CN107669912A - 一种康复视力口服液 - Google Patents

一种康复视力口服液 Download PDF

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CN107669912A
CN107669912A CN201711164125.8A CN201711164125A CN107669912A CN 107669912 A CN107669912 A CN 107669912A CN 201711164125 A CN201711164125 A CN 201711164125A CN 107669912 A CN107669912 A CN 107669912A
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rehabilitation
oral liquid
medicine
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朱美霖
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Abstract

本发明公开了一种康复视力口服液，该药采用人参、山茱萸、山药等25种中药制成。与视力医口服液相比，本发明增加了石斛、木贼、谷精草三味药，增加了珍珠母用量，兼用生地黄和熟地黄，同时制备工艺节约了时间。实际使用表明，本发明功效比视力医口服液更为显著，对提高青少年近视患者的视力和改善视疲劳症状有效率达95％以上，比原方临床有效率85％高出10个点以上。此外，长期服用本发明安全无毒，没有口干、咽痛等副反应，患者顺应性高。因此，本发明康复视力口服液具有滋养肝肾、调补气血、开窍明目、强健体质、康复视力的功效，为近视患者提供了防治视力减退、视力疲劳、头晕目眩、腰酸腿软的保健佳品。

Description

一种康复视力口服液
技术领域
本发明属于视力康复保健技术领域，尤其涉及一种康复视力口服液。
背景技术
中国专利“视力医口服液”(专利号94109293.3公开日1995.08.23)公开了由人参、山茱萸、山药等21味中草药制成的视力保健口服液，该口服液具有滋养肝肾、调补气血、开窍明目、强健体质、康复视力等功效。然而，长期实践应用表明，视力医口服液存在上火的问题，即患者服用后有多有口干、咽痛等副反应，而且临床有效率有待提高。
发明内容
本发明要解决的技术问题是提供一种疗效优良、无副作用的康复视力口服液。
为解决上述技术问题，本发明采用以下技术方案：
康复视力口服液，包括以下重量份的中草药，人参9～15份、山茱萸12～15份、山药12～15份、泽泻12～18份、覆盆子9～18份、青葙子9～18份、沙苑子9～18份、茯苓10～20份、菟丝子10～20份、牡丹皮10～20份、决明子10～20份、石菖蒲10～20份、五味子6～12份、车前子10～20份、枸杞子10～20份、茺蔚子6～12份、远志10～20份、龟板6～12份、菊花10～20份，还包括：生地黄15～30份、熟地黄15～30份、珍珠母10～20份、石斛10～20份、木贼10～20份、谷精草10～20份。
上述康复视力口服液，以下方法制备：将中草药经分别洗、选后，除菊花外置提取罐内，加水浸润，菊花不用浸润最后放入；分三次煎煮提取液，合并三次提取液，浓缩成含原药1～1.3mg/ml的稠膏；稠膏加适量蒸馏水，搅匀，静置水沉，过滤除杂质得上清液；上清液加适量蔗糖、少量尼泊金乙酯、蒸馏水至制备量，即得。
浸润时间为1.5～2.5小时。
三次煎煮中，第一次煎煮加水浸过药面50cm，煮沸1.5小时，第二次和第三次煎煮，加水浸过药面30cm，煮微沸1小时。
静置时间为12小时。
针对视力医口服液副反应明显、疗效待提高的问题，发明人在原有组方基础上，结合传统医学和长期临床实践，研制了一种康复视力口服液，该药采用人参、山茱萸、山药等25种中药制成。与视力医口服液相比，本发明增加了石斛、木贼、谷精草三味药，增加了珍珠母用量，兼用生地黄和熟地黄，同时制备工艺节约了时间。实际使用表明，本发明功效比视力医口服液更为显著，对提高青少年近视患者(***观察500例)的视力和改善视疲劳症状有效率达95％以上，比原方临床有效率85％高出10个点以上。此外，长期服用本发明安全无毒，没有口干、咽痛等副反应，患者顺应性高。因此，本发明康复视力口服液具有滋养肝肾、调补气血、开窍明目、强健体质、康复视力、养阴生津的功效，为近视患者提供了防治视力减退、视力疲劳、头晕目眩、腰酸腿软、目疾、口干、咽痛的保健佳品。康复视力口服液方解
“内经”认为：“肾主骨、藏精生髓……肾精充沛、则耳聪目明……。”“肝藏血、主筋、开窍目……。”临床上肝阴虚与肝血虚表现相同，实际上是由于肝血虚所至视力减退、夜盲、头晕、耳鸣、爪甲干枯等表现。
本发明由人参、远志、茯苓、石菖蒲四味以滋养、补气、益智、安神为君药，采用决明子、茺蔚子、枸杞子、车前子、五味子、沙苑子、青葙子、菟丝子、覆盆子等九味含多种微量元素、维生素A类物质及胡萝卜素、B1、B2等种子类药物为臣药，药物专走肝、肾两经。佐以六味地黄汤滋肾益肝，合成填精补髓之效，调以安神、潜阳、养阴生津、清热降火、疏散风热之龟板、菊花、珍珠母、生地、石斛、木贼、谷精草。本方繁而不杂，多而不乱，其特点是药性平和、作用专一。
因此，该方有滋养肝肾、调补气血、开窍明目、强健体质、康复视力、养阴生津等功效，是防治视力减退、视力疲劳、头晕目眩、腰酸腿软、目疾、口干、咽痛等的口服佳品。
附图说明
图1是本发明康复视力口服液的制备工艺流程图。
具体实施方式
实施例1
