CN107519370B - 治疗脾肾亏虚所致非过敏性紫癜的复方制剂及制备方法 - Google Patents

治疗脾肾亏虚所致非过敏性紫癜的复方制剂及制备方法 Download PDF

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CN107519370B
CN107519370B CN201710916858.6A CN201710916858A CN107519370B CN 107519370 B CN107519370 B CN 107519370B CN 201710916858 A CN201710916858 A CN 201710916858A CN 107519370 B CN107519370 B CN 107519370B
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马力
王维蔚
齐燕松
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Abstract

一种治疗脾肾亏虚所致非过敏性紫癜的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、党参6‑15、生白术9‑24、茯苓9‑24、熟地黄12‑32、山药9‑24、山茱萸6‑15、菟丝子12‑32、五味子4‑10、仙鹤草9‑24、紫草6‑15、怀牛膝9‑24。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，且有助于药物的吸收，从而能提高其生物利用度。另外，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

治疗脾肾亏虚所致非过敏性紫癜的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治疗脾肾亏虚所致非过敏性紫癜的复方制剂及制备方法。
背景技术
非过敏性紫癜是由于各种非过敏病因和疾病所引起的以血管异常为特征的一种出血性疾病，临床上多表现为：皮肤紫癜或瘀斑，粘膜或内脏出血(不多见)，毛细血管脆性试验可为阳性，凝血功能、血小板计数、血小板功能等检查一般为正常。引起非过敏性紫癜的病因和疾病甚多，类似中医学“肌衄”病的记载。虽然目前临床上用于治疗非过敏性紫癜的药物品种较多，但由于导致非过敏性紫癜的因素有多种，而且非过敏性紫癜也分多种类型，因此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脾肾亏虚所致的非过敏性紫癜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治疗脾肾亏虚所致非过敏性紫癜的复方制剂及制备方法。
为了达到上述目的，本发明提供的治疗脾肾亏虚所致非过敏性紫癜的复方制剂由用量为重量比的下列药物原料制成：
Figure BDA0001425974100000011
所述的治疗脾肾亏虚所致非过敏性紫癜的复方制剂的制备方法是将上述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，过滤去渣即可制成所述的治疗脾肾亏虚所致非过敏性紫癜的中药复方制剂。
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。
本发明提供的治疗脾肾亏虚所致非过敏性紫癜的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
非过敏性紫癜症状复杂，病程迁延，并发症较多。临床常见虚证、实证和虚实夹杂证等。此方立法于健脾补肾。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，故为君药。党参甘平，补脾肺气，补血，生津；茯苓甘淡平，利水渗湿，健脾化痰，宁心安神；山药甘平，补脾养胃，为慢性久病调补脾胃之佳品；菟丝子辛甘平，补肾益精，养肝明目，止泻；仙鹤草苦涩平，收敛止血，补虚，以上诸药，健脾利湿，补肝肾，益气养血，共为臣药。生白术甘苦温，益气健脾，燥湿利尿，为补气健脾第一要药；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；五味子酸甘温，收敛固涩，益气生津，补肾宁心；紫草甘咸寒，清热凉血，活血，解毒透疹，以上诸药，益气健脾，养阴补血，清热解毒，共为佐药。怀牛膝苦甘酸平，活血通经，补肝肾，强筋骨，利水通淋，引火(血)下行，以为使药。本方健脾补肾，益气摄血，故适用于治疗脾肾亏虚所致的非过敏性紫癜。
下面结合实施例对本发明提供的治疗脾肾亏虚所致非过敏性紫癜的复方制剂及制备方法进行详细说明。
实施例1：
本实施例提供的治疗脾肾亏虚所致非过敏性紫癜的复方制剂由用量为重量比的下列药物原料制成：
Figure BDA0001425974100000031
所述的治疗脾肾亏虚所致非过敏性紫癜的复方制剂的制备方法是将上述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，过滤去渣即可制成所述的治疗脾肾亏虚所致非过敏性紫癜的中药复方制剂。
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：
本实施例提供的治疗脾肾亏虚所致非过敏性紫癜的复方制剂由用量为重量比的下列药物原料制成：
Figure BDA0001425974100000032
制备方法同实施例1。
实施例3：
本实施例提供的治疗脾肾亏虚所致非过敏性紫癜的复方制剂由用量为重量比的下列药物原料制成：
Figure BDA0001425974100000041
制备方法同实施例1。
本发明提供的治疗脾肾亏虚所致非过敏性紫癜的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420例患有脾肾亏虚型非过敏性紫癜的患者进行了***临床观察，其中21-30岁患者102例，31-40岁129例，41-50岁189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(出血症状基本消失)198例，占47.1％；有效(主要症状有改善)146例，占34.8％；无效(主要症状无改善)76例，占18.1％；总有效率为81.9％。经2个疗程治疗后共治愈311例，占74.0％；有效79例，占18.8％；无效30例，占7.1％；总有效率为92.9％。
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 BDA0001425974100000042
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脾肾亏虚型非过敏性紫癜，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 BDA0001425974100000051
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脾肾亏虚型非过敏性紫癜，随着治疗的深入，治愈率、有效率均明显提高。

Claims (3)

1.一种治疗脾肾亏虚所致非过敏性紫癜的复方制剂，其特征在于：所述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 党参6-15 生白术9-24 茯苓9-24 熟地黄12-32
山药9-24 山茱萸6-15 菟丝子12-32 五味子4-10 仙鹤草9-24
紫草6-15 怀牛膝9-24。
2.一种如权利要求1所述的治疗脾肾亏虚所致非过敏性紫癜的复方制剂的制备方法，其特征在于：所述的制备方法是将上述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，过滤去渣即可制成所述的治疗脾肾亏虚所致非过敏性紫癜的中药复方制剂。
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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