复方环丙沙星烧伤凝胶抗菌作用与毒理学研究

目的观察复方环丙沙星烧伤凝胶的体外抗菌作用及对皮肤的毒性反应。方法采用试管双倍稀释法测定复方环丙沙星烧伤凝胶对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌的最低抑菌浓度（MIC）；豚鼠皮肤急性毒性实验、家兔皮肤刺激性实验及豚鼠皮肤过敏实验评价其安全性。结果复方环丙沙星烧伤凝胶对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌均有明显抑制作用，MIC分别为0.125 0，0.015 6和0.125 0 mg• mL－1；对豚鼠无明显急性毒性和致敏作用，未见其对家兔完整皮肤和破损皮肤有明显刺激作用。结论复方环丙沙星烧伤凝胶抗菌作用强，皮肤外用安全。     

薄荷脑鼻腔原位凝胶剂的制备及安全性研究

目的 制备薄荷脑鼻用原位凝胶剂,并对其进行安全性考察。方法 采用去乙酰结冷胶为材料制备离子敏感性原位凝胶。考察鼻腔原位凝胶对蟾蜍鼻黏膜纤毛的毒性及大鼠鼻黏膜的影响;并进行家兔皮肤刺激实验和豚鼠皮肤过敏实验,观察皮肤反应并评分。结果 薄荷脑鼻用原位凝胶剂对蟾蜍鼻黏膜纤毛无显著毒性,对大鼠鼻黏膜形态及细胞分化无显著影响;对家兔完整皮肤无刺激作用,豚鼠皮肤无过敏反应。结论 薄荷脑鼻用原位凝胶剂具有制备工艺简便、纤毛毒性低、生理相容性好的优点,开发为经鼻给药系统可行性良好。     

牛眼透明质酸的毒性评价

目的对牛眼透明质酸的毒性进行评价。方法按照国家化妆品安全性评价程序和方法研究牛眼透明质酸对豚鼠皮肤和小鼠灌胃的急性毒性 ,对家兔皮肤和眼睛的刺激性 ,豚鼠的皮肤变态反应。结果对豚鼠经皮给药的LD50 >2 g/kg ,小鼠灌胃LD50 >10 g/kg ,对家兔眼及皮肤无刺激性 ,对豚鼠无变态反应 ,但有累积性致敏反应。结论牛眼透明质酸钠毒性及刺激性甚微 ,对皮肤的累积致敏反应可能与SO4 2 -有关。     

双氯芬酸二乙胺凝胶的体外透皮扩散研究

目的:制备双氯芬酸二乙胺凝胶并考察其释药影响因素。方法:采用正交试验,对双氯芬酸二乙胺凝胶进行体外透皮试验,以透皮扩散速率常数为考察指标。结果:双氯芬酸二乙胺凝胶的处方中异丙醇浓度为15%,丙二醇为10%,卡泊姆934为0.5%时,药物的透皮扩散速率最快。结论:卡泊姆934的浓度为影响透皮扩散的主要因素。     

复方双氯芬酸辣椒凝胶贴膏的质量控制及体外透皮

目的:建立复方双氯芬酸辣椒凝胶贴膏质量控制方法,并考察其体外透皮效果。方法:以HPLC法测定主药双氯芬酸二乙胺和辣椒素的含量,并测定凝胶膏剂含膏量、粘接性能、重量差异等指标;同时对其小鼠离体皮肤透皮特性进行了测试。结果:建立的HPLC法可同时测定双氯芬酸和辣椒素含量,双氯芬酸(以钠盐计)和辣椒素分别在25～800 mg.L-1和0.5～16.0mg.L-1内线性关系良好,平均加样回收率分别为98.49%和98.37%。小鼠透皮实验中,与市售扶他林乳胶剂相比,本凝胶膏剂中双氯芬酸二乙胺释放较慢,但24 h累积透皮量与扶他林近似;与市售好及施贴片相比,本凝胶贴膏中辣椒素释放较快和较多。结论:建立的方法可用于复方双氯芬酸辣椒凝胶贴膏的质量控制,其体外透皮效果良好,为开发凝胶膏剂新产品提供了实验依据。     

