CN110876788A - 一种活血止痛中药药物及其制备方法 - Google Patents
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Abstract
本发明公开了一种活血止痛中药药物及其制备方法，由丹参、当归尾、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、藏红花、苏木、土鳖虫、血竭、三七、木香、香附、青皮、牡丹皮、连翘、莪术、蒲黄、茯苓、栀子、五灵脂、儿茶、北刘寄奴和穿山甲制成；本发明具有活血散瘀、消肿止痛功效，能有效治疗软跌打损伤，瘀血肿痛；本发明使用毒副作用小，治疗周期短，治疗效果好。
Description
技术领域
本发明涉及一种活血止痛中药药物及其制备方法，属于药品技术的领域。
背景技术
跌打损伤以软组织损伤为主，包括刀枪、跌仆、殴打、闪挫、刺伤、擦伤、运动损伤等，伤处多有疼痛、肿胀、出血或骨折、脱臼等，也包括一些内脏损伤。
瘀血是疾病过程中形成的病理产物，又是某些疾病的致病因素。其形成原因有气虚、气滞、血寒、血热均可使血行不畅，而形成瘀血。各种外伤损伤肌肤和内脏，使离经之血积存体内而形成瘀血。瘀血的临床表现有疼痛如针刺，痛有定处，拒按，夜间尤甚；肿块在体表者，色呈青紫，在腹内者，坚硬按之不移，称为症积；出血反复不止，色泽紫暗，中夹血块，或大便色黑如柏油；面色黧黑，肌肤甲错，***爪甲紫暗，或肌肤紫斑、蛛丝红缕，或腹部青筋外露，或下肢青筋胀痛；妇女经少紫暗成块，或闭经；舌紫暗，或见瘀斑瘀点，脉细涩或结代等。
面对跌打损伤，瘀血肿痛，目前西药内服药虽具有镇痛活性强的效果，但副作用会引起胃肠功能紊乱，对心脏、肝、肾都存在不同程度的损害。所以发明一种具有活血散瘀、消肿止痛功效的活血止痛的中药药物具有重要的意义。
发明内容
本发明的目的在于，提供一种活血止痛中药药物。本发明具有活血散瘀、消肿止痛功效，能有效治疗软跌打损伤，瘀血肿痛；本发明使用毒副作用小，治疗周期短，治疗效果好。
本发明的技术方案：一种活血止痛中药药物，药用有效成分照重量组份计算，由丹参4-14份、当归尾4-14份、赤芍4-14份、川芎0.5-3份、延胡索1-5份、三棱5-15份、乳香1-9份、没药1-9份、桃仁2-10份、藏红花1-5份、苏木2-10份、土鳖虫0.5-3份、血竭1-3份、三七1-5份、木香2-10份、香附2-10份、青皮2-10份、牡丹皮2-10份、连翘2-10份、莪术1-5份、蒲黄2-10份、茯苓4-14份、栀子2-10份、五灵脂2-10份、儿茶1-5份、北刘寄奴2-10份、穿山甲0.5-3份制成。
前述的活血止痛中药药物中，所述药物的药用有效成分照重量组份计算，由丹参7-11份、当归尾7-11份、赤芍7-11份、川芎1-2份、延胡索2-4份、三棱8-12份、乳香3-7份、没药3-7份、桃仁4-8份、藏红花2-4份、苏木4-8份、土鳖虫1-2份、血竭1-3份、三七2-4份、木香4-8份、香附4-8份、青皮4-8份、牡丹皮4-8份、连翘4-8份、莪术2-4份、蒲黄4-8份、茯苓7-11份、栀子4-8份、五灵脂4-8份、儿茶2-4份、北刘寄奴4-8份、穿山甲1-2份制成。
前述的活血止痛中药药物中，所述药物的药用有效成分照重量组份计算，由丹参9份、当归尾9份、赤芍9份、川芎1.5份、延胡索3份、三棱10份、乳香5份、没药5份、桃仁6份、藏红花3份、苏木6份、土鳖虫1.5份、血竭2份、三七3份、木香6份、香附6份、青皮6份、牡丹皮6份、连翘6份、莪术3份、蒲黄6份、茯苓9份、栀子6份、五灵脂6份、儿茶3份、北刘寄奴6份、穿山甲1.5份制成。
前述活血止痛中药药物的制备方法，取丹参、当归尾、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、藏红花、苏木、土鳖虫、血竭、三七、木香、香附、青皮、牡丹皮、连翘、莪术、蒲黄、茯苓、栀子、五灵脂、儿茶、北刘寄奴和穿山甲，与药物中可接受的辅料进行组合，按照常规方法进行加工，制成相应的药物。
