CN107854651B - 治疗中风和高血脂、高血粘的中药制剂及其生产方法 - Google Patents
治疗中风和高血脂、高血粘的中药制剂及其生产方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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- A61K2236/30—Extraction of the material
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Abstract
本发明公开了一种治疗中风和高血脂、高血粘的中药制剂及其生产方法，由如下重量份的原料组成：丹参12~18份、灵芝7~10份、水蛭2~3份、西洋参8~10份、川芎5~10份、黄芪5~10份、天麻5~8份、田七3~6份、郁金5~10份和甘草2~3份。以上原料经过加工可以制成胶囊剂、口服液、片剂和滴丸。该中药制剂具有舒筋活血、通脉活络、抗血栓、抗血凝、活血化淤的功效，能促进血液循环，降低血液胆固醇，阻断血栓形成，扩张冠状动脉，提高心肌缺血的耐受性，改善脑梗塞，修复受损脑神经，对多种心脑血管疾病均有疗效，且治疗后不易反复，持效期长。
Description
技术领域
本发明属于中药领域，具体涉及治疗中风和高血脂、高血粘的中药制剂及其生产方法。
背景技术
心脑血管疾病就是心脏血管和脑血管的疾病统称。也被称为“富贵病”的“三高症”。60岁以上老年人中40%～45%患有高血压的同时，还患有高血糖或高血脂。心脑血管疾病是一种严重威胁人类特别是中老年人健康的常见病。心脑血管疾病具有“发病率高、死亡率高、致残率高、复发率高、并发症多”，“四高一多”的特点。
中风病是由于正气亏虚，饮食、情志、劳倦内伤等引起气血逆乱，产生风、火、痰、瘀，导致脑脉痹阻或血溢脑脉之外为基本病机，以突然昏仆、半身不遂、口舌歪斜、言语謇涩或不语、偏身麻木为主要临床表现的病证。中风病急性期标实症状突出，急则治其标，治疗当以祛邪为主，常用平肝熄风、清化痰热、化痰通腑、活血通络、醒神开窍等治疗方法。闭、脱二证当分别治以祛邪开窍醒神和扶正固脱、救阴回阳。内闭外脱则醒神开窍与扶正固本可以兼用。在恢复期及后遗症期，多为虚实夹杂，邪实未清而正虚已现，治宜扶正祛邪，常用育阴熄风、益气活血等法。
高血脂，中医认为本病的发生是由于外源性脂质摄入过多，体内脂质代谢紊乱所致，以正虚为本，痰浊血瘀为标。高脂血症的病位在血脉，主要是因为肝脾肾三脏功能失调，致使气血不归正化而产生痰、瘀、并且相互夹杂为患，反之又可加重肝脾肾三脏功能失调，互为因果，恶性循环。中医在文献上记载多以“痰浊”、“肥人”、“中风”、“眩晕”等为描述，乃是因水谷中之浊气、水谷不化之痰湿、瘀滞不通之血液凝结于脉中而成。中医对高血脂的辨证治疗原则分为：（1）湿热内蕴，脉络瘀滞：症候：头重身倦，心胸烦闷，头昏，腹胀纳呆，口干口苦，小便黄浊，舌质偏红，苔黄浊腻，脉滑数。治法：清热化湿，通络行滞。（2）脾失健运，湿浊滞脉：症候：头重体倦，腹胀纳呆，乏力懒言，口淡不渴，大便溏薄，小便清长，健忘，面欠华，或有下肢肿，眼睑浮肿，肢体麻木，舌体淡胖，边有齿痕，苔白浊腻，脉缓无力。治法：益气健脾，泄浊通脉。（3）肝肾阴虚，脂浊阻脉：症候：腰膝酸软，易疲劳，眩晕耳鸣，目干眼花，五心烦热，潮热颧红，舌红少苔，脉细数。治法：补益肝肾，降浊调脂。（4）湿凝成痰，谈浊阻脉：症候：眩晕头重，心胸憋闷，恶心欲吐，纳呆，腹胀，或有咳嗽咳痰，形体肥胖，反应迟钝，肢体沉重，或有胁下痞块，舌苔腻厚，脉象弦滑。治法：祛痰化浊，通脉活络。（5）气滞血瘀，瘀阻脉络：症候：胸闷心痛，痛处固定，入夜为甚，或头晕头痛，或项强肢麻，舌质暗红，或瘀斑瘀点，脉涩或脉弦细。治法：行气活血，化瘀通络。
