CN104383369A - 一种治疗妇科黄褐斑的药物组合物 - Google Patents

一种治疗妇科黄褐斑的药物组合物 Download PDF

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CN104383369A
CN104383369A CN201410740891.4A CN201410740891A CN104383369A CN 104383369 A CN104383369 A CN 104383369A CN 201410740891 A CN201410740891 A CN 201410740891A CN 104383369 A CN104383369 A CN 104383369A
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范旭升
马金环
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Abstract

本发明涉及一种治疗妇科黄褐斑的药物组合物，它包含下列重量份的物质：匐地风毛菊30-50份、猫脚印20-40份、长管假茉莉10-30份、珍珠莲30-50份、粘人花20-50份、麻黄10-30份、鹿耳翎20-50份、荷叶20-50份、旋覆花10-30份、茜草10-30份、望江南10-30份、地骨皮10-30份、春不见20-50份、栀子10-30份、鸡血藤10-20份、剪刀股10-20份、桑寄生10-20份、珍珠风20-30份、猪毛菜20-30份、黄芪20-30份、薏苡仁10-30份、补骨脂10-20份、萹蓄1-20份、鸡内金10-30份、金钱草1510-20份和甘草10-30份。本发明所述的药物组合物互相影响，协同作用，共收肝疏瘀化、美容消斑之效，治疗妇科黄褐斑效果显著，值得临床推广。

