CN107432909B - 一种预防和治疗干眼症的中药组合物及其制备方法和用途 - Google Patents
一种预防和治疗干眼症的中药组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明涉及一种预防和治疗干眼症的中药组合物及其制备方法和用途,本发明根据枸杞子滋补肝肾,麦冬泄热生津,滋阴降火,生地清热生津、桑叶凉血明目,黄芩泄实火、除湿热,菊花/野菊花散风清热的功效,并以甘草为使药调和诸药,并依据干眼症发病过程中存在的角膜上皮细胞的破坏与凋亡,从而可能继发角膜感染、角膜溃疡,甚至导致失明的病理过程,有针对性的重用了枸杞子,并添加了人参,筛选出枸杞子与人参的最优用量配比,使得本发明的中药组合物可有效增强泪膜稳定性,增加泪液分泌,并且具有明显的角膜上皮细胞的保护作用,针对干眼症可以标本兼治,有效缓解干眼症的临床症状,减少干眼症患者继发结膜炎、角膜溃疡、失明的比例。
Description
技术领域
本发明属于中医药领域,具体涉及一种预防和治疗干眼症的中药组合物及其制备方法和用途。
背景技术
干眼症(Dry Eye),又称结膜干燥症,是指由于泪液的量或质或流体动力学异常引起的泪膜不稳定或眼表损害,导致眼部不适,视功能障碍的一种疾病,临床表现为干涩感、异物感、烧灼感、视线模糊、视力波动及视疲劳等,对患者的生活已经工作带来较大影响,严重者可引起角膜感染、角膜溃疡,甚至失明。近年来干眼症的发病率逐渐上升,流行病学及临床调查发现在30-40岁人群中干眼症的发病率已经超过20%,而在70岁以上的人群中干眼症的发病率更是超过了35%,干眼症的发病原因多种多样,具体包括年龄、生活环境、眼部疾病,如泪腺相关炎症,服用抗组胺药、阿托品等影响胆碱能神经功能的药物等。由于我国部分地区的大气环境污染问题及我国社会的老龄化,我国干眼症的发病率将继续呈上升趋势。
目前西医针对于干眼症的治疗方法多以对症治疗为主,其中包括:物理治疗、手术治疗、药物治疗等,其中药物治疗包括:服用促进泪液分泌的药物、使用模拟泪液功能的人工泪液等,以上治疗方法虽然可以有效改善干眼症的部分临床症状,但由于干眼症的致病原因多种多样,以上的对症治疗方法仍不能有效治愈干眼症。
中医对于泪液的描述,最早见于《内经》,《素问·宣明五气论篇》记载了“五脏化液,肝为泪”,《灵枢·口问》中也记载了“宗脉感则液道开,液道开故泣涕出焉”,“故上液之道开,则泣,泣不止则液竭,液竭则精不灌,精不灌则目无所见矣”,由以上记载可见,中医认为津、液为维持视觉的重要物质。中医将干眼症首次作为一种疾病“白涩症”提出,见于明代傅仁宇所著的《审视瑶函》,书中记录了白涩症的临床症状包括:“不肿不赤、爽快不得、沙涩昏朦,名曰白涩”。中医认为干眼症的病机关键是肝肾不足,津液亏损,湿热内蕴,治疗多以滋补肝肾、养阴生津、清利湿热为主,如郑静采用杞菊地黄汤加减以补肾益气、滋阴明目,显效18例,有效10例,有效率为82.35%。陈婕采用石斛、当归、枸杞、菊花、茺蔚子、茯苓、凌霄花各10g,生地黄、白芍各15g,山药、决明子各20g等,对于干眼症的改善程度明显大于人工泪液。
虽然中医对于干眼症的治疗取得了较好的疗效,但由于中医对于干眼症的病因病机以肝肾不足,津液亏损,湿热内蕴为主,而角膜上皮细胞的破坏、凋亡与脱落也为干眼症的重要病理过程,目前中医在干眼症的治疗过程中,对于角膜上皮细胞的破坏、凋亡与脱落的关注度仍然不足,从而制约了中医药对于干眼症的治疗效果。
发明内容
本发明的目的是提供一种预防和治疗干眼症的中药组合物。
