CN114010591A - 一种视疲劳治疗的外用中药凝胶膏及其制备方法 - Google Patents
一种视疲劳治疗的外用中药凝胶膏及其制备方法 Download PDFInfo
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Abstract
本发明属于视疲劳治疗药物技术领域,公开了一种视疲劳治疗的外用中药凝胶膏及其制备方法,所述视疲劳治疗的外用中药凝胶膏的制备方法包括药材准备、提取物浸膏粉末制备和凝胶膏剂制备,所述中药原料药包括重量份艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆5‑10份,人工牛黄、芦荟、冰片、薄荷1‑5份。经提取后制成浸膏粉末,采用凝胶制备方法制作成凝胶膏外用制剂。本发明以中医临床治疗视疲劳的配方为基础,通过现代制剂方法,制作了方便易用、效果显著的纯天然中药凝胶膏,通过眼外贴敷,对于视疲劳的阅读疲劳、眼睛干涩、视物模糊、眼睛酸痛等症状,均具有明显的缓解作用。
Description
技术领域
本发明属于视疲劳治疗药物技术领域,尤其涉及一种视疲劳治疗的外用中药凝胶膏及其制备方法。
背景技术
目前,随着我国社会和经济的发展,社会环境已经发生了深刻的变化,电子视频终端如pad、手机、电脑等电子产品已深深地融入人们的生活和工作之中,加之工作节奏不断加快,学习任务重,视觉超负荷形成的视疲劳已成为时时困扰人们生活和工作的严重问题,越来越多的人出现眼睛干涩、胀痛、视物模糊、眼睛酸痛等视疲劳症状。据统计,我国约三分之一的学龄儿童、大部分的电脑使用者均出现了不同程度的视疲劳症状。目前西医多采取对症治疗,如施图伦眼药水、润洁萘扑维滴眼液,只能暂时缓解症状,长期疗效并不明显。中医针灸治疗虽然有效,但因为痛苦明显,治疗次数频繁,患者不易坚持。内服中药同样存在起效慢,患者对于长期服药不能坚持的问题。并不能达到根治的目的。
通过上述分析,现有技术存在的问题及缺陷为:
(1)目前西医多采取对症治疗只能暂时缓解症状,长期疗效并不明显。
(2)目前中医针灸治疗痛苦明显,治疗次数频繁,患者不易坚持;内服中药同样存在起效慢,患者对于长期服药不能坚持的问题。
解决以上问题及缺陷的难度为:随着青少年学业的加重,电子产品的普及,成年人对手机等电子产品的依赖,视疲劳的发生率呈暴发性增长,目前还没有疗效明显的治疗手段。
解决以上问题及缺陷的意义为:通过天然中药配制成外用制剂,不仅使用安全,疗效明显,而且携带方便,易于使用,成本低廉。视疲劳也是发展成近视的一个重要因素,通过天然中药外用制剂进行治疗,对防止近视的发生和发展也具有重要意义。
发明内容
针对现有技术存在的问题,本发明提供了一种视疲劳治疗的外用中药凝胶膏及其制备方法。
本发明是这样实现的,一种视疲劳治疗的外用中药凝胶膏,所述视疲劳治疗的外用中药凝胶膏按照重量份由艾叶5-10份、菊花5-10份、枸杞5-10份、生地5-10份、生山药5-10份、山茱萸5-10份、丹皮5-10份、茯苓5-10份、泽泻5-10份、白芍5-10份、牛膝5-10份、楮实子5-10份、鹅不食草5-10份、绿豆5-10份、人工牛黄1-5份、芦荟1-5份、冰片1-5份及薄荷1-5份组成。
本发明中药组合中各成分的功效:
