CN103751617B - 一种治疗慢性肾小球肾炎的中药制剂 - Google Patents
一种治疗慢性肾小球肾炎的中药制剂 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性肾小球肾炎的中药制剂，该药物由原料和辅料制备而成，按重量份计，所述的原料包括萱草根48-60份、冬瓜皮32-45份、金银花15-25份、槐花12-21份、竹叶12-21份、赤小豆50-80份、通草8-12份、牛蒡子8-12份。本发明的中药制剂能明显提高慢性肾小球肾炎的疗效，对消除患者尿中蛋白、红细胞，降低肾功能血清学指标作用明显。
Description
技术领域
本发明涉及一种治疗慢性肾小球肾炎的中药制剂，属于中药技术领域。
背景技术
慢性肾小球肾炎简称慢性肾炎，系指蛋白尿、血尿、高血压、水肿为基本临床表现，起病方式各有不同，病情迁延．病变缓慢进展，可有不同程度的肾功能减退，最终将发展成慢性肾衰竭的一组肾小球病。
在美国和欧洲，慢性肾炎是导致终末期肾病(ESRD)排位第三的病因，在美国ESRD发病率中占10％-15％，在发展中国家包括我国，慢性肾炎则是引起ESRD的主要病因。本病的发病机制尚不明了，目前研究表明其主要与原发病的免疫炎症损伤、大量蛋白尿、高血脂、高血压肾小动脉硬化有关。本病治疗颇为棘手，预后较差。在临床治疗中，目前尚无满意的治疗药物。
发明内容
鉴于现有技术的不足，本发明人本着以防止或延缓肾功能进行性恶化、改善或缓解临床症状及防治严重并发症为主要目的，对传统中药药理进行研究后重新组方，从而提供一种治疗慢性肾小球肾炎的中药制剂。
本发明的目的是这样实现的：
一种治疗慢性肾小球肾炎的中药制剂，由原料和辅料制备而成，按重量份计，所述的原料包括萱草根48-60份、冬瓜皮32-45份、金银花15-25份、槐花12-21份、竹叶12-21份、赤小豆50-80份、通草8-12份、牛蒡子8-12份。
优选地，如上所述的治疗慢性肾小球肾炎的中药制剂，按重量份计，所述的原料包括萱草根52-55份、冬瓜皮35-40份、金银花18-21份、槐花15-17份、竹叶15-17份、赤小豆60-65份、通草9-10份、牛蒡子9-10份。
在一个最优选的实施例中，如上所述的治疗慢性肾小球肾炎的中药制剂，按重量份计，它由如下重量份的中药材原料制备而成：萱草根53份、冬瓜皮37份、金银花18份、槐花16份、竹叶16份、赤小豆62份、通草9份、牛蒡子9份。
进一步优选地，所述的治疗慢性肾小球肾炎的中药制剂是口服制剂。
再进一步优选地，所述的治疗慢性肾小球肾炎的中药制剂是口服液、颗粒剂、片剂和胶囊剂。
通过临床应用研究发现，由上述中药材制备而成的药物组合物在治疗慢性肾小球肾炎患者方面获得了满意的疗效。因此，本发明的第二个目的在于提供一种医药新用途，即上述的中药材原料在制备治疗慢性肾小球肾炎的中药中的应用。
将上述各中药材制备成本发明的中药制剂的制备方法，包括如下步骤：称取清洗干净且干燥的萱草根48-60份、冬瓜皮32-45份、金银花15-25份、槐花12-21份、竹叶12-21份、赤小豆50-80份、通草8-12份和牛蒡子8-12份,合并，加水煎煮两次，合并煎液，减压浓缩至70℃时相对密度为1.15-1.20，加乙醇使含醇量的体积百分比达75-85%，搅拌，静置，过滤，滤液减压浓缩至70℃时相对密度为1.10-1.20并回收乙醇得浓缩液。将浓缩液加水及辅料配制成口服液，或者将该浓缩液真空干燥（60℃以下）成干膏，粉碎，加药用辅料，制成40目颗粒粉剂并包装。
本发明的中药制剂能明显提高慢性肾小球肾炎的疗效，对消除患者尿中蛋白、红细胞，降低肾功能血清学指标作用明显。同时，该中药制剂能明显消除水肿、有效消除尿蛋白、尿红细胞，明显改善肾功能。
具体实施方式
需要说明的是，本发明所采用的药材原料具有如下来源：萱草根选用百合科植物萱草HemerocallisfulvaL.的干燥根。冬瓜皮选用葫芦科植物冬瓜的外层果皮。金银花选用忍冬科植物忍冬（LonicerajaponicaThunb）的干燥花蕾。槐花选用豆科植物槐（SophorajaponicaL.）的干燥花朵。竹叶选用禾本科植物淡竹的干燥叶。赤小豆选用豆科植物赤小豆PhaseoluscalcaratusRoxb.的干燥成熟种子。通草选用五加科植物通脱木Tetrapanaxpapyriferus（Hook.）K.Koch的干燥茎髓。牛蒡子选用菊科植物牛蒡ArctiumlappaL.的干燥成熟果实。
下面通过实施例进一步说明本发明。本发明的实施例仅仅是用于说明本发明，而不是对本发明的限制，在本发明的构思前提下对本发明制备方法的简单改进都属于本发明要求保护的范围。