配方：人参12g、山茱萸15g、山药15g、泽泻16g、覆盆子13g、青葙子18g、沙苑子9g、茯苓16g、菟丝子19g、牡丹皮11g、决明子10g、石菖蒲15g、五味子6g、车前子140g、枸杞子10g、茺蔚子7g、远志10g、龟板11g、菊花10g，生地黄20g、熟地黄30g、珍珠母16g、石斛10g、木贼20g、谷精草20g。
制法：如图1所示，将中草药经分别洗、选后，除菊花外置提取罐内，加水浸润1.5～2.5小时，菊花不用浸润最后放入；分三次煎煮提取液，第一次煎煮加水浸过药面50cm，煮沸1.5小时，收集蒸馏液密封备用，滤放出提取液后，第二次煎煮加水浸过药面30cm，煮微沸1小时，不收集蒸馏液，滤放出第二次提取液后，第二次煎煮加水浸过药面30cm，煮微沸1小时，不收集蒸馏液，滤放出节三次提取液，合并三次提取液，浓缩成含原药1～1.3mg/ml的稠膏；稠膏加适量蒸馏水，搅匀，静置水沉(12小时)，过滤除杂质得上清液；上清液加适量蔗糖(质量浓度约2％)、少量尼泊金乙酯(质量浓度约0.05％)、蒸馏水至制备量，即得。
实施例2
配方：人参9g、山茱萸14g、山药14g、泽泻12g、覆盆子9g、青葙子9g、沙苑子18g、茯苓20g、菟丝子10g、牡丹皮20g、决明子20g、石菖蒲20g、五味子12g、车前子20g、枸杞子13g、茺蔚子10g、远志16g、龟板6g、菊花13g，生地黄15g、熟地黄15g、珍珠母10g、石斛20g、木贼10g、谷精草15g。
制法同实施例1。
实施例3
配方：人参15g、山茱萸12g、山药12g、泽泻18g、覆盆子18g、青葙子11g、沙苑子17g、茯苓10g、菟丝子16g、牡丹皮16g、决明子17g、石菖蒲10g、五味子10g、车前子10g、枸杞子20g、茺蔚子12g、远志11g、龟板12g、菊花18g，生地黄30g、熟地黄20g、珍珠母20g、石斛18g、木贼18g、谷精草12g。
制法同实施例1。
临床应用
A、视力医口服液(参考前述专利94109293.3制备)
为表明视力医口服液具有养肝明目、补益气血、滋阴补肾、填精补髓的功效，适用于青少年近视患者。发明人对其进行验证，组织人员有计划地选取120例***临床观察，广西中医学院一附院，广西中医学院二附院，广西壮族自治区人民医院各观察40例，另设对照组61例，广西中医学院一附院20例，广西中医学院二附院21例，广西壮族自治区人民医院20例，总共181例。
(一)一般资料
所纳入之观察对象，符合青少年近视诊断标准，中医辨证属心气不足，肝肾两虚型，年龄7-25岁，五分记法运视力＜5.0，近视力＜5.0的患者，治疗组120例男性57例，女性63例，年龄14.24±4.62岁(X±SD)对照组61例，男性30例，女性31例，年龄15.29±4.21岁，两组年龄、性别分布无显著性差异(P＞0.05)。
(二)诊断标准(高等医学院中医眼科教材)
一般近视力良好，远视模糊不清，高度近视者，眼球较为突出，远视力显著减退，为了视物清晰不得不移近所视目标，常眯目视物，视疲劳，严重出现外斜视。
(三)中医辩证分型标准
1、心气不足：视近清楚，视远模糊，全身无明显不适，或面色光白，心悸神疲，舌淡脉弱。
2、肝肾两虚：视近祛远，眼前黑花渐生，全身可有头晕耳鸣、夜眠多梦、腰膝酸软、脉细。
(四)纳入病例标准
1、青少年近视患者，年龄7-25岁，五分记法远视力＜5.0，矫正视力≥5.0，近视力≥5.0。
2、中医辨证属心气不足，肝肾两虚者。
(五)排除病例标准
1、外伤、肿瘤、炎症引起的视力减退。
2、伴斜视、弱视、色盲。
3、视力减至4.0以下者。
4、有严重心脑血管、肝肾、造成***、神经***疾病患者、精神病患者。
5、不符合纳入标准，未按规定用药、资料不全无法判定疗效者。
观察方法
采用区组随机，实验对照方法观察。治疗组用视力医口服液每次20ML，每天3次，连服4周，对照组用石斛夜光丸(广州陈李济药厂生产)日服3次，每次1丸，连服4周。试验前常规时患者作详细体格检查，近视者裸眼远视力和近视力，试验后每周随诊1次，询问用药后情况，记录病情及副作用，疗程结束后复查裸眼视力，疗效判定直接由观察者作出，观察期间停用其他药物和治疗措施。
结果
(一)疗效判断标准
1、痊愈：裸眼远视力≥5.0视力疲劳症状消失。
2、显效：裸眼远视力增加4行以上(包括4行)。
3、好转：裸眼远视力增加2-3行。
4、无效：裸眼远视力不增加或增加不到2行。
(二)治疗结果(见表1)
表1青少年近视治疗前后视力(五分记法)比较(X±SD)
注：治疗前后比例*P＜0.01两组比较P＜0.01
治疗组120例，近视眼数231只，治疗后视力增加非常明显(P＜0.01)对照组61例，近视眼数115只，治疗后视力增加亦非常明显(P＜0.01)2，两组比较，治疗组较对照组有非常显著差异(P＜0.01)。
2、对视疲劳等症状的影响(见表2)
表2治疗前后见证积分比较(X±SD)
注：治疗前后比较*P＜0.01
试验组和对照组对视力疲劳主证积分，心气不足型症候积分，肝肾两虚型症侯积分，以及总积分，治疗后有非常明显的下降(P＜0.01)。
3、两组疗效比较(见表3)
表3两组疗效比较(Ridit分析)
治疗组120例，痊愈15例，显效45例，好转43例，无效17例，总有效率85.8％。对照组61例，痊愈0例，显效12例，好转21例，无效28例，总有效率54.1％。两组疗效，治疗组较对照组有非常显著性差异(P＜0.01)。
然而，视力医口服液患者服用后普遍反应有口干、咽痛等不适现象。
B、康复视力口服液(本发明)
本发明的服用方式：摇匀后口服，每日2-3次，每次服20ml，30天为1疗程。发明人将实施例1至实施例3所得产品在中小学试用一个月，参照前述疗效判断方法，结果如表4。
表4康复视力口服液试用结果
从上表看出，共194例，痊愈75例，显效79例，好转39例，无效1例，治愈率38.7％，总有效率99.4％。试用期间，患者没有出现口干、咽痛等不适感。

