CN116966235A - 一种治疗近视的中药眼膏及其制备方法 - Google Patents
一种治疗近视的中药眼膏及其制备方法 Download PDFInfo
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Abstract
一种治疗近视的中药眼膏及其制备方法,所述中药眼膏包括中药原料和辅料,以重量份计,中药原料包括:决明子2‑8份、菊花3‑8份、枸杞1‑5份、桑叶1‑5份、远志1‑5份、川芎1‑3份、白芍1‑5份、当归2‑6份、茯苓1‑6份、白术1‑5份、蒺藜3‑8份、黄芪3‑8份和甘草3‑8份;所述辅料包括:硬脂酸40‑100份、单甘脂20‑50份、医用凡士林10‑30份、透明质酸5‑15、薄荷脑5‑15份、三乙醇胺5‑15份。本发明在合理搭配组分配比外,将超声、微波、冷冻干燥、破壁处理等多种现代处理技术加以利用,减小有效成分损失,提高有效成分利用率,并兼顾使用舒适度,高质高效地制备治疗近视的中药眼膏。
Description
技术领域
本发明属于中药技术领域,特别涉及一种治疗近视的中药眼膏及其制备方法。
背景技术
目前,由于用眼环境和未来用眼要求的改变,近视的高发生率、低龄化、重度化问题日益严重,眼睛是人体最大的感受器官,人眼是人自出生后知识获取的重要器官,这一点充分说明了人眼睛的重要性。
近视发展趋势渐进累加且不可逆,有研究报道27-33%的近视可发展为病理性近视,高度近视与病理性近视的关系密切,当近视发展为高度近视时,视网膜功能随近视度数增加而降低,随着病情的发展,视网膜等结构会出现病理改变,如视网膜色素上皮层、感光细胞层及整个视网膜萎缩变性、内外核层及神经节细胞空泡样改变,此外眼轴长度过度伸长会导致视网膜脉络膜萎缩、脉络膜新生血管、黄斑劈裂等各种并发症。
对于近视的治疗及矫正,大多数人采用配戴眼镜或者其他矫正工具的方法矫正视力,也有通过外科手术的方式治疗近视的,还有的通过服用治疗近视的药物来矫正视力。然而,佩戴眼镜容易导致近视进一步加重,使用其它矫正工具也是治标不治本,通过外科手术治疗近视不但成本高而且隐患也大,服用治疗近视的药物也会有诸如扩瞳及畏光、调节力降低及过敏性结膜炎等副作用。以上各种治疗方法,均存在治愈时间久,治疗效果低的问题。
中医认为,肝藏血,开窍于目,而眼睛的功能是否正常,则需要我们的肝血来荣养、滋润的,如果肝血亏虚的话,眼睛就得不到肝血的滋养,渐渐的就会出现视力模糊、下降、干涩等一些病理现象。近年来,缓解疲劳、治疗近视等眼部外用中药日益受到关注,其以用药简单、副作用少、成本低廉等优势被各年龄段消费者所追捧。专利CN105343739B公开了一种用于治疗近视眼的纯中药药膏及其制备方法。该药膏由桑椹子,枸杞子,黄芪,麝香,远志,红花,石菖蒲,覆盆子,青葙子,五味子,决明子,升麻,冰片,白人参,茯神,益智仁,楮实子,女贞子,杏仁,石决明,三七,植物油、铅丹制备而成。该药膏,通过敷贴相关经穴,标本兼治治疗近视眼,而不产生治疗反复、并发症等副作用。专利申请CN114010709A公开了一种治疗近视外用中药膏及其制备方法,属于中药技术领域。所述中药膏包括石菖蒲、远志、当归、楮实子、山茱萸、菟丝子、枸杞子、丹参、川芎、党参、黄芪、白术、青皮、洋地黄、秦皮、白芍、茜草等多种中草药原料。