共查询到19条相似文献,搜索用时 359 毫秒
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目的观察连虎丹烧伤膏连续13周家兔皮肤局部用药的长期毒性。方法取健康家兔36只,雌雄各半,按体重随机分为正常皮肤对照组和连虎丹烧伤膏低(每只5g/d)、高(每只15g/d)剂量组,每周用药7d,连续13周,每天观察动物的外观和行为变化,并于用药13周及停药2周将各组动物耳缘动脉采血,测定其血液学指标(RBC、HB、WBC及分类和PLT)和血清生化指标(AST、ALT、ALP、BUN、Crea、TP、ALB、TBIL、TC、和GLU);然后剖检动物,取其脏器称重,计算脏器系数并取用药部位皮肤进行病理检查。结果连虎丹烧伤膏每只5g/d和15g/d给予正常及破损皮肤家兔13周,动物一般状况良好,外观体征、行为活动、体重增长、血液学、血液生化学及组织病理学检查与对照组比均未见药物所致异常变化。惟破损皮肤家兔经组织病理学检查可见因划伤造成用药部位皮肤复层扁平上皮角化,毛囊稍有增宽,停药2周后基本恢复正常。结论临床应用连虎丹烧伤膏安全,并无长期毒性不良反应。 相似文献
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目的 观察紫连膏经家兔皮肤给药的急性毒性反应及其严重程度,为临床用药提供参考。方法 新西兰家兔24只,随机分为完整皮肤2组和破损皮肤模型2组,即正常对照组、正常紫连膏组、模型对照组和模型紫连膏组,每组6只,雌、雄各半。各组均按经体质量折算的10%家兔体表面积,以50 mg·(cm2)-1的给药面积皮肤涂擦白凡士林和紫连膏[折合以体质量计的总给药剂量为12.50 g·kg-1,单位面积给药剂量为150 mg·(cm2)-1,相当于10%人体表面积拟用剂量的5倍],24 h内给予3次,每次间隔(4.0±0.5) h。给药并连续观察14 d。观察家兔的一般情况、给药局部皮肤刺激性及体质量、体温、血常规、血清生化及电解质,大体解剖观察各脏器的体积、颜色、质地等情况。结果 给药各组家兔一般情况良好,给药局部皮肤无明显刺激,体质量、体温、血常规、血清生化及电解质无异常,主要脏器无异常改变。结论 紫连膏在单次毒性实验最大给药量条件下,家兔未发生刺激和毒性反应。 相似文献
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芦荟冰片烧伤膏的皮肤毒性实验 总被引:1,自引:0,他引:1
目的:考察芦荟冰片烧伤膏的安全性。方法:对健康大鼠皮肤进行急性毒性实验;采用20%甲醛作阳性对照.对健康家兔进行皮肤刺激实验;用健康豚鼠进行皮肤过敏实验。结果:芦荟冰片烧伤膏对健康大鼠完整皮肤和破损皮肤均未引起急性毒性反应,对家兔完整皮肤和破损皮肤无刺激性;且对豚鼠皮肤无致敏作用。结论:芦荟冰片烧伤膏外用安全、无毒。 相似文献
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连虎丹烧伤膏是自1991年起研制并应用于治疗烧伤烫伤的外用新药。为了保证新药的质量,按国家新药研究的有关要求,用正交设计法提取工艺进行了研究。 相似文献
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目的:通过降糖搽剂对皮肤用药的药效学研究以了解它是否优于口服用药以及了解它对局部用药的毒性强弱。方法:按内分泌系统药物药效学指导原则中的胰岛类及降糖药试验方法和局部用药的毒性试验方法进行。结果:降糖搽剂对大鼠和家兔皮肤给药降血糖试验表明:以3.2mg/kg,4.8mg/kg,8mg/kg(临床用量7、10、16倍)给药,对正常大鼠和家兔降血糖用量分别为20%、30%、50%及10%、20%、30%。另外,对大鼠和家兔糖耐量试验表明:以3.2mg/kg的对大鼠和家兔糖耐量都没有降低的作用。毒性作用测定结果表明:本品对家兔皮肤急性毒性不引起动物死亡,对豚鼠不致敏,对家兔皮肤无刺激作用。结论:降糖搽剂对大鼠和家兔皮肤用药的药效学作用比口服用药的药效学作用强。 相似文献
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复方生肌膏的毒理学研究 总被引:1,自引:0,他引:1
目的:观察动物对复方生肌膏的急性毒性反应.方法:①皮肤正常及破损的家兔各16只随机平均分为4组,观察复方生肌膏的皮肤急性毒性反应;②家兔10只随机平均分为2组,观察复方生肌膏对家兔完整及破损皮肤的刺激反应;③豚鼠30只随机平均分为4组,观察复方生肌膏的皮肤过敏反应.结果:复方生肌膏对家兔完整及破损皮肤无任何急性毒性反应,也未出现任何刺激反应,豚鼠皮肤也未见过敏反应.结论:复方生肌膏是一个安全无毒的药物. 相似文献
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目的: 研究胡矾口腔膜的安全性为临床安全用药提供科学依据.方法:急性毒性试验:12只家兔分为给药组和对照组,每组6只.给药组将用于制备胡矾口腔膜的浸膏(含苦矾0.14 g/ml)每次10 ml涂于兔下唇与齿龈之间,面积为5 cm×5 cm,每天6次.对照组同法给予相同剂量的赋型剂.给药24 h后观察与记录家兔体重、皮肤、皮毛和黏膜变化,共7 d.口腔黏膜刺激试验:12只家兔分为给药组和对照组,每组6只.给药组家兔口腔黏膜每次涂抹胡矾浸膏(含苦矾0.07 g/ml)0.5 ml, 4 h内涂药8次,共7 d,对照组同法给予同体积的赋型剂.观察口腔黏膜涂药部位的局部反应,并对呼吸道黏膜组织进行病理检查.皮肤刺激试验:16只家兔分为4组--完整皮肤组与对照组,破损皮肤组与对照组,每组4只家兔.2个给药组均于家兔背部去毛皮肤处每次贴胡矾口腔膜7片,2个对照组贴无药的赋型剂膜7片,均1次/d,连续给药7 d.末次给药24 h后,用温水去除残留物,然后于1、24、48、72 h观察皮肤反应.结果:给药组和对照组比较,家兔体重、皮肤、皮毛、黏膜均无异常变化.口腔黏膜涂药第7天,给药组有1只家兔口腔黏膜轻度充血,其余家兔口腔黏膜未见局部反应.组织病理检查示:给药组仅1只家兔鳞状上皮有少量炎性细胞浸润.完整皮肤组和破损皮肤组各有1只家兔于涂药后1 h出现红斑,24 h红斑减轻,48 h消退.结论:胡矾口腔膜是一种较为安全的治疗口腔溃疡的中药制剂. 相似文献
