CN116098970A - 一种脉络舒通提取物的制备方法 - Google Patents
一种脉络舒通提取物的制备方法 Download PDFInfo
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- CN116098970A CN116098970A CN202111327184.9A CN202111327184A CN116098970A CN 116098970 A CN116098970 A CN 116098970A CN 202111327184 A CN202111327184 A CN 202111327184A CN 116098970 A CN116098970 A CN 116098970A
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Abstract
本发明属于中药技术领域,具体涉及一种脉络舒通提取物的制备方法。所述脉络舒通提取物由黄芪、金银花、黄柏、苍术、薏苡仁、玄参、当归、白芍、甘草、水蛭、全蝎、蜈蚣十二味原料药材制备而成。本发明所述的制备方法,首先对水蛭、全蝎、蜈蚣3种贵细动物药材采用微滤和超滤进行滤过,并采用冷冻干燥工艺,有效去除了动物药材的腥臭味,减少了提取物干粉的量,在保证动物药材全成分提取入药的前提下,减少了服用剂量,改善了口感。金银花采用后下的方式进行挥发油提取,提高了脉络舒通提取物药效成分的含量及挥发油得量,操作过程趋于简单、连续、高效,并可提高产品稳定性,保证了产品质量。
Description
技术领域
本发明属于中药技术领域,具体涉及一种中药提取物的制备方法,尤其涉及一种脉络舒通提取物的制备方法。
背景技术
脉络舒通制剂处方在祖传验方的基础上,结合当归补血汤、芍药甘草汤、四妙勇安汤、止痉散等方衍化而来,处方由黄芪、金银花、黄柏、苍术、薏苡仁、玄参、当归、白芍、甘草、水蛭、全蝎、蜈蚣十二味中药精制而成,具有清热解毒,化瘀通络,祛湿消肿之功效,主要用于湿热瘀阻脉络所致的血栓性浅静脉炎,非急性期深静脉血栓形成所致的下肢肢体肿胀、疼痛、肤色暗红或伴有条索状物。本方以黄芪、金银花为君药,益气利水、清热解毒、泻阴火、解肌毒、清秽恶、疗积毒;黄柏、苍术、薏苡仁、当归、白芍、玄参为臣药,清热祛湿、补血养血、缓急解挛、和营止痛、软坚散结、消肿解毒、使脉络通畅;水蛭、全蝎、蜈蚣为佐药,活血消瘀、攻毒散结、通络止痛;甘草为使药调和诸药。诸药配伍,共奏清热解毒、化瘀通络、利水消肿之功,药专力宏,取得了良好的临床疗效。
同系产品包括脉络舒通颗粒、脉络舒通颗粒(无糖型)、脉络舒通丸(浓缩丸)等剂型,其中脉络舒通颗粒于1998年获得新药证书(中药第三类新药)和生产批件;脉络舒通颗粒(无糖型)于2012年获得药品补充申请批件;脉络舒通丸(浓缩丸)于2009年获得药品注册批件,均为国内独家生产,是第一个批准用于治疗血栓性浅静脉炎的中成药,该系列产品的上市填补了国内外中药治疗湿热瘀阻脉络药物的市场空白。
CN1201787C公开了一种治疗血栓性静脉炎的药物,CN103933410A公开了一种中药组合物的医药用途及其制备方法,CN101618161B公开了一种治疗血栓性静脉炎的中药组合物及其制备方法,以上专利文献公开的脉络舒通提取、制剂方法均为:水蒸气蒸馏提取挥发油,加入环糊精进行包合,得环糊精包合物;剩余药材加入1/2处方量的动物药材及提取挥发油后的药渣进行水提醇沉,减压浓缩出浸膏,进行干燥得提取物干粉;将剩余1/2处方量动物药材粉碎成所需粒径药粉,加入提取物干粉、挥发油包合物及适量不同品种的药用辅料制成适宜的剂型。CN110123968A公开了一种脉络舒通制剂的制备方法,该专利文献技术方案主要是在上述专利文件脉络舒通常规提取、制剂方法的基础上,对3种动物药材采用双提法(醇回流和水煎煮)进行单独提取,其余提取、制剂方法与以上方法一致。
现有脉络舒通制剂的制备方法存在诸多缺点与不足,如金银花随其他提取挥发油药材同时投入进行挥发油提取,但金银花中绿原酸在长时间受热情况下易被破坏;原制剂方法中有1/2处方量的动物药材不经过提取步骤直接以动物原粉入药,不仅增大患者的服用剂量,而且浓烈的动物药材的腥臭味导致患者服用的依从性差;采用双提取法对动物药材进行单独提取,虽然解决了服用剂量大及制剂浓烈的腥臭味,但动物药材中有效成分不仅仅含有水溶性及醇溶性有效成分,双提取法不能够将动物药材中有效成分完全提出,特别是此3种动物药材为贵细动物药材,会造成资源浪费,影响制剂疗效。
