CN105435131A - 一种治疗慢性心衰的中药组合物及其制备方法 - Google Patents

一种治疗慢性心衰的中药组合物及其制备方法 Download PDF

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CN105435131A
CN105435131A CN201610024788.9A CN201610024788A CN105435131A CN 105435131 A CN105435131 A CN 105435131A CN 201610024788 A CN201610024788 A CN 201610024788A CN 105435131 A CN105435131 A CN 105435131A
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radix
chinese medicine
rhizoma
heart failure
medicine composition
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不公告发明人
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Qingdao You Cheng New And High Technology Co Ltd
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Qingdao You Cheng New And High Technology Co Ltd
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    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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Abstract

本发明涉及中医药领域,尤其涉及一种治疗慢性心衰的中药组合物。由黄芪、丹参、枸杞、甘草、决明子、益母草、金银花、葛根、瓜蒌、茯苓、五加皮、莪术、酸枣仁、桑寄生、龙骨、白术、熟附子、三棱、天麻、葶苈子、猪苓、桂枝、枳实、杜茎山、麦冬、山茱萸等组成。本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明具有补益心气、活血化瘀、利水化痰等功效,各药相互配伍,达到治疗心力衰竭的目的。与同类药物比较,本发明药物具有配伍严谨,药性平和,疗效显著的特点,便于在临床上大面积推广应用。

Description

一种治疗慢性心衰的中药组合物及其制备方法
技术领域
[0001] 本发明属于中药学技术领域,具体涉及一种治疗慢性心衰的中药组合物及其制备 方法。
背景技术
[0002] 心力衰竭是由于心肌梗死、心肌病、血流动力学负荷过重、炎症等任何原因引起的 心肌损伤,造成心肌结构和功能的变化,最后导致心室栗血或充盈功能低下。临床主要表现 为呼吸困难、乏力和体潴留。慢性心力衰竭(CHF)是指持续存在的心力衰竭状态,可以稳定、 恶化或失代偿。治疗心衰的目标不仅是改善症状、提高生活质量,而且针对心肌重构的机 制,延缓和防止心肌重构的发展,降低心衰的住院率和死亡率。
[0003] 近年来,心衰的发病率和病死率呈现不断上升的趋势,由此产生的医疗费用和社 会负担也迅速增加,2005年美国CHF患者达到550万,直接或间接用于治疗CHF的费用高达 279亿美元。我国对35~74岁城乡居民共15518人随机抽样调查的结果:心衰患病率为 0.9%,按计算约有400万心衰患者,其中男性为0.7%,女性为1 ·0% Tramingham研究显示, CHF5年存活率,男性为25%,女性为38%,重症患者一般存活不到1年。据我国部分地区42家 医院,在1980、1990、2000年3个全年段,对心衰住院病例共10714例所作的回顾性调查,病因 中冠心病由1980年的36.8%上升至2000年的45.6%,居各种病因之首。
[0004] 我国中医药在长期的治病过程中,积累了丰富的经验。中医传统文献中无"心衰" 之名,根据其临床特征,涉及中医"喘证"、"水肿"、"心悸"、"怔忡"、"痰饮"、"心痹"等范畴。 大多数研究认为,本病属本虚标实、虚实夹杂之证,以心气心阳虚衰为本,血脉瘀滞、水饮内 停、痰浊不化为标。
发明内容
[0005] 为了克服现有技术中的不足,本发明提供一种治疗慢性心衰的中药组合物,对慢 性心衰具有显著疗效。
[0006] 为了解决上述技术问题,本发明采用的技术方案如下:一种治疗慢性心衰的中药 组合物,由以下重量份数的各组分组成:
[0007] 黄芪1-30份、丹参1-30份、枸杞1-30份、甘草1-30份、决明子1-30份、益母草1-30 份、金银花1-30份、葛根1-30份、瓜蒌1-30份、茯苓1-30份、五加皮1-30份、莪术1-30份、酸枣 仁1-30份、桑寄生1-30份、龙骨1-30份、白术1-30份、熟附子1-30份、三棱1-30份、天麻1-30 份、葶苈子1-30份、猪苓1-30份、桂枝1-30份、枳实1-30份、杜茎山1-30份、麦冬1-30份、山茱 萸1-30份、车前子1-30份、石菖蒲1-30份、合欢皮1-30份、当归1-30份、三七1-30份、黄连1-30份、五味子1-30份、茵陈1-30份、赤芍1-30份、丹皮1-30份、鹿角1-30份、远志1-30份、蒲黄 1-30份、川穹1-30份、杜仲1-30份、地龙1-30份、冷水七1-30份、铁箍散1-30份。
