预防和治疗念珠菌感染免疫生物药物的化学分析及质量指标研究

IF 1 Q4 CHEMISTRY, MULTIDISCIPLINARY Chemistry & Chemical Technology Pub Date : 2020-12-15 DOI:10.23939/chcht14.04.455
M. Rybalkin, L. Strelnikov, O. Strilets, O. Kaliuzhnaia, S. Kutsenko
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引用次数: 2

摘要

研制的以白色念珠菌和热带念珠菌为原料的注射用疫苗液(VSI)“假丝酵母”的蛋白质含量、多糖含量、酚含量、pH值等质量指标均符合标准要求。通过透明度指标和浊度指标确定试验溶液为透明,通过显色度指标确定为无色,通过无菌指标确定为无菌。第一次开封后确定的不育期为8小时。结果发现,溶液中不存在固体颗粒;装有溶液的容器是密封的;装溶液的容器体积不小于5.0 ml。测试溶液在275-265 K下可稳定保存2年。
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Chemical Analysis and the Study of Quality Indicators of the Immunobiological Drug for Preventing and Treating Candidal Infections
Quality indicators such as protein content, polysaccharide content, phenol content, and pH of the developed vaccine solution for injection (VSI) “Candidocyde” based on cells of C. albicans and C. tropicalis fungi have been found to meet the standard requirements. It was determined that by the indicator of transparency and degree of turbidity the test solution is transparent, by the coloration degree it is colorless, by the sterility indicator it is sterile. The sterility period, determined after the first opening, is 8 hours. It was found that no solid particles were present in the solution; the container with the solution is hermetic; the volume of the container with a solution is not less than 5.0 ml. The test solution is stable for 2 years of storage at 275-265 K.
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来源期刊
Chemistry & Chemical Technology
Chemistry & Chemical Technology CHEMISTRY, MULTIDISCIPLINARY-
CiteScore
1.70
自引率
44.40%
发文量
60
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