该中药膏精选原料配方,工艺简单,可直接涂敷,使用方便,具有促进眼周血液循环、缓解眼肌痉挛、消除眼部疲劳的功效。目前的现有技术为了得到较好的疗效,往往通过增加配方中的中草药种类等手段,但相对传统的制备过程却存在对有效成分提取率低、有机组分难以充分提取等问题,导致一定程度上中草药原材料的浪费。且现有药膏多数仅以中草药为组成成分,并未关注药膏施用舒适度和滋润性等相关用户体验,长期使用难以获得较好的用户满意度。
因此,采用何种配方,配合何种制备方法,减小制备过程中有效成分损失,提高中草药有效成分利用率,并兼顾使用舒适度,高质高效地制备治疗近视的中药眼膏,成为本领域亟待解决的技术问题。
发明内容
针对上述现有技术中存在的缺陷,本发明的目的在于提供一种治疗近视的中药眼膏及其制备方法。根据药物的归经特点进行不同药物配伍,在补血平肝的同时,补气益脾,通过脾肝同时调理,来促进人体精血生成,同时加入安神作用药物以在外用时补血养心,益肝宁神。多种组分相互协同达到精血养目以治疗近视的作用。同时在药物的制备过程中,合理利用了现代超微粉碎技术、超声提取技术、真空冷冻干燥技术及微波加热技术等有效解决了中草药有效成分利用率低的问题。
具体的,本发明提供了一种治疗近视的中药眼膏,包括中药原料和辅料,以重量份计,中药原料包括:决明子2-8份、菊花3-8份、枸杞1-5份、桑叶1-5份、远志1-5份、川芎1-3份、白芍1-5份、当归2-6份、茯苓1-6份、白术1-5份、蒺藜3-8份、黄芪3-8份和甘草1-5份;所述辅料包括:硬脂酸40-100份、单甘脂20-50份、医用凡士林10-30份、透明质酸5-15、薄荷脑5-15份、三乙醇胺5-15份。
优选的,以重量份计,中药原料包括:决明子4-6份、菊花4-6份、枸杞3-5份、桑叶2-4份、远志2-4份、川芎1.5-2.5份、白芍2-4份、当归3-5份、茯苓1-4份、白术2-4份、蒺藜4-6份、黄芪4-6份和甘草1-3份。
肝藏血,开窍于目,肝血足,则能为眼睛提供更多的荣养、滋润。采用养肝护肝类中草药是本发明中药原料的选择方向。枸杞,味甘性平,是传统的药食同源食物,含有丰富的枸杞多糖、多酚及类胡萝卜素等活性成分,枸杞提取物不仅能有效保护视网膜,同时还具有降压、降血糖血脂、调节机体免疫力、抗氧化、抗肿瘤和抗疲劳等作用。菊花,味甘、苦、微寒,具有平肝明目、清热解毒、疏风解郁的功效,黄酮类化合物、挥发油和三萜类化合物是菊花的主要有效成分。决明子,味苦、甘、咸,性微寒,具有降压、调脂、保肝明目、抑菌、抗氧化等功效。桑叶是常见的传统中药材,具有疏散风热、清肺润燥、清肝明目等功效。将决明子、菊花、枸杞和桑叶配伍一方面可以用于肝火上炎所致的目赤肿痛、羞明多泪、心烦易怒等的治疗;另一方面也可以用于肝阳上亢所致的头晕、头痛、耳鸣、面红目赤、烦躁、失眠等的调理。
所云“久视伤血 ”,是指肝的窍道因久视失荣,而失精血,有两种情况,一是体内阴血不足,无以滋荣;二是久视局部组织凝集失疏泄不得滋荣。川芎、白芍、当归、黄芪均可滋阴养肝血,其配伍,既能健脾以助补气,又能养阴以助补血,故具补气生血之用,为气血同调之法。
