罗红霉素片生产过程的工艺验证  

Process Validation of the Production Process of Roxithromycin Tablets

作　　者：文雯 胡家栋 杨子琪 WEN Wen;HU Jia-dong;YANG Zi-qi(Yangling Vocational and Technical College,Yangling,Shaanxi 712100,China)

机构地区：[1]杨凌职业技术学院,陕西杨凌712100

出　　处：《杨凌职业技术学院学报》2023年第2期9-11,19,共4页Journal of Yangling Vocational & Technical College

基　　金：杨凌职业技术学院院内基金项目(ZK21-83,ZK20-75,BG2021006);陕西高校青年创新团队项目。

摘　　要：采用同步验证法对某制药企业的产品罗红霉素片的各个工序的产品进行验证,通过验证确认该药企新车间罗红霉素片生产工艺的可行性和可靠性。验证试验表明,连续三批罗红霉素片(150 mg)在粉碎、过筛、制粒、干燥、总混、压片、包衣等工序均符合企业内定标准,所验证的罗红霉素片各批次的各项指标都符合质量标准要求,该工艺在正常条件下可生产出稳定可靠的罗红霉素片。The simultaneous verification method was used to verify the products of each process of a pharmaceutical company’s product roxithromycin tablets,and the feasibility and reliability of the production process of roxithromycin tablets in the new workshop of the pharmaceutical company were confirmed through verification.The verification test showed that three consecutive batches of roxithromycin tablets(150 mg)met the company’s default standards in the processes of grinding,sieving,granulation,drying,total mixing,tableting,coating,etc.The indicators of each batch of the verified roxithromycin tablets meet the requirements of quality standards,and this process can produce stable and reliable roxithromycin tablets under normal conditions.

关 键 词：罗红霉素片 工艺规程 工艺验证 

分 类 号：TQ465.5[化学工程—制药化工]