高血粘，在临床上，一般根据中医辨证施治的理论可将血粘度升高分为以下几种类型：（1）气虚血瘀型：主要表现为血液粘稠度升高，伴心悸怔忡、气短乏力、胸闷心痛、舌苔薄白、舌质紫暗并有瘀点或瘀斑、脉涩结代等。在治疗上应以益气活血、通络散瘀为主。（2）气滞血瘀型：主要表现为血液粘稠度升高，伴小便短少、大便溏薄、腰痛如刺且固定不移、舌淡苔薄、舌边有瘀点或瘀斑、脉细涩等。在治疗上应以活血化瘀、行气导滞为主。（3）肝肾阴虚型：主要表现为血液粘稠度升高，伴疲乏无力、头晕目眩、耳鸣健忘、急躁易怒、失眠多梦、五心烦热、咽干颧红、腰膝酸软甚至遗精、舌红苔少、脉细数等。在治疗上应以滋补肝肾、育阴潜阳为主。（4）脾肾阳虚型：主要表现为血液粘稠度升高，伴形寒肢冷、面色恍白、腰膝酸软、少腹冷痛、腹胀便溏、面浮肢肿、小便不利、舌质淡、苔薄白滑、脉沉细弱等。在治疗上应以健脾温肾为主。
目前，针对以上心脑血管疾病的药物多以西药为主，中药为辅。西药的长期使用治标不治本，难以从根本上对人体进行调理，难以达到理想效果，而中药见效慢，而且容易反复，效果不易把握。长期服用中药还会对人体造成伤害，同时治疗心脑血管疾病的中药价格昂贵，长期服用势必加重患者的经济负担。
发明内容
本发明是针对现有技术的不足，提供一种见效快、不反复、无任何毒副作用，对多种心脑血管疾病疗效俱佳，尤其对中风、高血脂和高血粘疗效显著的中药制剂及其生产方法。
本发明的技术方案是这样实现的：
一种治疗中风和高血脂、高血粘的中药制剂，由如下重量份的中药原料组成：丹参12~18份、灵芝7~10份、水蛭2~3份、西洋参8~10份、川芎5~10份、黄芪8~12份、天麻5~8份、田七3~6份、郁金5~10份和甘草2~3份；以上原料经过加工制成胶囊剂、口服液、片剂和滴丸。
所述的治疗中风和高血脂、高血粘的中药制剂，制成胶囊剂生产方法包括如下步骤：
（1）按上述重量份称取各中药原料。
（2）使用超微粉碎机粉碎各原料，过800目筛，得细粉备用。
（3）将细粉充分混合搅拌均匀，装入胶囊，制成胶囊剂。
所述的治疗中风和高血脂、高血粘的中药制剂，制成口服液、片剂和滴丸的生产方法包括如下步骤：
（1）按上述重量份称取各中药原料。
（2）水提：将上述称取的中药原料加入水提容器中，加入8~12倍量水，煮沸1~2h，固液分离，取滤液；滤渣再加入3~5倍量水，煮沸1~2h，固液分离，取滤液；滤渣再加入3倍量水，煮沸1h，取滤液；弃去滤渣，合并三次滤液，备用。
（3）减压浓缩步骤（2）所得滤液，得水提浸膏。
（4）水提浸膏中加入4~8倍量体积分数为75~90%的乙醇，加热回流提取2~3次，回收合并滤液，备用。
（5）将步骤（4）所得滤液减压浓缩，得25℃下相对密度为1.018~1.115的浸膏。
（6）步骤（5）所得浸膏，加入甜味剂、纯净水，充分搅拌，溶解透明，即得口服液。
（7）步骤（5）所得浸膏，在真空干燥器中干燥成粉；加入医学上可接受的辅料制成片剂。
（8）步骤（5）所得浸膏，加入木糖醇和羧甲纤维素钠，充分混合，加热，使呈流动态，置于滴置装置中，在65~85℃下以40~50滴/min速度滴入加热的甲基硅油中，收集，自然冷却，干燥，即得。
医学上研究表明本发明所选用的中草药组分具有如下功效：
丹参，【别名】红根、大红袍、血参根、血山根、红丹参、紫丹参。【来源】为唇形科植物丹参Salvia miltiorrhiza Bunge. 的干燥根及根茎。春、秋二季采挖，除去泥沙，干燥。【性味】苦，微寒。【归经】归心、肝经。【功能主治】祛瘀止痛，活血通经，清心除烦。用于月经不调，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。
灵芝，【别名】灵芝草、菌灵芝、木灵芝。【来源】为多孔菌科真菌赤芝Ganodermalucidum（Leyss.ex Fr.）Karst．或紫芝Ganodermasinense Zhao，Xu et Zhang的干燥子实体。全年采收，除去杂质，剪除附有朽木、泥沙或培养基质的下端菌柄，阴干或在40～50℃烘干。【性味】甘，平。【归经】归心、肺、肝、肾经。【功能主治】补气安神，止咳平喘。用于眩晕不眠，心悸气短，虚劳咳喘。
