基于微量量热技术的注射用增溶辅料生物安全性评价

被引:2
作者
张少锋 [1 ,2 ]
鄢丹 [1 ]
唐慧英 [1 ]
杨明 [2 ]
王跃生 [2 ]
肖小河 [1 ]
机构
[1] 解放军第医院全军中药研究所
[2] 江西中医学院现代中药制剂教育部重点实验室
关键词
注射用增溶辅料; 生物安全性; 微量量热技术; 嗜热四膜虫BF5;
D O I
暂无
中图分类号
R318.08 [生物材料学]; R94 [药剂学];
学科分类号
100103 [病原生物学]; 100702 [药剂学];
摘要
为筛选适宜的注射用增溶辅料、减少注射剂不良反应的发生,以嗜热四膜虫BF5为模式生物,建立基于微量量热技术的注射用增溶辅料生物安全性评价方法.恒温28℃时,监测不同注射用增溶辅料(泊洛沙姆188、吐温80、吐温20、聚乙二醇600、聚乙二醇400)干预嗜热四膜虫BF5生长代谢的热谱曲线,抽提生物热动力学特征参数进行量化评价.结果表明,在不同浓度的上述增溶辅料干预下,嗜热四膜虫BF5生长速率常数(k)、5%抑制浓度(IC5)、最大输出功率(P1,P2)、达峰时间(T1,T2)和发热量(Q)呈现规律性变化;且k与增溶辅料浓度间的线性关系良好(r>0.9),IC5依次是泊洛沙姆188为2.18mg/mL,聚乙二醇600为1.35mg/mL,吐温80为1.07mg/mL,聚乙二醇400为0.58mg/mL,吐温20为0.045mg/mL.主成分分析表明,参数k,P1和Q能够较好体现热谱曲线整体信息,可用于增溶辅料生物安全性的量化评价.这也得到综合评价结果的印证,即在相同浓度下,泊洛沙姆188对嗜热四膜虫BF5生长代谢毒性较小,而吐温20毒性较大.
引用
收藏
页码:3384 / 3390
页数:7
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