前述活血止痛中药药物的制备方法中，所述药物为：丸剂、颗粒剂或片剂。
前述活血止痛中药药物的制备方法中，所述丸剂这样制备：按比例称以上药物，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，加12倍量水浸泡1h后加热回流1h，滤过得药渣A，药渣A加12倍水煎煮1h，滤过得药渣B，药渣B再加12倍水煎煮1h，滤过，弃去药渣，合并三次滤液，浓缩至密度为1.0-1.1g/mL，再与药物C混合均匀制成软材，塑制法制丸，筛选，将选出药丸放入包衣锅滚圆，60℃干燥，即得。
前述活血止痛中药药物的制备方法中，所述颗粒剂这样制备：按比例称以上药物，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，用水浸泡1h，加8倍水煎煮1.5h，煎煮3次，8层纱布过滤，合并三次滤液，滤液60℃浓缩至相对密度为1.15，再与药物C混合均匀，加入常规量可溶性淀粉制软材，挤压过筛，干燥，即得。
前述活血止痛中药药物的制备方法中，所述片剂这样制备：按比例称以上药物，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，用水浸泡1h，加8倍水煎煮1.5h，煎煮3次，8层纱布过滤，合并三次滤液，滤液60℃浓缩至相对密度为1.15，再与药物C混合均匀，加入常规量的可压性淀粉，整粒，压片，用果维膜包薄膜衣，即得。
本发明由丹参、当归尾、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、藏红花、苏木、土鳖虫、血竭、三七、木香、香附、青皮、牡丹皮、连翘、莪术、蒲黄、茯苓、栀子、五灵脂、儿茶、北刘寄奴和穿山甲制成，其中丹参，为唇形科植物丹参Salvia miltiorrhiza Bunge.的干燥根及根茎；功能主治祛瘀止痛，活血通经，清心除烦；用于***，经闭痛经，症瘕积聚，胸腹刺痛，热痹疼痛，疮疡肿痛，心烦不眠；肝脾肿大，心绞痛。当归尾，为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根的尾部，当归尾的功效：活血祛瘀；应用：经闭不通及瘀血积滞肿痛的病症。赤芍，为毛茛科植物芍药Paeonia lactiflora Pall.或川赤芍Paeonia veitchii Lynch的干燥根，功能主治清热凉血，散瘀止痛；用于温毒发斑，吐血衄血，目赤肿痛，肝郁胁痛，经闭痛经，症瘕腹痛，跌扑损伤，痈肿疮疡。川芎，为伞形科植物川芎Ligusticum chuanxiong Hort.(或Ligusticum wallichii Franch.)的干燥根茎；功能主治活血行气，祛风止痛；用于***，经闭痛经，症瘕腹痛，胸胁刺痛，跌扑肿痛，头痛，风湿痹痛。延胡索，为罂粟科植物延胡索Corydalis yanhusuo W.T.Wang的干燥块茎；功能主治活血，利气，止痛；用于胸胁、脘腹疼痛，经闭痛经，产后瘀阻，跌扑肿痛。三棱，为黑三棱科植物黑三棱Sparganium stoloniferum Buch.-Ham.的干燥块茎；功能主治破血行气，消积止痛。用于症瘕痞块，瘀血经闭，食积胀痛。乳香，为橄榄科乳香树属植物乳香树Boswellia carterii Birdw.[B.sacra Fluek.]、药胶香树B.bhawdajiana Birdw.及野乳香树B.neglecta M.Moore等树干皮部伤口渗出的油胶树脂；功能主治调气活血，定痛，追毒；治气血凝滞、心腹疼痛，痈疮肿毒，跌打损伤，痛经，产后瘀血刺痛。没药，为橄榄科没药属植物没药树Commiphora myrrha Engl.[C.molmol Engl.]及同属他种植物的树干皮部渗出的油胶树脂；功能主治散血去瘀，消肿定痛；治跌损，金疮，筋骨，心腹诸痛，症瘕，经闭，痈疽肿痛，痔漏，目障。桃仁，为蔷薇科植物桃Prunus persica(L.)Batsch或山桃Prunusdavidiana(Carr.)Franch.