CN103372139B - 含有生脉饮有效成分的药物组合物 - Google Patents
含有生脉饮有效成分的药物组合物 Download PDFInfo
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- CN103372139B CN103372139B CN201210123905.9A CN201210123905A CN103372139B CN 103372139 B CN103372139 B CN 103372139B CN 201210123905 A CN201210123905 A CN 201210123905A CN 103372139 B CN103372139 B CN 103372139B
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- fruit
- tuber
- chinese magnoliavine
- dwarf lilyturf
- extract
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Abstract
本发明涉及一种含有生脉饮有效成分的药物组合物,该组合物含有红参总皂苷15‑35重量份,麦冬总多糖150‑250重量份,五味子木脂素2‑4重量份。
Description
技术领域:
本发明涉及一种药物组合物,特别涉及一种含有生脉饮有效成分的药物组合物。
背景技术:
生脉饮,为一种传统中药,配方为:人参100克,麦冬200克,五味子100克。
方中人参甘平,益气复脉,生津止渴,振兴元气,为主药。麦冬甘寒,益胃生津,清心除烦,润肺养阴,为辅药。五味子酸温,敛肺益气,生津止渴,固表止汗,宁心安神。三药合用,一补一清一敛,共奏益气复脉、养阴生津、润肺止咳之功。
生脉饮主治温病热伤气阴,倦怠气短懒言,口渴多汗脉虚;或气阴不足,亡津失水,心悸气短,脉微虚汗;或肺虚久咳,干咳少痰或无痰,咽干舌燥,舌红而干,脉虚细者。西医诊为中暑、急性感染性发热性疾病、流行性乙型脑炎、感染性休克、慢性气管炎、慢性咽炎均可用此药。
生脉饮方中人参含有人参皂苷,能强心气、补肺气;五味子具收敛的功用,能预防元气耗散;麦门冬含糖体,能滋阴清热,因此生脉饮在夏天既能预防中暑,也能保气养生。
其中,红参(Radix ginseng Rubra)为人参(Panax ginseng C.A.Meyer)经人工蒸制并干燥后得到的干燥根及根茎。味甘,微苦,性温,归脾、肺、心经,具有大补元气,复脉固脱,益气摄血之功效。红参的有效成分主要分为三类,即挥发油,人参皂苷和多糖。其中人参皂苷是红参的主要生物活性成分,其生物活性主要表现在以下四个方面:(1)具有强心作用,可以扩张血管,具有抗心肌缺血的作用;(2)具有抗肿瘤作用;(3)可以提高机体免疫力,改善免疫系统功能;(4)对中枢神经的作用为改善记忆力,抗抑郁,镇定及镇痛并能有效改善老龄化动物衰退的活动能力。
麦冬为百合科沿阶草属(Ophiopogon Ker Gawl)植物麦冬(Ophiopogonjaponicus(Lf)Ker Gawl)的干燥块根,是传统中药之一。味甘、微苦。具有养阴生津,润肺清心的功效。临床上主要用于热病伤津、心烦口渴、肺燥干咳等症。麦冬主要化学成分为甾体皂苷、多糖、高异黄酮类、氨基酸等。其中麦冬多糖为麦冬的主要成分之一。近年来麦冬多糖的生物活性研究表明,麦冬多糖具多种生物活性,主要集中在抗心肌缺血、降血糖、耐缺氧能力、免疫活性、抗过敏活性、对胃肠道作用活性等方面,可以增加机体耐缺氧;具有抗心律失常的作用;能降血糖,并能促使胰岛细胞的恢复;提高免疫功能和核酸合成率,促进抗体、补体、溶菌酶等的产生等。