由于视疲劳的发生因久视劳心伤神,耗伤气血,或劳瞻竭视,肝肾精血亏虚、目窍失养所致,与肝肾阴虚、脾胃虚弱、气滞血瘀有关,主要诱发因素是过用目力、劳心伤神。居于上述中医认识,本发明中药组合在长期临床治疗的基础上,进行了高效的配方筛选,形成了效果明显的中药组合。
艾叶:具有散寒止痛、温经活血的功效,有利于促进眼部血液循环、增加新陈代谢的能力。
菊花:具有散风清热、平肝明目的功效,有利缓解酸胀、眼睛发痒、视物昏花的症状。
枸杞:具有滋补肝肾、益精明目的功效,针对视疲劳肝肾阴虚的病机。
生地:具有清热凉血、养阴生津的功效,针对视疲劳肝肾阴虚的病机。
山药、茯苓:均具有健脾益胃的功能,针对视疲劳脾胃虚弱的病机。
山茱萸:具有补益肝肾的功效,针对视疲劳肝肾阴虚的病机。
丹皮:具有清热凉血、活血化瘀的功效,针对视疲劳气滞血瘀的病机。
泽泻:具有利水渗湿的功效,针对视疲劳脾胃虚弱引起的水湿停留的病机。
白芍:具有平肝止痛、养血敛阴、柔肝缓急的功效,有利于缓解视疲劳眼眶疼痛、眼部肌肉紧张的症状。
牛膝:具有补肝肾、强筋骨、逐瘀通经、引血下行的功效,针对视疲劳肝肾阴虚、瘀血阻滞的病机。
楮实子:具有补肾清肝、明的作用,可缓解视疲劳引起的眼胀、流泪、视物模糊的症状。
鹅不食草:具有解毒、通鼻窍、明目、散目赤肿的功效,可协助清除视疲劳状态下眼部聚集的毒素,缓解视物模糊的症状。
绿豆、人工牛黄、芦荟:三种中药均具有解毒功效,可协助清除视疲劳状态下眼部聚集的毒素,并可预防本发明中药组合制成的制剂在使用过程中皮肤的不适反应。
冰片:具有开窍醒神、散热止痛、明目的功效,不仅可缓解视疲劳的视物模糊症状,还可促进本发明中药组合的成分透皮吸收,其清凉的肤感也能增加本发明中药组合制成的外用制剂的舒适度。
薄荷:具有宣散风热、清头目的功效,可缓解视疲劳引起的前额部不适、眼球酸痛等症状。另外,薄荷本身的清凉肤感也能增加本发明中药组合制成的外用制剂的舒适度。
本发明的另一目的在于提供一种所述的视疲劳治疗的外用中药凝胶膏的制备方法,所述制备方法包括以下步骤:
第一步,准备各药材重量份为艾叶5-10份、菊花5-10份、枸杞5-10份、生地5-10份、生山药5-10份、山茱萸5-10份、丹皮5-10份、茯苓5-10份、泽泻5-10份、白芍5-10份、牛膝5-10份、楮实子5-10份、鹅不食草5-10份、绿豆5-10份、人工牛黄1-5份、芦荟1-5份、冰片1-5份、薄荷1-5份;
第二步,将艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆、薄荷表面的杂质和灰尘清理干净,人工牛黄、芦荟、冰片不做处理;
第三步,除人工牛黄、芦荟、冰片外,将重量份药材加入纯净水,浸泡;
第四步,煎煮提取,滤出药液;药渣再加量纯净水,煎煮提取,滤出药液;药渣再加纯净水,煎煮提取,滤出药液;
第五步,将三次滤出的药液合并,加入工牛黄、芦荟、冰片,边加热边搅拌,让人工牛黄、芦荟、冰片充分溶解;
第六步,将药液在室温状态下,密闭静置过夜,取上清;对上清进行离心,充分除去沉淀和杂质,得澄清滤液;将澄清滤液进行浓缩,制成浓缩液;
第七步,将上述浓缩液加入乙醇,充分搅拌混匀后,冷藏密封静置,过滤除去沉淀,回收乙醇,得提取物浸膏;将浸膏冷冻干燥后得到浸膏粉末;
第八步,将卡波姆940和泊洛沙姆188放置在蒸馏水内,使卡波姆940和泊洛沙姆188在蒸馏水溶液内分散;加入NaOH调节溶液的pH值;
第九步,向溶液内加入甘油,混合均匀;向溶液中加入抗氧化剂EDTA-2Na和表面活性剂吐温-80,混合均匀后得到凝胶膏基质;