的干燥成熟种子；功能主治活血祛瘀，润肠通便；用于经闭，痛经，癓瘕痞块，跌扑损伤，肠燥便秘。藏红花，为鸢尾科植物番红花花柱的上部及柱头；功能主治活血化瘀，散郁开结；治忧思郁结，胸膈痞闷，吐血，伤寒发狂，惊怖恍惚，妇女经闭，产后瘀血腹痛，跌扑肿痛。苏木，为豆科云实属植物苏木Caesalpinia sappanL.的干燥心材；功能主治行血祛瘀，消肿止痛；用于经闭痛经，产后瘀阻，胸腹刺痛，外伤肿痛。土鳖虫，为鳖蠊科昆虫地鳖Eupolyphaga sinensis Walker或冀地鳖Steleophaga plancyi(Boleny)的雌虫干燥体；功能主治破瘀血，续筋骨；用于筋骨折伤，瘀血经闭，症瘕痞块。血竭，为棕榈科植物麒麟竭Daemonorops draco Blume.果实渗出的树脂经加工制成；功能主治祛瘀定痛，止血生肌；用于跌扑折损，内伤瘀痛；外伤出血不止。三七，为五加科植物三七Panaxnotoginseng(Burk.)F.H.Chen的干燥根；功能主治散瘀止血，消肿定痛；用于咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹剌痛，跌扑肿痛。木香，为菊科植物木香Aucklandia lappaDecne.的干燥根；功能主治行气止痛，健脾消食。功能主治行气止痛，健脾消食。用于胸脘胀痛，泻痢后重，食积不消，不思饮食。煨木香实肠止泻。用于泄泻腹痛。香附，为莎草科植物莎草Cyperus rotundusL.的干燥根茎；功能主治行气解郁，调经止痛；用于肝郁气滞，胸、胁、脘腹胀痛，消化不良，胸脘痞闷，寒疝腹痛，***胀痛，***，经闭痛经。青皮，为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥幼果或未成熟果实的果皮；功能主治疏肝破气，消积化滞；用于胸胁胀痛，疝气，乳核，乳痈，食积腹痛。牡丹皮，为毛茛科植物牡丹Paeonia suffruticosa Andr.的干燥根皮；功能主治清热凉血，活血化瘀；用于温毒发斑，吐血衄血，夜热早凉，无汗骨蒸，经闭痛经，痈肿疮毒，跌扑伤痛。连翘，木犀科植物连翘Forsythia suspensa(Thunb.)Vahl的干燥果实；功能主治清热解毒，消肿散结；用于痈疽，瘰疠，乳痈，丹毒，风热感冒，温病初起，温热入营，高热烦渴，神昏发斑，热淋尿闭。莪术，为姜科植物蓬莪术Curcuma phaeocaulis Val.、广西莪术Curcuma Kwangsiensis S.G.Leeet C.F.Liang或温郁金Curcuma wenyujin Y.H.Chen et C.Ling的干燥根茎；功能主治破血行气，消积止痛；。用于血瘀腹痛、肝脾肿大、心腹胀痛，积聚，妇女血瘀经闭，跌打损伤作痛饮食积滞。蒲黄，为香蒲科植物水浊香蒲Typha angustifolia L.、东方香蒲Typhaorientalis Presl、或同属植物的干燥花粉；功能主治止血，化瘀，通淋；用于吐血，衄血，咯血，崩漏，外伤出血，经闭痛经，脘腹刺痛，跌扑肿痛，血淋涩痛。茯苓，为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核；功能主治利水渗湿，健脾宁心；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。栀子，为茜草科植物栀子Gardeniajasminoides Ellis的干燥成熟果实，其根也可入药。功能主治果实：泻火除烦，清热利尿，凉血解毒。用于热病心烦，黄疸尿赤，血淋涩痛，血热吐衄，目赤肿痛，火毒疮疡；外治扭挫伤痛；根：泻火解毒，清热利湿，凉血散瘀。用于传染性肝炎，跌打损伤，风火牙痛。五灵脂，为鼯鼠科动物橙足鼯鼠Trogopterus Xanthipes Milne-Edwards或飞鼠科动物小飞鼠Pteromysvolans L.的干燥粪便；功能主治生用行血止痛；治心腹血气诸痛，妇女经闭，产后瘀血作痛；外治蛇、蝎、蜈蚣咬伤；炒用止血。儿茶，为豆科合欢属植物儿茶树Acacia catechu(L.f.)Willd.