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目的评价冻干ACYW135群脑膜炎球菌多糖疫苗的稳定性。方法取3批冻干ACYW135群脑膜炎球菌多糖疫苗,分别置2~8℃及37℃存放,于不同时间点(37℃第1、2、3、4、12、24、48周;2~8℃第3、6、12、18、24、30、36个月)取样,上XK16/100 Sepharose CL-4B层析柱后,采用火箭电泳法检测4种多糖分子大小(KD值)及多糖回收率。另取3批疫苗,置2~8℃存放,分别于第12、18、24、30个月取样,进行疫苗全面检定;取同批疫苗进行酸(调p H值至5.0和4.0)、碱(调p H值至10.0和12.0)处理后置2~8℃,于不同时间点取样,上XK16/100 Sepharose CL-4B层析柱后,采用火箭电泳法检测多糖KD值及回收率。结果于2~8℃存放36个月、37℃存放24周的疫苗的多糖KD值及回收率,以及2~8℃存放30个月的疫苗的鉴别试验、外观、水分、多糖含量、分子大小及回收率、无菌检查、异常毒性检查、热源试验、细菌内毒素检查结果均符合企业内部《ACYW135群脑膜炎球菌多糖疫苗制造和检定规程》(草案)要求。疫苗调p H值至5.0及10.0后置2~8℃存放48 h,多糖KD值及回收率均符合本企业内部《ACYW135群脑膜炎球菌多糖疫苗制造检定规程》(草案)要求。结论冻干ACYW135群脑膜炎球菌多糖疫苗于2~8℃存放30个月,性能稳定。
Objective To evaluate the stability of lyophilized ACYW135 meningococcal polysaccharide vaccine. Methods Three batches of lyophilized ACYW135 meningococcal polysaccharide vaccine were prepared and stored at 2-8 ℃ and 37 ℃, respectively, at different time points (1st, 2nd, 3rd, 4th, 12th, 24th and 48th weeks at 37 ℃, 8 ℃ 3,6,12,18,24,30,36 months) sampling, XK16 / 100 Sepharose CL-4B column, rocket electrophoresis was used to detect four kinds of polysaccharide molecular size (KD value) and polysaccharides Recovery rate. Another 3 batches of vaccine were set up and stored at 2-8 ° C. Sampling was performed on the 12th, 18th, 24th and 30th months respectively to conduct a comprehensive vaccine test. The same batches of vaccine were used for acid (pH = 5.0 and 4.0) (Adjusted p H values to 10.0 and 12.0), and then treated at 2 ~ 8 ℃. Samples were collected at different time points and analyzed by X-ray photoelectron spectroscopy (XK16 / 100 Sepharose CL-4B). The KD values and recoveries of polysaccharides were determined by rocket electrophoresis. Results The KD value and recovery rate of polysaccharides of the vaccines stored at 37 ℃ for 24 weeks at 37 ℃ and the identification test of vaccines stored at 2 ℃ ~ 8 ℃ for 30 months showed that the appearance, water content, polysaccharide content, molecular size And recovery rate, sterility test, abnormal toxicity test, heat source test and bacterial endotoxin test results are in line with the requirements of the “ACYW135 group meningococcal polysaccharide vaccine manufacturing and testing procedures” (draft). The pK value of the vaccine was adjusted to 5.0 and 10.0 and stored at 2-8 ° C for 48 h. The KD value and recovery rate of the polysaccharides all met the requirements of the “Regulation of Manufacturing and Validating the Group of Meningococcal Polysaccharide Vaccines of ACYW135 (Draft)” within the enterprise. Conclusions Lyophilized ACYW135 meningococcal polysaccharide vaccine is stable at 2-8 ℃ for 30 months.