一致性评价背景下磺达肝癸钠注射液处方再研发  

Prescription re-development for sodium fondaparinux injection under consistency evaluation program background

作　　者：申鹏 熊莹莹 李胤飞 孙长山[1] SHEN Peng;XIONG Yingying;LI Yinfei;SUN Changshan(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;Yangtze River Pharmaceutical(Group)Co.,Ltd.,Taizhou 225321,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]扬子江药业集团有限公司,江苏泰州225321

出　　处：《中国药剂学杂志(网络版)》2025年第2期90-99,共10页Chinese Journal of Pharmaceutics:Online Edition

摘　　要：目的 探讨磺达肝癸钠注射液的处方再研发过程,对自研制剂处方进行一致性评价,确保产品的有效性和安全性。方法 通过一致性评价工作的开展,对参比制剂的处方组成进行了深入研究,并提出了自研制剂的初步拟定处方。功能性辅料及原料药对制剂的质量属性会产生一定的影响,在处方设计风险评估中,对处方中氯化钠的用量、氢氧化钠或盐酸的用量进行了详细评估。结果 基于质量源于设计和风险评估原则,确定了原料药和功能性辅料的合适剂量,确定了最终的产品处方。结论 本自研制剂处方合理可行,能够确保产品的有效性和安全性。Objective To explore the prescription re-development process of sodium fondaparinux injection,the consistency evaluation of self-developed prescription was carried out to ensure the effectiveness and safety of product.Methods Through the consistency evaluation work,an in-depth study was conducted on the prescription of the reference list drug(RLD),and a preliminary prescription for the self-developed preparation was proposed.In the risk assessment of prescription design,both of functional accessory and bulk drug showed great impact to quality,the amount of excipients such as sodium chloride sodium hydroxide and hydrochloric acid were evaluated.Result Based on the principles of quality comes from design and risk assessment,the exact dosage of functional accessory and bulk drug were determined and the final prescription of product was confirmed.Conclusion The prescription of self-developed agent is reasonable and feasible,which can ensure the effectiveness and safety of the product.

关 键 词：磺达肝癸钠注射液 处方再研发 一致性评价 pH范围 风险评估 

分 类 号：R94[医药卫生—药剂学]