厄贝沙坦氢氯噻嗪片工艺验证

Technology Verification for Irbesartan and Hydrochlorothiazide Tablets

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.