摘要
目的考察替米沙坦片在不同溶出介质中与原研药美卡素的相似性。方法采用流化床制粒法制备替米沙坦颗粒,用普通旋转压片机压片制备替米沙坦片;以其15 min累积溶出率为指标,采用L_(9)(3^(4))正交试验设计优化替米沙坦片处方;采用紫外-分光光度法测定累积溶出率,并进行f_(2)因子比较。结果优化后的替米沙坦处方为每片含羧甲基淀粉钠5 mg、氢氧化钠3.5 mg、甘露醇40 mg,此时的体外溶出曲线最理想。替米沙坦片累积溶出率与原研药美卡素相似,在pH 7.5磷酸盐缓冲液中的f_(2)因子为75。结论流化床制粒法制备工艺简单,效率高,其制备样品的体外溶出特征和原研药美卡素具有相似性。
Objective To investigate the similarity between Telmisartan Tablets and the original-patented drug Micardis in different dissolution media.Methods Telmisartan Particles were prepared by the fluidized-bed granulation method,and Telmisartan Tablets were prepared by the ordinary rotary tablet machine.The formulation of Telmisartan Tablets was optimized by the L_(9)(3^(4))orthogonal test with the cumulative dissolution rate within 15 min as the index.The cumulative dissolution rate was determined by UV spectrophotometry,and f_(2) factor was compared.Results The optimized formulation of telmisartan contained 5 mg of sodium carboxymethyl starch,3.5 mg of sodium hydroxide and 40 mg of mannitol in each tablet,and the dissolution profile of telmisartan in vitro was the best at this moment.The cumulative dissolution rate of Telmisartan Tablets was similar to that of the original-patented drug Micardis.The f_(2) factor in the phosphate buffer solution(PBS)of pH7.5 was 75.Conclusion Telmisartan Tablets prepared by the one-step granulation method have simple process and high efficiency.The in vitro dissolution characteristics of the prepared samples are similar to those of the original-patented drug Micardis.
作者
杨敏
祖文
李君
沈柏汐
YANG Min;ZU Wen;LI Jun;SHEN Boxi(Wulanchabu Central Hospital,Wulanchabu,Inner Mongolia,China 012000;Inner Mongolia Medical University,Hohhot,Inner Mongolia,China 010110)
出处
《中国药业》
CAS
2022年第5期64-67,共4页
China Pharmaceuticals
作者简介
第一作者:杨敏,男,硕士,主管药师,研究方向为医院药学,(电子信箱)97010547@qq.com。