Claims (5)

1.一种康复视力口服液，包括以下重量份的中草药，人参9～15份、山茱萸12～15份、山药12～15份、泽泻12～18份、覆盆子9～18份、青葙子9～18份、沙苑子9～18份、茯苓10～20份、菟丝子10～20份、牡丹皮10～20份、决明子10～20份、石菖蒲10～20份、五味子6～12份、车前子10～20份、枸杞子10～20份、茺蔚子6～12份、远志10～20份、龟板6～12份、菊花10～20份，其特征在于还包括：生地黄15～30份、熟地黄15～30份、珍珠母10～20份、石斛10～20份、木贼10～20份、谷精草10～20份。
2.根据权利要求1所述的康复视力口服液，其特征在于按以下方法制备：将中草药经分别洗、选后，除菊花外置提取罐内，加水浸润，菊花不用浸润最后放入；分三次煎煮提取液，合并三次提取液，浓缩成含原药1～1.3mg/ml的稠膏；稠膏加适量蒸馏水，搅匀，静置水沉，过滤除杂质得上清液；上清液加适量蔗糖、少量尼泊金乙酯、蒸馏水至制备量，即得。
3.根据权利要求2所述的康复视力口服液，其特征在于：所述浸润时间为1.5～2.5小时。
4.根据权利要求3所述的康复视力口服液，其特征在于：所述三次煎煮中，第一次煎煮加水浸过药面50cm，煮沸1.5小时，第二次和第三次煎煮，加水浸过药面30cm，煮微沸1小时。
5.根据权利要求4所述的康复视力口服液，其特征在于：所述静置时间为12小时。
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