CN108815390A - 一种改善视力的中药组合物及其制备方法 - Google Patents
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Abstract
本发明涉及中药技术领域,具体一种改善视力的中药组合物及其制备方法,通过对洋参、黄芪、石菖蒲、炙远志、草决明、密蒙花、石斛、石决明、女贞子、菟丝子、夜明砂、枸杞、葛根、蔓荆子、白芍、黄柏、茯苓、升麻、炙甘草、熟地、枣皮、菊花、柴胡、羊角进行组合,使得该中药组合物具有益气养血、通络明目,能消除眼疲劳、恢复视力、滋益肝肾、清热生津、补血活血的功效。
Description
技术领域
本发明涉及中药技术领域,具体一种改善视力的中药组合物及其制备方法。
背景技术
眼疲劳属眼科常见病,它所引起的眼干、眼涩、眼酸胀,视物模糊甚至视力下降直接影响着人的工作与生活。眼疲劳主要由长时间关注电脑、手机等屏幕时眼睛眨眼次数减少,造成眼泪分泌相应减少,同时闪烁荧屏强烈刺激眼睛而引起的,同时,导致人的颈、肩等相应部位出现疼痛,还会引发和加重各种眼病。
长期用眼过度或眼睛将会引起不同程度的病变可致眼视力下降,形成近视、弱视、视疲劳或出现眼部酸困、眼框疼痛等症,严重可使视力模糊、眼花甚至失明。
目前,保护视力的方法主要有针灸、按摩、耳穴贴敷、放射状角膜切开术或镭射屈光性切除术或者药物治疗。针灸、按摩、耳穴贴敷其效果缓慢、不显著,且易反复;而通过手术方法治疗,眼角膜将减少原来的1/4,易产生脱落等不良状况。佩戴眼镜易导致视力下降,眼镜度数升高;药物治疗见效慢,药味难闻、口感差,长期服用不仅产生毒副作用,还产生患者排斥感,进而使得药物治疗只是治标不治本。
发明内容
本发明为解决上述技术问题,本发明提供了一种改善视力的中药组合物及其制备方法。
具体按照以下技术方案实现:
本发明提供了一种改善视力的中药组合物,所述中药组合物处方由如下重量份数原料组成:洋参5-6份、黄芪18-20份、石菖蒲10-12份、炙远志10-12份、草决明17-20份、密蒙花10-12份、石斛17-20份、石决明17-20份、女贞子10-20份、菟丝子17-20份、夜明砂10-12份、枸杞16-18份、葛根16-18份、蔓荆子16-18份、白芍10-12份、黄柏10-12份、茯苓18-20份、升麻8-10份、炙甘草4-6份、熟地18-20份、枣皮18-20份、菊花18-20份、柴胡18-20份、羊角8-10份。
进一步地优选,所述中药组合物处方由如下重量份数原料组成:洋参5.6份、黄芪19.3份、石菖蒲11.4份、炙远志11.7份、草决明18.5份、密蒙花11.0份、石斛19.0份、石决明18.6份、女贞子16.1份、菟丝子17.7份、夜明砂10.9份、枸杞17.0份、葛根17.2份、蔓荆子16.8份、白芍10.2份、黄柏11.2份、茯苓19.0份、升麻9.1份、炙甘草4.8份、熟地18.6份、枣皮19.1份、菊花18.7份、柴胡19.4份、羊角8.8份。
本发明的另一个目的是提供改善视力的中药组合物的制备方法,是将中药组合物中原料药按药味“甘、辛、苦”和“咸、酸”两种组合进行分类提取后依次经纳滤膜过滤、超滤膜过滤,合并过滤液,经超声波处理20-25s后,经减压浓缩,即得中药组合物。
所述药味“甘、辛、苦”的原料药,其提取方法为:将原料药采用冷风风干后,研磨至粒度过200目筛,然后向原料药中加入该类药味原料药总重(1.5-2)倍的水、(0.2-0.3)倍的葡萄糖/尿素组合物、(0.001-0.002)倍的纤维素酶/蛋白酶/果胶酶组合物,于温度为30-40℃条件下酶处理1-2h,再加入该类药味原料药总重(0.1%-0.2%)的乳酸菌,保持温度不变条件下恒温发酵1-2h。
所述葡萄糖/尿素组合物,葡萄糖与尿素的质量比为1:(0.2-0.3)。
所述纤维素酶/蛋白酶/果胶酶组合物,其接种量为纤维素酶:蛋白酶:果胶酶=(0.7-0.8):1:(0.2-0.5)。
