尿激酶的质量研究

Study on the Quality of Urokinase

尿激酶,是从新鲜人尿中提取的一种能激活纤维蛋白溶酶原的酶。注射用尿激酶是常用的抗血栓药物之一,常用于治疗心肌梗塞、脑卒中等疾病,为国家医保药物目录中的甲级药品,已在临床应用多年,并收载于《中国药典》中。近年来,伴随人们生活质量的提高及我国人口老龄化程度日益加剧,血栓性疾病发病率不断上升,溶栓类药品的需求量也随之增加,这对该类药品的质量提出了更高要求。同时,国家“药品安全十三五规划”中,也明确提出了提高药品质量的要求。因此,各药品生产企业须不断提高产品质量,对产品质量标准和质控方法作进一步研究。

Urokinase is an enzyme extracted from fresh human urine that activates plasminogen. Urokinase for injection is one of the commonly used anti-thrombotic drugs, which is often used in the treatment of myocardial infarction, stroke. Urokinase is a Class A drug in the national medical insurance drug catalogue, it has been in clinical use for many years and is included in the Chinese Pharmacopoeia. In recent years, with the improvement of people’s quality of life and the increasing aging of our population, the incidence of thrombotic diseases is also increasing, which puts forward higher requirements for the quality of such drugs. At the same time, in the 13th Five-Year Plan for Drug Safety, requirement for the improvement of drug quality has been clearly put forward. Therefore, pharmaceutical manufactures should continuously improve the quality of products and further study the quality standards and quality control methods.