OBJECTIVE:A RP-HPLC method was established to determine the concentration of ambroxol hydrochloride in human plasma.METHODS:Waters HPLC instrument was used with the Hypersil BDS C 18 column(5?m,250mm?4.6mm). Ditiazem hydrochloride was chosen as the internal standard.The mobile phase was composed of acetonitrile-methyl alcohol-0.01mol/L phosphatic buffer(pH7.0)-tetrahydrofuran(35∶35∶27.5∶2.5).Flow rate was1.0ml/min.Detection wavelength was242nm.A single oral dose of90mg imported ambroxol hydrochloride tablet was given to9healthy male volunteers.Ambro xol concentration in plasma was assayed.RESULTS:The standard curve of ambroxol hydrochloride was linear in the range of10～640ng/ml.The minium detection concentration was10ng/ml.The extraction recovery was more than90%.A one-compartment open pharmacokinetic model was adopted in ambroxol plasma concentration-time data analysis.The main pharmac okinetic parameters were as follows:C max =(226.53?34.59)ng/ml,T max =(1.82?0.80)h,T 1/2ke =(6.27?0.66)h,AUC 0～24 =(2363.55?448.86)ng/(h?ml).CONCLUSION:The method is simple.The sensitivity and accuracy are high.It is applicable to study the pharmacokinetics of ambroxol hydrochloride in healthy male volunteers.

OBJECTIVE:To established a method for determining matrine and oxymatrine in human plasma.METHODS:The plasma was extracted with chloroform-n-butyl alcohol(98∶2) after basification and purified with neutral alumina solid-phase extraction.Then it was eluted with a Lichrosorb-NH2 column and CH3CN-CH3CH2OH-H3PO4(80∶10∶8),detected at ? 220nm.RESULTS:The linear range was 1.25mg～40mg/L and the limit of detection was 0.1mg/L(S/N=2).The average recoveries of matrine and oxymatrine were 106.96% and 105.04%,respectively.RSDs of within-day and between-day were lower than 13% and 7% respectively.CONCLUSION:The present study provides a simple and reliable method for determining concentrations of matrine and oxymatrine in human plasma.

Objective To study the clinical curative effect of syndrome differentiation-based treatment with traditional Chinese medicine on patient with Chronic Kidney Disease (CKD3-4). Method According to prospective multicenter randomized controlled study which was applied to the patients with CKD3-4 , the total of 339 patients were divided into two groups. To one group as standard including 167 patients ,the other including 172 patients. Chinese Traditional Patent Medicine single or combined-prescription oral treatment according to syndrome differentiation-based treatment was employed. To the other group as reference , Chinese Traditional Patent Medicine oral treatment according to experienced rule was applied. The clinical curative effect results were obtained after a 24 weeks-treatment. Result The Scr ,eGFR and UTP with CKD3 in standard group illustrate statistics significance (P<0.05). On the opposite, those of the reference group remain insignificance (P > 0.05). The clinical curative effect result of patient in standard group was better than that of reference group. About the clinical curative effect of CKD4, no statistics significance difference (P > 0.05) could be found between groups or between patients in one group. The TCM score of patient with CKD3-4 in standard group have improved (P < 0.05) according to baseline. However, that of reference group did not show any statistics significance (P > 0.05). Conclusion Syndrome differentiation-based treatment with traditional Chinese medicine illustrated a better result in protection of renal function, reduction in urinary protein and decline in TCM score than the treatment according to experienced rule.