所述药味“咸、酸”的原料药,其提取方法为:向该类药味原料药中加入其总重(5-7)倍的水,然后加热至42-48℃,保温30-45min,然后加热至65-68℃,保温1-1.5h,然后再加热至80-88℃,保温30-40min。
所述超声波,其功率为400-500W,频率为20MHz-30MHz。
所述纳滤膜,其分子量为600-1000道尔顿。
所述超滤膜,其分子量为2000-5000道尔顿。
所述减压浓缩是先在压力为0.3-0.4MPa的条件下浓缩至原体积1/2,然后在压力为0.2-0.28MPa的条件下浓缩至原体积1/3,然后在压力为0.09-0.15MPa的条件下浓缩至原体积1/4。
所述中药组合物提取物可直接或加入药学上可接受的辅料,制备各种口服制剂。
所述口服制剂的剂型包括但不限于丸剂、片剂、胶囊、颗粒剂或口服液。
本发明的中药组合物中各原料的功能、性状如下:
洋参又名西洋参,药性凉,药味甘、苦,归心、肺、肾经,无毒;具有益肺阴,清虚火,生津止渴的功效。治肺虚久嗽,失血,咽干口渴,虚热烦倦。
黄芪药性温,药味甘,归肺、脾经,具有补气固表,托疮生肌的功效。主治体虚自汗,久泻,脱肛,子宫脱垂,慢性肾炎,体虚浮肿,慢性溃疡,疮口久不愈合。
石菖蒲药性温,药味辛,归胃、心经,无毒;具有化湿开胃,开窍豁痰,醒神益智的功效。用于脘痞不饥,噤口下痢,神昏癫痫,健忘耳聋。
炙远志药性温,药味辛、苦、归心、肾经,无毒;具有宁心安神,祛痰开窍,解毒消肿的功效。主心神不安;惊悸失眠;健忘;惊痫;咳嗽痰多;痈疽发背;乳房肿痛。
草决明又名决明子,药性凉,药味甘、苦,归肝、肾经;无毒;具有清热明目,润肠通便的功效。用于目赤涩痛,羞明多泪,头痛眩晕,目暗不明,大便秘结。
密蒙花药性凉,药味甘,归肝经,无毒;具有清热养肝,明目退翳的功效。用于目赤肿痛,多泪羞明,眼生翳膜,肝虚目暗,视物昏花。
石斛药性寒,药味甘,归胃、肾经,无毒;具有益胃生津,滋阴清热的功效。用于热病津伤,口干烦渴,胃阴不足,食少干呕,病后虚热不退,阴虚火旺,骨蒸劳热,目暗不明,筋软。
石决明药性寒,药味咸,归肝经,无毒,具有平肝清热,明目去翳的功效。主头痛眩晕;目赤翳障;视物昏花;青盲雀目
女贞子药性平,药味甘、苦,归肝、肾经,无毒;具有滋补肝肾,明目乌发的功效。用于眩晕耳鸣,腰膝酸软,须发早白,目暗不明。
菟丝子药性温,药味甘,归肝、肾经,无毒;具有补肾益精,养肝明目,固胎止泄的功效。主腰膝酸痛;遗精;阳痿;早泄;不育;消渴;淋浊;遗尿;目昏耳鸣;胎动不安;流产;泄泻
夜明砂药性寒,药味辛,归肝经,无毒;具有清热明目,活血消积的功效。用于夜盲症,白内障,角膜云翳。
枸杞药性平,药味甘,归肝、肾经,无毒;具有滋补肝肾,益精明目的功效。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明。
葛根药性平,药味辛、甘,归胃、脾经,无毒,具有升阳解肌,透疹止泻,除烦止温的功效。治伤寒、温热头痛项强,烦热消渴,泄泻,痢疾,癍疹不透,高血压,心绞痛,耳聋。
蔓荆子药性凉,药味辛、苦,归胃、肝、膀胱经;具有疏散风热,清利头目的功效。用于风热感冒头痛,齿龈肿痛,目赤多泪,目暗不明,头晕目眩。
白芍药性寒,药味苦、酸,归肝、脾经;具有养血调经,敛阴止汗,柔肝止痛,平抑肝阳的功效。用于血虚萎黄,月经不调,自汗,盗汗,胁痛,腹痛,四肢挛痛,头痛眩晕。
黄柏药性寒,药味苦,归肾、膀胱经,无毒;具有清热燥湿,泻火解毒的功效。主湿热痢疾、泄泻、黄疸;梦遗、淋浊、带下;骨蒸劳热;以及口舌生疮;目赤肿痛;痈疽疮毒;皮肤湿疹。
茯苓药性平,药味甘、淡,归心、肺、脾经,具有利水渗湿,健脾宁心的功效。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