五味子为木兰科五味子属植物五味子Schisandra chiensis(Turcz)Ball或华中五味子Schisandra sphenanthera Rehd Et Wils的干燥成熟果实,始载于《神农本草经》。前者主要分布于我国东北、内蒙古和华东地区,俗称“北五味子”,后者主产于华中和西南地区、以及秦岭以南诸省,其功效与北五味子相同,俗称“南五味子”。五味子性温、味酸、甘。能收敛固涩、益气生津、补肾宁心。用于久咳虚喘、津亏口渴、遗精、自汗、盗汗、久泻、神经衰弱、肝炎等症。五味子主要含有木脂素、挥发油、有机酸及多糖等多种化学成分。五味子中含有的多种木脂素成分被认为是五味子中最主要的药理活性成分,除具有降低肝脏细胞SGPT作用外还具有抗HIV病毒、抗氧化、保护中枢神经系统作用以及安定作用。五味子挥发油主要成分为萜类化合物,以倍半萜类为主,具有镇咳作用,能间接调节中枢神经系统。对五味子挥发油进行药理活性筛选,显示其有较强的抗纤溶酶原激活物抑制剂活性。
目前,现有的生脉散或生脉饮产品均为人参、麦冬、五味子三味药按照一定的比例共煎或者分别提取后再混合的方法制备的,例如:人参,麦冬,五味子粉碎成粗粉,用65%乙醇作溶剂,浸渍24小时后进行渗漉,收集漉液约4500ml,减压浓缩至约250ml,放冷,加水400ml稀释,滤过,另加60%糖浆300ml及适量防腐剂,并调节pH值至规定范围,调整总量至1000ml,搅匀,静置,滤过,灌封,灭菌,即得。
然而中药复方成分复杂,常由几种,十几种到几十种或更多种成分组成,这些成分中有些无疑对于治疗疾病起到关键作用,而另一些成分则难免有毒副作用。例如生脉注射液,其临床不良反应报道日益增多。如生脉注射液致严重腹胀,皮肤过敏性红斑,过敏性休克及低血压,并且可以诱发心跳过速,心绞痛等,虽为少数病例,但应当引起重视。
本发明经过长时间的反复验证研究,选择分别提取三味药的有效成分:红参总皂苷、麦冬总多糖、五味子木脂素,将这三种有效成分按照一定的比例进行混合,最终得到本发明的药物组合物。本发明还包括该药物组合物的制备方法及其制剂和用途。
并且,本发明发现当弃掉五味子挥发油成分后,也可得到和现有技术同样的效果,且改善了制剂的味道,使制剂的制备更加方便,快捷,节约了成本,更加利于制剂的工业生产。
发明内容:
本发明的一个目的在于,提供一种包含红参总皂苷、麦冬总多糖、五味子木脂素的药物组合物。本发明的另一个目的在于,提供上述药物组合物的制备方法。本发明的又一个目的在于,提供包含上述药物组合物的制剂。本发明的最后一个目的在于,提供上述药物组合物的用途。
本发明提供一种含有生脉饮有效成分的药物组合物,该组合物含有:红参总皂苷15-35重量份,麦冬总多糖150-250重量份,五味子木脂素2-4重量份。
优选的,该组合物含有:该组合物含有:红参总皂苷20-30重量份,麦冬总多糖170-200重量份,五味子木脂素2.5-3.5重量份。
特别优选的,该组合物含有:红参总皂苷23.76重量份,麦冬总多糖183.6重量份,五味子木脂素3.24重量份。
本发明的药物组合物,根据需要还可含有药物可接受的载体。
本发明的药物组合物,为任意一种药物制剂形式。
本发明的药物组合物,为胃肠道给药或非胃肠道给药的药物制剂。
本发明还提供本发明的药物组合物的制备方法,如通过混合红参总皂苷,麦冬总多糖,五味子木脂素以及药物可接受的载体制备。
本发明还提供本发明的药物组合物在制备治疗慢性心衰的药物上的应用。
本发明的药物组合物,可以是任何可服用的药物形式:如:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、膏剂、丹剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。
本发明的药物组合物,优选的是单位剂量的药物制剂形式。
本发明的药物组合物,在制成药剂时,单位剂量的药剂可含有本发明的药物活性物质0.1-1000mg,其余为药学上可接受的载体。药学上可接受的载体以重量计可以是制剂总重量的0.01-99.99%。