茯苓有保护视力、清除眼部湿气、改善眼疲劳等功效。茯苓中含有丰富的多糖和微量元素等成分,可以促进眼睛的新陈代谢,增强视网膜的抵抗力,从而保护眼睛的视力。茯苓的渗透利尿作用,可以有效地排除体内湿气,改善眼部水肿和浮肿等问题。此外,茯苓还有镇静安神的作用,可以缓解眼部疲劳和不适感。然而,过量的茯苓可能会引起肝损伤等问题,因而其用量必须有效控制。
白术具有保肝利胆、提高免疫、抗氧化、抗血凝、抗菌、镇静、血管扩张等功效,是治疗气虚、健运脾气不可缺少的一味药材。
远志和蒺藜相配伍则可以补血养心,益肝宁神,改善睡眠,使机体得以很好的休息,用以消除眼部疲劳。
甘草起到调和诸药的作用,与菊花等搭配可以使得这类寒性药材不伤及体内的阳气,充分发挥中药组分散风清热、清肝明目的作用。然而,过量的甘草会引起中毒,导致视力下降,因而其用量必须有效控制。
优选的,中药原料先用小分子水提取,再用有机溶液提取。采用膜分离技术、离子交换、纳滤等技术能够得到小分子水,其更容易进入细胞,快速渗透到细胞内部,相对于普通水更容易将中草药的水溶性成分溶出提取。之后采用有机溶液,例如乙醇水溶液,则能够将中草药的非水溶性有效成分提取出来。
优选的,所述黄芪、甘草、当归、远志中的至少一种经过炮制加工。具体炮制的方法有多种可选,例如酒制、炒制、蜜制等,优选采用蜜制,将待制物加入炼熟的蜂蜜(蜂蜜质量约占待制物质量的15-25%),加开水拌匀闷制,放锅内炒至不粘手,取出晾凉。中药炮制一方面有利于消除或降低药物的毒性,烈性或副作用。二是更容易去除杂质,便于准确计量、制剂以及后续储存。
针对前述中药眼膏,本发明进一步提供了针对所述治疗近视的中药眼膏的制备方法,包括如下制备步骤:
步骤一:按比例称取中药原料,加入中药原料4-8倍体积的小分子水,浸泡5-12小时;
步骤二:升温煮沸,保温煎煮20-60分钟,过滤,重复2-4次,合并滤液得到第一滤液和滤渣;
步骤三:将滤渣破壁处理,得到粒径在5-50μm的超细滤渣,加入乙醇溶液提取1-3次,过滤合并得到第二滤液,合并第一滤液和第二滤液,减压、浓缩成浓缩液;
步骤四:将硬脂酸、单甘脂、医用凡士林、薄荷脑加热溶化后与所述浓缩液、三乙醇胺、透明质酸混合搅拌乳化而制出眼膏。
优选的,步骤一中,将中药原料粉碎过30-60目筛,之后再加入小分子水。
步骤一中,在经小分子水长时间浸泡之后,小分子逐步进入细胞内部,大部分中药材被溶胀,有利于高温下提取水溶性成分。步骤三中,滤渣破壁的粒径控制在5-50μm的微米级别,优选5-30μm,更优选5-20μm,细胞破壁率高,经过破壁处理后几乎不存在未破壁药材提取时有效成分从细胞内到溶剂中的浓度梯度差或造成较低提取率的浓度平衡,因此有效成分的提取率高,且经破壁后的药材混合均匀度高,为后续的有机溶剂提取提供更好的原料。
优选的,步骤一中,浸泡5-8小时,且每小时中超声处理5-10分钟。超声提取技术利用一定频率超声波的空化作用,强化传质过程,加速有效成分的溶出;超声波传递的机械能可在液体中形成有效的搅动与流动,从而破坏介质结构,粉碎液体中的颗粒,从而产生普通低频机械搅拌起不到的效果,加速溶解/溶胀、提取过程的进行,提高了提取率。本发明采用间歇性超声处理,能够有效缩短浸泡时间,并提高浸泡溶胀和溶出效果,有利于有效成分的后续提取。
