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通过人体单次封闭性斑贴试验对一种新型草本护肤品及其成分进行人体皮肤刺激性研究。

The study of human skin irritation of a novel herbal skin care product and ingredients by human single closed patch testing.

作者信息

Wattanakrai Penpun, Suwanachote Suthida, Kulkollakarn Sutinee, Rajatanavin Natta

机构信息

Division of Dermatology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.

出版信息

J Med Assoc Thai. 2007 Jun;90(6):1116-22.

PMID:17624205
Abstract

BACKGROUND

The Government Pharmaceutical Organization of Thailand (GPO) has developed many products using liposome nanotechnology and Thai herbal extracts.

OBJECTIVE

Evaluate the irritation potential of GPO products on human skin using the single application closed patch test under occlusion. The authors also studied the moisturizing efficacy of a commercial curmin extract cream (GPO curmin cream).

MATERIAL AND METHOD

Thirty-six female volunteers were tested with 12 test materials developed by GPO including liposome, curmin extract: tetrahydrocurcuminoids (THC), and commercial curmin cream. Two and a half percent sodium dodecyl sulfate (SDS) was used as positive control. Standard Finn chambers on Scanpor tape with webril cotton were used as occlusive patch test devices. Cutaneous irritation responses were graded after patch removal and the incidence of irritation compared to the positive control was used for evaluation. Corneometer was used to measure skin hydration before and after application of curmin cream.

RESULTS

All volunteers completed the present study. The skin irritation effects from the test materials were significantly lower (p-value < 0.001, McNemar statistic test) than the positive control. Measurement of skin hydration after twice daily application of GPO curmin cream was significantly higher (p-value < 0.001, paired t-test) than the control skin.

CONCLUSION

The test materials and finished products developed by the GPO are not likely to induce skin irritation under normal conditions of use. Furthermore, twice-daily application of the commercial GPO curmin cream can significantly increase skin hydration.

摘要

背景

泰国政府制药组织(GPO)已利用脂质体纳米技术和泰国草药提取物开发了多种产品。

目的

采用单次应用封闭贴剂试验评估GPO产品对人体皮肤的刺激潜力。作者还研究了一种市售姜黄素提取物乳膏(GPO姜黄素乳膏)的保湿功效。

材料与方法

36名女性志愿者对GPO开发的12种测试材料进行了测试,包括脂质体、姜黄素提取物:四氢姜黄素类化合物(THC)和市售姜黄素乳膏。2.5%的十二烷基硫酸钠(SDS)用作阳性对照。带有网眼棉的Scanpor胶带上的标准芬兰小室用作封闭贴剂试验装置。去除贴剂后对皮肤刺激反应进行分级,并将与阳性对照相比的刺激发生率用于评估。使用角质层水合测定仪测量姜黄素乳膏应用前后的皮肤水合作用。

结果

所有志愿者均完成了本研究。测试材料对皮肤的刺激作用明显低于阳性对照(p值<0.001,McNemar统计检验)。每天两次应用GPO姜黄素乳膏后皮肤水合作用的测量值明显高于对照皮肤(p值<0.001,配对t检验)。

结论

GPO开发的测试材料和成品在正常使用条件下不太可能引起皮肤刺激。此外,每天两次应用市售GPO姜黄素乳膏可显著增加皮肤水合作用。

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