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目的考察盐酸多塞平乳膏(Doxepin H ydrochloride Cream)连续30d家兔皮肤用药的长期毒性。方法40只家兔按体重随机分为4组,以0、25、50、100m g/kg·d,皮肤用药,连续给药30d,每天观察动物的外观和行为活动,并于用药30d及停药14d将各组动物耳动脉采血,测定血液学指标和血液生化指标;然后剖检动物,取其脏器称重,计算脏器系数并进行组织病理学检查。结果盐酸多塞平乳膏3个剂量组对家兔的进食量、行为、体重、脏器系数、血液学、血液生化学及组织病理学检查与对照组比较,均无显著性差异(P>0.05)。结论盐酸多塞平乳膏对家兔安全剂量为100m g/kg·d,为拟定人用安全剂量提供了实验依据。 相似文献
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目的 观察康丽烧伤膏对Ⅱ度烧伤创面的治疗作用。方法 以大白兔制成 18%Ⅱ度烧伤模型 ,观察康丽烧伤膏治疗Ⅱ度烧伤创面的愈合情况以及对肉体组织生长、体重的影响 ,并以麻油作对照。结果 伤后第 10d康丽烧伤膏治疗组有 1只创面愈合 ,第 2 0d ,6只创面愈合 ,占 85 .8% (6 / 7) ,愈合率显著高于对照组 2 8.6 % (2 / 7) ,并有增长体重和促进肉芽组织增生作用 (P <0 .0 5 )。结论 康丽烧伤膏有促进Ⅱ度烧伤创面愈合和增加体重及促进肉芽组织增生作用 相似文献
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目的:观察烧伤膏对烫伤小鼠皮肤组织细胞自由基代谢和DNA损伤的影响,探讨烧伤膏治疗烫伤皮肤的作用机制。方法:将50只小鼠随机分为5组:正常组、模型组,烧伤膏高、中、低剂量组。除正常组和模型组外,烧伤膏实验组小鼠每天外涂烧伤膏治疗,连用15天。治疗结束后,检测各组小鼠皮肤细胞中超氧化物歧化酶(SOD)、过氧化脂质(LPO)和各种自由基浓度,采用单细胞电泳技术检测DNA慧星细胞数和慧星平均尾长。结果:模型组小鼠皮肤细胞中SOD活力明显低于正常组(P<0.01),LPO和自由基浓度均比正常组明显升高(P<0.01)。与正常组相比,模型组小鼠皮肤细胞中慧星细胞数显著上升,DNA慧星平均拖尾明显加长,而应用烧伤膏治疗后,各项实验指标均明显得到改善。结论:烧伤膏可显著提高烫伤小鼠皮肤细胞中抗氧化酶活性,减少脂质过氧化产物和自由基的生成,对烫伤皮肤中DNA损伤有明显的保护效应。 相似文献
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目的研究刘氏烫伤膏对深Ⅱ度烫伤新西兰兔创面治疗作用。方法将新西兰兔麻醉后,采用恒温水浴法复制深Ⅱ度烫伤模型;每只动物采用自身对照法,各有5 个烫伤部位,分别给予生理盐水、5% 磺胺嘧啶锌软膏、刘氏烫伤膏低、中、高剂量;采用透明硫酸纸法比较各组动物烫伤创面愈合率;比较5 个部位创面完全愈合时间;取创缘组织制作病理切片,苏木精-伊红染色,按照组织学标准定量评价,比较各组创面愈合情况。结果在给药后第4,7,10,14,21 和28 天,与阴性对照组比较,阳性对照组、刘氏烫伤膏各剂量组创面愈合率明显提高(P 〈0. 01);创面完全愈合时间缩短(P 〈 0. 05);第7 和21 天各组病理组织切片评分之间无显著性差别(P 〉0.05),但第14 天各组组织病理切片表皮结构、胶原束和皮肤结构、表皮再生、粒细胞浸润评分有显著性差别(P 〈0. 05),阴性对照组评分低于阳性对照组、刘氏烫伤膏各剂量组。结论刘氏烫伤膏可明显提高深Ⅱ度烫伤新西兰兔创面愈合率,缩短创面愈合时间,加速创面愈合。 相似文献
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《International journal of toxicology》2006,25(Z2):121-138
Triethylene Glycol and PEG-4 (polyethylene glycol) are polymers of ethylene oxide alcohol. Triethylene Glycol is a specific three-unit chain, whereas PEG-4 is a polymer with an average of four units, but may contain polymers ranging from two to eight ethylene oxide units. In the same manner, other PEG compounds, e.g., PEG-6, are mixtures and likely contain some Triethylene Glycol and PEG-4. Triethylene Glycol is a fragrance ingredient and