格列齐特缓释片的制备及体外释放研究  

Preparation and In Vitro Release of Gliclazide Sustained Release Tablets

作　　者：刘正平 杨雪华 陈倩倩 毛楷凡 薛松 李大伟 LIU Zheng-ping;YANG Xue-hua;CHEN Qian-qian;MAO Kai-fan;XUE Song;LI Da-wei(Shandong Engineering Research Center of Novel Sustained and Controlled Release Formulations and Targeted Drug Delivery Systems,Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China;Shandong Provincial Engineering Research Center for Sustained-release Preparation of Chemical Drugs,Jinan 250101,China;National Medical Products Administration Key Laboratory for Technology Research and Evaluation of Drug Products,Jinan 250101,China)

机构地区：[1]山东省药学科学院新型缓控释制剂与药物靶向递送系统山东省工程研究中心,山东济南250101 [2]山东省化学药物缓释制剂工程技术研究中心,山东济南250101 [3]国家药监局药物制剂技术研究与评价重点实验室,山东济南250101

出　　处：《食品与药品》2023年第2期178-182,共5页Food and Drug

摘　　要：目的 制备格列齐特缓释片,考察其体外释放行为。方法 考察缓释材料羟丙甲纤维素(HPMC)K4M和K100LV不同比例、填充剂(二水磷酸氢钙和糊精)不同用量及不同润湿剂对格列齐特缓释片体外释放度的影响,筛选确定最优处方,并考察其在pH 7.4磷酸盐缓冲液、pH 6.8磷酸盐缓冲液、pH 4.5醋酸盐缓冲液和纯化水4种介质中的释放行为。结果 最优处方中,HPMC K4M和K100LV质量比为1:1,二水磷酸氢钙用量为50%,糊精用量为10%,润湿剂为50%乙醇溶液,制备的格列齐特缓释片在4种介质中的相似因子(f2)均大于70,体外释放符合Higuchi方程。结论 制备的格列齐特缓释片与参比制剂体外释放行为相似。Objective To prepare Gliclazide Sustained Release Tablets and investigate the in vitro release behavior.Methods The effect of ratio of HPMC K4M to HPMC K100LV,dosage of calcium hydrogen phosphate and dextrin,and different wetting agents on in vitro release behavior was observed to screen the optimum formulation.In vitro drug release behavior of Gliclazide Sustained Release Tablets in pH 7.4 phosphate buffer,pH 6.8 phosphate buffer,pH 4.5 acetate buffer and purified water were studied.Results In the optimal formulation,the mass ratio of HPMC K4M to HPMC K100LV was 1:1,the dosage of calcium hydrogen phosphate dihydrate was 50 %,the dosage of dextrin was 10 %,and the wetting agent was 50 % ethanol solution.The similarity factor(f2) of the prepared Gliclazide Sustained Release Tablets in four release media was greater than 70,and the in vitro release conformed to the Higuchi equation.Conclusion The in vitro release behavior of Gliclazide Sustained Release Tablets are similar with that of reference preparation.

关 键 词：格列齐特 缓释片 羟丙甲纤维素 体外释放 

分 类 号：R943[医药卫生—药剂学]