CN104127535B - 一种治疗干眼症的药物组合物及其应用 - Google Patents

一种治疗干眼症的药物组合物及其应用 Download PDF

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CN104127535B
CN104127535B CN201410412545.3A CN201410412545A CN104127535B CN 104127535 B CN104127535 B CN 104127535B CN 201410412545 A CN201410412545 A CN 201410412545A CN 104127535 B CN104127535 B CN 104127535B
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姜良柱
邱世彦
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Nantong Qiwu Agricultural Products Co ltd
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Abstract

本发明公开了一种治疗干眼症的药物组合物及其应用，该药物组合物由如下重量份的中药材作为原料经水提醇沉法制备而成：银杏叶21-30份、鬼针草21-30份、余甘子32-46份、桑叶21-30份、金樱子8-13份。该药物具有滋阴润燥、养血明目之功，使神水滋生，目得以滋润濡养，目珠润滑。

Description

一种治疗干眼症的药物组合物及其应用
技术领域
本发明属于中医药技术领域，具体涉及一种治疗干眼症的药物组合物及其应用。
背景技术
干眼症又称眼干燥症，是指角膜前泪液成分缺乏或分布异常，导致泪液减少、眼球表面干燥的一种常见病症，以眼部干涩不适、异物感、灼热感等为主要表现，可导致角膜表面磨损、炎症甚至溃疡，最终影响视力。
西医认为，眼干燥症主要与用眼过度、免疫炎症反应、滥用抗生素以及年龄等因素有关。西医治疗眼干燥症的主要方法是局部使用模仿人体泪液理化特性的人工泪液，以刺激泪液分泌，增加眼表湿度，提高角膜润滑度，从而缓解眼部干涩、灼热感等不适症状。新泪然眼水是临床应用最广泛的一种人工泪液，是羟丙甲纤维素2910和右旋糖酐70的复合制剂。其中主要成分羟丙甲纤维素能够提高泪液的黏度，延长泪液黏附于角膜表层的时间，并有助于减少水分的蒸发，从而发挥补充泪液、缓解局部症状的作用。但人工泪液只能缓解局部干涩症状，起不到根治作用，停药后极易复发，因而疗效不甚理想。因此，开发一种疗效好、无复发的中药显得很有必要。
发明内容
本发明的目的在于通过对祖传秘方进行深入研究后，提供一种治疗干眼症的药物组合物及应用。该药物具有滋阴润燥、养血明目之功，使神水滋生，目得以滋润濡养，目珠润滑。
本发明的目的是这样实现的：
一种治疗干眼症的药物组合物，所述的药物组合物由如下重量份的中药材作为原料经水提醇沉法制备而成：银杏叶21-30份、鬼针草21-30份、余甘子32-46份、桑叶21-30份、金樱子8-13份。
优选地，如上所述的治疗干眼症的药物组合物，其由如下重量份的中药材作为原料经水提醇沉法制备而成：银杏叶24-26份、鬼针草24-26份、余甘子37-40份、桑叶24-26份、金樱子9-11份。
在本发明的一个最优选的实施例中，如上所述的治疗干眼症的药物组合物，其由如下重量份的中药材作为原料经水提醇沉法制备而成：银杏叶25份、鬼针草25份、余甘子38份、桑叶25份、金樱子10份。
需要说明的是，本发明的药物组合物在制备时所采用的中药材原料具有如下来源：银杏叶选用银杏科植物银杏GinkgobilobaL．的干燥叶。鬼针草选用菊科植物鬼针草BidensbipinnataL.的干燥全草。余甘子选用大戟科油柑属植物余甘子PhyllanthusemblicaL.的干燥根。桑叶选用桑科植物桑MorusalbaL.的干燥叶。金樱子选用蔷薇科植物金樱子RosalaevigataMichx.的干燥成熟果实。
本发明涉及的治疗干眼症的药物组合物的制备方法包括如下步骤：称取银杏叶21-30份、鬼针草21-30份、余甘子32-46份、桑叶21-30份、金樱子8-13份合并，加水煎煮两次，第一次加水为药材重量的8-12倍量，煎煮1.5-2.5h，第二次加水为药材重量的6-10倍量，煎煮1-2h，合并煎液，减压浓缩至70℃时相对密度为1.10-1.20，加95%(v/v)乙醇使含醇量达70-80%(v/v)，搅拌，静置过夜，过滤，滤液减压浓缩回收乙醇，并继续浓缩至含原生药1-4g/mL，添加防腐剂，分装。
使用方法：分早晚两次使用，每次服药前先取1小瓶药液（规格20mL），加100mL沸水混匀，取厚纸卷成桶状，一端罩住罐口，一端对准双眼，利用热蒸汽熏蒸眼部10-15min，熏完后将汤剂内服。2周为一个疗程，一般用药治疗2-3个疗程。
