CN105582290B - 一种治疗血液透析患者皮肤病变的中药组合物 - Google Patents
一种治疗血液透析患者皮肤病变的中药组合物 Download PDFInfo
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- CN105582290B CN105582290B CN201610037021.XA CN201610037021A CN105582290B CN 105582290 B CN105582290 B CN 105582290B CN 201610037021 A CN201610037021 A CN 201610037021A CN 105582290 B CN105582290 B CN 105582290B
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Abstract
本发明属于中药领域，具体涉及一种治疗血液透析患者皮肤病变的中药组合物。其由以下重量份的原料药制成：葛根10‑100份、生地黄10‑100份、玄参10‑100份、麦冬10‑100份、防风10‑100份、地肤子10‑100份、白鲜皮10‑100份、蒺藜10‑100份、当归10‑100份、鸡血藤10‑100份。
Description
技术领域
本发明属于中药领域，具体涉及一种治疗血液透析患者皮肤病变的中药组合物。
背景技术
慢性肾衰竭是多种原因导致肾脏功能受损，尿素氮、肌酐水平逐渐升高，水、电解质紊乱，酸中毒，大、中分子毒素滞留，以至出现全身中毒症状的一类临床综合征。慢性肾衰竭发展的终末阶段即为尿毒症，亦称为终末期肾脏病（end-stage renal disease, ESRD）。ESRD患者必须依赖肾移植、血液透析或者腹膜透析来维持生命。血液透析作为肾脏替代治疗的方法之一，是目前ESRD患者主要的治疗方法，而且维持性血液透析已使一些严重的ESRD患者得以长期生存，部分患者可以恢复一定劳动力，获得较高的生活质量。
ESRD的替代治疗主要采用腹膜透析和血液透析，其中，血液透析是目前治疗ESRD的主要方法之一。血液透析在延续尿毒症患者生命的同时，也存在着一些问题，如昂贵的费用及如何提高透析充分性和患者的营养状况等。尿毒症患者因电解质与内分泌紊乱、自主神经病变及其经常服用的药物（如含钙或铝的磷结合剂、口服铁剂等）均可导致大肠运动功能受损，引起便秘，而长期便秘可引起毒素蓄积，体重增加，影响患者的透析治疗效果和生活质量。
尿毒症中医病机是脾肾虚衰，浊毒瘀血内停，早期以脾肾气阴两虚为主，晚期则表现为脾肾阳气虚衰，临床上多采用益气健脾、祛湿化浊、活血化瘀为治疗原则。
皮肤瘙痒也是尿毒症血液透析患者的常见并发症, 是严重影响透析患者生活质量的一大顽症，有文献报道，维持性血液透析患者皮肤瘙痒发生率较高，表现为全身或局部不同程度的瘙痒，以额部、项背部、前臂、手掌部为主，瘙痒呈阵发性发作，持续时间不等，有时可自行缓解。皮肤瘙痒使患者不仅烦躁不安、失眠、血压波动，生活质量受到严重影响，甚至在一定程度上影响到尿毒症患者的远期生存率。
尿毒症血液透析合并皮肤瘙痒的原因目前尚不完全明了。现代医学近年研究表明，这一顽固性瘙痒可能与肾衰时尿素氮、肌酐、尿酸等代谢产物潴留，毒素对皮肤的刺激，皮脂腺分泌减少及汗腺萎缩致使皮肤干燥有关。也可能与继发性甲状旁腺功能亢进，钙磷代谢紊乱、维生素过多症、肝素和透析膜成分的变态反应，以及普通血液透析难于透出的中分子毒素在体内的蓄积有关。
发明内容
在本发明的一个目的是一种治疗血液透析患者皮肤病变的中药组合物，其由以下重量份的原料药制成：葛根10-100份、生地黄10-100份、玄参10-100份、麦冬10-100份、防风10-100份、地肤子10-100份、白鲜皮10-100份、蒺藜10-100份、当归10-100份、鸡血藤10-100份。