升麻药性凉,药味辛、甘、苦,归胃、肺、脾经,无毒;具有发表透疹,清热解毒,升举阳气的功效。用于风热头痛,齿痛,口疮,咽喉肿痛,麻疹不透,阳毒发斑;脱肛,子宫脱垂,
炙甘草药性平,药味甘,归胃、心、肺、脾经;具有补脾和胃,益气复脉的功效。用于脾胃虚弱,倦怠乏力,心动悸,脉结代。
熟地又名熟地黄,药性温,药味甘,归肾、肝经;具有滋阴,补血的功效。治阴虚血少,腰膝痿弱,劳嗽骨蒸,遗精,崩漏,月经不调,消渴,溲数,耳聋,目昏。
枣皮药性温,药味酸,归肝、肾经,无毒;具有补肝肾,涩精气,固虚脱的功效。
菊花药性凉,药味甘、苦,归肺、肝经,无毒;具有散风清热,平肝明目的功效。用于风热感冒,头痛眩晕,目赤肿痛,眼目昏花。
柴胡药性凉,药味苦,归胆、肝经,无毒;具有和解表里,疏肝,升阳的功效。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子官脱垂,脱肛。
羊角药性温,药味咸,无毒,归肝、肾、大肠经;具有润肠通便,清肝明目的功效,治疗便秘及高血脂,高血压。
本发明的有益效果在于:
本发明通过对洋参、黄芪、石菖蒲、炙远志、草决明、密蒙花、石斛、石决明、女贞子、菟丝子、夜明砂、枸杞、葛根、蔓荆子、白芍、黄柏、茯苓、升麻、炙甘草、熟地、枣皮、菊花、柴胡、羊角进行组合,使得该中药组合物具有益气养血、通络明目,能消除眼疲劳、恢复视力、滋益肝肾、清热生津、补血活血的功效。
本发明通过对原料药进行提取,充分提取了有效成分,提高药物的功效,能够有效调节肺、脾、肝、肾、胆等功能器官,进而改善了有效成分的药性发挥,本发明通过按照原料药的药味进行分类提取,不仅克服了提取率低下的问题,还调节了药味浓和口感涩的缺陷。
具体实施方式
下面对本发明的具体实施方式作进一步详细的说明,但本发明并不局限于这些实施方式,任何在本实施例基本精神上的改进或代替,仍属于本发明权利要求所要求保护的范围。
实施例1
一种改善视力的中药组合物,所述中药组合物处方由如下原料组成:洋参6g、黄芪20g、石菖蒲12g、炙远志12g、草决明20g、密蒙花12g、石斛20g、石决明20g、女贞子20g、菟丝子20g、夜明砂12g、枸杞18g、葛根18g、蔓荆子18g、白芍12g、黄柏12g、茯苓20g、升麻10g、炙甘草6g、熟地20g、枣皮20g、菊花20g、柴胡20g、羊角10g。
实施例2
一种改善视力的中药组合物,所述中药组合物处方由如下原料组成:洋参5g、黄芪18g、石菖蒲10g、炙远志10g、草决明17g、密蒙花10g、石斛17g、石决明17g、女贞子10g、菟丝子17g、夜明砂10g、枸杞16g、葛根16g、蔓荆子16g、白芍10g、黄柏10g、茯苓18g、升麻8g、炙甘草4g、熟地18g、枣皮18g、菊花18g、柴胡18g、羊角8g。
实施例3
一种改善视力的中药组合物,所述中药组合物处方由如下原料组成:洋参5.6g、黄芪19.3g、石菖蒲11.4g、炙远志11.7g、草决明18.5g、密蒙花11.0g、石斛19.0g、石决明18.6g、女贞子16.1g、菟丝子17.7g、夜明砂10.9g、枸杞17.0g、葛根17.2g、蔓荆子16.8g、白芍10.2g、黄柏11.2g、茯苓19.0g、升麻9.1g、炙甘草4.8g、熟地18.6g、枣皮19.1g、菊花18.7g、柴胡19.4g、羊角8.8g。
实施例4
一种改善视力的中药组合物,所述中药组合物处方由如下原料组成:洋参6.1g、黄芪20.1g、石菖蒲12.1g、炙远志12.1g、草决明20.1g、密蒙花12.1g、石斛20.1g、石决明20.1g、女贞子20.1g、菟丝子20.1g、夜明砂12.1g、枸杞18.1g、葛根18.1g、蔓荆子18.1g、白芍12.1g、黄柏12.1g、茯苓20.1g、升麻10.1g、炙甘草6.1g、熟地20.1g、枣皮20.1g、菊花20.1g、柴胡20.1g、羊角10.1g。
实施例5
