应用四条溶出曲线筛选厄贝沙坦片处方工艺

Screening the Irbesartan Tablet Formulations According to 4 Dissolution Profiles

采用比较自研处方与参比制剂（亦称原研制剂）在水、醋酸盐缓冲液、盐酸、磷酸盐缓冲液中四条溶出曲线的f2因子,确定自研处方。通过调整厄贝沙坦片处方中辅料的含量,比较自制制剂（处方一~五）和参比制剂（批号：3A292）的f2因子,得到当处方中乳糖、微晶纤维素、交联羧甲基纤维素钠、羟丙基甲基纤维素、二氧化硅和硬脂酸镁含量分别为18.60%、14.34%、4.65%、1.16%、2.71%、0.39%时和参比制剂比较相似,工艺具有良好稳定性及重现性。

After compare the f2 factors of 4 dissolution profiles obtained from water,acetate buffer solution,hydrochloric acid solution and phosphate buffer solution due to self-developed products and reference product,the final formulation is determined.By compare the different f2 factor due to homemade products with different excipients content（Formulation 1~5） and the reference product（Lot No.：3A292）,we found that when the content of lactose,microcrystalline cellulose,croscarmellose sodium carboxymethyl cellulose,hydroxypropyl methyl cellulose,silica and magnesium stearate is 18.60%,14.34%,4.65%,1.16%,2.71%and 0.39% respectively,the f2 factor of homemade product is similar with the reference product.What＇s more,the process is stable and repeatable.