CN110585387A - 一种壮骨舒筋药物及其制备方法 - Google Patents
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Abstract
本发明公开了一种壮骨舒筋药物及其制备方法，由党参、白术、白芍、当归、熟地黄、川芎、鹿茸、淫羊藿、杜仲、续断、锁阳、益智仁、海马、牛膝、骨碎补、威灵仙、秦艽、五加皮、桑寄生、苍术、砂仁、桂枝、茯神、远志及酸枣仁制成；本发明具有祛风除湿、散寒止痛、补益肝肾、舒筋活络、壮骨舒筋的功效，能有效治疗风湿性关节炎、类风湿性关节炎、坐骨神经炎及肩周炎；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
本发明涉及一种壮骨舒筋药物及其制备方法，属于药品技术的领域。
背景技术
风湿性关节炎(rheumatic arthritis)是一种常见的急性或慢性结缔组织炎症。通常所说的风湿性关节炎是风湿热的主要表现之一，临床以关节和肌肉游走性酸楚、红肿、疼痛为特征。
类风湿关节炎(RA)是一种慢性、以炎性滑膜炎为主的系统性疾病。其特征是手、足小关节的多关节、对称性、侵袭性关节炎症，经常伴有关节外器官受累及血清类风湿因子阳性，可以导致关节畸形及功能丧失。
坐骨神经痛是以坐骨神经径路及分布区域疼痛为主的综合征。坐骨神经痛的绝大多数病例是继发于坐骨神经局部及周围结构的病变对坐骨神经的刺激压迫与损害，称为继发坐骨神经痛；少数系原发性，即坐骨神经炎。
肩周炎又称肩关节周围炎，俗称凝肩、五十肩。以肩部逐渐产生疼痛，夜间为甚，逐渐加重，肩关节活动功能受限而且日益加重，达到某种程度后逐渐缓解，直至最后完全复原为主要表现的肩关节囊及其周围韧带、肌腱和滑囊的慢性特异性炎症。肩周炎是以肩关节疼痛和活动不便为主要症状的常见病症。
面对风湿性关节炎、类风湿性关节炎、坐骨神经炎及肩周炎等疾病，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。所以发明一种具有祛风除湿、散寒止痛、补益肝肾、舒筋活络、壮骨舒筋功效的中药药物具有重要的意义。
发明内容
本发明的目的在于，提供一种壮骨舒筋药物。本发明具有祛风除湿、散寒止痛、补益肝肾、舒筋活络、壮骨舒筋的功效，能有效治疗风湿性关节炎、类风湿性关节炎、坐骨神经炎及肩周炎；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：一种壮骨舒筋药物，药用有效成分照重量组份计算，由党参4-14份、白术1-11份、白芍1-11份、当归1-11份、熟地黄4-14份、川芎1-5份、鹿茸1-3份、淫羊藿1-11份、杜仲1-11份、续断1-11份、锁阳1-11份、益智仁1-5份、海马1-5份、牛膝1-11份、骨碎补1-11份、威灵仙1-5份、秦艽1-5份、五加皮1-5份、桑寄生1-11份、苍术1-5份、砂仁1-5份、桂枝1-5份、茯神1-5份、远志1-5份、酸枣仁1-5份制成。
前述的壮骨舒筋药物中，所述药物的药用有效成分照重量组份计算，由党参7-11份、白术4-8份、白芍4-8份、当归4-8份、熟地黄7-11份、川芎2-4份、鹿茸1-3份、淫羊藿4-8份、杜仲4-8份、续断4-8份、锁阳4-8份、益智仁2-4份、海马2-4份、牛膝4-8份、骨碎补4-8份、威灵仙2-4份、秦艽2-4份、五加皮2-4份、桑寄生4-8份、苍术2-4份、砂仁2-4份、桂枝2-4份、茯神2-4份、远志2-4份、酸枣仁2-4份制成。