的去皮枝、干的干燥煎膏；为豆科金合欢属植物儿茶树Acacia catechu(L.)Willd.的干枝加水煎汁浓缩而成的干浸膏；功能主治清热化痰，敛疮止血；用于肺热咳嗽，咯血，腹泻，小儿消化不良；外用治疮疡久不收口，皮肤湿疹，口疮，扁桃体炎。北刘寄奴，为玄参科植物阴行草Siphonostegia chinensis Benth.的干燥全草；有活血祛瘀，通络止痛，凉血止血，清热利湿功效；用于跌打损伤，外伤出血，瘀血经闭，***，产后瘀痛，瘢瘕积聚，血痢，血淋，湿热黄疸，水肿腹胀，白带过多；穿山甲，为鲮鲤科动物穿山甲Manispentadactyla Linnaeus的鳞甲；功能主治通经下乳，消肿排脓，搜风通络；用于经闭癓瘕，乳汁不通，痈肿疮毒，关节痹痛，麻木拘挛。
方解：跌打损伤后、局部脉道破裂、致出血、血液停滞则成瘀、瘀则化热、阻滞脉道不通、局部肿痛红肿难忍。因气伤痛、行伤肿、气无行、血有行、伤血必及气、故肿且痛，固定不移位。故以凉血止血、活血化瘀、行气止痛消肿之法而治，方中当归、藏红花、赤芍、苏木、桃仁、丹参、北刘寄奴、蒲黄活血祛瘀；乳香、没药、血竭、三七、延胡索、木香、香附、五灵脂、儿茶、川芎活血行气止痛；三棱、莪术、地鳖虫、青皮、穿山甲、茯苓、破瘀通经，消肿止痛；牡丹皮、栀子、连翘清热凉血；
发明人对本发明的药物做了以下研究
实验例：
一、丸剂提取工艺研究
1丹酚酸B含量测定
1.1色谱条件
色谱柱：ZORBAX SB-C18(250mm4.6mm，5μm)；流动相：乙睛-0.1％磷酸溶液(21：79)；流速：1.2mL/min；检测波长:286nm；柱温20℃；进样量10μL。理论塔板数按丹酚酸B计算应不低于6000。在选定的色谱条件下，丹酚酸B色谱峰与样品中相邻色谱峰可达基线分离，分离度大于1.5，理论塔板数为6000以上，拖尾因子T在0.95～1.05之间，而阴性无干扰。
1.2对照品溶液的制备
取丹酚酸B对照品适量，精密称定，加甲醇-水(8：2)混合溶液制成每1ml含0.1mg的溶液，即得。(见图1)
1.3供试品溶液的制备
精密称取1/20处方量丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子以及1/40的当归、木香、香附、青皮、连翘、茯苓，加12倍量水加热回流，提取2次，每次1h，待药液冷却至室温后滤过，合并三次滤液，静置2h，取上清液过微孔滤膜，进样10μL至高效液相色谱仪测定。(见图2)
1.4阴性对照溶液的制备
按处方要求制备不含丹参的阴性样品，同供试品溶液的制备方法制成缺丹参的阴性对照溶液。用高效液相色谱法测定，进样量10μL。(见图3)
2干浸膏得率的测定
称取全处方量水提部分药材，照试验安排表进行试验，煎液(合并)浓缩至1：1时量取10ml置干燥恒重的蒸发皿中，水浴挥干，105℃干燥3h后置于干燥器内冷却0.5h，称重，记录，计算，得浸膏率。
干浸膏得率(％)＝Vm1/10m
式中：V为浓缩液体的总体积，单位为毫升(ml)
m为水提药材的生药质量。单位为克(g)
m1为10ml浓缩液干浸膏质量，单位为克(g)
3采用正交试验法优选丸剂的提取工艺
3.1正交试验设计
采用正交试验法，L9(34)正交表安排实验，对部分药材的水煎煮提取工艺进行优选。经预试验，对有效成分丹酚酸B含量影响较大的因素有：加水量、煎煮时间、煎煮次数。以丹酚酸B含量作为评价指标，提取时间(A)、提取次数(B)、提取体积(C)为影响因素进行优化，因素及水平见表1。
表1因素与水平设计表
3.2正交试验结果及方差分析结果
精密称取1/20处方量丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子以及1/40处方量的当归、木香、香附、青皮、连翘、茯苓，按正交表进行提取，按“2.1”“2.2”项下方法测定丹酚酸B的含量和干膏得率。结果见表2，方差分析见表3。
表2 L9(34)正交试验方案及结果
注：综合评分＝((出膏率/最大出膏率)×0.2+(丹酚酸B含量/丹酚酸B最大提取量)×0.8)×100％
