El-Sayed A, Boraie N A, Ismail F A, El-Khordagui L K, Khalil S A
Department of Pharmaceutics, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt.
East Mediterr Health J. 2007 Nov-Dec;13(6):1427-37. doi: 10.26719/2007.13.6.1427.
The pharmaceutical quality of 7 local omeprazole capsule brands in Egypt was assessed relative to the proprietary product (Losec). Drug content, content uniformity, drug release (using USP test for enteric coated articles and a modified release test) were determined. Products were subjected to a 3-month stability study. Of the 7 brands, 6 had satisfactory drug content and content uniformity. All brands passed the USP drug release test. The modified release test proved to be more discriminative. After 3 months storage, drug content of 3 brands remained > 90% and 2 of these brands maintained drug release above 75%. Changes in pellet appearance during storage were indicative of omeprazole chemical degradation.
对埃及当地7个品牌的奥美拉唑胶囊的药品质量相对于专利产品（洛赛克）进行了评估。测定了药物含量、含量均匀度、药物释放度（采用美国药典肠溶包衣制剂试验和改良释放试验）。对产品进行了为期3个月的稳定性研究。7个品牌中，6个品牌的药物含量和含量均匀度令人满意。所有品牌均通过了美国药典药物释放度试验。改良释放试验结果显示更具区分性。储存3个月后，3个品牌的药物含量仍＞90%，其中2个品牌的药物释放度保持在75%以上。储存期间微丸外观的变化表明奥美拉唑发生了化学降解。
