The objective of this study was to develop once-daily metformin hydrochloride sustained-release tablets (MHSRT) and evaluate their in vitro release behavior. MHSRT were prepared by the film coating method. The in vitr...The objective of this study was to develop once-daily metformin hydrochloride sustained-release tablets (MHSRT) and evaluate their in vitro release behavior. MHSRT were prepared by the film coating method. The in vitro drug release rate of MHSRT and the commercial tablets Fortamet? made in the United States of America in water was fitted with zero order kinetic equation, and Ritger-Peppas kinetic equation in 0.1 M HCl and pH 6.8-phosphate buffer, respectively. The similarity factor f2 values of MHSRT in three different dissolution medium were 82, 80 and 74, respectively in comparison with imported Fortamet?, which were all greater than 50. The results of storage-stability showed that MHSRT were stable for at least 6 months under stress condition (40℃ ± 2℃, RH 75% ± 5%). Therefore, in this study, MHSRT were successfully prepared using optimized formulation technologies that meet mass produce. The in vitro release behavior of MHSRT was almost similar to that of imported Fortamet?.展开更多
目的:系统评价盐酸羟考酮缓控释片治疗中重度癌痛的有效性和安全性。方法:计算机检索PubMed、Web of Science、Embase、Cochrane Library、CBM、中国知网、VIP、万方等数据库,检索时限为建库至2023年3月25日。纳入盐酸羟考酮缓控释片(...目的:系统评价盐酸羟考酮缓控释片治疗中重度癌痛的有效性和安全性。方法:计算机检索PubMed、Web of Science、Embase、Cochrane Library、CBM、中国知网、VIP、万方等数据库,检索时限为建库至2023年3月25日。纳入盐酸羟考酮缓控释片(试验组)对比同类药物(对照组)用于治疗中重度癌痛的随机对照试验。采用Cochrane偏倚风险评价手册对纳入的文献进行质量评价,运用RevMan 5.3和Stata 17.0软件进行Meta分析。结果:共纳入70项RCT,共计6449例患者。70篇文献按照对照组所用药物的不同,分组进行Meta分析。Meta分析结果显示,试验组患者的疼痛有效缓解率均显著高于对照组,盐酸曲马多缓释片[RR=1.12,95%CI(1.08,1.17),P<0.01]、硫酸吗啡缓控释片[RR=1.16,95%CI(1.12,1.20),P<0.01]、美沙酮片[RR=1.13,95%CI(1.03,1.25),P=0.01]、氨酚羟考酮片[RR=1.09,95%CI(1.01,1.19),P=0.03]。在药物安全性方面,试验组患者的便秘、恶心、呕吐、头晕等不良反应发生率低于对照组硫酸吗啡缓控释片(P<0.05),部分不良反应发生率(头晕、恶心及呼吸抑制)低于对照组氨酚羟考酮片(P<0.05),而与对照组盐酸曲马多缓释片和美沙酮片相比,不良反应发生率差异无统计学意义(P>0.05)。结论:盐酸羟考酮缓控释片镇痛效果相比同类药物盐酸曲马多缓释片、硫酸吗啡缓控释片、美沙酮片、氨酚羟考酮片具有明显优势,且不增加药物不良反应,安全性良好。展开更多
文摘The objective of this study was to develop once-daily metformin hydrochloride sustained-release tablets (MHSRT) and evaluate their in vitro release behavior. MHSRT were prepared by the film coating method. The in vitro drug release rate of MHSRT and the commercial tablets Fortamet? made in the United States of America in water was fitted with zero order kinetic equation, and Ritger-Peppas kinetic equation in 0.1 M HCl and pH 6.8-phosphate buffer, respectively. The similarity factor f2 values of MHSRT in three different dissolution medium were 82, 80 and 74, respectively in comparison with imported Fortamet?, which were all greater than 50. The results of storage-stability showed that MHSRT were stable for at least 6 months under stress condition (40℃ ± 2℃, RH 75% ± 5%). Therefore, in this study, MHSRT were successfully prepared using optimized formulation technologies that meet mass produce. The in vitro release behavior of MHSRT was almost similar to that of imported Fortamet?.
