CN102671211A - 一种芒果脂作为透皮促渗剂的应用 - Google Patents
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Abstract
本发明涉及医药材料技术领域，具体公开了一种芒果脂作为透皮促渗剂的应用，尤其是芒果脂作为药物透皮促渗剂的应用。经小鼠皮肤刺激及致敏实验和体外透皮实验证明，芒果脂能够显著增加经皮给药制剂的皮肤透过率，具有较强的透皮促渗作用，其透皮促渗能力显著优于氮酮，且具有低毒性及对皮肤的低刺激等特点，可以作为新的透皮促渗剂使用。
Description
技术领域
本发明涉及医药材料技术领域，具体涉及一种芒果脂作为透皮促渗剂的应用。
背景技术
透皮给药系统(Transdermal Therapeutic System，简称TTS)是指经皮肤给药而起全身治疗作用的控释制剂。TTS系统具有超越一般给药方法的独特优点，可以不经过肝脏的“首过效应”和胃肠道的破坏，提供可预定的和较长的作用时间，维持稳定、持久的血药浓度，减少给药次数，给药方便等。但药物透皮吸收率低是这种给药方法的主要缺点，从而限制了其广泛的应用。因此开发新的有效的透皮促渗剂对于推动透皮给药制剂的发展至关重要。
渗透促进剂(Penetration Enhancer)的研究始于1970年，Zellerbach和Miburn采用二甲亚砜和二甲基乙酰胺促进甾体药物的局部给药获得专利。目前的技术多用添加氮酮(Azone)、丙二醇(PG)等透皮促渗剂来增加药物的穿透性和提高药物的透皮速率。最近研究发现某些天然成份也具有和氮酮相似的促渗作用，由于天然成分的透皮促渗剂具有起效快、效果好、副作用小等优点，因此从天然产物宝库中寻找透皮促渗剂正日益引起人们的重视。
发明内容
本发明的目的在于提供一种芒果脂作为透皮促渗剂的应用，尤其是芒果脂作为药物透皮促渗剂的应用。
芒果是常见的热带水果，具有益胃、止呕、止晕的功效。果肉或以芒果煎水进食，对抑制孕妇作呕也有很好的效果。芒果脂是由芒果果核里提取的油脂成分，对皮肤具有很好的润泽功效。利用GC-MS分析了芒果脂所含的油脂成分，结果显示，芒果脂的6个主要成分及其重量百分含量为：棕榈酸15.235％、油酸78.041％、11-二十碳烯酸0.425％、花生酸4.681％、山俞酸0.674％、木质素酸0.549％。
经小鼠皮肤刺激及致敏实验和体外透皮实验证明，芒果脂能够显著增加经皮给药制剂的皮肤透过率，具有较强的透皮促渗作用，其透皮促渗能力显著优于氮酮，且具有低毒性及对皮肤的低刺激等特点，可以作为新的透皮促渗剂使用。
具体实施方式
实施例芒果脂的透皮促渗作用试验
1、制备试验药品
1.1制备利多卡因霜剂
制备过程为：
(1)制备油相：在10.0g二甲基硅油中加入15.0g液体石蜡、15.0g白油、5.0g芒果脂，搅拌均匀；
(2)制备水相：将1.0g卡波姆ultrez-10溶于100.0g水中，加入5.0g甘油、5.0g PEG-400，搅拌10分钟，加入5.0g利多卡因，最后加入5.0g乳化剂山梨糖醇脂，搅拌10分钟；
(3)将步骤(1)中制备的油相和步骤(2)中制备的水相在70℃的水浴中加热，然后将水相加到油相中，搅拌冷却至室温，用浓度质量分数为15％的NaOH调pH为6.5，制备成霜剂。
1.2制备对照药品
将步骤(1)中的芒果脂用氮酮代替，制备对照药品，制备过程为：
(1)制备油相：在10.0g二甲基硅油中加入15.0g液体石蜡、15.0g白油、5.0g氮酮，搅拌均匀；
(2)制备水相：将1.0g卡波姆ultrez-10溶于100.0g水中，加入5.0g甘油、5.0g PEG-400，搅拌10分钟，加入5.0g利多卡因，最后加入5.0g乳化剂山梨糖醇脂，搅拌10分钟；
(3)将步骤(1)中制备的油相和步骤(2)中制备的水相在70℃的水浴中加热，然后将水相加到油相中，搅拌冷却至室温，用浓度质量分数为15％的NaOH调pH为6.5，制备成霜剂。
