国际生物制品学杂志
國際生物製品學雜誌
국제생물제품학잡지
INTERNATIONAL JOURNAL OF BIOLOGICALS
2013年
5期
229-232
,共4页
程鹏飞%马雷钧%陈英娇%马相虎
程鵬飛%馬雷鈞%陳英嬌%馬相虎
정붕비%마뢰균%진영교%마상호
病毒疫苗%冰点下降法%渗透压摩尔浓度%质量控制
病毒疫苗%冰點下降法%滲透壓摩爾濃度%質量控製
병독역묘%빙점하강법%삼투압마이농도%질량공제
Viral vaccines%Freezing point depression%Osmolality%Quality control
目的 通过检测6种病毒性疫苗成品的渗透压摩尔浓度,比较不同疫苗检测均值的差异,并观察同种疫苗检测值的批间稳定性,为增加病毒性疫苗质量控制手段提供依据.方法 采用冰点下降法检测麻疹减毒活疫苗、风疹减毒活疫苗、麻疹腮腺炎联合减毒活疫苗、麻疹腮腺炎风疹联合减毒活疫苗、水痘减毒活疫苗、流感病毒裂解疫苗的渗透压摩尔浓度,对检测值进行统计学处理,计算变异系数.以麻疹腮腺炎风疹联合减毒活疫苗的渗透压摩尔浓度检测均值作为对照,进行方差齐性检验及假设检验,比较各疫苗检测均值的差异.结果 麻疹腮腺炎联合减毒活疫苗与对照相比,均值差异无统计学意义(t =1.66,P＞0.05);麻疹减毒活疫苗、风疹减毒活疫苗、水痘减毒活疫苗及流感病毒裂解疫苗与对照相比,均值差异均有统计学意义(Z＞1.96,P＜0.001).同种疫苗批间渗透压摩尔浓度较为稳定,变异系数均＜3％,变化幅度能控制在90％～110％均值范围内.结论 6种病毒性疫苗渗透压摩尔浓度存在一定差异,但同种疫苗检测值批间稳定性较好,因此,应根据不同疫苗的渗透压摩尔浓度,分别制定质量控制标准.
目的 通過檢測6種病毒性疫苗成品的滲透壓摩爾濃度,比較不同疫苗檢測均值的差異,併觀察同種疫苗檢測值的批間穩定性,為增加病毒性疫苗質量控製手段提供依據.方法 採用冰點下降法檢測痳疹減毒活疫苗、風疹減毒活疫苗、痳疹腮腺炎聯閤減毒活疫苗、痳疹腮腺炎風疹聯閤減毒活疫苗、水痘減毒活疫苗、流感病毒裂解疫苗的滲透壓摩爾濃度,對檢測值進行統計學處理,計算變異繫數.以痳疹腮腺炎風疹聯閤減毒活疫苗的滲透壓摩爾濃度檢測均值作為對照,進行方差齊性檢驗及假設檢驗,比較各疫苗檢測均值的差異.結果 痳疹腮腺炎聯閤減毒活疫苗與對照相比,均值差異無統計學意義(t =1.66,P＞0.05);痳疹減毒活疫苗、風疹減毒活疫苗、水痘減毒活疫苗及流感病毒裂解疫苗與對照相比,均值差異均有統計學意義(Z＞1.96,P＜0.001).同種疫苗批間滲透壓摩爾濃度較為穩定,變異繫數均＜3％,變化幅度能控製在90％～110％均值範圍內.結論 6種病毒性疫苗滲透壓摩爾濃度存在一定差異,但同種疫苗檢測值批間穩定性較好,因此,應根據不同疫苗的滲透壓摩爾濃度,分彆製定質量控製標準.
목적 통과검측6충병독성역묘성품적삼투압마이농도,비교불동역묘검측균치적차이,병관찰동충역묘검측치적비간은정성,위증가병독성역묘질량공제수단제공의거.방법 채용빙점하강법검측마진감독활역묘、풍진감독활역묘、마진시선염연합감독활역묘、마진시선염풍진연합감독활역묘、수두감독활역묘、류감병독렬해역묘적삼투압마이농도,대검측치진행통계학처리,계산변이계수.이마진시선염풍진연합감독활역묘적삼투압마이농도검측균치작위대조,진행방차제성검험급가설검험,비교각역묘검측균치적차이.결과 마진시선염연합감독활역묘여대조상비,균치차이무통계학의의(t =1.66,P＞0.05);마진감독활역묘、풍진감독활역묘、수두감독활역묘급류감병독렬해역묘여대조상비,균치차이균유통계학의의(Z＞1.96,P＜0.001).동충역묘비간삼투압마이농도교위은정,변이계수균＜3％,변화폭도능공제재90％～110％균치범위내.결론 6충병독성역묘삼투압마이농도존재일정차이,단동충역묘검측치비간은정성교호,인차,응근거불동역묘적삼투압마이농도,분별제정질량공제표준.
Objective To compare the difference of mean osmolalities among 6 viral vaccines and observe lot-to-lot stability of a single vaccine,and provide a basis for increasing an approach of quality control of viral vaccines.Methods The osmolalities of 5 live attenuated viral vaccines (measles,mumps and rubella combined vaccine,measles and mumps combined vaccine,measles vaccine,rubella vaccine,varicella vaccine) and influenza vaccine (split virion) were determined by a method of freezing point depression.Coefficient of variation was calculated.The mean osmolality of measles,mumps and rubella combined vaccine was used as a control and mean osmolalities of the remaining 5 vaccines were compared with the control by homogeneity test of variance and hypothesis test.Results There was no significant difference of mean osmolalities between measles and mumps combined vaccine and the control (t =1.66,P ＞ 0.05).The mean osmolalities of measles vaccine,rubella vaccine,varicella vaccine,and influenza vaccine were significantly different from that of the control (Z ＞ 1.96,P ＜0.001).The lot-to-lot stability of a single vaccine was good.None of the coefficients of variation were more than 3％,and the measurements ranged between 90％ and 110％ of the mean values.Conclusions There are some differences of the osmolalities among 6 viral vaccines,but lot-to-lot stability of a single vaccine is satisfactory.Therefore,corresponding criteria should be set for different vaccines.
