苦黄栓的制备与刺激性评价
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摘要
[目的]制备中药妇科栓剂苦黄栓,并进行初步刺激性评价。[方法]以融变时限为指标,筛选了水溶性基质与油溶性基质,并进行苦黄栓儿茶的薄层色谱鉴别。以健康雌性SD大鼠为模型动物,考察SUPPOCIRE NAS50基质苦黄栓的大鼠阴道黏膜刺激性。[结果] SUPPOCIRE基质栓剂偏硬,融变时限符合药典规定。S40基质栓剂与PEG1500基质栓剂的融变时限偏长。综合考虑,采用SUPPOCIRE NAS50作为苦黄栓的基质;在与对照品色谱和对照药材色谱相应的位置上,供试品色谱显相同颜色的荧光斑点,阴性无干扰,大鼠阴道解剖前后直观结果与病理切片分析结果表明,SUPPOCIRE NAS50基质苦黄栓给药组与空白组间无显著性差异。[结论]选择SUPPOCIRE NAS50作为苦黄栓的基质;SUPPOCIRE NAS50基质苦黄栓对大鼠阴道黏膜无刺激,安全性好,可用于阴道炎的治疗。
[Objective] To study the preparation and safety of HS Shuan,a gynecological disease preparation.[Methods] Screen matrix of HS Shuan,investigate the effect of different matrix(water soluble matrix and oil soluble matrix)on melting time. Observe and study the irritation to vaginal mucosa of female SD rats. [Results] The melting time of oil soluble matrix prepared suppositories was short,while that of water soluble matrix prepared was long. At last,we choose oil soluble matrix to prepare HS Shuan. HS Shuan prepared by oil soluble matrix had no irritation to vaginal mucosa of female SD rats. [Conclusion] The process is steady to prepare HS Shuan from oil soluble matrix.HS Shuan has no irritation to vaginal mucosa of female SD rats. HS Shuan can be used to treat vaginitis.
[Objective] To study the preparation and safety of HS Shuan,a gynecological disease preparation.[Methods] Screen matrix of HS Shuan,investigate the effect of different matrix(water soluble matrix and oil soluble matrix)on melting time. Observe and study the irritation to vaginal mucosa of female SD rats. [Results] The melting time of oil soluble matrix prepared suppositories was short,while that of water soluble matrix prepared was long. At last,we choose oil soluble matrix to prepare HS Shuan. HS Shuan prepared by oil soluble matrix had no irritation to vaginal mucosa of female SD rats. [Conclusion] The process is steady to prepare HS Shuan from oil soluble matrix.HS Shuan has no irritation to vaginal mucosa of female SD rats. HS Shuan can be used to treat vaginitis.
引文
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[15]刘用国,王江融,李鸣.赛霉安阴道栓对家兔阴道黏膜刺激试验[J].海峡药学,2007,19(4):27-29.
[16]孙志强.苦柏洁阴栓的研制[D].济南:山东中医药大学,2015.
[2]孙翠珍,张雪芬.孕妇患霉菌性阴道炎对新生儿的危害[J].人口战线,1994,8(2):64.
[3]李影.中医治疗阴道炎的临床方案探析[J].中国医药指南,2012,10(26):245-246.
[4]梁卫勇.湿热郁蒸致女性外阴炎、阴道炎发病机制探讨[J].长春中医药大学学报,2012,28(2):198-199.
[5]国家药典委员会.中华人民共和国药典[M].一部.北京:化学工业出版社,2015:1435-1436.
[6]田芳,周红精,王玉柱,等.Nifeviroc微乳热敏原位凝胶对大鼠阴道和阴道细胞的毒性研究[J].毒理学杂志,2013,27(6):447-450.
[7]迟晓娟,朱志杰,张淞,等.治糜康栓的黏膜刺激性研究[J].现代中医药,2013,33(6):88-89.
[8]国家食品药品监督管理局.中药、天然药物刺激性和溶血性研究的技术指导原则[M].北京:人民卫生出版社,2005.
[9]张恒,普俊学,王乙鸿,等.中药栓剂的临床应用及其新剂型[J].安徽医药,2015,9(10):1841-1844.
[10]吴茗玉,张海虹.克霉唑与氟康唑联合治疗复发性念珠菌性阴道炎疗效观察[J].现代中西医结合杂志,2013,22(20):2204-2206.
[11]康玖玉.炎复康栓治疗阴道炎的疗效观察[J].实用妇科内分泌杂志(电子版),2016,3(6):32-33.
[12]王娜梅,崔琳,马春芬,等.苦参凝胶联合氟康唑胶囊治疗霉菌性阴道炎的临床观察[J].中国中药杂志,2015,40(5):978-980.
[13]孙敏哲,赵健铤,李修琴,等.栓剂的研究与应用进展[J].广州化工,2016,44(13):1-3,28.
[14]马慧平,何晓英,葛欣,等.三种不同基质的苯巴比妥栓在家兔体内的药物动力学研究[J].华西药学杂志,1999,14(5-6):349-351.
[15]刘用国,王江融,李鸣.赛霉安阴道栓对家兔阴道黏膜刺激试验[J].海峡药学,2007,19(4):27-29.
[16]孙志强.苦柏洁阴栓的研制[D].济南:山东中医药大学,2015.