在本发明的一个的实施方案中，所述中药组合物由如下重量份的原料药制成：葛根10-30份、生地黄10-30份、玄参10-30份、麦冬10-30份、防风10-30份、地肤子10-30份、白鲜皮10-30份、蒺藜10-30份、当归10-30份、鸡血藤10-30份。
在本发明的优选实施方案中，所述中药组合物由如下重量份的原料药制成：葛根20份、生地黄20份、玄参15份、麦冬15份、防风15份、地肤子15份、白鲜皮15份、蒺藜15份、当归15份、鸡血藤15份。
本发明的另一个目的是提供一种所述中药组合物的制备方法，具体步骤如下：
（1）按照原料药重量比例称取中药材葛根、生地黄、玄参、麦冬、防风、地肤子、白鲜皮、蒺藜、当归、鸡血藤，净选，混合，粉碎成100目～200目的粉末，备用；
（2）将步骤（1）制得的粉末，加8-12倍量水，加热煎煮2-4次，每次2-4小时，过滤，除药渣，合并煎煮液，浓缩至药液在65℃测时相对密度为1.15-1.30的清膏，干燥，粉碎，得干膏粉，即得。
本发明的又一个目的是提供一种包含所述中药组合物的药物制剂，其由所述中药组合物和药学上可接受的辅料制成。
所述药学上可接受的辅料为：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。
具体实施方式
下面将进一步的详细说明本发明。需要指出的是，以下说明仅仅是对本发明要求保护的技术方案的举例说明，并非对这些技术方案的任何限制。本发明的保护范围以所附权利要求书记载的内容为准。
实施例1 中药组合物的制备
（1）按照原料药重量比例称取中药材葛根20kg、生地黄20kg、玄参15kg、麦冬15kg、防风15kg、地肤子15kg、白鲜皮15kg、蒺藜15kg、当归15kg、鸡血藤15kg，净选，混合，粉碎成100目～200目的粉末，备用；
（2）将步骤（1）制得的粉末，分别加8、10、10倍量水，加热煎煮3次，每次2小时，过滤，除药渣，合并煎煮液，浓缩至药液在65℃测时相对密度为1.15-1.30的清膏，干燥，粉碎，得干膏粉，即得（收率12.7%）。
实施例2 中药组合物对慢性肾衰竭大鼠皮肤的影响
取雄性SD大鼠，体重200g左右，随机分组，适应性喂养7天，戊巴比妥钠麻醉，从左腹部切口，分离肾周脂肪后，弧型切除2/3肾组织，止血后滴加纤维蛋白原和凝血酶溶液，缝合。一周后切除整个右肾，两次手术切除肾脏80%左右，正常组仅进行手术而不切除肾脏。于第二次手术后饲养12周开始灌胃给药，给药组给予实施例1制备的中药组合物，剂量为50mg/kg，模型组和正常组给予等量的生理盐水，连续给药一周。然后将大鼠放入单独的饲养笼中观察30min内的大鼠搔抓反应次数，然后处死大鼠，腹主动脉取血，检测SCr、BUN和P物质含量，其中P物质采用ELISA方法进行检测，SCr、BUN采用常规方法检测即可，具体结果如下：
中药组合物对大鼠搔抓反应次数的影响
对比例1的中药组合物制备方法同实施例1，区别仅在于制备过程不添加中药材玄参，给药剂量为50mg/kg。
对比例2的中药组合物制备方法同实施例1，区别仅在于制备过程不添加中药材生地黄，给药剂量为50mg/kg。
中药组合物对大鼠血清中的影响SCr、BUN和P物质含量的影响
实施例3 临床研究
收集100 例门诊尿毒症血液透析患者，随机分为2 组。治疗组50 例，年龄36～62岁，中位年龄47岁；病程5～14年, 平均8.9年；对照组66 例，年龄35～60岁，中位年龄49岁；病程4～15年, 平均8.6年；上述患者均伴有严重的皮肤瘙痒症，且经药物治疗无效。
