CN106421198A - 一种杞明中药组合物的新用途 - Google Patents
一种杞明中药组合物的新用途 Download PDFInfo
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Abstract
本发明涉及一种杞明中药组合物的新用途,具体涉及该中药组合物在制备治疗干眼症药物中的用途,属于医药技术领域。申请人在对杞明胶囊的临床研究和动物实验中,发现其对于临床上的干眼症具有很好的治疗效果,在药物学研究过程中,申请人通过中药加减味原则在杞明胶囊的处方基础上加入了百合、三七以及石菖蒲后其对干眼症的治疗效果更佳,该中药组合物可以显著改善干眼症新西兰兔的SIT、BUT、荧光素染色分级,因此具有很好的临床应用前景。
Description
技术领域
本发明涉及一种杞明中药组合物的新用途,具体涉及所述中药组合物在制备治疗干眼症药物中的用途,属于医药技术领域。
背景技术
干眼症为临床眼科常见疾病,其是指由于泪液量或质的异常引起泪膜不稳定和眼表面损害,从而导致眼部不适的一类疾病,它是一种常见的眼表疾病,中医称为白涩症。常见主要症状有眼部异物感、干涩感、烧灼感、畏光、视物模糊、易疲劳等症状,目前认为病因与视频终端综合征、环境污染、佩戴角膜接触镜、女性内分泌异常、年龄等因素有关。干眼症患者如果得不到及时治疗会引起角膜混浊、溃疡、视力下降、甚至失明等严重后果。
干眼症的治疗目标是尽可能重建足够质量的泪液膜,以适当治愈形成上皮,重建眼表使之正常化;防止永久性上皮病变、无菌性角膜溃疡和继发性角膜炎等与泪液膜异常有关的严重并发症。完成这些目标依赖于多种途径。如治疗严重睑板腺炎和脂溢性睑炎从而提高脂泪膜的稳定性,局部应用维生素A、粘液溶解剂改善粘液层状况,使用泪液替代、保存、刺激泪液分泌以补充液性泪液膜和降低渗透压。其中局部应用人工泪液替代物是治疗干眼症最广泛的治疗学药征。理想的替代物应具有:良好的耐受性,低表面张力,不含毒性保存剂,接近正常的泪膜电解质成分以及长时间的角结膜驻留时间。由于保存剂引起的药物毒作用造成干眼症加重的假象且解决药物毒作用需停用毒性保存剂几个月时间,使得其药物使用范围受到限制。临床上溴卞环乙胺等药物刺激泪液产生仅适应于对刺激有反应的正常泪腺。由此看出,临床上治疗干眼症的药物仍不能让人满意,研发一种干眼症治疗药物仍然具有重要的现实意义和经济价值。
祖国医学在治疗干眼症方面积累了丰富的临床经验和临床理论,中医辨证论治从整体上改善患者的泪液分泌,抑制泪液的蒸发,达到了较好的效果。杞明胶囊是由西安碑林药业生产的中药制剂,其由枸杞子、菟丝子、女贞子、谷精草、决明子、丹参、川芎等19味中药组成,其具有显著提高淋巴T细胞,增强机体免疫功能,且抗菌、抗炎作用明显,并有降压降血脂,抗血小板聚集,增强巨噬细胞吞噬作用,护肝作用,针对外周白细胞,镇静,对血栓形成、血小板聚集、心脏、血液粘滞度均有影响。
2003年10月29日中国专利公报公开了“一种治疗眼底出血症的中药及其制备方法”,公开号为CN1451422A的专利申请,组成发明所述中成药的各味药物原料的重量配比为:蒲黄65-80份、丹参65-80份、地黄50-70份、墨旱莲50-70份、菊花40-60份、炭黄芩35-50份、决明子35-50份、车前子35-50份、茺蔚子35-50份、女贞子35-50份、夏枯草35-50份、龙胆35-50份、郁金20-40份、木贼35-50份、赤芍20-40份、牡丹皮20-40份、山楂20-40份、当归20-40份、川芎5-15份。
中国发明专利CN1299731C公开了一种治疗眼疾近视,消除视疲劳症状的中药及其制备方法,其处方组成为:枸杞子80-100份、菟丝子50-70份、女贞子50-70份、茺蔚子50-70份、何首乌50-70份、山茱萸50-70份、淫羊藿50-70份、谷精草50-70份、木贼50-70份、决明子50-70份、赤芍50-70份、川芎50-70份、丹参50-70份、黄柏50-70份、牡丹皮50-70份、地黄50-70份、红花50-70份、鸡血藤50-70份、冰片10-30份,其通过毒性实验研究了该中药具有很好的安全性,并且对于近视具有很好的治疗效果。