优选的,步骤二中,重复2-3次升温煮沸、保温煎煮和过滤,且至少1次采用微波加热,微波频率在2-300GHz,保温煎煮20-40分钟。微波加热时,一方面微波的热效应能使药材基质内部的水分的能量转化成介质内的热能,使介质温度出现宏观上的升高,即介质材料利用自身损耗电磁场能量而发热,升温和汽化。迅速温升导致药材基质结构组织发生变化,材料变得疏松,减少了传质阻力,从而使细胞中有效成分更易溶出;另一方面,微波的非热效应能使得基质材料中各组分之间的作用力减弱,解吸作用增强,溶解度提高,从而达到提高提取效率的目的。简而言之,微波可穿透极性分子而到达中草药细胞内,细胞内受热升温增压导致细胞由内而外的破壁,促使有效成分溢出,具有时间短、得率高、安全、污染小等特点。本发明充分利用微波加热受热均匀、加热效率高、有效成分易于提取等优点,进一步提升提取效果。
优选的,在滤渣破壁处理前,进行冷冻干燥处理,冷冻温度为-60℃至-40℃,真空度为10至50Pa。
对残渣进行真空冷冻干燥处理可避免常见的干燥加工过程中物料热敏性成分的破坏和易氧化成分的氧化等劣变反应,药用有效成分保存率高,芳香物质挥发性降低,且冷冻干燥脱水彻底,质量好,保存性好。
优选的,步骤三中,每次加入滤渣4-8倍体积的40-70wt%乙醇水溶液,采用超声提取20-40分钟。同理,在有机溶剂提取时,配合超声处理,将有利于加速有效成分的溶出,有效避免高温对活性成分的破坏,提取效果优于传统提取方法。
本发明,与现有技术相比,优点包括不限于:
1.本发明从中草药配伍协同作用,及中草药与辅料配合的方式得到效果良好,使用舒适方便的中药眼膏。一方面,从气血同补,平肝益脾的角度进行中药材选择配伍,肝与脾相互作用,二者相辅相成,肝主疏泄,协调脾胃升降,脾的运化功能正常,营养吸收良好,保证气血生成正常,可促进肝气正常,达到“精血充盛,目有所养”的作用;另一方面,通过辅料的添加,使得中药眼膏具有保湿滋润等功效,在皮肤表面产生一层粘性薄膜,减少经皮水分流失同时促进药物渗透,改善药物的经皮吸收,有利于提升中药眼膏的药用渗透性和持久力,提高中药膏对近视的治疗效果。
2.本发明采用超声、微波、冷冻干燥、破壁处理等多种现代处理技术,显著提高中药材的提取效率和质量,且避免药物在制备过程中有效成分的流失,同时避免高温等因素破坏药物内有效成分结构,能够使更多的有效成分克服皮肤屏障,附着并穿过皮肤角质层,提高产品药效,且整体降低成本。
附图说明
图1为本发明治疗近视的中药眼膏的制备方法流程示意图。
具体实施方式
下面将根据具体实施方式和实施例对本发明的技术方案进行清楚、完整地描述。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
本发明提供一种治疗近视的中药眼膏,包括中药原料和辅料,以重量份计:
中药原料包括:决明子2-8份、菊花3-8份、枸杞1-5份、桑叶1-5份、远志1-5份、川芎1-3份、白芍1-5份、当归2-6份、茯苓1-6份、白术1-5份、蒺藜3-8份、黄芪3-8份和甘草1-5份;优选的,中药原料以重量份计,优选包括:决明子4-6份、菊花4-6份、枸杞3-5份、桑叶2-4份、远志2-4份、川芎1.5-2.5份、白芍2-4份、当归3-5份、茯苓1-4份、白术2-4份、蒺藜4-6份、黄芪4-6份和甘草1-3份。
所述黄芪、甘草、当归、远志中的至少一种经过炮制加工,具体炮制的方法有多种可选,例如酒制、炒制、蜜制等,优选采用蜜制。