[0008] 进一步的,本发明由以下重量份数的各组分组成:
[0009] 黄芪1-20份、丹参1-20份、枸杞1-20份、甘草1-20份、决明子1-20份、益母草1-20 份、金银花1-20份、葛根1-20份、瓜蒌1-20份、茯苓1-20份、五加皮1-20份、莪术1-20份、酸枣 仁1-20份、桑寄生1-20份、龙骨1-20份、白术1-20份、熟附子1-20份、三棱1-20份、天麻1-20 份、葶苈子1-20份、猪苓1-20份、桂枝1-20份、枳实1-20份、杜茎山1-20份、麦冬1-20份、山茱 萸1-20份、车前子1-20份、石菖蒲1-20份、合欢皮1-20份、当归1-20份、三七1-20份、黄连1-20份、五味子1-20份、茵陈1-20份、赤芍1-20份、丹皮1-20份、鹿角1-20份、远志1-20份、蒲黄 1-20份、川穹1-20份、杜仲1-20份、地龙1-20份、冷水七1-20份、铁箍散1-20份。
[0010] 进一步的,本发明由以下重量份数的各组分组成:
[0011] 黄芪1-10份、丹参1-10份、枸杞1-10份、甘草1-10份、决明子1-10份、益母草1-10 份、金银花1-10份、葛根1-10份、瓜蒌1-10份、茯苓1-10份、五加皮1-10份、莪术1-10份、酸枣 仁1-10份、桑寄生1-10份、龙骨1-10份、白术1-10份、熟附子1-10份、三棱1-10份、天麻1-10 份、葶苈子1 _1〇份、猪苳1_1〇份、桂枝1_1〇份、枳实1_1〇份、杜莖山1 _1〇份、麦冬1_1〇份、山茱 萸1-10份、车前子1-10份、石菖蒲1-10份、合欢皮1-10份、当归1-10份、三七1-10份、黄连1-10份、五味子1-10份、茵陈1-10份、赤芍1-10份、丹皮1-10份、鹿角1-10份、远志1-10份、蒲黄 1-10份、川穹1-10份、杜仲1-10份、地龙1-10份、冷水七1-10份、铁箍散1-10份。
[0012] 进一步的,本发明所述中药制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片 剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射 剂、栓剂、硬膏剂或糖浆剂。
[0013] 为了解决上述技术问题,本发明还提供一种治疗慢性心衰的中药组合物的制备方 法,所述胶囊制备包括以下步骤:
[0014] a.将所述原料药放入粉碎机粉碎后过筛,
[0015] b.将过筛后的中药放入乙醇中加热回流提取2次;
[0016] C.再取上述乙醇提取后的药渣,加水加热回流提取2次;
[0017] d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;药粉装入胶囊制为 胶囊剂。
[0018] 进一步的,所述步骤a中,将所述原料药放入粉碎机粉碎后过100目细筛,使能通过 100目筛的细粉量在达到50%,收集通过100目筛的原料细粉备用。
[0019] 进一步的,所述步骤b中,将过筛后的中药放入乙醇中加热回流提取2次,每次1~3 小时,将2次提取液合并静置;所述步骤C中,将上述乙醇提取过的药渣加10倍量水加热回流 提取2次,每次1~3小时,将2次提取液合并静置。
[0020] 进一步的,所述步骤d中将上述两种提取液合并,减压浓缩相对密度为70°C时1.08 的滤液,回收乙醇,将所得滤液调整比重到1.06,通入喷雾干燥机进行喷雾干燥,过喷雾干 燥机喷头的压缩空气压力为4kg/m2,干燥室热气流温度是60°C,得原料药粉;将原料药粉装 入胶囊。
[0021] 进一步的,所述中药制剂的剂型为口服液剂,其制备步骤包括:
[0022] a、取原料药放入水中浸泡,热提取2次,成浸膏状,为组分1;
[0023] b、药渣乙醇提取1次,浓缩过滤为浸膏状,为组分2;
[0024] c、将上述两种浸膏浓缩成糊状,浓缩液用⑶60灭菌,辐照剂量8k,加入糊精,然后 真空冷冻密封即得。
[0025]进一步的,所述内服药物的剂型为丸剂,其制备步骤包括:
[0026] a.将所述原料药混合,切碎,过120目筛,得细药粉备用;
[0027] b.将未过筛的粗粉浸泡乙醇中提取2次;
[0028] c.再取上述步骤提取后的药渣,加水加热回流提取2次;
[0029] d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉合并加入蜂 胶搓成丸剂。
[0030] 本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发 明具有补益心气、活血化瘀、利水化痰等功效,各药相互配伍,达到治疗心力衰竭的目的。与 同类药物比较,本发明药物具有配伍严谨,药性平和,疗效显著的特点,便于在临床上大面 积推广应用。
具体实施方式
[0031] 治疗CHF的传统药物主要包括利尿剂、ACEI(血管紧张素转换酶抑制剂)类、血管扩 张剂、强心剂、心肌营养剂、钙通道阻滞剂等,但并未从根本上提高患者的生活质量,也未能 有效降低CHF的死亡率,临床应用中也存在诸多问题。随着对CHF发生和发展基本病理机 制一一心肌重构的认识,传统的强心、利尿、扩血管的常规治疗理念正在逐步淡化,从短期 的药理学措施改善症状,逐渐转变为长期的、修复性的策略及对CHF发病机制的干预。
[0032] 黄苗: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。
