CN117482207A - 一种活血通络改善微循环的中药制剂及其制备方法 - Google Patents
一种活血通络改善微循环的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明属于医药生物技术领域,具体为一种活血通络改善微循环的中药制剂及其制备方法。本发明的活血通络改善微循环的中药制剂由内服制剂和外敷制剂两部分组成,内外协调,活血化瘀,能够快速的达到消肿止痛的作用。本发明利用介孔二氧化硅控制中药组分的释放速率,采用椰子油、芦荟多糖作为渗透剂,通过调整配比,能够较大化的提高中药组分的利用率。本发明进一步采用壳聚糖接枝聚乳酸衍生物对缓释纳米球进行包覆,其能够提高缓释纳米球的分散性和稳定性,从而进一步提高中药组分的利用率。由此,本发明采用的活血通络改善微循环的中药制剂对中药提取物的利用效果极佳,能够长时间稳定的发挥出活血通络改善微循环,促进消炎止痛的作用。
Description
技术领域
本发明属于医药生物技术领域,具体为一种活血通络改善微循环的中药制剂及其制备方法。
背景技术
"活血通络"是中医中常用的一个概念,它涉及到促进血液流动和改善微循环,以维持身体健康。具体来说,活血通络指的是以下方面的功能和效果:(1)促进血液循环:活血通络有助于改善全身的血液循环,确保氧气和营养物质能够有效地输送到各个组织和细胞中,同时有害代谢产物和废物能够被及时清除。(2)缓解瘀血和淤血:这一概念强调减轻和消散体内的瘀血(由于血液淤积而引起的血液淤滞)和淤血(局部血液循环障碍)。这些问题可能会导致疼痛、肿胀、瘀斑和其他不适症状。(3)解决气血不畅:中医认为,气血畅通对于身体健康至关重要。"活血通络"的概念包括调整和平衡体内的气血,以确保它们自由流动,不受阻碍。(4)缓解疼痛:通过促进血液流动,活血通络可以减轻因瘀血、淤血或气血不畅引起的疼痛,特别是关节疼痛、肌肉疼痛和头痛等。
随着现代工业、交通的发展和体育运动的普及,急性软组织损伤是人类生活中的一利常见病、多发病,且对人体所造成的疼痛对工作和生活造成严重影响。急性软组织损伤包括软组织挫伤和关节扭伤。软组织挫伤是指直接暴力(如跌扑、撞击、重物挤压等)作用于人体而引起的闭合性损伤,以局部皮下及深部软组织损伤为主、轻者局部瘀肿,重者肌肉、肌腱、韧带乃至血管、神经受损。关节扭伤系指任何关节(包括可动和微动关节)突然发生超出生理范围的活动,引起关节周围的关节囊、肌肉、肌腱、韧带过度牵拉而造成部分组织结构的扭错或微细的断裂损伤。急性扭挫伤多由暴力打击或冲撞肢体局部,或不慎跌扑强力扭转肢体而发病。受伤的组织产生组织间出血、渗出、水肿和坏死等反应,伤后局部立刻出现剧痛、肿胀和活动受限。中医认为急性软组织损伤属于中医急性伤筋范畴,主要是指外来暴力猛烈撞击,不慎跌扑或强力扭转,以致气滞血瘀,筋肉受损,经络阻隔,故见疼痛剧烈;淤血阻滞则见瘀斑、肿胀,由于气血阻隔,经络不通,故见肢节屈伸不利等证。这是暴力作用于人体局部,致使局部筋脉损伤,气血妄行于脉外并瘀阻经脉而成。及时有效的治疗极为重要,否则就会造成淤血久滞经络,形成筋挛、紧缩等迁延难愈的慢性损伤。
对于急性扭挫伤一般采用冰敷、休息、固定和中药外敷等治疗。传统的中药外敷虽然具有一定的效果,但存在着使用不便、药物浪费等缺点;近年来研制的一些外用制剂也存在着作用短暂、皮肤刺激性强、气味浓烈和易于污染衣物等问题。中医中药对于跌打损伤的治疗具有丰富的经验和特色,在市售药品中虽不少见,但是能够迅速起效者为数甚少,因此,如何增强外用活血通络中药的药效,延长药效作用时间,使其使用方便、作用迅速成为了研究的重点。
发明内容
针对现有技术存在的缺陷,本发明提供了一种活血通络改善微循环的中药制剂及其制备方法。
所述活血通络改善微循环的中药制剂,由内服制剂和外敷制剂两部分组成。
所述内服制剂,包括以下原料:人参、酸枣仁、葛根、蒲公英、海参肽、决明子、山楂、枸杞、黄精、乌梢蛇、维生素C、维生素E、维生素B、葡萄糖、牛蒡根、牛磺酸、麦芽糊精、低聚果糖。
优选地,所述内服制剂,按质量份计,包括以下原料:1-2份人参、3-5份酸枣仁、3-5份葛根、0.5-1份蒲公英、5-7份决明子、5-7份山楂、6-8份枸杞、3-5份黄精、1-3份乌梢蛇、3-5份牛蒡根、0.1-0.5份海参肽、0.05-0.1份维生素C、0.05-0.1份维生素E、0.05-0.1份维生素B、0.5-1份葡萄糖、0.05-0.1份牛磺酸、0.5-1份麦芽糊精、1-2份低聚果糖。
