Studies On Quality Control Of Oxymatrine Injection And Radix Sophorae Flavescentis

Oxymatrine was one of quinolizidine alkaloids and extracted from leguminous plants, such as radix sophorae flavescentis, Sophora alopecuroide and Sophora tonkinensis. The listed oxymatrine injection was made of oxymatrine, and oxymatrine injection is used to treat chronic hepatitis, low white blood cells aroused by radiotherapy and chemotherapy of tumour and hypoleukocytosis caused by other reasons.The primal problem of the current quality standards of oxymatrine injection was that the quality standards were different among different enterprise in the same variety. It mainly reflected in the method diversity between related substance and content determination. Some quality standards check related substance by thin layer chromatography scanning (TLC) which show low sensitivity, and some determine the content of oxymatrine by titrimetry which has poor specificity. The purpose of the study was to establish a sensitive, exclusive and reproducible method, and use a uniform quality standard to evaluate the quality of oxymatrine injection produced by different manufacturing enterprises.The study was optimized the method of HPLC and established a accordant method to check up related substance and determine the content of oxymatrine. As a result, the maximum impurity of8batch of samples is greater than0.5%, and related substance of1batch sample over2.0%. It can deduce that the main related substances may be sophoranol N-oxide,14p-hydroxymatrine and matrine by using HPLC-MSn.The study established a method to determine solvent residual quantity in oxymatrine injection by capillary gas chromatography with headspace sampling for the first time to control solvent residual quantity in preparation, because organic solvent, such as ethanol,acetone and chloroform, were used in extracting oxymatrine from the raw material of oxymatrine injection. In order to evaluate if solvent residual quantity in oxymatrine injection achieve acceptable level, the study detected solvent residual quantity for47batches samples from14manufacturing enterprises. As a result, the first kind and second kind organic solvent was no find, and the third kind organic solvent, ethanol and acetone, were detected with the residual quantity under0.5%.Radix sophorae flavescentis was the raw material of oxymatrine, and was one of common chinese medicinal crop, which was recorded by Chinese Pharmacopoeia. Alkaloids and flavonoida were the main constituents. Alkaloids has many pharmacological actions, such as antitumor, antiarrhythmic, antimicrobial, antiulcer, etc. The content of matrine and oxymatrine as the quality control index of the radix sophorae flavescentis in Chinese Pharmacopoeia cannot react the quality of Radix sophorae flavescentis totally. The study established for a method to determine simultaneously7kinds of alkaloids for the first time.16batches of radix sophorae flavescentis were collected from14different areas and the contents of7kinds of alkaloids in radix sophorae flavescentis were determined. The result indicates the content of matrine, oxymatrine and oxysophocarpine is higher. Oxysophocarpine has some pharmacodynamic actions, and was one of main active constituents. So, to determine the contents of multiple alkaloids can provide data support for controlling the quality of radix sophorae flavescentis. The fragmentation reactions of the alkaloids in radix sophorae flavescentis are summu-ried in this paper by HPLC-MS", and was helpful to analysis where the related substances in oxymatrine injection from.