[논문]Alternative Methods for Testing Botulinum Toxin: Current Status and Future Perspectives

Nepal, Mahesh Raj; Jeong, Tae Cheon

doi:10.4062/biomolther.2019.200

Alternative Methods for Testing Botulinum Toxin: Current Status and Future Perspectives 원문보기

Biomolecules & therapeutics, v.28 no.4, 2020년, pp.302 - 310

Nepal, Mahesh Raj (College of Pharmacy, Yeungnam University) , Jeong, Tae Cheon (College of Pharmacy, Yeungnam University)

Abstract ▼ AI-Helper

Botulinum toxins are neurotoxic modular proteins composed of a heavy chain and a light chain connected by a disulfide bond and are produced by Clostridium botulinum. Although lethally toxic, botulinum toxin in low doses is clinically effective in numerous medical conditions, including muscle spasticity, strabismus, hyperactive urinary bladder, excessive sweating, and migraine. Globally, several companies are now producing products containing botulinum toxin for medical and cosmetic purposes, including the reduction of facial wrinkles. To test the efficacy and toxicity of botulinum toxin, animal tests have been solely and widely used, resulting in the inevitable sacrifice of hundreds of animals. Hence, alternative methods are urgently required to replace animals in botulinum toxin testing. Here, the various alternative methods developed to test the toxicity and efficacy of botulinum toxins have been briefly reviewed and future perspectives have been detailed.

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제안 방법

In this review, we briefly listed the methods for the identification of botulinum toxins and described the most successful developments in this field. All test methods described in this review have the common goal to address the 3R concept and replace the in vivo MLB. Among the several, proposed alternative methods for the detection of botulinum toxins, some have better sensitivity and response time than MLB, which could be a clear indication for developing alternative tests (Table 1).

성능/효과

, 1996). A linear relationship was achieved between the mean scores of response vs toxin doses, which proved that the developed method was sensitive and highly efficient for the determination of botulinum toxins. With the confidence interval of 95%, the geometric coefficient of variation within assays was achieved as 16%.
With the confidence interval of 95%, the geometric coefficient of variation within assays was achieved as 16%. In this method, the accuracy and precision obtained using sub-lethal doses of botulinum toxin were comparable to the MLB, confirming that the FDA and other regulatory agencies can accept the assay method as a replacement for MLB.
A linear relationship was achieved between the mean scores of response vs toxin doses, which proved that the developed method was sensitive and highly efficient for the determination of botulinum toxins. With the confidence interval of 95%, the geometric coefficient of variation within assays was achieved as 16%. In this method, the accuracy and precision obtained using sub-lethal doses of botulinum toxin were comparable to the MLB, confirming that the FDA and other regulatory agencies can accept the assay method as a replacement for MLB.

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