本发明预防和治疗干眼症的中药组合物由下列重量份数的原料药制成:枸杞10-20份;麦冬10-15份;玄参10-15份;生地10-15份;薄荷5-10份;甘草5-10份;桑叶5-10份;黄芩5-10份;菊花/野菊花5-10份;人参5-10份。
优选的,本发明预防和治疗干眼症的中药组合物由下列重量份数的原料药制成::枸杞15份;麦冬15份;玄参15份;生地15份;薄荷10份;甘草10份;桑叶10份;黄芩10份;菊花/野菊花10份;人参10份。
更优选的,本发明预防和治疗干眼症的中药组合物由下列重量份数的原料药制成枸杞20份;麦冬15份;玄参15份;生地15份;薄荷10份;甘草10份;桑叶10份;黄芩10份;菊花/野菊花10份;人参10份。
本发明的另一目的在于提供一种预防和治疗干眼症的中药组合物的制备方法,所述制备方法包括以下步骤:
(1)备料;
(2)薄荷粉碎后采用水蒸气蒸馏法提取薄荷精油,所得薄荷精油备用;
(3)薄荷提取精油后剩余物与粉碎后的麦冬、玄参、生地、甘草、桑叶、枸杞、人参、黄芩、菊花/野菊花混合,加3-8倍水,煎煮2-3次,每次1-3h,煎煮液过滤后合并备用;
(4)向步骤(3)滤渣中再次加入3-5倍的60%-80%乙醇,减压回流提取2~3次,每次1-2h,提取液过滤后合并备用;
(5)将步骤(3)和步骤(4)的煎煮液与提取液合并,减压浓缩得浸膏;
(6)在步骤(5)所得浸膏中加入步骤(2)所得薄荷精油后混合均匀,制备成相应剂型后即得。
优选的,步骤(3)中加5倍水,煎煮3次,每次1.5h;步骤(4)中加入3倍75%的乙醇,减压回流提取2次,每次1h。
本发明预防和治疗干眼症的中药组合物为口服制剂或外用制剂,优选的所述口服制剂选自:汤剂、片剂、散剂、胶囊剂、颗粒剂等,所述外用制剂选自:熏蒸剂、洗剂、滴眼剂等;更优选的,所述片剂选自:包衣片、咀嚼片、口含片,所述熏蒸剂选自:常温熏蒸剂、热熏蒸剂。
本发明还提供了一种预防和治疗干眼症的保健食品,所述保健食品包含上述中药组合物,所述保健食品优选为茶饮。
本发明还提供了所述中药组合物制备预防和治疗干眼症的药物添加剂的用途,所述药物选自:包衣片、咀嚼片、口含片、胶囊剂等。
本发明还提供了上述中药组合物在制备预防和治疗干眼症的药物、保健品及其添加剂中的用途。
本发明所述中药组合物中各药材的药性及原理如下:
枸杞:味甘,性平,归肝、肾经,有益精明目,滋补肝肾的功效,主治虚劳精亏、腰膝酸痛、视力下降、眩晕耳鸣等。
麦冬:味甘、微苦,性微寒,归胃、肺、心经,有润肺清心、泄热生津的功效,现代药理学研究表明麦冬具有镇静、催眠、抗肿瘤、抗心律失常等功效。
玄参:味甘、苦、咸,性微寒,归脾、胃、肾经,有清热凉血、滋阴降火、解毒散结的功效,主治津伤便秘、目涩昏花。
生地:味甘、苦,性凉,归心、肝、肾经,有清热生津、滋阴养血的功效,主治热风伤阴、热病烦渴、阴虚内热等。
甘草:味甘,性平,归心、肺、脾、胃经,有补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药的功效,主治脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,缓解药物毒性。
桑叶:味苦、甘,性微寒,归肺、肝经,有散风清热、清肺润燥、凉血明目的功效,主治风热感冒、肺热咳嗽、头痛、目赤、眩晕等。
黄芩:味苦,性寒,归心、肺、大肠经,有泄实火、除湿热,止血、安胎的功效,主治壮热烦渴、肺热咳嗽,湿热泻痢、目赤肿痛、痈肿疔疮等。
菊花/野菊花:味苦、甘,性微寒,归肺、肝经,有散风清热、平肝明目、清热解毒的功效,主治风热感冒、肝阳眩晕、目赤昏花、创痈肿痛等。
