肤痒舒喷剂外用安全性的实验研究
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摘要
目的:通过动物实验观察肤痒舒喷剂外用的安全性。方法:将SPF级SD大鼠随机分为空白组、实验组、对照组,分别进行皮肤的急性毒性实验、皮肤刺激性实验、皮肤过敏性实验。结果:急性毒性实验结果表明,观察组、对照组在皮肤破损用药后7天中除皮毛微红肿外,行为活动、饮食、眼和黏膜、呼吸、体质量、死亡情况等指标与空白组比较,差异无统计学意义(P> 0.05)。皮肤刺激性实验结果表明,完整皮肤的3组大鼠均无红斑、水肿形成,破损皮肤的空白组、实验组大鼠在用药1 h、24 h、48 h、72 h的红斑及水肿分值均低于对照组。主动皮肤过敏实验结果表明,实验组、空白组红斑及水肿分值均低于阳性对照组。结论:肤痒舒喷剂对实验大鼠皮肤无毒无刺激,无致敏现象。
Objective: To observe the safety of the Fuyangshu spray( 肤痒舒喷剂) by animal experiments. Methods: SD rats were randomly divided into the blank group, experimental group and control group; the skin acute toxicity test, skin irritation test and skin allergy test of rats in three group were performed. Results: In acute toxicity test, there was no difference in behavioral activities, diet, eye and mucous membrane, respiration, body weight, and death status between groups(P>0.05), except for the slight redness and swelling of the skin. In skin irritation test, there were no erythema and edema in three groups of intact skin. The erythema and edema scores of the rats in the blank group and the experimental group at 1 hour, 24 hours, 48 hours and 72 hours were lower than the control group. In skin allergy test, the erythema and edema scores in the experimental group and blank group were lower than the positive control group. Conclusion:Itching spray is non-toxic and non-irritating to the skin of experimental rats; and there is no sensitization.
Objective: To observe the safety of the Fuyangshu spray( 肤痒舒喷剂) by animal experiments. Methods: SD rats were randomly divided into the blank group, experimental group and control group; the skin acute toxicity test, skin irritation test and skin allergy test of rats in three group were performed. Results: In acute toxicity test, there was no difference in behavioral activities, diet, eye and mucous membrane, respiration, body weight, and death status between groups(P>0.05), except for the slight redness and swelling of the skin. In skin irritation test, there were no erythema and edema in three groups of intact skin. The erythema and edema scores of the rats in the blank group and the experimental group at 1 hour, 24 hours, 48 hours and 72 hours were lower than the control group. In skin allergy test, the erythema and edema scores in the experimental group and blank group were lower than the positive control group. Conclusion:Itching spray is non-toxic and non-irritating to the skin of experimental rats; and there is no sensitization.
引文
[1]中华人民共和国卫生部药政局.中药新药研究指南(药学,药理学,毒理学)[M].北京:人民卫生出版社,1994:209-212.
[2]张晓东,潘国凤.对中药有效成分和有效部位新药长期毒性试验剂量设计的思考[J].中药新药与临床药理,2007,18(03):244-245.
[3]陈奇.中药药理研究方法学[M].北京:人民卫生出版社,1993:164-165.
[4]刘强,周莉玲,刘莉.论“中药皮肤药动学”的构建[J].中国实验方剂学杂志,2011,17(05):242-245.
[5]张玉琴,李树君,贾育蓉,等.肤痒舒擦剂治疗瘙痒性皮肤病356例[J].西部中医药,2011,8(06):79-80.
[2]张晓东,潘国凤.对中药有效成分和有效部位新药长期毒性试验剂量设计的思考[J].中药新药与临床药理,2007,18(03):244-245.
[3]陈奇.中药药理研究方法学[M].北京:人民卫生出版社,1993:164-165.
[4]刘强,周莉玲,刘莉.论“中药皮肤药动学”的构建[J].中国实验方剂学杂志,2011,17(05):242-245.
[5]张玉琴,李树君,贾育蓉,等.肤痒舒擦剂治疗瘙痒性皮肤病356例[J].西部中医药,2011,8(06):79-80.