一种新型富血小板因子血浆制剂的动物实验安全性研究

The Safety of a Novel Preparation Platelet Factor Rich Plasma in Animal

目的本研究旨在评价一种采用新型制备方法获得的富血小板因子血浆(platelet factor rich plasma,PFRP)的临床前安全性。方法全血经传染病检测后,通过离心冻融的方式富集血小板中的生长因子得到PFRP;将30只C57小鼠随机分为低剂量组(low dose group,LD)、高剂量组(high dose group,HD)和对照组(Control group);第0、14、28d时,LD组(3倍正常剂量)和HD(10倍正常剂量)组分别尾静脉注射PFRP溶液,Control组注射等体积的生理盐水;每周对各组小鼠的体重、精神行为以及肢体活动进行评价;第42d时,采用脏器百分比和HE染色分别对各组小鼠的脏器大小及组织结构进行评价。结果所有试验小鼠注射PFRP后未发现精神行为及肢体活动异常;注射2周后HD组小鼠体重较Control组明显下降,差异有统计学意义(P<0.05),其它时间点各试验组小鼠体重没有明显变化;第42d时,脏器百分比的比较显示,除HD组心脏出现显著增大外,其它脏器百分比与Control组相比均未有明显差异;HE染色显示各组小鼠脏器的组织结构均正常。结论采用新型的制备方法获得的富血小板因子血浆PFRP,注射3倍正常剂量至受试动物体内是安全的。

Objective Evaluation the safety of novel preparation Platelet Factor Rich Plasma（ PFRP） in animal. Methods30 C57 mice were randomly divided into three groups; Low Dose group（ LD group）,High Dose group（ HD group） and Control group. PFRP were prepared according to related patent,different concentration PFRP was injected into caudal vein of LD and HD mice at a volume of 200μL every two weeks for three times respectively. Mice of Control group only received the same volume injection of Normal Saline. Body weight,mental activity and motor function of all three groups mice were recorded every week. Mice were sacrificed at day 42 to investigate the effect of PFRP on main organs（ heart,liver,spleen,lung and kidney） by organ coefficient ration and HE staining. Results At day 14,the body weight of HD group was significantly higher than that of Control group,however no obvious difference of body weight was found between different groups at any other day and no abnormal mental activity or movement was found in all three groups during the process. At day 42,organ coefficient ration of heart in HD group was significantly higher than that in Control group,and no other obvious difference of main organ coefficient ration was found in HD group and in LD group compared to Control group. Furthermore,HE staining revealed that there was no difference in all main organs among the three groups. Conclusion Caudal vein injection of PFRP prepared according to our patent in LD group didn＇t cause abnormal events on mice.