论文部分内容阅读
目的探讨奥美拉唑肠溶胶囊的释放度。方法采用由美国安捷伦公司生产的安捷伦1100型高相液相色谱仪,以及天津天大天发科技有限公司生产的RCZ-8B型溶出试验仪,进行6次精密度实验。结果在45 min内,4所厂家生产的奥美拉唑肠溶胶囊完全释放,与2010年版中国药典中的二部标准完全相符,但是由于厂家的不同,释放度出现微小差异。15 min时,企业3、企业2、企业1在释放度值达到最大,其中企业4的释放度值最小,企业2的释放度值最大,药物释放存在着持续性释放和突然性释放的特点。结论光纤药物溶出度实时测定仪是一种临床应用效果较佳的新型药物溶出度分析仪器,还可以对不同厂家制剂工艺差别进行有效比较,对药品内在质量进行全面反映。
Objective To investigate the release of omeprazole enteric-coated capsules. Methods The Agilent 1100 High-Resolution Liquid Chromatograph manufactured by Agilent Company of USA and the RCZ-8B Dissolution Tester produced by Tianjin Tianda Tiafa Science and Technology Co., Ltd. were used for 6 precision experiments. Results Within 45 min, the omeprazole enteric-coated capsules produced by the 4 manufacturers were completely released, which was in good agreement with the two standards in the 2010 edition of the Chinese Pharmacopoeia. However, due to different manufacturers, small differences in release were observed. At 15 min, Enterprise 3, Enterprise 2 and Enterprise 1 reached the maximum release value, among which Enterprise 4 had the lowest release value and Enterprise 2 had the largest release value. Drug release had the characteristics of sustained release and sudden release. Conclusion The real-time optical fiber drug dissolution tester is a new type of drug dissolution analysis instrument with better clinical application. It can also make an effective comparison between different manufacturers’ preparation process and fully reflect the intrinsic quality of the drug.