CN107184750B - 治疗慢性肾小球肾炎、肾病综合征的药物及其制备方法 - Google Patents
治疗慢性肾小球肾炎、肾病综合征的药物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性肾小球肾炎、肾病综合征的药物及其制备方法，所述药物主要由黄芪、地锦草、党参、山萸肉、熟地、白术、茯苓和泽泻制成。制成的药物具有健脾益肾、升阳固元、利水渗湿作用，能减少蛋白尿、血尿，治疗慢性肾炎、肾病综合征。适用于慢性肾炎、肾病综合征蛋白尿、血尿的治疗，中医证属脾肾气虚兼湿浊者。
Description
技术领域
本发明涉及一种治疗慢性肾小球肾炎、肾病综合征的药物及其制备方法，属于药品技术的领域。
技术背景
慢性肾小球肾炎(简称慢性肾炎)、肾病综合征是肾小球毛细血管对蛋白滤过屏障系统损坏，使蛋白质被滤出，产生蛋白尿、低蛋白血症、水肿、高脂血症等为表现的一种的综合征。大量蛋白尿的漏出将引起低蛋白血症导致水肿、免疫力低下、血栓形成等，免疫因素在疾病的发生过程中起主导作用，所以，减少蛋白尿、血尿是治疗慢性肾炎、肾病综合征的关键点和难点。中医认为，蛋白尿、血尿是尿中流失的机体水谷精微物质，其基本病机为脾肾气虚，内生湿浊。脾气亏虚，清气不升则湿浊内生，精微不固，下泄外流而发生蛋白尿、血尿；肾元不足，封藏失司，精气不藏，则精微物质随尿液而漏出。
目前对慢性肾炎、肾病综合征的治疗主要集中在糖皮质激素及免疫抑制剂的使用方面，在控制病情上疗效可，但是，其在难治性肾病的病例效果有限及存在诸多的副作用，在一定程度上限制了其使用；其次，减少蛋白尿主要依赖于ACEI/ARB的使用，需要大剂量、足疗程的使用，对于不同类型的慢性肾炎、肾病综合征疗效不一，同时存在血压、血肌酐等使用限制。
发明内容：
本发明的目的在于，提供一种治疗慢性肾小球肾炎、肾病综合征的药物及其制备方法。所述药物有健脾益肾、升阳固元、利水渗湿作用，能减少蛋白尿、血尿，治疗慢性肾炎、肾病综合征。适用于慢性肾炎、肾病综合征蛋白尿、血尿的治疗，中医证属脾肾气虚兼湿浊者。
本发明采用以下技术方案实现：一种治疗慢性肾小球肾炎、肾病综合征的药物，按重量份计算，主要由黄芪20-30份、地锦草15-20份、党参10-20份、山萸肉10-20份、熟地15-20份、白术10-15份、茯苓10-15份和泽泻10-15份制成。
前述的治疗慢性肾小球肾炎、肾病综合征的药物，按重量份计算，主要由黄芪23-27份、地锦草16-19份、党参13-17份、山萸肉13-17份、熟地16-19份、白术12-14份、茯苓12-14份和泽泻12-14份制成。
前述的治疗慢性肾小球肾炎、肾病综合征的药物，按重量份计算，主要由黄芪25份、地锦草17份、党参15份、山萸肉15份、熟地17份、白术13份、茯苓13份和泽泻13份制成。
一种前述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，取上述药物，可以加辅料，也可以不加辅料，按照常规工艺，制成口服制剂。
前述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，所述口服制剂为胶囊剂、汤剂、片剂、颗粒剂或丸剂。
前述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，所述胶囊剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.20-1.25的浸膏，另取浸膏量30％的淀粉和0.7％的硬脂酸镁与浸膏混匀，用60％的乙醇制粒，干燥，粉碎，填充胶囊，即得。
前述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，所述汤剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min至沸后，再继续用小火煎煮15-25min，过滤，滤渣再加入4-6倍量水煎煮2次，每次20-40min，过滤，合并滤液，即得。