本发明的组合物在使用时根据病人的情况确定用法用量,如一日1-3次。一次1-10片等。
优选的,本发明的组合物为口服制剂或注射剂。
其中,所述口服制剂选自胶囊剂、片剂、滴丸、颗粒剂、浓缩丸、口服液和合剂中的一种。
其中,所述注射剂选自注射液、冻干粉针剂和水针剂中的一种。
本发明的药物组合物,其口服给药的制剂可含有常用的赋形剂,诸如粘合剂、填充剂、稀释剂、压片剂、润滑剂、崩解剂、着色剂、调味剂和湿润剂,必要时可对片剂进行包衣。
适用的填充剂包括纤维素、甘露糖醇、乳糖和其它类似的填充剂。适宜的崩解剂包括淀粉、聚乙烯吡咯烷酮和淀粉衍生物,例如羟基乙酸淀粉钠。适宜的润滑剂包括,例如硬脂酸镁。适宜的药物可接受的湿润剂包括十二烷基硫酸钠。
本发明的药物组合物可通过混合,填充,压片等常用的方法制备固体口服组合物。进行反复混合可使活性物质分布在整个使用大量填充剂的那些组合物中。
口服液体制剂的形式例如可以是水性或油性悬浮液、溶液、乳剂、糖浆剂或酏剂,或者可以是一种在使用前可用水或其它适宜的载体复配的干燥产品。这种液体制剂可含有常规的添加剂,诸如悬浮剂,例如山梨醇、糖浆、甲基纤维素、明胶、羟乙基纤维素、羧甲基纤维素、硬脂酸铝凝胶或氢化食用脂肪,乳化剂,例如卵磷脂、脱水山梨醇一油酸酯或阿拉伯胶;非水性载体(它们可以包括食用油),例如杏仁油、分馏椰子油、诸如甘油的酯的油性酯、丙二醇或乙醇;防腐剂,例如对羟基苯甲酯或对羟基苯甲酸丙酯或山梨酸,并且如果需要,可含有常规的香味剂或着色剂。
对于注射剂,制备的液体单位剂型含有本发明的活性物质和无菌载体。根据载体和浓度,可以将此化合物悬浮或者溶解。溶液的制备通常是通过将活性物质溶解在一种载体中,在将其装入一种适宜的小瓶或安瓿前过滤消毒,然后密封。辅料例如一种局部麻醉剂、防腐剂和缓冲剂也可以溶解在这种载体中。为了提高其稳定性,可在装入小瓶以后将这种组合物冰冻,并在真空下将水除去。
本发明的药物组合物,在制备成药剂时可选择性的加入适合的药物可接受的载体,所述药物可接受的载体选自:甘露醇、山梨醇、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素C、EDTA二钠、EDTA钙钠,一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁等。
本发明所述的红参总皂苷,麦冬总多糖,五味子木脂素,可以根据现有技术制备,也可以通过以下方法制备:
红参皂苷组分的制备:
红参用20~95%乙醇提取1~5次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比1∶2~1∶10,过滤得滤液,滤液经大孔树脂柱层析,依次用水,0.1~10%NaOH(4-5BV)、20~95%乙醇洗脱,收集50~80%乙醇洗脱液浓缩至干,即得。
麦冬多糖组分的制备:
麦冬用水提取1~5次,合并提取液,浓缩至药材比1∶2~1∶10,过滤得滤液,滤液经大孔树脂柱层析,用水洗(2-4BV),收集流出液和水洗液,浓缩至密度分别为1.05-1.10、1.13-1.17,经过两次醇沉(60~80%、65~85%),收集沉淀,烘干,即得。
五味子木脂素的制备:
五味子粗粉经过超临界萃取得到五味子挥发油,弃掉挥发油,药渣用20~95%乙醇提取1~5次,合并提取液,过滤,滤液合并,浓缩至药材比1∶2~1∶10,过滤,滤液经大孔树脂柱层析,依次用水、30~95%乙醇洗脱,洗脱液浓缩至干,即得。
优选的,本发明所述的红参总皂苷,麦冬总多糖,五味子木脂素通过以下方法制备:
红参皂苷组分的制备:
红参用80%乙醇提取2次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1∶5,过滤,滤液经大孔树脂依次用水、0.1%NaOH(4~5BV)、80%乙醇洗脱,收集洗脱液,浓缩至干,得红参总皂苷。