发明内容
针对现有技术存在的缺陷与不足,本发明提供了一种脉络舒通提取物的制备方法,通过对原有脉络舒通组合物提取方法进行改进,对3种贵细动物药材粉碎加水搅拌提取后,进一步采用微滤和超滤进行滤过,对滤液进一步冷冻干燥成冻干粉,有效去除动物药材的腥臭气味,并且减少了提取物干粉的量,在保证了动物药材全成分提取入药的前提下,减少了服用剂量,改善了口感。
本发明还将金银花以后下的方式进行挥发油提取,提高了脉络舒通提取物中标志性药效成分的含量及挥发油的提取量,使操作过程趋于简单、连续、高效,并可提高产品稳定性,保证产品质量,进而保证了产品的临床疗效。
本发明的技术方案如下:
一种脉络舒通提取物的制备方法,所述脉络舒通提取物由黄芪、金银花、黄柏、苍术、玄参、当归、白芍、薏苡仁、甘草、蜈蚣、全蝎和水蛭等12味原料药材制成。所述方法包括对蜈蚣、全蝎和水蛭三味动物药材进行粉碎后加水搅拌提取,离心后得上清液和沉淀,上清液经微滤、超滤处理后再冷冻干燥成细粉,沉淀进行水煮提取;对当归、苍术、玄参、白芍和金银花药材采用水蒸馏提取挥发油后再用水煎煮提取;对黄芪、黄柏、薏苡仁、甘草进行加水煎煮提取。
优选地,所述中药组合物的提取方法包括如下步骤:
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加纯化水,搅拌,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以微孔滤膜滤过,收集滤液,超滤,收集截留液,冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加6-12倍量纯化水蒸馏提取挥发油5-6h,然后加入金银花继续提取挥发油1-2h,得挥发油,加入环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加8-12倍量水,煎煮两次,每次1-3h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.12-1.20的浸膏,加入乙醇使含醇量达60%-80%,冷藏24-48h,回收乙醇,浓缩至60℃时相对密度为1.15-1.25的浸膏,干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉。
优选地,步骤1)加水量为5-12倍药材量水,搅拌5-36h;
优选步骤1)加水量为药材的10倍量,搅拌24-36h。
优选地,步骤2)所述超滤膜的截留相对分子质量为1000-10000Da,超滤所得截留液保留至0.25-0.4倍量动物药材重量;
优选地,步骤2)所述超滤膜的截留相对分子质量为6000-10000Da,超滤所得截留液保留至0.25-0.3倍量动物药材重量。
优选地,步骤1)所述的冷冻干燥曲线如下:
进一步优选,步骤1)所述的冷冻干燥曲线如下:
优选地,步骤3)中当归、苍术、玄参、白芍加8倍量水蒸馏提取挥发油6h后,再加入金银花提取挥发油1h。
优选地,步骤5)加入乙醇使醇含量达70%,冷藏36h。
优选地,步骤5)所述的干燥过程为常压干燥、减压干燥或流化干燥;进一步包括烘箱常压干燥,真空带式干燥,喷雾干燥等。
脉络舒通提取物由以下重量份原料药材的制成:
优选地,所述的脉络舒通提取物由以下重量份原料药材的制成:
优选地,所述的脉络舒通提取物由以下重量份原料药材的制成:
需要说明的是,本发明的提取方法可应用于脉络舒通制剂中,必要时还可在浸膏中加入药用辅料以制备适合临床上可接受的制剂。
本发明所述脉络舒通提取物的制备方法的技术优势在于:
1、本发明的制备方法,将水蛭、蜈蚣、全蝎三种贵细动物药材采用搅拌法提取,使得更接近原生药粉入药的制剂方式,避免了仅醇溶性成分和水溶性成分入药造成的资源浪费,改善了动物药材原粉入药造成的强烈的腥臭味;本发明脉络舒通提取纯化工艺所得的干粉量相比现有技术所得冻干粉量显著减少,降低了制剂的服用剂量,提高了制剂的有效性及患者用药的顺应性。
2、本发明对金银花药材选用后下的方式进行提取挥发油,挥发油提取量相比现有技术得到有效提高,既可以保证处方中含有挥发性成分的药材提取所得挥发油可以更加全面,又可以使长时间受热易被破坏的金银花中绿原酸成分得到保护,药效成分保留率显著提高。