前述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，所述片剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.20-1.25的浸膏，浸膏与浸膏量20％的淀粉混匀，压片，包薄膜衣，即得。
前述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，所述颗粒剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.15-1.20的浸膏，浸膏与浸膏量20％的淀粉和20％的糊精粉混合制粒，干燥，即得。
前述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，所述丸剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.15-1.20的浸膏，浸膏与浸膏量15％的淀粉混合泛丸，干燥，包衣，即得。
本发明药物主要由黄芪、地锦草、党参、山萸肉、熟地、白术、茯苓和泽泻制成。其中，黄芪，Astragalus membranaceus(Fisch.)Bunge.，性味：甘，微温。归经：归肺、脾、肝、肾经。黄芪有增强机体免疫功能、保肝、利尿、抗衰老、抗应激、降压和较广泛的抗菌作用。能消除实验性肾炎蛋白尿，增强心肌收缩力，调节血糖含量。黄芪不仅能扩张冠状动脉，改善心肌供血，提高免疫功能，而且能够延缓细胞衰老的进程。黄芪食用方便，可煎汤，煎膏，浸酒，入菜肴等。地绵草，中药名。为大戟科植物地锦或斑地锦的干燥全草，夏、秋二季采收，除去杂质，晒干。其性味辛平，有清热解毒，凉血止血，利湿退黄之功效。用于痢疾，泄泻，咯血，尿血，便血，崩漏，疮疖痈肿，湿热黄疸。党参(学名；Codonopsis pilosula(Franch.)Nannf.)桔梗科党参属，多年生草本植物，有乳汁。具有补中益气，健脾益肺之功效。党参有增强免疫力、扩张血管、降压、改善微循环、增强造血功能等作用。此外对化疗放疗引起的白细胞下降有提升作用。山萸肉，Common Macrocarpium Fruit，成熟果实为中药，用于眩晕耳鸣，腰膝酸痛，阳痿遗精，遗尿尿频，崩漏带下，大汗虚脱。【性味】酸、涩、微温。【性味归经】：酸，微温。①《本经》：“味酸，平。”②《吴普本草》：“神农、黄帝、雷公、扁鹊：酸，无毒。岐伯，辛。”③《别录》：“微温，无毒。”④《药性论》：“味咸辛，大热”。熟地，为玄参科植物地黄(学名：Rehmanniaglutinosa)的块根，具有补血滋阴功效，可用于血虚萎黄，眩晕，心悸失眠，月经不调，崩漏等症，亦可用于肾阴不足的潮热骨蒸、盗汗、遗精、消渴等症，是虚证类非处方药药品六味地黄丸主要成分之一。白术(zhú)，拉丁学名Atractylodes macrocephala。具有健脾益气，燥湿利水，止汗，安胎的功效，用于脾虚食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安。《医学启源》记载：“除湿益燥，和中益气，温中，去脾胃中湿，除胃热，强脾胃，进饮食，安胎”。茯苓，中药名。为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。味甘、淡，性平。归心、肺、脾、肾经。功效：利水渗湿，健脾，宁心。主治：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。泽泻(学名：Alisma plantago-aquatica Linn.)，多年生水生或沼生草本。亦可入药，主治肾炎水肿、肾盂肾炎、肠炎泄泻、小便不利等症。性味：甘，寒。归经：入肾、膀胱经。功效：利水，渗湿，泄热。治小便不利，水肿胀满，呕吐，泻痢，痰饮，脚气，淋病，尿血。