viscosity decreasing agent in cosmetic formulations, with a maximum concentration of use of 0.08% in skin-cleansing products. Following oral doses, Triethylene Glycol and its metabolites are excreted primarily in urine, with small amounts released in feces and expired air. With oral LD50 values in rodents from 15 to 22 g/kg, this compound has little acute toxicity. Rats given short term oral doses of 3% in water showed no signs of toxicity, whereas all rats given 10% died by the 12th day of exposure. At levels up to 1 g/m3, rats exposed to aerosolized Triethylene Glycol for 6 h per day for 9 days showed no signs of toxicity. Rats fed a diet containing 4% Triethylene Glycol for 2 years showed no signs of toxicity. There were no treatment-related effects on rats exposed to supersaturated Triethylene Glycol vapor for 13 months nor in rats that consumed 0.533 cc Triethylene Glycol per day in drinking water for 13 months. Triethylene Glycol was not irritating to the skin of rabbits and produced only minimal injury to the eye. In reproductive and developmental toxicity studies in rats and mice, Triethylene Glycol did not produce biologically significant embryotoxicity or teratogenicity. However, some maternal toxicity was seen in dams given 10 ml/kg/day during gestation. Triethylene Glycol was not mutagenic or genotoxic in Ames-type assays, the Chinese hamster ovary mutation assay, and the sister chromatid exchange assays. PEG-4 is a humectant and solvent in cosmetic products, with a maximum concentration of use of 20% in the "other manicuring preparations" product category. This ingredient, with an oral LD50 in rats of 32.77 g/kg, has low acute toxicity. Rats given up to 50,000 ppm PEG-4 in drinking water for 5 days showed no permanent signs of toxicity. Rats given daily oral doses up to 2 g/kg/day of PEG-4 for 33 days showed no signs of toxicity. Undiluted PEG-4 produced only minimal injury to the rabbit eye. PEG-4 was not mutagenic in Ames-type assays, did not induce chromosome aberration in an in vivo bone marrow assay, and was negative for genotoxicity in a dominant lethal assay using rats. Other PEG compounds, which have previously been reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel, e.g., PEG-6, are mixtures that likely include Triethylene Glycol and PEG-4, so these data were also considered. PEG-6 and PEG-8 were not dermal irritants in several rabbit studies. PEG-2 Stearate had a potential for slight irritation