为验证本发明脉络舒通提取物制备工艺的稳定性和可行性,发明人开展了标志性药效成分含量测定对比试验研究、腥臭味评价试验研究。需要说明的是,本发明药效学试验所选取的脉络舒通提取物为本发明具有代表性的制备方法所得样品。本发明所包含的其它制备方法所得样品所涉及的试验及其结果,限于篇幅,在此不一一穷举。
实验例1标志性药效成分含量测定对比试验研究
为了验证本发明技术方案对制剂中标志性药效成分绿原酸含量的提升效果,对本发明实施例1-3所制备的提取物细粉加入适量糊精、阿司帕坦、羟丙基淀粉钠等辅料,混匀,制粒,干燥,制成10kg颗粒剂。对不同提取方法制备的颗粒剂进行测定,绿原酸含量测定方法如下:
色谱条件与系统适用性试验用十八烷基硅烷键合硅胶为填充剂;乙腈:0.4%磷酸溶液=10:90为流动相;蒸发光散射检测器检测;检测波长为327nm;理论板数按绿原酸峰计算应不低于1000。
对照品溶液的制备精密称取绿原酸对照品适量,加甲醇制成每1ml含0.05mg的溶液。摇匀,即得。
供试品溶液的制备取样品1g精密称定重量,置具塞锥形瓶中,加50%的甲醇50ml,称定重量,超声30min,放冷,再称定重量。用50%的甲醇补足减失重量,摇匀,滤过,取滤液适量加入棕色量瓶即得供试样品溶液。
测定法取对照品溶液、供试品溶液,分别进样20μl,采用外标两点法对数方程计算样品中绿原酸的含量。测定结果如表1所示。
表1 不同提取方法绿原酸含量的测定
实验例2腥臭味评价试验
选取10名(5男5女)20-35岁成年男女作为志愿者,建立味觉评价小组。分别对实施例1及对比实施例1-2所制备的颗粒剂进行评价,每个样品由评价小组评价三次,漱口后品尝不同方法制备的颗粒剂,并在口腔内停留30后吐出。根据口感评价0s和30s后的腥臭味,并根据表2的评价标准分级进行打分,分值越高,口感效果较差。各志愿者独立测试,并且两个样品之间间隔2min。
表2 味觉评价小组腥臭味评价标准分级表
实施例1和对比实施例1-2是基于相同重量份的原料药材,不同制备方法所得到的颗粒剂;实施例1是采用本发明的方法制备的颗粒剂,对比实施例1-2是采用现有技术制备的颗粒剂。评价结果如表3所示。
表3 味觉评价评分结果
以上结果表明,本发明脉络舒通提取物制备方法相比现有技术,能够更大程度地去除动物药材腥臭气味,提高患者用药依从性,且能有效避金银花有效成分损失,有利于脉络舒通临床价值的充分发挥。
具体实施方式
下面通过具体实施例来对本发明得技术方案进行详细说明;但本领域技术人员应该知晓,所述实施例并不以任何方式限制本发明。
实施例1脉络舒通提取物的制备
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加10倍量纯化水,搅拌36h,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以0.22μm滤膜滤过,收集滤液,再经截留分子量为8000Da的超滤膜超滤约至1L,收集截留液,按照下述冷冻曲线冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加8倍量纯化水蒸馏提取挥发油6h,然后加入金银花继续提取挥发油1h,收集挥发油9.1ml,加入90gβ-环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加10倍量水,煎煮两次,每次2h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.12的浸膏,加入乙醇使含醇量达70%,冷藏36h,回收乙醇,浓缩至60℃时相对密度为1.25的浸膏,真空带式干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉3.32kg。
实施例2脉络舒通提取物的制备
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加12倍量纯化水,搅拌24h,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以0.22μm滤膜滤过,收集滤液,再经截留分子量为6000Da的超滤膜超滤至1.2L,收集截留液,按照下述冷冻曲线冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加8倍量纯化水蒸馏提取挥发油5h,然后加入金银花继续提取挥发油2h,收集挥发油8.9ml,加入71.2gβ-环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加8倍量水,煎煮两次,第1次煎煮3h,第2次煎煮2h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.15的浸膏,加入乙醇使含醇量达60%,冷藏48h,回收乙醇,浓缩至60℃时相对密度为1.20的浸膏,真空带式干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉3.41kg。