表3正交试验丹酚酸B含量统计分析结果
注：F0.05(1,2)＝19
以丹酚酸B的含量为指标，通过表3对试验结果的极差分析可以看出各因素作用主次顺序依次为提取次数、提取时间、提取体积，即C>B>A。方差分析表显示A、B、C因素差异不显著(p＞0.05)。由表2直观分析，A因素中A1＞A3＞A2,故选择A1；B因素中B2＞B3＞B1,故选择B2；C因素中C3＞C2＞C1，故选择C3,由此可以推出，以丹酚酸B为指标，最佳提取工艺为A1B2C3。即加12倍量水，提取2次，每次1小时。
3.3验证实验
将水提部分药材按优选的最佳提取工艺条件提取，并测定提取液中丹酚酸B的含量和干浸膏得率，结果见表4，按最佳工艺进行提取，丹酚酸B的含量和干膏得率均处于较高水平，表明该工艺合理可行，稳定可靠。
表4丸剂水提工艺三批验证试验结果
二、丸剂成型工艺研究
2.1提取液浓缩温度的考察
将提取所得水提液分别用60℃、70℃、80℃、90℃旋蒸以及直火浓缩至一定体积，倒入小烧杯中，60℃、70℃、80℃、90℃水浴浓缩以及直火浓缩至40ml，加入药粉，制成软材，然后用塑制法制成丸，50℃逐渐升温至80℃干燥，即得丸剂。以丹酚酸B含量为评价指标。(取lg丸粉于锥形瓶中，加入10ml80％甲醇，精密称重，超声30min，取出，称重，用80％甲醇补足重量，取续滤液过微孔滤膜，即得。)结果见表5。
表5水提药液浓缩温度考察结果
由上表可知：丸剂在80℃浓缩、干燥时，丹酚酸B含量最高。故选择80℃作为丸剂的浓缩干燥温度。
2.2丸剂成型研究
将提取液用旋转蒸发仪80℃浓缩，浓缩至大约75mL，然后倒入烧杯中，在80℃的水浴锅中浓缩至40mL，浓缩液相对密度为1.0546时，加入药粉，刚好可以成型，然后放入烘箱中50℃逐渐升温至80℃干燥即可。
2.3丸剂干燥时间考察
取丸剂，置于已恒重的蒸发皿中，平行2份，置于105℃烘箱中干燥至恒重，丸剂水分不得超过9.0％。结果见表6。
表6不同干燥时间丸剂中含有的水分(％)
结论：由上表可知，丸剂干燥7小时可达到水分要求。因此丸剂的最佳成型工艺为提取液旋转蒸发仪80℃浓缩至约75mL，继续80℃水浴浓缩至相对密度为1.0546(40ml)时，加入药粉，成型，然后放入烘箱中50℃逐渐升温至80℃干燥7小时即可。
确定丸剂的制法为：将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，加12倍量水浸泡1h后加热回流1h，滤过得药渣A，药渣A加12倍水煎煮1h，滤过得药渣B，药渣B再加12倍水煎煮1h，滤过，弃去药渣，合并三次滤液，浓缩至密度为1.0-1.1g/mL，再与药物C混合均匀制成软材，塑制法制丸，筛选，将选出药丸放入包衣锅滚圆，60℃干燥，即得。
三、颗粒剂提取工艺研究
1丹参药材中丹酚酸B的含量测定
按照2015版《中国药典》，取丹参粉末(过三号筛)约0.15g，精密称定，置于具塞锥形瓶中，精密加入(甲醇:水＝8:2)50ml，称定重量，超声处理30min，冷却至室温，称定，用(甲醇:水＝8:2)补足减失的重量，摇匀，滤过，取续滤液10μl，测定，本批丹参药材中丹酚酸B含量为3.7％，符合药典要求(丹酚酸B含量不少于3.0％)。
2干浸膏得率的测定
称取全处方量水提部分药材，照试验安排表进行试验，煎液(合并)浓缩至1:1时量取10ml置干燥恒重的蒸发皿中，水浴挥干，105℃干燥3h后置于干燥器内冷却0.5h，称重，记录，计算，得浸膏率。
干浸膏得率(％)＝V·m1/10·m×100％
式中：V为浓缩液体的总体积，单位为毫升(ml)
m为水提药材的生药质量。单位为克(g)
m1为10ml浓缩液干浸膏质量，单位为克(g)
3采用正交试验法优选提取工艺
3.1正交试验设计
将水提部分药材的提取工艺，通过L9(34)正交表进行试验设计。预试验，对有效成分含量影响较大的因素有：加水量、煎煮时间、煎煮次数。以丹酚酸B含量作为评价指标，提取时间(A)、提取次数(B)、提取体积(C)为影响因素进行优化，因素及水平见表7。