所述内服制剂的制备方法,包括以下步骤:按质量份计,将1-2份人参、3-5份酸枣仁、3-5份葛根、0.5-1份蒲公英、5-7份决明子、5-7份山楂、6-8份枸杞、3-5份黄精、1-3份乌梢蛇、3-5份牛蒡根混合,加入100-200份水,置于自动煎药设备上,煎药工序分为两步,第一步90-98℃下,以100-200r/min速率搅拌5-8min,第二步45-60℃下,以100-200r/min速率搅拌20-30min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:(6-12)混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作1-2次,将多次过滤得到的滤液合并,低温干燥,得到中药提取物粉末;将上述中药提取物粉末和0.1-0.5份海参肽、0.05-0.1份维生素C、0.05-0.1份维生素E、0.05-0.1份维生素B、0.5-1份葡萄糖、0.05-0.1份牛磺酸、0.5-1份麦芽糊精、1-2份低聚果糖混合,得到所述内服制剂。
所述外敷制剂,包括以下原料:活血通络中药缓释剂、渗透剂、乳化剂、溶剂。
优选地,所述外敷制剂,按质量份计,包括以下原料:15-30份活血通络中药缓释剂、2-4份渗透剂、4-6份乳化剂、70-80份溶剂。
所述渗透剂为椰子油、芦荟多糖、甘油中的至少一种;优选地,所述渗透剂由椰子油、芦荟多糖按质量比(1-2):1混合而成。
所述乳化剂为卵磷脂、明胶、胶原蛋白中的至少一种。
所述溶剂为水、松节油中的至少一种;优选地,所述溶剂由水、松节油按质量比(6-10):(1-2)混合而成。
所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备中药提取物缓释纳米球;
(2)制备微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体混合,制备活血通络中药缓释剂。
优选地,所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将10-20份当归、15-30份川芎、5-10份丹参、10-20份川牛膝、10-20份三七、20-30份桃仁、10-20份红花、600-1000份水混合,置于自动煎药设备上,煎药工序分为两步,第一步90-98℃下,以100-200r/min速率搅拌5-8min,第二步45-60℃下,以100-200r/min速率搅拌20-30min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:(6-12)混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作1-2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物;接着,将5-10份介孔二氧化硅纳米球、10-20份步骤(1)得到的活血通络中药提取物混合,以100-200r/min转速搅拌10-20min,使得活血通络中药提取物被介孔二氧化硅充分吸附,经干燥后,得到中药提取物缓释纳米球;
(2)按质量份计,将20-30份壳聚糖接枝聚乳酸衍生物、80-100份20wt%乙醇水溶液混合,以100-200r/min转速搅拌10-20min,得到微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球加入到步骤(2)得到的微胶囊前驱体中,以100-200r/min转速搅拌40-60min,然后置于室温下干燥,得到所述活血通络中药缓释剂。
步骤(3)中所述步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体的质量比为1:(2-4)。
步骤(2)所述壳聚糖接枝聚乳酸衍生物的制备方法,包括以下步骤:
S1按质量份计,在80-90℃、氮气氛围下,将1-2份壳聚糖溶于5-10份1-丁基-3-甲基咪唑氯盐中,并以100-200r/min转速搅拌2-4h,制得壳聚糖溶液;
