利升体育

美国食品药品监督管理局最近提出了监管电子雾化装置上市的PMTA法规，法规要求在美国上市的电子雾化装置产品必须审查化学品成份，添加剂，尼古丁浓度，毒理学特征和对人体健康的影响，从而获得上市许可。同样，英国的电子雾化装置制造商或进口商也必须严格遵守产品安全法规，对产品成份和释放物进行毒理学测试，兴奋剂、色素和维生素添加剂受到严格监管，以评估对人体健康的影响。

According to Premarket Tobacco Product Applications (PMTA) For ENDS, FDA requires manufacturers and importers submit testing reports of chemicals, additives, Nicotine concentration, and a full toxicological and pharmacological assessment for health risks of new tobacco products. In EU countries, such as UK, manufacturers and importers of E-Cigarettes also need to submit test reports of components, ingredients, additives, and toxicological assessment, according to EU Tobacco Products Directive (TPD) on E-Cigarettes, to assess the public health risks.

因此，全球电子雾化装置市场对电子烟产品的监管均日趋严格，对产品进行毒理学评估成为大势所趋。利升体育机构以国际认可的加拿大卫生部毒理测试为标准，已开发出完善的电子雾化装置体外毒理学检测方法，面向电子雾化装置各类企业，提供电子雾化装置烟油及气溶胶的体外毒理学评估测试服务。

Under the background of more strict supervision of E-Cigarettes marketing in global market, toxicological assessment of ENDS is essential for E-Cigarettes products marketing. As one of the earliest independent testing organizations in E-Cigarettes test field, SKYTE has developed complete in vitro toxicological assessment methods for E-Cigarettes, according to Health Canada official methods.

电子雾化装置体外毒理学测试内容具体包含：
We can provide E-liquids and aerosol in vitro toxicological assessment services as follows:

主流烟气样品的收集。
Preparation and collection of mainstream tobacco smoke for in vitro toxicological assessment.

中性红试验：用细胞的半数致死率来评估受试物毒性。
Neutral Red Uptake Assay. Assess cytotoxicity of test sample by half maximal inhibitory concentration (IC50).

细菌回复突变试验：用细菌的致突变性来评估受试物毒性。
Bacterial Reverse Mutation Assay (Ames Assay). Assess cytotoxicity of test sample by bacterial mutagenicity.

体外微核试验：用细胞核微核率来评估受试物毒性的报告。
In Vitro Micronucleus Assay. Assess cytotoxicity of test sample by ratio of micronucleated cells per 1000 observed cells.