蔡司多功能护理液的遗传毒性研究

目的:检测医疗器械境外注册产品蔡司多功能护理液的遗传毒性。方法:以蔡司多功能护理液产品原液为供试液,采用细菌回复突变试验(Ames试验)和小鼠淋巴瘤细胞试验(MLA),在代谢活化和非代谢活化(±S9)条件下检测其遗传毒性。Ames试验采用平板掺入法,检测每皿50、100、200μl 3个剂量组诱发鼠伤寒沙门氏菌TA98、TA100、TA1535、TA1537及大肠杆菌WP2uvrA的回变菌落数;MLA采用微孔法检测终浓度2.5%、5%、10%(V/V)3个浓度组,在+S9/3 h、-S9/3 h、-S9/24 h 3种处理条件下诱发的L5178Y细胞tk~(+/-)突变频率(MF)和小集落突变百分率,在-S9/24 h处理条件下追加检测0.5%、1%、2%(V/V) 3个浓度。结果:与氯化钠注射液阴性对照组相比,每皿50、100、200μl 3个剂量组诱发上述5株菌的回变菌落数,均无明显增加(P0.05);在-S9/24 h处理条件下,2.5%浓度组诱发的MF值远超出阳性判定数值,相对总生长率(RTG)仅为3%,2%浓度组的RTG升至16%,诱发的MF与阴性对照组比较虽有增加(P0.01),但未达到阳性判定标准。结论:蔡司多功能护理液对测试菌株his~-/trp~-无明显诱变作用,但在-S9/24 h处理条件下可导致tk~(+/-)基因突变频率增加,是否与其细胞毒性有关尚待进一步阐明。

Genotoxicity study of Zeiss "All in One Advance"

OBJECTIVE:To investigate the genotoxicity of Zeiss "All in One Advance"（ZAOA）. METHODS:Original product fluid was used as tested in bacterial reverse mutation test（Ames test） and mouse lymphoma assay（MLA） with and without metabolic activation of S9.Ames test was performed by the plate incorporation method for its ability to induce reverse mutations in three treatment dosage groups:50,100,200μl/plate using S.typhimurium TA98,TA100,TA1535,TA1537 and E.coli WP2 uvrA.Micropore method was employed in MLA,the mutation frequency（MF） and the percentage of small colony mutants of L5178 tk^+/- cells induced by ZAOA at final concentration of 2.5%,5%and 10%（V/V） were calculated and assayed with +S9/3 h,-S9/3 h,-S9/24 h.Three concentrations of ZAOA of 0.5%,1%,2%were added for -S9/24 h.RESULTS:Ames test showed that ZAOA did not cause obvious increases in the mean number of revertant per plate in groups compared with negative control.MLA indicated that under the condition of -S9/24 h treatment,MF of 2.5%group was far above positive decision value,the relative total growth rate（RTO） was 3%.MF of 2%group,which RTG was up to 16%,did not reach positive decision value（P<0.01）.CONCLUSION: ZAOA did not induce point mutation at his^-/trp^- to test strains.The frequency of gene tk^+/- mutation increased significantly under the condition of -S9/24 h treatment,whether this could be related to its cytotoxic is still unknown.