《杞明胶囊联合复方托吡卡胺治疗儿童近视眼的疗效观察》一文中观察口服杞明胶囊联合复方托吡卡胺点眼治疗儿童近视眼的疗效,结果发现,试验组疗效优于对照组,口服杞明胶囊联合复方托吡卡胺点眼治疗儿童近视眼疗效显著。《杞明胶囊治疗儿童远视性弱视的效果观察》发现杞明胶囊作为辅助治疗方法可以提高中、重度儿童远视性弱视患者的治愈率,且可缩短其治疗时间。
综上,现有技术中杞明胶囊在临床上的适应症为近视,具有较好的治疗效果,但现有技术中未发现其对干眼症具有治疗效果,基于此,特提出本发明。
发明内容
申请人在对杞明胶囊的临床研究和动物实验中,发现其对于临床上的干眼症的具有很好的治疗效果,这引起了申请人的关注,在药物学研究过程中,申请人通过中药加减味原则对杞明胶囊的处方进行了深入研究,开发了一种专门适用于干眼症治疗的中药组合物,基于此特提出本发明。
本发明上述技术效果通过以下技术方案实现:
一种中药组合物在制备治疗干眼症药物中的用途,其中所述的中药组合物的处方组成为:枸杞子90g、菟丝子60g、女贞子60g、茺蔚子60g、何首乌60g、山茱萸60g、淫羊藿60g、谷精草60g、木贼60g、决明子60g、赤芍60g、川芎60g、丹参60g、黄柏60g、牡丹皮60g、地黄60g、红花60g、鸡血藤60g、冰片18g。
在上述处方的基础上,加入百合、三七和石菖蒲后,其对干眼症的治疗效果显著增强,治疗效果明显超出了本领域技术人员的预期。申请人根据组方后对干眼症的治疗效果的增强对处方进行了进一步优选,优选地,所述的中药组合物还含有百合30g、三七25g和石菖蒲20g。或者优选地,所述的中药组合物还含有百合15g、三七15g和石菖蒲20g。
上述所述的药物用途中,所述包含中药组合物的药物制剂为其口服制剂,所述的口服制剂为其片剂、胶囊剂、颗粒剂,糖浆,滴丸剂中的一种,优选为其片剂。所述中药组合物的药物制剂的制备方法均可按照本领域技术人员所熟知的制备工艺制备得到。优选地,所述中药组合物的药物制剂的制备方法包括如下步骤:
除冰片外,牡丹皮、何首乌、黄柏、赤芍粉碎成细粉,其余十四味加水煎煮三次,第一次加8倍量水,浸泡30分钟,煎煮1小时,第二、第三次各加6倍量水,煎煮1小时,合并煎液,滤过,滤液60℃下减压浓缩至相对密度为1.30的稠膏,加入上述药材细粉,混匀,低温干燥,粉碎成细粉,制成颗粒,干燥,冰片研细,加入上述颗粒中,混匀后加入各剂型适宜辅料,按各剂型常规工艺制成片剂、胶囊剂、颗粒剂或滴丸剂。
本发明中药组合物与现有技术相比具有如下有益效果:
1)杞明胶囊为在临床上应用多年用于治疗近视的中药制剂,申请人在实验中发现其具有很好的治疗干眼症的效果,且申请人发现其对于干眼症的治疗效果与杞明中药组合物处方的中药材的用量关系很大,中药材的用量发生变化,其对于干眼症的治疗效果显著下降。
2)在杞明胶囊处方基础上加入百合、三七和石菖蒲后其对于干眼症的治疗效果显著增强,这表明加入的三种中药材与原有处方产生了治疗干眼症方面的协同效果,经过处方优选发现,当加入百合30g、三七25g和石菖蒲20g,或者百合15g、三七15g和石菖蒲20g时,其治疗效果最为优异。
3)杞明胶囊在临床上应用多年,有很好的临床实践经验,其用药安全,使用方便,给无数患者带来福音,本发明发现杞明胶囊的治疗新用途,可以极大地扩展杞明胶囊的临床使用范围,且用药安全性高。
具体实施方式
以下通过具体实施例进一步描述本发明,但所述实施例并不以任何方式限定本发明的专利保护范围。
实施例1本发明用于治疗干眼症的中药组合物
一种中药组合物在制备治疗干眼症药物中的用途,其中所述的中药组合物的处方组成为:枸杞子90g、菟丝子60g、女贞子60g、茺蔚子60g、何首乌60g、山茱萸60g、淫羊藿60g、谷精草60g、木贼60g、决明子60g、赤芍60g、川芎60g、丹参60g、黄柏60g、牡丹皮60g、地黄60g、红花60g、鸡血藤60g、冰片18g。
