CN116585412B - 一种治疗慢性肾炎的中药组合物及其制备方法 - Google Patents
一种治疗慢性肾炎的中药组合物及其制备方法 Download PDFInfo
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Abstract
一种用于治疗慢性肾炎的中药组合物及其制备方法。中药组合物由生黄芪、赤芍、防风、穿山龙、麸炒芡实、金樱子肉、白花蛇舌草、桑枝、刺五加制成，可以加入药学上的常用辅料制成片剂、胶囊剂或颗粒剂。该组合物组方严谨、配伍科学、疗效显著、能最大限度地发挥药物疗效，并且制备方便、患者依从性良好、无毒副作用的治疗慢性肾炎气虚血瘀证。
Description
技术领域
本发明涉及中药领域，尤其涉及一种治疗慢性肾炎气虚血瘀证的中药组合物及其制备方法。
背景技术
慢性肾脏病(chronic kidney disease,CKD)是指各种原因导致的肾脏病理学异常和(或)血、尿、影像学检查异常，或肾小球滤过率(glomerular filtration rate,GFR)<60ml/min·1.72m2并持续3个月以上，包括各类肾小球疾病、肾小管间质疾病以及肾血管疾病，其中慢性肾小球肾炎(简称慢性肾炎)占大多数。张路霞等对47204名中国成年人(18-95岁)进行横断面研究，其中CKD患者约占10.8％，相当于全国有1亿2千万左右成年人患有不同程度的CKD。对我国4931例肾穿患者进行统计分析后发现，慢性肾小球肾炎最多，约占82％。随着慢性肾炎病情进展，患者的肾功能将进一步下降，进而发展至慢性肾衰竭，最终进入终末期肾脏病(end stage renal disease,ESRD)。ESRD不仅死亡率高，致残率高，而且维持生存需要的治疗(透析或肾移植)费用昂贵，耗费大量卫生资源，给家庭和社会带来沉重的负担。目前，慢性肾炎已成为重要的公共健康问题。
蛋白尿是慢性肾炎常见的临床表现之一，持续不缓解的蛋白尿是慢性肾炎进展到慢性肾衰竭的主要危险因素，也是全因死亡率的独立预测因素，此外，严重下降的GFR可进一步增加全因死亡率的风险。当前治疗慢性肾炎主要围绕控制血压、减少尿蛋白、延缓肾功能衰竭进行。国际KDIGO指南推荐慢性肾炎患者使用肾素-血管紧张素系统(renin-angiotensin system,RAS)阻断剂，包括血管紧张素转换酶抑制剂(angiotensinconverting enzyme inhibitor，ACEI)或血管紧张素受体拮抗剂(angiotensin receptorblocker，ARB)，即所谓支持治疗(supportive therapy)；如治疗后尿蛋白仍≥1g/d且肾小球滤过率(glomerular filtration rate，GFR)>50ml/(min·1.73m2)可考虑应用激素治疗。研究表明，ACEI或ARB可呈剂量依赖的方式减少40-50％的蛋白尿，然而，部分患者经ACEI或ARB治疗后仍残留有蛋白尿。同时，应用激素治疗可出现肥胖、痤疮、类固醇型糖尿病等副作用，应用免疫抑制剂也可能出现肝肾功能损害等；激素与支持治疗能够在一定程度上减轻蛋白尿，但并未显示出减缓肾功能进展的作用，反而与高风险事件呈相关性。文献研究表明，慢性肾炎临床常见的证候类型为脾肾两虚证(32.16％)、气阴两虚证(19.36％)、肺肾气虚证(7.46％)、肝肾阴虚证(6.49％)以及湿热内蕴证(6.09％)，代偿期以脾肾气虚证为主，失代偿期以脾肾阳虚证为主；慢性肾炎以气虚、阴虚为本，以湿热、血瘀为标，气虚+血瘀为频率最高的虚实夹杂证候。慢性肾炎中医病机可总结为“虚-风-瘀-毒”复杂病机网络，其中“脾肾两虚”为本，是发病的内在因素，“外风”为始动因素或诱因，“伏风”是导致慢性肾炎迁延难愈，病情反复的基本因素，而“内风”的形成，络脉中的“瘀血”，以及“毒邪”的化生是加重肾脏病进展，导致病情恶化的继发性因素。
因此，寻求一种有效且安全的治疗慢性肾炎的方法是十分必要的。在西医支持治疗的基础上联合中药治疗降低蛋白尿，延缓ESKD进程，减少不良事件的发生是当前研究的重点。
发明人张昱教授在临床治疗中曾使用加味黄芪赤风汤(药物组成：生黄芪20g，赤芍10g，防风10g，金樱子20g，芡实20g，穿山龙20g，地龙10g，白花蛇舌草10g)治疗慢性肾炎蛋白尿，常可收到满意疗效且无不良反应，在随后多年的进一步的临床研究和治疗实践中，研发出了疗效更好的治疗慢性肾炎气虚血瘀证的本发明中药组合物。鉴于本发明所涉及的中药组合物优良的治疗效果，本发明的技术方案同时还申请了《首都医学科技创新成果转化优促计划实施方案》的项目。
发明内容
本发明目的在于提供一种具有组方严谨、配伍科学、疗效显著、能最大限度地发挥药物疗效，并且制备方便、患者依从性良好、无毒副作用的治疗慢性肾炎气虚血瘀证的中药组合物及其制备方法。
