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近年来,我国一些地区出现了布氏菌病的暴发。用布氏菌素作皮肤试验是布氏菌病防治工作中一个重要的检查项目。现用的旧菌素是本世纪初开始应用的一种粗制品,缺点甚多。为了提高制品质量,增强其安全性和特异性,中国药品生物制品检定所研制了一种新的纯化布氏菌素(Purifited Brucellin),经卫生部药审中心批准已在疫区进行了现场使用观察。证实了其安全性好、特异性强、能定量。同时对其在实际使用中的可操作性做了标化和规定。为取代旧菌素,付与临床应用,我们对人用剂量,观察时间及阳性反应的判定标准等都作了比较和最适选择。为了使这一新制品更好地服务于布氏菌病的防治工作,我们就其在不同类型人群中的特异性和敏感性方面与参考标准品和现用旧菌素进行了比较观察,它将为本新制品在全国推广应用提供数据。
In recent years, outbreaks of brucellosis have emerged in some areas of our country. The use of brucellin skin test is an important check in the prevention and treatment of brucellosis. The old used crude is a crude product that has been in use since the turn of the century, with many drawbacks. In order to improve the quality of products and enhance their safety and specificity, a new purified Purifited Brucellin has been developed by China National Institute for the Control of Pharmaceutical and Biological Products. It has been approved in the epidemic area by the Ministry of Health for approval Observed. Confirmed its safety, specificity, can be quantitative. At the same time, it has standardized and stipulated its operability in actual use. To replace the old verapamil, to pay for clinical applications, we have to human dose, observation time and the positive response to determine the standard made a comparison and the most appropriate choice. In order to better serve this new product in the prevention and treatment of brucellosis, we compared it with the reference standard and the current use of the former antibiotics in terms of their specificity and sensitivity in different types of people. It The new products will be popularized in the country to provide data.