强力脑清素片质量标准研究

Study on quality standard for Qianglinaoqingsu tablets

目的 建立强力脑清素片的质量标准。方法 采用薄层色谱法对处方中的五味子、鹿茸进行定性鉴别，采用高效液相色谱法对刺五加中的紫丁香苷进行含量测定。色谱条件为VP-ODS（4．5mm×150mm）C18柱，甲醇-水（20：80）为流动相，流速：1．0mL·min^-1；检测波长为265nm。采用紫外-可见分光光度法对制剂中的甘油磷酸钠进行了含量制定。结果在TCL图谱中可检测出五味子、鹿茸的特征斑点。紫丁香苷的线性范围为20μg·mL^-1-222μg·mL^-1，回收率为99．45％，RSD=1．4％；甘油磷酸钠线性范围为3．1μg·mL^-17．7μg·mL^-1，回收率为98．3％，RSD=0．6％。结论方法简便、准确，可用于强力脑清素片的质量控制。

OBJECTIVE To establish a quality standard for Qianglinaoqingsu tablets. METHODS Galla chinensis, cornu cervi pantotrichum were identified by TCL. The content of Syringin in Qianglinaoqingsu tablets was determined by HPLC.The HPLC system used Alltima C18 column VP-ODS（4.5mm ×150mm）, Methanol-water （20 ： 80） was used as mobile phase , the flow rate was 1.0mL· min^- 1, UV detect wavelength was set at 265 nm. The content of Glycerol sodium was determined by UV-visible spectrophotometry. RESULTS Galla chinen- sis, cornu cervi pantotrichum could be identified by TCL; The Syringin curves were linear between 20μg·mL^-1-222μg·mL^-1the recovery was 99.45 % , RSD = 1.4 %. The Glycerol sodium curves were linear between 3.1μg·mL^-17.7μg·mL^-1, the recovery was 98.3 %, RSD = 0.6 %. CONCLUSION The method is simple, accurate and can be used for quality control of Qianglinaoqingsu tablets.