冻干过程中A型肉毒杆菌毒素的稳定性
Stabilization of botulinum toxin type A during lyophilization.
作者信息
Goodnough M C, Johnson E A
机构信息
Department of Food Microbiology and Toxicology, University of Wisconsin, Madison 53706.
出版信息
Appl Environ Microbiol. 1992 Oct;58(10):3426-8. doi: 10.1128/aem.58.10.3426-3428.1992.
Abstract
Botulinum toxin for medical use is diluted to very low concentrations (nanograms per milliliter); when it is preserved by lyophilization, considerable loss of activity can occur. In the present study, conditions that gave > 90% recovery of the toxicity after lyophilization of solutions containing 20 to 1,000 mouse 50% lethal doses per ml were found. Toxicity was recovered upon drying 0.1 ml of toxin solution when the pH was maintained below 7 and bovine or human serum albumins were used as stabilizers. Various other substances tested with albumin, including glucose, sucrose, trehalose, mannitol, glycine, and cellibiose, did not increase recovery on drying.
摘要
医用肉毒杆菌毒素被稀释到非常低的浓度（每毫升纳克）；当通过冻干保存时，可能会发生相当大的活性损失。在本研究中，发现了在冻干每毫升含有20至1000小鼠50%致死剂量的溶液后，毒性回收率>90%的条件。当pH值保持在7以下，并用牛血清白蛋白或人血清白蛋白作为稳定剂时，干燥0.1毫升毒素溶液后毒性得以恢复。与白蛋白一起测试的各种其他物质，包括葡萄糖、蔗糖、海藻糖、甘露醇、甘氨酸和纤维二糖，在干燥时并没有提高回收率。
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本文引用的文献
1
Statistical analysis of a rapid in vivo method for the titration of the toxin of Clostridium botulinum.一种用于肉毒梭菌毒素体内快速滴定方法的统计分析。
J Bacteriol. 1966 Nov;92(5):1580-1. doi: 10.1128/jb.92.5.1580-1581.1966.
2
Distant effects of local injection of botulinum toxin.局部注射肉毒杆菌毒素的远隔效应。
Muscle Nerve. 1987 Jul-Aug;10(6):552-5. doi: 10.1002/mus.880100610.
3
Double-blind study of botulinum toxin in spasmodic torticollis.肉毒杆菌毒素治疗痉挛性斜颈的双盲研究。
Lancet. 1986 Aug 2;2(8501):245-7. doi: 10.1016/s0140-6736(86)92070-2.
4
Dose standardisation of botulinum toxin.
Lancet. 1989 Apr 29;1(8644):964. doi: 10.1016/s0140-6736(89)92551-8.
5
Therapeutic use of type F botulinum toxin.
N Engl J Med. 1992 Jan 30;326(5):349-50. doi: 10.1056/NEJM199201303260516.
6
Interactions of stabilizing additives with proteins during freeze-thawing and freeze-drying.在冻融和冻干过程中稳定剂与蛋白质的相互作用。
Dev Biol Stand. 1992;74:225-38; discussion 238-9.
7
Properties and use of botulinum toxin and other microbial neurotoxins in medicine.肉毒杆菌毒素及其他微生物神经毒素在医学中的特性与应用。
Microbiol Rev. 1992 Mar;56(1):80-99. doi: 10.1128/mr.56.1.80-99.1992.
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