第十步,向凝胶膏基质中加入中药提取物浸膏粉末,均质后得到本发明的中药凝胶膏。
进一步,所述第三步将重量份药材加入10倍量纯净水,浸泡2小时。
进一步,所述第四步煎煮提取1小时,滤出药液;药渣再加10倍量纯净水,煎煮提取1小时,滤出药液;药渣再加10倍量纯净水,煎煮提取1小时,滤出药液。
进一步,所述第六步将澄清滤液进行浓缩,制成1:2的浓缩液。
进一步,所述第七步将浓缩液加入95%乙醇至乙醇终浓度50%,充分搅拌混匀后,冷藏密封静置48小时。
进一步,所述第八步溶液终浓度中含卡波姆940为1%w/v,泊洛沙姆188为2.5%w/v;加入NaOH调节溶液的pH值为7.0。
进一步,所述第九步溶液终浓度中含甘油10%v/v,混合均匀;EDTA-2Na加入浓度为0.25‰w/v,吐温-80加入浓度为2%v/v,混合均匀后得到凝胶膏基质。
进一步,所述第十步向凝胶膏基质中加入中药提取物浸膏粉末,加入浓度为2.5~10%w/v。
进一步,所述凝胶膏剂的剂型为外用敷剂。
结合上述的所有技术方案,本发明所具备的优点及积极效果为:视疲劳是一个需要长期面对的疾病,外用凝胶膏剂具有携带便捷、使用方便、舒适滋润的特点,将中药提取物制成凝胶膏,通过涂抹上下眼睑给药,发挥了中药的外用的作用和外用凝胶膏的优势,避免了眼内直接给予眼药水或滴眼液等对眼部的刺激,可作为长期使用的视疲劳防治用品。
本发明的中药组合采用经过长期临床应用的中药配方,包括重量份艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆5-10份,人工牛黄、芦荟、冰片、薄荷1-5份,经现代技术方法提取浓缩活性成分,制备成方便易用的中药凝胶膏,对于视疲劳所出现的眼睛干涩、胀痛、视物模糊、眼睛酸痛等症状具有显著的治疗作用。
本发明以中医临床治疗视疲劳的配方为基础,通过现代制剂方法,制作了方便易用、效果显著的纯天然中药凝胶膏,采用优选配方制备的外用凝胶膏,通过眼外贴敷,对于视疲劳的眼睛干涩、胀痛、视物模糊、眼睛酸痛症状,均具有显著的缓解作用。
本发明通过现代技术对中药原料进行提取精制,提升了凝胶膏的质量,不仅有利于提高治疗视疲劳的效果,而且避免了局部的刺激和过敏现象,且滋润效果良好,使用舒适度高。
附图说明
图1是本发明实施例提供的视疲劳治疗的外用中药凝胶膏的制备方法流程图。
图2是本发明实施例提供的视疲劳治疗的外用中药凝胶膏的制备方法原理图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
针对现有技术存在的问题,本发明提供了一种视疲劳治疗的外用中药凝胶膏及其制备方法,下面结合附图对本发明作详细的描述。
本发明提供的视疲劳治疗的外用中药凝胶膏按照重量份由艾叶5-10份、菊花5-10份、枸杞5-10份、生地5-10份、生山药5-10份、山茱萸5-10份、丹皮5-10份、茯苓5-10份、泽泻5-10份、白芍5-10份、牛膝5-10份、楮实子5-10份、鹅不食草5-10份、绿豆5-10份、人工牛黄1-5份、芦荟1-5份、冰片1-5份及薄荷1-5份组成。
如图1所示,本发明提供的视疲劳治疗的外用中药凝胶膏的制备方法包括以下步骤:
S101:准备各药材重量份为艾叶5-10份、菊花5-10份、枸杞5-10份、生地5-10份、生山药5-10份、山茱萸5-10份、丹皮5-10份、茯苓5-10份、泽泻5-10份、白芍5-10份、牛膝5-10份、楮实子5-10份、鹅不食草5-10份、绿豆5-10份、人工牛黄1-5份、芦荟1-5份、冰片1-5份、薄荷1-5份;
