蕲蛇抗栓酶注射液稳定性的研究  

Study on Stabilization of the Acutobin

作　　者：吕炜锋[1] 王悦[1] 刘芸[1] 乐素清 高向东[1] 

机构地区：[1]中国药科大学生命科学与技术学院,江苏南京210009 [2]福建三明汇天药业有限公司,福建三明365000

出　　处：《药物生物技术》2004年第6期385-388,共4页Pharmaceutical Biotechnology

摘　　要：为获取对蕲蛇抗栓酶 (acutobin)注射液的酶活有保护作用且使制剂稳定的保护剂配方 ,本实验设计了 7个单方及四组正交实验共 16个保护剂处方 ,以加入保护剂的蕲蛇抗栓酶为样品 ,未加保护剂的为空白对照 ,在 37℃温度加速实验下 ,间隔一定时间观测蕲蛇抗栓酶制剂的酶活及澄明度的变化。结果 ,单方氨基酸和小肽类的加入使酶活力保存率提高 ,而多元醇类的加入使澄明度得到改善 ;In order to study the prescriptions which could protect the enzymic acticity and clarity of the acutobin,we designed 7 single prescriptions and 4 groups orthogonal experiment, including 16 complex prescriptions which involved carbohydrate, polylol,amino acid, and polypeptide, and then,kept the test groups which involved protective agent and the control groups which contained TLE only at 37℃,monitored the enzymic activity and the clarity. The result indicated that the preservative rate of enzymic activity in the test samples which contained amino acid and polypeptide were much higher than the control groups when they were at 37℃ for 31 days, and polylol could make the clarity of the test sample better. The protective effect of complex prescriptions was not desirable.

关 键 词：蕲蛇抗栓酶 凝血酶样酶 稳定性 温度加速实验 正交实验 

分 类 号：R994.11[医药卫生—毒理学]