S2称取3-4份D-丙交酯直接加入到壳聚糖溶液中,并逐滴加入0.3-1份辛酸亚锡,将反应温度升至120-140℃,搅拌反应20-26h;反应完成后,将反应产物倒入20-400ml的无水乙醇中,搅拌20-40min并静置沉淀,然后过滤得到褐色沉淀,将所述褐色沉淀用无水乙醇洗涤2-4次,然后在索氏抽提器中以丙酮为溶剂抽提20-30h,将抽提后的固体产物于室温下真空干燥12-24h,即得到两亲性的壳聚糖接枝聚乳酸衍生物。
所述外敷制剂的制备方法,包括以下步骤:按质量份计,将15-30份活血通络中药缓释剂、2-4份渗透剂、4-6份乳化剂、70-80份溶剂混合,以100-200r/min转速搅拌5-10min后,得到所述活血通络改善微循环的中药制剂。
当归(Angelica sinensis(Oliv.)Diels):当归是一种常用的中药,被认为有助于促进血液循环,调节月经,以及缓解疼痛。
川芎(Ligusticum sinense'Chuanxiong'):川芎也有助于改善血液循环,特别是在头部和颈部,可以帮助缓解头痛和偏头痛。
丹参(Salvia miltiorrhiza Bunge):丹参被广泛用于中医,有助于改善心血管系统功能,促进血液循环。
川牛膝(Cyathula officinalis Kuan):川牛膝也可以帮助活血通络,特别是在关节和肌肉的微循环。
三七(Panax notoginseng(Burkill)F.H.Chen ex C.H.Chow):三七被认为可以帮助减轻淤血和瘀血,促进血液循环。
桃仁(Prunus persica(L.)):桃仁有助于防止血液凝结,有助于改善血液流动。
本发明采用了介孔二氧化硅吸收中药提取物,得到缓释纳米球,利用介孔二氧化硅控制中药组分的释放速率,达到延长药物作用时间的目的。此外,本发明还采用椰子油、芦荟多糖作为渗透剂,椰子油中的中链脂肪酸可以增加皮肤对药物成分的吸收,同时具有保湿作用,芦荟中的多糖和生物活性化合物可以增加药物成分在皮肤上的分布和渗透,二者协同,通过调整配比,能够较大化的提高中药组分的利用率。进一步的,由于介孔二氧化硅较小的粒径,其易团聚沉淀,分散性不佳,本发明采用壳聚糖接枝聚乳酸衍生物对缓释纳米球进行包覆,由于壳聚糖接枝聚乳酸衍生物在水和有机溶剂中均表现出良好的溶解性,其能够提高缓释纳米球的分散性和稳定性,从而进一步提高中药组分的利用率。此外,由于壳聚糖接枝聚乳酸衍生物在制备过程中,壳聚糖是溶解在1-丁基-3-甲基咪唑氯盐中的,1-丁基-3-甲基咪唑氯盐可以与药物分子相互作用,降低角质层的抵抗力,促进药物的渗透,其还可以改善药物的溶解度,从而提高了药物的稳定性和吸收性。由此,本发明采用的活血通络改善微循环的中药制剂对中药提取物的利用效果极佳,能够长时间稳定的发挥出活血通络改善微循环,促进消炎止痛的作用。
本发明的有益效果:
本发明的活血通络改善微循环的中药制剂由内服制剂和外敷制剂两部分组成,内外协调,活血化瘀,能够快速的达到消肿止痛的作用。本发明利用介孔二氧化硅控制中药组分的释放速率,采用椰子油、芦荟多糖作为渗透剂,通过调整配比,能够较大化的提高中药组分的利用率。本发明进一步采用壳聚糖接枝聚乳酸衍生物对缓释纳米球进行包覆,其能够提高缓释纳米球的分散性和稳定性,从而进一步提高中药组分的利用率。由此,本发明采用的活血通络改善微循环的中药制剂对中药提取物的利用效果极佳,能够长时间稳定的发挥出活血通络改善微循环,促进消炎止痛的作用。
具体实施方式
在本发明中,若非特指,所有设备和原料均可从市场购得或是本行业常用,下述实施例中的方法,如无特别说明,均为本领域常规方法。
椰子油,货号:YHZC0105,上海茁忻实业有限公司。
芦荟多糖,货号:SXBC0001,陕西邦诚生物科技有限公司。
胶原蛋白,货号:20220302YJY,肽度科技(厦门)有限公司。
松节油,货号:8006-64-2,吉水县聚源堂天然香料油有限公司。
介孔二氧化硅纳米球,粒径:200-400nm。
壳聚糖,货号:FM-112605,陕西飞米生物科技有限公司。
D-丙交酯,货号:GA3989,湖北广奥生物科技有限公司。
实施例1
一种活血通络改善微循环的中药制剂,由内服制剂和外敷制剂两部分组成。
所述内服制剂,按质量份计,包括以下原料:1.8份人参、3.2份酸枣仁、4份葛根、0.8份蒲公英、6份决明子、6份山楂、7份枸杞、4份黄精、2份乌梢蛇、4份牛蒡根、0.3份海参肽、0.07份维生素C、0.06份维生素E、0.06份维生素B、0.8份葡萄糖、0.08份牛磺酸、0.8份麦芽糊精、1.2份低聚果糖。