S102:将艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆、薄荷表面的杂质和灰尘清理干净,人工牛黄、芦荟、冰片不做处理;
S103:除人工牛黄、芦荟、冰片外,将重量份药材加入10倍量纯净水,浸泡2小时;
S104:煎煮提取1小时,滤出药液;药渣再加10倍量纯净水,煎煮提取1小时,滤出药液;药渣再加10倍量纯净水,煎煮提取1小时,滤出药液;
S105:将三次滤出的药液合并,加入工牛黄、芦荟、冰片,边加热边搅拌,让人工牛黄、芦荟、冰片充分溶解;
S106:将药液在室温状态下,密闭静置过夜,取上清;对上清进行离心,充分除去沉淀和杂质,得澄清滤液;将澄清滤液进行浓缩,制成1:2的浓缩液;
S107:将上述浓缩液加入95%乙醇至乙醇终浓度50%,充分搅拌混匀后,冷藏密封静置48小时,过滤除去沉淀,回收乙醇,得提取物浸膏;将浸膏冷冻干燥后得到浸膏粉末;
S108:将卡波姆940和泊洛沙姆188放置在蒸馏水内,使卡波姆940和泊洛沙姆188在蒸馏水溶液内分散,溶液终浓度中含卡波姆940为1%(w/v),泊洛沙姆188为2.5%(w/v);加入NaOH调节上述溶液的pH值为7.0;
S109:向溶液内加入甘油,溶液终浓度中含甘油10%(v/v),混合均匀;向溶液中加入抗氧化剂EDTA-2Na和表面活性剂吐温-80,EDTA-2Na加入浓度为0.25‰(w/v),吐温-80加入浓度为2%(v/v),混合均匀后得到凝胶膏基质;
S110:向凝胶膏基质中加入中药提取物浸膏粉末,加入浓度为2.5~10%(w/v),均质后得到本发明的中药凝胶膏。
在本发明的实施例中:凝胶膏剂的剂型为外用敷剂。
本发明提供的视疲劳治疗的外用中药凝胶膏的制备方法业内的普通技术人员还可以采用其他的步骤实施,图1的本发明提供的视疲劳治疗的外用中药凝胶膏的制备方法仅仅是一个具体实施例而已。
下面结合具体实施例对本发明的技术方案作进一步的描述。
实施例1
本发明所述通过的中药组合浸膏粉的制备方法包括以下步骤:
步骤一:准确称取艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆各5克,人工牛黄、芦荟、冰片、薄荷各1克。
步骤二:除人工牛黄、芦荟、冰片外,将上述重量份计71克药材去除杂质和灰尘,加入10倍量纯净水计701ml,浸泡2小时。
步骤三:煎煮提取1小时,滤出药液;药渣加10倍量纯净水701ml,煎煮提取1小时,滤出药液;药渣再加10倍量纯净水701ml,煎煮提取1小时,滤出药液。
步骤四:将三次煎煮提取后的药液合并,加入人工牛黄、芦荟、冰片,边加热边搅拌,充分溶解于合并的滤液中。
步骤五:将上述药在室温状态下,密闭静置过夜,取上清。
步骤六:对上清进行离心,充分除去沉淀和杂质,得澄清滤液。
步骤七:将澄清滤液进行浓缩,制成1:2的浓缩液,计148ml。
步骤八:将上述浓缩液加95%的乙醇164ml,至乙醇终浓度为50%,充分搅拌混匀后,冷藏密封静置48小时,过滤除去沉淀,回收乙醇,浓缩成浸膏。
步骤九:将上述浸膏冷冻干燥后得到浸膏粉末。
实施例2
本发明实施例提供的中药组合浸膏粉的制备方法包括以下步骤:
步骤一:准确称取艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆各7.5克,人工牛黄、芦荟、冰片、薄荷各2.5克。
步骤二:除人工牛黄、芦荟、冰片外,将上述重量份计107.5克药材去除杂质和灰尘,加入10倍量纯净水计1075ml,浸泡2小时。
步骤三:煎煮提取1小时,滤出药液;药渣加10倍量纯净水1075ml,煎煮提取1小时,滤出药液;药渣再加10倍量纯净水1075ml,煎煮提取1小时,滤出药液。
步骤四:将三次煎煮提取后的药液合并,加入人工牛黄、芦荟、冰片,边加热边搅拌,充分溶解于合并的滤液中。
步骤五:将上述药在室温状态下,密闭静置过夜,取上清。
步骤六:对上清进行离心,充分除去沉淀和杂质,得澄清滤液。
步骤七:将澄清滤液进行浓缩,制成1:2的浓缩液,计230ml。
步骤八:将上述浓缩液加95%的乙醇256ml,至乙醇终浓度为50%,充分搅拌混匀后,冷藏密封静置48小时,过滤除去沉淀,回收乙醇,浓缩成浸膏。
步骤九:将上述浸膏冷冻干燥后得到浸膏粉末。
实施例3
本发明实施例提供的中药组合浸膏粉的制备方法包括以下步骤:
步骤一:准确称取艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆各10克,人工牛黄、芦荟、冰片、薄荷各5克。
步骤二:除人工牛黄、芦荟、冰片外,将上述重量份计145克药材去除杂质和灰尘,加入10倍量纯净水计1450ml,浸泡2小时。
步骤三:煎煮提取1小时,滤出药液;药渣加10倍量纯净水1450ml,煎煮提取1小时,滤出药液;药渣再加10倍量纯净水1450ml,煎煮提取1小时,滤出药液。
步骤四:将三次煎煮提取后的药液合并,加入人工牛黄、芦荟、冰片,边加热边搅拌,充分溶解于合并的滤液中。
步骤五:将上述药在室温状态下,密闭静置过夜,取上清。
步骤六:对上清进行离心,充分除去沉淀和杂质,得澄清滤液。
步骤七:将澄清滤液进行浓缩,制成1:2的浓缩液,计320ml。
步骤八:将上述浓缩液加95%的乙醇242ml,至乙醇终浓度为50%,充分搅拌混匀后,冷藏密封静置48小时,过滤除去沉淀,回收乙醇,浓缩成浸膏。
步骤九:将上述浸膏冷冻干燥后得到浸膏粉末。
实施例4
本发明实施例提供的凝胶基质的制备方法包括以下步骤:
步骤一:将卡波姆940(1克)和泊洛沙姆188(2.5克)放置在蒸馏水100ml内,使卡波姆940和泊洛沙姆188在蒸馏水溶液内分散。
步骤二:加入NaOH调节上述溶液的pH值为7.0。
步骤三:向上述溶液内加入甘油10毫升,搅拌混合均匀。
步骤四:向上述溶液内加入抗氧化剂EDTA-2Na(27.5毫克)和表面活性剂吐温-80(2.2毫升),混合均匀后得到凝胶基质。
实施例5
将实施例1中所得的中药提取物冻干浸膏粉,加入实施例4的凝胶基质中,均质后得到本发明的中药凝胶膏样品1。
实施例6
将实施例2中所得的中药提取物冻干浸膏粉,加入实施例4的凝胶基质中,均质后得到本发明的中药凝胶膏样品2。
实施例7
将实施例3中所得的中药提取物冻干浸膏粉,加入实施例4的凝胶基质中,均质后得到本发明的中药凝胶膏样品3。
下面结合试验对本发明的技术效果作详细的描述。
1.观察对象:受试例共200例,年龄18~45岁,其中男性,120例,女性80例。根据性别和年龄随机分组,保持各组在性别和年龄上的一致性。共分为4组,每组50例,分别为实施例5、实施例6、实施例7,以及对比例组,前三组分别外敷实施例5、实施例6、实施例7制备的样品1~3,对比例组外敷实施例4的凝胶膏基质。