马应龙麝香痔疮栓的临床前安全性评价

目的评价马应龙麝香痔疮栓安全性。方法根据《中药新药研究指南》进行家兔急性毒性实验、家兔直肠刺激性实验、家兔皮肤刺激性实验和豚鼠皮肤过敏实验。结果未见急性毒性反应，直肠给药未观察到明显刺激作用，皮肤给药未观察到明显刺激作用，豚鼠皮肤未见明显致敏反应。结论马应龙麝香痔疮栓是一种较安全的药物。     

菌癣灵乳膏的制备和皮肤变态反应及刺激性实验

目的：制备菌癣灵乳膏剂并考察其外用的安全性。方法：拟订菌癣灵乳膏剂处方与制备工艺。进行家兔完整与破损皮肤接触后产生的皮肤刺激性实验，豚鼠皮肤变态反应实验。结果：该乳膏剂白色、细腻、均匀、涂展性强。家兔完整皮肤、破损皮肤涂药后未发现明显红斑和水肿反应，未出现皮肤局部刺激反应。豚鼠皮肤变态反应实验结果显示：给药6～72 h未见红斑和水肿。结论：菌癣灵乳膏剂处方合理，制备工艺可靠。经动物实验证实，该药无皮肤变态反应性和刺激性，为临床应用提供了可靠的安全性保证。     

田七增发素对动物皮肤毛发生长的影响

目的：观察田七增发素的生发作用。方法：采用大鼠、豚鼠、家兔及小鼠的皮肤温度改变实验，皮肤刺激实验，过敏实验，动物体毛生长实验及光敏实验方法进行。结果和结论：田七增发素对大鼠有促进体毛生长的作用（P＜0．05），无致光敏作用，豚鼠皮肤过敏实验阴性，有使大鼠皮肤温度升高的作用，对大鼠皮肤有一定的刺激性，对家兔无皮肤刺激作用。     

祛痘新肤乳的皮肤毒性实验

目的 考察祛痘新肤乳的安全性. 方法 对健康SD大鼠皮肤进行急性毒性实验; 对健康新西兰兔进行皮肤刺激实验; 用健康豚鼠进行皮肤变态反应实验. 结果祛痘新肤乳对健康大鼠完整皮肤和破损皮肤均未引起急性毒性反应, 对家兔完整皮肤无刺激性, 对破损皮肤有轻微刺激性; 且对豚鼠皮肤无致敏作用. 结论祛痘新肤乳外用安全、无毒.     

碳糊电极阳极吸附伏安法测定雷贝拉唑

目的:考察乳癖消巴布膏皮肤用药的安全性.方法:用健康家兔分别进行完整与破损皮肤的皮肤刺激性试验;用健康豚鼠进行皮肤过敏试验;用健康大鼠进行慢性经皮毒性试验.结果与结论:乳癖消巴布膏对家兔无皮肤刺激性.对豚鼠无致敏性,对大鼠无经皮毒性.     

伤必止的皮肤毒性实验研究

目的研究伤必止对动物皮肤的毒性作用。方法对健康家兔进行皮肤急性毒性实验、皮肤刺激性实验,对健康豚鼠进行皮肤过敏实验。结果伤必止对家兔完整及破损皮肤均未引起急性毒性反应和刺激反应,对豚鼠无致敏作用。结论伤必止应用于临床安全、无毒。     

伤疡愈软膏皮肤毒性实验研究

目的 :考察伤疡愈软膏对动物皮肤的毒性作用。方法 :对健康家兔进行皮肤急性毒性实验、皮肤刺激性实验 ;对健康豚鼠进行皮肤过敏实验。结果 :伤疡愈软膏对家兔完整皮肤和破损皮肤均未引起急性毒性反应和刺激反应 ;对豚鼠完整皮肤无致敏作用。结论 :伤疡愈软膏用于临床安全、无毒。     

四物消风洗剂临床用量的安全性评价

目的　通过临床前毒理学试验———急性皮肤毒性试验 (限量试验 )和过敏试验 (限量试验 )考察四物消风洗剂临床用量的安全性。方法　①对健康家兔进行皮肤急性毒性试验 ;②对健康豚鼠进行皮肤过敏性试验。结果　四物消风洗剂对家兔皮肤未引起急性毒性反应和刺激反应。对豚鼠完整皮肤无致敏作用。结论　四物消风洗剂用于临床安全、无毒     