麦冬多糖组分的制备:
麦冬用水提取2次,合并提取液,回收至药材比1∶5,过滤,滤液经大孔树脂水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05-1.10、1.13-1.17,两次醇沉(80%、85%),收集沉淀,烘干,得麦冬总多糖。
五味子木脂素的制备:
五味子粗粉经过超临界萃取得到五味子挥发油,,弃掉挥发油,药渣用80%乙醇提取2次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1∶5,过滤,滤液经大孔树脂依次用水、95%乙醇洗脱,洗脱液浓缩至干,得五味子木脂素。
为证实去掉挥发油成分而得到的总皂苷、总多糖、总木脂素三种成分的结合同样具有治疗慢性心衰的作用,本发明设计了以下实验。
实验一、去掉挥发油成分的有效性验证实验
1实验材料
1.1实验动物
SD大鼠(200±5g,许可证号:SCXk(津)2009-0001),购于天津山川红实验动物有限公司。
1.2实验用药
去挥发油组:总皂苷、总木脂素、总多糖(实施例6方法制备)
阳性对照药:生脉饮口服液(吉林显峰科技制药有限公司)
1.3实验仪器
彩色超声成像诊断仪(VIVID 7);八导生理记录仪;JA1003型上皿电子天平(上海精科公司);CKF-06A型电烤箱(顺德市长盛电器有限公司);202-AUBS型电热干燥箱(天津市华北实验仪器有限公司);BCD-256KF B型-20℃冰箱(青岛海尔股份有限公司);OLYMPUS U-CMAD3型光学显微镜(日本OLYMPUS公司生产);OLYMPUS C5060-ADU型光镜照相机(日本OLYMPUS公司生产);820ROTARY MICROTOME型石蜡切片机(美国American Optical公司)。
1.4实验试剂
37.0%~40.0%甲醛溶液(天津市赢达稀贵化学试剂厂);无水乙醇(天津市风船化学试剂科技有限公司);95%乙醇(天津市风船化学试剂科技有限公司);二甲苯(分析纯,天津市北方天医化学试剂厂);石蜡(熔点58~60℃)(中国上海懿洋仪器有限公司);高效切片石蜡(熔点48~50℃)(上海华永石蜡有限公司);Masson试剂盒(南京建成科技有公司)。
2实验方法
2.1腹主动脉缩窄法复制大鼠心衰模型
参照文献[1-2]方法并根据本实验室前期预实验复制大鼠心衰模型,简要步骤如下:大鼠用10%水合氯醛腹腔注射麻醉,剑突下腹正中切口,分层打开腹腔,在左右肾动脉分支间钝性游离腹主动脉,将7号注射器针头平行置于腹主动脉上,用4号手术丝线将腹主动脉和注射器一同结扎,然后缓慢将注射器撤出,关腹、分层缝合,使大鼠腹主动脉直径缩窄为0.7mm。假手术组开腹后将手术丝线穿过腹主动脉,除不缩窄腹主动脉外,其它操作与手术组完全相同。
2.2实验分组及给药方法
手术后连续腹腔注射庆大霉素3天,待老鼠状态稳定后开始给药。实验设置假手术组、模型组、原药(即阳性对照药生脉饮口服液)高、中、低组、去挥发油组。各组动物均灌胃给药,0.5ml/100g,连续给药8周。
表1 各组分配伍分组情况(mg/kg)
注:临床等效剂量下各组分比例为:总皂苷23.76mg/kg、总多糖183.6mg/kg、总木脂素3.24mg/kg、总挥发油0.41mg/kg。临床等效剂量是将原药(即对照药生脉饮口服液)按照日服生药量结合各个组分的出膏率折算出来的。
3.检测指标
3.1检测心功能