[0033] 丹参:性味:苦,微温。①《本经》;〃味苦,微寒,无毒。〃②《吴普本草》:〃岐伯:咸。〃③ 李当之《药录》:〃大寒。〃④《本草经疏》:〃味苦,平,微温。〃归经:入心、肝经。①《纲目》:〃手少 阴、厥阴血分药。〃②《本草经疏》:〃入手足少阴、足厥阴经。〃③《本草正》:〃心、脾、肝、肾血分 之药。〃功能主治:活血祛瘀,安神宁心、,排脓,止痛。治心、绞痛,月经不调,痛经,经闭,血崩带 下,症瘕,积聚,瘀血腹痛,骨节疼痛,惊悸不眠,恶疮肿毒。
[0034] 枸杞:性味:甘,平。①《别录》:〃微寒,无毒。〃②《药性论》:〃味甘,平。〃③《食疗本 草》:〃寒,无毒。〃归经:入肝、肾经。①《本草汇言》:〃入足少阴、足厥阴经。〃②《本草经解》:〃 入足少阴肾经、手少阴心经。〃③《要药分剂》:〃入肝、胃二经,兼入肺经。〃功能主治:滋肾,润 肺,补肝,明目。治肝肾阴亏,腰膝酸软,头晕,目眩,目昏多泪,虚劳咳嗽,消渴,遗精。①陶弘 景:〃补益精气,强盛阴道。〃②《药性论》:〃能补益精诸不足,易颜色,变白,明目,安神。〃③ 《食疗本草》:〃坚筋耐老,除风,补益筋骨,能益人,去虚劳。〃④王好古:〃主心病嗌干,心痛, 渴而引饮,肾病消中。"
[0035] 甘草:性味:甘,平。①《本经》:〃味甘,平。〃②《别录》:〃无毒。〃③《本草衍义》:〃微 凉。〃④《珍珠囊》:〃生甘,平;炙甘,温。〃归经:入脾、胃、肺经。①《汤液本草》:〃入足厥阴、太 阴、少阴经。〃②《雷公炮制药性解》:〃入心、脾二经。〃③《本草通玄》:〃入脾、胃。〃④《本草经 解》:〃入手太阴肺经、足太阴脾经。〃功能主治:和中缓急,润肺,解毒,调和诸药。炙用,治脾 胃虚弱,食少,腹痛便溏,劳倦发热,肺痿咳嗽,心悸,惊痫;生用,治咽喉肿痛,消化性溃疡, 痈疽疮疡,解药毒及食物中毒。
[0036] 决明子:性味:苦甘,凉。①《本经》:〃味咸,平。〃②《别录》:〃苦甘,微寒,无毒。〃③ 《本草正》:〃味微苦微甘,性平,微凉。〃归经:入肝、肾经。①《雷公炮制药性解》:〃入肝经。〃② 《本草经疏》:〃足厥阴肝,亦入胆、肾。〃功能主治:清肝,明目,利水,通便。治风热赤眼,青盲, 雀目,高血压,肝炎,肝硬化腹水,习惯性便秘。①《本经):〃治青盲,目淫肤赤白膜,眼赤痛, 泪出,久服益精光。〃②《别录》:〃疗唇口青。〃③《药性论》:〃利五脏,除肝家热。〃④《日华子本 草》:〃助肝气,益精水;调末涂,消肿毒,焴太阳穴治头痛,又贴脑心止鼻衄;作枕胜黑豆,治 头风,明目。"
[0037] 益母草:性味:辛苦,凉。①《本草拾遗》:〃寒。"②《本草蒙筌》:〃味辛甘,气微温,无 毒。〃③《纲目》:〃味辛微苦,无毒。〃④《本草正》:〃味微苦、微辛。微寒,性滑。〃归经:入心包、 肝经。①《本草汇言》:〃手、足厥阴经。〃②《药品化义》:〃入肝、脾、包络三经。〃③《本草再 新》:〃入心、脾、肾三经。〃功能主治:活血,祛瘀,调经,消水。治月经不调,胎漏难产,胞衣不 下,产后血晕,瘀血腹痛,崩中漏下,尿血,泻血,痈肿疮疡。
[0038] 金银花:性味:甘,寒。①《滇南本草》:〃性寒,味苦。〃②《本草正》:〃味甘,气平,其性 微寒。〃归经:入肺、胃经。①《雷公炮制药性解》:〃入肺经。〃②《得配本草》:〃入足阳明、太阴 经。〃功能主治:清热,解毒。治温病发热,热毒血痢,痈疡,肿毒,瘰疬,痔漏。①《滇南本草》:〃 清热,解诸疮,痈疽发背,丹流瘰疬。〃②《生草药性备要》;〃能消痈疽疔毒,止痢疾,洗疳疮, 去皮肤血热。〃③《本草备要》:〃养血止渴。治疥癣。〃④《重庆堂随笔》:〃清络中风火湿热,解 温疫秽恶浊邪,息肝胆浮越风阳,治痉厥癫痫诸症。〃
[0039] 葛根:性味:甘、辛,凉。归经:归脾、胃经。功能主治:解肌退热,生津,透疹,升阳止 泻。用于外感发热头痛、项背强痛,口渴,消渴,麻疹不透,热痢,泄泻;高血压颈项强痛。
[0040] 瓜蒌:性味:甘、微苦、寒。归经:归肺、胃、大肠经。功能主治:清热涤痰,宽胸散结, 润燥滑肠。用于肺热咳嗽,痰浊黄稠,胸痹心痛,结胸痞满,乳痈,肺痈,肠痈肿痛,大便秘结。
[0041] 茯苳:性味:甘、淡,平。归经:归心、肺、脾、肾经。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。
[0042] 五加皮:性味:辛,温。①《本经》:〃味辛,温。〃②《别录》:〃苦,微寒,无毒。〃③《药性 论》:〃有小毒。〃④《医林纂要》:〃苦微辛,寒。〃⑤《四川中药志》:〃性温,味甘,无毒。〃归经:入 肝、肾经。①《雷公炮制药性解》:〃入肺、肾二经。〃②《本草经疏》:〃入足少阴、厥阴经。〃功能 主治:祛风湿,壮筋骨,活血去瘀。治风寒湿痹,筋骨挛急,腰痛,阳痿,脚弱,小儿行迟,水肿, 脚气,疮疽肿毒,跌打劳伤。
[0043]莪术:性味:苦辛,温。入肝、脾经。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。(1)行气止痛,破血消 积:用于气滞血瘀之经闭、胸胁痛、腹痛及症瘕肿块等。常配三棱。(2)消食化积:用于饮食积 滞之胃腹胀痛,常配焦麦芽、焦槟榔。
[0044]酸枣仁:性味:甘,平。①《本经》:〃味酸,平。〃②《别录》:〃无毒。〃③《本草衍义》:〃微 温。〃④《饮膳正要》:〃味酸甘,平。〃归经:入心、脾、肝、胆经。①《纲目》:〃足厥阴、少阳。〃② 《雷公炮制药性解》:〃入心、脾、肝、胆四经。〃功能主治:养肝,宁心,安神,敛汗。治虚烦不眠, 惊悸怔忡,烦渴,虚汗。
