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目的:对格列喹酮缓释片进行处方研究。方法:以药物的累积释放度为标准,同时结合相似因子,首先进行单因素试验,确定影响药物释放的主要因素,在此基础上,以HPMC(K4M)及乳糖的含量为变量,进行比较试验,采用综合评分法确定最优处方。并且对最优处方进行验证。结果:最优处方为格列喹酮、HPMC(K4M)、乳糖用量分别为60mg、30mg、55mg,70%乙醇为粘合剂,所制得的格列喹酮缓释片在2,6,12h的体外累积释放度分别为(19.82±0.92)%,(51.07±0.95)%和(83.48±0.71)%。结论:格列喹酮缓释片体外显示出缓释行为,释放度符合规定,可进一步研究开发。
Objective: To study the prescription of gliquidone sustained release tablets. Methods: The cumulative release of drugs as the standard, combined with similar factors, the first single factor test to determine the main factors that affect drug release, on this basis, the HPMC (K4M) and lactose content as a variable, comparative test , Using the comprehensive score method to determine the optimal prescription. And verify the optimal prescription. Results: The best prescription was gliquidone, HPMC (K4M), lactose dosage was 60mg, 30mg, 55mg, 70% ethanol as the adhesive, the prepared gliquidone sustained-release tablets in 2,6, The cumulative release in vitro was (19.82 ± 0.92)%, (51.07 ± 0.95)% and (83.48 ± 0.71)%, respectively. Conclusion: Glibenclamide sustained-release tablets showed sustained release behavior in vitro and the release was in line with the regulations for further research and development.