用彩色多普勒超声检测各组药物对心衰大鼠心功能的影响。给药8周后,各组大鼠用戊巴比妥钠腹腔麻醉,用弯眼科剪仔细剪去大鼠胸腹部毛发,在左心长轴切面上测量并记录大鼠心脏各项指标:左室舒张末期内径(LVDd)、左室收缩末期内径(LVDs);左室舒张末期室间隔厚度(LVSd)、左室收缩末期室间隔厚度(LVSs);左室舒张末期后壁厚度(LVPWd)、左室收缩末期后壁厚度(LVPWs);左室射血分数(EF)=SV/LVEDV×100%;左室短轴缩短率(FS)=(LVDd-LVDs)/LVDd×100%;左室舒张末期容积(LVEDV)、左室收缩末期容积(LVESV);每搏心排血量(SV)。所有数据均测量3次,记录其平均值。
4实验结果
4.1各组药物对心衰大鼠心功能的影响
各组大鼠用药8周后,用彩色多普勒超声检测各组药物对心衰大鼠心功能的影响(见表2,图1)。与假手术组比较,模型组大鼠EF显著降低(P<0.01);与模型组比较,生脉饮原药高、中、低剂量组均能升高EF(P<0.01、P<0.05、P<0.05);与模型组比较,去挥发油组能升高EF(P<0.05);另外,各组药物对心衰大鼠心功能其他指标的影响有相似的趋势。
参考文献:
[1]张冬颖,罗羽慧,杨辉,等.冠状动脉结扎与腹主动脉缩窄所致慢性心力衰竭大鼠模型比较[J].中国微循环,2005,9(3):171-174.
[2]胡咏梅,李法琦,罗羽慧,等.腹主动脉缩窄大鼠模型制作及临床意义[J].重庆医科大学学报,2004,29(3):322-324.
附图说明
图1各组药物对心衰大鼠心功能的影响
具体实施方式
下面通过具体的实施例进一步说明本发明,下述实施例是用于说明本发明而不是对本发明的限制,根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。
实施例1
该组合物含有:红参总皂苷15重量份,麦冬总多糖150重量份,五味子木脂素2重量份。
淀粉100重量份
微晶纤维素100重量份
硬脂酸镁10重量份
经过混合,制粒,干燥,整粒,压片,包衣得到包衣片。
实施例2
红参总皂苷35重量份,麦冬总多糖250重量份,五味子木脂素4重量份。
淀粉100重量份
微晶纤维素100重量份
硬脂酸镁10重量份
经过混合,制粒,干燥,整粒,装胶囊,即得。
实施例3
红参总皂苷20重量份,麦冬总多糖170重量份,五味子木脂素2.5重量份。
糊精50重量份
淀粉100重量份
微晶纤维素100重量份
硬脂酸镁10重量份
经过混合,制粒,干燥,整粒,压片,包衣得到包衣片。
实施例4
红参总皂苷30重量份,麦冬总多糖200重量份,五味子木脂素3.5重量份。
淀粉100重量份
微晶纤维素100重量份
硬脂酸镁10重量份
经过混合,制粒,干燥,整粒,装胶囊,即得。
实施例5
红参总皂苷23.76重量份,麦冬总多糖183.6重量份,五味子木脂素3.24重量份。
乳糖100重量份
维生素C 20重量份
注射用水200重量份
经过混合,过滤,灭菌,装瓶,即得。
实施例6
以上实施例中的活性成分红参总皂苷,麦冬总多糖,五味子木脂素的制备:
(1)红参,80%乙醇提取2次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1∶5,过滤,滤液经大孔树脂(D101)依次用水(至无色)、0.1%NaOH(4~5BV)、80%乙醇洗脱,收集80%乙醇洗脱液,浓缩至干,得红参总皂苷;
(2)麦冬,水提取2次,合并提取液,回收至药材比1∶5,过滤,滤液经大孔树脂(D941)水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05-1.10、1.13-1.17,两次醇沉(80%、85%),收集沉淀,烘干,得麦冬总多糖;
(3)五味子,粉碎成粗粉,五味子粗粉经超临界萃取,得五味子挥发油组分,去掉该组分,残渣用80%乙醇提取2次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1∶5,过滤,滤液经大孔树脂(AB-8)依次用水(至无色)、95%乙醇洗脱,收集95%乙醇洗脱液,洗脱液浓缩至干,得五味子木脂素。
实施例7
