摘要
目的对国内外海藻酸钠、海藻酸钙的药品和医疗器械标准进行比对,并依据各标准对工艺参数的监控进行重点阐述。方法对国内外海藻酸钠、海藻酸钙的标准进行整理、汇总,比较分析各标准间的共性与差异。结果国内外海藻酸钠、海藻酸钙无论是药品标准还是医疗器械标准,均存在一定差异,但基本控制点几乎一致。结论企业应针对自身产品质量的控制要求并结合其工艺特点制定合理可控的质量标准,才能保证临床使用的安全性和有效性。
Objective To compare product standards of drug and medical device made from sodium alginate and calcium alginate between domestic and abroad,and to emphases on the process parameters monitoring based on different standards.Methods Sodium alginate and calcium alginate standards of both domestic and foreign were analyzed and summarized,and the differences and commonalities of various product standards among each standard were compared.Results Differences exist in product standards of sodium alginate and calcium alginate between domestic and abroad,whether drug or medical device,but the fundamental control points are concordant.Conclusion Companies should focus on product quality control requirements combined with its own unique manufacturing process characteristics to develop reasonable and controllable quality standards,which can ensure safe and effective clinical use.
出处
《中国修复重建外科杂志》
CAS
CSCD
北大核心
2013年第6期760-764,共5页
Chinese Journal of Reparative and Reconstructive Surgery
关键词
海藻酸钠
海藻酸钙
产品标准
质量控制
Sodium alginate Calcium alginate Product standard Quality control