人参:味甘、味苦,性温、平,归脾、肺、心经,有大补元气、复脉固脱、补脾益肺、生津、安神、益智的功效,主治体虚欲脱、肢冷脉微、内热消渴、惊悸失眠、阳痿宫冷、心力衰竭、久虚不复等。
虽然中医对于干眼症病因病机存在多种不同的理论,其中又以肝肾不足、津液亏损、湿热内蕴为主,但以往中医理论中对于角膜上皮细胞的破坏、凋亡与脱落在干眼症发病过程中的影响的关注较少,而角膜上皮细胞的破坏、凋亡与脱落会导致干眼症患者继发角膜感染、角膜溃疡等,继而可能导致失明等严重的后果,因此,本发明通过多种中药组方的筛选,获得了具有更好滋补肝肾、养阴生津、清利湿热效果的组方,并加入和重用了具有抑制角膜上皮细胞的破坏、凋亡与脱落效果的人参与枸杞,筛选出枸杞与人参的最优配比,从而在取得治疗干眼症的优异效果的同时,还明显减少了干眼症继发疾病的发生,明显提高了中药对于干眼症的预防和治疗效果。
有益效果
1.本发明提供了一种预防和治疗干眼症的中药组合物,标本兼治,以枸杞子为君药,在起到滋补肝肾作用的同时,佐以人参,筛选出枸杞子与人参的最优用量配比,可起到明显的角膜上皮细胞的保护作用,有效减少了干眼症患者继发结膜感染、结膜溃疡、失明的比例,而麦冬泄热生津,滋阴降火,生地清热生津、桑叶凉血明目,黄芩泄实火、除湿热,菊花/野菊花散风清热,为臣药,发挥养阴生津、清利湿热的作用,以甘草为使药以调和诸药,各味中药配伍合理,协同发挥作用,可有效缓解干眼症临床症状,增加泪膜稳定性,增加泪液分泌和角膜上皮细胞的保护作用。
2.本发明中药组合物中枸杞与人参的配伍,发挥角膜上皮细胞保护的协同效果,其中又以枸杞∶人参=2∶1时效果最为显著。
具体实施方式
在下文中更详细地描述了本发明以有助于对本发明的理解。
实施例1:一种预防和治疗干眼症的中药组合物
枸杞20g;麦冬15g;玄参15g;生地15g;薄荷10g;甘草10g;桑叶10g;黄芩10g;菊花/野菊花10g;人参10g。
按照以下方法制备:
(1)备料;
(2)薄荷粉碎后采用水蒸气蒸馏法提取薄荷精油,所得薄荷精油备用;
(3)薄荷提取精油后剩余物与粉碎后的麦冬、玄参、生地、甘草、桑叶、枸杞、人参、黄芩、菊花/野菊花混合,加5倍水,煎煮3次,每次1.5h,煎煮液过滤后合并备用;
(4)向步骤(3)滤渣中再次加入3倍的75%乙醇,减压回流提取2次,每次1h,提取液过滤后合并备用;
(5)将步骤(3)和步骤(4)的煎煮液与提取液合并,减压浓缩得浸膏;
(6)在步骤(5)所得浸膏中加入步骤(2)所得薄荷精油后混合均匀,制备成相应剂型后即得。
实施例2:一种预防和治疗干眼症的中药组合物
枸杞15g;麦冬15g;玄参15g;生地15g;薄荷10g;甘草10g;桑叶10g;黄芩10g;菊花/野菊花10g份;人参10g,按照实施例1所述方法制备得到预防和治疗干眼症的中药组合物。
对比例1:
按照实施例1所述组成和制备方法制备预防和治疗干眼症的中药组合物,其区别在于:不含有人参。
对比例2:
按照实施例1所述组成和制备方法制备预防和治疗干眼症的中药组合物,其区别在于:人参用量为15g。
对比例3:预防和治疗干眼症的中药组合物
枸杞子20g、菊花20g、麦冬20g、黄芪20g、熟地15g、茯苓15g、桑叶15g,按照以下方法制备:
按照以下方法制备:
(1)备料;
(2)枸杞子、菊花、麦冬、黄芪、熟地、茯苓、桑叶粉碎后混合均匀,加5倍水,煎煮3次,每次1.5h,煎煮液过滤后合并备用;
(3)向步骤(2)滤渣中再次加入3倍的75%乙醇,减压回流提取2次,每次1h,提取液过滤后合并备用;
(4)将步骤(2)和步骤(3)的煎煮液与提取液合并,减压浓缩得浸膏制备成相应剂型后即得。
