血浆冻干制剂的制备与质量评价  

Preparation and quality evaluation of lyophilized preparations of plasma

作　　者：孙珍珠 贾俊婷 王强 章金刚 赵雄 马玉媛 SUN Zhenzhu;JIA Junting;WANG Qiang;ZHANG Jingang;ZHAO Xiong;MA Yuyuan(NMPA Key Laboratory for Quality Control of Blood Products,Institute of Health Service and Transfusion Medicine,Academy of Military Medical Sciences,Academy of Military Sciences,Beijing 100850,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]军事科学院军事医学研究院卫生勤务与血液研究所,国家药品监督管理局血液制品质量控制重点实验室,北京100850 [2]国家药典委员会,北京100061

出　　处：《军事医学》2023年第10期754-760,共7页Military Medical Sciences

基　　金：国家药品监督管理局血液制品质量控制重点实验室开放性课题(KF2021010)。

摘　　要：目的采用冷冻干燥工艺制备血浆冻干制剂,并对其质量进行评价。方法检测血浆共晶点并设定血浆冻干程序,将血浆样品进行冷冻干燥,对冻干后的血浆外观形态、水分含量、复溶时间进行检测,并对比冻干前后血浆的酸碱度、凝血参数等指标,评价所制备的血浆冻干制剂样品质量。结果利用该研究设定的冷冻干燥工艺制备的血浆冻干制剂外观形态良好,水分含量为(1.955±0.321)%,复溶时间为(12.98±0.56)min;冻干后使用无菌注射用水复溶的血浆酸碱度为8.15±0.10,略高于冻干前;血浆冻干制剂中测定的大部分血浆蛋白(12/15)的活性/含量与冻干前血浆比较无显著差异(P>0.05);仅凝血因子Ⅴ、凝血因子Ⅷ、纤溶酶原活性低于冻干前血浆(P<0.05),回收率分别为80.70%、78.70%和86.70%;凝血酶原时间与冻干前血浆相当(P>0.05),活化部分凝血活酶时间显著延长(P<0.05)。结论建立的冷冻干燥工艺成功制备了血浆冻干制剂,为国内冻干血浆制品的开发奠定了基础。Objective To prepare the lyophilized preparation of plasma via the freeze⁃drying process and evaluate its quality.Methods The eutectic point of plasma was detected before the freeze⁃drying procedures wereestablished.After the plasma samples were freeze⁃dried,the appearance,moisture content,and reconstitution time were detected.The pH value and coagulation parameters of the plasma before and after lyophilization were compared to evaluate the quality of the lyophilized preparation of plasma.Results The resulting plasma lyophilized via the freeze⁃drying procedure in this study had a good appearance,with a moisture content of(1.955±0.321)%and a reconstitution time of(12.98±0.56)min.The pH value of the lyophilized plasma reconstituted with sterile water for injection was 8.15±0.10,slightly higher than before lyophilization.There was no significant change in the activity or content of most of the tested plasma proteins(12 out of 15)in the lyophilized preparation of plasma afterlyophilization(P>0.05).Only the activities of factorⅤ,factorⅧand plasminogen in the lyophilized preparation of plasma were significantly reducedafter lyophilization(P<0.05),and the recovery rates were 80.70%,78.70%,and 86.70%,respectively.The prothrombin time hardly changed after lyophilization(P>0.05),but the activated partial thromboplastin time was significantly prolonged(P<0.05).Conclusion The lyophilized preparation of plasma is made available by the freeze⁃drying process in this study,which is expected of contribute to the development of freeze⁃dried plasma products in China.

关 键 词：干燥血浆 血浆 冻干制剂 冷冻干燥 凝血参数 

分 类 号：R944.9[医药卫生—药剂学] R97[医药卫生—药学]