CAJ | 학술논문

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5 s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21 d之内效价下降程度平均值小于10%,保存28 d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.
근거<중화인민공화국수용생물제품규정>2000년판제비우형제순결핵균소(우PPD)국가표준품후선물4비.근거다당、핵산화담함량측정결과,사선200804비제비위대검국가표준품,기검험결과위:물이성상위유백색소송단괴,가생리염수후재5 s내용해;무균검험합격.200804비준검국가표준품우희석전각양품변이계수위1.4%,동간후각양품변이계수위4.8%.효개측정:대검국가표준품4개희석도인기적돈서피부홍종면적여국제표준품상대응적희석도인기적피부홍종면적적차치평균치도재10%이내.2자적제량반응곡선기본평행,즉대검국가표준품효개여국제표준품기본상동.200804비대검국가표준품우50℃보존21 d지내효개하강정도평균치소우10%,보존28 d효개하강정도평균치대우10%.기특이성화안전성균부합요구.
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.