51批奥美拉唑肠溶胶囊含量均匀度的评价与研究好吃的早餐
目的 对17个厂家51批奥美拉唑肠溶胶囊“含量均匀度”检查项进行评价与研究。方法 按照《中国药典》2015年版二部奥美拉唑肠溶胶囊“含量均匀度”方法检查,并进行去胶囊壳、统一乙醇量及具体实验细节进行修正。结果 去胶囊壳的51批奥美拉唑肠溶胶囊含量均匀度全部合格,使用流化床工艺的两个厂家含量均匀度均匀性較好。结论 检查时必须去胶囊壳取内容物进行,10 mg与20 mg规格都加入20 mL乙醇进行溶解,建议标准进行修订;建议推广使用流化床工艺的应用,保证药品的均匀性。
标签: 奥美拉唑;含量均匀度;胶囊壳;工艺
核心价值观内容[Abstract] Objective To evaluate and rearch the uniformity of content of 51 batches of omeprazole enteric-coated capsules from 17 factories. Methods The examination was bad on the content uniformity of omeprazole enteric-coated capsules of Chine Pharmacopoeia (2015 Edition) volume 军号铃声>厌食症怎么办Ⅱ过年必做12道菜退休发言稿, and some aspects of capsule shelling, unifying the ethanol content and specific experimental details were revid. Results The uniformity of content of 51 batches of omeprazole enteric-coated capsules was qualified, 如何做外贸生意
and the content uniformity of two factories using the circulating fluid bed reactor was better. Conclusion We must take contents at examination after capsule shelling, and 10mg and 20mg should be dissolved after adding 20ml ethanol, and it is suggested to promote the application of circulating fluid bed reactor thus ensuring the drug uniformity.