市售天然橡胶胶乳和人工合成聚氨酯材质避孕套的生物安全性研究

Investigation of the Biosafety of Commercially Available Natural Rubber Latex and Synthetic Polyurethane Condom Materials

目的 调查研究市售天然橡胶胶乳和人工合成聚氨酯材质避孕套的生物安全性。方法 天然橡胶胶乳避孕套品牌A1、品牌A2,聚氨酯避孕套品牌B1、品牌B2,购自成都大型连锁药店,每个品牌避孕套随机选3个包装。参照国家标准检测避孕套浸提液对小鼠成纤维细胞L-929的毒性反应,对避孕套对兔阴道和阴茎的刺激反应进行大体观察和组织病理学(HE染色)评价(每个品牌用3只兔),以及评价避孕套对豚鼠皮肤的致敏作用;制备避孕套浸提液,并连续灌注SD大鼠阴道30 d(每个品牌用5只大鼠),观察浸提液对大鼠生殖系统(子宫)的影响。结果 品牌A1、品牌A2的浸提液体积分数为100%、50%时,具有明显的细胞毒性,其光密度(optical density, OD)值低于空白对照组和品牌B1、品牌B2浸提液组(P<0.01);品牌B1、品牌B2不同积分数浸提液组细胞形态、OD值与空白对照组细胞差异均无统计学意义(P>0.05)。品牌A1组兔阴道有3例、品牌A2组兔阴道有1例出现充血;品牌A1组有2例、品牌A2组有1例兔阴茎在实验过程出现短暂极轻微红斑;组织病理学检查发现,品牌A1有3例、品牌A2有2例兔阴道组织有炎细胞散在浸润,固有层内血管轻微充血,品牌A1有1例兔阴茎真皮内见毛细血管周围小灶性淋巴细胞,品牌A2组兔阴茎组织未见明显病理改变。3例品牌A1组和2例品牌A2组大鼠子宫有充血。聚氨酯品牌组兔阴道均未见明显充血和明显病理改变,兔阴茎未见红斑和明显病理改变,大鼠子宫均未见明显充血。4组浸提液对豚鼠皮肤均未产生明显致敏现象。结论 不同材质、不同品牌避孕套的生物安全性存在明显差异,避孕套上市后的产品质量需要得到监管部门更多的关注。

Objective To investigate the biological safety of commercially available natural rubber latex and synthetic polyurethane condoms.Methods Natural rubber latex condom brands of A1 and A2 and polyurethane condom brands of B1 and B2 were purchased from large chain pharmacies in Chengdu,with three packages randomly selected for each brand.The study assessed the toxic effects of condom extracts on L-929 mouse fibroblasts according to GB/T standards.Gross observation and histopathological evaluation were conducted to assess the irritation reactions of condoms on the vagina and penis of rabbits(3 rabbits were used for each brand),as well as their sensitization effects on guinea pig skin.Additionally,the impact of continuous perfusion of condom extracts of the vaginas of SD rats for 30 days on their reproductive systems was evaluated,following GB/T standards(5 rats were used for each brand).Results Extracts from natural rubber latex condom brands A1 and A2,at concentrations of 100%and 50%,exhibited significant cytotoxicity,with optical density(OD)values being significantly lower than those of the blank control group and the polyurethane condom brands B1 and B2(P<0.01).There was no significant difference in cell morphology and OD values between the extracts of B1 and B2 and the blank control group(P>0.05).Vaginal congestion was found in 3 rabbits from A1 group and 1 rabbit from the A2 group,while no obvious congestion was noted in rabbits from the B1 and the B2 groups.Histopathological examination showed scattered inflammatory cell infiltration in the vaginal tissue of 3 rabbits from the A1 group and 2 rabbits from the A2 group,and slight congestion in the blood vessels of the lamina propria.No obvious pathological changes were observed in the vaginal tissue of polyurethane brand rabbits.Two rabbits from the A1 group and 1 rabbit from the A2 group showed transient and mild erythema on the penis during the experiment.Histopathological examination showed that 1 rabbit from A1 group had small foci of pericapillary lymphocytes in the dermis of the penis,while no significant pathological changes were observed in the penile tissue of A2,B1,and B2 groups.After 30 days of continuous vaginal perfusion with condom extract,3 rats in A1 group and 2 rats in the A2 group had uterine congestion,with the degree of congestion being lower in the A2 group.No significant congestion or pathological changes were observed in the vaginal and penile tissues of rabbits,or in the uterine tissues of rats from the polyurethane groups.None of the 4 groups of guinea pigs showed significant skin allergic reactions to the condom extracts.Conclusion Significant differences in biosafety exist among condoms of various materials and brands.To ensure product safety,it is crucial to strengthen quality control and regulatory oversight after condoms become commercially available.