水蛭，【别名】蚂蝗、马鳖、肉钻子。【来源】为水蛭科动物蚂蟥WhitmaniapigraWhitman、水蛭Hirudonipponica Whitman或柳叶蚂蟥Whit~ maniaacranulataWhitman 的干燥体。夏、秋二季捕捉，用沸水烫死，晒干或低温干燥。【性味】咸、苦，平；有小毒。【归经】归肝经。【功能主治】破血，逐瘀，通经。用于症瘕痞块，血瘀经闭，跌扑损伤。
西洋参，【别名】西洋人参（《本草从新》），洋参（《药性考》），西参（《增订伪药条辨》），花旗参、广东人参（《中国药植志》）。【来源】为五加科植物西洋参PanaxquinquefoliumL．的干燥根。均系栽培品，秋季采挖，洗净，晒干或低温干燥。【性味】甘、微苦，凉。【归经】归心、肺、肾经。【功能主治】补气养阴，清热生津。用于气虚阴亏，内热，咳喘痰血，虚热烦倦，消渴，口燥咽干。
川芎，【别名】芎藭、小叶川芎。为伞形科植物川芎Ligusticumchuanxiong Hort.（或LigusticumwallichiiFranch.）的干燥根茎。【性味】辛，温。【归经】归肝、胆、心包经。【功能主治】活血行气，祛风止痛。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。
黄芪，【别名】绵芪、绵黄芪。【来源】为豆科植物蒙古黄芪Astragalusmembranaceus（Fisch.）Bge. var. mongholicus（Bge.）Hsiao 或膜荚黄芪 Astragalusmembranaceus（Fisch.）Bge.的干燥根。春、秋二季采挖，除去须根及根头，晒干。【性味】甘，温。【归经】归肺、脾经。【功能主治】补气固表，利尿托毒，排脓，敛疮生肌。用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，痈疽难溃，久溃不敛，血虚痿黄，内热消渴；慢性肾炎蛋白尿，糖尿病。
天麻，【别名】赤箭、木浦、明天麻、定风草根、白龙皮。【来源】为兰科植物天麻GastrodiaelataBlume. 的干燥块茎。春季4～5月间采挖为“春麻”；立冬前9～10月间采挖的为“冬麻”，质量较好。挖起后趁鲜洗去泥土，用清水或白矾水略泡，刮去外皮，水煮或蒸透心，切片，摊开晾干。【性味】甘，平。【归经】归肝经。【功能主治】平肝息风止痉。用于头痛眩晕，肢体麻木，小儿惊风，癫痫抽搐，破伤风。
田七，【别名】三七、滇七、参三七、汉三七。【来源】为五加科植物三七Panaxnotoginseng（Burk.）F. H. Chen的干燥根。【性味】甘、微苦，温。【归经】归肝、胃经。【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。
郁金，【别名】玉金、白丝郁金。【来源】为姜科植物温郁金Curcuma wenyujin Y. H.Chen et C. Ling、姜黄Curcuma longa L.、广西莪术Curcuma kwangsiensis S. G. Leeet C. F. Liang或蓬莪术Curcuma phaeocaulisVal.的干燥块根。前两者分别习称“温郁金”和“黄丝郁金”，其余按性状不同习称“桂郁金”或“绿丝郁金”。冬季茎叶枯萎后采挖，除去泥沙及细根，蒸或煮至透心，干燥。【性味】辛、苦，寒。
【归经】归肝、心、肺经。【功能主治】行气化瘀，清心解郁，利胆退黄。用于经闭痛经，胸腹胀痛、刺痛，热病神昏，癫痫发狂，黄疸尿赤。
甘草，【别名】甜草根、红甘草、粉甘草、粉草。【来源】本品为豆科植物甘草GlycyrrhizauralensisFisch.、胀果甘草 Glycyrrhizainflata Bat. 或光果甘草 GlycyrrhizaglabraL. 的干燥根。春、秋二季采挖，除去须根，晒干。【性味】甘，平。【归经】归心、肺、脾、胃经 。【功能主治】补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
