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目的:制备苦参碱硼酸阴道生物黏附栓,考察其体外释放行为,并与保妇康栓治疗外阴念珠菌病的临床疗效进行比较。方法:以不同pH的磷酸盐缓冲液为释放介质,用HPLC测定苦参碱硼酸阴道生物黏附栓的释放度;将120例外阴念珠菌病门诊患者随机分成2组,分别采用苦参碱硼酸阴道生物黏附栓和保妇康栓治疗(各60例),比较2组疗效。结果:苦参碱硼酸阴道生物黏附栓的释药趋势是苦参碱和硼酸缓慢释放,符合零级释药模型;治疗组有效率为81.67%、对照组有效率为73.33%,疗效差异无显著性(P>0.05)。结论:苦参碱硼酸阴道生物黏附栓的体外释放行为符合控释制剂的要求,经临床试验表明其能有效治疗外阴念珠菌病。
OBJECTIVE: To prepare the vaginal bioadhesive suppository of matrine boric acid and investigate its in vitro release behavior, and to compare the clinical efficacy of Baofukang suppository in the treatment of vulvovaginal candidiasis. Methods: The release of matrine boric acid vaginal bioadhesive suppository was measured by HPLC with different pH of phosphate buffer. 120 cases of vulvarian candidiasis outpatients were randomly divided into two groups, respectively, with matrine boric acid vagina Bioadhesive suppository and Baofukang suppository (each 60 cases), the efficacy of the two groups were compared. Results: The releasing tendency of matrine boric acid vaginal bioadhesive suppository was the slow release of matrine and boric acid, which was consistent with the zero-order release model. The effective rate was 81.67% in the treatment group and 73.33% in the control group, with no significant difference in efficacy (P> 0.05). Conclusion: Matrine boric acid vaginal bioadhesive plug in vitro release behavior in line with the requirements of controlled release formulations, clinical trials show that it can effectively treat vulvar candidiasis.