摘要
缺铁性贫血严重威胁人类健康,采用铁制剂补铁是首选的治疗手段。与传统的口服补铁制剂相比,铁-碳水化合物复合物通过静脉给药进行补铁,具有起效更为迅速、安全性更高等优点。铁-碳水化合物复合物属于非生物复合药(NBCDs),生产条件及工艺流程的差异可能会导致药物质量的差异。本文综述了铁-碳水化合物复合物中代表性的蔗糖铁原研药与仿制药在理化性质、临床疗效、药物经济性以及不良反应等方面的研究,比较两者之间的异同。蔗糖铁仿制药与原研药之间在Zeta电位等方面差别不大,在粒径、还原电位与不稳定铁含量方面则存在一定差异。制剂理化性质的不同有可能导致临床治疗效果的差异。因此,从源头控制铁-碳水化合物复合物的工艺高度一致,同时加强仿制药与原研药之间的对比性临床研究,以保证仿制药与原研药之间的治疗等效性,才可能得到高质量的铁-碳水化合物复合物仿制药。
Iron deficiency anemia is a serious threat to human health.Iron supplementation is the preferred treatment.Compared with the traditional oral iron supplements,iron-carbohydrate complex used for intravenous iron supplementation has the advantages of more rapid effect and higher safety.However,iron-carbohydrate complexes are non-biological com?pound drugs(NBCDs),and the differences in production conditions and processes may lead to different drug quality.This pa?per reviewed the researches on the physicochemical properties,clinical efficacy,drug economy and adverse reactions of the representative iron-carbohydrate complex iron sucrose(IS)and intended copies of the iron sucrose originator(ISS),and com?pared the similarities and differences between them.There was little difference in zeta potential between IS and ISS,but there were some differences in particle size,reduction potential and unstable iron content.These similarities and differences also in?dicated that the different physicochemical properties of the preparation may lead to the different clinical therapeutic effect.Therefore,the process of controlling iron-carbohydrate complex from the source should be with highly consistency,and com?parative clinical studies between generic and original drugs should be conducted to ensure the therapeutic equivalence be?tween generic and original drugs,so as to obtain high-quality iron-carbohydrate complex generic drugs.
作者
阎妍
封卫毅
YAN Yan;FENG Wei-yi(Department of Pharmacy,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China)
出处
《临床药物治疗杂志》
2023年第1期39-43,共5页
Clinical Medication Journal
关键词
非生物复合药
铁-碳水化合物复合物
蔗糖铁原研药
仿制药
治疗等效性
non-biological complex drug
iron-carbohydrate complex
iron sucrose
intended copies of the iron su?crose originator(ISS)
therapeutic equivalence
