目的 制備厄貝沙坦仿制片并對(duì)其進(jìn)行工藝與溶出度一致性研究。方法 以原研藥（卡壓舒®）為參比制劑，通過單因素實(shí)驗(yàn)考察黏合劑種類、黏合劑用量、片劑硬度、不同含水量和包衣增重對(duì)溶出度的影響，確定處方組成。放大制備3批厄貝沙坦仿制片，在4種不同溶出介質(zhì)中考察3批樣品和原研藥的溶出一致性，通過相似因子（f₂）法評(píng)價(jià)自制與參比制劑溶出曲線的相似性。結(jié)果 3% HPMC-E5作為黏合劑較5% PVP K30作為黏合劑時(shí)穩(wěn)定，黏合劑用量、硬度和水分在考察的范圍內(nèi)基本不影響，包衣增重2%~3%，3批自制片與原研片在不同溶出介質(zhì)中f₂均大于50。結(jié)論 厄貝沙坦片制備工藝穩(wěn)定且自制制劑與參比制劑在不同溶出介質(zhì)中的體外溶出行為一致。

Objective To prepare generic irbesartan tablets and to evaluate its consistency of dissolution tests. Methods Using the original drugs (irbesartan) as reference drug, the single factor experiments were applied to investigating the type and amount of adhesive, tablet hardness, water content of tablets, and coating weight. ZRS-8G Dissolution Tester was used to conduct the dissolution tests which were carried on four different dissolution media. Then the similar factor (f₂) was adopted to evaluate the similarity of dissolution between the original drug and generic drug. Results As the stabilizer, 3% HPMC-E5 was more stable than 5% PVP K30. It had no difference of dissolution between original and generic drugs when the amount of adhesive, tablets hardness and water content were within the range of investigation. And the coating weight was 2% to 3%. Moreover, the f₂ values of original drug and generic drug were all greater than 50 in different dissolution media. Conclusion The f₂ results indicate a similarity in the dissolution behavior of reference drug and generic irbesartan tablets prepared by the single factor experiments. And the preparation process of generic irbesartan tablets is stable.