妇炎消泡腾片对新西兰兔阴道皮肤和黏膜的刺激性试验研究  

Experimental Study of Fuyanxiao Effervescent Tablets on the Irritation of Vaginal Skin and Mucosa in New Zealand Rabbits

作　　者：黄秋凌 骆永伟[2,3] 姜娟[2] 崇立明[2] 李雷[2] 周杰 周莉[2] 孙祖越[2] 

机构地区：[1]广州白云山中一药业有限公司,广州510000 [2]上海市计划生育科学研究所药理毒理学研究室,中国生育调节药物毒理检测中心,上海200032 [3]复旦大学药学院,上海201203

出　　处：《世界中西医结合杂志》2015年第3期326-329,334,共5页World Journal of Integrated Traditional and Western Medicine

基　　金：十二五"重大新药创制"科技重大专项(2011ZX09301-005);上海市实验动物创新行动计划项目(14140901302)

摘　　要：目的观察妇炎消泡腾片多次阴道内及阴道外周经皮给药对兔阴道黏膜及阴道外周皮肤的局部刺激反应。方法新西兰兔分为赋形剂组、阳性对照组、妇炎消泡腾片低、中和高剂量组。分别经破损阴道外周皮肤和破损阴道黏膜给药,每天1次,共7次。去除药物后1 h、再次贴敷前及末次贴敷后,去除药物后1 h和24 h对动物阴道外周皮肤进行观察及记录红斑及水肿等刺激性症状。给药期结束24 h后,每组新西兰兔剖杀一半进行阴道外周皮肤和阴道黏膜进行病理学检查。余继续观察至14 d进行病理检查。结果妇炎消泡腾片对每组动物的破损阴道外周皮肤刺激性积分均为0;给药期赋形剂组、阳性对照组、高、中和低剂量组阴道黏膜刺激指数分别为0、5.25、0.25、0.58和0,刺激性强度分别为无刺激性、轻度刺激性、无刺激性、无刺激性和无刺激性;恢复期赋形剂组和低剂量组阴道黏膜刺激性平均积分均为0,阳性对照组、高和中剂量组阴道黏膜刺激指数分别为0.83、0.08和0.25,刺激性强度均为无刺激性。结论妇炎消泡腾片低(0.1 g/只)、中(0.15 g/只)和高剂量组(0.2 g/只)对新西兰兔破损阴道外周皮肤均无刺激性;妇炎消泡腾片低(0.6 g/只)、中(1.2g/只)和高剂量组(1.8 g/只),对新西兰兔破损阴道黏膜均无刺激性。Objective To observe the local irritative reaction of vaginal mucosa and vaginal peripheral skin by repeated endovaginal and transdermal drug delivery of fuyanxiao effervescent tablets in rabbits.Methods The New Zealand rabbits were divided into an excipient group,a positive control group,a low-dose fuyanxiao effervescent tablets group,a middle- dose fuyanxiao effervescent tablets group and a high-dose fuyanxiao effervescent tablets group. The drug was delivered via the damaged peripheral vaginal skin and mucosa,once every day,for 7 times totally. The animal peripheral vaginal skin was observed 1 h after drug removal,before re- application and after the last application and 24 h after drug removal. The irritative symptoms such as erythema and edema were recorded. In 24 h at end of drug delivery period,a half of New Zealand rabbits were sacrificed in each group for the pathological examination of peripheral vaginal skin and mucosa. The rest rabbits were kept on observation for the pathological examination till the 14 thday. Results The irritative score induced by fuyanxiao effervescent tablets on the damaged peripheral vaginal skin was 0point in each group. The irritative scores were 0,5. 25,0. 25,0. 58 and 0 in the excipient group,the positive control group,the low- dose fuyanxiao effervescent tablets group,the middle- dose fuyanxiao effervescent tablets group and the high- dose fuyanxiao effervescent tablets group successively,and the irritative intensities were no irritation,mild irritation,no irritation,no irritation and no irritation successively. Conclusion Fuyanxiao effervescent tablets at low dose（ 0. 1 g / rabbit）,middle dose（ 0. 15 g / rabbit） and high dose（ 0. 2 g /rabbit） induces no irritation on the damaged vaginal peripheral skin and those at low dose（ 0. 6 g / rabbit）,middle dose（ 1. 2 g / rabbit） and high dose（ 1. 8 g / rabbit） bring no irritation on the damaged vaginal mucosa in New Zealand rabbits.

关 键 词：妇炎消 阴道泡腾片 阴道黏膜刺激 

分 类 号：R285.6[医药卫生—中药学]