CN116747285A - 一种治疗血液病合并下肢静脉血栓的中药及制剂制备方法 - Google Patents
一种治疗血液病合并下肢静脉血栓的中药及制剂制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗血液病合并下肢静脉血栓的中药及制剂制备方法,所述中药的组方如下:水蛭10‑15g、土鳖虫9‑12g、白附片10‑15g、干姜10‑15g、肉桂10‑15g、炙甘草20‑30g、白芍20‑30g、三七9‑12g、砂仁15‑20g、紫苏叶3‑6g;本发明制备方法:将水蛭、土鳖虫、白附片、干姜、肉桂、炙甘草、白芍、三七、砂仁、紫苏叶全部粉碎后,水提1~3次,得到水提液减压浓缩成稠浸膏,再减压干燥,将浸膏粉碎,与粉状辅料混合,做成混合粉,将混合粉用水润湿,制作成软材,然后制粒,再干燥得到所需的颗粒剂;本发明相较于以前的中药组方剂改变了君药选择,更新了活血化瘀但不上正、防出血的特色,扩大了临床应用范围,囊括了包括血液病在内的更多凝血异常伴有血栓发生的疑难病症。
Description
技术领域
本发明属于中药及其制备方法技术领域,具体涉及一种治疗血液病合并下肢静脉血栓的中药及其颗粒剂、膏方的制备方法。
背景技术
血栓性疾病是严重危害人类健康和生命的疾病,其发病率致残率和死亡率都很高,临床上常见的血栓性疾病包括急性冠脉综合征、急性缺血性脑血管病、糖尿病患者的血栓形成、血栓闭塞性脉管炎、下肢深静脉血栓、急性肿瘤引起的血栓等。血栓形成和梗塞在心肌梗死、脑梗死和肺梗死中扮演最主要角色。全世界每年至少有数十万由下肢深静脉血栓形成(DVT)导致死亡的患者。因此,数十年来溶栓治疗成为上述疾病的研究焦点。1950年代,尿激酶用于治疗静脉血栓形成,紧接着链激酶治疗急性心肌梗塞获得成功,开创了溶栓疗法的新纪元。尽管溶栓药物在心脑血管病治疗中获得一些进展,但现有药物对纤维蛋白的特异性不高,有内出血危险等缺点,如何提高溶栓成功率和减少出血及再闭塞的危险性是溶栓治疗面临的重要课题。血管内皮损伤、静脉回流减慢、血液高凝状态被认为是深静脉血栓形成三大因素,至今仍被公认为主要原因。长期以来,中医中药在血栓病的治疗上积累了丰富可靠的经验。血栓栓塞性疾病的中医分型尽管名目繁多,但从阴阳辨证上归根结底分为两型:阴寒凝滞和瘀热互结。在血瘀病因上,《内经》最强调因寒致瘀,《素问·调经论》指出:“寒独留,则血凝泣,凝则血脉不通”。汉唐时代,张仲景、孙思邈随瘀血之不同而寒热均用,创虫类化瘀中药之先河,明清温病学派兴起,叶天士“凉血散血”治疗原则对后世治疗瘀血影响甚深,使得目前国内绝大多数中医药治疗血栓的医者喜用清热活血,凉血化瘀的药物,这易误将下肢深静脉血栓患处局部的红、肿、热、痛这种本寒标热的表现就视之为瘀热互结,而大量使用凉血活血药物,使得越用寒郁越重,以至于收效甚微。除此之外,许多科研工作也围绕着凉血活血药物对血栓的治疗而展开。本发明申请人经过多年对血栓性疾病的中西医联合治疗,发现许多发生血栓性疾病、甚至很多动脉硬化的患者往往年龄较大,基础存在饮食不节、作息紊乱、情绪不良等因素,或长期伴有腰膝酸软、手足厥寒、二便异常等表现。《黄帝内经》有言“年半百而动作皆衰者......”恰好与上述饮食、作息、情绪密切相关。且“年四十而阴气自半”,可见中老年高发的血栓性疾病是基于本虚之上的,温阳通络以助营卫,阴阳得以平衡,“营行脉中,卫行脉外”,二者共奏气血调和而不产生瘀滞,而这一生理过程,用大量寒凉活血的药物是无法奏效的。