治疗组和对照组均采用瑞典生产的金宝AK-200ULTRAS 血滤透析机进行血液透析治疗，德国Fresenuise公司生产的F60高通量透析器，材料为聚砜膜，表面积113m2，超滤系数40ml/(h·mmHg)。
治疗组给予实施例1制备的中药组组合物（口服），每次100mg，每日3次；对照组：口服降压药，纠正贫血，维持水、电解质、酸碱平衡，降磷补钙。以4周为一个疗程，共治疗1个疗程。
疗效判定标准：治愈：瘙痒症状消失，继发性皮损消退；显效：瘙痒症状明显减轻，继发性皮损消退80％；好转：瘙痒症状减轻，继发性皮损消退50％左右；无效：瘙痒症状无减轻或加重，继发性皮损消退＜50％。
具体结果如下：
实施例4 片剂制备
取实施例1制备的中药组合物15g，加入微晶纤维素15g混合均匀，用80%乙醇制软材，过16目筛制粒，将湿颗粒于45℃干燥，整粒，加入4%的硬脂酸镁混合均匀，压片，得片剂（每片200mg）。
本发明内容仅仅举例说明了要求保护的一些具体实施方案，其中一个或更多个技术方案中所记载的技术特征可以与任意的一个或多个技术方案相组合，这些经组合而得到的技术方案也在本申请保护范围内，就像这些经组合而得到的技术方案已经在本发明公开内容中具体记载一样。
Claims (6)
1.一种治疗血液透析患者皮肤病变的中药组合物，其由以下重量份的原料药制成：葛根10-100份、生地黄10-100份、玄参10-100份、麦冬10-100份、防风10-100份、地肤子10-100份、白鲜皮10-100份、蒺藜10-100份、当归10-100份、鸡血藤10-100份。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物由如下重量份的原料药制成：葛根10-30份、生地黄10-30份、玄参10-30份、麦冬10-30份、防风10-30份、地肤子10-30份、白鲜皮10-30份、蒺藜10-30份、当归10-30份、鸡血藤10-30份。
3.根据权利要求2所述的中药组合物，其特征在于，所述中药组合物由如下重量份的原料药制成：葛根20份、生地黄20份、玄参15份、麦冬15份、防风15份、地肤子15份、白鲜皮15份、蒺藜15份、当归15份、鸡血藤15份。
4.一种权利要求1-3任一项所述中药组合物的制备方法，具体步骤如下：
（1）按照原料药重量比例称取中药材葛根、生地黄、玄参、麦冬、防风、地肤子、白鲜皮、蒺藜、当归、鸡血藤，净选，混合，粉碎成100目～200目的粉末，备用；
（2）将步骤（1）制得的粉末，加8-12倍量水，加热煎煮2-4次，每次2-4小时，过滤，除药渣，合并煎煮液，浓缩至药液在65℃测时相对密度为1.15-1.30的清膏，干燥，粉碎，得干膏粉，即得。
5.一种包含权利要求1-3任一项所述中药组合物的药物制剂，其由所述中药组合物和药学上可接受的辅料制成。
6.根据权利要求5所述的药物制剂，所述药学上可接受的辅料为：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、矫味剂、防腐剂。
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| CN104666597A (zh) * | 2015-02-10 | 2015-06-03 | 青岛市市立医院 | 一种治疗血液透析后皮肤瘙痒症的中药乳膏 |
| CN104940503A (zh) * | 2015-05-31 | 2015-09-30 | 相丽 | 一种治疗血液透析患者皮肤瘙痒的中药组合物 |
| CN104940647A (zh) * | 2015-07-13 | 2015-09-30 | 马力群 | 缓解血液透析后皮肤过敏、瘙痒的中药药浴及其制备方法 |
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