一种改善视力的中药组合物,所述中药组合物处方由如下原料组成:洋参4.9g、黄芪17.9g、石菖蒲9.9g、炙远志9.9g、草决明16.9g、密蒙花9.9g、石斛16.9g、石决明16.9g、女贞子9.9g、菟丝子16.9g、夜明砂9.9g、枸杞15.9g、葛根15.9g、蔓荆子15.9g、白芍9.9g、黄柏9.9g、茯苓17.9g、升麻7.9.g、炙甘草3.9g、熟地17.9g、枣皮17.9g、菊花17.9g、柴胡17.9g、羊角7.9g。
实施例6-10
实施例6-10分别在实施例1-5的基础上提供改善视力的中药组合物的制备方法,是将中药组合物中原料药按药味“甘、辛、苦”和“咸、酸”两种组合进行分类提取后依次经纳滤膜过滤、超滤膜过滤,合并过滤液,经超声波处理25s后,经减压浓缩,即得中药组合物;
所述药味“甘、辛、苦”的原料药,其提取方法为:将原料药采用冷风风干后,研磨至粒度过200目筛,然后向原料药中加入该类药味原料药总重1.8倍的水、0.2倍的葡萄糖/尿素组合物、0.002倍的纤维素酶/蛋白酶/果胶酶组合物,于温度为35℃条件下酶处理1.5h,再加入该类药味原料药总重0.1%的乳酸菌,保持温度不变条件下恒温发酵2h;
所述葡萄糖/尿素组合物,葡萄糖与尿素的质量比为1:0.3;
所述纤维素酶/蛋白酶/果胶酶组合物,其接种量为纤维素酶:蛋白酶:果胶酶=0.8:1:0.2;
所述药味“咸、酸”的原料药,其提取方法为:向该类药味原料药中加入其总重6倍的水,然后加热至45℃,保温40min,然后加热至66℃,保温1.2h,然后再加热至85℃,保温35min;
所述超声波,其功率为450W,频率为25MHz;
所述纳滤膜,其分子量为900道尔顿;
所述超滤膜,其分子量为3000道尔顿;
所述减压浓缩是先在压力为0.3MPa的条件下浓缩至原体积1/2,然后在压力为0.22MPa的条件下浓缩至原体积1/3,然后在压力为0.12MPa的条件下浓缩至原体积1/4。
实施例11-15
实施例11-15分别在实施例6-10的基础上加入药学上可接受的辅料,制备各种口服制剂;所述口服制剂的剂型包括但不限于丸剂、片剂、胶囊、颗粒剂。
实施例16-20
实施例16-20分别在实施例6-10的基础上,加入葡萄糖和蒸馏水进行溶解,制成口服液,每100mL口服液中含中药组合物提取物25mg,葡萄糖20mg,每支10mL。
试验例1
临床试验
1.1一般资料
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100例,男、女各50例,平均年龄20-25岁;
对照组60例,男、女各30例,平均年龄20-25岁;
1.2试验方法
对照组用石斛夜光丸日服3次,每次1丸,连服4周;
治疗组用实施例18口服液每次20mL,每天3次,连服4周;
1.3疗效判断标准
痊愈:裸眼远视力≥5.0视力疲劳症状消失。
显效:裸眼远视力增加4行以上(包括4行)。
好转:裸眼远视力增加2-3行。
无效:裸眼远视力不增加或增加不到2行。
1.4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)
分组 | 例数 | 近视眼数 | 治疗前视力 | 治疗后视力 |
治疗组 | 100 | 234 | 4.56±0.32 | 4.93±0.22 |
对照组 | 60 | 118 | 4.57±0.28 | 4.70±0.17 |
注:治疗前后比例*P<0.01两组比较P<0.01
按照4周1个疗程,继续给药2个疗程,其疗效情况如下(见表2):
表2
分组 | 痊愈/例 | 显效/例 | 好转/例 | 无效/例 |
治疗组 | 30 | 58 | 12 | 0 |
对照组 | 4 | 26 | 30 | 1 |
试验例2
毒性试验
