Bottrill Krys
FRAME, Russell & Burch House, 96-98 North Sherwood Street, Nottingham NG1 4EE, UK.
Altern Lab Anim. 2003 Sep;31(4):381-91. doi: 10.1177/026119290303100404.
The explosive growth in the use of botulinum toxin for cosmetic purposes has undoubtedly had an impact on the number of animals used in the potency testing of this product. The test used is a classical LD50, a severe procedure during which animals experience increasing paralysis until the occurrence of death. The enthusiastic adoption by the general public of the use of botulinum toxin as an anti-wrinkle treatment has, at least in Europe, paradoxically taken place against a background of moves to stop animal testing of cosmetics and cosmetic ingredients. There appears to be a dearth of information aimed at the public concerning botulinum toxin testing. Botulinum toxin does have important medical applications; however, the question arises whether a blanket licence for the testing can be justified, when a large proportion of the product is being used cosmetically. A further question is why death continues to be the endpoint of the potency test, when a more-humane endpoint has been proposed. In addition, a number of alternative methods have been developed, which could have the potential to replace the lethal potency test altogether. These methods are discussed in this paper, and the importance of establishing a strategy for their validation is emphasised, a need that has become even more urgent in the light of the recently published draft monograph on botulinum toxin by the European Pharmacopoeia Commission.
肉毒杆菌毒素在美容用途上的迅猛增长无疑对该产品效力测试中所用动物的数量产生了影响。所采用的测试是经典的半数致死剂量（LD50）测试，这是一个严苛的过程，在此过程中动物会逐渐麻痹直至死亡。在欧洲，公众热衷于将肉毒杆菌毒素用作抗皱治疗，这一现象自相矛盾地出现在停止化妆品及化妆品成分动物测试的背景之下。针对公众的有关肉毒杆菌毒素测试的信息似乎匮乏。肉毒杆菌毒素确实有重要的医学应用；然而，当很大一部分产品用于美容时，对其测试给予全面许可是否合理就成了问题。另一个问题是，既然已经提出了更人道的终点指标，为何死亡仍然是效力测试的终点。此外，已经开发出一些替代方法，这些方法有可能完全取代致死性效力测试。本文将对这些方法进行讨论，并强调为其验证制定策略的重要性，鉴于欧洲药典委员会最近发布的肉毒杆菌毒素专论草案，这一需求变得更加紧迫。