前述的壮骨舒筋药物中，所述药物的药用有效成分照重量组份计算，由党参9份、白术6份、白芍6份、当归6份、熟地黄9份、川芎3份、鹿茸2份、淫羊藿6份、杜仲6份、续断6份、锁阳6份、益智仁3份、海马3份、牛膝6份、骨碎补6份、威灵仙3份、秦艽3份、五加皮3份、桑寄生6份、苍术3份、砂仁3份、桂枝3份、茯神3份、远志3份、酸枣仁3份制成。
前述壮骨舒筋药物的制备方法，取党参、白术、白芍、当归、熟地黄、川芎、鹿茸、淫羊藿、杜仲、续断、锁阳、益智仁、海马、牛膝、骨碎补、威灵仙、秦艽、五加皮、桑寄生、苍术、砂仁、桂枝、茯神、远志及酸枣仁，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。
前述壮骨舒筋药物的制备方法，所述药物为：丸剂、片剂或胶囊剂。
前述壮骨舒筋药物的制备方法中，所述丸剂这样制备：按比例称以上药物，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生加10倍量水煎煮3次，每次2小时，滤过，合并三次滤液，滤液采用常压浓缩至总体积0.0085倍的稠膏；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与稠膏混合均匀，搓条，制丸；将制成丸剂用包衣锅滚圆，80℃干燥10-14h即得。
前述壮骨舒筋药物的制备方法中，所述片剂这样制备：按比例称以上药物，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生加10倍量水煎煮3次，每次2小时，滤过，合并三次滤液，滤液采用常压浓缩至总体积0.0085倍的稠膏；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与稠膏混合均匀，60℃常压干燥或减压干燥，粉碎，过60目以下筛，加入适量辅料淀粉混匀，整粒，压片，用果维膜包薄膜衣，即得。
前述壮骨舒筋药物的制备方法中，所述胶囊剂这样制备：按比例称以上药物，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生加10倍量水煎煮3次，每次2小时，滤过，合并三次滤液，滤液采用常压浓缩至总体积0.0085倍的稠膏；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与稠膏混合均匀，60℃常压干燥或减压干燥，粉碎，过60目以下筛，装入胶囊，即得。
本发明由党参、白术、白芍、当归、熟地黄、川芎、鹿茸、淫羊藿、杜仲、续断、锁阳、益智仁、海马、牛膝、骨碎补、威灵仙、秦艽、五加皮、桑寄生、苍术、砂仁、桂枝、茯神、远志及酸枣仁制成，其中党参，为桔梗科植物党参、素花党参、或川党参等的干燥根；有补中，益气，生津的功效；治脾胃虚弱，气血两亏，体倦无力，食少，口渴，久泻，脱肛。白术，为菊科植物白术Atractylodes macrocephala Koidz.的干燥根茎；有健脾益气，燥湿利水，止汗，安胎的功效；用于脾虚食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安。土白术健脾，和胃、安胎。白芍，为毛茛科植物芍药Paeonia lactiflora Pall.的干燥根；有平肝止痛，养血调经，敛阴止汗功效；用于头痛眩晕，胁痛，腹痛，四肢挛痛，血虚萎黄，月经不调，自汗，盗汗。当归，为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根；有补血活血，调经止痛，润肠通便的功效；用于血虚萎黄，眩晕心悸，月经不调，经闭痛经，虚寒腹痛，肠燥便秘，风湿痹痛，跌扑损伤，痈疽疮疡。酒当归活血通经。用于经闭痛经，风湿痹痛，跌扑损伤。