所述外敷制剂的制备方法,包括以下步骤:按质量份计,将20份活血通络中药缓释剂、3份渗透剂、5份乳化剂、72份溶剂混合,以120r/min转速搅拌10min后,得到所述活血通络改善微循环的中药制剂。
所述乳化剂为胶原蛋白。
所述溶剂由水、松节油按质量比(6-10):(1-2)混合而成。
所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将15份当归、20份川芎、8份丹参、15份川牛膝、15份三七、25份桃仁、15份红花、900份水混合,置于自动煎药设备上,煎药工序分为两步,第一步96℃下,以120r/min速率搅拌6min,第二步50℃下,以120r/min速率搅拌25min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:8混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物;接着,将8份介孔二氧化硅纳米球、16份步骤(1)得到的活血通络中药提取物混合,以120r/min转速搅拌15min,使得活血通络中药提取物被介孔二氧化硅充分吸附,经干燥后,得到中药提取物缓释纳米球;
(2)按质量份计,将25份壳聚糖接枝聚乳酸衍生物、90份20wt%乙醇水溶液混合,以120r/min转速搅拌15min,得到微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球加入到步骤(2)得到的微胶囊前驱体中,以120r/min转速搅拌50min,然后置于室温下干燥,得到所述活血通络中药缓释剂。
步骤(3)中所述步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体的质量比为1:3。
步骤(2)所述壳聚糖接枝聚乳酸衍生物的制备方法,包括以下步骤:
S1按质量份计,在80℃、氮气氛围下,将1份壳聚糖溶于5份1-丁基-3-甲基咪唑氯盐中,并以120r/min转速搅拌3h,制得20wt%的壳聚糖溶液;
S2称取3.6份D-丙交酯直接加入到壳聚糖溶液中,并逐滴加入0.5份辛酸亚锡,将反应温度升至130℃,搅拌反应24h;反应完成后,将反应产物倒入250ml的无水乙醇中,搅拌30min并静置沉淀,然后过滤得到褐色沉淀,将所述褐色沉淀用无水乙醇洗涤3次,然后在索氏抽提器中以丙酮为溶剂抽提24h,将抽提后的固体产物于室温下真空干燥24h,即得到两亲性的壳聚糖接枝聚乳酸衍生物。
实施例2
一种活血通络改善微循环的中药制剂,由内服制剂和外敷制剂两部分组成。
所述内服制剂,按质量份计,包括以下原料:1.8份人参、3.2份酸枣仁、4份葛根、0.8份蒲公英、6份决明子、6份山楂、7份枸杞、4份黄精、2份乌梢蛇、4份牛蒡根、0.3份海参肽、0.07份维生素C、0.06份维生素E、0.06份维生素B、0.8份葡萄糖、0.08份牛磺酸、0.8份麦芽糊精、1.2份低聚果糖。
所述外敷制剂的制备方法,包括以下步骤:按质量份计,将20份活血通络中药缓释剂、3份渗透剂、5份乳化剂、72份溶剂混合,以120r/min转速搅拌10min后,得到所述活血通络改善微循环的中药制剂。
所述渗透剂为椰子油。
所述乳化剂为胶原蛋白。
所述溶剂由水、松节油按质量比(6-10):(1-2)混合而成。
所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将15份当归、20份川芎、8份丹参、15份川牛膝、15份三七、25份桃仁、15份红花、900份水混合,置于自动煎药设备上,煎药工序分为两步,第一步96℃下,以120r/min速率搅拌6min,第二步50℃下,以120r/min速率搅拌25min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:8混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物;接着,将8份介孔二氧化硅纳米球、16份步骤(1)得到的活血通络中药提取物混合,以120r/min转速搅拌15min,使得活血通络中药提取物被介孔二氧化硅充分吸附,经干燥后,得到中药提取物缓释纳米球;