制备工艺:准确称处方量中药材,除冰片外,牡丹皮、何首乌、黄柏、赤芍粉碎成细粉,其余十四味加水煎煮三次,第一次加8倍量水,浸泡30分钟,煎煮1小时,第二、第三次各加6倍量水,煎煮1小时,合并煎液,滤过,滤液60℃下减压浓缩至相对密度为1.30的稠膏,加入上述药材细粉,混匀,低温干燥,粉碎成细粉,制成颗粒,干燥,冰片研细,加入上述颗粒中,混匀后加入各剂型适宜辅料,按各剂型常规工艺制成片剂、胶囊剂、颗粒剂或滴丸剂。
实施例2本发明用于治疗干眼症的中药组合物
一种中药组合物在制备治疗干眼症药物中的用途,其中所述的中药组合物的处方组成为:枸杞子90g、菟丝子60g、女贞子60g、茺蔚子60g、何首乌60g、山茱萸60g、淫羊藿60g、谷精草60g、木贼60g、决明子60g、赤芍60g、川芎60g、丹参60g、黄柏60g、牡丹皮60g、地黄60g、红花60g、鸡血藤60g、冰片18g、百合30g、三七25g和石菖蒲20g。
制备工艺同实施例1。
实施例3-8本发明用于治疗干眼症的中药组合物
分别按照如下处方比例制备中药组合物的药物制剂,其中除百合、三七和石菖蒲的用量有差别外,其余的处方比例均同实施例2。
表1实施例3-8药物制剂中百合、三七和石菖蒲的用量
处方 | 百合(g) | 三七(g) | 石菖蒲(g) |
实施例3 | 15 | 15 | 20 |
实施例4 | 30 | 20 | 20 |
实施例5 | 45 | 25 | 20 |
实施例6 | 30 | 20 | 30 |
实施例7 | 45 | 25 | 30 |
实施例8 | 15 | 20 | 30 |
实施例9口服本发明中药组合物对干眼症新西兰兔的治疗效果
1.干眼症模型的制作
干眼症模型的制作取健康新西兰白兔,雌雄各半,体重2.0~2.5kg。用3%戊巴比妥钠1.5mL/kg腹腔注射,全身麻醉。在手术显微镜下用纤细电刀直接灼烙睑板腺开口,每个约1s,然后手术摘除瞬膜。造模5周后,观察模型建立情况。
2.方法与给药
将造模成功的兔眼(200眼),雌雄各半,随机分为10个治疗组:中药1组、中药2组、中药3组、中药4组、中药5组、中药6组、中药7组、中药8组、西维美林组、对照组,每组20眼,其中中药治疗组灌胃按照实施例1-8中方法制备得到50mg/kg本发明中药组合物片剂,每日1次;西维美林治疗组灌胃给予5mg/kg西维美林口服组合物,每日1次;对照组灌胃等体积的蒸馏水。连续用药4周后评价疗效。
对照组采用中国专利CN1299731C中实施例三所述的处方和制备工艺制备得到,其处方为:枸杞子100g、菟丝子70g、女贞子70g、茺蔚子70g、何首乌70g、山茱萸70g、淫羊藿70g、谷精草70g、木贼70g、决明子70g、赤芍70g、川芎70g、丹参70g、黄柏70g、牡丹皮70g、地黄70g、红花70g、鸡血藤70g、冰片30g。。
3.观察指标及观察方法
3.1泪液基础分泌试验(schirmerItest,SIT),将schirmer试纸条插入兔眼,记录试纸润湿的长度,连续3次,取平均值。
3.2泪膜破裂时间测定试验(break-uptime,BUT)1%荧光素钠20μl滴入兔结膜囊内,被动眨眼数次后在裂隙灯钴蓝光下观察泪膜,记录泪膜出现干燥斑的时间,连续测3次,取平均值。
3.3荧光素染色试验(fluoresceinstaining,FLS)1%荧光素钠10μl滴入兔结膜囊内,被动眨眼数次,裂隙灯钴蓝光下观察角膜荧光素的染色情况。将角膜分成上、中、下3部分,每部分按0~3计分。0代表无着色;1代表散在点染;2代表稍密集的荧光素染色点;3代表密集的点状或斑片状染色,共0~9分。分别记录用药前后SIT试验、BUT及荧光素染色结果,并记录兔干眼症状的变化。结果如表2所示。
表2不同治疗组对新西兰兔的SIT、BUT、荧光素染色分级结果
与治疗前相比p<0.05,p<0.01;与西维美林治疗后相比◆P<0.05,◆◆P<0.01;