所述辅料包括:硬脂酸40-100份、单甘脂20-50份、医用凡士林10-30份、透明质酸5-15、薄荷脑5-15份、三乙醇胺5-15份。
参见附图1,针对前述治疗近视的中药眼膏,本发明还提供了相应的制备方法,具体包括如下步骤:
步骤一:按比例称取中药原料并混合,将中药原料粉碎过30-60目筛,加入中药原料4-8倍体积的小分子水,浸泡5-12小时,优选5-8小时,且每小时中超声处理5-10分钟;
步骤二:升温煮沸,保温煎煮20-60分钟,优选20-40分钟,过滤,重复2-4次,优选2-3次,且其中至少1次采用微波加热,微波频率在2-300GHz,合并滤液得到第一滤液和滤渣;
步骤三:将滤渣进行冷冻干燥处理,冷冻温度为-60℃至-40℃,真空度为10至50Pa,再将滤渣破壁处理,得到粒径在5-50μm的超细滤渣,加入乙醇溶液提取1-3次,每次加入滤渣4-8倍体积的40-70wt%乙醇水溶液,采用超声提取20-40分钟,过滤合并得到第二滤液,合并第一滤液和第二滤液,减压、浓缩成浓缩液;
步骤四:将硬脂酸、单甘脂、医用凡士林、薄荷脑在75-95℃加热溶化后与所述浓缩液、三乙醇胺、透明质酸混合搅拌乳化而制出眼膏。
实施例1
本实施例的治疗近视的中药眼膏,包括中药原料和辅料,以重量份计:
中药原料包括:决明子4份、菊花4份、枸杞3份、桑叶2份、远志2份、川芎1份、白芍2份、当归3份、茯苓1份、白术2份、蒺藜4份、黄芪4份和甘草1份;
辅料包括:硬脂酸50份、单甘脂20份、医用凡士林15份、透明质酸5、薄荷脑5份和三乙醇胺5份。
该中药眼膏的制备方法,具体制备步骤如下:
步骤一:按比例称取中药原料,将中药原料粉碎过40目筛,加入中药原料4倍体积的小分子水,浸泡12小时;
步骤二:升温煮沸,保温煎煮30分钟,过滤,重复3次,合并滤液得到第一滤液和滤渣;
步骤三:将滤渣破壁处理,得到粒径在20±5μm的超细滤渣,加入乙醇溶液提取2次,每次加入滤渣4倍体积的50wt%乙醇水溶液,采用超声提取30分钟,过滤合并得到第二滤液,合并第一滤液和第二滤液,减压、浓缩成浓缩液;
步骤四:将硬脂酸、单甘脂、医用凡士林、薄荷脑加热溶化后与所述浓缩液、三乙醇胺、透明质酸混合搅拌乳化而制出眼膏。
实施例2
本实施例治疗近视的中药眼膏,其中药原料和辅料配比与实施例1相同,区别在于制备方法,具体制备步骤如下:
预备步骤:将黄芪、甘草、当归、远志蜜制加工;
步骤一:按比例称取中药原料,将中药原料粉碎过40目筛,加入中药原料4倍体积的小分子水,浸泡8小时,且每小时中超声处理5分钟;
步骤二:微波加热升温煮沸,保温煎煮30分钟,过滤,重复3次,微波频率在100±2GHz,合并滤液得到第一滤液和滤渣;
步骤三:将滤渣进行冷冻干燥处理,冷冻温度为-40℃,真空度为20Pa,再将滤渣破壁处理,得到粒径在15±5μm的超细滤渣,加入乙醇溶液提取2次,每次加入滤渣4倍体积的50wt%乙醇水溶液,采用超声提取30分钟,过滤合并得到第二滤液,合并第一滤液和第二滤液,减压、浓缩成浓缩液;
步骤四:将硬脂酸、单甘脂、医用凡士林、薄荷脑加热溶化后与所述浓缩液、三乙醇胺、透明质酸混合搅拌乳化而制出眼膏。
实施例3
本实施例的治疗近视的中药眼膏,包括中药原料和辅料,以重量份计:
中药原料包括:决明子6份、菊花6份、枸杞5份、桑叶4份、远志4份、川芎3份、白芍4份、当归5份、茯苓2份、白术4份、蒺藜6份、黄芪6份和甘草2份。其中,黄芪、甘草、当归、远志均经过蜜制加工。
所述辅料包括:硬脂酸80份、单甘脂50份、医用凡士林30份、透明质酸15、薄荷脑15份、三乙醇胺15份。
本实施例的制备方法各参数与实施例2相同。
实施例4
本实施例的治疗近视的中药眼膏,包括中药原料和辅料,以重量份计:
中药原料包括:决明子5份、菊花5份、枸杞4份、桑叶3份、远志3份、川芎2份、白芍3份、当归4份、茯苓3份、白术3份、蒺藜5份、黄芪5份和甘草2份。其中,黄芪、甘草、当归、远志均经过蜜制加工。
所述辅料包括:硬脂酸65份、单甘脂35份、医用凡士林20份、透明质酸10、薄荷脑10份、三乙醇胺10份。
本实施例的制备方法各参数与实施例2相同。
实施例5
本实施例的治疗近视的中药眼膏,其中药原料和辅料配比与实施例4相同,区别在于制备方法,具体制备步骤如下:
预备步骤:将黄芪、甘草、当归、远志蜜制加工;
步骤一:按比例称取中药原料,将中药原料粉碎过60目筛,加入中药原料6倍体积的小分子水,浸泡8小时,且每小时中超声处理10分钟;
步骤二:微波加热升温煮沸,保温煎煮30分钟,过滤,重复3次,微波频率在200±2GHz,合并滤液得到第一滤液和滤渣;
步骤三:将滤渣进行冷冻干燥处理,冷冻温度为-50℃,真空度为10Pa,再将滤渣破壁处理,得到粒径在10±3μm的超细滤渣,加入乙醇溶液提取3次,每次加入滤渣4倍体积的70wt%乙醇水溶液,采用超声提取30分钟,过滤合并得到第二滤液,合并第一滤液和第二滤液,减压、浓缩成浓缩液;
步骤四:将硬脂酸、单甘脂、医用凡士林、薄荷脑加热溶化后与所述浓缩液、三乙醇胺、透明质酸混合搅拌乳化而制出眼膏。
对比例1
本对比例中药眼膏的中药原料和辅料与实施例1相同,区别在于制备方法不同,本对比例省略有机溶剂提取等环节,具体制备步骤如下:
步骤一:按比例称取中药原料,将中药原料粉碎过40目筛,加入中药原料4倍体积的小分子水,浸泡12小时;
步骤二:升温煮沸,保温煎煮30分钟,过滤,重复3次,合并滤液,减压、浓缩成浓缩液;
步骤三:将硬脂酸、单甘脂、医用凡士林、薄荷脑加热溶化后与所述浓缩液、三乙醇胺、透明质酸混合搅拌乳化而制出眼膏。
对比例2
本对比例与实施例5的中药原料及重量份相同,但辅料仅使用20份医用凡士林和10份薄荷脑,制备过程中,预备步骤至步骤三与实施例5相同,步骤四包括将医用凡士林和薄荷脑加热溶化后与浓缩液混合搅拌得到膏体。
测试及结果
对实施例1至5及对比例1至2得到的中药眼膏进行性能检测,具体检测包括直接观察、稳定性测试、保湿能力测试、黄酮类成分检测和临床实验对比。
1、直接观察和涂抹感受各中药眼膏样品的性状,除对比例2外,其余样品呈细腻均一的乳状物,粘度适中。
2、稳定性测试:
2.1快速离心测试:
分别称取各中药眼膏样品2.5g分别置于对应的离心管中,以2000r/min的转速离心30min后,观察是否有分层现象;
2.2长时间静置测试:
将各样品各10g置于内径1cm透明玻璃管中,室温下,竖直放置6个月后,观察是否有分层现象。测试结果见表1。
表1 稳定性测试结果
3、保湿能力测试:
