微生物学免疫学进展
微生物學免疫學進展
미생물학면역학진전
PROGRESS IN MICROBIOLOGY AND IMMUNOLOGY
2015年
5期
27-32
,共6页
萧在澜%徐永浩%刘佳%孔素娟%刘爱萍%王媛%冯琪瑢%刘方蕾%吴兵%于旭博%袁菲%谢贵林
蕭在瀾%徐永浩%劉佳%孔素娟%劉愛萍%王媛%馮琪瑢%劉方蕾%吳兵%于旭博%袁菲%謝貴林
소재란%서영호%류가%공소연%류애평%왕원%풍기용%류방뢰%오병%우욱박%원비%사귀림
1-氰基-4-二甲氨基-吡啶四氟硼酸(CDAP)%C群脑膜炎球菌%结合疫苗%稳定性试验%温度
1-氰基-4-二甲氨基-吡啶四氟硼痠(CDAP)%C群腦膜炎毬菌%結閤疫苗%穩定性試驗%溫度
1-청기-4-이갑안기-필정사불붕산(CDAP)%C군뇌막염구균%결합역묘%은정성시험%온도
CDAP%Meningococcal Group C%Conjugate vaccine%Stability test%Temperature
目的：评价以1－氰基－4－二甲氨基－吡啶四氟硼酸（ CDAP ）活化制备的C群脑膜炎球菌结合疫苗原液的稳定性。方法以变通的现有工艺为基础，选取C群脑膜炎球菌结合疫苗原液连续3批样品，分别放置于（37±2）℃、（25±2）℃，和2～8℃三种温度下，根据稳定性试验原则定期取样并进行主要指标的检测，评估原液的稳定性。结果 C群脑膜炎球菌结合疫苗原液于2～8℃保存18个月，（25±2）℃保存20周，37℃保存7天，各项检测指标均符合质量标准的要求。结论在2～8℃之下，施行变通的工艺， C群脑膜炎球菌结合疫苗原液可稳定存放18个月。
目的：評價以1－氰基－4－二甲氨基－吡啶四氟硼痠（ CDAP ）活化製備的C群腦膜炎毬菌結閤疫苗原液的穩定性。方法以變通的現有工藝為基礎，選取C群腦膜炎毬菌結閤疫苗原液連續3批樣品，分彆放置于（37±2）℃、（25±2）℃，和2～8℃三種溫度下，根據穩定性試驗原則定期取樣併進行主要指標的檢測，評估原液的穩定性。結果 C群腦膜炎毬菌結閤疫苗原液于2～8℃保存18箇月，（25±2）℃保存20週，37℃保存7天，各項檢測指標均符閤質量標準的要求。結論在2～8℃之下，施行變通的工藝， C群腦膜炎毬菌結閤疫苗原液可穩定存放18箇月。
목적：평개이1－청기－4－이갑안기－필정사불붕산（ CDAP ）활화제비적C군뇌막염구균결합역묘원액적은정성。방법이변통적현유공예위기출，선취C군뇌막염구균결합역묘원액련속3비양품，분별방치우（37±2）℃、（25±2）℃，화2～8℃삼충온도하，근거은정성시험원칙정기취양병진행주요지표적검측，평고원액적은정성。결과 C군뇌막염구균결합역묘원액우2～8℃보존18개월，（25±2）℃보존20주，37℃보존7천，각항검측지표균부합질량표준적요구。결론재2～8℃지하，시행변통적공예， C군뇌막염구균결합역묘원액가은정존방18개월。
Objective To evaluate the stability of Meningococcal serogroup C conjugate bulks which were activated by CDAP.Methods Based on the present technical process, three consecutive batches of group C meningococcal conjugate bulks were selected, and kept in three different temperatures, as (37±2) ℃, (25±2) ℃and 2-8 ℃.The main indexes of bulks were performed in sampling periodically and detecting according to the principle of stability test, so as to assess the stability of the conjugate.Results The conjugate bulks were stable when stored at 2-8 ℃for 18 months, (25±2) ℃for 20 weeks, 37 ℃for 7 days, and all test indexes met the requirement of quality standard.Conclusion Under the condi-tion of 2-8 ℃, these meningococcal serogroup C conjugate vaccine bulks can be steadily preserved for 18 months in the modified process.