(2)按质量份计,将25份壳聚糖接枝聚乳酸衍生物、90份20wt%乙醇水溶液混合,以120r/min转速搅拌15min,得到微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球加入到步骤(2)得到的微胶囊前驱体中,以120r/min转速搅拌50min,然后置于室温下干燥,得到所述活血通络中药缓释剂。
步骤(3)中所述步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体的质量比为1:3。
步骤(2)所述壳聚糖接枝聚乳酸衍生物的制备方法,包括以下步骤:
S1按质量份计,在80℃、氮气氛围下,将1份壳聚糖溶于5份1-丁基-3-甲基咪唑氯盐中,并以120r/min转速搅拌3h,制得20wt%的壳聚糖溶液;
S2称取3.6份D-丙交酯直接加入到壳聚糖溶液中,并逐滴加入0.5份辛酸亚锡,将反应温度升至130℃,搅拌反应24h;反应完成后,将反应产物倒入250ml的无水乙醇中,搅拌30min并静置沉淀,然后过滤得到褐色沉淀,将所述褐色沉淀用无水乙醇洗涤3次,然后在索氏抽提器中以丙酮为溶剂抽提24h,将抽提后的固体产物于室温下真空干燥24h,即得到两亲性的壳聚糖接枝聚乳酸衍生物。
实施例3
一种活血通络改善微循环的中药制剂,由内服制剂和外敷制剂两部分组成。
所述内服制剂,按质量份计,包括以下原料:1.8份人参、3.2份酸枣仁、4份葛根、0.8份蒲公英、6份决明子、6份山楂、7份枸杞、4份黄精、2份乌梢蛇、4份牛蒡根、0.3份海参肽、0.07份维生素C、0.06份维生素E、0.06份维生素B、0.8份葡萄糖、0.08份牛磺酸、0.8份麦芽糊精、1.2份低聚果糖。
所述外敷制剂的制备方法,包括以下步骤:按质量份计,将20份活血通络中药缓释剂、3份渗透剂、5份乳化剂、72份溶剂混合,以120r/min转速搅拌10min后,得到所述活血通络改善微循环的中药制剂。
所述渗透剂为芦荟多糖。
所述乳化剂为胶原蛋白。
所述溶剂由水、松节油按质量比(6-10):(1-2)混合而成。
所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将15份当归、20份川芎、8份丹参、15份川牛膝、15份三七、25份桃仁、15份红花、900份水混合,置于自动煎药设备上,煎药工序分为两步,第一步96℃下,以120r/min速率搅拌6min,第二步50℃下,以120r/min速率搅拌25min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:8混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物;接着,将8份介孔二氧化硅纳米球、16份步骤(1)得到的活血通络中药提取物混合,以120r/min转速搅拌15min,使得活血通络中药提取物被介孔二氧化硅充分吸附,经干燥后,得到中药提取物缓释纳米球;
(2)按质量份计,将25份壳聚糖接枝聚乳酸衍生物、90份20wt%乙醇水溶液混合,以120r/min转速搅拌15min,得到微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球加入到步骤(2)得到的微胶囊前驱体中,以120r/min转速搅拌50min,然后置于室温下干燥,得到所述活血通络中药缓释剂。
步骤(3)中所述步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体的质量比为1:3。
步骤(2)所述壳聚糖接枝聚乳酸衍生物的制备方法,包括以下步骤:
S1按质量份计,在80℃、氮气氛围下,将1份壳聚糖溶于5份1-丁基-3-甲基咪唑氯盐中,并以120r/min转速搅拌3h,制得20wt%的壳聚糖溶液;
S2称取3.6份D-丙交酯直接加入到壳聚糖溶液中,并逐滴加入0.5份辛酸亚锡,将反应温度升至130℃,搅拌反应24h;反应完成后,将反应产物倒入250ml的无水乙醇中,搅拌30min并静置沉淀,然后过滤得到褐色沉淀,将所述褐色沉淀用无水乙醇洗涤3次,然后在索氏抽提器中以丙酮为溶剂抽提24h,将抽提后的固体产物于室温下真空干燥24h,即得到两亲性的壳聚糖接枝聚乳酸衍生物。
