快净栓的研制、药动学特性及临床应用

目的 :研制治疗妇科炎症的阴道缓释栓。方法 :研究该栓剂的制备方法 ,建立质量标准和稳定性试验。根据新药要求进行局部刺激试验。采用紫外分光光度法测定血浆中的替硝唑 ,在临床进行疗效观察。结果 :该栓剂质量稳定 ,无局部刺激性 ,药 -时曲线呈多峰 ,作用时间长达24h以上 ,临床治疗滴虫性阴道炎痊愈率为90 00 %。结论 :快净栓具优异的药动学特性 ,体内释药平稳 ,作用时间长 ,值得推广应用

Preparation,Pharmacokinetic Characteristics and Clinical Use of Kuaijing Pessary

OBJECTIVETo prepare a controlled-release pessary for treating gynecologic inflammatorydiseases.METHODS To study the preparation technic and establish the quality standard ofthe pessary.According to the requirement of new drug,local irritability test was carriedout.The plasma concentration of tinidazole was assayed with UV-spectrophotometry and theclinical therapeutic effect was observed.RESULTS The quality of the pessary wasstable.Multiple peaks appeared on concentration-time curve.The drug effect could last over24h.The cure rate for trichomonal vaginitis was 90.00％ .CONCLUSION Kuaijing pessaryhas satisfactory pharmacokinetic characteristics with a steady in vivo drug release rateand long time action.It is worth popularizing.