2.诊断标准:根据《视疲劳诊疗专家共识2014》制定如下标准。
(1)无法耐受长时间近距离的用眼,视物重影或模糊,停止用眼后可缓解。
(2)持续3月以上的眼干、眼痒、眼部胀痛、畏光流泪、异物感、烧灼感等眼部局部不适症状。
(3)有或无头晕头痛、乏力、记忆力下降、恶心呕吐、焦虑烦躁等全身症状。
(4)眼科检查无斜视、弱视、屈光参差以及眼感染性、器质性疾病者。
(5)双眼远视力或矫正视力达到1.0及以上。
3.药物:实施例5~实施例7,实施例4(对比例)。
4.治疗方法:医用纱布及保鲜膜剪成5×6厘米大小备用,患者平躺于治疗床上,闭目,取一层纱布覆盖于双眼,然后均匀涂于本发明的中药凝胶膏,涂药范围包括整个眼部,涂药后先盖一层保鲜膜,再盖两层纱布,保持20分钟。
5.疗效标准:
5.1症状改善有效率:眼酸痛、眼胀、畏光、视物模糊、眼干涩、异物感、流泪,全身不适8种症状中有3种改善,且其他症状无恶化即判定症状改善。
症状改善有效率(%)=症状改善例数/总例数×100。
5.2症状积分评定:
表1视疲劳症状判定方法(半定量积分法)
注:“偶感”指1~2次/2天;“时有”指1~3次/天;“经常”指>3次/天。
5.3明视持久度检测:在检查表上绘制“品”字形立体方块图,方块每边长1cm,局部照明100~150LX(可使用专门制作的灯箱)。检查表与眼睛的距离应按照受试者视物习惯保持在适当距离不动,规定受试者看到“品”字图像视为明视,倒“品”字时为不明视,测定时间为3分钟。
明视持久度=(明视时间/注视总时间)×100%。
6.疗效判定:
(1)试验组自身比较或与对照组间比较,症状改善有效率或症状总积分差异有显著性(P<0.05)。
(2)试验组自身比较或试验组与对照组组间比较,明视持久度差异具有显著性(P<0.05),且平均明视持久度提高≥10%。
7.试验结果:
7.1本发明症状总积分及改善有效率;分别对四组受试者试验前后的症状改善总有效率进行了统计,表明实施例5~实施例7外敷治疗后总有效率达88%以上,且实施例7效果最佳,见表2。
表2中药凝胶膏外敷治疗前后症状改善总有效率(%)
同时,分别对四组受试者试验前后的症状总积分进行了分析,表明实施例5~实施例7外敷治疗前后的症状总积分显著改善(P<0.01),见表3。同时,实施例5~实施例7与实施例4(对比例)比较症状总积分也有明显改善(P<0.01),见表3。
表3中药凝胶膏外敷治疗前后症状总积分变化
外敷前后比较*P<0.01;与对照例比较,#P<0.01。
(2)明视持久度变化:实施例5~实施例7与实施例4(对比例)比较,明视持久度均有显著提高(P<0.01),见表4。且实施例5~实施例7的平均明视持久度提高≥10.1%。
外敷前后比较*P<0.01;与对照例比较,#P<0.01。
试验结果还表明,所有实施例和对照例在治疗过程中均未出现皮肤过敏和皮肤刺激反应,表明本发明的中药凝胶膏具有较高的使用安全性。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,都应涵盖在本发明的保护范围之内。
Claims (10)