实施例1中药口服液的制备
称取萱草根5.3kg、冬瓜皮3.7kg、金银花1.8kg、槐花1.6kg、竹叶1.6kg、赤小豆6.2kg、通草0.9kg和牛蒡子0.9kg合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL，加水及蔗糖配制成口服液。
实施例2中药颗粒剂的制备
称取萱草根4.8kg、冬瓜皮3.2kg、金银花1.5kg、槐花2.0kg、竹叶1.2kg、赤小豆7.0kg、通草0.9kg和牛蒡子1.1kg合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL的浸膏，浸膏置不锈钢盘中，真空干燥（60℃以下）成干膏粉碎，加蔗糖粉，制成40目颗粒粉剂并包装，每包20g。
实施例3中药口服液的制备
称取萱草根5.7kg、冬瓜皮4.2kg、金银花2.0kg、槐花1.8kg、竹叶1.5kg、赤小豆5.0kg、通草0.8kg和牛蒡子0.8kg合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL，加水及蔗糖配制成口服液。实施例4中药口服液的制备
称取萱草根6.0kg、冬瓜皮3.3kg、金银花2.5kg、槐花1.2kg、竹叶2.1kg、赤小豆6.5kg、通草1.2kg和牛蒡子1.0kg合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、70℃下减压浓缩至70℃时相对密度为1.20，加95%(v/v)乙醇使含醇量达80%(v/v)，搅拌，静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.15g/mL，加水及蔗糖配制成口服液。
实施例5中药方剂对慢性肾小球肾炎患者的疗效研究
慢性肾小球肾炎患者57例，采用随机化的方法分为试验组28例和对照组29例。两组在性别、年龄、病程等方面比较无明显差异。对照组患者给予低盐低脂、优质蛋白饮食；控制高血压，控制感染等西医常规治疗。试验组患者在对照组常规治疗的基础上，给予中药方剂，方药组成：萱草根53g、冬瓜皮37g、金银花18g、槐花16g、竹叶16g、赤小豆62g、通草9g、牛蒡子9g。服药方法：每日1剂，每剂水煎2次，取汁200mL，分早晚2次餐后30min温服，每次100mL。疗程为1个月。观察记录两组患者治疗前及治疗后24h尿蛋白含量、尿沉渣红细胞计数和肾功能。按如下判定标准统计疗效：
治愈：24h尿蛋白定量正常，尿沉渣红细胞计数正常；肾功能正常；
显效：24h尿蛋白定量减少≥40％，尿沉渣红细胞计数检查减少≥40％；肾功能正常或基本正常(与正常值相差不超过15％)；
有效：24h尿蛋白定量减少<40％，尿沉渣红细胞计数检查减少<40％；肾功能正常或有改善；
无效：临床表现与上诉实验室检查均无改善或加重者。
试验结果具体参见表1。从表1的试验数据可见，试验组总有效率明显高于对照组，分别为92.86%和65.52%。
表1试验组与对照组疗效统计结果
典型治疗例
赵某，男，58岁，工人，患慢性肾小球肾炎2年，尿蛋白长期波动于(+)-(++)之间，虽经多种药物治疗，收效甚微，于2008年l1月来诊，症见：浮肿，尿少，尿混浊而多泡沫，腰膝乏力，头晕目眩，失眠多梦，大便干结，舌淡苔薄白，脉细。尿检蛋白(++)，颗粒管型少许，白细胞(+)，红细胞(+)。在常规治疗的基础上，给予中药方剂，方药组成：萱草根53g、冬瓜皮37g、金银花18g、槐花16g、竹叶16g、赤小豆62g、通草9g、牛蒡子9g。服药方法：每日1剂，每剂水煎2次，取汁200mL，分早晚2次餐后30min温服，每次100mL。10剂后，尿蛋白(±)，继服2周，化验均转阴，患者自觉周身轻松，继续服药lO余剂，后经多次尿检均为阴性，未复发。
Claims (4)
1.一种治疗慢性肾小球肾炎的中药制剂，由原料和辅料制备而成，其特征在于：按重量份计，所述的原料由萱草根53份、冬瓜皮37份、金银花18份、槐花16份、竹叶16份、赤小豆62份、通草9份和牛蒡子9份组成。
2.根据权利要求1所述的治疗慢性肾小球肾炎的中药制剂，其特征在于：所述的中药制剂是口服制剂。
3.根据权利要求2所述的治疗慢性肾小球肾炎的中药制剂，其特征在于：所述的中药制剂是口服液、颗粒剂、片剂或胶囊剂。
4.权利要求1所述的中药制剂在制备治疗慢性肾小球肾炎的药物中的应用。
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