表7因素与水平设计表
3.2正交试验结果及方差分析结果
精密称取处方量丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子以及半处方量的当归、木香、香附、青皮、连翘、茯苓，按正交表进行提取，按“1.1.4”“1.2”项下方法测定丹酚酸B的含量和干膏得率。结果见表8，方差分析见表9。
表8 L9(34)正交试验方案及结果
注：综合评分＝((出膏率/最大出膏率)×0.2+(丹酚酸B含量/丹酚酸B最大提取量)×0.8)×100％
表9正交试验丹酚酸B含量统计分析结果
注：F0.05(1,2)＝19
以丹酚酸B的含量为指标，通过表3对试验结果的极差分析可以看出各因素作用主次顺序依次为提取次数、提取时间、提取体积，即C>B>A。方差分析表显示A、B、C因素差异不显著(p＞0.05)。由表2直观分析，A因素中A1＞A3＞A2,故选择A1；B因素中B2＞B3＞B1，故选择B2；C因素中C3＞C2＞C1，故选择C3，由此可以推出，以丹酚酸B为指标，最佳提取工艺为A1B2C3，即12倍量的水提取1h，分别提取2次。
3.3验证实验
将水提部分药材按优选的最佳提取工艺条件提取，并测定提取液中丹酚酸B的含量和干浸膏得率，结果见表10，按最佳工艺进行提取，丹酚酸B的含量和干膏得率均处于较高水平，表明该工艺合理可行，稳定可靠。
表10颗粒剂水提工艺三批验证试验结果
四、颗粒剂的成型工艺研究
1提取液浓缩温度的考察
将提取所得水提液分别用60℃、70℃、80℃、90℃旋蒸以及直火浓缩至一定体积，倒入小烧杯中，60℃、70℃、80℃、90℃水浴浓缩以及直火浓缩至40ml，加入70g的可溶性淀粉及药粉，制成软材，挤出制粒，80℃干燥，整粒，分剂量，即得颗粒。以丹酚酸B含量为评价指标。(取lg颗粒于锥形瓶中，加入10ml80％甲醇，精密称重，超声30min，取出，称重，用80％甲醇补足重量，取续滤液过微孔滤膜，即得。)结果见表11。
表11水提药液浓缩温度考察结果
由上表可知：颗粒在80℃浓缩、干燥时，丹酚酸B含量最高。故选择80℃作为水提药液的浓缩温度。
2加入辅料的考察
试验分别选择了糊精和淀粉，结果显示糊精粘度较大，无法成型；以淀粉为辅料成型后的颗粒流动性良好，故选择淀粉。最后考察了淀粉的加入量，分别考察了60g、70g、80g淀粉对颗粒成型的影响。结果显示，60g淀粉制成的软材较黏，不好挤压过筛；80g淀粉制成的软材太散，导致颗粒成型性不好；70g淀粉制成的软材达“手捏成团，手触即散”，颗粒成型性较好。故选择70g。
3颗粒干燥温度的考察
取10g湿颗粒平铺于搪瓷盘上厚度在2mm以内，平行3份，分别放入60℃、70℃、80℃的烘箱中干燥30min，取不同干燥温度得到的颗粒适量，按“丹酚酸B含量测定”方法制备供试品溶液并进行测定，结果见表12。
表12不同干燥温度下颗粒中丹酚酸B的峰面积
结论：由上表可知，颗粒的干燥温度为80℃最佳，故选择80℃作为颗粒干燥温度。
4颗粒干燥时间考察
取约1.5g干颗粒，置于已恒重的蒸发皿中，平行3份，置于80℃烘箱中干燥至恒重，颗粒水分不得超过8.0％。结果见表13。
表13不同干燥时间颗粒中含有的水分(％)
结论：由上表可知，颗粒干燥30min即可。
确定颗粒剂的制法为：将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，用水浸泡1h，加8倍水煎煮1.5h，煎煮3次，8层纱布过滤，合并三次滤液，滤液60℃浓缩至相对密度为1.15，再与药物C混合均匀，加入常规量可溶性淀粉制软材，挤压过筛，干燥，即得。
与现有技术相比，本发明所述中药药物本发明具有活血散瘀、消肿止痛功效，能有效治疗软跌打损伤，瘀血肿痛；本发明使用毒副作用小，治疗周期短，治疗效果好，达到了发明的目的。
附图说明
图1本发明实验例中丹酚酸B对照品色谱图；
图2本发明实验例中水提液高液图谱图；
图3本发明实验例中阴性对照溶液高液图谱。
具体实施方式
下面结合实施例对本发明作进一步的说明，但并不作为对本发明限制的依据。
实施例1.
