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结核病高危人群预防用无细胞耻垢分枝杆菌疫苗的研制

Preparation of Acellular M. smegmatis Vaccine for Prevention of M. tuberculosis Infection in High Risk Population

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【作者】 陈保文沈小兵徐苗苏城王国治

【Author】 CHEN Bao-wen, SHEN Xiao-bing, XU Miao, et al (National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China)

【机构】 中国药品生物制品检定所细菌一室

【摘要】 目的研制结核病高危人群预防用无细胞耻垢分枝杆菌疫苗(MS疫苗)。方法耻垢分枝杆菌培养物经多次洗涤后,制备所需浓度的菌悬液,高压匀浆后,经高压灭菌、稀释、分装、冻干,制成MS疫苗。将结核杆菌感染的豚鼠随机分为A组(接种疫苗8.7μg/次)、B组(接种疫苗17.5μg/次)和C组(接种生理盐水),观察疫苗对结核杆菌感染豚鼠的保护作用。结果MS疫苗浓度确定为每支蛋白含量为17.5μg(0.25mg湿菌)。疫苗具有良好的安全性,且可有效抑制或杀死豚鼠体内的结核杆菌,减轻豚鼠各脏器的病变程度。结论已成功制备MS疫苗,其对结核杆菌感染动物有较好的预防效果,有望成为结核病高危人群预防用疫苗。

【Abstract】 Objective To prepare acellular M. smegmatis(MS)vaccine for prevention of M. tuberculosis infection in high risk population. Methods The culture of M. smegmatis was washed for several times and prepared into a suspension at the required concentration, then homogenized by high pressure homogenizer, sterilized under high pressure, diluted, distributed and lyophilized. The guinea pigs infected with M. tuberculosis were divided into three groups randomly. The guinea pigs in groups A and B were inoculated with the prepared MS vaccine 3, 10, 17 and 24 after infection, at dosages of 8. 7 and 17. 5 μg respectively, while those in group C with physiological saline. The protective effect of vaccine on infected guinea pigs was observed. Results The concentration of MS vaccine was determined as 17. 5 μg protein (0. 25 mg wet bacteria)per container. The vaccine showed good safety, inhibited or killed the M. tuberculosis in guinea pigs effectively and decreased the pathological change of various organs. Conclusion Acellular MS vaccine was successfully prepared, which showed good protective effect on guinea pigs infected with M. tuberculosis and might be used for prevention of M. tuberculosis infection in high risk population.

【关键词】 结核病高危人群耻垢分枝杆菌疫苗
【Key words】 TuberculosisHigh risk populationM. smegmatisVaccine
【基金】 国家高技术研究发展计划(863计划)(2004AA2Z3450)
  • 【文献出处】 中国生物制品学杂志 ,Chinese Journal of Biologicals , 编辑部邮箱 ,2009年09期
  • 【分类号】R392
  • 【被引频次】5
  • 【下载频次】111
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