活性成分红参总皂苷,麦冬总多糖,五味子木脂素的其他制备方法:
(1)红参,20%乙醇提取1次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1∶2,过滤,滤液经大孔树脂(D101)依次用水(至无色)、0.1%NaOH(4~5BV)、20%乙醇洗脱,收集洗脱液,浓缩至干,得红参总皂苷;
(2)麦冬,水提取1次,合并提取液,回收至药材比1∶2,过滤,滤液经大孔树脂(D941)水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05~1.10、1.13~1.17,两次醇沉(60%、65%),收集沉淀,烘干,得麦冬总多糖;
(3)五味子,粉碎成粗粉,五味子粗粉经超临界萃取,得五味子挥发油组分,去掉该组分,残渣用20%乙醇提取1次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1∶2,过滤,滤液经大孔树脂(AB-8)依次用水(至无色)、30%乙醇洗脱,洗脱液浓缩至干,得五味子木脂素。
实施例8
活性成分红参总皂苷,麦冬总多糖,五味子木脂素的其他制备方法:
(1)红参,95%乙醇提取5次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1∶10,过滤,滤液经大孔树脂(D101)依次用水(至无色)、10%NaOH(4~5BV)、95%乙醇洗脱,收集洗脱液,浓缩至干,得红参总皂苷;
(2)麦冬,水提取5次,合并提取液,回收至药材比1∶10,过滤,滤液经大孔树脂(D941)水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05~1.10、1.13~1.17,两次醇沉(80%、85%),收集沉淀,烘干,得麦冬总多糖;
(3)五味子,粉碎成粗粉,五味子粗粉经超临界萃取,得五味子挥发油组分,去掉该组分,残渣用95%乙醇提取5次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1∶10,过滤,滤液经大孔树脂(AB-8)依次用水(至无色)、95%乙醇洗脱,洗脱液浓缩至干,得五味子木脂素。
实施例9
活性成分红参总皂苷,麦冬总多糖,五味子木脂素的其他制备方法:
(1)红参,50%乙醇提取3次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1∶5,过滤,滤液经大孔树脂(D101)依次用水(至无色)、5%NaOH(4~5BV)、50%乙醇洗脱,收集洗脱液,浓缩至干,得红参总皂苷;
(2)麦冬,水提取3次,合并提取液,回收至药材比1∶5,过滤,滤液经大孔树脂(D941)水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05~1.10、1.13~1.17,两次醇沉(70%、75%),收集沉淀,烘干,得麦冬总多糖;
(3)五味子,粉碎成粗粉,五味子粗粉经超临界萃取,得五味子挥发油组分,去掉该组分,残渣用50%乙醇提取3次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1∶5,过滤,滤液经大孔树脂(AB-8)依次用水(至无色)、50%乙醇洗脱,洗脱液浓缩至干,得五味子木脂素。
实施例10
活性成分红参总皂苷,麦冬总多糖,五味子木脂素的其他制备方法:
(1)红参,95%乙醇提取1次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1∶2,过滤,滤液经大孔树脂(D101)依次用水(至无色)、10%NaOH(4~5BV)、95%乙醇洗脱,收集洗脱液,浓缩至干,得红参总皂苷;
