Study On Preparation Technology Of Cinepazide Maleate Liposome Tablets

Objective:Establishing an in vitro analytical method of cinepazide maleate,selecting the best prescription and preparation process in the preparation process of cineridezide liposomes(CM-Lip)and its stable preparation,and solving the maleic acid The characteristics of cinepazide in the process of light exposure are drastically reduced,and the CM-Lip powder prepared by the best process is characterized.The quality standard of CM-Lip and its tablets is established and mathematical model is proposed.To explore its drug release mechanism.Method:High-performance liquid chromatography(HPLC)was used to determine the content of CM in vitro.The single factor method and response surface test method were used to evaluate the optimal formulation and preparation process of CM liposome with encapsulation efficiency as the index.CM-Lip The powder properties and their yields were investigated.The best drying process was optimized by single factor test.The formation of liposomes was verified by infrared,differential calorimetry(DSC)and particle size determination of liposomes.The tablet traits,hardness and angle of repose were taken as indicators.The single factor test method was used to optimize the tablet molding process and establish the quality standard of CM-Lip tablets.The release mechanism of CM-Lip solid preparations was simulated by mathematical model.Hehe.Results:The final prescription preparation process for CM-Lip was as follows: the mixed solvent of diethyl ether:ethanol(3:1)was used as the organic phase,the dosage was 60 ml,the hydration temperature was 60 ?,and the p H of the hydration medium was 7.8-8.0.For intermittent ultrasound,the ultrasonic time is 10min;the rotary steaming temperature is 75?,the ratio of drug to fat is 10:1 hydration time is 1.5h,the hydration medium is p H 5.8PBS,the ratio of organic phase to water phase is 3:1;Drying method to obtain CM-Lip dry powder,the process is: mannitol as protection,the amount of protective agent added is phospholipid:protective agent(4:1);the characterization of CM-Lip verifies the formation of CM-Lip,CM-Lip The dry powder was made into tablets and the optimum preparation process was as follows: microcrystalline cellulose was used as a filler,the dosage was 14%,the amount of glidant was 0.2%,and the best process was verified to prove the tablet.The molding process is stable and feasible.Accelerated test proved that CM-Lip tablets have good stability.The results of in vitro release test showed that CM-Lip had a certain sustained release effect,and the release model proved that it was a Higuchi equation release model.Conclusion:The preparation process of CM-Lip and the preparation process of the stable preparation are simple,suitable for industrial production,and the quality is stable and controllable.