实施例4
一种活血通络改善微循环的中药制剂,由内服制剂和外敷制剂两部分组成。
所述内服制剂,按质量份计,包括以下原料:1.8份人参、3.2份酸枣仁、4份葛根、0.8份蒲公英、6份决明子、6份山楂、7份枸杞、4份黄精、2份乌梢蛇、4份牛蒡根、0.3份海参肽、0.07份维生素C、0.06份维生素E、0.06份维生素B、0.8份葡萄糖、0.08份牛磺酸、0.8份麦芽糊精、1.2份低聚果糖。
所述外敷制剂的制备方法,包括以下步骤:按质量份计,将20份活血通络中药缓释剂、3份渗透剂、5份乳化剂、72份溶剂混合,以120r/min转速搅拌10min后,得到所述活血通络改善微循环的中药制剂。
所述渗透剂由椰子油、芦荟多糖按质量比2:1混合而成。
所述乳化剂为胶原蛋白。
所述溶剂由水、松节油按质量比(6-10):(1-2)混合而成。
所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将15份当归、20份川芎、8份丹参、15份川牛膝、15份三七、25份桃仁、15份红花、900份水混合,置于自动煎药设备上,煎药工序分为两步,第一步96℃下,以120r/min速率搅拌6min,第二步50℃下,以120r/min速率搅拌25min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:8混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物;接着,将8份介孔二氧化硅纳米球、16份步骤(1)得到的活血通络中药提取物混合,以120r/min转速搅拌15min,使得活血通络中药提取物被介孔二氧化硅充分吸附,经干燥后,得到中药提取物缓释纳米球;
(2)按质量份计,将25份壳聚糖接枝聚乳酸衍生物、90份20wt%乙醇水溶液混合,以120r/min转速搅拌15min,得到微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球加入到步骤(2)得到的微胶囊前驱体中,以120r/min转速搅拌50min,然后置于室温下干燥,得到所述活血通络中药缓释剂。
步骤(3)中所述步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体的质量比为1:3。
步骤(2)所述壳聚糖接枝聚乳酸衍生物的制备方法,包括以下步骤:
S1按质量份计,在80℃、氮气氛围下,将1份壳聚糖溶于5份1-丁基-3-甲基咪唑氯盐中,并以120r/min转速搅拌3h,制得20wt%的壳聚糖溶液;
S2称取3.6份D-丙交酯直接加入到壳聚糖溶液中,并逐滴加入0.5份辛酸亚锡,将反应温度升至130℃,搅拌反应24h;反应完成后,将反应产物倒入250ml的无水乙醇中,搅拌30min并静置沉淀,然后过滤得到褐色沉淀,将所述褐色沉淀用无水乙醇洗涤3次,然后在索氏抽提器中以丙酮为溶剂抽提24h,将抽提后的固体产物于室温下真空干燥24h,即得到两亲性的壳聚糖接枝聚乳酸衍生物。
实施例5
一种活血通络改善微循环的中药制剂,由内服制剂和外敷制剂两部分组成。
所述内服制剂,按质量份计,包括以下原料:1.8份人参、3.2份酸枣仁、4份葛根、0.8份蒲公英、6份决明子、6份山楂、7份枸杞、4份黄精、2份乌梢蛇、4份牛蒡根、0.3份海参肽、0.07份维生素C、0.06份维生素E、0.06份维生素B、0.8份葡萄糖、0.08份牛磺酸、0.8份麦芽糊精、1.2份低聚果糖。
所述外敷制剂的制备方法,包括以下步骤:按质量份计,将20份活血通络中药缓释剂、3份渗透剂、5份乳化剂、72份溶剂混合,以120r/min转速搅拌10min后,得到所述活血通络改善微循环的中药制剂。
所述渗透剂由椰子油、芦荟多糖按质量比2:1混合而成。
所述乳化剂为胶原蛋白。
所述溶剂由水、松节油按质量比(6-10):(1-2)混合而成。