血液病患者往往存在凝血功能紊乱的情况,目前西医抗凝制剂如肝素、华法令、新型抗凝药物的使用对于血液病患者而言,有增加出血的风险。因此,在对于凝血功能异常的静脉血栓患者临床用药成为极大的难点、痛点。寻找合适的中药抗凝药物具有重要意义。
回溯近现代中医领域治疗血栓的方剂,有许多名方涌现。1997 年,我国第一个通过美国FDA审批准许进行临床Ⅱ期和Ⅲ期试验的中成药复方丹参滴丸(IND 号码:56956)出现。复方丹参滴丸由丹参、 三七和冰片组成,全方以活血化瘀治疗为主,经过大量的基础研究和临床实践,成为家喻户晓的冠心病防治中成药。通心络胶囊是由吴以岭教授结合中医络病学说和现代科学构建的脉络学说产生,该制剂在活血化瘀治疗的基础上,加用补气的人参为君药,加入蝉蜕等祛风的中药,全方以虫类药物为组方特色,水蛭、全蝎和土鳖虫活血,搜风通络,共为臣药,赤芍凉血散血,以制人参之温,针对郁久化热的沉疴,酸枣仁养血安神以防逐瘀伤正,多药共用以为佐药,以降香、冰片芳香走窜共为使药,以引诸药入窍通络。诸药合用,达到益气扶正、脉络畅通之效。陈可冀院士提出了“三通两补”治疗老年冠心病,主要包括“芳香温通、宣痹通阳、活血化瘀、补肾、补气血”这几种方法。然而,以往研究主要集中于心脑血管病人、代谢综合征患者、亚健康人群,但存在的问题是仍然未将血栓合并出血风险的病症涵盖,缺乏临床实践,临床中对于原本有出血风险的血栓病人面临着的巨大困境。
发明内容
本发明的目的是解决现有技术的不足,提供一种对包含恶性血液系统疾病在内各种下肢静脉血栓患者疗效确切,治疗恶性血液病合并下肢静脉血栓有效的中药,本发明还提供这种中药的制剂制备方法。
本发明采取的技术方案如下:
一种治疗血液病合并下肢静脉血栓的中药,所述中药的组方如下:水蛭10-15g、土鳖虫9-12g、白附片10-15g、干姜10-15g、肉桂10-15g、炙甘草20-30g、白芍20-30g、三七9-12g、砂仁15-20g、紫苏叶3-6g。
上述治疗血液病合并下肢静脉血栓的中药制剂制备方法如下:
(1)将水蛭、土鳖虫、白附片、干姜、肉桂、炙甘草、白芍、三七、砂仁、紫苏叶全部粉碎后,水提1~3次,得到水提液;
(2)将水提液减压浓缩成稠浸膏,再减压干燥成干浸膏;
(3)将干浸膏粉碎,与粉状辅料混合,做成混合粉;
(4)将混合粉用水润湿,制作成软材,然后制粒,再干燥得到所需的颗粒剂。
上述治疗血液病合并下肢静脉血栓的中药制剂制备方法还可以如下:
(1)将干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶浸湿后用蒸汽蒸馏提取挥发油,挥发油收集待用;
(2)将步骤(1)提取挥发油后的药渣与水蛭、土鳖虫、白附片、三七一起加水煎煮提取;
(3)将提取液减压浓缩成稠浸膏,再减压干燥成干浸膏;
(4)将干浸膏粉碎,与粉状辅料混合,做成混合粉;
(5)将混合粉用水润湿,制作成软材,然后制粒;
