儿童钙补充剂药学研究的相关考虑  

Relevant Considerations on Pharmaceutical Research of Calcium Supplements for Children

作　　者：王宏亮 许真玉 WANG Hongliang;XU Zhenyu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国医药工业杂志》2022年第11期1588-1592,共5页Chinese Journal of Pharmaceuticals

摘　　要：儿童期是身体生长发育的关键时期,充足的钙摄入是骨骼正常生长和健康发育的基本保证,因此儿童钙补充剂的研发、生产和质量控制至关重要。该研究以葡萄糖酸钙片、葡萄糖酸钙锌口服液、碳酸钙咀嚼片、碳酸钙D_(3)咀嚼片等为例,从原辅料、包材、处方工艺、质量研究等方面出发,浅析儿童钙补充剂药学研究的相关考虑,以期为业界提供相应参考。Childhood is a critical period for body growth and development.Adequate calcium intake is the basic guarantee for normal growth and healthy development of bones.Thereof,the development and quality control of calcium supplements for children are very important.Taking calcium gluconate tablets,calcium and zinc gluconate oral solution,chewable calcium carbonate tablets,calcium carbonate-vitamin D_(3)chewable tablets as the examples,aiming to provide the corresponding references for the industry,this paper simply analyzes the relevant considerations on pharmaceutical research of calcium supplements for children from the aspects of raw materials,excipients,packing materials,formulation and process,and quality research.

关 键 词：儿童用药 钙补充剂 药学研究 

分 类 号：R977.5[医药卫生—药品]