磺丁基倍他环糊精钠包合物注射剂仿制药药学研究探究

司晓菲; 龚青; 那馨竹; 梁锦锋; 姜典卓

引用本文:	司晓菲,龚青,那馨竹,梁锦锋,姜典卓.磺丁基倍他环糊精钠包合物注射剂仿制药药学研究探究[J].中国现代应用药学,2024,41(22):157-156.
	sixiaofei,gongqing,naxinzhu,liangjinfeng,jiangdianzhuo.Discussion on the Pharmaceutical Development of Generic Betadex Sulfobutyl Ether Sodium Inclusion Complexes Injections[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(22):157-156.

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磺丁基倍他环糊精钠包合物注射剂仿制药药学研究探究
司晓菲¹, 龚青¹, 那馨竹¹, 梁锦锋², 姜典卓¹
1.国家药品监督管理局药品审评中心;2.浙江省药品化妆品审评中心

摘要:

磺丁基倍他环糊精钠已广泛应用于难溶性药物包合物注射剂,此类注射剂一般安全性良好、临床治疗效果明显,可以一定程度上满足患者需求。通过检索相关国外审评报告和文献资料,概述国内外上市的磺丁基倍他环糊精钠包合物注射剂情况,对此类药物的仿制药药学研究进行探讨,提出关注处方工艺和质量控制(特别是关键辅料的控制)等研究的考虑,为其研究开发提供一定的参考。

关键词: 磺丁基倍他环糊精钠包合物注射剂药学研究

DOI：

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Discussion on the Pharmaceutical Development of Generic Betadex Sulfobutyl Ether Sodium Inclusion Complexes Injections

sixiaofei¹, gongqing¹, naxinzhu¹, liangjinfeng², jiangdianzhuo¹

1.Center for Drug Evaluation, National Medical Products Administration;2.Zhejiang Center for Drug ＆Cosmetic Evalution

Abstract:

ABSTRACT: Betadex sulfobutyl ether sodium（SBECD）have been used in pharmaceutical preparations especially inclusion complexes injection for poorly soluble drugs. These injections have demonstrated definite good drug safety and therapeutic effectiveness, which can meet the patient’s demand to some extent. Based on literature investigation, we briefly analyzed the application cases and discussed the CMC requirements of generic SBECD inclusion complexes injection. The pharmaceutical considerations were put forward in terms formulation, manufacturing process and quality control, especially the control of critical excipient, in order to provide references for the development of SBECD inclusion complexes injection .

Key words: betadex sulfobutyl ether sodium inclusion complexes injection pharmaceutical research