(6)将步骤(1)收集的挥发油用乙醇溶解后喷入颗粒混匀,经干燥得到所需的颗粒剂。
上述治疗血液病合并下肢静脉血栓的中药制剂制备方法还可以如下:
(1)将干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶浸湿后用蒸汽蒸馏提取挥发油,挥发油收集待用;
(2)将步骤(1)提取挥发油后的药渣与水蛭、土鳖虫、白附片、三七一起加水煎煮提取;
(3)将提取液减压浓缩成稠浸膏;
(4)将步骤(1)收集的挥发油用环糊精包合后加入到步骤(3)制备的稠浸膏中,制作成软材,然后制粒,经干燥得到所需的颗粒剂。
上述治疗血液病合并下肢静脉血栓的中药制剂制备方法还可以是:将白附片煎煮至少1小时,再加入干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶煎煮,同时收集挥发油,最后再加入水蛭、土鳖虫煎煮,然后过滤,将滤液浓缩收膏,将收集的挥发油和三七打粉加入到膏中搅拌均匀,即得中药膏剂。
本发明的中药组方方解如下:
(1)水蛭:性平,味咸、苦,有小毒,归肝经,具有破血、逐瘀、通经的功效。主要含蛋白质,亦含铁、锰、锌等多种微量元素。药理研究发现,其具有防止血栓形成、并溶解血栓的作用,可降低血小板的活性,抑制血小板的释放、聚集、粘附,而具有抗凝血、抗血小板的作用,并具有影响血液流变学、降低血脂、抑制成维细胞增殖、保护内皮细胞、改善心血管功能,还能促进脑血肿和皮下血肿的吸收,减轻周围炎症和水肿,缓解颅内高压,改善局部血流循环。水蛭对新瘀效果好,组方中重用水蛭,起逐瘀,通经消肿之效。
(2)土鳖虫:性寒,味咸,有小毒,归肝经。具有逐瘀血,续筋骨的功效。主要含蛋白质、挥发油、脂肪酸、氨基酸、甾醇及多种微量元素,另含各种脂肪醛和芳香醛及二氯苯和二甲基二硫醚等其他中药少见的成分。药理研究分析,其具有改善心脑血管功能、显著的调脂和对白血病细胞抑制作用。动物实验表明,土鳖虫水提物有抗凝血作用,还有抗缺氧、抗突变、降低总胆固醇和提高高密度脂蛋白/胆固醇比值的作用。土鳖虫对陈瘀效果最佳。
水蛭、土鳖虫皆为化瘀佳品,功善破血逐瘀,其中水蛭长于祛新瘀,土鳖虫长于祛陈瘀;二者相须为用,化瘀之力更著,故共为方中君药。
(3)白附片:性热,味辛、甘,有大毒,归心经、肾经、脾经,具有回阳救逆、补火助阳、散寒止痛的功效,属温里药。主要含有各种乌头碱。药理研究表明,其具有强心、抗心肌缺血、抗休克、抑制凝血功能和抗血栓形成、抗炎、镇痛、增强体液免疫作用。
本发明创新性地将白附片在组方中与水蛭、土鳖虫联用为君药,起抑制凝血功能和抗血栓形成的功效。尤其适用于恶性血液病、凝血功能紊乱的患者。此类患者归结于中医虚劳,运用附子温阳、固阳、回阳从而起到温通且摄血的作用,使活血化瘀的同时防止出血。同时这些基础病较重、凝血功能紊乱的患者往往存在“久病入络”的问题,本发明采用水蛭和土鳖虫与白附片共为君药,针对血虚、虚劳、寒凝等因素导致的下肢深静脉血栓有显著的疗效。