实施例3脉络舒通提取物的制备
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加8倍量纯化水,搅拌24h,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以0.22μm滤膜滤过,收集滤液,再经截留分子量为10000Da的超滤膜超滤至1.1L,收集截留液,按照下述冷冻曲线冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加8倍量纯化水蒸馏提取挥发油3h,然后加入金银花继续提取挥发油4h,收集挥发油7.2ml,加入72gβ-环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加12倍量水,煎煮两次,第1次煎煮2h,第2次煎煮1h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.20的浸膏,加入乙醇使含醇量达80%,冷藏24h,回收乙醇,浓缩至60℃时相对密度为1.25的浸膏,真空带式干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉3.28kg。
实施例4脉络舒通提取物的制备
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加10倍量纯化水,搅拌36h,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以0.22μm滤膜滤过,收集滤液,再经截留分子量为8000Da的超滤膜超滤至750ml,收集截留液,按照下述冷冻曲线冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加8倍量纯化水蒸馏提取挥发油6h,然后加入金银花继续提取挥发油1h,收集挥发油7.7ml,加入80gβ-环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加10倍量水,煎煮两次,每次2h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.10的浸膏,加入乙醇使含醇量达70%,冷藏36h,回收乙醇,浓缩至60℃时相对密度为1.21的浸膏,真空带式干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉2.65kg。
实施例5脉络舒通提取物的制备
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加5倍量纯化水,搅拌36h,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以0.22μm滤膜滤过,收集滤液,再经截留分子量为8000Da的超滤膜超滤至600ml,收集截留液,按照下述冷冻曲线冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加8倍量纯化水蒸馏提取挥发油6h,然后加入金银花继续提取挥发油1h,收集挥发油4.3ml,加入35gβ-环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加10倍量水,煎煮两次,每次2h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.10的浸膏,加入乙醇使含醇量达70%,冷藏48h,回收乙醇,浓缩至60℃时相对密度为1.15的浸膏,真空干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉1.80kg。
实施例6脉络舒通提取物的制备
