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Study On Quality Standard And Pharmacokinetics Of KUHUANG Injection

Posted on:2006-12-26Degree:MasterType:Thesis
Country:ChinaCandidate:J J ChenFull Text:PDF
GTID:2144360182977496Subject:Drug analysis
Abstract/Summary:PDF Full Text Request
The quality control and the pharmacokinetics are important subjects to modernization of Chinese Traditional Medicine (TCM). In this paper, KUHUANG injection was chosen as an object, on the basis of existing standard, for exploring the methodology for TCM's quality control. Alkaloids of KUHANG injection were selected as objects for investigating the pharmacokinetics.A column separation technology and an HPLC-MS method were used for identifying some constituents of KUHUANG injection from Rhubarb and Herba Artemesiae Scopariae. This method was simple and rapid, which could be the basis of analyzing constitutes of KUHUANG injection.An RP-HPLC method was established for analyzing the principal chemical compounds in KUHUANG injection. Rhein, emodin, chrysophanol, and physcion were determined. Their linear ranges were 0.0875~1.75μg for rhein, 0.0825~1.65μg for emodin, 0.159~3.17μg for chrysophanol and 0.0525~1.05μg for physcion, respectively. The recoveries of rhein, emodin, chrysophanol and physcion were between 98.9% and 102.5%. The results suggested that the described method is accurate, sensitive and reliable, and can be used for the quality control of KUHUANG injection.A simple and rapid method was developed to study the pharmacokinetics of sophoridine (SRI), sophocarpine (SC) and matrine (MT) in rabbits. The KUHUANG injection and mixed standard solution were injected into the rabbit through ear veins, and the blood was collected at the concerned time. The concentrations of SRI, SC and MT in plasma were determined by a reversed phase HPLC-MS method. There was a good linear relationship between peak area and concentration of analytes over the concentration range of 13.2-995.0ng/ml for SRI, 7.0-530.0ng/mL for SC and 8.8-655.0ng/mL for MT, respectively. The accuracy of assay was between 92.0-103.2%. The inter-day and intra-day coefficients of variation (RSD) were all less than 10.1%. The pharmacokinetics' parameters were calculated with the software "3P87" on basis of the analysis results. The concentration-time profiles of SRI and SCafter iv administration were found to fit with two-compartment open models while that of MT fitted with three-open model. Finally, through comparing the parameters of KUHUANG injection and standard solution, it was shown that the other constituents in KUHUANG injection could promote the clearance (CL) of SC and accelerate the CL of SRI probably. No effect to MT was found.
Keywords/Search Tags:TCM, Quality Control, KUHUANG injection, Quantitative Determination, Pharmacokinetics
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