RESUMO
Topical vaginal preparations are administered via vaginal channels to play a local role. This paper discussed review points of vaginal generic drugs in order to provide references for research and review of this drugs in china. METHODS By literature research, the paper collected the approval information and the pharmacopoeia record information of the USA, the EU, the JP and the China, discussed the review points of vaginal generic drugs in combination with the review requests of FDA and EMA, and analyzed the technical points of the quality and efficacy of vaginal generic drugs. RESULTS AND CONCLUSION S The pharmacy researches on vaginal generic drugs should focus on the rationality of prescription, process and critical quality attribute researches, concerned the consistence of inter-batch and reference listed drug. FDA and EMA usually review the equivalence of efficacy and safety with clinical trials which often need a great deal of volunteers.
RESUMO
Objective To compare the clinical effect of povidone-iedine cream plus vagina scrubbing with traditional preoperative vaginal preparation method in order to seek a more safe,effective,convenient and efficient method to prepare the vagina.Methods 100 cases of married patients undergoing elective gynecological surgery were divided into the observation group and the control group with 50 patients in each.The observation group adopted povidone-iodine cream plus vagina scrubbing and the control group used traditional method.Two groups were prepared in the vagina before and after taking cervical swabs for bacterial culture to compare the positive rate of bacterial culture.Results Intra-group comparison of vaginal bacterial culture before and after vaginal preparation was significantly different,but no statistical significance was seen between the two groups.Conclusions Vagina preparation with povidoneiodine cream plus vagina scrubbing can not only reduce the workload of nurses but also improve patient comfort degree.