Study on skin irritation and allergenicity by indomethacin emulsion
-
摘要: 目的 考察吲哚美辛乳剂的皮肤刺激性和皮肤过敏性,为临床安全用药提供依据。 方法 采用新西兰白兔进行皮肤刺激性实验,分为完整皮肤组和破损皮肤组,每组8只。采用同体左、右侧自身对比法,左侧给予吲哚美辛乳剂0.5 g,右侧给予等量空白乳剂,连续给药14 d。实验期间观察皮肤刺激反应,每组6只于末次给药后72 h处死,取皮肤做组织病理检查,剩余2只于末次给药后14 d取皮肤做病理检查。采用豚鼠进行皮肤过敏实验,于第0、7、14天给予吲哚美辛0.5 g局部诱导,第28天在未给药豚鼠的肋腹部皮肤给予吲哚美辛0.4 g以局部激发。 结果 吲哚美辛乳剂对兔正常皮肤和破损皮肤均有轻微刺激性,但停药后可恢复,对豚鼠皮肤无过敏反应。 结论 吲哚美辛乳剂在临床上不宜长期使用,需重点观察皮肤刺激性。Abstract: Objective Study on skin irritation and allergenicity of indomethacin emulsion, in order to provide theoretical basis for clinical safe medication. Methods New Zealand white rabbits were used to test skin irritation, given 0.5g test substance for 14 days. The skin irritation was observed in the two groups with eight rabbits each during the experiment. Six rabbits in each group were sacrificed 72 hours after the last medication and skin tissues were taken for histopathology examination; and the skin tissues of remaining two rabbits were taken for histopathology examination in 14th day after the last medication. Guinea pigs were used to test skin allergenicity, given 0.5g test substance on day 0, 7, 14 for local induction. On day 28, the animal subjects were given 0.4g test substance on non-administration skin of guinea pigs for local excitation. Results Slight irritation of indomethacin emulsion on normal or damaged skin was observed but it is reversible after withdrawal for rabbits. Sensitization effect on the skin of guinea pig was not found. Conclusion Indomethacin emulsion is not suitable to long-term use clinically, and skin irritation need to pay more attention.
-
Key words:
- indomethacin /
- skin /
- irritation /
- allergenicity
-
[1] Mozafari MR, Omri A. Importance of divalent cations in nanolipoplex gene delivery[J]. J Pharm Sci, 2007, 96(8):1955-1966. [2] Chow TH, Lin YY, Hwang JJ, et al. Diagnostic and therapeutic evaluation of 111 in-vinorelbine-liposomes in a human colorectal carcinoma HT-29/luc-bearing animal model[J]. Nucl Med Biol, 2008, 35(5):623-634. [3] 潘菽浪. 用复方吲哚美辛酊治疗面部化妆品接触性皮炎[J]. 贵阳医学院学报, 2005, 30(3):266 [4] 光红梅, 王庆利, 王海学.解读《药物刺激性、过敏性和溶血性研究技术指导原则》[J].中国新药与临床杂志, 2015, 34(9):700-702 [5] 陈小平, 王志旺,刘彩民, 等. 荣骨定痛膏皮肤刺激性与皮肤过敏性实验研究[J]. 甘肃中医学院学报, 2015,32(3):7-9. [6] 徐叔云,卞如濂,陈修.药理实验方法学[M].3版. 北京:人民卫生出版社, 2002. [7] 路绪文, 康才, 苏芳. 复方吲哚美辛搽剂的研制与临床疗效观察[J]. 中国药业, 2002, 11(7):60-61. [8] 李艳春, 马恩龙, 王敏伟. 4%与1%吲哚美辛乳膏的镇痛抗炎作用比较[J]. 中国医院药学杂志, 2004, 24(10):626-627. [9] 王海为, 李剑勇, 杨亚军, 等. 非甾体抗炎药物研究进展[J]. 动物医学进展, 2011,32(1):77-80.
计量
- 文章访问数: 3365
- HTML全文浏览量: 407
- PDF下载量: 640
- 被引次数: 0