复方助孕栓的安全性和稳定性试验研究

Security and Stability of Fertility-Promoting Vaginal Suppository from Chinese Herbal Prescription

为了兽医临床治疗奶牛不孕症提供安全性和稳定性的理论依据,观察复方助孕栓的安全性和稳定性。采用阴道黏膜急性毒性实验和阴道用药黏膜刺激性试验,并采用加速试验及室温留样考查试验等方法考察其安全性和稳定性,通过药物稳定性实验对其进行检测对复方助孕栓的安全性和稳定性进行研究。观察新西兰兔的外观体征、行为活动、体重和阴道组织病理学检查观察新西兰兔的外观体征、行为活动、体重和阴道组织病理学检查与空白对照组无显著差异。结果显示:本品无毒性和刺激性以及对强光不太稳定,在日光及高湿的环境中稳定,在3个月的加速试验期内稳定。结论:助孕栓对阴道粘膜局部用药无明显刺激性,其临床使用安全可靠,本品在遮光、阴凉条件下性质稳定,有效期为1年。

In order to provide veterinary clinical treatment of infertility cows′ security and stability of the theoretical basis,the effect of progesterone suppository security and stability were investigated in this paper.The acute toxicity and irritation test of vaginal mucosa,as well as the acceleration and room temperature test were used to investigate its safety and stability.The appendix drug stability experiment was applied to test the security and stability of compound vaginal suppository.The features of appearance,behavior, weight and vaginal histology of New Zealand rabbit were also observed.But the weight and vaginal tissue pathological of New Zealand rabbit had no significant difference compared with the blank control group.The results showed that the drug was toxic and irritating free,and it was unstable to strong light,but stable in sunlight and high humidity environment,as well as in the accelerated test period of 3 months.Fertility-promoting vaginal suppository did not induce acute toxicity and severe mucosal irritation,and it could be used safely in clinical practice.