(4)三七:性温,味甘、微苦,归肝经、胃经,毒性较低,长期用药基本无副反应。具有散瘀止血、消肿定痛的功效。主要含人参皂苷 Rgi、槲皮素、乙酸、丁香烯、人参皂苷 Re、亮氨酸、β-谷固醇-D-葡萄糖苷、人参炔三醇、三七皂苷等12种单体皂苷及止血成分田七氨酸,对血液及造血系统具有止血、抗血小板聚集及溶栓、溶血、造血等作用,对心血管系统具有抗心律失常、抗动脉粥样硬化、耐缺氧及抗休克、改善脑缺血等作用,对神经系统具有中枢神经抑制、镇痛等作用。组方中三七为臣药,辅助水蛭行活血之功,三七化瘀不伤正,使全方效果活血而又止血,溶栓的同时减少出血风险。
(5)干姜、炙甘草、白芍、肉桂四药在组方中为辅佐药。
干姜性热、味辛,归脾经、胃经、心经、肾经、肺经;具有温中散寒、回阳通脉、燥湿消痰的功效。干姜含挥发油,主要成分为姜酮、6-姜辣素、β-没药烯、a-姜黄烯、β-倍半水芹烯及姜醇、8-茨烯、桉油精、枸橼醛、龙脑等,具有镇静、镇痛、抗炎、升血压、抗凝血作用,干姜长于通心脉、助心阳、祛寒邪。
炙甘草性温、味甘,归心经、肺经、胃经、脾经;具有补脾和胃、益气复脉的功效,主要含甘草苷、甘草酸、甘草甜素、子丁香烯氧化物、甘草萜醇、18-羟基甘草次酸、异甘草次酸、甘草香豆精、刺芒柄花素、新甘草查耳酮D、光果甘草苷元、异甘草黄酮醇等成分。
白芍性微寒,味苦、酸,归肝经、脾经;具有平肝止痛、养血调经、敛阴止汗的功效。白芍含芍药苷、羟基芍药苷、苯甲酰芍药苷、芍药内酯苷、氧化芍药苷、白芍苷、常春藤皂苷元、芍药苷元酮、没食子酰芍药苷、山柰酚-3,7-二-O-β-D-葡萄糖苷、胡萝卜苷、β-谷固醇、芍药乳糖酮等,挥发油中主要含苯甲酸、牡丹酚等。应用HPLC研究表明,芍药根经去皮、水煮后苷类成分略有下降,但其中的有害成分苯甲酸则明显降低,有解痉、镇痛、抗炎、抗心肌缺血等药理作用,可解热降温,镇静催眠,具有解痉、抗炎、抗溃、增强细胞免疫和体液免疫、扩张血管、增加血流量、耐缺氧、降血压、抑制血小板凝集、抗菌、保肝、抗诱变抗肿瘤、抑制肥大细胞组织胺释放、神经接头去极化等作用。
干姜、炙甘草配伍有温阳活血之效,而白芍、炙甘草配伍功效敛阴调肝以摄血,两个配伍合用有阴阳双调以增强活血摄血之功。
肉桂性大热,味辛、甘,归肾经、脾经、心经、肝经;具有补火助阳,引火归元,散寒止痛,温通经脉的功效。肉桂含挥发油,主要成分为桂皮醛,还有乙酸桂皮酯、苯甲酸苄酯、反式桂皮酸、桂皮苷等成分。药理研究表明,肉桂对肠胃有缓和的刺激作用,并能解除胃肠平滑肌痉挛,具有很强的抗溃疡作用;可拮抗血小板聚集,具有改善心血管系统的作用,调节机体免疫功能;对中枢神经系统,具有镇静、镇痛、解热、抗惊厥等作用;对阳虚、阴虚模型有预防和保护作用;具有一定的抗炎作用;具有很强的杀真菌作用;抗肿瘤;升高小鼠血清三酰甘油有明显降低作用,能延长亚硝酸钠中毒小鼠的存活时间。
(6)砂仁、紫苏叶芳香辟秽,以制衡虫类药水蛭的腥臭之味,在组方中为使药。
砂仁性温,味辛,归胃经、脾经、肾经,具有化湿开胃、温脾止泻的功效。肉桂主含挥发油,主要成分为龙脑、右旋龙脑、醋酸龙脑脂、芳樟醇、橙花叔醇等成分。药理研究表明,肉桂具有抗血小板聚集、扩张血管、抑制胃蛋白酶活性、抑制胃酸分泌、促进肠道运动、镇痛等作用。
紫苏叶性温、味辛,归肺经、脾经。具有解表散寒,行气和胃的功效。紫苏叶含紫苏醛、紫苏酮,白苏酮、薄荷醇、高山黄芩苷、新西兰牡荆苷II、鹭樱苷等成分。药理研究表明,紫苏叶具有镇静及较弱的解热作用,可使兴奋性膜产生抑制作用,能促进消化液分泌,增强胃肠蠕动,对血液系统,具有止血和抗凝血双重作用,可调节机体免疫功能,具有抗诱变能力,具有广谱的抗菌作用。