采用实施例5和对比例2的样品,参考QB/T4256-2011化妆品保湿功效评价指南,在恒温环境下(22±1℃),相对湿度50±5%,休息一小时后,按(2.0±0.1)mg/cm2用量涂在受试者左手前臂内侧与右前臂内侧(4cm×4cm)。分别在涂完样品的2h、3h和4h测试皮肤的水合度状态,受试者包括年龄在8-35岁之间30人。评价结果用水合度平均值表示,测试结果见表2。
表2 保湿能力测试结果
通过稳定性和保湿能力测试结果可见,对比例2与实施例5采用相同中药原料,但由于辅料选择不同,对比例2的样品在稳定性和保湿能力方面均显不足。本发明的中药眼膏不仅可直接涂抹眼周,更优选配合对眼周穴位进行按摩,以便药用成分充分被吸收,在这样的操作需求下,中药眼膏的保湿能力和持久舒适性备受关注,本发明中药眼膏的涂抹、保湿、持久性等综合性能有别于现有纯中药产品,能够满足中药眼膏的实际使用需求。
4、黄酮成分检测
为了比较制备方法的提取效率,对实施例1、2、5和对比例1得到的浓缩液分别干燥制得提取物样品,对提取物样品中黄酮类物质含量进行比较。黄酮类物质是一类具有多酚结构的化合物,存在于很多植物中。黄酮类物质对眼部疲劳、视力下降、眼部炎症、黄斑病变等有一定的缓解治疗作用。黄酮类物质水溶性差,主要是有机溶剂提取。
1)定性:经盐酸-镁粉法确定各样品含有黄酮类物质。
2)定量——分光光度法:
以芦丁为标准品,采用NaNO2-Al(NO3)3比色法计算总黄酮提取量。取稀释一定倍数的提取物样品或芦丁标准液(0、30、60、90、120、150μL/mL)2.5mL,加入150μL 5% NaNO2溶液,振摇后放置6min,再加入300μL 10% Al(NO3)3溶液摇匀后放置5min,加入1mL 1.0mol/LNaOH溶液,用水定容至6mL,测定510nm波长处的吸光度。分别绘制芦丁标准曲线,并计算黄酮含量,结果见表3。
表3 不同制备方法的黄酮含量
通过测试结果可见,实施例2与实施例1具有相同的中药原料和辅料,但实施例2利用微波加热、冷冻干燥等技术环节显然更有利于黄酮类物质的提取。实施例5在进一步调整物料组成的同时,对浸泡超声辅助时间、微波频率、冷冻干燥条件等参数有了进一步改进,使中药水溶组分及非水溶组分都更好的释放提取。相对而言,仅依赖水相介质提取的对比例1显然没有能够充分对水溶性低的黄酮类物质进行提取,导致其黄酮百分含量较低。此外,本测试仅以黄酮提取为例进行说明本发明制备方法所涉及的提取环节具有较好的提取效果,由于中药药用成分较为复杂,水溶性较低的有效成分可参考黄酮类提取比较的方式进行推广。
5、临床实验结果
2022年上半年,在不同地区线下门店随机抽取7-16岁的200名近视志愿者,分为4组,每组50人,第1组使用实施例1样品,第2组使用实施例5样品,第3组使用对比例1样品,每日使用三次,每次15分钟,一个疗程为20日;第4组为对照组,每日正常配戴眼镜,只做眼保健操,每日2次,每次5分钟。
3个疗程后判断疗效,结果见表4。
疗效标准:
恢复:视力提高达到1.0或以上者;
显效:视力提高3行以上但未达到1.0者;
有效:视力提高l-2行;
无效:治疗后视力较前不变,或下降,或提高不足l行。
总有效率=(恢复+显效+有效)/总例数×100%
表4 四组临床实验结果
