摘要
目的:验证厄贝沙坦氢氯噻嗪片中试工艺的可行性、可靠性。方法:按照确定的处方工艺中试生产3批样品,对工艺中的关键工艺参数进行验证。结果:验证批次的厄贝沙坦氢氯噻嗪片各项指标符合质量标准要求。结论:厄贝沙坦氢氯噻嗪片中试工艺生产可行,工艺流程及工艺参数能够保证产品质量;工艺可靠、稳定。
Objective: To verify the feasibility and reliability of the pilot process of irbesartan and hydrochlorothiazide tablets. Methods:Three batches of the tablets were produced according to the determined formula and process, and the key parameters in the pilot production were verified. Results:All the indices for each batch of irbesartan and hydrochlorothiazide tablets conformed to the re-quirements of the quality standard. Conclusion: The pilot process of irbesartan and hydrochlorothiazide tablets is feasible, and the technological process and parameters can ensure the product quality with promising reliability and stability.
出处
《中国药师》
CAS
2015年第3期490-493,共4页
China Pharmacist
关键词
厄贝沙坦氢氯噻嗪片
工艺参数
验证
Irbesartan and hydrochlorothiazide tablets
Process parameter
Verification