Development Of New Technique For Analysis And Evaluation Of Chinese-western Drugs

The Chinese-western combination drugs were complex and variety. To preventing and curing the disease was becoming more common along with the development of the Chinese-western combination drugs, so the Chinese-western combination drug’s quality standard and research become popular. Zhenjujiangya tablets belong to the Chinese-western combination drugs. It was recorded in the twentieth volume of Traditional Chinese Medicines edition of PPCM in 1998.It consist of chrysanthemi indici flos、zhenjucengfen、clonidine hydrochloride、hydrochlorothiazide、rutin. It only qualitative identification of zhenzhucengfen and rutin without quantitative item presented in the quality standard of Zhenjujiangya tablets, which could not reflect the comprehensive quality circumstance of this drug. The paper’s object of study was Zhenjujiangya tablets. a rapid and sensitive HPLC method was established for Zhenjujiangya tablets on clonidine hydrochloride、hydrochlorothiazide、rutin. In this study, the main antihypertensive components of the Zhenjujiangya tablets were studied and the quality standards were improved.The study was used in the Agilent chromatography column ZORBAX Eclipse XDB C18(250mm×4.6mm,5μm).the mobile phase A was 0.06mol·L-1 monopotassiump(adjusted to p H 3.0 with phosphoric acid)- acetonitrile(94:6)and the mobile phase B was 0.06mol·L-1 monopotassiump(adjusted to p H 3.0 with phosphoric acid)- acetonitrile(50:50), gradient elution, 0~13min(100:0),13~28min(100→60:0→40).Flow rate:1.0m L·min-1;Detection wavelength:280nm;Column Temperature:35℃. Results of the correlation between the concention and the chromatographic peak area of clonidine hydrochloride 、hydrochlorothiazide、rutin were in good linear in ranges of 3.120~31.170μg·m L-1、5.050~50.540μg·m L-1、20.02~200.19μg·m L-1respectively,and the correlation coefficient value was greater than 0.9997. The average recovery rates(n=9) of above three components were 96.9%(RSD=1.1%)、97.3%(RSD=1.4%)、97.3%(RSD=1.7%). It is proved that the method of precision, stability and repeatability of results were better.The method could be used to simulataneous determination of clonidine hydrochloride 、 hydrochlorothiazide 、 rutin in Zhenjujiangya tablets by HPLC. The average contents of above three components in ten samples were 28.8μg、5.1mg、19.2mg respectively by this method. The paper provided scientific basis for the overall quality of Zhenjujiangya tablets control, but also provided ideas and methods for the Chinese-western combination drug’s quality analysis and research.