郭娇娜吉林省白城市食品药品检验所，吉林白城137000

毓麟Ⅲ号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

毓麟Ⅲ号胶囊在《吉林省食品药品监督管理局医疗机构制剂标准（试行）》的基础上，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毓麟Ⅲ号胶囊中的主要成分苍术，用甲醇提取，以石油醚（60～90℃）-丙酮（9: 2）为展开剂，喷以10%硫酸乙醇溶液，加热至斑点显色清晰；远志用甲醇提取，以三氯甲烷-甲醇-水（6:3:0.5）为展开剂，喷以10%硫酸乙醇溶液，加热至斑点显色清晰；淫羊藿用乙醇提取，以乙酸乙酯-丁酮-甲酸-水（10:1:1:1）为展开剂，喷以三氯化铝试液，置紫外光灯（365 nm）下检视，在与对照药材色谱相应的位置上，显相同的颜色荧光斑点；建立显微鉴别根据茯苓和香附的特征鉴别茯苓香附的存在。

薄层色谱鉴别；苍术；淫羊藿

［Abstract］The microscopic and thin-layer chromatography qualitative identification of Yulin III capsule is added on the basis of the Jilin Province Food and Drug Administration Medical Institution Preparation Standard（Trial）.Themain components of Yulin III capsule are identified by establishing the thin-layer chromatographymethod，rhizoma atractylodis is extracted withmethyl alcohol，with petroleum ether（60～90℃）-acetone（9:2）as the developing solvent，spraying with 10%sulfuric acid ethyl alcohol solution，heated to clear spot color；polygala tenuifolia is extracted withmethyl alcohol，with chloroform-methanol-water（6:3:0.5）as the developing solvent，spraying with 10%sulfuric acid ethyl alcohol solution，heated to clear spot color；herba epimedii is extracted with methyl alcohol，with ethyl acetate-butanone-formic acid-water（10:1:1:1）as the developing solvent，spraying with aluminum chloride test solution and viewed by ultraviolet（365 nm），and the fluorescent speckle in the same color is showed at the corresponding positions compared to the controls，the existence of poria and rhizoma cyperi is identified according to their features by establishingmicroscopic identification.

［Key words］Thin-layer chromatography identification；Rhizoma atractylodis；Herba epimedii

毓麟Ⅲ号胶囊为医疗机构制剂品种，批准文号：吉药制字Z20130571。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：JLZJ-ZB-0571-2013。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：20130901、20130902、20130903。根据吉林省医疗机构制剂再注册技术要求，在《吉林省食品药品监督管理局医疗机构制剂标准（试行）》的基础上，增加了显微特征鉴别项，增加了苍术、淫羊藿、远志的薄层色谱鉴别。

1　显微鉴别与薄层色谱鉴别

1.1显微鉴别

取本品粉末，置显微镜下观察：不规则颗粒状团块和分枝状团块无色，遇水合氯醛液渐溶化。……