国际生物制品学杂志
國際生物製品學雜誌
국제생물제품학잡지
INTERNATIONAL JOURNAL OF BIOLOGICALS
2014年
5期
220-222
,共3页
许敬敏%尚玥%蒋宁%罗丽
許敬敏%尚玥%蔣寧%囉麗
허경민%상모%장저%라려
肺炎球菌菌苗%内毒素类%散射测浊法和比浊法%有效性研究
肺炎毬菌菌苗%內毒素類%散射測濁法和比濁法%有效性研究
폐염구균균묘%내독소류%산사측탁법화비탁법%유효성연구
Pneumococcal vaccines%Endotoxins%Nephelometry and turbidimetry%Validation studies
目的 对动态浊度法检测23价肺炎链球菌多糖疫苗(23-valent pneumococcal polysaccharide vaccine,PPV23)细菌内毒素进行方法学确认并加以应用.方法 按照《中华人民共和国药典》2010版三部中的动态浊度法操作,配制系列稀释的细菌内毒素标准品,验证动态浊度法的线性、准确度、重复性和中间精密度.根据2012年和2013年连续20批PPV23成品的细菌内毒素检测结果,分析PPV23对动态浊度法的影响.结果 动态浊度法的标准曲线具有可靠性,细菌内毒素标准品的回收率为90％～129％,变异系数为6.2％～12.4％,均符合规定的标准,且操作人员(F=4.80,P=0.06)和时间(F=1.01,P=0.34)变化对检测结果没有影响.2012年和2013年各连续20批PPV23成品的细菌内毒素检测结果保持稳定,细菌内毒素均值分别为0.165和0.355 EU/ml,PPV23对动态浊度法没有影响(F=0.00,P=0.97).结论 动态浊度法有效可行,可用于PPV23细菌内毒素检测.
目的 對動態濁度法檢測23價肺炎鏈毬菌多糖疫苗(23-valent pneumococcal polysaccharide vaccine,PPV23)細菌內毒素進行方法學確認併加以應用.方法 按照《中華人民共和國藥典》2010版三部中的動態濁度法操作,配製繫列稀釋的細菌內毒素標準品,驗證動態濁度法的線性、準確度、重複性和中間精密度.根據2012年和2013年連續20批PPV23成品的細菌內毒素檢測結果,分析PPV23對動態濁度法的影響.結果 動態濁度法的標準麯線具有可靠性,細菌內毒素標準品的迴收率為90％～129％,變異繫數為6.2％～12.4％,均符閤規定的標準,且操作人員(F=4.80,P=0.06)和時間(F=1.01,P=0.34)變化對檢測結果沒有影響.2012年和2013年各連續20批PPV23成品的細菌內毒素檢測結果保持穩定,細菌內毒素均值分彆為0.165和0.355 EU/ml,PPV23對動態濁度法沒有影響(F=0.00,P=0.97).結論 動態濁度法有效可行,可用于PPV23細菌內毒素檢測.
목적 대동태탁도법검측23개폐염련구균다당역묘(23-valent pneumococcal polysaccharide vaccine,PPV23)세균내독소진행방법학학인병가이응용.방법 안조《중화인민공화국약전》2010판삼부중적동태탁도법조작,배제계렬희석적세균내독소표준품,험증동태탁도법적선성、준학도、중복성화중간정밀도.근거2012년화2013년련속20비PPV23성품적세균내독소검측결과,분석PPV23대동태탁도법적영향.결과 동태탁도법적표준곡선구유가고성,세균내독소표준품적회수솔위90％～129％,변이계수위6.2％～12.4％,균부합규정적표준,차조작인원(F=4.80,P=0.06)화시간(F=1.01,P=0.34)변화대검측결과몰유영향.2012년화2013년각련속20비PPV23성품적세균내독소검측결과보지은정,세균내독소균치분별위0.165화0.355 EU/ml,PPV23대동태탁도법몰유영향(F=0.00,P=0.97).결론 동태탁도법유효가행,가용우PPV23세균내독소검측.
Objective To validate and apply the turbidimetric-kinetic method for determination of bacterial endotoxin in 23-valent pneumococcal polysaccharide vaccine (PPV23).Methods The bacterial endotoxin standards were diluted serially in accordance with the turbidimetric-kinetic method in Chinese Pharmacopoeia 2010 edition (Volume Ⅲ).Linearity,accuracy,repeatability and intermediate precision of the turbidimetric-kinetic method were validated.According to the determination results of bacterial endotoxins in 20 batches of consecutively manufactured PPV23 in 2012 and 2013,the influence of PPV23 on the turbidimetric-kinetic method was studied.Results The standard curve of the turbidimetric-kinetic method was reliabile.The recoveries of the bacterial endotoxin standard were 90％-129％,and the coefficients of variation were 6.2％-12.4％.Both results met standard requirement.The changes of operator (F=4.80,P=0.06) and time (F=1.01,P=0.34) had no effect on the turbidimetric-kinetic method.The determination results of bacterial endotoxins in 20 batches of consecutively manufactured PPV23 in 2012 and 2013 remained stable,and the average values of bacterial endotoxins in 20 batches of PPV23 in 2012 and 2013 were 0.165 and 0.355 EU/ml,respectively.PPV23 had no influence on the turbidimetric-kinetic method.Conclusion The turbidimetric-kinetic method is effective and feasible and can be used to detect bacterial endotoxin in PPV23.