[0045]桑寄生:性味:苦甘,平。①《本经》:〃苦,平。〃②《别录》:〃甘,无毒。〃③《滇南本 草》:〃性微温,味苦甘。〃归经:入肝、肾经。①《得配本草》:〃入足厥阴经。〃②《本草求真》:〃入 肝、肾。〃③《本草再新》:〃入心、肾二经。〃功能主治:补肝肾,强筋骨,除风湿,通经络,益血, 安胎。治腰膝酸痛,筋骨痿弱,偏枯,脚气,风寒湿痹,胎漏血崩,产后乳汁不下。①《本经》:" 主腰痛,小儿背强,痈肿,安胎,充肌肤,坚发、齿,长须眉。〃②《别录》:〃主金疮,去痹,女子崩 中,内伤不足,产后余疾,下乳汁。〃③《药性论》:〃能令胎牢固,主怀妊漏血不止。〃④《日华子 本草》:〃助筋骨,益血脉。〃
[0046] 龙骨:性味:甘涩,平。①《本经》:〃味甘,平。〃②《别录》:〃微寒,无毒。〃③《药性 论》:〃有小毒,〃④《本草正》:〃甘,平,性涩。〃⑤《医学衷中参西录》:〃味淡微辛,性平。〃归经: 入心、肝、肾、大肠经。①《纲目》:〃入手足少阴、厥阴经。〃②《本草经疏》:〃入足厥阴、少阳、少 阴,兼入手少阴、阳明经。〃功能主治:镇惊安神,敛汗固精,止血涩肠,生肌敛疮。治惊痫癫 狂,怔忡健忘,失眠多梦,自汗盗汗,遗精淋浊,吐衄便血,崩漏带下,泻痢脱肛,溃疡久不收 □ 〇
[0047] 白术:性味:苦、甘,温。归经:归脾、胃经。功能主治:健脾益气,燥湿利水,止汗,安 胎。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。用 于脾虚食少,泄泻便溏,胎动不安。
[0048]熟附子:性味:辛、甘,大热;有毒。归经:归心、肾、脾经。功能主治:回阳救逆,补火 助阳,逐风寒湿邪。用于亡阳虚脱,肢冷脉微,阳萎,宫冷,心腹冷痛,虚寒吐泻,阴寒水肿,阳 虚外感,寒湿痹痛。
[0049]三棱:性味:苦辛,平。①《本草拾遗》:〃甘平,温。〃②《日华子本草》:〃味甘涩,凉。〃 ③ 《开宝本草》:〃味苦,平,无毒。〃④《本草衍义补遗》:〃辛苦。〃归经:入肝。脾经。①《雷公炮 制药性解〃〉雷公炮制药性解》:〃入肺、脾二经。〃②《本草经疏》:〃入足厥阴、太阴。〃功能主 治:破血,行气,消积,止痛。治症瘕积聚,气血凝滞,心腹疼痛,胁下胀疼,经闭,产后瘀血腹 痛,跌打损伤。疮肿坚硬。
[0050] 天麻:性味:甘,平。①《本经》:〃味辛,温。〃②《药性论》:〃无毒。味甘,平。〃③《医学 启源》:〃气平,味苦。〃归经:入肝经。①《纲目》:〃入肝经气分。〃②《雷公炮制药性解》:〃入肝、 膀胱二经。〃③《本草新编》:〃入脾、肾、肝、胆、心经。〃功能主治:息风,定惊。治眩晕眼黑,头 风头痛,肢体麻木,半身不遂,语言蹇涩,小儿惊痫动风。①《本经》:〃主恶气,久服益气力,长 阴肥健。〃②《别录》:〃消痈肿,下支满,痛,下血。〃③《药性论》:〃治冷气顽痹,瘫缓不遂,语多 恍惚,多惊失志。〃④《日华子本草》:〃助阳气,补五劳七伤,通血脉,开窍。〃⑤《开宝本草》:〃 主诸风湿痹,四肢拘挛,小儿风痫、惊气,利腰膝,强筋力。〃
[0051 ] 葶苈子:性味:辛苦,寒。①《本经》:〃味辛,寒。〃②《别录》:〃苦,大寒,无毒。〃③《药 性论》:〃味酸,有小毒。〃归经:入肺、膀胱经。①《雷公炮制药性解》:〃肺、心、脾、膀胱四经。〃 ②《本草经疏》:〃为手太阴经正药,亦入手阳明,足太阳经。〃③《本草求真》:〃入肺,兼入胃。〃 ④ 《本草再新》:〃入肝、肺二经。〃功能主治:下气行水。治肺壅喘急,痰坎咳嗽,水肿胀满。 [0052]猪苓:性味:甘淡,平。①《本经》:〃味甘,平。〃②《药性论》:〃微热。〃③李杲:〃淡甘, 平。〃归经:入脾、肾、膀胱经。①《汤液本草》:〃入足太阳、少阴经。〃②《药品化》:〃入脾、膀胱 二经。〃③《本草经解》:〃入手太阴肺经、足太阴脾经。〃功能主治:利尿渗湿。治小便不利,水 肿胀满,脚气,泄泻,淋、池,带下。
[0053] 桂枝:性味:辛、甘,温。归经:归心、肺、膀胱经。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。 [0054]枳实:性味:苦,寒。①《本经》:〃味苦,寒。〃②《吴普本草》:〃雷公:酸,无毒。李当之: 大寒。〃③《别录》:〃酸,微寒,无毒。〃④《药性论》:〃味苦辛。〃归经:入脾、胃经。①《雷公炮制 药性解》:〃入心、脾二经。〃②《本草经疏》:〃入足阳明、太阴经。〃③《本草再新》:〃入肝、脾二 经。〃功能主治:破气,散痞,泻痰,消积。治胸腹胀满,胸痹,痞痛,痰癖,水肿,食积,便秘,胃 下垂,子宫下垂,脱肛。
[0055] 杜茎山:性味:苦,寒。功能主治:祛风利尿,止血,消肿。根:头痛,腰痛,水肿,腹水; 叶:外用治创伤出血。
[0056] 麦冬:性味:甘,微苦,微寒。归经:归心、肺、胃经。功能主治:养阴生津,润肺清心。 用于肺燥干咳。虚痨咳嗽,津伤口渴,心烦失眠,内热消渴,肠燥便秘;咽白喉。
[0057]山茱萸:味酸涩,气平、微温,无毒。入肾、肝二经。温肝经之血,补肾脏之精,兴阳道 以长阴茎,暖腰膝而助阳气,经候可调,小便能缩,通水窍,去三虫,强力延年,轻身明目。其 核勿用,用则滑精难收,实益阴之圣丹、补髓之神药。仲景夫子所以采入于八味丸中,取其固 精而生水也。《本经》谓其九窍堪通,而世人疑之者,以其味过于涩,则窍闭而不能开,恐难以 通之也。予以为不然。夫人五脏安,则九窍自利,而五脏之内,一脏不安,则四脏因之不安矣。 所谓一脏者何?即肾脏也。肾为四脏之本,肾安而四脏倶安。安四脏而利九窍,又何疑乎。山 茱萸佐八味以补肾,正安肾以安五脏之药也。五脏既安,而谓九窍之不能利乎。且山茱萸不 止利九窍也。三焦六腑,无不藉其庇荫,受其滋益。此八味汤中之所必用,而岐伯天师新立补 肾诸方,无不用之以救垂绝之症也。
