肾康宁胶囊的薄层色谱定性鉴别质量控制方法研究

Study on qualitative identification and quality control of Shenkangning Capsules by TLC

目的建立肾康宁胶囊中泽泻、丹参、茯苓和锁阳的薄层色谱定性鉴别质量控制方法。方法采用单因素试验方法,对不同的展开系统、显色剂、点样量、温湿度进行系统考察,确定鉴定泽泻、丹参、茯苓和锁阳的最佳薄层色谱条件。结果泽泻、丹参采用硅胶G薄层板,以正己烷-乙酸乙酯-甲酸(7∶4∶0.6)为展开剂,展开、取出、晾干,置紫外光灯(365 nm)下检视荧光斑点,再喷以2%磷钼酸乙醇溶液,在105℃加热至斑点显色清晰;茯苓采用硅胶G薄层板,以正己烷-乙酸乙酯-甲酸(7∶4∶0.4)为展开剂,展开、取出、晾干,置紫外光灯(365 nm)下检视荧光斑点;锁阳采用硅胶G薄层板,以环己烷-乙酸乙酯-甲醇-甲酸(8∶6∶1∶1)为展开剂,展开、取出、晾干,用0.04%DPPH无水乙醇溶液浸板,取出、晾干,置日光下检视斑点显色清晰。结论薄层色谱特征鉴别斑点清晰、专属性强、阴性对照无干扰。该方法简单方便,重复性好,可用于肾康宁胶囊的质量控制。

Objective To establish a method for qualitative identification and quality control of Alismatis Rhizoma,Salviae miltiorrhizae Radix et Rhizoma,Poria and Cynomorii Herba in Shenkangning Capsule by thin layer chromatography(TLC).Methods The single-factor test method was used to systematically investigate the factors of TLC conditions,including different developing solvents,chromogenic reagents,spot volume,temperature,humidity,and to determine the optimal TLC conditions for the identification of Alismatis Rhizoma,Salviae miltiorrhizae Radix et Rhizoma,Poria and Cynomorii Herba.Results The TLC conditions for Alismatis Rhizoma and Salviae miltiorrhizae Radix et Rhizoma were to develop on silica gel G thinlayer plate with n-hexane-ethyl acetate-formic acid(7∶4∶0.6)as the developing solvent.After the plate was taken out and dried,the fluorescent spots were observed under ultraviolet lamp(365 nm),then sprayed with 2%phosphomolybdate ethanol solution,heated at 105℃until the spots became clear.The TLC conditions for Poria were to develop on silica gel G thin-layer plate with n-hexane-ethyl acetate-formic acid(7∶4∶0.4)as the developing solvent.After the plate was taken out and dried,the fluorescent spots were observed under ultraviolet lamp(365 nm).The TLC conditions for Cynomorii Herba were to develop on silica gel G thin-layer plate with cyclohexane-ethyl acetate-methanol-formic acid(8∶6∶1∶1)as the developing solvent After the plate was taken out and dried,it was soaked in 0.04%DPPH absolute ethanol solution.The spots were clear under daylight after the plate was dried again.Conclusions Thin layer chromatography features clear identification spots,strong specificity,negative control without interference.The method is also simple,convenient and has good repeatability,which can be adopted for the quality control of Shenkangning capsule.