使用实施例5样品的第2组中,部分患者治疗案例数据如表5所示,本发明的中药眼膏在临床应用中取得了良好的治疗效果,经过治疗近视减轻明显,在使用电子产品及网上授课等近视高发的环境下,治疗总有效率达98%,且恢复率较高,在30%以上,部分患者在1-2个疗程即恢复,后期跟踪,一年内无人反弹。
本发明治疗近视的中药眼膏用料相对简单便宜,安全无副作用,利用现代的加工手段提升提取效率,缩短康复疗程,降低了患者治疗费用,提高了治疗舒适度,为近视患者提供了更高的康复概率,具有极大的推广价值和现实需求。
表5 第2组部分患者治疗数据示例
以上介绍了本发明的较佳实施方式,旨在使得本发明的精神更加清楚和便于理解,并不是为了限制本发明,凡在本发明的精神和原则之内,所做的修改、替换、改进,均应包含在本发明所附的权利要求概括的保护范围之内。
Claims (10)
1.一种治疗近视的中药眼膏,其特征在于,包括中药原料和辅料,以重量份计,中药原料包括:决明子2-8份、菊花3-8份、枸杞1-5份、桑叶1-5份、远志1-5份、川芎1-3份、白芍1-5份、当归2-6份、茯苓1-6份、白术1-5份、蒺藜3-8份、黄芪3-8份和甘草1-5份;所述辅料包括:硬脂酸40-100份、单甘脂20-50份、医用凡士林10-30份、透明质酸5-15、薄荷脑5-15份、三乙醇胺5-15份。
2.如权利要求1所述的中药眼膏,其特征在于,以重量份计,中药原料包括:决明子4-6份、菊花4-6份、枸杞3-5份、桑叶2-4份、远志2-4份、川芎1.5-2.5份、白芍2-4份、当归3-5份、茯苓1-4份、白术2-4份、蒺藜4-6份、黄芪4-6份和甘草1-3份。
3.如权利要求1或2所述的中药眼膏,其特征在于,中药原料先用小分子水提取,再用有机溶液提取。
4.如权利要求3所述的中药眼膏,其特征在于,所述黄芪、甘草、当归、远志中的至少一种经过炮制加工。
5.根据权利要求1-4任一项所述治疗近视的中药眼膏的制备方法,其特征在于,包括如下制备步骤:
步骤一:按比例称取中药原料,加入中药原料4-8倍体积的小分子水,浸泡5-12小时;
步骤二:升温煮沸,保温煎煮20-60分钟,过滤,重复2-4次,合并滤液得到第一滤液和滤渣;
步骤三:将滤渣破壁处理,得到粒径在5-50μm的超细滤渣,加入乙醇溶液提取1-3次,过滤合并得到第二滤液,合并第一滤液和第二滤液,减压、浓缩成浓缩液;
步骤四:将硬脂酸、单甘脂、医用凡士林、薄荷脑加热溶化后与所述浓缩液、三乙醇胺、透明质酸混合搅拌乳化而制出眼膏。
6.如权利要求5所述的制备方法,其特征在于,步骤一中,将中药原料粉碎过30-60目筛,之后再加入小分子水。
7.如权利要求6所述的制备方法,其特征在于,步骤一中,浸泡5-8小时,且每小时中超声处理5-10分钟。
8.如权利要求6或7所述的制备方法,其特征在于,步骤二中,重复2-3次升温煮沸、保温煎煮和过滤,且至少1次采用微波加热,微波频率在2-300GHz,保温煎煮20-40分钟。
9.如权利要求8所述的制备方法,其特征在于,在滤渣破壁处理前,进行冷冻干燥处理,冷冻温度为-60℃至-40℃,真空度为10至50Pa。
10.如权利要求9所述的制备方法,其特征在于,步骤三中,每次加入滤渣4-8倍体积的40-70wt%乙醇水溶液,采用超声提取20-40分钟。
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