[0058] 车前子:性味:甘,寒。①《本经》:〃味甘,寒。〃②《别录》:〃咸,无毒。〃③《药性论》:〃 甘,平。〃④《药品化义》:〃味淡,性平。〃归经:入肾、膀胱经。①《本草蒙筌》:〃入膀胱。〃②《雷 公炮制药性解》:〃入肝、膀胱、小肠三经。〃③《本草经疏》:〃入肾、肝、膀胱三经。〃功能主治: 利水,清热,明日,祛痰。治小便不通,淋浊,带下,尿血,暑湿泻痢,咳嗽多痰,湿痹,目赤障 翳。
[0059] 石菖蒲:性味:辛,微温,①《本经》:〃辛,温。〃②《另口录》:〃无毒。〃③《药性论》:〃味 苦辛,无毒。〃归经:入□、肝、脾经。①《纲目》:〃手少阴、足厥阴。〃②《雷公炮制药性解》:〃入 心、脾、膀胱三经。〃③《本草经解》:〃入足厥阴肝经、手太阴肺经。〃功能主治:开窍,豁痰,理 气,活血,散风,去湿。治癫痫,痰厥,热病神昏,健忘,气闭耳聋,心胸烦闷,胃痛,腹痛,风寒 湿痹,痈疽肿毒,跌打损伤。
[0060] 合欢皮:性味:甘,平。①《本经》:〃甘,平。〃②《本草汇言》:〃甘,温平。〃归经:入心、 肝经。①《雷公炮制药性解》:〃入心经。〃②《本草再新》:〃入心、肝二经。〃功能主治:解郁,和 血,宁心,消痈肿。治心神不安,忧郁失眠,肺痈,痈肿,瘰疬,筋骨折伤。《本经》:〃主安五脏, 和心志,令人欢乐无忧。〃
[0061 ]当归:性味:甘、辛,温。归经:归肝、心、脾经。功能主治:补血活血,调经止痛,润肠 通便。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。
[0062]三七: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,胸腹刺痛,跌扑肿痛。
[0063]黄连:性味:苦,寒。归经:归心、脾、胃、肝、胆、大肠经。功能主治:清热燥湿,泻火解 毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤, 牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。酒黄连善清上焦火热。用于目赤,口疮。姜 黄连清胃和胃止呕。用于寒热互结,湿热中阻,痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不 和,呕吐吞酸。
[0064] 五味子:性味:酸、甘,温。归经:归肺,心、肾经。功能主治:收敛固涩,益气生津,补 肾宁心。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗,盗汗,津伤口渴,短气脉虚,内 热消渴,心悸失眠。
[0065] 茵陈:性味。味苦、辛,性微寒。归经:归脾、胃、肝、胆经。功能:有清利湿热,利胆退 黄的功效。主治:用于黄疸尿少,湿温暑湿,湿疮瘙痒。
[0066] 赤芍:性味:苦,微寒。归经:归肝经。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。
[0067] 丹皮:性味:辛苦,凉。①《本经》:〃味辛,寒。〃②《滇南本草》:〃性寒,味酸辛。〃③《本 草备要》:〃辛甘,微寒。〃归经:入心、肝、肾经。①《珍珠囊》:〃手厥阴、足少阴。〃②《纲目》:〃手 足少阴、厥阴四经。〃③《雷公炮制药性解》:〃入肺经。〃功能主治:清热,凉血,和血,消瘀。治 热入血分,发斑,惊痫,吐、衄、便血,骨蒸劳热,经闭,症瘕,痈疡,扑损。①《本经》:〃主寒热, 中风瘈疯、痉、惊痫邪气,除症坚瘀血留舍肠胃,安五脏,疗痈疮。〃②《别录》:〃除时气头痛, 客热五劳,劳气头腰痛,风噤,癫疾。〃③《药性论》:〃治冷气,散诸痛,治女子经脉不通,血沥 腰疼。〃④《日华子本草》:〃除邪气,悦色,通关腠血脉,排脓,通月经,消扑损瘀血,续筋骨,除 风痹,落胎下胞,产后一切冷热血气。〃
[0068] 鹿角:性味:咸,温。①《本经》:〃温。〃②《别录》:〃味咸,微温,无毒。〃归经:入肝、肾 经。①《得配本草》:〃入手少阳、足少阴经血分。〃②《要药分剂》:〃入肾经,兼入心、肝二经。〃 功能主治:行血,消肿,益肾。治疮疡肿毒,瘀血作痛,虚劳内伤,腰脊疼痛。①《本经》:〃主恶 疮痈肿,逐邪恶气,留血在阴中。〃②《别录》:〃除小腹血急痛,腰脊痛,折伤恶血,益气。〃③ 《千金•食治》:〃肩服方寸匕,日三,益气力,强骨髓,补绝伤。〃④孟诜:〃妇人梦交者,鹿角末 三指撮,和清酒服;女子胞中余血不尽欲死者,以清酒和鹿角灰服方寸匕,日三夜一。〃⑤《日 华子本草》:〃疗患疮痈肿热毒等,醋摩敷;脱精尿血,水摩服;小儿重舌鹅口疮,炙熨之。〃
[0069] 远志:性味:苦辛,温。①《本经》:〃味苦,温。〃②《别录》:〃无毒。〃③《本草经疏》:〃苦 微辛,温。〃④《医学衷中参西录》:〃味酸微辛,性平。〃归经:入心、肾经。①王好古:〃肾经气 分。〃②《滇南本草》:〃入心、肝、脾三经。〃功能主治:安神益智,祛痰,解郁。治惊悸,健忘,梦 遗,失眠,咳嗽多痰,痈疽疮肿。(1)祛痰开窍:用于痰阻心窍之神昏痰盛及精神失常,可配菖 蒲、郁金。(2)交通心肾:用于心肾不交之失眠,常配茯苓、酸枣仁。①《本经》:〃主咳逆伤中, 补不足,除邪气,利九窍,益智慧,耳目聪明,不忘,强志倍力。〃②《本草经集注》:〃杀天雄、附 子毒。〃③《别录》:〃定心气,止惊悸,益精,去心下膈气、皮肤中热、面目黄。〃④《药性论》:〃治 心神健春,坚壮阳道。主梦邪。〃