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加12倍量纯化水,搅拌5h,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以0.22μm滤膜滤过,收集滤液,再经截留分子量为8000Da的超滤膜超滤至1.5L,收集截留液,按照下述冷冻曲线冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加8倍量纯化水蒸馏提取挥发油6h,然后加入金银花继续提取挥发油1h,收集挥发油13.4ml,加入107gβ-环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加10倍量水,煎煮两次,每次2h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.15的浸膏,加入乙醇使含醇量达65%,冷藏36h,回收乙醇,浓缩至60℃时相对密度为1.23的浸膏,喷雾干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉4.65kg。
对比实施例1脉络舒通颗粒的制备
1)取金银花、苍术、玄参、当归、白芍置于多功能提取罐内进行水蒸气蒸馏7h,得挥发油6.8ml,加无水乙醇,混合均匀,得乙醇挥发油溶液,置密闭容器内贮存。
2)取黄芪、黄柏、薏苡仁、甘草及1/2处方量得水蛭、蜈蚣、全蝎以及蒸馏后得要炸加水煎煮2次,时间分别为1.5小时和1小时,合并两次煎液,过滤,取蒸馏后的药液合并浓缩,冷去后加乙醇至醇含量60%,静置12小时以上,使之充分沉淀;将上青叶过滤,回收乙醇,减压浓缩至相对密度为1.30的浸膏,浸膏经真空干燥得干膏;
3)将另1/2量的水蛭、蜈蚣、全蝎粉碎成细粉,与步骤2)所得干膏混匀得干物质5.15kg,加入适量糖粉、糊精混匀;加入乙醇作为润湿剂制成软材,入沸腾式干燥床干燥,喷洒步骤1)所得挥发油,得脉络舒通颗粒剂。
对比实施例2脉络舒通颗粒的制备
1)将水蛭、蜈蚣、全蝎三种动物药材净选、水洗、灭菌、干燥处理后,超微粉碎机组进行超微粉碎,使药粉平均粒径小于1μm;
2)将金银花、苍术、玄参、当归、白芍加入8倍量水提取挥发油7h,收集挥发油6.5ml;药渣与黄芪、黄柏、薏苡仁、甘草一起加10倍量水煎煮2次,每次2h,煎煮液合并后过滤、浓缩至相对密度为1.20,再加乙醇至醇含量为60%,醇沉24h,取上清液减压浓缩回收乙醇至相对密度1.30得浸膏;浸膏经真空干燥成细粉;
3)将步骤1)所得超微粉碎粉与步骤2)所得细粉混匀共6.8kg,加适量制粒液混合搅拌制粒,干燥,整粒,喷入步骤2)所得挥发油,混匀后得脉络舒通颗粒。
Claims (10)
1.一种脉络舒通提取物的制备方法,其特征在于,包括下列步骤:
1)取蜈蚣、水蛭、全蝎3味动物药材,粉碎,加纯化水,搅拌,混匀,离心,分别收集上清液和沉淀,备用;
2)取步骤1)上清液,以微孔滤膜滤过,收集滤液,超滤,收集截留液,冷冻干燥,得动物药材冻干粉,备用;
3)取当归、苍术、玄参、白芍4味原料药材,加6-12倍量纯化水蒸馏提取挥发油5-6h,然后加入金银花继续提取挥发油1-2h,得挥发油,加入环糊精包合,制成挥发油环糊精包合物,备用;蒸馏后的水溶液及药渣,备用;
4)取黄芪、黄柏、薏苡仁4味原料药材以及步骤1)沉淀和步骤2)药渣,混匀,加8-12倍量水,煎煮两次,每次1-3h,煎煮液滤过,减压浓缩,得浓缩液,备用;
5)取步骤4)浓缩液,与步骤3)蒸馏后的水溶液合并,减压浓缩至60℃时相对密度为1.1-1.2的浸膏,加入乙醇使含醇量达60%-80%,冷藏24-48h,回收乙醇,浓缩至60℃时相对密度为1.15-1.25的浸膏,干燥成细粉,得提取物干粉,备用;
6)取步骤2)动物药材冻干粉、步骤3)挥发油环糊精包合物和步骤5)提取物干粉,混匀,即得脉络舒通提取物细粉。
2.根据权利要求1所述的制备方法,其特征在于,步骤1)加5-12倍量纯化水,搅拌5-36h。
3.根据权利要求1所述的制备方法,其特征在于,步骤2)所述超滤膜的截留相对分子质量为6000-10000Da,超滤所得截留液保留至0.25-0.3倍量动物药材重量。
6.根据权利要求1所述的制备方法,其特征在于,步骤3)中当归、苍术、玄参、白芍加8倍量水蒸馏提取挥发油6h后,再加入金银花提取挥发油1h。
7.根据权利要求1所述的制备方法,其特征在于,步骤5)加入乙醇使得醇含量为70%,冷藏36h。
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