Study On Stability And Novel Dosage Forms Of Potassium Dehydroandrographolidi Succinas

Potassium Dehydroandrographolidi Succinas (DAS-K) have extensive use in treat various infection in clinic. Up to date, the patients occasionally suffered from the side effects due to the stability and quality problems. The substances which cause the side effects are probably the vegetable proteins with high molecule or the degradation products and the pigments caused by the oxidative and hydrolytic degradation of the DAS-K.We developed a method to determine the content of DAS-K by HPLC; determine the primary physico-chemical property of DAS-K; study the degradation products from the DAS-K; the HPLC method was used to determine the degradation kinetic parameters of DAS-K aqueous solution. The hydrolytic degradation followed first-order kinetics as measured by HPLC. The stability of the drug was found to be dependent on pH, buffer concentration, buffer species and temperature.The degradation kinetics of DAS-K in aqueous solution was investigated at different pH, different HP- β -CD concentration and various temperatures. The apparent fate constant(kc) for degradation of DAS-K in inclusion complex and apparent stability constant(Ka) were calculated by the curve-fitting method.The basic prescription and preparation technology was initially defined by the study about formulation screening and technology optimizing , based on the pharmacy rule as indicator.In the quality study of the injection of DAS-K. The main components included that the chemical, spectrographic and chromatographic identification methods were set up, the HPLC method was developed for the content determination. Further more, the injection of DAS-K testing method of the correlated material was founded.The initial stability study showed that light, high temperature had some effects on the injection. The results suggest the injection of DAS-K should be preserved under cold enviroment way from light.