보툴리눔 A형 독소의 역가 유지기간에 대한 실험적 연구

Abstract

The type A neurotoxin produced by Clostridium botulinum is a potent neuromuscular blocking agent. It has been recommended that the botulinum toxin should be used within 4 hours after reconstitution. The reports on the decrease of potency according to storage duration were contradictory among the investigators. The purpose of this study is to compare the potency of two kinds of botulinum type A toxin according to storage duration(0, 2, 4, and 6 weeks). In the present study, we used mouse lethality assay to estimate the potency of botulinum toxin. 160 mice were divided into four groups. In each storage duration(10 mice per each storage duration), the control group received intraperitoneal injection with saline not containing botulinum toxin, while the experimental group 1 and group 2 received injection with Botox짋 and BTXA짋 reconstituted by preservative-free saline, respectively. The experimental group 3 received BTXA짋 reconstituted by saline containing preservative. The potency of botulinum type A toxin was evaluated at 48 hr and 72 hr after injection. The results are as follows; 1. The experimental group 2 and group 3 maintained the potency of botulinum type A toxin diluted by saline up to 6 weeks after storage at 4℃. However, the experimental group 1 lost the potency at 2 weeks after storage. 2. There was no significant difference between the experimental group 2 and group 3. However, the experimental group 2 and group 3 showed a great higher potency than the experimental group 1 even immediately after dilution by saline(0 week). 3. There was no effect of saline itself used in reconstitution of botulinum toxin. 4. There was no contamination of botulinum type A toxin during the storage period.

These results suggest that botulinum type A toxin used in the experimental group 2 and group 3 has a higher biological activity (potency) than that used in the experimental group 1. In addition, it is shown that botulinum toxin used in the experimental group 2 and experimental group 3 will maintain a relatively high potency at 6 week after storage.