Study On The Quality Control And Process Reseach Of Shuanghuanglian Booster Injection

The current quality standards of Shuanghuanglian injection received in the State Food and Drug Administration“pharmaceutical standard”.In the Standard,there are only the content determination of baicalin,Chlorogenic acid,not to develop the content index of Forsythia suspense and fingerprint.In order to perfect and improve the quality standard,this experiment established the content of forsythia suspense index and fingerprint index of Shuanghuanglian powder injection.New method using high-performance liquid chromatography gradient elution to determination the content of chlorogenic acid,baicalin,Phillyrin three components of Shuanghuanglian injection and the fingerprint of monitoring at the same time.The optimum mobile phase gradient elution system,detection wavelength,detection column,column temperature,flow rate and solvent for the sample was settled,and the method validation showed that the method is simple,accurate,repeatable,stable and consist with the test requirements;llco-exist peaks in the chromatographic fingerprints were identif-ied,The studies confirmed that the chromatographic fingerprint of Medicinal material have a good relationship with those of intermediate and Shuanghuanglian powder injection,and the co-exist peaks in the chromatographic fingerprints of intermediates and final products can be traced in that of the medicinal material.At the same time,finished the fingerprint chromatogram peaks of final products,made the material basis for the pharmacological effects clear,ensure the stability and uniform of the product quality and show that the experimental method has good applicability.In the process of preparation,adding activated carbon and dealing with ultrafiltration for liquid to remove pyrogens and macromolecular impurities is necessary,this experiment adopts the chromatographic conditions above for the three batches liquid changes in concentrations of the main effective components,fingerprint comparison research which add activated carbon or ultrafiltration treatment before and after.The results before and after treatment showed that the contents of chlorogenic acid,phillyrin and baicalin are almost no change;liquid solids content is slightly reduced,but little effect.Fingerprint similarity was greater than 0.999.The test method showed that applies to this study.The research is to improve the quality standard of Shuanghuanglian injection,to ensure the safety and effectiveness of clinical medication great significance.