[0070]蒲黄:性味:甘辛,凉。①《本经》:〃味甘,平。〃②《本草正》:〃味微甘,性微寒。〃③《本 草汇言》:〃性凉,炒味涩。〃④《要药分剂》:〃味甘辛,性平,无毒。〃归经:入肝、心经。①《纲 目》:〃手、足厥阴血分。〃②《本草经疏》:〃入手少阴、太阳、太阴,足阳明、厥阴。〃③《药品化 义》:〃入脾经。〃功能主治:凉血止血,活血消瘀。生用治经闭腹痛,产后瘀阻作痛,跌扑血闷, 疮疖肿毒;炒黑止吐血,衄血,崩漏,泻血,尿血,血痢,带下;外治重舌,口疮,聘耳流脓,耳中 出血,阴下湿痒。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、跌打肿痛、血淋湿痛。止血、活血:用于各种出血、痛经、跌损、痈肿疼痛。配五灵脂名失 笑散,能祛瘀止痛,常用于产后腹痛、痛经及胃腹瘀痛。
[0071] 川穹:性味:辛,温。①《本经》:〃味辛,温。〃②《吴普本草》:〃黄帝、岐伯、雷公:辛,无 毒,香。扁鹊:酸,无毒。李氏:生温,熟寒。〃③《唐本草》:〃味苦辛。〃④《本草正》:〃味辛微甘, 气温。〃归经:入肝、胆经。①《汤液本草》:〃入手足厥阴经、少阳经。〃②《药品化义》:〃入肝、 脾、三焦三经。〃功能主治:行气开郁,法风燥湿,活血止痛。治风冷头痛旋晕,胁痛腹疼,寒痹 筋挛,经闭,难产,产后瘀阻块痛,痈疽疮疡。用于月经不调,经闭痛经,瘕腹痛,胸胁刺痛,跌 扑肿痛,头痛,风湿痹痛。
[0072] 杜仲:性味:甘微辛,温。①《本经》:〃味辛,平。〃②《别录》:〃甘,温,无毒。〃③《药性 论》:〃味苦。〃归经:入肝、肾经。①王好古:〃肝经气分。〃②《雷公炮制药性解》:〃入肾经。〃③ 《本草经解》:〃入手太阴肺经。〃功能主治:补肝肾,强筋骨,安胎。治腰脊酸疼,足膝痿弱,小 便余沥,阴下湿痒,胎漏欲堕,胎动不安,高血压。①《本经》:〃主腰脊痛,补中益精气,坚筋 骨,强志,除阴下痒湿,小便余沥。〃②《别录》:〃主脚中酸痛,不欲践地。〃③《药性论》:〃治肾 冷臀腰痛,腰病人虚而身强直,风也。腰不利加而用之。〃④《日华子本草》:〃治肾劳,腰脊挛。 入药炙用。〃⑤王好古:〃润肝燥,补肝经风虚。〃
[0073] 地龙:性味:味咸;性寒。归经:归肝;脾;膀胱经。功能主治:清势止痉;平肝熄风;通 经活络;平喘利尿。主热病发热狂燥;惊痫抽搐;肝阳头痛;中风偏瘫;风湿痹痛;肺热喘咳; 小便不通。
[0074] 冷水七:性味:味甘;苦;性凉;有毒。归经:肝;脾经。功能主治:消积除胀;泻下逐 水;破瘀定痛。主食积臌胀;二便不通;跌打损伤。
[0075] 铁箍散:性味:甘、辛,平。功能主治:祛风活血,解毒消肿,止痛。根:风湿麻木,跌打 损伤,胃痛,月经不调,血栓闭塞性麦管炎;叶:外用治疮疖,毒蛇咬伤,外伤出血。
[0076] 下面结合具体实施例对本发明做进一步阐述。
[0077] 实施例1
[0078] 将黄芪2份、丹参1份、枸杞2份、甘草2份、决明子3份、益母草5份、金银花5份、葛根2 份、瓜蒌1份、茯苓2份、五加皮1份、莪术2份、酸枣仁1份、桑寄生2份、龙骨1份、白术2份、熟附 子2份、三棱2份、天麻1份、葶苈子2份、猪苓1份、桂枝2份、枳实2份、杜茎山2份、麦冬2份、山 茱萸2份、车前子2份、石菖蒲2份、合欢皮2份、当归2份、三七3份、黄连5份、五味子3份、茵陈3 份、赤苟3份、丹皮3份、鹿角3份、远志3份、蒲黄3份、川穹3份、杜仲3份、地龙3份、冷水七3份、 铁箍散3份原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在达到50 %, 收集通过100目筛的原料细粉备用;将过筛后的中药放入乙醇中加热回流提取2次,每次1~ 3小时,将2次提取液合并静置;将上述乙醇提取过的药渣加10倍量水加热回流提取2次,每 次1~3小时,将2次提取液合并静置。将上述两种提取液合并,减压浓缩相对密度为70°C时 1.08的滤液,回收乙醇,将所得滤液调整比重到1.06,通入喷雾干燥机进行喷雾干燥,过喷 雾干燥机喷头的压缩空气压力为4kg/m2,干燥室热气流温度是60°C,得原料药粉;将过筛后 得到的原料药粉装入胶囊。
[0079] 实施例2
[0080]将黄芪2份、丹参1份、枸杞2份、甘草2份、决明子3份、益母草5份、金银花5份、葛根2 份、瓜蒌1份、茯苓2份、五加皮1份、莪术2份、酸枣仁1份、桑寄生2份、龙骨1份、白术2份、熟附 子2份、三棱2份、天麻1份、葶苈子2份、猪苓1份、桂枝2份、枳实2份、杜茎山2份、麦冬2份、山 茱萸2份、车前子2份、石菖蒲2份、合欢皮2份、当归2份、三七3份、黄连5份、五味子3份、茵陈3 份、赤苟3份、丹皮3份、鹿角3份、远志3份、蒲黄3份、川穹3份、杜仲3份、地龙3份、冷水七3份、 铁箍散3份原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在达到50 %, 收集通过100目筛的原料细粉备用;将过筛后的中药放入乙醇中加热回流提取2次,每次1~ 3小时,将2次提取液合并静置;将上述乙醇提取过的药渣加10倍量水加热回流提取2次,每 次1~3小时,将2次提取液合并静置。将上述两种提取液合并,减压浓缩干燥成干膏,混合粉 碎,加10 %氯化钠,冷藏,分取上层清液,加入4倍量β-环糊精,适量水,加入环糊精包合物、 淀粉、混合均匀,压片,再用薄膜包衣液,进行包衣,即得片剂。
[0081 ] 实施例3
