小牛血红细胞提取物的制备工艺及质量评价

Preparation and Quality Evaluation of Bred Cell Calf Blood Extract

目的:制备小牛血红细胞提取物并进行质量评价。方法:以小牛血红细胞为原料提取生物活性物质,并与小牛血清提取物及进口同类药品比较评价其生物活性。结果:该制备工艺所制取的小牛血红细胞提取物经鉴别、检查均符合2005年版《中国药典》中的关于原料药的相关规定;经测定小牛血红细胞提取物生物活性显著高于同等浓度下血清提取物,并且与同类进口产品具有相近的产品质量,说明从红细胞中提取出来的原料明显优于从血清中提取的原料。结论:该制备工艺提取易行、质量控制好、制备的活性物质生物活性高,能满足临床用药的要求。

Objective：To study Preparation and quality determination of bred cell calf blood extract, Methods：The bred cell calf blood was used as material to extract bioactive substance.Assessment its potency by compared with calf serum extract and imported similar drugs. Results：The property of the prepared bred cell calf blood extract fitted the description of Chinese Pharmacopeia（2005 editionl. The potency of bred cell calf blood extract was higher than calf serum extract.and it has the same quality standard as solcosery and Actovegin, Conclusion：The preparation technique of bred celt calf blood extract is feasible.the potency of extract bioactive substance is high,reliable quality control and fulfilling the clinical requirement.