所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将15份当归、20份川芎、8份丹参、15份川牛膝、15份三七、25份桃仁、15份红花、900份水混合,置于自动煎药设备上,煎药工序分为两步,第一步96℃下,以120r/min速率搅拌6min,第二步50℃下,以120r/min速率搅拌25min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:8混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物;接着,将8份介孔二氧化硅纳米球、16份步骤(1)得到的活血通络中药提取物混合,以120r/min转速搅拌15min,使得活血通络中药提取物被介孔二氧化硅充分吸附,经干燥后,得到所述活血通络中药缓释剂。
实施例6
一种活血通络改善微循环的中药制剂,由内服制剂和外敷制剂两部分组成。
所述内服制剂,按质量份计,包括以下原料:1.8份人参、3.2份酸枣仁、4份葛根、0.8份蒲公英、6份决明子、6份山楂、7份枸杞、4份黄精、2份乌梢蛇、4份牛蒡根、0.3份海参肽、0.07份维生素C、0.06份维生素E、0.06份维生素B、0.8份葡萄糖、0.08份牛磺酸、0.8份麦芽糊精、1.2份低聚果糖。
所述外敷制剂的制备方法,包括以下步骤:按质量份计,将20份活血通络中药缓释剂、3份渗透剂、5份乳化剂、72份溶剂混合,以120r/min转速搅拌10min后,得到所述活血通络改善微循环的中药制剂。
所述渗透剂由椰子油、芦荟多糖按质量比2:1混合而成。
所述乳化剂为胶原蛋白。
所述溶剂由水、松节油按质量比(6-10):(1-2)混合而成。
所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将15份当归、20份川芎、8份丹参、15份川牛膝、15份三七、25份桃仁、15份红花、900份水混合,置于自动煎药设备上,煎药工序分为两步,第一步96℃下,以120r/min速率搅拌6min,第二步50℃下,以120r/min速率搅拌25min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:8混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物,经干燥后,得到所述活血通络中药缓释剂。
测试例1
采用成龄健康雄鼠120只,随机分成6个组,每组20只。
将大鼠右侧臀部软组织区域的毛剪去4cm2,然后置软组织砸伤架上,用打击锤对准剪毛区并避开腿骨,将重量为1000克的铁锤由24cm高度砸下致伤。致伤1小时后在损伤部位涂抹药物,给药量为1mL,每天1次,连续3天。观察肿胀程度。结果见表1。
表1:消肿作用检测结果
至伤1h(mm) | 第1天(mm) | 第3天(mm) | |
实施例1 | 2.31 | 1.62 | 0.64 |
实施例2 | 2.34 | 1.39 | 0.45 |
实施例3 | 2.33 | 1.37 | 0.42 |
实施例4 | 2.37 | 1.26 | 0.23 |
实施例5 | 2.35 | 1.87 | 0.87 |
实施例6 | 2.36 | 2.03 | 0.92 |
由表1可以看出,本发明实施例4采用的活血通络改善微循环的中药制剂消肿效果最好,仅三天小鼠肿胀部位基本消肿,这是由于本发明采用了介孔二氧化硅吸收中药提取物,得到缓释纳米球,利用介孔二氧化硅控制中药组分的释放速率,达到延长药物作用时间的目的。此外,本发明还采用椰子油、芦荟多糖作为渗透剂,椰子油中的中链脂肪酸可以增加皮肤对药物成分的吸收,同时具有保湿作用,芦荟中的多糖和生物活性化合物可以增加药物成分在皮肤上的分布和渗透,二者协同,通过调整配比,能够较大化的提高中药组分的利用率。进一步的,由于介孔二氧化硅较小的粒径,其易团聚沉淀,分散性不佳,本发明采用壳聚糖接枝聚乳酸衍生物对缓释纳米球进行包覆,由于壳聚糖接枝聚乳酸衍生物在水和有机溶剂中均表现出良好的溶解性,其能够提高缓释纳米球的分散性和稳定性,从而进一步提高中药组分的利用率。此外,由于壳聚糖接枝聚乳酸衍生物在制备过程中,壳聚糖是溶解在1-丁基-3-甲基咪唑氯盐中的,1-丁基-3-甲基咪唑氯盐可以与药物分子相互作用,降低角质层的抵抗力,促进药物的渗透,其还可以改善药物的溶解度,从而提高了药物的稳定性和吸收性。由此,本发明实施例4采用的活血通络改善微循环的中药制剂对中药提取物的利用效果最佳,能够长时间稳定的发挥出活血通络改善微循环,促进消炎止痛的作用。由实施例1、实施例2、实施例3、实施例4的对比可以看出,渗透剂对于促进中药组分的吸收有着积极的作用。尤其是涂抹药物的第三天,实施例1不加渗透剂,其消肿效果明显弱于实施例2-4。实施例4和实施例5、实施例6的对比也可以明显看出,介孔二氧化硅和壳聚糖接枝聚乳酸衍生物的包覆对发挥中药提取物的药力有着积极的作用。