(2)麦冬,水提取1次,合并提取液,回收至药材比1∶2,过滤,滤液经大孔树脂(D941)水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05~1.10、1.13~1.17,两次醇沉(80%、85%),收集沉淀,烘干,得麦冬总多糖;
(3)五味子,粉碎成粗粉,五味子粗粉经超临界萃取,得五味子挥发油组分,去掉该组分,残渣用95%乙醇提取1次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1∶10,过滤,滤液经大孔树脂(AB-8)依次用水(至无色)、95%乙醇洗脱,洗脱液浓缩至干,得五味子木脂素。
Claims (9)
1.一种含有生脉饮有效成分的药物组合物,该组合物的有效成分为:红参总皂苷15-35重量份,麦冬总多糖150-250重量份,五味子木脂素2-4重量份。
2.一种如权利要求1所述的药物组合物,该组合物的有效成分为:红参总皂苷20-30重量份,麦冬总多糖170-200重量份,五味子木脂素2.5-3.5重量份。
3.一种如权利要求1所述的药物组合物,该组合物的有效成分为:红参总皂苷23.76重量份,麦冬总多糖183.6重量份,五味子木脂素3.24重量份。
4.一种如权利要求1所述的药物组合物,该组合物中根据需要还可含有药物可接受的载体。
5.一种如权利要求1所述的药物组合物,该组合物为胃肠道给药或非胃肠道给药的药物制剂。
6.一种如权利要求1所述的药物组合物的制备方法,其特征在于,通过混合红参总皂苷,麦冬总多糖,五味子木脂素,用制剂学常规技术制备。
7.一种如权利要求6的制备方法,其中所述红参总皂苷,麦冬总多糖,五味子木脂素分别按照以下方法制备:
(1)红参,20~95%乙醇提取1~5次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1:2~1:10,过滤,滤液经大孔树脂依次用水、0.1~10%NaOH(4~5BV)、20~95%乙醇洗脱,收集洗脱液,浓缩至干,得红参总皂苷;
(2)麦冬,水提取1~5次,合并提取液,回收至药材比1:2~1:10,过滤,滤液经大孔树脂水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05~1.10、1.13~1.17,两次醇沉(60~80%、65~85%),收集沉淀,烘干,得麦冬总多糖;
(3)五味子,粉碎成粗粉,五味子粗粉经超临界萃取,得五味子挥发油组分和残渣,弃掉挥发油,残渣用20~95%乙醇提取1~5次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1:2~1:10,过滤,滤液经大孔树脂依次用水、30~95%乙醇洗脱,洗脱液浓缩至干,得五味子木脂素。
8.一种如权利要求6的制备方法,其中所述红参总皂苷,麦冬总多糖,五味子木脂素分别按照以下方法制备:
(1)红参,80%乙醇提取2次,合并提取液,提取液回收乙醇至无醇味,加水稀释至药材比为1:5,过滤,滤液经大孔树脂依次用水、0.1%NaOH(4~5BV)、80%乙醇洗脱,收集洗脱液,浓缩至干,得红参总皂苷;
(2)麦冬,水提取2次,合并提取液,回收至药材比1:5,过滤,滤液经大孔树脂水洗(2~4BV),收集流出液和水洗液,浓缩至密度分别为1.05-1.10、1.13-1.17,两次醇沉(80%、85%),收集沉淀,烘干,得麦冬总多糖;
(3)五味子,粉碎成粗粉,五味子粗粉经超临界萃取,得五味子挥发油组分和残渣,弃掉挥发油,残渣用80%乙醇提取2次,合并提取液,提取液过滤,滤液合并,浓缩至药材比为1:5,过滤,滤液经大孔树脂依次用水、95%乙醇洗脱,洗脱液浓缩至干,得五味子木脂素。
9.权利要求1所述的药物组合物在制备治疗慢性心衰的药物上的应用。
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