一款舒缓凝胶的临床功效评测研究

doi:10.3969/j.issn.1001-1803.2021.04.008

摘要/Abstract

摘要：

对实验室自制的舒缓凝胶进行临床功效测试,评价其舒缓刺激的效果。选择30名18~55岁有效健康志愿者作为研究对象,使用胶带重复撕拉破坏皮肤屏障后,用组胺溶液刺激建立皮肤模型,分别在使用舒缓凝胶15、40、60和90 min后,采集受试者前臂内侧照片和皮肤红斑指数（EI值）,并通过专家评估和自我评估对泛红、红肿、刺痛和瘙痒进行评估。结果显示,自制舒缓凝胶可有效改善皮肤因刺激而产生的泛红和红肿,同时能缓解瘙痒、疼痛和灼热感,其效果显著好于皮肤自身改善效果,说明其对皮肤具有一定的舒缓刺激的功效。

关键词: 舒缓, 临床功效, 凝胶

Abstract:

Self-developed soothing gel was tested on the clinical efficacy and its soothing effect was evaluated. At the inception of the study, 30 healthy volunteers at the age of 18-55 were selected. Their skin barriers had been destroyed by means of repeatedly tearing the adhesive tapes and the skin models was built by the stimulation of histamine solution. Then the medial forearm photos and skin erythema index （EI values） after using the soothing gel for 15, 40, 60 and 90 minutes were collected. The redness, swelling, stinging and itching could be evaluated by expert evaluation and self-evaluation. The results show that the soothing gel can effectively improve the redness and swelling of skin after stimulation. It also relieves itching and pain, and its effect is significantly better than that of skin self-repair. This indicates that soothing repair gel has a certain effect on soothing irritation.

Key words: soothing, clinical efficacy, gel

中图分类号:

TQ658

孙金媛,陈奕齐,赵华. 一款舒缓凝胶的临床功效评测研究[J]. 日用化学工业, 2021, 51(4): 312-318.

SUN Jin-yuan,CHEN Yi-qi,ZHAO Hua. Study on the clinical efficacy of a soothing gel[J]. China Surfactant Detergent & Cosmetics, 2021, 51(4): 312-318.

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参考文献 7

[1]	He Li, Liu Wei. Cosmetic dermatology [M]. Beijing: People’s Medical Publishing House, 2010: 120-123.
[2]	Li Lixian, Gao Ying, Kong Xiangye, et al. Study on preparation and properties of a soothing repair mask[J]. Flavour Fragrance Cosmetics, 2020,6(3) : 33-37.
[3]	Chen Lihao, Jiang Juan. Update of pathogenesis of sensitve skin and related skin diseases[J]. Chinese Journal of Leprosy and Dermatology, 2020,8(36) : 505-508.
[4]	Ou Tingting, Yang Xing, Liang Jiayi. Study on efficacy evaluation method of soothing repair products[J]. Guangdong Chemical, 2020,47(428) : 68-70.
[5]	Ohta M, Hikima R, Ogawa T. Physiological characteristics of sensitive skin classified by stinging test[J]. Journal of Japanese Cosmetic Science Society, 2000,23(6) : 163-167.
[6]	Wang Ruiqi, Zhang Hongyu. Comparative activity of antihistamines on area under dose-response curve from histamine-induced wheal and flare responses in human skin[J]. Acta Academiae Medicinae Sinicae, 2004,26(6) : 634-638.
[7]	Ruan Yan. Making use of the Histamin3-skin-test compared the function of chinese traditional medicine and western medicine[D]. Guangzhou: Guangzhou University of Chinese Medicine, 2005.

