CN107029081B - 用于治疗肾虚血亏所致贫血病的中药复方制剂及制备方法 - Google Patents

用于治疗肾虚血亏所致贫血病的中药复方制剂及制备方法 Download PDF

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CN107029081B
CN107029081B CN201710308657.8A CN201710308657A CN107029081B CN 107029081 B CN107029081 B CN 107029081B CN 201710308657 A CN201710308657 A CN 201710308657A CN 107029081 B CN107029081 B CN 107029081B
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马力
王维蔚
齐燕松
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Tianjin Shanji Hongxing Technology Development Co ltd
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Abstract

一种用于治疗肾虚血亏所致贫血病的中药复方制剂及制备方法。制剂由用量为重量比的下列药物原料制成：生黄芪18‑48、熟地黄12‑32、山药9‑24、山茱萸6‑15、茯苓9‑24、当归6‑15、炒白芍9‑24、菟丝子9‑24、补骨脂6‑15、枸杞子6‑15、阿胶6‑15、炙甘草4‑10。本发明制剂是采用水煮提取的方法来提取原料药物中的有效成分，并保持其活性，这样不仅可使药物中有效成分的溶出度大大提高，而且有助于药物的吸收，从而能够提高其生物利用度。另外，本发明的药物为纯中药复方制剂，因而患者长期服用后不会产生毒副作用，所以安全性好。此外，本发明的制备方法工艺简单，操作方便。

