control product quality.

关 键 词：肾络通胶囊 正交试验 制剂工艺 质量标准 薄层色谱法 高效液相色谱法 含量测定 黄芪甲苷 

分 类 号：R917[医药卫生—药物分析学]