本发明中药制剂可以制成多种医学剂型，如胶囊剂、口服液、片剂和滴丸，适合于不同年龄段，不同服药需求的人群，对中风、高血脂和高血粘效果显著，对其它心脑血管疾病也有疗效。
本发明的有益效果在于：方中诸药配伍合理，相得益彰，诸药药性均能得到有效发挥：丹参、川芎、水蛭活血通经；西洋参、灵芝、黄芪、补气养阴，固表，兼具行气通经功效；田七、天麻、郁金行气化瘀，祛风利湿；甘草补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。诸药合用共行舒筋活血、通脉活络、抗血栓、抗血凝、活血化淤的功效，能促进血液循环，降低血液胆固醇，阻断血栓形成，扩张冠状动脉，提高心肌缺血的耐受性，改善脑梗塞，修复受损脑神经，对多种心脑血管疾病均有疗效，且治疗后不易反复，持效期长。
具体实施方式
实施例1
治疗中风和高血脂、高血粘的中药制剂，由如下重量份的原料组成：丹参12份、灵芝7份、水蛭2份、西洋参8份、川芎5份、黄芪8份、天麻5份、田七3份、郁金5份和甘草2份。
实施例2
治疗中风和高血脂、高血粘的中药制剂，由如下重量份的原料组成：丹参18份、灵芝10份、水蛭3份、西洋参10份、川芎10份、黄芪12份、天麻8份、田七6份、郁金10份和甘草3份。
实施例3
治疗中风和高血脂、高血粘的中药制剂，由如下重量份的原料组成：丹参15份、灵芝8份、水蛭2.5份、西洋参9份、川芎8份、黄芪10份、天麻7份、田七5份、郁金8份和甘草2.5份。
实施例4
治疗中风和高血脂、高血粘的中药制剂，由如下重量份的原料组成：丹参14份、灵芝9份、水蛭2份、西洋参8份、川芎7份、黄芪11份、天麻6份、田七4份、郁金9份和甘草3份。
实施例5
治疗中风和高血脂、高血粘的中药制剂，由如下重量份的原料组成：丹参16份、灵芝8份、水蛭2份、西洋参8份、川芎6份、黄芪8份、天麻8份、田七5份、郁金8份和甘草2份。
实施例6 胶囊剂的生产方法
胶囊剂生产方法包括如下步骤：
（1）按实施例1~5任一项配方所需重量份称取诸原料。
（2）使用超微粉碎机粉碎各原料，过800目筛，备用。
（3）将细粉充分混合搅拌均匀，装入胶囊，制成胶囊剂。
实施例6 口服液的生产方法
口服液生产方法包括如下步骤：
（1）按实施例1~5任一项配方所需称取诸原料。
（2）水提：将诸原料加入水提容器中，加入8~12倍量水，煮沸1~2h，固液分离，取滤液；滤渣再加入3~5倍量水，煮沸1~2h，固液分离，取滤液；滤渣再加入3倍量水，煮沸1h，取滤液；弃去滤渣，合并三次滤液，备用。
（3）减压浓缩步骤（2）所得滤液，得水提浸膏。
（4）水提浸膏中加入4~8倍量体积分数为75~90%的乙醇，加热回流提取2~3次，回收合并滤液，备用。
（5）将步骤（4）所得滤液减压浓缩，得25℃下相对密度为1.018~1.115的浸膏。
（6）步骤（5）所得浸膏加入甜味剂、纯净水，充分搅拌，溶解透明，即得口服液。
实施例7 片剂的生产方法
制成片剂的生产方法包括如下步骤：
（1）取实施例6步骤（5）所得浸膏，真空干燥器中干燥成粉。
（2）加入医学上可接受的辅料制成片剂。
实施例8 滴丸的生产方法
制成滴丸的生产方法包括如下步骤：
（1）取实施例6步骤（5）所得浸膏，加入木糖醇和羧甲纤维素钠，充分混合。
（2）加热，使呈流动态。
（3）置于滴置装置中，在65~85℃下以40~50滴/min速度滴入加热的甲级硅油中，收集，自然冷却，干燥，即得。
实施例9
为表明本发明的中药制剂对中风、高血脂和高血粘疾病的治疗效果，本发明人对695例病例临床观察，其中男性328人，女性367人，年龄33岁~74岁，病程2~5年，其中中风患者171例，高血脂313例，高血粘患者211例。
通过服用本发明的药物，一般用药 1~4个疗程，共有571人治愈，治愈率达 82.2%，695人有效，有效率为100%。并且发明人对以上695例患者进行了长达2年的跟踪回访调查，发现有95%以上患者并未出现病情反复状况，说明本发明中药制剂疗效期较长，且没有1例有毒副作用。
