摘要
目的 回顾评估某国产儿童四价流感病毒裂解疫苗关键质量指标,分析疫苗的有效性、安全性和批间一致性.方法 以某国产公司生产的14批儿童四价流感病毒裂解疫苗为研究样品,检测样品血凝素含量、总蛋白含量、总蛋白/血凝素比值、卵清蛋白含量、细菌内毒素含量、游离甲醛含量,和企业注册标准、中国药典标准及WHO标准比较,同时计算标准差(s),评价产品质量.结果 14批儿童四价流感病毒裂解疫苗血凝素含量为31.9～35.9 μg/mL(s 0.6～1.2)、总蛋白含量 223.4～256.0 μg/mL(s 9.0)、总蛋白/血凝素比值 1.7～1.8(s 0.06)、卵清蛋白含量 0.84～2.32 ng/mL(s 0.47)、细菌内毒素含量0.03～0.04 EU/mL(s 0.004)、游离甲醛含量2.05～2.70 μg/mL(s 0.23),检测符合标准要求.结论 该国产儿童四价流感病毒裂解疫苗14批产品检测结果均符合企业注册标准、中国药典标准及WHO标准,批间一致性好,产品具有良好的安全性和有效性.
Abstract
Objective To review and evaluate the key quality indicators of quadrivalent split-virion influenza vaccine for children(QSIVC)manufactured by a domestic company,and analyze the safety and effectiveness indicators and Inter-batch consistency of vaccines.Methods In total,14 batches of the QSIVC samples produced by the domestic company were taken as the study samples,and the hemagglutinin content,total protein content,protein/hemagglutinin ratio,ovalbumin content,bacterial endotoxin content,and free formaldehyde content of the samples were detected,and compared with the registration standards,China Pharmacopoeia standards and WHO standards.At the same time the standard deviation(s)was calculated to evaluate the product quality.Results The content of hemagglutinin(31.9-35.9 μg/mL,s 0.6-1.2),total protein(223.4-256.0 μg/mL,s 9.0),total protein/hemagglutinin(1.7-1.8,s 0.06)and ovalbumin(0.84-2.32 ng/mL,s 0.47),bacterial endotoxin(0.03-0.04 EU/mL,s 0.004),free formaldehyde(2.05-2.70 μg/mL,s 0.23)in 14 batches of the QSIVC samples met the standard requirements.Conclusions The test results of 14 batches of this domestic QSIVC all meet the standards of enterprise registration,China Pharmacopoeia and WHO,and have good consistency between batches and good safety and effectiveness.
基金项目
国家"重大新药创制"科技重大专项(2015ZX09101044-004)
河南省重大科技专项(171100310400)
NETL
NSTL
万方数据