熟地黄，为玄参科植物地黄Rehmannia glutinosa Libosch.块根的炮制加工品；有滋阴补血，益精填髓的功效；用于肝肾阴虚，腰膝酸软，骨蒸潮热，盗汗遗精，内热消渴，血虚萎黄，心悸怔忡，月经不调，崩漏下血，眩晕，耳鸣，须发早白。川芎，为伞形科植物川芎Ligusticumchuanxiong Hort.(或Ligusticum wallichii Franch.)的干燥根茎；有活血行气，祛风止痛的功效；用于月经不调，经闭痛经，症瘕腹痛，胸胁刺痛，跌扑肿痛，头痛，风湿痹痛。鹿茸，为鹿科动物梅花鹿Cervus nippon Temminck或马鹿Cervus elaphus Linnaeus的雄鹿未骨化密生茸毛的幼角；有壮肾阳，益精血，强筋骨，调冲任，托疮毒的功效；用于阳痿滑精，宫冷不孕，羸瘦，神疲，畏寒，眩晕耳鸣耳聋，腰脊冷痛，筋骨痿软，崩漏带下，阴疽不敛。淫羊藿，为小檗科植物淫羊藿Epimedium brevicornum Maxim.、箭叶淫羊藿Epimedium sagittatum(Sieb.et Zucc.)Maxim.、柔毛淫羊藿Epimedium pubescens Maxim.、巫山淫羊藿Epimedium wushanense T.S.Ying、或朝鲜淫羊藿Epimediumkoreanum Nakai的干燥地上部分；有补肾阳，强筋骨，祛风湿功效；用于阳痿遗精，筋骨痿软，风湿痹痛，麻木拘挛；更年期高血压。杜仲，为杜仲科植物杜仲Eucommia ulmoides Oliv.的干燥树皮；有补肝肾，强筋骨，安胎的功效；用于肾虚腰痛，筋骨无力，妊娠漏血，胎动不安；高血压。续断，为川续断科植物川续断Dipsacus asperoides C.Y.Cheng et T.M.Ai(或Dipsacus asper Wall)的干燥根；有补肝肾，强筋骨，续折伤，止崩漏的功效；用于腰膝酸软，风湿痹痛，崩漏，胎漏，跌扑损伤。酒续断多用于风湿痹痛，跌扑损伤。盐续断多用于腰膝酸软。锁阳，为锁阳科植物锁阳Cynomorium songaricum Rupr.的干燥肉质茎；有补肾阳，益精血，润肠通便的功效；用于腰膝痿软，阳痿滑精，肠燥便秘。益智仁，为姜科植物益智的果实；功能主治温脾，暖肾，固气，涩精；治冷气腹痛，中寒吐泻，多唾，遗精，小便余沥，夜多小便。海马，为海龙科动物线纹海马Hippocampus kelloggi Jordan et Snyder、刺海马Hippocampus histrix Kaup、大海马Hippocampus kuda Bleeker、三斑海马Hippocampus trimaculatus Leach或小海马(海蛆)Hippocampus japonicus Kaup的干燥体；功能主治温肾壮阳，散结消肿；用于阳痿，遗尿，肾虚作喘，症瘕积聚，跌扑损伤；外治痈肿疔疮。牛膝，为苋科植物牛膝Achyranthesbidentata Blume.的干燥根；功能主治补肝肾，强筋骨，逐瘀通经，引血下行；用于腰膝酸痛，筋骨无力，经闭症瘕，肝阳眩晕。骨碎补，为水龙骨科植物槲蕨Drynaria fortunei(Kunze)J.Sm.的干燥根茎；功能主治补肾强骨，续伤止痛；用于肾虚腰痛，耳鸣耳聋，牙齿松动，跌扑闪挫，筋骨折伤；外治斑秃，白癜风。威灵仙，为毛茛科植物威灵仙Clematischinensis Osbeck、棉团铁线莲(山蓼)Clematis hexapetala Pall.或东北铁线莲(黑薇)Clematis manshurica Rupr.的干燥根及根茎；功能主治祛风除湿，通络止痛；用于风湿痹痛，肢体麻木，筋脉拘挛，屈伸不利，骨哽咽喉。