Studies On Quality Control Of Tanreqing Injection

Traditional Chinese medicine injection(TCMI) is a new dosage form of Traditional Chinese medicine which was independently developed by China with independent intellectual property rights.Comprehensive and systematic quality control is the precondition of TCMI's safety,effectiveness,stability and uniformity.Taking Tanreqing injection as the research object,we have established a series of methods for the quality control of bear biliary drainage powder which is the main component in Tanreqing injection's prescription,and studied on the key parameters in the process of production.The research can provide the basis to improve the production's process and products' quality standards.The main content of this paper is described as follows:1.An HPLC-UV-ELSD method for the simultaneous determination of the main component of chlorogenic acid,baicalin,ursodeoxycholic acid and the limited component of chenodeoxycholic acid in Tanreqing injection was established.The method can provide the basis for the quality control of Tanreqing injection,which is simple and accurate.2.An HPLC-ELSD method for the simultaneous determination of tauroursodeoxycholic acid and taurochenodeoxycholic acid in bear biliary drainage powder.The method is simple,accurate,reproducible,and can be used for the quality control of bear biliary drainage powder.3.An HPLC-ELSD method for the determination of the solubility of ursodeoxycholic acid and chenodeoxycholic acid was established.Several pure solvents and mixed solvents are tested and mixed ethanol-ethyl acetate solvent was selected as the new solvent for the purification of bear biliary drainage powder.Compared with ethyl acetate,the new solvent can provide larger solubility and higher selectivity.The solubility of ursodeoxycholic acid and chenodeoxycholic acid in the new solvent was determined at different temperatures.The UNIQUAC model was used for the correlation and prediction of the solubility of ursodeoxycholic acid and chenodeoxycholic acid.The prediction results will be helpful to optimize the separation process of bear biliary drainage powder.4.Preliminary studies on the impaction of five process parameters,which are pH value, temperature,the time of incubation,medicinal charcoal and propylene glycol on the content of ursodeoxycholic acid and chenodeoxycholic acid in the prepared physic liquor.The research can provide the basis for the quality control of the extract of bear biliary drainage powder in the preparation process.