|
|
|
| Study on β-Propiolactone in Inactivation Process of Rabies Vaccine by Gas Chromatography |
Yan GAO,Jing-jing DU,Bin WANG,Qi LIU,Zhi-qiang SHEN( ) |
| Hualan Biological Engineering, INC R&D Center, Xinxiang 453000, China |
|
|
|
Abstract Objective: According to GC-FID method, the content and stability of β-propiolactone which was used as an inactivator in the preparation of rabies vaccines were systematically studied. Methods: Gas chromatography condition: Agilent DB-624 (30m×0.530mm×3.00μm)capillary column was adopted. The temperature program: Initial temperature of 80℃ was maintained for 1min, then was raised to 200℃ at the rate of 20℃/min and was maintained for 3min. Column flow: 3ml/min. The temperatures of detector and inlet were 250℃ and 150℃ respectively. The linear velocity of the carrier gas (nitrogen) was set to 25cm/s. The injection volume was 1μl and the split ratio was 2∶1. The sampling mode: Manual injection. Results: BPL showed good linear relationship in the range of 1∶100-1∶32 000 with a correlation coefficient more than 0.999. A recovery study of BPL at three different concentration (1∶200, 1∶1 000, 1∶8 000) of spiked samples with range from 95.04% to 116.86% with RSD less than 3.2% further demonstrated the reliability and feasibility of this method. Moreover, the LOD of established method can be achieved as low as 0.112μg/ml. Conclusion The method is simple, specific, stable and can be carried out at room temperature with a satisfactory result, which reduces the requirements of complicated operation. In a word, the proposed method can meet the need that determines BPL in the process of inactivating rabies virus.
|
|
Received: 25 October 2018
Published: 12 July 2019
|
|
|
|
Corresponding Authors:
Zhi-qiang SHEN
E-mail: szq3219@hualan.com
|
|
|
| [1] |
谭寿南, 张凤羽 . 狂犬病及人用狂犬病疫苗研究. 临床医学, 2011,24(5):2841-2843.
|
|
|
| [1] |
Tan S N, Zhang F Y . Rabies and human rabies vaccine research. Clinical Medicine, 2011,24(5):2841-2843.
|
|
|
| [2] |
李义 . 狂犬病的诊断与防治研究. 上海畜牧兽医通讯, 2018,23(4):56-57.
|
|
|
| [2] |
Li Y . Diagnosis and prevention of rabies. Shanghai Livestock and Veterinary Communication, 2018,23(4):56-57.
|
|
|
| [3] |
蔡黎, 朱政纲, 文丽 , 等. 人用狂犬病疫苗研究进展. 药物流行病学杂志, 2017,26(12):841-844.
|
|
|
| [3] |
Cai L, Zhu Z G, Wen L , et al. Progress in research on human rabies vaccine. Chinese Journal of Pharmacoepidemiology, 2017,26(12):841-844.
|
|
|
| [4] |
王春雨, 徐琳凯, 李超 , 等. 工艺处理过程中病毒的灭活效果研究. 实验动物科学, 2015,32(2):15-17.
|
|
|
| [4] |
Wang C Y, Xu L K, Li C , et al. Study on the inactivation effect of virus during process. Laboratory Animal Science, 2015,32(2):15-17.
|
|
|
| [5] |
国家药品监督管理局. 生物制品生产工艺过程变更管理技术指导原则.[ 2018-09-15]. http://www.sda.gov.cn/WS01/CL0844/9350.html.
|
|
|
| [5] |
State Drug Administration. Biological product production process change management techn-ology guiding principles.[ 2018-09-15]. http://www.sda.gov.cn/WS01/CL0844/9350.html.
|
|
|
| [6] |
宋清爽, 吴恩应, 张运佳 , 等. 血液制品病毒灭活及去除工艺进展. 生物技术通讯, 2012,23(4):627-630.
|
|
|
| [6] |
Song Q S, Wu E Y, Zhang Y J , et al. Advance in virus inactivation and removal processes of blood products. Letters In Biotechnology, 2012,23(4):627-630.
|
|
|
| [7] |
She Y M, Cheng K D, Aaron Farnsworth , et al. Surface modifications of influenza proteins upon virus inactivation by β-propiolactone. Proteomics, 2013,13(23):3537-3547.
doi: 10.1002/pmic.v13.23-24
|
|
|
| [8] |
Sasaki Y, Yoshino N, Sato S , et al. Analysis of the beta-propiolactone sensitivity and optimization of inactivation methods for human influenza H3N2 virus. Journal of Virological Methods, 2016,235(4):105-111.
doi: 10.1016/j.jviromet.2016.04.013
|
|
|
| [9] |
Chen W, Li Z, Liu J , et al. Application of β-propiolactone in HFRS vaccine. Chinese Journal of Public Health, 2003,19(6):669-670.
|
|
|
| [10] |
Zhang Y H, Gao C, Pan G , et al. Determination of β-propiolactone residues in human rabies vaccine for Vero cells. Chinese Journal of Biologicals, 1998,11(3):144.