秦艽，为龙胆科植物秦艽Gentianamacrophylla Pall.、麻花秦艽Gentiana straminea Maxim.、粗茎秦艽Gentianacrassicaulis Duthie ex Burk.或小秦艽Gentiana dahurica Fisch.的干燥根；功能主治祛风湿，清湿热，止痹痛；用于风湿痹痛，筋脉拘挛，骨节酸痛，日晡潮热，小儿疳积发热。五加皮，为五加科植物细柱五加Acanthopanax gracilistylus W.W.Smith的干燥根皮；功能主治祛风湿，补肝肾，强筋骨；用于风湿痹痛，筋骨痿软，小儿行迟，体虚乏力，水肿，脚气。桑寄生，为桑寄生科植物桑寄生Taxillus chinensis(DC.)Danser的干燥带叶茎枝；功能主治补肝肾，强筋骨，祛风湿，安胎元；用于风湿痹痛，腰膝酸软，筋骨无力，崩漏经多，妊娠漏血，胎动不安；高血压。苍术，为菊科植物茅苍术Atractylodes lancea(Thunb.)DC.或北苍术Atractylodes chinensis(DC.)Koidz.的干燥根茎；功能主治燥湿健脾，祛风散寒，明目；用于脘腹胀满，泄泻，水肿，脚气痿躄，风湿痹痛，风寒感冒，夜盲。砂仁，为姜科植物阳春砂Amomum villosum Lour.、绿壳砂Amomum villosum Lour.var.xanthioides T.L.Wu etSenjen或海南砂Amomum longiligulare T.L.Wu的干燥成熟果实；功能主治化湿开胃，温脾止泻，理气安胎；用于湿浊中阻，脘痞不饥，脾胃虚寒，呕吐泄泻，妊娠恶阻，胎动不安。桂枝，为樟科植物肉桂Cinnamomum cassia Presl的干燥嫩枝；功能主治发汗解肌，温通经脉，助阳化气，平冲降气。用于风寒感冒，脘腹冷痛，血寒经闭，关节痹痛，痰饮，水肿，心悸，奔豚。茯神，茯苓菌核中间(白茯苓)抱有松根或细松木心者的部份；功能主治宁心安神；适用于心悸怔忡、失眠健忘等症。远志，为远志科植物远志Polygala tenuifolia Willd.或卵叶远志Polygala sibirica L.的干燥根；功能主治安神益智，祛痰，消肿；用于心肾不交引起的失眠多梦，健忘惊悸，神志恍惚，咳痰不爽，疮疡肿毒，乳房肿痛。酸枣仁，为鼠李科植物酸枣Ziziphus jujuba Mill.var.spinosa(Bunge)Hu ex H.F.Chou的干燥成熟种子；功能主治补肝，宁心，敛汗，生津；用于虚烦不眠，惊悸多梦，体虚多汗，津伤口渴。
方解:损伤后期,气血两虚，脾胃不足，肝肾亏损，筋骨失养，筋骨未坚，致肌体肌肉关节疼痛；损伤后期、阳气不足，腠理空虚，风寒湿邪乘虚侵袭经络，导致肢体经络不利、疼痛。故治疗上以“补气血,养心脾,补肝肾,强筋骨,祛风湿,通经络”为治则。本方以党参、当归、白芍、熟地、川芎、白术、陈皮、苍术、砂仁补气健脾养血、充养肌肉；杜仲、续断、牛膝、骨碎补、鹿茸、淫羊藿、锁阳、海马补肝肾、强筋骨；威灵仙、秦艽、五加皮、桑寄生、桂枝、苍术、防己、祛风除湿、通络活络；茯神、远志、酸枣仁养心安神。
发明人对本发明的药物做了以下研究
实验例：
一、制备工艺研究
(一)剂型的选择
散剂见效快，但存在服用量过大，药物不稳定易吸湿结块，挥发性成分易挥发损失等不足；丸剂是中药原粉较理想的剂型，药材药粉可以直接与黏合剂挤压成丸，单位重量下能较多地容纳固体、半固体或黏液状药物。生产技术和设备比较简单，制造成本相对低廉，比散剂更稳定，故考虑制成丸剂。
(二)工艺的选择