1.一种视疲劳治疗的外用中药凝胶膏,其特征在于,所述视疲劳治疗的外用中药凝胶膏按照重量份由艾叶5-10份、菊花5-10份、枸杞5-10份、生地5-10份、生山药5-10份、山茱萸5-10份、丹皮5-10份、茯苓5-10份、泽泻5-10份、白芍5-10份、牛膝5-10份、楮实子5-10份、鹅不食草5-10份、绿豆5-10份、人工牛黄1-5份、芦荟1-5份、冰片1-5份及薄荷1-5份组成。
2.一种如权利要求1所述的视疲劳治疗的外用中药凝胶膏的制备方法,其特征在于,所述制备方法包括以下步骤:
第一步,准备各药材重量份为艾叶5-10份、菊花5-10份、枸杞5-10份、生地5-10份、生山药5-10份、山茱萸5-10份、丹皮5-10份、茯苓5-10份、泽泻5-10份、白芍5-10份、牛膝5-10份、楮实子5-10份、鹅不食草5-10份、绿豆5-10份、人工牛黄1-5份、芦荟1-5份、冰片1-5份、薄荷1-5份;
第二步,将艾叶、菊花、枸杞、生地、生山药、山茱萸、丹皮、茯苓、泽泻、白芍、牛膝、楮实子、鹅不食草、绿豆、薄荷表面的杂质和灰尘清理干净,人工牛黄、芦荟、冰片不做处理;
第三步,除人工牛黄、芦荟、冰片外,将重量份药材加入纯净水,浸泡;
第四步,煎煮提取,滤出药液;药渣再加量纯净水,煎煮提取,滤出药液;药渣再加纯净水,煎煮提取,滤出药液;
第五步,将三次滤出的药液合并,加入工牛黄、芦荟、冰片,边加热边搅拌,让人工牛黄、芦荟、冰片充分溶解;
第六步,将药液在室温状态下,密闭静置过夜,取上清;对上清进行离心,充分除去沉淀和杂质,得澄清滤液;将澄清滤液进行浓缩,制成浓缩液;
第七步,将上述浓缩液加入乙醇,充分搅拌混匀后,冷藏密封静置,过滤除去沉淀,回收乙醇,得提取物浸膏;将浸膏冷冻干燥后得到浸膏粉末;
第八步,将卡波姆940和泊洛沙姆188放置在蒸馏水内,使卡波姆940和泊洛沙姆188在蒸馏水溶液内分散;加入NaOH调节溶液的pH值;
第九步,向溶液内加入甘油,混合均匀;向溶液中加入抗氧化剂EDTA-2Na和表面活性剂吐温-80,混合均匀后得到凝胶膏基质;
第十步,向凝胶膏基质中加入中药提取物浸膏粉末,均质后得到本发明的中药凝胶膏。
3.如权利要求2所述的制备方法,其特征在于,所述第三步将重量份药材加入10倍量纯净水,浸泡2小时。
4.如权利要求2所述的制备方法,其特征在于,所述第四步煎煮提取1小时,滤出药液;药渣再加10倍量纯净水,煎煮提取1小时,滤出药液;药渣再加10倍量纯净水,煎煮提取1小时,滤出药液。
5.如权利要求2所述的制备方法,其特征在于,所述第六步将澄清滤液进行浓缩,制成1:2的浓缩液。
6.如权利要求2所述的制备方法,其特征在于,所述第七步将浓缩液加入95%乙醇至乙醇终浓度50%,充分搅拌混匀后,冷藏密封静置48小时。
7.如权利要求2所述的制备方法,其特征在于,所述第八步溶液终浓度中含卡波姆940为1%w/v,泊洛沙姆188为2.5%w/v;加入NaOH调节溶液的pH值为7.0。
8.如权利要求2所述的制备方法,其特征在于,所述第九步溶液终浓度中含甘油10%v/v,混合均匀;EDTA-2Na加入浓度为0.25‰w/v,吐温-80加入浓度为2%v/v,混合均匀后得到凝胶膏基质。
9.如权利要求2所述的制备方法,其特征在于,所述第十步向凝胶膏基质中加入中药提取物浸膏粉末,加入浓度为2.5~10%w/v。
10.如权利要求2所述的制备方法,其特征在于,所述凝胶膏剂的剂型为外用敷剂。
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