牛型提纯结核菌素国家标准品的研制

根据《中华人民共和国兽用生物制品规程》2000年版制备牛型提纯结核菌素(牛PPD)国家标准品候选物4批。根据多糖、核酸和氮含量测定结果,筛选200804批制备为待检国家标准品,其检验结果为:物理性状为乳白色疏松团块,加生理盐水后在5s内溶解;无菌检验合格。200804批准检国家标准品于稀释前各样品变异系数为1.4%,冻干后各样品变异系数为4.8%。效价测定:待检国家标准品4个稀释度引起的豚鼠皮肤红肿面积与国际标准品相对应的稀释度引起的皮肤红肿面积的差值平均值都在10%以内,2者的剂量反应曲线基本平行,即待检国家标准品效价与国际标准品基本相同。200804批待检国家标准品于50℃保存21d之内效价下降程度平均值小于10%,保存28d效价下降程度平均值大于10%。其特异性和安全性均符合要求。

Purified protein derivative (PPD) of Mycobacterium bovis tuberculin

Four lots of purified protein derivative (PPD) of Mycobacterium bovis Tuberculin were prepared according to the national standard for animal biological products. Based on the content of polysaccharide, nucleic acid and protein, lot 200804 was selected for further test. The results were as follows. Physical appearance: ivory white, instant dissolved in saline within 5 seconds. Homogenicity: 1.4 % coefficient of variation before dilution and 4.8 % after freezing dried respectively. Potency: less than 10 % differences was observed between the Intemational and National Standard for PPD of M. bovis Tuberculin and the dose-response curves of the two standards were almost parallel, which suggested both potencies were almost the same. Stability: After stored at 50 ℃ for less than 21 days, the average potency degression was less than 10 %, while the sample stored at 50 ℃ for 28 days showed more than 10 % degression.