Claims (10)
1.一种活血通络改善微循环的中药制剂,其特征在于,由内服制剂和外敷制剂两部分组成。
2.如权利要求1所述活血通络改善微循环的中药制剂,其特征在于,所述内服制剂,包括以下原料:人参、酸枣仁、葛根、蒲公英、海参肽、决明子、山楂、枸杞、黄精、乌梢蛇、维生素C、维生素E、维生素B、葡萄糖、牛蒡根、牛磺酸、麦芽糊精、低聚果糖。
3.如权利要求1所述活血通络改善微循环的中药制剂,其特征在于,所述外敷制剂,包括以下原料:活血通络中药缓释剂、渗透剂、乳化剂、溶剂。
4.如权利要求3所述活血通络改善微循环的中药制剂,其特征在于,所述渗透剂为椰子油、芦荟多糖、甘油中的至少一种。
5.如权利要求3所述活血通络改善微循环的中药制剂,其特征在于,所述乳化剂为卵磷脂、明胶、胶原蛋白中的至少一种。
6.如权利要求3所述活血通络改善微循环的中药制剂,其特征在于,所述溶剂为水、松节油中的至少一种。
7.如权利要求3所述活血通络改善微循环的中药制剂,其特征在于,所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备中药提取物缓释纳米球;
(2)制备微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体混合,制备活血通络中药缓释剂。
8.如权利要求7所述活血通络改善微循环的中药制剂,其特征在于,所述活血通络中药缓释剂的制备方法,包括以下步骤:
(1)制备活血通络中药提取物:按质量份计,将10-20份当归、15-30份川芎、5-10份丹参、10-20份川牛膝、10-20份三七、20-30份桃仁、10-20份红花、600-1000份水混合,置于自动煎药设备上,煎药工序分为两步,第一步90-98℃下,以100-200r/min速率搅拌5-8min,第二步45-60℃下,以100-200r/min速率搅拌20-30min,冷却、过滤,收集滤液并回收滤渣,进行滤渣的再次煎煮,将滤渣和水以质量比1:(6-12)混合,使用相同两步煎药工序煎煮,再次冷却、过滤,重复回收滤渣、滤渣的再次煎煮操作1-2次,将多次过滤得到的滤液合并,置入自动浓缩设备中,低温减压浓缩至原体积的1/5-1/10,得到活血通络中药提取物;接着,将5-10份介孔二氧化硅纳米球、10-20份步骤(1)得到的活血通络中药提取物混合,以100-200r/min转速搅拌10-20min,使得活血通络中药提取物被介孔二氧化硅充分吸附,经干燥后,得到中药提取物缓释纳米球;
(2)按质量份计,将20-30份壳聚糖接枝聚乳酸衍生物、80-100份20wt%乙醇水溶液混合,以100-200r/min转速搅拌10-20min,得到微胶囊前驱体;
(3)将步骤(1)得到的中药提取物缓释纳米球加入到步骤(2)得到的微胶囊前驱体中,以100-200r/min转速搅拌40-60min,然后置于室温下干燥,得到所述活血通络中药缓释剂。
9.如权利要求8所述活血通络改善微循环的中药制剂,其特征在于,步骤(3)中所述步骤(1)得到的中药提取物缓释纳米球和步骤(2)得到的微胶囊前驱体的质量比为1:(2-4)。
10.如权利要求8所述活血通络改善微循环的中药制剂,其特征在于,步骤(2)所述壳聚糖接枝聚乳酸衍生物的制备方法,包括以下步骤:
S1按质量份计,在80-90℃、氮气氛围下,将1-2份壳聚糖溶于5-10份1-丁基-3-甲基咪唑氯盐中,并以100-200r/min转速搅拌2-4h,制得壳聚糖溶液;
S2称取3-4份D-丙交酯直接加入到壳聚糖溶液中,并逐滴加入0.3-1份辛酸亚锡,将反应温度升至120-140℃,搅拌反应20-26h;反应完成后,将反应产物倒入20-400ml的无水乙醇中,搅拌20-40min并静置沉淀,然后过滤得到褐色沉淀,将所述褐色沉淀用无水乙醇洗涤2-4次,然后在索氏抽提器中以丙酮为溶剂抽提20-30h,将抽提后的固体产物于室温下真空干燥12-24h,即得到两亲性的壳聚糖接枝聚乳酸衍生物。
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