选择50只健康小鼠,体重80-120g,随机分为5组,每组雌雄各半,分别以实施例16-20制成的口服液进行给药,口服制剂灌胃给药0.5ml/次,每日早晚各一次。给药7天后,实施例16-18组的小鼠未见有异常表现,饮食和运动情况良好,死亡率为0;给予实施例20的小鼠出现轻微萎靡现象,食欲不振,毛发光泽度差;给予实施例19的小鼠出现昏厥、呕吐现象;给药15周后,实施例16-18的小鼠血象、生化指标、脏器系数均无显著性差异。并且,选择给药15周后,实施例16-18组的小鼠,分别在清醒和麻醉状态下进行中枢神经功能影响试验,发现给药后动物的血压、心率、呼吸等指标,用药前后均无明显变化,且未见动物有兴奋或抑制现象;
结果表明:在本发明的处方范围内,用药安全。
Claims (10)
1.一种改善视力的中药组合物,其特征在于,所述中药组合物处方由如下重量份数原料组成:洋参5-6份、黄芪18-20份、石菖蒲10-12份、炙远志10-12份、草决明17-20份、密蒙花10-12份、石斛17-20份、石决明17-20份、女贞子10-20份、菟丝子17-20份、夜明砂10-12份、枸杞16-18份、葛根16-18份、蔓荆子16-18份、白芍10-12份、黄柏10-12份、茯苓18-20份、升麻8-10份、炙甘草4-6份、熟地18-20份、枣皮18-20份、菊花18-20份、柴胡18-20份、羊角8-10份。
2.如权利要求1所述的改善视力的中药组合物,其特征在于,所述中药组合物处方由如下重量份数原料组成:洋参5.6份、黄芪19.3份、石菖蒲11.4份、炙远志11.7份、草决明18.5份、密蒙花11.0份、石斛19.0份、石决明18.6份、女贞子16.1份、菟丝子17.7份、夜明砂10.9份、枸杞17.0份、葛根17.2份、蔓荆子16.8份、白芍10.2份、黄柏11.2份、茯苓19.0份、升麻9.1份、炙甘草4.8份、熟地18.6份、枣皮19.1份、菊花18.7份、柴胡19.4份、羊角8.8份。
3.如权利要求1或2所述的改善视力的中药组合物的制备方法,其特征在于,是将中药组合物中原料药按药味“甘、辛、苦”和“咸、酸”两种组合进行分类提取后依次经纳滤膜过滤、超滤膜过滤,合并过滤液,经超声波处理20-25s后,经减压浓缩,即得中药组合物。
4.如权利要求3所述的改善视力的中药组合物的制备方法,其特征在于,所述药味“甘、辛、苦”的原料药,其提取方法为:将原料药采用冷风风干后,研磨至粒度过200目筛,然后向原料药中加入该类药味原料药总重(1.5-2)倍的水、(0.2-0.3)倍的葡萄糖/尿素组合物、(0.001-0.002)倍的纤维素酶/蛋白酶/果胶酶组合物,于温度为30-40℃条件下酶处理1-2h,再加入该类药味原料药总重(0.1%-0.2%)的乳酸菌,保持温度不变条件下恒温发酵1-2h。
5.如权利要求4所述的改善视力的中药组合物的制备方法,其特征在于,所述葡萄糖/尿素组合物,葡萄糖与尿素的质量比为1:(0.2-0.3)。
6.如权利要求4所述的改善视力的中药组合物的制备方法,其特征在于,所述纤维素酶/蛋白酶/果胶酶组合物,其接种量为纤维素酶:蛋白酶:果胶酶=(0.7-0.8):1:(0.2-0.5)。
7.如权利要求3所述的改善视力的中药组合物的制备方法,其特征在于,所述药味“咸、酸”的原料药,其提取方法为:向该类药味原料药中加入其总重(5-7)倍的水,然后加热至42-48℃,保温30-45min,然后加热至65-68℃,保温1-1.5h,然后再加热至80-88℃,保温30-40min。
8.如权利要求3所述的改善视力的中药组合物的制备方法,其特征在于,所述超声波,其功率为400-500W,频率为20MHz-30MHz。
9.如权利要求3所述的改善视力的中药组合物的制备方法,其特征在于,所述纳滤膜,其分子量为600-1000道尔顿。
10.如权利要求3所述的改善视力的中药组合物的制备方法,其特征在于,所述超滤膜,其分子量为2000-5000道尔顿。
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