甲磺酸帕珠沙星搽剂皮肤用药安全性实验

目的：对甲磺酸帕珠沙星搽剂进行皮肤急性毒性试验、皮肤刺激性试验及皮肤过敏性试验,以考察其皮肤用药安全性。方法：将甲磺酸帕珠沙星搽剂涂抹于家兔背部完整或破损区脱毛皮肤,观察给药后动物局部皮肤红斑及水肿等急性毒性和刺激性情况。采用致敏与激发接触甲磺酸帕珠沙星搽剂,观察豚鼠过敏反应。结果：甲磺酸帕珠沙星搽剂对家兔完整或破损皮肤无明显局部毒性或局部刺激性。对豚鼠皮肤无过敏反应。结论：甲磺酸帕珠沙星搽剂短期皮肤用药是安全的。     

鬼二白凝胶的制备及安全性评价

摘 要 目的：制备鬼二白凝胶,并进行安全性试验。方法: 将处方药材经回流提取、浓缩、干燥、粉碎制成干粉,溶于乙醇后加入丙二醇,混入调制好的卡波姆,制成凝胶剂;分别对进行大鼠皮肤急性毒性、豚鼠皮肤刺激性、豚鼠皮肤过敏性及大鼠长期毒性试验,观察大鼠一般情况及体质量,并检测大鼠血液生化情况和心、脑、肝、肾变化情况。结果: 皮肤急性毒性试验中,大鼠完整皮肤及破损皮肤均未出现红斑及水肿;豚鼠皮肤刺激性试验中,仅破损皮肤组出现轻度红斑及水肿,完整皮肤组未出现异常情况;豚鼠皮肤过敏性试验中,仅高剂量组产生轻微过敏反应,其他组豚鼠均正常;长期毒性试验中,仅高剂量组大鼠血液生化指标有一定影响,停药14 d后均恢复正常。结论: 鬼二白凝胶临床剂量用于大鼠及豚鼠皮肤安全性良好。     

伤必止的药效学和毒理学研究

目的:研究伤必止的药效学和毒理学。方法:采用热板法、扭体法、二甲苯致炎法及镜下观察小鼠耳廓微循环法研究伤必止的镇痛、抗炎、活血化淤作用;对健康家兔进行急性毒性试验、长期毒性试验、皮肤刺激性试验;对健康豚鼠进行皮肤过敏试验。结果:伤必止可提高小鼠痛阈,明显减少其扭体反应次数,抑制二甲苯所致的小鼠耳廓肿胀,使其中央静脉血管口径增大;对家兔完整及破损皮肤均未引起急性毒性反应和刺激反应,对家兔皮肤长期应用无毒性反应;对豚鼠无致敏作用。结论:伤必止具有较好的抗炎、镇痛、活血化淤作用,且安全无毒。     

Dermal toxicity,eye and dermal irritation and skin sensitization evaluation of a new formulation of Bacillus thuringiensis var israelensis SH-14

Bacillus thuringiensis (Bt) is the best known and most widely used of all pesticidal microbes. The aim of this study was to assess the toxicity of a new formulation of Bacillus thuringiensis var israelensis SH-14 in rats through acute dermal toxicity, dermal and eye irritation experiments. The acute dermal toxicity and dermal and eye irritation studies were performed using rabbits according to the United States Environmental Protection Agency guidelines 885.3100, 870.2500 and 870.2500, respectively. The skin sensitization study was carried out in accordance to the EPA OPPTS 870.2600 using guinea pigs. There was no mortality and no evidence of treatment-related toxicity in acute dermal toxicity test. No dermal responses, including erythema/eschar or edema, were found in rabbits treated with the new formulation of Bti SH-14. Minimum response was observed after eye application of test substance. No skin sensitization reactions were observed after the challenge with the new formulation of Bti SH-14 in the Bti SH-14-treated guinea pigs. In summary, the present study demonstrated that the new formulation of Bti SH-14 is not acutely toxic via dermal route, has low eye irritation and would not cause dermal irritation or hypersensitivity to tested animals.     