Description

用于治疗肾虚血亏所致贫血病的中药复方制剂及制备方法
技术领域
本发明涉及一种中药制剂及其制备方法，特别是涉及一种以中药为原料制成的用于治疗肾虚血亏所致贫血病的中药复方制剂及制备方法。
背景技术
贫血是指外周血单位体积血液中的血红蛋白(Hb)浓度、红细胞(RBC)计数及血细胞比容(HCT)低于可比人群正常值的下限，其中以血红蛋白最为重要。贫血属于中医学“虚劳”、“黄病”、“虚黄”等范畴，多由于先天禀賦不足、饮食不节、长期失血、烦劳过度、妊娠失养和大病久病虚损等引起脾肾亏损，脾虚则运化失职，气血生化无源，肾虚则精气不足，无以生髓化血，导致气血亏虚。虽然目前临床上用于治疗贫血病的药物品种很多，但由于导致贫血病的因素有多种，因此贫血病也分多种类型，所以这些药物缺乏针对性，疗程相对较长，且部分药物具有一定副作用或过敏反应，所以服用后对于治疗属于肾虚血亏所致的贫血病这种疾病来说效果不理想。
发明内容
为了解决上述问题，本发明的目的在于提供一种用于治疗肾虚血亏所致贫血病的中药复方制剂及其制备方法。
为了达到上述目的，本发明提供的用于治疗肾虚血亏所致贫血病的中药复方制剂由用量为重量比的下列药物原料制成：
生黄芪18-48熟地黄12-32山药9-24山茱萸6-15茯苓9-24
当归6-15炒白芍9-24菟丝子9-24补骨脂6-15枸杞子6-15
阿胶6-15炙甘草4-10
所述的用于治疗肾虚血亏所致贫血病的中药复方制剂的制备方法是按照下列步骤顺序进行∶
(a)将上述药物原料中除阿胶之外的其它药物原料进行称量并混合，然后加水浸泡25分钟，之后煎煮一次，大约30分钟，过滤去渣；
(b)将阿胶粉碎成小块或粉末状，加入少许黄酒，隔水加热蒸至溶化；
(c)将步骤(a)所得清液与步骤(b)所得阿胶溶液混合均匀即可制成所述的用于治疗肾虚血亏所致贫血病的中药复方制剂。
所述的中药复方制剂能够与常用的药用辅料制成颗粒剂、片剂、胶囊剂、糖浆剂、口服液、丸剂和膏剂。
本发明提供的用于治疗肾虚血亏所致贫血病的中药复方制剂是采用水煮提取的方法来提取原料药物中的有效成分，并保持其活性，这样不仅可使药物中有效成分的溶出度大大提高，而且有助于药物的吸收，从而能够提高其生物利用度。另外，本发明的药物为纯中药复方制剂，因而患者长期服用后不会产生毒副作用，所以安全性好。此外，本发明的制备方法工艺简单，操作方便。
具体实施方式
贫血病症状复杂，病程迁延，并发症较多。临床常见虚证、实证和虚实夹杂证等。此方立法于补肾填精，滋阴补气。方中生黄芪甘微温，健脾补中，升阳举陷，益卫固表，利尿，托毒生肌，为补中益气之要药，为君药。熟地黄甘微温，补血养阴，填精益髓；山茱萸酸涩微温，补益肝肾，收敛固涩，为平补阴阳之要药；当归甘辛温，补血，活血止痛；菟丝子辛甘平，补肾益精，养肝明目，止泻；枸杞子甘平，滋补肝肾，益精明目，为平补肾精肝血之精品，以上诸药，滋补肝肾精血，共为臣药。山药甘平，补脾养胃，为慢性久病调补脾胃之佳品；茯苓甘淡平，利水渗湿，健脾化痰，宁心安神；炒白芍苦酸微寒，养血敛阴，柔肝止痛，平抑肝阳；补骨脂苦辛温，补肾壮阳，固精缩尿，温脾止泻，纳气平喘；阿胶甘平，补血止血，滋阴润肺，为补血之要药，以上诸药，健脾养胃，养阴生血，补肾，为佐药。炙甘草甘平，补脾益气，清热解毒止痛，调和诸药，以为使药。本方补肾健脾，滋阴养血，故适用于治疗肾虚血亏所致的贫血病。
下面结合实施例对本发明提供的用于治疗肾虚血亏所致贫血病的中药复方制剂及其制备方法进行详细说明。
实施例1：
本实施例提供的用于治疗肾虚血亏所致贫血病的中药复方制剂由用量为重量比的下列药物原料制成：
生黄芪18熟地黄12山药9山茱萸6茯苓9
当归6炒白芍9菟丝子9补骨脂6枸杞子6
阿胶6炙甘草4
所述的用于治疗肾虚血亏所致贫血病的中药复方制剂的制备方法是按照下列步骤顺序进行∶
(a)将上述药物原料中除阿胶之外的其它药物原料按照配比进行称量并混合，然后加水浸泡25分钟，之后煎煮30分钟，过滤去渣；
(b)将阿胶粉碎成直径5mm左右的小块或粉末状，加入少许黄酒，隔水加热蒸至溶化；
(c)将步骤(a)所得清液与步骤(b)所得阿胶溶液混合均匀即可制成所述的用于治疗肾虚血亏所致贫血病的中药复方制剂。
另外，所述的中药复方制剂能够与常用的药用辅料制成颗粒剂、片剂、胶囊剂、糖浆剂、口服液、丸剂和膏剂。
实施例2：
本实施例提供的用于治疗肾虚血亏所致贫血病的中药复方制剂由用量为重量比的下列药物原料制成：
生黄芪48熟地黄32山药24山茱萸15茯苓24
当归15炒白芍24菟丝子24补骨脂15枸杞子15
阿胶15炙甘草10
制备方法同实施例1。
实施例3：
本实施例提供的用于治疗肾虚血亏所致贫血病的中药复方制剂由用量为重量比的下列药物原料制成：
生黄芪32熟地黄22山药17山茱萸12茯苓17
当归12炒白芍17菟丝子17补骨脂12枸杞子12
阿胶12炙甘草8
制备方法同实施例1。
本发明提供的用于治疗肾虚血亏所致贫血病的中药复方制剂呈棕色至棕褐色；气淡，味微苦。为了验证该中药复方制剂的治疗效果，本发明人利用上述中药复方制剂对327例患有肾虚血亏型贫血病的患者进行了系统临床观察，其中21-30岁患者92例，31-40岁118例，41-50岁117例,每次用药150ml，每日3次，120天为1个疗程。经1个疗程治疗后共治愈(血红蛋白(Hb)浓度、红细胞(RBC)计数及血细胞比容(HCT)等主要症状明显改善)157例，占48.0％；有效(各项化验检查明显改善，主要症状有改善)134例，占41.0％；无效(各项化验检查无变化，主要症状无改善)36例，占11.0％；总有效率为89.0％。经2个疗程治疗后共治愈213例，占65.1％；有效89例，占27.2％；无效25例，占7.6％；总有效率为92.4％。
同时，本发明人对治疗效果与年龄、治疗效果与疗程之间的关系进行了分析，分析结果分别见表1、表2。
表1：本发明提供的中药复方制剂治疗效果与年龄关系表
Figure BDA0001286479570000051
将上述表1中的数据用x2检验法进行计算，结果为0.050＞P＞0.025，由此可以证明服用本发明提供的中药复方制剂来治疗肾虚血亏型贫血病，对各年龄组的治疗效果不随年龄而变化。
表2：本发明提供的中药复方制剂治疗效果与疗程关系表
Figure BDA0001286479570000052
将上述表2中的数据用x2检验法进行计算，结果为P＜0.005，由此可以证明服用本发明提供的中药复方制剂来治疗肾虚血亏型贫血病，随着治疗的深入，治愈率、有效率均明显提高。

Claims (3)

1.一种用于治疗肾虚血亏所致贫血病的中药复方制剂，其特征在于：所述的用于治疗肾虚血亏所致贫血病的中药复方制剂由用量为重量比的下列药物原料制成：
生黄芪18-48 熟地黄12-32 山药9-24 山茱萸6-15 茯苓9-24
当归6-15 炒白芍9-24 菟丝子9-24 补骨脂6-15 枸杞子6-15
阿胶6-15 炙甘草4-10。
2.一种如权利要求1所述的用于治疗肾虚血亏所致贫血病的中药复方制剂的制备方法，其特征在于：所述的制备方法是按照下列步骤顺序进行∶
（a）将上述药物原料中除阿胶之外的其它药物原料按照配比进行称量并混合，然后加水浸泡25分钟，之后煎煮30分钟，过滤去渣；
（b）将阿胶粉碎成小块或粉末状，加入少许黄酒，隔水加热蒸至溶化；
（c）将步骤（a）所得滤液与步骤（b）所得阿胶溶液混合均匀即可制成所述的用于治疗肾虚血亏所致贫血病的中药复方制剂。
3.根据权利要求2所述的制备方法，其特征在于：所述的中药复方制剂与常用的药用辅料制成颗粒剂、片剂、胶囊剂、糖浆剂、口服液、丸剂或膏剂。
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