2、试验药品的皮肤刺激及致敏实验
取白豚鼠12只，体重(180±30)g，为清洁级(Ⅱ级)。背部两侧剃毛，硫化钠快速脱毛，温水冲干净，待皮肤干燥后，涂抹甘油。24小时后，开始给药。去毛区皮肤无损伤者留作完整皮肤实验组(6只)；去毛区皮肤用针头作多处“井”字形划破，且只限于划破皮肤，不伤及皮下组织，以皮肤上有出血点为度，此种皮肤有损伤的动物留作损伤皮肤实验组(6只)。
每天定时给药3次，所用药物为利多卡因霜剂和对照药品，每只白豚鼠背部一侧涂抹含药霜剂，另一侧对称位置涂抹空白基质。给药面积40×40mm2。连续给药三天后，清洗给药处皮肤，观察皮肤情况。
三天急性皮肤刺激实验显示，各组白豚鼠外观体征、行为活动、进食、排泄均正常。无异常瘙痒行为，所有动物体重增长正常，受药部位皮肤无红斑、无水肿、无色素沉着、无出血点、无皮肤粗糙、无皮肤菲薄，未见白豚鼠出现咳嗽、抽搐等过敏反应。从给药至观察期结束，全部动物情况良好，无一死亡。说明芒果脂对白豚鼠皮肤无刺激，不会致敏。
3、试验药品的体外透皮实验
将体重约为200±20g的SD大鼠按体重麻醉(2.5-3mL/kg的3％戊巴比妥钠)，剪毛后用市售的绿茶脱毛膏进行脱毛，用温水冲净后剥皮修皮，漂洗后备用。
将一称量瓶(d＝50mm)盛满含0.5U/mL肝素(抗凝血，利于保持皮肤活性)和0.01％庆大霉素(防腐)的生理盐水，然后将皮蒙在瓶口，用皮筋扎好，保证无气泡。将0.2g的药均匀涂在皮肤上，所用药物为利多卡因霜剂和对照药品，然后再蒙上一层保鲜膜(防止水分散失)，用皮筋扎好，将其置于37℃恒温水浴中恒速搅拌，然后分别于0.5h、1h、2h、4h、6h取样，每次取样后更换新鲜溶液。所取样品液以10000r·min-1离心5min，用针头过滤器(0.45μm)取上清液0.5mL，用HPLC法测定其中利多卡因浓度。取样时间点的累积透皮量和累积透皮率计算公式如下：
Q＝Cn×V+∑Ci×Vi，
A＝Q/W×100％，
式中Q为累积透皮量，V为接收池内接收液的体积，Ci为第i次至上次取样时接收液中药物浓度，Cn为该次取样收液中药物浓度，Vi为每次取样体积，A为累积透皮率，W为0.2g试验药品中利多卡因的质量。得到的氮酮和芒果脂促渗效果数据见表1所示。
表1 氮酮和芒果脂促渗效果数据
在实验选取的时间段内，氮酮组和芒果脂组对利多卡因的累积透皮量Q分别为794.84μg和1208.7μg，累积透皮率A分别为7.95％和12.8％。实验结果显示，芒果脂能显著提高利多卡因霜剂的透皮渗透能力，芒果脂的透皮促渗能力比氮酮强，且差异具有显著性(P＞0.05)。
通过以上试验证明，芒果脂具有较强的透皮促渗作用，对利多卡因霜剂的透皮促渗效果优于目前公认的透皮促渗剂氮酮，且对皮肤无刺激，不会致敏，可以作为新型的强效透皮促渗剂使用。
Claims (3)
1.一种芒果脂作为透皮促渗剂的应用。
2.根据权利要求1所述的芒果脂作为透皮促渗剂的应用，其特征在于，芒果脂作为药物透皮促渗剂的应用。
3.根据权利要求1或2所述的芒果脂作为透皮促渗剂的应用，其特征在于，芒果脂作为利多卡因膏剂透皮促渗剂的应用。
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| US7420020B2 (en) * | 2004-05-14 | 2008-09-02 | Fuji Xerox Co., Ltd. | Resin particles and producing method thereof, toner for developing electrostatic latent image and producing method thereof, electrostatic latent image developer as well as image forming method |
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