综上,本发明的中药全方既逐新瘀又祛陈瘀,对急慢性血栓都有效。从配伍上来讲,通过水蛭、土鳖虫、三七活血化瘀,白附片抑制凝血功能和抗血栓形成,炙甘草、干姜温阳摄血,白芍、炙甘草敛阴调肝摄血,加用肉桂温阳以助药性,使全方既可温通血脉以活血化瘀,又可敛阴摄血而减少出血风险。故此方为活血化瘀,兼有摄血之功的良方,可以解决目前溶栓药所急需解决的提高溶栓成功率和减少出血及再闭塞的危险性的技术难题。
本方所治之证,乃心阳不足,行血无力,阳虚生寒,或挟有寒邪外侵,寒凝经脉,瘀血内生所致。瘀血壅遏于经脉,或停滞于脏腑肢体百骸,则诸变证由生。首当化瘀血、通经脉,以恢复血运;兼以温补阳气,以助行血。
本发明的中药组方,创新立意鲜明,不仅作用于普通静脉血栓的患者,更针对恶行血液病患者,对于这部分凝血功能异常、选择抗凝剂棘手的患者,运用以白附片和虫类药物水蛭、土鳖虫连用为君药的温阳通痹中药,通过中医温阳摄血,活血而收摄脉管卫阳之气,使血液无法溢出脉外,也是发生急性出血而“亡阴、亡阳”的“失血性休克”几率大大减少,因此在抗血栓的同时减少出血风险。在本发明以前的中药组方中虽有温阳成分,但未将温阳固脱的药物放在核心的君药位置。本发明相较于以前的中药组方剂改变了君药选择,更新了活血化瘀但不上正、防出血的特色,扩大了临床应用范围,囊括了包括血液病在内的更多凝血异常伴有血栓发生的疑难病症。
具体实施方式
以下结合实施例进一步阐述本发明的内容。
实施例1
本发明所述治疗血液病合并下肢静脉血栓的中药,其组方如下:水蛭15g、土鳖虫9g、白附片15g、干姜15g、肉桂15g、炙甘草30g、白芍30g、三七9g、砂仁15g、紫苏叶3g。
本发明的中药组方可以水煎成汤剂服用。将上述处方量药材首次加水600ml煨煮30分钟,收取药液300-400ml,再次加水400ml煨煮30分钟,收取药液200-300ml,合并两次药液约600ml左右,分3次服用,每次200ml左右。
1、临床研究方案
收集近5年云南省第一人民医院血液科门诊及病房的规律服上述温阳通痹中药治疗的下肢深静脉血栓患者,诊断标准及疗效标准参照中国中西医结合学会周围血管疾病专业委员会《下肢深静脉血栓形成诊断及疗效标准》(2015年修订稿)。
研究采用患者自身前后对照研究,运用量化症状积分、下肢彩超为主要检测手段,对所收集到的32例患者下肢血栓恢复情况进行研究。
(1)诊断标准:
a.患肢胀痛或剧痛,股三角区或小腿有明显压痛;患肢皮肤呈暗红色,温度升高;浅静脉怒张;Homans征阳性。
b.多有卧床、手术、创伤、恶性肿瘤、旅行、血栓形成倾向、既往静脉血栓栓塞史、妊娠等DVT危险因素。
c.超声多普勒、静脉血流图和静脉造影等可以确诊。
d.急性期血浆D-二聚体高于正常。
排除急性动脉栓塞、急性淋巴管炎、丹毒、原发性盆腔肿瘤、小腿损伤性血肿、小腿肌纤维组织炎等疾病。
(2)分期标准
a.急性期:发病15天以内;
b.亚急性期为发病15-30天;
c.慢性期为发病超过30天。
(3)分型标准
a.周围型:包括小腿肌肉静脉丛血栓形成及小腿深静脉血栓形成两型。起病隐匿,小腿疼痛,Homans征阳性。