in rabbits but was not a sensitizer in guinea pigs. PEG-2 Cocamine was a moderate irritant in rabbits, producing severe erythema. In one dermal study, PEG-2 Cocamine was determined to be corrosive to rabbit skin, causing eschar and necrosis. PEG-6 and PEG-8 caused little to no ocular irritation. PEG-8 was not mutagenic or genotoxic in a Chinese hamster ovary assay, a sister-chromatid exchange assay, and in an unscheduled DNA synthesis assay. In clinical studies on normal skin, PEG-6 and PEG-8 caused mild cases of immediate hypersensitivity; PEG-8 was not a sensitizer; PEG-2 Stearate was not an irritant, a sensitizer, or a photosensitizer; and PEG-6 Stearate was not an irritant or sensitizer. In damaged skin, cases of systemic toxicity and contact dermatitis in burn patients were attributed to a PEG-based topical ointment. The CIR Expert Panel acknowledged the lack of dermal sensitization data for Triethylene Glycol and dermal irritation and sensitization data for PEG-4. That PEG-6, PEG-8, and PEG-2 Stearate were not irritants or sensitizers suggested that Triethylene Glycol and PEG-4 also would not be irritants or sensitizers, and the absence of any reported reactions in the case literature and the professional experience of the Expert Panel further supported the absence of any significant sensitization potential. The need for additional data to demonstrate the safety of PEGs Cocamine was related to the Cocamine moiety and is not relevant here. The Panel reminded formulators of cosmetic products that, as with other PEG compounds, Triethylene Glycol and PEG-4 should not be used on damaged skin because of cases of systemic toxicity and contact dermatitis in burn patients have been attributed to a PEG-based topical ointment. Based on its consideration of the available information, the CIR Expert Panel concluded that Triethylene Glycol and PEG-4 are safe as cosmetic ingredients in the present practices and concentrations of use as described in this safety assessment. 相似文献
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的 研究701 跌打镇痛膏经皮给药急性毒性、皮肤刺激性和过敏性,为其临床应用和推广提供实验依据。 方法 选用新西兰兔和 Hartley 豚鼠为研究对象,分别采用最大耐受量法和同体左右侧对照给药的方法考察701 跌打镇痛膏经皮给药的急性毒性、皮肤刺激性和过敏性。 结果 701 跌打镇痛膏经皮给药后对新西兰兔未见明显毒性反应;对新西兰兔破损皮肤会产生刺激性反应,但此刺激性可于停药后14 d 完全恢复;对新西兰兔完整皮肤也会产生轻度刺激性,但此刺激性是一过性反应;对 Hartley 豚鼠未产生明显过敏反应。 结论 701 跌打镇痛膏具有良好的安全性,经皮单次和多次给药后除轻微的皮肤刺激性外未见其他明显毒性反应,且所产生的皮肤刺激性均为可逆性反应,值得进一步推广应用。 但在临床应用中701 跌打镇痛膏应尽量在损伤局部皮肤无明显破损时使用,尽量避免在破损皮肤上使用,以减少药物对皮肤的刺激性。 相似文献