具体病例：
常某，男57岁，患有中风，并于2年前脑梗塞过一次，经过手术治疗后，精神状态较差，嘴歪流涎。服用本发明口服液，4个疗程后，病情有所好转，继续使用3个疗程，身体状况恢复正常，生活自理，能正常行走。
孙某，女，60岁，农民，2年前发现经常头晕目眩，随机入院检查，诊断为轻微脑梗塞。查血诊断为“高血脂”，并伴有高血压，医生劝其使用降压药，并入院治疗，15天后并无好转。服用本发明胶囊剂2个疗程后，头脑清楚，血压恢复正常，继续使用3个疗程后，血脂降低至正常水平。如今改为3天服用一次，身体状况正常。
李某，男42岁，某企业高管，患有三高，血粘稠度高。长期工作后容易感觉疲惫，每年都会入院调养休息。后改为使用本发明片剂，使用3个疗程后，三高症状有了明显好转，血液粘稠度降低，继续使用2个疗程，血液指标恢复正常。
Claims (1)
1.治疗中风和高血脂、高血粘的中药制剂，其特征在于：由如下重量份的中药原料组成：丹参12～18份、灵芝7～10份、水蛭2～3份、西洋参8～10份、川芎5～10份、黄芪8～12份、天麻5～8份、田七3～6份、郁金5～10份和甘草2～3份；以上原料经过加工制成胶囊剂、口服液、片剂和滴丸；
所述胶囊剂的生产方法包括如下步骤：
（1）按上述重量份称取各中药原料；
（2）使用超微粉碎机粉碎各原料，过800目筛，得细粉备用；
（3）将细粉充分混合搅拌均匀，装入胶囊，制成胶囊剂；
所述口服液、片剂和滴丸的生产方法包括如下步骤：
（1）按上述重量份称取各中药原料；
（2）水提：将上述称取的中药原料加入水提容器中，加入8～12倍量水，煮沸1～2h，固液分离，取滤液；滤渣再加入3～5倍量水，煮沸1～2h，固液分离，取滤液；滤渣再加入3倍量水，煮沸1h，取滤液；弃去滤渣，合并三次滤液，备用；
（3）减压浓缩步骤（2）所得滤液，得水提浸膏；
（4）水提浸膏中加入4～8倍量体积分数为75～90%的乙醇，加热回流提取2～3次，回收合并滤液，备用；
（5）将步骤（4）所得滤液减压浓缩，得25℃下相对密度为1.018～1.115的浸膏；
（6）步骤（5）所得浸膏，加入甜味剂、纯净水，充分搅拌，溶解透明，即得口服液；
（7）步骤（5）所得浸膏，在真空干燥器中干燥成粉；加入医学上可接受的辅料制成片剂；
（8）步骤（5）所得浸膏，加入木糖醇和羧甲纤维素钠，充分混合，加热，使呈流动态，置于滴制 装置中，在65～85℃下以40～50滴/min速度滴入加热的甲基硅油中，收集，自然冷却，干燥，即得。
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| CN102240376A (zh) * | 2011-07-04 | 2011-11-16 | 王启凌 | 一种治疗中风的药物 |
| CN103156934A (zh) * | 2011-12-12 | 2013-06-19 | 廖凤武 | 治疗中风后遗症的中药 |
| CN104984262A (zh) * | 2015-08-03 | 2015-10-21 | 青岛云天生物技术有限公司 | 一种治疗缺血性中风的中药制剂及其制备方法 |
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| CN102240376A (zh) * | 2011-07-04 | 2011-11-16 | 王启凌 | 一种治疗中风的药物 |
| CN103156934A (zh) * | 2011-12-12 | 2013-06-19 | 廖凤武 | 治疗中风后遗症的中药 |
| CN104984262A (zh) * | 2015-08-03 | 2015-10-21 | 青岛云天生物技术有限公司 | 一种治疗缺血性中风的中药制剂及其制备方法 |
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