[0082]将黄芪2份、丹参1份、枸杞2份、甘草2份、决明子3份、益母草5份、金银花5份、葛根2 份、瓜蒌1份、茯苓2份、五加皮1份、莪术2份、酸枣仁1份、桑寄生2份、龙骨1份、白术2份、熟附 子2份、三棱2份、天麻1份、葶苈子2份、猪苓1份、桂枝2份、枳实2份、杜茎山2份、麦冬2份、山 茱萸2份、车前子2份、石菖蒲2份、合欢皮2份、当归2份、三七3份、黄连5份、五味子3份、茵陈3 份、赤苟3份、丹皮3份、鹿角3份、远志3份、蒲黄3份、川穹3份、杜仲3份、地龙3份、冷水七3份、 铁箍散3份原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在达到50 %, 收集通过100目筛的原料细粉;将过筛后的细粉放入水中浸泡,热提取2次,成浸膏状,为组 分1;药渣加10倍量水加热回流提取2次,每次1~2小时,浓缩过滤为浸膏状,为组分2;将上 述两种浸膏浓缩成糊状,浓缩液用C060灭菌,辐照剂量8k,加入糊精,然后真空冷冻密封即 得。
[0083] 毒性试验:
[0084] 实验动物
[0085]小白鼠由青岛市实验动物和动物实验中心提供。
[0086]小白鼠灌胃给药急性毒性实验
[0087]应用小鼠进行急性毒性实验表明:小鼠口服灌胃本发明的中药制剂胶囊剂,在 387. Ig生药/kg剂量下,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观 察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常,实验结果表明:小 鼠口服灌胃本发明的中药制剂胶囊剂的最大给药量为388.8g生药/kg/d(LD50>388.8g生 药/kg)。本发明的中药制剂每日临床用药总量为0.1 g生药/kg/d;按体重计,小鼠灌胃本发 明的中药制剂的耐受量为临床病人的3888倍。提示该药急性毒性低,临床用药安全。
[0088]大鼠灌胃给药长期毒性实验 [0089] 毒性试验:
[0090]选用SD大鼠,给予不同浓度(16.0、5.0、1.0 g生药/kg)的本发明的中药制剂片剂, 每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继 续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化,给药后90天和 停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、 Glu、BUN、Crea、TP、T. BIL、ALB、CH0L)、尿液生化、脏器系数、病理组织学等指标检查。试验结 果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进 食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检 查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标 停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的160、50、10倍,根据试验结 果本发明的中药制剂在高、中、低三个剂量(16.0、5.0、1.0 g生药/kg)连续90天给药对大鼠 无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本 发明的中药制剂临床应用的剂量安全性较高。
[0091]临床资料。
[0092] 实验材料:
[0093]作为治疗慢性心衰的药物,选择慢性心衰患者180例进行临床观察,其中男101例, 女性79例,年龄18-70岁,平均年龄45岁,病程1-10年。
[0094]临床使用
[0095]实验组服用实施例3的药物,早晚各一次,7天为一个疗程,根据病情连续服用3-4 个疗程,病情严重者遵医嘱酌增用量。对照组:给予西药常规强心、扩冠利尿治疗(开搏通 6.25~12.5mg,每日2次;双氢克尿噻12.5~25mg,每日2~3次;地戈辛0.125~0.25mg,每日 1次),并根据病情调整剂量。
[0096]疗效评定标准
[0097] 根据美国纽约心脏病学会心衰分级标准(NYHA分级),无心衰者BNP〈80ng/L、心功 能I级者BNP 95~221ng/L、心功能Π 级患者BNP221~459ng/L、心功能ΙΠ 级患者BNP459~ 1006ng/L、心功能IV级患者BNP 2 1006ng/L。目前,在国际上把心衰患者BNP的阳性阈值定为 100ng/L,当BNP测值在正常值以下时,可以认为能够排除心衰。
[0098]显效:临床症状基本消失,试验室检查各相关指标接近正常水平,BNP〈100ng/L。 [0099]有效:临床症状减轻,试验室检查各相关指标有所改善,NYHA分级向好转方向提 升,体征有改善。
[0100]无效:临床症状无明显好转或加重。
[0101]临床结果:
Figure CN105435131AD00131
[0103] 不良反应
[0104] 对于101例患者在治疗过程中进行跟踪观察,未发现明显的不良反应。
[0105] 以上所述,仅是本发明的最佳实施例而已,并非对本发明作任何形式上的限制,任 何熟悉本领域的技术人员,在不脱离本发明技术方案范围情况下,利用上述揭示的方法内 容对本发明技术方案做出许多可能的变动和修饰,均属于权利要求书保护的范围。

Claims (10)