b.中央型(髂-股静脉血栓形成):发病急骤,先有腹股沟区胀痛,随后下肢迅速出现广泛性粗肿、胀痛,股三角区压痛,Homans征阴性。
c.混和型(全下肢深静脉血栓形成):患肢皮肤呈暗红色,广泛粗肿、胀疼,股三角区压痛,Homans征阳性。
(4)症状量化评分标准
a.皮肤温度:①正常,0分;②皮肤微热,2分;③皮肤轻度热,4分;④皮肤温度明显高,6分。
b.皮肤色泽:①皮肤色泽正常,0分;②皮肤轻度潮红,2分;③皮肤淡紫,4分;④皮肤暗红,6分。
c.疼痛:①正常,0分;②偶尔出现,2分;③经常出现,可以忍受,4分;④明显胀痛,难以忍受,6分。
d.患肢肿胀(与健侧肢体肢围比较):①正常,0分;②肿胀≥1 cm,2分;③,肿胀≥2cm,4分;④肿胀≥4 cm,6分;⑤肿胀≥6 cm,8分。
e.Homans征:①正常,0分;②轻微疼痛,2分;③疼痛,4分;④明显疼痛,6分。
f.彩色超声多普勒变化:①血管腔完全再通,0分;②血管腔再通率≥80%,2分;③血管腔再通率≥60%,4分;④血管腔再通率≥40%,6分;⑤血管腔再通率≥20%,8分;⑥血管腔再通率<20%,10分。
(5)中医证候疗效(主症+次症)评价标准痊愈:临床症状、体征消失或基本消失,证候积分减少≥90%;显效:临床症状、体征明显改善,证候积分减少≥70%,<90%;有效:临床症状、体征均有好转,证候积分减少≥30%,<70%;无效:临床症状、体征无明显改善,甚或加重,证候积分减少不足30%。
注:参照尼莫地平,[(疗前总积分-疗后总积分)/疗前总积分]×100%。
(6)纳入和排除标准
纳入标准:
a. 符合诊断标准的患者;
b. 治疗前后资料完整的患者;
c. 年龄≥18岁的患者;
d. 未合并出血、急性心血管事件、脑卒中等危重症患者;
e. 未合并严重精神疾患的患者。
排除标准:
a. 不符合诊断标准的患者;
b. 治疗前后资料不完整的患者;
c. 未连续规律服中药患者;
d. 年龄小于18岁,或为孕妇、生活不能自理人群;
e. 合并严重心脑疾患、出血的患者;
f. 严重精神疾患患者。
(7)一般情况
共纳入32例下肢静脉血栓患者,其中血液病患者22例(淋巴瘤12例、多发性骨髓瘤3例、急性非M3型白血病5例、急性早幼粒白血病1例、血小板减少患者1例),非血液病患者10例,根据彩超评估血栓部位分为:中央型4例、外周型11例、混合型9例。急性期12例、慢性期11例、亚急性期9例。服汤剂中药时间为15-90天,中位时间为42天。32例患者中3例患者为中药联合低分子肝素方案。
2、结果
(1)治疗前各项证候积分情况(平均数±标准差)
(2) 治疗后各项证候积分情况(平均数±标准差)
(3)疗效评价
3、结论
通过对各种类型的下肢静脉血栓患者、包含恶性血液系统疾病在内各种下肢静脉血栓患者、尤其是具有高危肺栓塞可能的急性期中央型下肢静脉血栓患者的治疗前后对比可以看到,本发明的中药组方疗效确切,表明其是治疗恶性血液病合并下肢静脉血栓的有效中药复方。这对于除了肺栓塞,使用抗凝药物还有出血风险的血液病患者来说,具有重要意义。
