论文部分内容阅读
利用尿素[13C]呼气试验检查胃幽门螺杆菌,是一种简便、准确、灵敏、特异性和重复性高而又无损伤的方法。国外已有尿素[13C]呼气试验药盒上市（其中,尿素[13C]是以散剂形式提供）,并已在中国注册。 同位素研究所在进口尿素[13C]原料的基础上,研制了尿素[13C]-胶囊。在便于服用的基础上,尿素[13C]-胶囊更能消除由于口腔滞留可能带来的误差。该药盒经中国药品生物制品检定所检验合格,通过国家药品监督管理局药品审评中心的技术评审,并获得国家药品监督管理局药品注册司批准的《新药临床研究批件》,同意该药盒进入临床研究。
The use of urea [13C] breath test to check Helicobacter pylori is a simple, accurate, sensitive, specific and reproducible method without damage. Foreign countries have urea [13C] breath test kit listing (which, urea [13C] is provided in the form of powder), and has been registered in China. Isotope Institute in the import of urea [13C] on the basis of raw materials, developed urea [13C] - capsule. Based on its ease of administration, urea [13C] - capsules are more likely to eliminate the potential for bump in the mouth. The kit was tested by the China National Institute for the Control of Pharmaceutical and Biological Products, passed the technical review of the Center for Drug Evaluation of the State Drug Administration, and obtained the “New Drug Clinical Research Approval” approved by the Drug Registration Department of the State Drug Administration, Enter clinical research.