复方镰形棘豆凝胶剂的皮肤安全性评价

目的:制备一种外用复方镰形棘豆凝胶剂,并对其皮肤用药的安全性进行评价。方法:选用壳聚糖为凝胶基质制备复方镰形棘豆凝胶剂;用复方镰形棘豆凝胶剂考察豚鼠皮肤致敏性、家兔皮肤刺激试验、急性毒性试验和30 d 长期毒性试验。结果:复方镰形棘豆凝胶剂对豚鼠无致敏性,对家兔完整皮肤及破损皮肤无刺激;急性毒性试验中家兔体质量变化无差异,未见死亡及中毒反应发生;家兔连续给药30 d 后凝胶剂低中高剂量组对家兔的一般情况、体质量、脏器系数及病理组织、血液学指标、血液生化学指标均无明显影响,恢复期亦无延迟性毒性反应。结论:制备的复方镰形棘豆凝胶剂是一种安全性较高的外用制剂。     

Acute toxicity, subchronic dermal toxicity, and delayed contact sensitization evaluations of dicyclopentenyloxyethyl methacrylate in rabbits and guinea pigs

The subchronic dermal toxicity of dicyclopentenyloxethyl methacrylate (DPOMA) was evaluated in young adult New Zealand White rabbits, and its potential to produce delayed contact sensitization was evaluated in Harley guinea pigs by a modified Buehler's closed patch technique. In addition, studies were conducted to evaluate the acute systemic toxicity of DPOMA in rats (oral) and rabbits (dermal), and its eye and skin irritancy in rabbits. In the subchronic dermal toxicity study, 4 groups of rabbits were treated percutaneously with DPOMA at 0 (acetone), 10, 107, and 1067 (undiluted) mg/kg X day in a volume of 1 ml/kg, over a 4-wk period. The application sites were unoccluded. No deaths occurred, and no signs of systemic toxicity were observed. No treatment-related effects were seen on body weights, hematology, clinical chemistry, urinalysis, organ weights, or histopathology (except the treated skin). The only treatment-related effect was slight to moderate skin irritation in the mid- and high-dose groups. The severity of skin irritaton was dependent on the number of applications and the concentration of DPOMA. Maximal skin irritation occurred after 1 wk. No skin irritation was seen in the control and low-dose group. In the DCS study, guinea pigs received 6 induction doses of 0.5 ml 100% DPOMA and were challenged with 0.5 ml of 50% (w/v) DPOMA in acetone 2 wk after the last induction treatment. No erythema or edema was observed in any of the challenged guinea pigs in either the treated and control groups. These acute toxicity studies indicate that DPOMA is practically nontoxic by a single exposure via both oral and dermal routes (the oral LD50 in rat and dermal LD50 in rabbits were greater than 5.0 g/kg body weight), slightly irritating to the skin, and inconsequentially irritating to the eyes. The no-observed-effect level (NOEL) for systemic toxicity of DPOMA applied repeatedly to rabbits skin is at least 1067 mg/kg X d. DPOMA is not a strong or moderate skin sensitizer in guinea pigs.     

Ketoprofen: experimental overview of dermal toxicity

Ketoprofen (KP) is a widely used non-steroidal anti-inflammatory drug (NSAID). However, an increasing number of case reports suggest that in broad use, KP can cause allergic dermatitis. Most of these adverse effects have been attributed to the photoallergic potential of KP and photosensitivity. With the exception of a few reports in experimental animals, there is little evidence that KP actually causes dermal toxicity. In this study, in order to investigate the eventual underlying causes of KP dermal toxicity, we conducted primary irritation, skin cumulative, skin sensitization, phototoxicity and photosensitization tests in rodents and rabbits. Primary irritation and skin cumulative testing using New Zealand white rabbits revealed that application of KP (22, 15 and 10%) did not induce erythema or edema formation. Moreover, in skin sensitization and skin phototoxicity testing, using Hartley albino guinea pigs, there was no evidence of allergic or phototoxic potential. In the photosensitization test, KP induced skin reactions in six of eight guinea pigs with signs of erythema on the application site. Histologically, in photosensitized skin, epidermal hyperplasia, including incremental stratum granulosum, acanthosis, keratinocyte hypertrophy and dermal inflammatory cell infiltration, was observed. In this animal study, no primary irritation, cumulative irritation, skin sensitization or skin phototoxicity was observed with KP treatment. However, we identified photosensitization as the underlying cause of KP dermal toxicity.