一种活血止痛中药药物，所述丸剂这样制备：称取丹参9g、当归尾9g、赤芍9g、川芎1.5g、延胡索3g、三棱10g、乳香5g、没药5g、桃仁6g、藏红花3g、苏木6g、土鳖虫1.5g、血竭2g、三七3g、木香6g、香附6g、青皮6g、牡丹皮6g、连翘6g、莪术3g、蒲黄6g、茯苓9g、栀子6g、五灵脂6g、儿茶3g、北刘寄奴6g、穿山甲1.5g，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，加12倍量水浸泡1h后加热回流1h，滤过得药渣A，药渣A加12倍水煎煮1h，滤过得药渣B，药渣B再加12倍水煎煮1h，滤过，弃去药渣，合并三次滤液，浓缩至密度为1.0-1.1g/mL，再与药物C混合均匀制成软材，塑制法制丸，筛选，将选出药丸放入包衣锅滚圆，60℃干燥，制成0.5g/丸。
用法用量：口服，每日2-3次，每次5丸。
实施例2。一种活血止痛中药药物，所述颗粒剂这样制备：称取丹参163.63g、当归尾163.63g、赤芍163.62g、川芎27.27g、延胡索54.55g、三棱181.82g、乳香90.91g、没药90.91g、桃仁109.09g、藏红花54.55g、苏木109.09g、土鳖虫27.27g、血竭36.36g、三七54.55g、木香109.09g、香附109.09g、青皮109.08g、牡丹皮109.08g、连翘109.09g、莪术54.54g、蒲黄109.09g茯苓163.63g栀子109.09g五灵脂109.0、儿茶54.54g、北刘寄奴109.09g、穿山甲27.27g，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，用水浸泡1h，加8倍水煎煮1.5h，煎煮3次，8层纱布过滤，合并三次滤液，滤液60℃浓缩至相对密度为1.15，再与药物C混合均匀，加入常规量可溶性淀粉制软材，挤压过筛，干燥，制得20g/袋。
用法用量：口服，每日2-3次，开水冲化，每次1袋。
实施例3。一种活血止痛中药药物，所述片剂这样制备：称取由丹参11份、当归尾11份、赤芍11份、川芎2份、延胡索4份、三棱12份、乳香7份、没药7份、桃仁8份、藏红花4份、苏木8份、土鳖虫2份、血竭3份、三七4份、木香8份、香附8份、青皮8份、牡丹皮8份、连翘8份、莪术4份、蒲黄8份、茯苓11份、栀子8份、五灵脂8份、儿茶4份、北刘寄奴8份、穿山甲2份，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，用水浸泡1h，加8倍水煎煮1.5h，煎煮3次，8层纱布过滤，合并三次滤液，滤液60℃浓缩至相对密度为1.15，再与药物C混合均匀，加入常规量的可压性淀粉，整粒，压片，用果维膜包薄膜衣，制得药片0.25g/片。
用法用量：口服，每日2-3次，每次4片。
Claims (8)
1.一种活血止痛中药药物，其特征在于：药用有效成分照重量组份计算，由丹参4-14份、当归尾4-14份、赤芍4-14份、川芎0.5-3份、延胡索1-5份、三棱5-15份、乳香1-9份、没药1-9份、桃仁2-10份、藏红花1-5份、苏木2-10份、土鳖虫0.5-3份、血竭1-3份、三七1-5份、木香2-10份、香附2-10份、青皮2-10份、牡丹皮2-10份、连翘2-10份、莪术1-5份、蒲黄2-10份、茯苓4-14份、栀子2-10份、五灵脂2-10份、儿茶1-5份、北刘寄奴2-10份、穿山甲0.5-3份制成。