相	成分	w/%
A相	乙醇	5
	羟苯基丙酰胺苯甲酸	0.1
	4-叔丁基环己醇	0.5
	红没药醇	0.12
	姜根提取物	0.05
	薄荷脑	0.1
B相	水	92.63
B相	聚丙烯酸酯交联聚合物-6	0.8
C相	苯氧乙醇	0.6
C相	乙基己基甘油	0.1

评估方式	评估要求	评分制	评估项
专家评估	由视感评价师对前臂内侧皮肤泛红、红肿的程度及整体状态进行分级打分	0分-无 1分-轻 2分-中 3分-重	泛红、红肿
自我评估	由受试者对自身皮肤状态进行自我评估	0分-无 1分-轻 2分-中 3分-重	泛红、红肿、刺痛、瘙痒、灼热感

组别	t/min	数据
		退红		消肿
		差值	组间差异	差值	组间差异
空白组	3	0	a	0	a
	8	0	a	0	a
	15	0	b	0	b
	40	0	c	0	c
	60	0	c	0	c
	90	0	c	0	c
阴性对照组	3	-0.01±0.09	a	-0.03±0.08	a
	8	-0.05±0.09	a	-0.1±0.08	a
	15	-0.15±0.09	b	-0.16±0.09	a
	40	-0.51±0.14^**	b	-0.66±0.13^***	b
	60	-0.88±0.15^***	b	-0.93±0.14^***	b
	90	-1.21±0.17^***	b	-1.26±0.14^***	b
实验组	3	-0.16±0.09	a	-0.08±0.11	a
	8	-0.19±0.09^*	a	-0.05±0.12	a
	15	-0.39±0.1^**	a	-0.31±0.15^*	a
	40	-0.98±0.15^***	a	-0.88±0.16^***	a
	60	-1.36±0.15^***	a	-1.25±0.15^***	a
	90	-1.73±0.14^***	a	-1.58±0.15^***	a

组别	t/min	数据
		退红		消肿
		差值	组间差异	差值	组间差异
空白组	3	0	b	0	a
空白组	8	0	c	0	b
空白组	15	0	c	0	b
	40	0	c	0	c
	60	0	c	0	c
	90	0	c	0	c
阴性对照组	3	-0.27±0.14	b	-0.06±0.13	a
	8	-0.30±0.12^*	b	-0.16±0.13	b
	15	-0.30±0.12^*	b	-0.33±0.14^*	b
	40	-0.57±0.12^***	b	-0.73±0.14^***	b
	60	-0.73±0.15^***	b	-0.86±0.13^***	b
	90	-1.17±0.17^***	b	-0.96±0.14^***	b
实验组	3	-0.40±0.13^**	a	-0.33±0.15^*	a
	8	-0.60±0.13^***	a	-0.43±0.16^*	a
	15	-0.77±0.11^***	a	-0.73±0.17^***	a
	40	-1.10±0.14^***	a	-1.27±0.17^***	a
	60	-1.40±0.12^***	a	-1.43±0.16^***	a
	90	-1.74±0.15^***	a	-1.47±0.16^***	a

组别	t/min	数据
		瘙痒		刺痛		灼热感
		差值	组间差异	差值	组间差异	差值	组间差异
空白组	3	0.07±0.05	b	-0.03±0.03	c	0	b
	8	0.04±0.03	b	-0.03±0.03	c	0	b
	15	0.04±0.03	c	0.03±0.03	c	0	b
空白组	40	0	c	0.03±0.03	c	0	c
	60	0	c	0.03±0.03	c	0	c
	90	0	c	0.03±0.03	c	0	c
阴性对照组	3	-0.44±0.19^***	a	-0.44±0.10^***	b	-0.23±0.09	a
	8	-0.64±0.18^*	a	-0.64±0.10^***	b	-0.30±0.09^*	a
	15	-0.80±0.18^**	b	-0.90±0.15^***	b	0^***	a
	40	-0.94±0.19^***	b	-0.87±0.15^***	b	-0.30±0.19^***	b
	60	-0.97±0.18^***	b	-0.97±0.15^***	b	-0.30±0.09^***	b
	90	-1.04±0.18^***	b	-0.97±0.15^***	b	-0.30±0.19^***	b
实验组	3	-0.83±0.20^***	a	-1.04±0.18^***	a	-0.40±0.13^***	a
	8	-1.03±0.19^***	a	-1.17±0.17^***	a	-0.47±0.13^**	a
	15	-1.26±0.19^***	a	-1.40±0.20^***	a	0^***	a
	40	-1.30±0.18^***	a	-1.34±0.18^***	a	-1.47±0.13^***	a
	60	-1.30±0.20^***	a	-1.47±0.20^***	a	-0.47±0.13^***	a
	90	-1.40±0.20^***	a	-1.47±0.20^***	a	-0.47±0.13^***	a