本发明人通过大量试验研究了该药物组合物对干眼症患者的疗效，试验结果均显示，治疗后泪液分泌量均较治疗前显著增加，泪膜破裂时间均较治疗前显著延长，患者不适症状消失，泪液分泌量增加＞10mm/5min，泪膜破裂时间＞l0s，角膜荧光素染色阴性。因此，本发明还提供了一种制药用途，即：上述原料组合物在制备治疗干眼症的药物中的应用。
本发明的药物组合物治疗眼干燥症临床疗效显著，可有效增加泪液分泌量，延长泪膜破裂时间，具有滋阴润燥、养血明目之功，使神水滋生，目得以滋润濡养，目珠润滑，从根本上达到了治愈干眼症的疗效。
具体实施方式
以下是本发明的具体实施例和临床应用例，对本发明的技术方案和技术效果做进一步作描述，但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例1
称取银杏叶250g、鬼针草250g、余甘子380g、桑叶250g、金樱子100g合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩至含原生药3.5g/mL，添加0.25%的防腐剂山梨酸钾，按20mL/瓶分装。
实施例2
称取银杏叶285g、鬼针草210g、余甘子350g、桑叶220g、金樱子130g合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩至含原生药3.5g/mL，添加0.25%的防腐剂山梨酸钾，按20mL/瓶分装。
实施例3
称取银杏叶220g、鬼针草250g、余甘子460g、桑叶300g、金樱子80g合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.20，加95%(v/v)乙醇使含醇量达80%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩至含原生药3.5g/mL，添加0.25%的防腐剂山梨酸钾，按20mL/瓶分装。
实施例4
经视力、裂隙灯、泪液分泌试验及眼表荧光素染色等检查确诊的干眼症患者54例，均为双眼患病，泪液分泌量＜5mm/5min，临床症状表现为眼干涩不适、异物感、灼热感、畏光、伴视物疲劳、视力减退等。随机将54例(108眼)患者分成试验组及对照组，每组27例(54眼)。试验组男11例，女16例，年龄l8-59岁，平均(41.6±5.9)岁，病程2周-10个月，平均(7.2±2.8)个月；对照组男10例，女17例，年龄18-61岁，平均(42.2±6.3)岁，病程3周-10个月，平均(6.9±2.6)个月。两组患者性别、年龄、病程等基本资料经统计学比较无差异性(P＞0.05)，具有可比性。
对照组患者给予新泪然眼水(美国AlconLaboratories，Inc生产，批准文号：H20090471，5ml/支)点眼治疗，4-6次/d，1~2滴/次。试验组患者给予实施1例制备的中药提取液治疗，分早晚两次使用。每次服药前先1小瓶药液（规格20mL），加100mL沸水混匀，取厚纸卷成桶状，一端罩住罐口，一端对准双眼，利用热蒸汽熏蒸眼部10-15min，熏完后将汤剂内服。两组患者的疗程均为4周。
观察两组患者临床症状变化，两组患者治疗前后行泪液分泌试验及角膜染色，比较两组患者泪液分泌量及泪膜破裂时间。另外，按照如下疗标准进行效评价：
显效：不适症状消失，泪液分泌量增加＞10mm/5min，泪膜破裂时间＞l0s，角膜荧光素染色阴性；
有效：不适症状明显减轻，泪液分泌量增加5-10mm/5min，泪膜破裂时间5-10s，角膜荧光素染色减少；
无效：症状无改善，泪液分泌、角膜荧光素染色无改善。
两组患者临床疗效比较结果显示，试验组显效22眼，有效28眼，总有效率为92.59%，对照组显效9眼，有效28眼，总有效率为68.52%。两组比较，试验组总有效率显著高于对照组，具体数据见表1。
表1试验组和对照组患者临床疗效比较
两组患者治疗前后泪液分泌量及泪膜破裂时间比较结果显示，治疗后泪液分泌量均较治疗前显著增加（P＜0.05或P＜0.01），泪膜破裂时间均较治疗前显著延长(P＜0.01)；另外，试验组泪液分泌量改善程度均优于对照组(P＜0.05)。具体数据见表2。
表2两组患者治疗前后泪液分泌量及泪膜破裂时间比较（n=54）
注：与本组治疗前比较，★ P＜0.05，★★ P＜0.01；与对照组比较，▲ P＜0.05，▲▲ P＜0.01。

Claims (2)

1.一种治疗干眼症的药物组合物，其特征在于由如下重量份的中药材作为原料经水提醇沉法制备而成：银杏叶25份、鬼针草25份、余甘子38份、桑叶25份、金樱子10份。
2.权利要求1所述治疗干眼症的药物组合物在制备治疗干眼症的药物中的应用。
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