2.根据权利要求1所述的活血止痛中药药物，其特征在于：所述药物的药用有效成分照重量组份计算，由丹参7-11份、当归尾7-11份、赤芍7-11份、川芎1-2份、延胡索2-4份、三棱8-12份、乳香3-7份、没药3-7份、桃仁4-8份、藏红花2-4份、苏木4-8份、土鳖虫1-2份、血竭1-3份、三七2-4份、木香4-8份、香附4-8份、青皮4-8份、牡丹皮4-8份、连翘4-8份、莪术2-4份、蒲黄4-8份、茯苓7-11份、栀子4-8份、五灵脂4-8份、儿茶2-4份、北刘寄奴4-8份、穿山甲1-2份制成。
3.根据权利要求2所述的活血止痛中药药物，其特征在于：所述药物的药用有效成分照重量组份计算，由丹参9份、当归尾9份、赤芍9份、川芎1.5份、延胡索3份、三棱10份、乳香5份、没药5份、桃仁6份、藏红花3份、苏木6份、土鳖虫1.5份、血竭2份、三七3份、木香6份、香附6份、青皮6份、牡丹皮6份、连翘6份、莪术3份、蒲黄6份、茯苓9份、栀子6份、五灵脂6份、儿茶3份、北刘寄奴6份、穿山甲1.5份制成。
4.一种如权利要求1-3中任一项所述活血止痛中药药物的制备方法，其特征在于：取丹参、当归尾、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、藏红花、苏木、土鳖虫、血竭、三七、木香、香附、青皮、牡丹皮、连翘、莪术、蒲黄、茯苓、栀子、五灵脂、儿茶、北刘寄奴和穿山甲，与药物中可接受的辅料进行组合，按照常规方法进行加工，制成相应的药物。
5.根据权利要求4所述活血止痛中药药物的制备方法，其特征在于：所述药物为：丸剂、颗粒剂或片剂。
6.根据权利要求5所述活血止痛中药药物的制备方法，其特征在于：所述丸剂这样制备：按比例称以上药物，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，加12倍量水浸泡1h后加热回流1h，滤过得药渣A，药渣A加12倍水煎煮1h，滤过得药渣B，药渣B再加12倍水煎煮1h，滤过，弃去药渣，合并三次滤液，浓缩至密度为1.0-1.1g/mL，再与药物C混合均匀制成软材，塑制法制丸，筛选，将选出药丸放入包衣锅滚圆，60℃干燥，即得。
7.根据权利要求5所述活血止痛中药药物的制备方法，其特征在于：所述颗粒剂这样制备：按比例称以上药物，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，用水浸泡1h，加8倍水煎煮1.5h，煎煮3次，8层纱布过滤，合并三次滤液，滤液60℃浓缩至相对密度为1.15，再与药物C混合均匀，加入常规量可溶性淀粉制软材，挤压过筛，干燥，即得。
8.根据权利要求5所述活血止痛中药药物的制备方法，其特征在于：所述片剂这样制备：按比例称以上药物，将三七、血竭、藏红花、儿茶、五灵脂、穿山甲粉碎，过100目筛，得药粉A；另将当归、木香、香附、青皮、连翘及茯苓分别分为二等分，取其中一等分的当归、木香、香附、青皮、连翘及茯苓粉碎，过100目筛，得药粉B，合并药粉A和药粉B得药粉C；取丹参、赤芍、川芎、延胡索、三棱、乳香、没药、桃仁、苏木、土鳖虫、牡丹皮、莪术、北刘寄奴、蒲黄、栀子，与另一等分的当归、木香、香附、青皮、连翘及茯苓混合，用水浸泡1h，加8倍水煎煮1.5h，煎煮3次，8层纱布过滤，合并三次滤液，滤液60℃浓缩至相对密度为1.15，再与药物C混合均匀，加入常规量的可压性淀粉，整粒，压片，用果维膜包薄膜衣，即得。
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