本发明所述药物主要由黄芪、地锦草、党参、熟地、山萸肉、白术、茯苓、泽泻制成。慢性肾炎、肾病综合征，脾气亏虚，清气不升则湿浊内生，精微不固，下泄外流发生蛋白尿、血尿；肾元不足，封藏失司，精气不藏，则精微物质随尿液而漏出。治疗当以健脾益肾，升阳固元、利水渗湿为法。本发明组方由中医传统名方“补中益气汤”合“六味地黄汤”化裁，加上贵州苗族、仡佬族医药专治水肿、血尿的民族药斑鸠窝(地锦草)而得。全方以黄芪健脾益气，益肾填精，地锦草升清利湿，泄浊，共为君药；党参、白术健脾益气，熟地补精益髓，山萸肉益肾固精，辅助黄芪健脾益肾之功，共为臣药，茯苓健脾渗湿，泽泻利水渗湿，辅助地锦草利湿泄浊之效，为佐药。诸物合用，共奏健脾益肾、升阳固元、利水渗湿之功，全方配伍得当，以补为主，以疏为辅。共同达到治疗蛋白尿、血尿的目的。
与现有技术相比，本发明采用上述原料制成药物，制成的药物具有健脾益肾、升阳固元、利水渗湿作用，能减少蛋白尿、血尿，治疗慢性肾炎、肾病综合征。适用于慢性肾炎、肾病综合征蛋白尿、血尿的治疗，中医证属脾肾气虚兼湿浊者。
申请人进行了下列实验，可证明本发明具有有效的效果；
临床观察
1.对象与方法
1.1一般资料：收集到2014年6月-2017年1月我院诊断为肾病综合患者64例，随机数字分为两组，治疗组及对照组各32例。治疗组男18例，女14例，年龄18-74岁，平均年龄42.59±16.17岁；对照组男17例，女15例，年龄24-74岁，平均年龄47.22±14.69岁。两组年龄、性别比较无差异。
1.2诊断标准，符合内科学(人民卫生出版社·第八版)肾病综合征诊断标准：大量蛋白尿，尿蛋白＞3.5g/d；低白蛋白血症，血浆白蛋白＜30g/l；伴不同程度水肿及高脂血症。
1.3方法：所有病例基础治疗一致，均给予优质低蛋白饮食，控制血压、利尿消肿、治疗感染、抗血小板聚集、降低血脂等对症支持治疗。
对照组给予泼尼松龙1mg/kd/d，持续治疗8周；每周减10mg减量至30mg，此后每2周减量5mg，1个月后每周减量5mg，减至10mg维持量口服。环磷酰胺，每月冲击一次，每次0.8g，共6个月(该临床实验观察节点为12周)。
治疗组口服本发明药物(按实施例1进行制备)，每日分三次服药，观察12周。
1.4观察指标与疗效判定：
观察指标：治疗前后测定24小时蛋白尿、血清白蛋白、总胆固醇。
不良反应：血常规、肝功能、心电图、其他不良反应。
疗效判定：完全缓解：①完全缓解：血清白蛋白＞30g/L，24小时尿蛋白＜0.3g，胆固醇正常。②部分缓解：血清白蛋白＞30g/L，24小时尿蛋白为O.3-3.5g。③无效：未达到以上两个指标。总有效率＝(完全缓解例数+部分缓解例数)/总例数×100％。
1.5统计方法：SPSS22.0进行统计。计量资料以均数±标准差
用t检验；计数资料以百分率表述，计数资料用x2检验。均采用双侧检验，以P＜0.05为有统计学意义。
1.6结果：64例患者全部完成实验，24h尿蛋白、血清白蛋白、总胆固醇治疗后12周与治疗前比较，试验组及对照组差异均有统计学意义(P＜0.05)，治疗组治疗后与对照组比较24h尿蛋白定量、白蛋白下降明显，有统计学差异(P＜0.05)，见表1。
表1 两组治疗前后24h尿蛋白、血清白蛋白、总胆固醇比较
注：与治疗前比较*P<0.05；与对照组治疗后比较△P<0.05；
两组治疗效果比较，治疗组完全缓解18例，部分缓解12例，无效2例，总有效率87.50％；对照组完全缓解12例，部分缓解10例，无效10例，总有效率65.62％，治疗组与对照组比较有统计学差异(P＜0.05)，见表2。
表2 两组治疗效果
注：与对照组比较，*P＜0.05
2.不良反应：治疗组出现腹泻1例，与药物可能有关1例；对照组出现胃肠道反应3例，骨髓抑制1例，脱发1例，与药物可能有关者5例。
3.结论：本研究提示：经过12周的治疗，中医方案可有效的降低临床表现为肾病综合征患者的蛋白尿，提升血浆白蛋白。安全性方面，中医方案发生严重不良事件的次数明显少于对照组。因此，与对照组相比，中药综合方案的安全性更好。
下面结合实施例对发明作进一步的说明，但并不作为对本发明限制的依据。
具体实施方式：
实施例1.