Description

一种治疗妇科黄褐斑的药物组合物
技术领域
本发明涉及医药领域，具体来说涉及一种治疗妇科黄褐斑的药物组合物。 
背景技术
妇科黄褐斑中医称为“肝斑”、“焦黑斑”，俗称“蝴蝶斑”。是常见的获得性色素障碍性皮肤病，好发于面部，以中青年女性多见。黄褐斑发病可能与内分泌失调、遗传、药物及化妆品使用、紫外线照射、氧自由基及局部微生态病变等因素有关。皮肤组织学特征为表皮中黑素和色素小体均增加，黑素细胞活性增强。影响患者的生活质量。 
发明内容
本发明的目的是提供一种治疗妇科黄褐斑的药物组合物。 
为了实现本发明的目的，本发明提供一种治疗妇科黄褐斑的药物组合物，它包含下列重量份的物质：匐地风毛菊30-50份、猫脚印20-40份、长管假茉莉10-30份、珍珠莲30-50份、粘人花20-50份、麻黄10-30份、鹿耳翎20-50份、荷叶20-50份、旋覆花10-30份、茜草10-30份、望江南10-30份、地骨皮10-30份、春不见20-50份、栀子10-30份、鸡血藤10-20份、剪刀股10-20份、桑寄生10-20份、珍珠风20-30份、猪毛菜20-30份、黄芪20-30份、薏苡仁10-30份、补骨脂10-20份、萹蓄1-20份、鸡内金10-30份、金钱草1510-20份和甘草10-30份。 
优选地，本发明所述的治疗妇科黄褐斑的药物组合物包含下列重量份的物质：匐地风毛菊40份、猫脚印35份、长管假茉莉25份、珍珠莲40份、粘人花30份、麻黄20份、鹿耳翎30份、荷叶30份、旋覆花20份、茜草25份、望江南25份、地骨皮20份、春不见30 份、栀子25份、鸡血藤15份、剪刀股15份、桑寄生15份、珍珠风25份、猪毛菜25份、黄芪25份、薏苡仁20份、补骨脂15份、萹蓄10份、鸡内金25份、金钱草15份和甘草20份。 
优选地，所述药物组合物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。 
本发明还提供组合物在制备治疗妇科黄褐斑的药物中的用途，所述组合物包含下列重量份的物质：匐地风毛菊30-50份、猫脚印20-40份、长管假茉莉10-30份、珍珠莲30-50份、粘人花20-50份、麻黄10-30份、鹿耳翎20-50份、荷叶20-50份、旋覆花10-30份、茜草10-30份、望江南10-30份、地骨皮10-30份、春不见20-50份、栀子10-30份、鸡血藤10-20份、剪刀股10-20份、桑寄生10-20份、珍珠风20-30份、猪毛菜20-30份、黄芪20-30份、薏苡仁10-30份、补骨脂10-20份、萹蓄1-20份、鸡内金10-30份、金钱草1510-20份和甘草10-30份。 
优选地，所述组合物包含下列重量份的物质：匐地风毛菊40份、猫脚印35份、长管假茉莉25份、珍珠莲40份、粘人花30份、麻黄20份、鹿耳翎30份、荷叶30份、旋覆花20份、茜草25份、望江南25份、地骨皮20份、春不见30份、栀子25份、鸡血藤15份、剪刀股15份、桑寄生15份、珍珠风25份、猪毛菜25份、黄芪25份、薏苡仁20份、补骨脂15份、萹蓄10份、鸡内金25份、金钱草15份和甘草20份。 
优选地，所述药物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。 
目前已公认“整体观念”、“辨证施治”、“复方使用”、“复方配伍用药如用兵”是中医最科学最有效的几大优势，其中“复方配伍用药如用兵”是非常科学的中医药原创理论。中医组方中各药如行兵布阵那样环环相扣的严密配伍，是其优于西药配方的有效手段。中医方剂理论认为，每一方剂，不仅需要根据病因病机选择合适的药物组合物妥善配伍，同时也应该符合方剂的基本结构，即“君、臣、佐、使”的组方 配伍理论，所谓“君、臣、佐、使”的组方配伍，就是其建立在对疾病病机的全方位判断基础上的科学配比。中医用方通过多环节、多靶点整合调节的生物学机制，可以取得比西药更持久、更绿色天然无毒副作用的治疗效果，而这种疗效是建立在上述中医传统原创理论的正确指导之上的，本发明正遵循了这一原则。 
发明人认为黄褐斑是由于肝气郁结、疏泄失职、气滞血瘀于面所致，治宜疏肝解郁、调畅气机、活血化瘀。在本发明的组合物中，匐地风毛菊、猫脚印、长管假茉莉疏肝健脾、调畅气机，为君药；珍珠莲、粘人花、麻黄、鹿耳翎、荷叶、旋覆花、望江南活血化瘀，局部疏通经络，调节面部肌肉收缩，为臣药；茜草、地骨皮、春不见、栀子、鸡血藤、剪刀股、桑寄生、珍珠风、猪毛菜、黄芪、薏苡仁、补骨脂、萹蓄、鸡内金、金钱草行气化瘀，加快血液循环，抑制络氨酸酶的活性，从而抑制皮肤黑色素细胞的生成，为佐药；甘草调和诸药，为使药。 
本发明所述的药物组合物互相影响，协同作用，相辅相成，共奏君臣佐使之功，共收肝疏瘀化、美容消斑之效，治疗妇科黄褐斑效果显著，值得临床推广。 
具体实施方式
下面通过实施例进一步说明本发明。应该理解的是，本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。除非另有说明，否则本发明中的百分数是重量百分数。 
实施例 本发明的汤剂 
称取匐地风毛菊40克、猫脚印35克、长管假茉莉25克、珍珠莲40克、粘人花30克、麻黄20克、鹿耳翎30克、荷叶30克、旋覆花20克、茜草25克、望江南25克、地骨皮20克、春不见30克、栀子25克、鸡血藤15克、剪刀股15克、桑寄生15克、珍珠风25 克、猪毛菜25克、黄芪25克、薏苡仁20克、补骨脂15克、萹蓄10克、鸡内金25克、金钱草15克和甘草20克，粉碎，加入5000毫升水，在装有冷凝管的烧瓶中加热回流3小时，然后过滤，得到滤液1和滤渣1；2)向滤渣1中加入3000毫升水，在装有冷凝管的烧瓶中加热3小时，过滤，得到滤液2和滤渣2；3)向滤渣2中加入1000毫升水，在装有冷凝管的烧瓶中加热1小时，过滤，得到滤液3和滤渣3,；4)合并所述滤液1、滤液2和滤液3，冷却至室温，即得。 
毒性试验 
急性毒性试验：应用NIH小鼠60只，SPF级，雌雄各半，体重17～24g，进行急性毒性试验。小鼠随机分为两组，每组30只，即对照组和给药组，实验前禁食12小时；调整实施例中制备的汤剂，使得浓度为7.35g生药/ml，灌胃，灌胃容积为5ml/kg(即单次给予药物组合物量为36.75g生药/kg)，对照组给予等量生理盐水，一天给药2次，给药间隔时间6小时，给药后连续观察14天，并记录小鼠的毒性反应及死亡数。实验结果表明：与对照组比较，给药后小鼠未见明显差异，实验连续观察14天，小鼠全身状况、饮食、饮水、体重增长均正常。选择处死给药组小鼠，显微镜下检查：心、肝、肺、胃内及胸腺等重要脏器，未见异常改变。小鼠口服灌胃本发明的汤剂LD50>36.75g生药/kg，每日最大给药量为73.5g生药/kg/日。本发明的药物临床用药量为6.15g生药/日/人，成人体重以60kg计，平均用药物组合物量为0.103g生药/kg/日。按体重计：小鼠(平均体重以21g计)口服灌胃本发明的中药的耐受量为临床用量的714倍。因此本发明内服的药物组合物急性毒性低，临床用药安全。 
长期毒性试验：应用SD大鼠，体重200g±10g，雌雄各半。使用实施例中制备的汤剂来进行测试。配制高、中、低三个剂量组，分别为临床用药量的300、150、75倍，用含2重量％阿拉伯树胶的生理盐水1:1混合。采用灌胃给药方式，连续用药16周(1.0ml/100g体 重，每天2次)及停药4周后，结果表明：本发明药物对大鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响，脏器肉眼没有发现异样变化和组织学检查结果表明，用药16周及停药4周后，大鼠各个脏器均无明显改变。说明本发明内服的药物组合物对大鼠长期用药后毒性小，停药后也没有异样反应，应用安全。 
实验例 
一般资料 
选取2013年1月至2014年5月我院收治的妇科黄褐斑患者57例，年龄29-55岁，均为女性，病程3月-1年不等。分为两组，即治疗组29例和对照组28例。两组患者在年龄、症状、病程、病情严重程度等方面均不具有显著性差异(P>0.05)，可以进行对照试验。诊断和辨证标准参照《中医病证诊断疗效标准》(国家中医药管理局.中医病证诊断疗效标准.南京:南京大学出版社，1994；156.)。 
对照组使用丝白祛斑软膏(生产企业：金陵药业股份有限公司浙江天峰制药厂)来治疗，涂于面部及患处，一日2次，每次涂抹5克，配合按摩5分钟。连续治疗10周。 
治疗组口服实施例中制备的汤剂来进行治疗，每日2次，本发明的药物临床用药量为6.15g生药/日/人。连续治疗10周。 
统计学处理 
对两组数据进行片方检验，应用SPSS 13.0软件处理。P<0.05说明两组疗效差异显著，有统计学意义。 
疗效评价标准 
痊愈：黄褐斑消失或不易看出；显效：黄褐斑退50％以上；有效： 黄褐斑变淡，但范围未缩小；无效：黄褐斑仍存，无变化。 
结果 
经过治疗，两组的疗效见下表： 
χ2检验；与对照组比较ΔP＜0.05。 

