杜米芬阴道用药安全性研究

A Study of the effect of Domiphen on the Vaginal Irritation Test in Rabbits and the Vaginal Lactobacillus Inhibition in Vitro.

为评价杜米芬阴道用药的安全性,本文观察了该药对家兔阴道的刺激性和对阴道乳酸杆菌的影响。阴道刺激实验结果表明,当杜米芬给药剂量在1mg 和5mg 时总分值分别是3.8±1.2和6.8±0.4,在可接受范围之内,当给药剂量在10mg,25mg 和50mg 时总分值分别为9.0±0.7,9.4±0.5和10.7±0.3,在8分以上为不可接受。阴道乳酸杆菌抑制实验结果表明,当杜米芬给药剂量在0.8μg时,对体外培养的人阴道乳酸杆菌的生长繁殖无影响。当给药剂量在0.8μg以上时,对乳酸杆菌的生长繁殖有明显的抑制作用。

The vaginal irritation experiment and lactobacillus inhibition of Domipnen were carried out in this study in order to evaluate the safety of the drug.The results of irritation experiment showed that total scores of the irri- tation were 3.8±1.2,6.8±0.4,9.0±0.7,9.4±0.5 and 10.7±0.3 as 1mg,5mg,10mg,25mg and 50mg doses of Domiphen were administred vaginally respec- tively.The scores of lrng and 5rag Domiphen were con- sidered not to have vaginal irritation while the scores of 10mg,25mg and 50rag were considered to have vaginal irritation.The results of lactobacillus inhibition showed that Domiphen did not have inhibitory effect on the growth of vaginal lactobacillus with the dose of 0.8μg, while had the remarkable inhibitory effect with the dose over 8μg.Conclusion:Domiphen is not suitable for vagi- nal spermicide use singly.If low dose of Domiphen can be combined with NP-9,it is possible to develop a new vaginal contraceptive suppository for the prevention of pregnancy and infection of reproductive tract.