三黄清热胶囊质量标准的研究

目的建立三黄清热胶囊中大黄、黄芩、黄柏的定性鉴别方法,及黄芩苷的含量测定方法。方法用显微观察法鉴别制剂中大黄、黄芩、黄柏,用薄层色谱法鉴别大黄、黄柏,用高效液相色谱法测定黄芩苷含量。结果粉末显微鉴别法可以鉴别出大黄、黄芩、黄柏,薄层色谱中检出大黄、黄柏可用于定性分析。黄芩苷在62.4～1246ng(r=0.99998)范围内呈良好线性关系;样品平均回收率98.29%,RSD为0.23%。HPLC法可用于黄芩苷的含量测定。结论本实验所建立的方法简便、准确,灵敏度高,重复性好,可用于三黄清热胶囊的质量控制。

Study of quality standard for the Sanhuang Qingre capsules

Objective To establish a qualitative method for identification of Radix et Rhizoma Rhei,Radix Scutellaria,Cortex Phelloderdri Chinensi and develop a method for determination of Baicalin in the Sanhuang Qingre capsules.Methods Radix et Rhizoma Rhei,Radix Scutellaria,Cortex Phelloderdri Chinensis were identified by pharmaeognistical identification,and Radix et Rhizoma Rhei,Cortex phellodendri chinensis were identified by TLC.The quality control of the Baicalin in Sanhuang Qingre capsules was used by HPLC.Results Radix et Rhizoma Rhei,Radix Scutellaria,Cortex Phellodendri Chinensis could be identified by pharmaeognosty.Radix et Rhizoma Rhei,Corex Phellodendri Chinensis could be identified by TLC.Baicalin calibration curve was linear within the range of 62.4-1246 ng(r=0.999 98),and the average recovery of puerarin was 98.29% RSD was 0.23%.The HPLC method can be used to determine the content of Baicalin.Conclusion The method is simple,aecurate,sensitive,reproducible and can be used for quantity control of the Sanhuang Qingre capsules.