摘要
目的本研究通过加速试验进行人纤维蛋白原与内包材的相容性试验,探讨药物的稳定性,确定内包材是否对产品的质量产生影响,为制剂设计、包装、运输、贮存提供必要的资料。方法使用供试品3批开展加速试验,在温度(25±2)℃条件下正置和倒置放置6个月。在试验期间,于第3个月、6个月末分别取样,按加速稳定性重点考察项目(外观、真空度、复溶时间、可见异物、渗透压摩尔浓度、稳定性试验、水分、pH值、纯度、人纤维蛋白原总量、凝固活力、盐酸精氨酸、枸橼酸离子、无菌检查)进行检测,并与0月结果进行比较。结果在(25±2)℃条件下放置6个月后,相关迁移物均符合要求,各活性指标无明显变化,其他各生化检测指标符合《中华人民共和国药典》(2020年版三部)要求,各指标检测结果变化无显著性差异。结论选用的包装系统对人纤维蛋白原质量无不良影响,所选包装容器中的药品质量稳定、可控,能够保持其使用的安全性和有效性。内包材对制剂质量无明显影响,相容性良好。
Objective This study aims to conduct a compatibility test between human fibrinogen and inner packaging materials through accelerated testing,explore the stability of drugs,determine whether inner packaging materials have an impact on product quality,and provide necessary information for formulation design,packaging,transportation,and storage.Methods Conduct accelerated testing using 3 batches of test samples,and place them upright and inverted at a temperature of(25±2)℃for 6 months.During the experimental period,samples were taken at the end of the third and sixth months respectively,and tested according to the accelerated stability key inspection items(appearance,vacuum degree,reconstitution time,visible foreign matter,osmotic pressure molar concentration,stability test,moisture,pH value,purity,total amount of human fibrinogen,coagulation activity,arginine hydrochloride,citrate ions,sterility test),and compared with the results of Month 0.Results After being stored at(25±2)℃for 6 months,the relevant migration products met the requirements,and there were no significant changes in the activity indicators.Other biochemical detection indicators met the requirements of the Chinese Pharmacopoeia(2020 edition,Part III),and there were no significant differences in the changes of the detection results of each indicator.Conclusion The selected packaging system has no adverse effects on the quality of human fibrinogen,and the drug quality in the selected packaging container is stable and controllable,which can maintain its safety and effectiveness in use.The inner packaging material has no significant impact on the quality of the formulation and has good compatibility.
作者
黄璠
邓志华
黄燚
张丽铃
HUANG Fan;DENG Zhi-Hua;HUANG Yi;ZHANG Li-Ling(Guangdong Danxia Bio-pharmaceutical Co.,Ltd.,Shaoguan 512029,China;Guangdong Plasma Protein Engineering Technology Research Center,Shaoguan 512029,China)
出处
《实验室检测》
2024年第9期119-121,共3页
Laboratory Testing
关键词
人纤维蛋白原
内包材
相容性
human fibrinogen
internal packaging materials
compatibility
