苦参碱硼酸阴道生物黏附栓的体外释放和临床疗效观察

Dissolution of matrine boric acid vaginal bioadhesive suppository in vitro and its clinical observation

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 matrine boric acid vaginal bioadhesive supposi-tory,to investigate their drug release in vitro and compare the clinical efficacy of the matrine boric acid vaginal bioadhesive suppository in the treatment of vulvovaginal candidiasis with Baofukangshuang.METHODS The release medium was various pH（3,4,5,6） buffer phosphate.The drug release rate in vitro was determined by HPLC to observe the delivery be-havior in vitro.120 patients with vulvovaginal candidiasis were randomly divided into two groups.60 patients of the test group were treated with the matrine boric acid vaginal bioadhe-sive suppository while the control group of 60 patients were treated with Baofukangshuang.Then the efficacy of the two groups was compared.RESULTS The delivery behavior of the vaginal suppository in various pH buffer phosphates was that matrine and boric acid delayed release and the release model was consistent with zero-order release equation.The effective rate of the treated group was 81.67%,and the rate of the control group was 73.33%.There was no significant difference between the two groups（P〉0.05）.CONCLUSION The delivery behavior of the matrine boric acid vaginal bioadhesive suppository in vitro fit the request of controlled release preparation.The matrine boric acid vaginal bioadhesive suppository has good effect on the treatment of vulvovaginal candidiasis.