|
|
|
| [11] |
杨健, 高军, 张庆义 , 等. β-丙内酯含量气相色谱检测方法的建立及其水解情况分析. 中国生物制品学杂志, 2010,23(3):323-324.
|
|
|
| [11] |
Yang J, Gao J, Zhang Q Y , et al. Development of gas chromatography for determination of Propiolactone(BPL)content and analysis of BPL hydrolysis. Chinese Journal of Biologicals, 2010,23(3):323-324.
|
|
|
| [12] |
梁婧, 李举, 马继华 , 等. 气相色谱法检测灭活狂犬病病毒浓缩液中β-丙内酯的含量. 中国生物制品学杂志, 2017,30(12):1317-1320.
|
|
|
| [12] |
Liang J, Li J, Ma J H , et al. Determination of β-propiolactone content in inactivated rabies virus concentrate by gas chromatography. Chinese Journal of Biologicals, 2017,30(12):1317-1320.
|
|
|
| [13] |
Shan G Z, Ma X, Ji H , et al. Determination of residual β-propiolactone in inactivated rabies virus concentrate by gas chromatography. China Pharmacy, 2014,25(25):2357-2359.
|
|
|
| [14] |
Xu Y, Wei R, Jiang Y , et al. Study on the determination of β-propiolactone in rotavirus vaccine by gas chromatography. Progress in Microbiology and Immunology, 2010,38(4):21-23.
|
|
|
| [15] |
Lei S, Gao X, Sun Y , et al. Gas chromatography-mass spectrometry method for determination of β-propiolactone in human inactivated rabies vaccine and its hydrolysis analysis. Journal of Pharmaceutical Analysis, 2018,6(3):373-377.
|
|
|
| [16] |
刘兆文, 李福安, 钱浩 . β-丙内酯在人用纯化地鼠肾细胞狂犬疫苗制备中的应用研究. 中国人兽共患病杂志, 1999,15(6):71-72.
|
|
|
| [16] |
Liu Z W, Li F A, Qian H . Study for application of β-propiolactone on preparation of human rabies vaccine of purified humster kidney cell. Chinese Journal of Zoonoses, 1999,15(6):71-72.
|
|
|
| [17] |
李福安, 窦志勇, 潘丽静 . 狂犬疫苗灭活后β-丙内酯水解的最佳pH值的选择. 中国公共卫生, 1999,15(11):964.
|
|
|
| [17] |
Li F A, Dou Z Y, Pan L J . Selection of optimal pH for hydrolysis of β-propiolactone after rabies vaccine inactivation. Chinese Journal of Public Health Management, 1999,15(11):964.
|
|
|
| [18] |
徐守振, 王新, 尹燕博 . 四种不同灭活剂对新城疫病毒的灭活效果研究. 中国家禽, 2011,33(14):15-19.
|
|
|
| [18] |
Xu S Z, Wang X, Yin Y B . Inactivation efficacy of newcastle disease virus with four different inactivants. China Poultry, 2011,33(14):15-19.
|
|
|
| [19] |
Delrue I, Verzele D, Madder A , et al. Inactivated virus vaccines from chemistry to prophylaxis: merits, risks and challenges. Expert Rev Vaccines, 2012,11(6):695-719.
doi: 10.1586/erv.12.38
|
|
|
| [20] |
龚文波, 郝伟伟, 廖韦萍 , 等. 两种不同灭活剂对基因Ⅶ型新城疫病毒灭活效果的影响研究. 四川畜牧兽医, 2017,44(10):21-23.
|
|
|
| [20] |
Gong W B, Hao W W, Liao W P , et al. Inactivation effect of genotype Ⅶ newcastle disease virus with two different inactivants. Sichuan Animal and Veterinary Sciences, 2017,44(10):21-23.
|
|
|
| [21] |
冯若飞, 樊得英, 韦鹏建 , 等. β-丙内酯对脑心肌炎病毒灭活效果的试验. 中国兽医杂志, 2011,47(8):19-21.
|
|
|
| [21] |
Feng R F, Fan D Y, Wei P J , et al. Experiment on the inactivation effect of β-propiolactone on encephalomyocarditis virus. Chinese Journal of Veterinary Medicine, 2011,47(8):19-21.
|
|
|
| [22] |
姜立民, 林晓波, 高磊 , 等. β-丙内酯对狂犬病病毒的灭活效果. 国际流行病学传染病学杂志, 2014,41(2):137-139.
|
|
|
| [22] |
Jing L M, Lin X B, Gao L , et al. Inactivation of rabies virus with β-propiolactone. Journal of the Chinese Medical Association, 2014,41(2):137-139.
|
|
|
| [23] |
国家药典委员会. 中国药典. 第三部. 北京: 中国医药科技出版社, 2015: 146-149.
|
|
|
| [23] |
Chinese Pharmacopoeia Commission. Chinese pharmacopoeia. Third part. Beijing: China Medical Science and Technology Press, 2015: 146-149.
|
|
|
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
| |
Shared |
|
|
|
|
| |
Discussed |
|
|
|
|