本发明的中药组方也可以制作成传统水丸剂(即颗粒剂)服用。水蛭15g、土鳖虫9g、白附片15g、干姜15g、肉桂15g、炙甘草30g、白芍30g、三七9g、砂仁15g、紫苏叶3g的处方量可制成40~60粒。每日服3次,每次服20~30粒。
中药颗粒剂的制备方法有多种,主要包括:
方法一:
(1)将水蛭、土鳖虫、白附片、干姜、肉桂、炙甘草、白芍、三七、砂仁、紫苏叶全部粉碎后,水提1~3次,得到水提液;
(2)将水提液减压浓缩成稠浸膏,再减压干燥成干浸膏;
(3)将干浸膏粉碎,过80目筛,与过80目筛的粉状辅料混合,做成混合粉;辅料以环糊精为宜,也可用其他适宜药品制粒的辅料;
(4)将混合粉用水润湿,制作成软材,然后制成小颗粒(12目为宜),再在不高于60℃的温度下干燥至含水率不超过8%,得到所需的颗粒剂。
方法二:
(1)将干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶浸湿后用蒸汽蒸馏提取挥发油,挥发油收集待用;
(2)将步骤(1)提取挥发油后的药渣与水蛭、土鳖虫、白附片、三七一起加水煎煮提取;
(3)将提取液减压浓缩成稠浸膏,再减压干燥成干浸膏;
(4)将干浸膏粉碎,与粉状环糊精混合,做成混合粉;
(5)将混合粉用水润湿,制作成软材,然后制成12目左右的小颗粒;
(6)将步骤(1)收集的挥发油用乙醇溶解后喷入颗粒混匀,经低温干燥得到所需的颗粒剂。
方法三:
(1)将干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶浸湿后用蒸汽蒸馏提取挥发油,挥发油收集待用;
(2)将步骤(1)提取挥发油后的药渣与水蛭、土鳖虫、白附片、三七一起加水煎煮提取;
(3)将提取液减压浓缩成稠浸膏;
(4)将步骤(1)收集的挥发油用环糊精包合后加入到步骤(3)制备的稠浸膏中,制作成软材,然后制粒,经低温干燥得到所需的颗粒剂。
上述方法二和方法三是先收集了药材中的挥发油有效成分,可解决传统的将处方10味药材共同煎煮提取,提取效率较低以及煎煮时间较长,导致浸膏鞣制、淀粉等杂质较多,制剂服用量大,无法保证水蛭、土鳖虫活性成分等问题。
本发明组方煎煮的汤剂和用于制备颗粒剂的提取液,均须进行标志性有效成分的含量测定,测定方法如下:
本发明的中药组方还可以制作成膏剂,制作方法如下:将白附片煎煮至少1小时,再加入干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶煎煮,同时收集挥发油,最后再加入水蛭、土鳖虫煎煮,然后过滤,将滤液浓缩收膏,将收集的挥发油和生三七打粉加入到膏中搅拌均匀,即得中药膏剂。
实施例2
本发明所述治疗血液病合并下肢静脉血栓的中药,其组方如下:水蛭10g、土鳖虫10g、白附片12g、干姜10g、肉桂13g、炙甘草25g、白芍20g、三七11g、砂仁18g、紫苏叶6g。
将上述治疗血液病合并下肢静脉血栓的中药组方制备成颗粒剂的方法如下:
(1)将水蛭、土鳖虫、白附片、干姜、肉桂、炙甘草、白芍、三七、砂仁、紫苏叶全部粉碎后,水提3次,得到水提液;
(2)将水提液减压浓缩成稠浸膏,再减压干燥成干浸膏;
(3)将干浸膏粉碎,与粉状辅料混合,做成混合粉;
(4)将混合粉用水润湿,制作成软材,然后制粒,再干燥得到所需的颗粒剂。
实施例3