配方：黄芪25kg、地锦草17kg、党参15kg、山萸肉15kg、熟地17kg、白术13kg、茯苓13kg和泽泻13kg。
工艺：取上述药物，加9倍量的水浸泡13分钟，先大火煎煮13min，再继续用小火煎煮20min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.20-1.25的浸膏，另取浸膏量30％的淀粉和0.7％的硬脂酸镁与浸膏混匀，用60％的乙醇制粒，干燥，粉碎，填充胶囊，即得胶囊剂。
规格：0.5g/粒；
用法用量：每日2-3次，每次2-3粒。
实施例2.
配方：黄芪27kg、地锦草19kg、党参17kg、山萸肉17kg、熟地19kg、白术14kg、茯苓14kg和泽泻14kg。
工艺：取上述药物，加9倍量的水浸泡13分钟，先大火煎煮13min至沸后，再继续用小火煎煮20min，过滤，滤渣再加入5倍量水煎煮2次，每次30min，过滤，合并滤液，即得汤剂。
用法用量：每日2-3次，每次100mL。
实施例3.
配方：黄芪23kg、地锦草16kg、党参13kg、山萸肉13kg、熟地16kg、白术12kg、茯苓12kg和泽泻12kg。
工艺：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮15min，再继续用小火煎煮25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.20-1.25的浸膏，浸膏与浸膏量20％的淀粉混匀，压片，包薄膜衣，即得片剂。
规格：0.5g/片
用法用量：每日2-3次，每次2-3片。
Claims (9)
1.一种治疗慢性肾小球肾炎、肾病综合征的药物，其特征在于：按重量份计算，由黄芪23-27份、地锦草16-19份、党参13-17份、山萸肉13-17份、熟地16-19份、白术12-14份、茯苓12-14份和泽泻12-14份制成。
2.如权利要求1所述的治疗慢性肾小球肾炎、肾病综合征的药物，其特征在于：按重量份计算，由黄芪25份、地锦草17份、党参15份、山萸肉15份、熟地17份、白术13份、茯苓13份和泽泻13份制成。
3.一种如权利要求1-2中任一项所述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，其特征在于：取上述药物，加辅料，按照常规工艺，制成口服制剂。
4.如权利要求3所述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，其特征在于：所述口服制剂为胶囊剂、汤剂、片剂、颗粒剂或丸剂。
5.如权利要求4所述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，其特征在于：所述胶囊剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.20-1.25的浸膏，另取浸膏量30%的淀粉和0.7%的硬脂酸镁与浸膏混匀，用60%的乙醇制粒，干燥，粉碎，填充胶囊，即得。
6.如权利要求4所述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，其特征在于：所述汤剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min至沸后，再继续用小火煎煮15-25min，过滤，滤渣再加入4-6倍量水煎煮2次，每次20-40min，过滤，合并滤液，即得。
7.如权利要求4所述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，其特征在于：所述片剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.20-1.25的浸膏，浸膏与浸膏量20%的淀粉混匀，压片，包薄膜衣，即得。
8.如权利要求4所述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，其特征在于：所述颗粒剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.15-1.20的浸膏，浸膏与浸膏量20%的淀粉和20%的糊精粉混合制粒，干燥，即得。
9.如权利要求4所述的治疗慢性肾小球肾炎、肾病综合征的药物的制备方法，其特征在于：所述丸剂这样制作：取上述药物，加8-10倍量的水浸泡10-15分钟，先大火煎煮10-15min，再继续用小火煎煮15-25min，煎煮3次，过滤，合并滤液，滤液浓缩成50-60℃时相对密度为1.15-1.20的浸膏，浸膏与浸膏量15%的淀粉混合泛丸，干燥，包衣，即得。
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