中药丸剂由于原生药材粉量大，为了便于成型，一般仅加适量的水或炼蜜，而不需要另加辅料。本发明的药物共有中药25味，药味多，药量大，患者的服用量大，为减少患者服用量，减少挥发性药物的受热损失，同时便于成型，因此考虑部分药材粉碎成细粉原生药直接制丸，另外一部分药材采用适宜的方法提取。
白术、苍术、砂仁、桂枝、当归所含苍术酮、苍术醇、樟脑、桂皮醛、藁本内酯等有效成分都具有挥发性，因此选择将这部分药物粉碎成细粉原生药直接入药。同时有2味贵重药物：鹿茸、海马，且处方量较少，为了减少提取造成的损失，故而将这两种药物也单独粉碎成细粉使用。经前期预实验，选择以白芍中的白芍苷为有效成分的检测指标，且白芍药材的粉性较强，其药材细粉利于丸剂的成型，为了减少其提取造成的损失，同时考虑到白芍的处方量较大，因此选择将50％白芍单独粉碎成细粉使用，50％白芍与其它药材提取。茯神药材的粉性较强，其药材细粉利于丸剂的成型，而茯神、远志、酸枣仁均有“宁心安神”之功效，药效有相通之处，酸枣仁单独粉碎又过于黏稠难于粉碎，故选择将茯神、远志、酸枣仁混合粉碎，以减少药量的损失。处方中的党参、熟地、川芎、淫羊藿等药材所含党参多糖、梓醇、川芎生物碱、淫羊藿苷等有效成分，均有一定的水溶性，考虑到工业生产的可行性、成本，兼虑到中医临床用药特点，加水回流提取有效成分，制成丸剂。
经预实验，发现党参、熟地、川芎、淫羊藿等共十五味药材提取所得的干浸膏，由于含糖较多，所以质地较坚硬，难于粉碎成干浸膏粉，因此将这些提取的药材，制成适宜稠度的稠浸膏，加入上述混匀的药材细粉，制成丸剂。
(四)提取工艺研究
(1)正交试验优选
按1/10投料，照制法项下的方法回流，浓缩至体积为回流液总体积的0.0085倍，以加水量，煎煮时间，煎煮次数为考查因素，进行L9(34)正交试验，并以芍药苷含量为评价指标，筛选出最佳工艺。试验安排及结果见表2、表3、表4，芍药苷含量测定方法如下：
含量测定照高效液相色谱法(中国药典2015年版四部0512)测定。
色谱条件与系统适用性试验以碳十八烷基硅烷键合硅胶为填充剂；乙腈-水(11:89)为流动相；检测波长为230nm。理论塔板数以芍药苷峰计，应不低于2000。
对照品溶液的制备取芍药苷对照品适量，精密称定，加甲醇制成每1ml约含237μg的溶液，即得。
供试品溶液的制备将浓缩至500ml煎煮液适量，用微孔滤膜(0.45μm)滤过，即得。
测定法分别精密吸取对照品溶液和供试品溶液各10μl，注入液相色谱仪，测定，计算，即得。
表2水提正交试验因素水平表
表3正交试验方案及结果
综合评分标准：综合评分＝权重系数(30)x浸膏得率/最大浸膏得率+权重系数(70)x峰面积/最大峰面积
表4芍药苷含量方差分析表
注：F0.05(2，2)＝19.00
由直观分析可见，煎煮次数对制剂中芍药苷含量有明显影响，由表3中极差R值大小显示，各因素作用主次为B＞A＞C；方差分析结果表明：B因素的影响具有显著性意义,以B3A2C3组合为佳，即煎煮三次，每次加水量为12倍，煎煮1.5小时，并对此工艺进行验证，证明此工艺稳定可行。
表5验证试验
(2)加水量及煎煮时间的确定加水量10，10，10倍(每次煎煮2小时)与加水量12，12，12倍(每次煎煮1.5小时)，比较结果见表6：
表6加水量及煎煮次数比较
结果表明：加水量10，10，10倍(每次煎煮2小时)与加水量12，12，12倍(每次煎煮1.5小时)之间有显著差异，因此最终采用如下提取工艺，即煎煮三次，每次加水量为10倍，煎煮2小时。
(四)浓缩工艺研究
经查阅文献及前期预实验，发现煎煮的这十五味药的主要有效成分，如芍药苷、川芎生物碱、淫羊藿苷等对热较稳定，同时处方中以挥发性成分为主要有效成分的药材都直接粉碎后制丸，所以为缩短浓缩时间，提高效率，将滤液采用常压浓缩。