本发明所述治疗血液病合并下肢静脉血栓的中药,其组方如下:水蛭12g、土鳖虫12g、白附片10g、干姜12g、肉桂10g、炙甘草20g、白芍25g、三七12g、砂仁20g、紫苏叶5g。
将上述治疗血液病合并下肢静脉血栓的中药组方制备成膏剂,方法如下:将白附片煎煮至少1.5小时,再加入干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶煎煮,同时收集挥发油,最后再加入水蛭、土鳖虫煎煮,然后过滤,将滤液浓缩收膏,将收集的挥发油和三七打粉加入到膏中搅拌均匀,即得中药膏剂。
本发明所述水提、减压浓缩、收集挥发油等方法均为现有技术方法,均可用现有技术设备完成相关操作。
Claims (5)
1.一种治疗血液病合并下肢静脉血栓的中药,其特征在于,所述中药的组方如下:水蛭10-15g、土鳖虫9-12g、白附片10-15g、干姜10-15g、肉桂10-15g、炙甘草20-30g、白芍20-30g、三七9-12g、砂仁15-20g、紫苏叶3-6g。
2.权利要求1所述的治疗血液病合并下肢静脉血栓的中药制剂制备方法,其特征在于,方法如下:
(1)将水蛭、土鳖虫、白附片、干姜、肉桂、炙甘草、白芍、三七、砂仁、紫苏叶全部粉碎后,水提1~3次,得到水提液;
(2)将水提液减压浓缩成稠浸膏,再减压干燥成干浸膏;
(3)将干浸膏粉碎,与粉状辅料混合,做成混合粉;
(4)将混合粉用水润湿,制作成软材,然后制粒,再干燥得到所需的颗粒剂。
3.权利要求1所述的治疗血液病合并下肢静脉血栓的中药制剂制备方法,其特征在于,方法如下:
(1)将干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶浸湿后用蒸汽蒸馏提取挥发油,挥发油收集待用;
(2)将步骤(1)提取挥发油后的药渣与水蛭、土鳖虫、白附片、三七一起加水煎煮提取;
(3)将提取液减压浓缩成稠浸膏,再减压干燥成干浸膏;
(4)将干浸膏粉碎,与粉状辅料混合,做成混合粉;
(5)将混合粉用水润湿,制作成软材,然后制粒;
(6)将步骤(1)收集的挥发油用乙醇溶解后喷入颗粒混匀,经干燥得到所需的颗粒剂。
4.权利要求1所述的治疗血液病合并下肢静脉血栓的中药制剂制备方法,其特征在于,方法如下:
(1)将干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶浸湿后用蒸汽蒸馏提取挥发油,挥发油收集待用;
(2)将步骤(1)提取挥发油后的药渣与水蛭、土鳖虫、白附片、三七一起加水煎煮提取;
(3)将提取液减压浓缩成稠浸膏;
(4)将步骤(1)收集的挥发油用环糊精包合后加入到步骤(3)制备的稠浸膏中,制作成软材,然后制粒,经干燥得到所需的颗粒剂。
5.权利要求1所述的治疗血液病合并下肢静脉血栓的中药制剂制备方法,其特征在于,方法如下:将白附片煎煮至少1小时,再加入干姜、肉桂、炙甘草、白芍、砂仁、紫苏叶煎煮,同时收集挥发油,最后再加入水蛭、土鳖虫煎煮,然后过滤,将滤液浓缩收膏,将收集的挥发油和三七打粉加入到膏中搅拌均匀,即得中药膏剂。
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