目的 通过复方妇科洗液豚鼠皮肤刺激试验、皮肤过敏试验及家兔阴道粘膜刺激试验,对其安全性进行评价。方法 皮肤刺激试验选取皮肤健康完好豚鼠3只,每只豚鼠一侧背部皮肤均匀涂抹复方妇科洗液,另一侧皮肤为空白对照,连续涂抹皮肤14 d,在每次涂抹后24 h观察皮肤局部反应并记录结果;豚鼠过敏试验选取48只豚鼠,随机分为给药组、阴性和阳性对照组,每组16只,雌雄各半,各组给相应药物进行诱导和激发处理后,观察皮肤是否出现过敏反应并计算致敏率;家兔阴道粘膜刺激试验选取成年雌性家兔6只,分为给药组和生理盐水阴性对照组,每组3只,连续给药5 d,末次给药24 h后采用气栓法处死动物取出完整阴道组织进行病理学制片,并于光学显微镜下观察家兔阴道粘膜的组织形态。以上试验均按相关标准对刺激强度进行打分并按评分标准进行评定。结果 皮肤刺激试验结果刺激指数为0;皮肤过敏试验均未观察到过敏反应,致敏率为0%;阴道粘膜刺激试验中肉眼观察未见明显异常,显微镜观察仅个别动物组织出现轻度充血、水肿,其它未见明显异常病理改变,阴道粘膜刺激指数为0.34。以上均按评分标准评价为无刺激。结论 妇科洗液无皮肤刺激,无致敏性,对家兔阴道粘膜无刺激。
Abstract
Objective To evaluate the safety of compound gynecological lotion by using skin irritation test, skin allergy test and vaginal mucosa irritation test. Methods Skin irritation test was used to select 3 healthy skin guinea pigs, the skin of each guinea pig was evenly smeared with compound gynecologic lotion, and the other side of the skin was blank, skin smear was applied for 14d, and observed the skin after 24h of each skin smear. Skin allergy test was used to select 48 healthy skin guinea pigs, which were divided into drug group and two control groups, each group had 16 pigs, half male and half female, then observed the skin and calculated the sensitization rate after the corresponding drug induction and irritation. Vaginal mucosa irritation test was used to select 6 adult female rabbits, which were divided into drug group and control group, each group had 3 rabbits. The rabbit vaginal tissues were taken for pathological observation after continuous administration of 5d and the last dose of 24h. The above tests were all graded and evaluated according to the relevant standards. Results SI of the skin irritation was 0. No anaphylaxis was found in the skin allergy test, and the sensitization rate was 0%. There was no significant abnormality in naked eye observation in vaginal mucosa irritation test, microscopic examination showed only slight congestion and edema in individual animal tissues, no significant abnormal pathological changes were found in the other animals, and SI of vaginal mucosal irritation was 0.34. Conclusion Compound gynecological lotion had no skin irritation, no anaphylaxis, and no irritation to the vaginal mucosa of the rabbit.
关键词
复方妇科洗液 /
皮肤刺激 /
皮肤过敏 /
阴道粘膜刺激 /
安全性评价 /
毒理试验 /
实验研究
Key words
Compound gynecological lotion /
Skin irritation /
Skin allergy /
Vaginal mucosa irritation /
Safety evaluation /
Toxicological test /
Experimental research
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] 中华人民共和国卫生部.消毒技术规范[S].2002:138-144.
[2] 中华人民共和国药典(一部)[S].北京:中国医药科技出版社,2010:287.
[3] 孙洁慧,左进.复方苦参洗剂的止痒作用及其对IL-5,IL-10表达的影响[J].甘肃医药,2013,32(1):19-21.
[4] 钟佳丽,梁丹灵,李丹,等.基于网络药理学观察苦参与蛇床子抗皮肤瘙痒的协同作用机制[J].广州中医药大学学报,2017,34(5):742-752.
[5] 崔玉杰,张春长,陈素良,等.聚六亚甲基双胍复方消毒剂杀菌性能试验观察[J].中国卫生检验杂志,2007,17(8):1499-1501.
[6] 汤佳鹏,金伟,徐丽华,等.不同消毒剂对氦氧饱和潜水舱室杀灭真菌效果研究[J].中国消毒学杂志,2017,34(10):915-918.
[7] 张卓娜,邱天,罗嵩,等.化学消毒剂有效成分应用情况调查[J].中国消毒学杂志,2017,34(10):925-927.
[8] 薛广波.现代消毒学[M].北京:人民军医出版社,2002:466.
[9] Kaminsky M,Willigan DA. pH and the potential irritancy of douche formulations to the vaginal mucosa of the albino rabbit and rat[J].Food Chem Texicol,1982,20(2):193-196.
[10] Kaminsky M, Szivos MM, Brown KR, et al. Comparison of the sensitivity of the vaginal mucous membranes of the albino rabbit and laboratory rat to nonoxynol-9[J].Food Chem Texicol,1985,23(7):705-708.
[11] Costin GE, Raabe HA, Priston R,et al. Vaginal irritation models: the current status of available alternative and in vitro tests[J].Atla-altern Lab Anim,2011,39(4): 317-337.
[12] Eckstein P, Jackson MCN, Millman N,et al. Comparison of vaginal tolerance tests of spermicidal preparations in rabbits and monkeys[J].J Reprod Fertil,1969,20(1):85-93.
PDF(1018 KB)