效果例1:本发明中药组合物对干眼症的治疗效果
实验对象:
筛选标准:(1)有干燥感,异物感,烧灼感,疲劳感,不适感,视力波动等主观症状之一和BUT≤5s或Schirmer l试验(物表面麻醉)≤5mm/5min;(2)有干燥感,异物感,烧灼感,疲劳感,不适感,视力波动等主观症状之一和5s<BUT≤10s或5mm/5min<Schirmer l试验结果(物表面麻醉)≤10mm/5min时,同时有角结膜荧光素染色阳性。
排除标准:(1)年龄小于18岁或者大于80岁的患者;(2)眼部急性炎症者,或同时患有眼科其他疾病需要眼部局部点药者(治疗干眼的非人工泪液类的药物亦应排除),以及1年内接受过眼科相关手术者。(3)属于过敏体质者,或明确对治疗相关药物有过敏史的患;(4)同时患有干燥综合征,类风湿关节炎,强直性脊柱炎等全身系统性免疫疾病的患者;(5)患有精神类疾病以及不能配合本病治疗者;(6)患有严重的器质性疾病者,如肿瘤,血液病,严重心脑血管疾病,肝,肾功能不全;(7)妊娠及哺乳期妇女;(8)1个月内接受过与本研究相关疾病治疗及用药者。
研究方法:
筛选干眼症患者60例,其中男性39例,女性21例,平均年龄36±5.24岁,以上患者随机分为5组,每组12例,分别为空白组、本发明组、对照例1-3组,其中空白组每日3次滴加卡波姆滴眼液,每次一滴,本发明组与对照例1-3组分别每日3次服用实施例1、对照例1-3组相应中药制剂,连续服用1个月,观察和对比用药前后各组OSDI,泪膜破裂时间,角膜荧光素染色,Schirmer l试验结果的变化。
检查方法:
(1)OSDI评分:
评分(A)
评分(B)
评分(C)
评分D=A+B+C;
回答的问题总数为E;
OSDI评分=D*25/E。
(2)泪膜破裂时间TFBUT
在结膜穹隆部滴入0.5%的荧光素,嘱患者眨眼以挤出多余的染料。等待两分钟让荧光素弥散,使泪膜和泪河充分染色,嘱患者眨眼一次,之后保持眼睛睁开,裂隙灯下观察患者泪膜,直到出现第一个泪膜破裂点,这段时间称为泪膜破裂时间。
(3)角膜荧光素染色
染色方法同TFBUT,观察点状上皮缺损(Punctate epithelial erosions,PEE),如果看到1-5个PEE,则评分为1,如果看到6-30个PEE,评分为2,大于30个,评分为3。
如果有以下情况,每项加1分:①如果PEE出现在视轴上(角膜中心3mm范围内);②如果角膜上有染料聚积;③如果可见角膜丝状物。
(4)Schirmer l试验
将试纸放在中外1/3处的下睑结膜内,嘱患者闭眼,5分钟后拿开试纸,或如果5分钟内试纸全部浸透,则浸透时拿出。记录试纸被浸透的长度。
4.统计学分析:
应用统计软件SPSS的多因素方差分析模块进行数据分析,P<0.05表示差异有统计学意义。
5.实验结果:
(1)OSDI评分
*与治疗前比较P<0.05;**与治疗前比较P<0.01。
表1实验结果显示,经1个月治疗后各组OSDI均呈现一定程度的下降,其中本发明组下降程度最为明显,其下降幅度超过了空白组的4倍,为对比例3组的近3倍,从而表明本发明中药组合物取得了缓解干眼症临床症状的优异效果,其治疗效果明显优于现有药物,而去掉人参的对比例1组OSDI虽然也呈现了一定程度的降低,且降低幅度仍然高于空白组和对比例3组,但相对于本发明组其降低幅度明显缩小,从而表明了人参的加入在本发明中药组合物治疗干眼症的效果中发挥了重要的作用,但表1实验结果同时也显示了增加人参用量的对比例2组OSDI下降幅度相对于本发明组却呈现了一定程度的减少,该实验结果表明了仅当含有特定比例的人参时本发明中药组合物才具有优异的治疗干眼症的效果。