Claims (6)

1.一种治疗妇科黄褐斑的药物组合物，其特征在于，它包含下列重量份的物质：匐地风毛菊30-50份、猫脚印20-40份、长管假茉莉10-30份、珍珠莲30-50份、粘人花20-50份、麻黄10-30份、鹿耳翎20-50份、荷叶20-50份、旋覆花10-30份、茜草10-30份、望江南10-30份、地骨皮10-30份、春不见20-50份、栀子10-30份、鸡血藤10-20份、剪刀股10-20份、桑寄生10-20份、珍珠风20-30份、猪毛菜20-30份、黄芪20-30份、薏苡仁10-30份、补骨脂10-20份、萹蓄1-20份、鸡内金10-30份、金钱草1510-20份和甘草10-30份。
2.根据权利要求1所述的治疗妇科黄褐斑的药物组合物，其特征在于，它包含下列重量份的物质：匐地风毛菊40份、猫脚印35份、长管假茉莉25份、珍珠莲40份、粘人花30份、麻黄20份、鹿耳翎30份、荷叶30份、旋覆花20份、茜草25份、望江南25份、地骨皮20份、春不见30份、栀子25份、鸡血藤15份、剪刀股15份、桑寄生15份、珍珠风25份、猪毛菜25份、黄芪25份、薏苡仁20份、补骨脂15份、萹蓄10份、鸡内金25份、金钱草15份和甘草20份。
3.根据权利要求1或2所述的治疗妇科黄褐斑的药物组合物，其特征在于，所述药物组合物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
4.组合物在制备治疗妇科黄褐斑的药物中的用途，其特征在于，所述组合物包含下列重量份的物质：匐地风毛菊30-50份、猫脚印20-40份、长管假茉莉10-30份、珍珠莲30-50份、粘人花20-50份、麻黄10-30份、鹿耳翎20-50份、荷叶20-50份、旋覆花10-30份、茜草10-30份、望江南10-30份、地骨皮10-30份、春不见20-50份、栀子10-30份、鸡血藤10-20份、剪刀股10-20份、桑寄生10-20份、珍珠风20-30份、猪毛菜20-30份、黄芪20-30份、薏苡仁10-30份、补骨脂10-20份、萹蓄1-20份、鸡内金10-30份、金钱草1510-20份和甘草10-30份。
5.根据权利要求4所述的用途，其特征在于，所述组合物包含下列重量份的物质：匐地风毛菊40份、猫脚印35份、长管假茉莉25份、珍珠莲40份、粘人花30份、麻黄20份、鹿耳翎30份、荷叶30份、旋覆花20份、茜草25份、望江南25份、地骨皮20份、春不见30份、栀子25份、鸡血藤15份、剪刀股15份、桑寄生15份、珍珠风25份、猪毛菜25份、黄芪25份、薏苡仁20份、补骨脂15份、萹蓄10份、鸡内金25份、金钱草15份和甘草20份。
6.根据权利要求4或5所述的用途，其特征在于，所述药物可以是片剂、分散片、胶囊剂、软胶囊剂或汤剂。
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