摘要
目的研制并验证治疗妇科炎症的阴道缓释剂。方法研究该栓剂的制备方法,建立质量标准和稳定性。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,在临床上观察疗效。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治愈率为90.00%。结论妇炎康栓剂具有较好的药动学特性,体内释药平稳,作用时间长,值得推广应用。
OBJECTIVE To perpare a controlled-release pessary for treating gynecologic inflammatory diseases. METHODS To study the preparation and establish the quality standard of the pessary. According to the requirement of new drug,local irritability test has carried out. The plasma concentration of tinidazole was aassayed with UV-spectrophotometry and the clinical therapeutic effect was observed. RESULTS ：The quality of the pessary was stable. Multiple peaks appeared on concentration-time curve. The drug effect could last over 24h. The cure rate for trichomonal vaginitis was 90. 00%. CONCLUSION Fuyankang pessary has satisfactory pharmacokinetic chareacteristics with a steady in vivo drug release rate and long time action. It is worth popularizing.
出处
《海峡药学》
2006年第4期26-28,共3页
Strait Pharmaceutical Journal
关键词
妇炎康栓剂
药物动力学
临床应用
Fuyankang pessary pharmacokinetics clinical study