(2)泪膜破裂时间TFBUT
表2的实验结果显示了本发明组泪膜破裂时间明显延长,表明本发明中药物组合物具有优异的保持泪膜稳定的效果,而去掉人参的对比例1组以及增加人参用量的对比例2组泪膜破裂时间的延长幅度均呈现了一定程度的缩小,因此,表2实验结果也显示了仅包含特定比例人参的中药组合物才能发挥更好的保持泪膜稳定的效果。
*与治疗前比较P<0.05。
(3)角膜荧光素染色
表3的实验结果显示了空白组与对比例3组患者治疗后角膜荧光素染色评分明显增高,表明了卡波姆滴眼液对于干眼症患者角膜上皮细胞不具有保护作用,治疗一个月后角膜上皮细胞的破坏加重,而本发明组患者治疗后角膜荧光素染色评分呈现出明显降低,从而表明了本发明中药组合物对于干眼症患者的角膜破坏具有明显的保护和治疗效果,而去掉人参的对比例1组在治疗后角膜荧光素染色评分虽然也呈现了一定程度的降低,但降低幅度明显低于本发明组,从而表明了人参在本发明中药组合物角膜上皮细胞的保护效果中发挥了重要的作用,而增加了人参用量的对比例2组角膜荧光素染色评分的降低程度相对于本发明组也呈现出了一定程度的减小,该实验结果显示了虽然人参在本发明中药组合物角膜上皮细胞的保护效果中发挥了重要的作用,但包含特定比例的人参时本发明中药组合物才具有优异的角膜上皮细胞保护作用。
*与治疗前比较P<0.05;**与治疗前比较P<0.01。
(4)Schirmer l试验
*与治疗前比较P<0.05;**与治疗前比较P<0.01。
表4实验结果显示了治疗后空白组的泪眼分泌量减少,从而表明了卡波姆滴眼液不具有刺激泪液分泌的作用,而本发明组和对比例1-3组则均显示了泪液分泌量的增加,其中本发明组与对比例1-2组泪液分泌增加量差距不明显,但均明显高于对比例3组,从而表明了本发明的中药组合物相对于对比例3中药组合物具有明显更优的刺激泪液分泌的效果。
效果例2:本发明中药组合物对角膜上皮细胞增殖的影响
实验药物:
将本发明实施例1、对比例1-3的中药组合物提取浸膏使用PBS溶液配置成2g生药/mL的混悬液;
实验方法:
收集对数生长期的兔角膜上皮细胞(购于赛百慷上海生物技术股份有限公司),以每孔5×103个的浓度接种于96孔板中,分为5组,依次为空白组、本发明组、对比例1-3组,均使用含10%胎牛血清的DMEM培养基,于37℃、5%CO2的恒温培养箱中培养24h,弃去上清液后加入含10%胎牛血清的DMEM培养基200μL,空白组再加入PBS溶液200μL,本发明组和对比例1-3组再加入相应药物混悬液200μL,继续培养48小时后使用MTT法在酶标仪上测定570nm波长的吸光度值,并计算角膜上皮细胞的增殖率,
其中增殖率=(实验组吸光度值-空白组吸光度值)/空白组吸光度值×100%。
统计学处理:
实验结果:
表5对角膜上皮细胞增殖的影响
*与空白组比较P<0.05;**与空白组比较P<0.01。
表5实验结果显示了本发明中药组合物角膜细胞增殖的促进活性显著高于对比例1-3组,表明了本发明包含特定组成的中药组合物具有显著的促角膜细胞增殖活性。
效果例3:本发明中药组合物对角膜上皮细胞的保护作用
实验药物:
(1)将本发明实施例1、对比例1-3的中药组合物提取浸膏使用PBS溶液配置成2g生药/mL的混悬液;
(2)使用PBS溶液配置10mg/mL的苯扎氯铵溶液。
实验方法:
收集对数生长期的兔角膜上皮细胞(购于赛百慷上海生物技术股份有限公司),以每孔5×103个的浓度接种于96孔板中,分为6组,依次为空白组、模型组、本发明组、对比例1-3组,均使用含10%胎牛血清的DMEM培养基,于37℃、5%CO2的恒温培养箱中培养24h,空白组再加入PBS溶液200μL,模型组先加入PBS溶液100μL,再加入配置的苯扎氯铵溶液100μL,本发明组和对比例1-3组先加入相应药物混悬液100μL,再加入配置的苯扎氯铵溶液100μL,继续培养24小时后使用MTT法在酶标仪上测定570nm波长的吸光度值,并计算角膜上皮细胞的破坏抑制率,
其中破坏抑制率=(实验组吸光度值-模型组吸光度值)/模型组吸光度值×100%。
统计学处理:
实验结果:
表6实验结果显示了模型组角膜上皮细胞吸光度值明显降低,表明使用苯扎氯铵处理后角膜上皮细胞被明显破坏,而对比例3组吸光度值与模型组相当,表明对比例3组中药组合物对于苯扎氯铵对角膜上皮细胞的破坏无保护作用,而本发明组的吸光度值明显高于模型组,甚至还高于未添
表6对角膜上皮细胞破坏的保护作用
*与模型组比较P<0.05;**与模型组比较P<0.01。
加苯扎氯铵的空白组,表明了本发明中药组合物对于苯扎氯铵对角膜上皮细胞的破坏具有显著的保护作用,而去除人参的对比例2组和调整人参用量的对比例3组吸光度值虽然均高于模型组,但均明显低于本发明组,表明了本发明中药组合物中特定含量的人参对于角膜上皮细胞的保护效果发挥了重要的作用,仅包含特定比例人参的本发明中药组合物才具有明显的角膜上皮细胞的破坏保护作用。
以上描述了本发明优选实施方式,然其并非用以限定本发明。本领域技术人员对在此公开的实施方案可进行并不偏离本发明范畴和精神的改进和变化。
Claims (8)
1.一种治疗干眼症的中药组合物,其特征在于由下列重量份数的原料药制成:枸杞10-20份;麦冬10-15份;玄参10-15份;生地10-15份;薄荷5-10份;甘草5-10份;桑叶5-10份;黄芩5-10份;菊花或野菊花5-10份;人参5-10份,其中枸杞:人参=2:1。
2.根据权利要求1所述的治疗干眼症的中药组合物,其特征在于由下列重量份数的原料药制成:枸杞20份;麦冬15份;玄参15份;生地15份;薄荷10份;甘草10份;桑叶10份;黄芩10份;菊花或野菊花10份;人参10份。
3.根据权利要求1-2任一项所述的治疗干眼症的中药组合物,其特征在于所述中药组合物为口服制剂或外用制剂。
4.根据权利要求3所述的治疗干眼症的中药组合物,其特征在于所述口服制剂选自:汤剂、片剂、散剂、胶囊剂、颗粒剂,所述外用制剂选自:熏蒸剂、洗剂、滴眼剂。
5.根据权利要求4所述的治疗干眼症的中药组合物,其特征在于所述片剂选自:包衣片、咀嚼片、口含片。
6.根据权利要求4所述的治疗干眼症的中药组合物,其特征在于所述熏蒸剂选自:常温熏蒸剂、热熏蒸剂。
7.权利要求1-2任一项所述的治疗干眼症的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)备料;
(2)薄荷粉碎后采用水蒸气蒸馏法提取薄荷精油,所得薄荷精油备用;
(3)薄荷提取精油后剩余物与粉碎后的麦冬、玄参、生地、甘草、桑叶、枸杞、人参、黄芩、菊花或野菊花混合,加3-8倍水,煎煮2-3次,每次1-3h,煎煮液过滤后合并备用;
(4)向步骤(3)滤渣中再次加入3-5倍的60%-80%乙醇,减压回流提取2~3次,每次1-2h,提取液过滤后合并备用;
(5)将步骤(3)和步骤(4)的煎煮液与提取液合并,减压浓缩得浸膏;
(6)在步骤(5)所得浸膏中加入步骤(2)所得薄荷精油后混合均匀,制备成相应剂型后即得。
8.权利要求1-2任一项所述的中药组合物在制备治疗干眼症的药物中的用途。
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