1. 一种治疗慢性心衰的中药组合物,其特征在于:由以下各组分组成: 黄芪1-30份、丹参1-30份、枸杞1-30份、甘草1-30份、决明子1-30份、益母草1-30份、金 银花1-30份、葛根1-30份、瓜蒌1-30份、茯苓1-30份、五加皮1-30份、莪术1-30份、酸枣仁Ι-ΒΟ份、桑寄生 1-30 份、龙骨 1-30 份、白术 1-30 份、熟附子 1-30 份、三棱 1-30 份、天麻 1-30 份、葶 苈子1-30份、猪苓1-30份、桂枝1-30份、枳实1-30份、杜茎山1-30份、麦冬1-30份、山茱萸Ι-ΒΟ份、车前子 1-30 份、石菖蒲 1-30 份、合欢皮 1-30 份、当归 1-30 份、三七 1-30 份、黄连 1-30 份、 五味子1-30份、茵陈1-30份、赤芍1-30份、丹皮1-30份、鹿角1-30份、远志1-30份、蒲黄1-30 份、川穹1-30份、杜仲1-30份、地龙1-30份、冷水七1-30份、铁箍散1-30份。
2. 根据权利要求1所述的一种治疗慢性心衰的中药组合物,其特征在于:由以下重量份 数的各组分组成: 黄芪1-20份、丹参1-20份、枸杞1-20份、甘草1-20份、决明子1-20份、益母草1-20份、金 银花1-20份、葛根1-20份、瓜蒌1-20份、茯苓1-20份、五加皮1-20份、莪术1-20份、酸枣仁1-20份、桑寄生1-20份、龙骨1-20份、白术1-20份、熟附子1-20份、三棱1-20份、天麻1-20份、葶 苈子1-20份、猪苓1-20份、桂枝1-20份、枳实1-20份、杜茎山1-20份、麦冬1-20份、山茱萸1-20份、车前子1-20份、石菖蒲1-20份、合欢皮1-20份、当归1-20份、三七1-20份、黄连1-20份、 五味子1-20份、茵陈1-20份、赤芍1-20份、丹皮1-20份、鹿角1-20份、远志1-20份、蒲黄1-20 份、川穹1-20份、杜仲1-20份、地龙1-20份、冷水七1-20份、铁箍散1-20份。
3. 根据权利要求1至2所述的一种治疗慢性心衰的中药组合物,其特征在于:由以下重 量份数的各组分组成: 黄芪1-10份、丹参1-10份、枸杞1-10份、甘草1-10份、决明子1-10份、益母草1-10份、金 银花1-10份、葛根1-10份、瓜蒌1-10份、茯苓1-10份、五加皮1-10份、莪术1-10份、酸枣仁1-10份、桑寄生1-10份、龙骨1-10份、白术1-10份、熟附子1-10份、三棱1-10份、天麻1-10份、葶 苈子1-10份、猪苓1-10份、桂枝1-10份、枳实1-10份、杜茎山1-10份、麦冬1-10份、山茱萸1-10份、车前子1-10份、石菖蒲1-10份、合欢皮1-10份、当归1-10份、三七1-10份、黄连1-10份、 五味子1-10份、茵陈1-10份、赤芍1-10份、丹皮1-10份、鹿角1-10份、远志1-10份、蒲黄1-10 份、川穹1 -10份、杜仲1 -10份、地龙1 -10份、冷水七1 -10份、铁箍散1 -10份。
4. 根据权利要求1至3所述的一种治疗慢性心衰的中药组合物,其特征在于:所述中药 制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、口 含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。。
5. 根据权利要求1至4所述的一种治疗慢性心衰的中药组合物的制备方法,其特征在 于:所述胶囊制备的包括以下步骤: a. 将所述原料药放入粉碎机粉碎后过筛; b. 将过筛后的中药放入乙醇中加热回流提取2次; C.再取上述乙醇提取后的药渣,加水加热回流提取2次; d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;药粉装入胶囊制为胶囊 剂。
6. 根据权利要求5所述的一种治疗慢性心衰的中药组合物的制备方法,其特征在于:所 述步骤的a中,将所述原料药放入粉碎机粉碎后过100目细筛,使能通过100目筛的细粉量在 达到50%,收集通过100目筛的原料细粉备用。
7. 根据权利要求5所述的一种治疗慢性心衰的中药组合物的制备方法,其特征在于:所 述步骤b中,将过筛后的中药放入乙醇中加热回流提取2次,每次1~3小时,将2次提取液合 并静置;所述步骤c中,将上述乙醇提取过的药渣加10倍量水加热回流提取2次,每次1~3小 时,将2次提取液合并静置。。
8. 根据权利要求6所述的一种治疗慢性心衰的中药组合物的制备方法,其特征在于:所 述步骤d中将上述两种提取液合并,减压浓缩相对密度为70°C时1.08的滤液,回收乙醇,将 所得滤液调整比重到1.06,通入喷雾干燥机进行喷雾干燥,过喷雾干燥机喷头的压缩空气 压力为4kg/m2,干燥室热气流温度是60°C,得原料药粉;将原料药粉装入胶囊。
9. 一种如权利要求1至4所述的治疗慢性心衰的中药组合物的制备方法,其特征在于, 所述中药制剂的剂型为口服液剂,其制备步骤包括: a、 取原料药放入水中浸泡,热提取2次,成浸膏状,为组分1; b、 药渣乙醇提取1次,浓缩过滤为浸膏状,为组分2; c、 将上述两种浸膏浓缩成糊状,浓缩液用C060灭菌,辐照剂量8k,加入糊精,然后真空 冷冻密封即得。
10. -种如权利要求1至4所述的治疗慢性心衰的中药组合物的制备方法,其特征在于: 所述内服药物的剂型为丸剂,其制备步骤的包括: a. 将所述原料药混合,切碎,过120目筛,得细药粉备用; b. 将未过筛的粗粉浸泡乙醇中提取2次; c. 再取上述步骤提取后的药渣,加水加热回流提取2次; d. 将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉合并加入蜂胶搓 成丸剂。
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