APP下载

痹康胶囊中显微和薄层色谱鉴别

2016-09-20郭娇娜吉林省白城市食品药品检验所吉林白城137000

中国卫生产业 2016年17期

郭娇娜吉林省白城市食品药品检验所,吉林白城 137000

痹康胶囊中显微和薄层色谱鉴别

郭娇娜
吉林省白城市食品药品检验所,吉林白城137000

痹康胶囊由地龙、防风、威灵仙、粉防已四味中药材组成的,为医疗机构制剂品种。在《吉林省食品药品监督管理局医疗机构制剂标准(试行)》标准的基础上,对痹康胶囊进行质量标准的增修订。该文增加了该药品显微鉴别和薄层色谱定性鉴别。建立薄层色谱法鉴别痹康胶囊中的主要成份地龙,用三氯甲烷提取,以甲苯-丙酮(9:1)为展开剂,点于硅胶G薄层板上,置紫外光灯(365 nm)下检视,供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的荧光斑点。建立显微鉴别根据地龙的特征鉴别地龙的存在。

薄层色谱鉴别;质量标准;显微鉴别

[Abstract]Bikang capsule is composed of four-flavored Chinese herbal medicines of dilong,fangfeng,weilingxian and fenfang,which is a preparation in medical institution.The quality standard was enlarged and revised on the basis of the Jinlin Food and Drug Administration Medical Institution Pharmaceutical Preparation Standard(Trail),the paper increases the microscopy identification and thin-layer chromatography qualitative identification of the drug,the main component dilong in the Bikang capsule is identified by establishing the thin-layer chromatography and extracted by chloroform,toluene and acetone(9:1)was used as developing agent and then analysed on silica gel-G plate and viewed by ultraviolet(365 nm),in the chromatography of samples,the fluorescent speckles takes an identical color at the corresponding positions of controls,the existence of dilong is identified according to the characteristics of dilong by establishing the microscopy identification.

[Key words]Thin-layer chromatography;Quality standard;Microscopy identification

痹康胶囊为医疗机构制剂品种,批准文号:吉药制字Z20130578。该制剂现行标准《吉林省食品药品监督管理局医疗机构制剂标准(试行)》,标准编号:JLZJZB-0578-2013。该次药品标准提高共收到样品3批,长春中西医结合医院提供样品,批号:20131001、20131002、20131003。根据吉林省医疗机构制剂再注册技术要求[1],在《吉林省食品药品监督管理局医疗机构制剂标准(试行)》标准的基础上,对痹康胶囊进行质量标准的增修订。修订了性状、显微特征鉴别(地龙);增加了显微特征鉴别项(防风),地龙的薄层色谱鉴别[2],现介绍如下。

1 痹康胶囊主要成份

地龙:本品为钜蚓科动物参环毛蚓Pheretima aspergillum (E.Perrier)、通俗环毛蚓 Pheretima vulgaris Chen、威廉环毛蚓Pheretima guillelmi(Michaelsen)或栉盲环毛蚓Pheretima pectinifera Michaelsen的干燥体。前一种习称“广地龙”,后三种习称“沪地龙”。……

登录APP查看全文