肠溶蛇毒复合酶胶囊的质量控制及其临床观察  

Quality Control and Clinical Observation of “Enteric Dissolution Venin Compound Enzyme Capsule”

作　　者：张丽英[1] 吴丽英[1] 倪爱娣[1] 赵正福 张锡明 毕爱玲 

机构地区：[1]上海中医药大学附属曙光医院 [2]上海黄山制药厂

出　　处：《上海中医药杂志》1999年第2期47-48,F003,共3页Shanghai Journal of Traditional Chinese Medicine

摘　　要：通过采用分子量监测、元素成份测定、蛋白质含量分析、酶活力测定等量化指标，对柱层法提取蛇毒复合酶建立严格的质量控制标准后，消除了原蛇毒的毒副反应，提高了降纤维蛋白原的药理作用，并使卫生学指标达到要求。经临床观察，肠溶蛇毒复合酶胶囊对肿瘤患者临床症状、生存质量和血液流变学相关指标的改变均优于原蛇毒胶囊。After the quality control standard was set up for venin compound enazyme extracted by colunm chromatography,depending upon the quantitative and chemical indexes by the determination of molecular weight and elementary composition,analysis of protein content and the determination of enzymatic activity,the toxic and side effect of original venin was eliminated and the pharmacological function to degrade fibrinogen was enhanced for meeting the requirements of the hygienic indexes.The clinical observation showed that “Enteric Dissolution Venin Compound Enzyme Capsule”was better in change of the clinical symptoms,survival quality and the related indexes of blood rheology in the patients with tumor than original venin capsule.

关 键 词：蛇毒复合酶 柱层法 毒副作用 纤维蛋白原 

分 类 号：R996.3[医药卫生—毒理学]