中国医药生物技术
中國醫藥生物技術
중국의약생물기술
Chinese Medicinal Biotechnology
2015年
5期
392-397
,共6页
魏东%尤明强%裴明玉%庄新海%翟雷%魏然%王国治%李恪梅
魏東%尤明彊%裴明玉%莊新海%翟雷%魏然%王國治%李恪梅
위동%우명강%배명옥%장신해%적뢰%위연%왕국치%리각매
鼠疫菌苗%布氏菌苗%炭疽菌苗%分光光度法,紫外线
鼠疫菌苗%佈氏菌苗%炭疽菌苗%分光光度法,紫外線
서역균묘%포씨균묘%탄저균묘%분광광도법,자외선
Plague vaccines%Brucellosis vaccines%Anthrax vaccines%Spectrophotometry,ultraviolet
目的将现用鼠疫、布氏菌、炭疽活疫苗3套浓度测定参考品整合成一套通用参考品。<br> 方法确定通用参考品吸光度值,从3套鼠疫、布氏菌及炭疽疫苗浓度测定用参考品共9个浓度中选取代表性3个浓度参考品;利用现用3种活疫苗浓度测定用参考品的线性方程,计算通用参考品所代表各种疫苗的浓度;制备参考品并进行质量控制;观察参考品的长期稳定性;组织3个实验室进行协作验证。<br> 结果确定通用参考品吸光度值为0.350、0.494、0.665;确定通用参考品所代表各种疫苗浓度;完成通用参考品的制备,各项检定符合规定;对4℃冷藏保存参考品进行稳定性研究,变异系数小于2.0%;经3个实验室协作验证,各实验室使用2种参考品的测定结果误差均小于2.0%。<br> 结论在现有参考品的基础上整合成一套鼠疫、布氏菌、炭疽活疫苗分光光度法浓度测定通用参考品,并为以后建立分光光度法细菌浓度测定通用参考品奠定基础。
目的將現用鼠疫、佈氏菌、炭疽活疫苗3套濃度測定參攷品整閤成一套通用參攷品。<br> 方法確定通用參攷品吸光度值,從3套鼠疫、佈氏菌及炭疽疫苗濃度測定用參攷品共9箇濃度中選取代錶性3箇濃度參攷品;利用現用3種活疫苗濃度測定用參攷品的線性方程,計算通用參攷品所代錶各種疫苗的濃度;製備參攷品併進行質量控製;觀察參攷品的長期穩定性;組織3箇實驗室進行協作驗證。<br> 結果確定通用參攷品吸光度值為0.350、0.494、0.665;確定通用參攷品所代錶各種疫苗濃度;完成通用參攷品的製備,各項檢定符閤規定;對4℃冷藏保存參攷品進行穩定性研究,變異繫數小于2.0%;經3箇實驗室協作驗證,各實驗室使用2種參攷品的測定結果誤差均小于2.0%。<br> 結論在現有參攷品的基礎上整閤成一套鼠疫、佈氏菌、炭疽活疫苗分光光度法濃度測定通用參攷品,併為以後建立分光光度法細菌濃度測定通用參攷品奠定基礎。
목적장현용서역、포씨균、탄저활역묘3투농도측정삼고품정합성일투통용삼고품。<br> 방법학정통용삼고품흡광도치,종3투서역、포씨균급탄저역묘농도측정용삼고품공9개농도중선취대표성3개농도삼고품;이용현용3충활역묘농도측정용삼고품적선성방정,계산통용삼고품소대표각충역묘적농도;제비삼고품병진행질량공제;관찰삼고품적장기은정성;조직3개실험실진행협작험증。<br> 결과학정통용삼고품흡광도치위0.350、0.494、0.665;학정통용삼고품소대표각충역묘농도;완성통용삼고품적제비,각항검정부합규정;대4℃랭장보존삼고품진행은정성연구,변이계수소우2.0%;경3개실험실협작험증,각실험실사용2충삼고품적측정결과오차균소우2.0%。<br> 결론재현유삼고품적기출상정합성일투서역、포씨균、탄저활역묘분광광도법농도측정통용삼고품,병위이후건립분광광도법세균농도측정통용삼고품전정기출。
Objective To establish a universal national reference materials for determining the concentrations of plague, brucellosis and anthrax vaccine. <br> Methods Firstly, absorbance of universal national reference materials were established. Secondly, correlation between absorbance of universal national reference materials and concentrations ofthreekinds of vaccine was studied using respective national reference material. The universal references were prepared. The stability of the references was tested by measuring absorbance. Finally, the universal reference materials were compared with old reference materials by three professional laboratories. <br> Results Absorbance of universal national reference materials were 0.350, 0.494 and 0.665. The relationship between absorbance of universal national reference materials and the concentrations ofthreekinds of vaccine was determined. Reference materials were successfully established. The reference materials stored at 4℃ were stable. By measuring three batches of each vaccine with two kinds of reference materials, the result errors were less than 2.0%. <br> Conclusion A set of universal national reference materials for determining the concentrations of plague, brucellosis and anthrax vaccine is established.