由表2可见,本发明中药组合物各治疗组和西维美林治疗组的治疗前后的SIT、BUT和荧光素染色分级均具有显著性差异,其中本发明中药组合物治疗组治疗前后的治疗效果更为显著,显著优于西维美林的治疗效果。这表明本发明中药组合物口服用于干眼症治疗时可以取得显著的治疗效果,其可以作为对滴眼液过敏或无效时的用药选择,也可以作为干眼症治疗的辅助治疗。具体结果如下所示:
1)中药1组治疗前后的SIT、BUT和荧光素染色分级均具有显著性差异,其中中药1组的治疗效果相对于西维美林组治疗效果更为显著,具有显著性差异,这表明中药1组可以作为干眼症治疗药物使用。
2)中药2组-8组治疗前后的SIT、BUT和荧光素染色分级与治疗1组相比差异更为显著,这表明在中药1组的基础上添加入百合、三七和石菖蒲后在治疗干眼症方面与原有处方药物之间取得了显著的协同作用,其中尤其以中药2组和中药3组最佳,为本发明最佳的两个实施例。
3)对照组在处方的中药材组成上与中药1组相近,只是在处方中各味中药材的具体含量不同,其虽然对干眼症治疗也有一定的改善效果,但治疗前后SIT、BUT和荧光素染色分级不具有显著性的差异。这表明,本发明中药组合物治疗干眼症的作用与各味中药材的具体使用量相关度很高。
Claims (8)
1.一种中药组合物在制备治疗干眼症药物中的用途,其中所述的中药组合物的处方组成为:枸杞子90g、菟丝子60g、女贞子60g、茺蔚子60g、何首乌60g、山茱萸60g、淫羊藿60g、谷精草60g、木贼60g、决明子60g、赤芍60g、川芎60g、丹参60g、黄柏60g、牡丹皮60g、地黄60g、红花60g、鸡血藤60g、冰片18g。
2.根据权利要求1所述的用途,其特征在于,所述的中药组合物还包括百合、三七和石菖蒲。
3.根据权利要求1所述的用途,其特征在于,所述的中药组合物的处方组成中还包括百合30g、三七25g和石菖蒲20g。
4.根据权利要求1所述的用途,其特征在于,所述的中药组合物的处方组成中还包括百合15g、三七15g和石菖蒲20g。
5.根据权利要求1-4任一所述的用途,其特征在于,所述包含中药组合物的药物制剂为其口服制剂。
6.根据权利要求5所述的用途,其特征在于,所述的口服制剂为其片剂、胶囊剂、颗粒剂、糖浆、滴丸剂中的一种。
7.根据权利要求6所述的用途,其特征在于,所述的口服制剂为其片剂。
8.根据权利要求1所述的用途,其特征在于,所述中药组合物的药物制剂的制备方法包括如下步骤:
除冰片外,牡丹皮、何首乌、黄柏、赤芍粉碎成细粉,其余十四味加水煎煮三次,第一次加8倍量水,浸泡30分钟,煎煮1小时,第二、第三次各加6倍量水,煎煮1小时,合并煎液,滤过,滤液60℃下减压浓缩至相对密度为1.30的稠膏,加入上述药材细粉,混匀,低温干燥,粉碎成细粉,制成颗粒,干燥,冰片研细,加入上述颗粒中,混匀后加入各剂型适宜辅料,按各剂型常规工艺制成片剂、胶囊剂、颗粒剂或滴丸剂。
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1544075A (zh) * | 2003-11-13 | 2004-11-10 | 西安碑林药业股份有限公司 | 一种治疗眼疾近视、消除视疲劳症状的中药及其制备方法 |
CN103007284A (zh) * | 2013-01-16 | 2013-04-03 | 闫莹 | HMGCoA还原酶抑制剂在制备治疗干眼症药物中的用途 |
CN105168590A (zh) * | 2015-10-29 | 2015-12-23 | 山东省中医药研究院 | 一种治疗干眼症的中药 |
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CN103007284A (zh) * | 2013-01-16 | 2013-04-03 | 闫莹 | HMGCoA还原酶抑制剂在制备治疗干眼症药物中的用途 |
CN105168590A (zh) * | 2015-10-29 | 2015-12-23 | 山东省中医药研究院 | 一种治疗干眼症的中药 |
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