(五)成型工艺研究
常压浓缩所得的稠膏，与前面处理的已混匀的鹿茸、海马、白术、白芍等药材细粉，混匀，搓条，制丸。
1、稠膏程度的确定
故将水煎液浓缩至回流液总体积0.0085倍稠膏时，丸剂成型效果最好。
与现有技术相比，本发明所述中药药物具有祛风除湿、散寒止痛、补益肝肾、舒筋活络、壮骨舒筋的功效，能有效治疗风湿性关节炎、类风湿性关节炎、坐骨神经炎及肩周炎；本发明制备方法简单，疗效显著，毒副作用小，治疗周期短，治疗效果好，达到了发明的目的。
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.
一种壮骨舒筋药物，所述丸剂这样制备：称取党参9g、白术6g、白芍6g、当归6g、熟地黄9g、川芎3g、鹿茸2g、淫羊藿6g、杜仲6g、续断6g、锁阳6g、益智仁3g、海马3g、牛膝6g、骨碎补6g、威灵仙3g、秦艽3g、五加皮3g、桑寄生6g、苍术3g、砂仁3g、桂枝3g、茯神3g、远志3g、酸枣仁3g，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生煎煮，浓缩煎煮药液至30ml；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与浓缩的药液混合均匀，搓条，制丸；将制成丸剂用包衣锅滚圆，80℃干燥12h，即得，制得丸剂称重49g。
用法用量：口服，每日2-3次，每次10g。
实施例2。一种壮骨舒筋药物，所述片剂这样制备：称取党参70g、白术40g、白芍40g、当归40g、熟地黄70g、川芎20g、鹿茸10g、淫羊藿40g、杜仲40g、续断40g、锁阳40g、益智仁20g、海马20g、牛膝40g、骨碎补40g、威灵仙20g、秦艽20g、五加皮20g、桑寄生40g、苍术20g、砂仁20g、桂枝20g、茯神20g、远志20g、酸枣仁20g，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生煎煮，浓缩煎煮药液至250ml；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与浓缩的药液混合均匀，60℃常压干燥或减压干燥，粉碎，过60目以下筛，加入适量辅料淀粉混匀，整粒，压片，用果维膜包薄膜衣，即得，制得药片0.25g/片。
用法用量：口服，每日2-3次，每次4片。
实施例3。一种壮骨舒筋药物，所述胶囊剂这样制备：称取党参110g、白术80g、白芍80g、当归80g、熟地黄110g、川芎40g、鹿茸30g、淫羊藿80g、杜仲80g、续断80g、锁阳80g、益智仁40g、海马40g、牛膝-80g、骨碎补80g、威灵仙40g、秦艽40g、五加皮40g、桑寄生80g、苍术40g、砂仁40g、桂枝40g、茯神40g、远志40g、酸枣仁40g，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生煎煮，浓缩煎煮药液至350ml；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与浓缩的药液混合均匀，60℃常压干燥或减压干燥，粉碎，过60目以下筛，装入胶囊，制得胶囊0.25g/粒。
用法用量：口服，每日2-3次，每次4粒。
Claims (8)
1.一种壮骨舒筋药物，其特征在于：药用有效成分照重量组份计算，由党参4-14份、白术1-11份、白芍1-11份、当归1-11份、熟地黄4-14份、川芎1-5份、鹿茸1-3份、淫羊藿1-11份、杜仲1-11份、续断1-11份、锁阳1-11份、益智仁1-5份、海马1-5份、牛膝1-11份、骨碎补1-11份、威灵仙1-5份、秦艽1-5份、五加皮1-5份、桑寄生1-11份、苍术1-5份、砂仁1-5份、桂枝1-5份、茯神1-5份、远志1-5份、酸枣仁1-5份制成。
