危害分析和关键控制点体系在湿法制粒压片工艺中的应用评价  

Application Evaluation of Hazard Analysis and Critical Control Point System in Wet Granulation and Tableting Technology

作　　者：于泳[1] 顾家慧[1] 崔文波[2] 方芳 沈启雯 

机构地区：[1]东南大学成贤学院,南京210088 [2]上海市食品药品监督管理局,上海200439 [3]南京医药中等专业学校,南京211100 [4]中国药科大学国际医药商学院,南京210009

出　　处：《中国药房》2015年第25期3460-3463,共4页China Pharmacy

摘　　要：目的:评价危害分析和关键控制点(HACCP)体系在氯雷他定片生产过程中应用的可行性和有效性。方法:通过介绍HACCP的概念,并以氯雷他定片的湿法制粒压片工艺为例,应用HACCP的基本理论与方法对其各生产环节进行危害分析,找出关键控制点并建立关键限值,进行生产质量管理。结果:经HACCP分析,最终确定干燥、整粒与混合、内外包装3个环节为氯雷他定片生产过程中的关键控制点,并据此设定关键控制限值进行监控,在确保对工艺过程的风险进行有效控制后建立HACCP工作计划并进行验证,结果显示,HACCP体系能有效控制与降低其生产过程中的风险,确保其质量安全。结论:将HACCP体系运用于氯雷他定片湿法制粒压片工艺,可以较为完整地体现其在该工艺中应用的可行性与有效性。OBJECTIVE：To evaluate the feasibility and effectiveness of Hazard analysis and critical control point（HACCP）system in the process of production of Loratadine tablets. METHODS：Taking wet granulation and tableting technology of Loratadine tablets as an example,and through the introduction of the concept of HACCP,the basic theory and method of HACCP were applied for hazard analysis on each production link to find critical control points and set critical limits for production quality management. RESULTS：By HACCP analysis,three links namely drying,granules fitting and mixing,internal and external packaging were finally determined as the critical control points in the process of production of Loratadine tablets,thereby critical control limits were set for monitoring. After effective control over the risks in the process was ensured,HACCP work plan was made and verified,and the results showed that HACCP system could effectively control and reduce the risks in the process of production and ensure quality safety. CONCLUSIONS：Application of HACCP system to wet granulation and tableting technology of Loratadine tablets can fully embody its feasibility and effectiveness.

关 键 词：危害分析 关键控制点 湿法制粒压片工艺 质量控制 药品生产质量管理规范 氯雷他定片 

分 类 号：R95[医药卫生—药学]