2.根据权利要求1所述的壮骨舒筋药物，其特征在于：所述药物的药用有效成分照重量组份计算，由党参7-11份、白术4-8份、白芍4-8份、当归4-8份、熟地黄7-11份、川芎2-4份、鹿茸1-3份、淫羊藿4-8份、杜仲4-8份、续断4-8份、锁阳4-8份、益智仁2-4份、海马2-4份、牛膝4-8份、骨碎补4-8份、威灵仙2-4份、秦艽2-4份、五加皮2-4份、桑寄生4-8份、苍术2-4份、砂仁2-4份、桂枝2-4份、茯神2-4份、远志2-4份、酸枣仁2-4份制成。
3.根据权利要求2所述的壮骨舒筋药物，其特征在于：所述药物的药用有效成分照重量组份计算，由党参9份、白术6份、白芍6份、当归6份、熟地黄9份、川芎3份、鹿茸2份、淫羊藿6份、杜仲6份、续断6份、锁阳6份、益智仁3份、海马3份、牛膝6份、骨碎补6份、威灵仙3份、秦艽3份、五加皮3份、桑寄生6份、苍术3份、砂仁3份、桂枝3份、茯神3份、远志3份、酸枣仁3份制成。
4.一种如权利要求1-3中任一项所述壮骨舒筋药物的制备方法，其特征在于：取党参、白术、白芍、当归、熟地黄、川芎、鹿茸、淫羊藿、杜仲、续断、锁阳、益智仁、海马、牛膝、骨碎补、威灵仙、秦艽、五加皮、桑寄生、苍术、砂仁、桂枝、茯神、远志及酸枣仁，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所述壮骨舒筋药物的制备方法，其特征在于：所述药物为：丸剂、片剂或胶囊剂。
6.根据权利要求5所述壮骨舒筋药物的制备方法，其特征在于：所述丸剂这样制备：按比例称以上药物，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生加10倍量水煎煮3次，每次2小时，滤过，合并三次滤液，滤液采用常压浓缩至总体积0.0085倍的稠膏，取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与稠膏混合均匀，搓条，制丸；将制成丸剂用包衣锅滚圆，80℃干燥10-14h即得。
7.根据权利要求5所述壮骨舒筋药物的制备方法，其特征在于：所述片剂这样制备：按比例称以上药物，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生加10倍量水煎煮3次，每次2小时，滤过，合并三次滤液，滤液采用常压浓缩至总体积0.0085倍的稠膏；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与稠膏混合均匀，60℃常压干燥或减压干燥，粉碎，过60目以下筛，加入适量辅料淀粉混匀，整粒，压片，用果维膜包薄膜衣，即得。
8.根据权利要求5所述壮骨舒筋药物的制备方法，其特征在于：所述胶囊剂这样制备：按比例称以上药物，将白芍分为二等分，取其中一等分白芍与党参、熟地黄、川芎、淫羊藿、杜仲、续断、锁阳、益智仁、牛膝、骨碎补、威灵仙、秦艽、五加皮及桑寄生加10倍量水煎煮3次，每次2小时，滤过，合并三次滤液，滤液采用常压浓缩至总体积0.0085倍的稠膏；取另一等分白芍与鹿茸、海马、白术、苍术、砂仁、桂枝、当归、茯神、远志及酸枣仁打粉，过六号筛，将打粉药物研匀，与稠膏混合均匀，60℃常压干燥或减压干燥，粉碎，过60目以下筛，装入胶囊，即得。
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