为达到上述目的，本发明提供了一种治疗慢性肾炎气虚血瘀证的中药组合物，其特征在于所述中药组合物由下列重量份配比的药物组成：黄芪9-40重量份、赤芍6-12重量份、防风5-10重量份、穿山龙9-15重量份、芡实9-15重量份、金樱子肉6-12重量份、白花蛇舌草15-30重量份、桑枝9-15重量份、刺五加9-27重量份。
本发明进一步优选方案是，本发明所述的中药组合物有以下重量份的原料制得：生黄芪9-40重量份、赤芍6-12重量份、防风5-10重量份、穿山龙9-15重量份、麸炒芡实9-15重量份、金樱子肉6-12重量份、白花蛇舌草15-30重量份、桑枝9-15重量份、刺五加9-27重量份。
最优选技术方案是，本发明所述的中药组合物由以下重量份的原料制得：生黄芪30重量份、赤芍10重量份、防风10重量份、穿山龙15重量份、麸炒芡实15重量份、金樱子肉10重量份、白花蛇舌草20重量份、桑枝10重量份、刺五加10重量份。
上述中药组合物的剂型为口服制剂。
上述口服制剂为汤剂、片剂、胶囊剂或颗粒剂。
本发明中的中药组合物组方原则主要依据慢性肾炎患者的病机特点研制而成，即“虚-风-瘀-毒”复杂病机网络。“脾肾两虚”为本，是发病的内在因素，“外风”为始动因素或诱因，“伏风”是导致慢性肾炎迁延难愈，病情反复的基本因素，而“内风”的形成，络脉中的“瘀血”，以及“毒邪”的化生是加重肾脏病进展，导致病情恶化的继发性因素。方中生黄芪为君药，最善补脾益肾；赤芍为臣药，活血化瘀；防风为臣药，祛风散邪，行气醒脾。黄芪、赤芍、防风三者配伍，王清任认为“能使周身之气通而不滞，血活而不瘀，气通血活，何患疾病不除”，与慢性肾炎基本病机气虚、血瘀、风扰契合。芡实、金樱子、穿山龙、白花蛇舌草、桑枝、刺五加均为佐药，芡实、金樱子、刺五加健脾益肾，固摄精微，辅佐生黄芪共建益肾健脾之功；穿山龙、桑枝均能袪风除湿，且穿山龙兼能活血通络，桑枝兼能行气利水，既可助防风祛风经络，又可助赤芍行气活血。因此，诸药合用，针对上述病机的每一环节，以达益气活血、祛风解毒之效。
本发明中药制剂采用合理的提取方式和工艺，充分提取有效成分，可制成方便口服或携带的中药制剂。
附图说明
图1为各组大鼠24小时尿蛋白定量比较结果。图中与空白组相比，**P<0.01；与模型组相比，#P<0.05，##P<0.01；与比较例1组相比，&P<0.05；与比较例2组相比，@@P<0.01；与比较例3组相比，$$P<0.01；与比较例4组相比，％％P<0.01。
图2为各组大鼠血生化指标结果
图3为肾组织HE病理染色结果
图4为肾组织Masson病理染色结果
图5为电镜下肾组织超微病理改变结果
具体实施方式
以下通过具体实施例进一步描述本发明，但是本发明不仅仅限于以下具体实施例。
实施例1
按以下重量克称取本发明各原料：生黄芪30克、赤芍10克、防风10克、穿山龙15克、麸炒芡实15克、金樱子肉10克、白花蛇舌草20克、桑枝10克、刺五加10克。
制备工艺如下：
将中药原料放入煎药容器中，加水煎煮2次，第一次加8倍量水煎煮30分钟，第二次加6倍量水煎煮20分钟，滤过，所得药汤，即汤剂。
实施例2
按以下重量克称取本发明各原料：生黄芪30克、赤芍10克、防风10克、穿山龙15克、麸炒芡实15克、金樱子肉10克、白花蛇舌草20克、桑枝10克、刺五加10克。
制备工艺如下：
将中药原料放入煎药容器中，加水煎煮2次，第一次加8倍量水煎煮30分钟，第二次加6倍量水煎煮20分钟，滤过，滤液浓缩至相对密度为1.10～1.15的清膏，加入适量辅料，压片包衣，即片剂。
实施例3
按以下重量克称取本发明各原料：生黄芪30克、赤芍10克、防风10克、穿山龙15克、麸炒芡实15克、金樱子肉10克、白花蛇舌草20克、桑枝10克、刺五加10克。
制备工艺如下：
将中药原料放入煎药容器中，加水煎煮2次，第一次加8倍量水煎煮30分钟，第二次加6倍量水煎煮20分钟，滤过，滤液浓缩至相对密度为1.10～1.15的清膏，加入适量辅料，混合均匀装入胶囊，即胶囊剂。
实施例4
按以下重量克称取本发明各原料：生黄芪30克、赤芍10克、防风10克、穿山龙15克、麸炒芡实15克、金樱子肉10克、白花蛇舌草20克、桑枝10克、刺五加10克。
制备工艺如下：
将中药原料放入煎药容器中，加水煎煮2次，第一次加8倍量水煎煮30分钟，第二次加6倍量水煎煮20分钟，滤过，滤液浓缩至相对密度为1.10～1.15的清膏，加入适量辅料，制成颗粒剂。
实施例5
申请人提供比较例1至4以证明本申请组合物的效果，可通过下述实验结果判断出本申请药物的效果比对比药物的效果更好。
本发明申请方组成为“生黄芪30克、赤芍10克、防风10克、穿山龙15克、麸炒芡实15克、金樱子肉10克、白花蛇舌草20克、桑枝10克、刺五加10克”；
比较例1的药物组成为“生黄芪30克、赤芍10克、防风10克、穿山龙20克、麸炒芡实20克、金樱子肉10克、白花蛇舌草20克”，即与本发明药物的区别为未使用桑枝和刺五加；
比较例2的药物组成为“生黄芪30克、赤芍10克、防风10克、穿山龙15克、麸炒芡实15克、金樱肉10克、白花蛇舌草20克、白芷10克、续断10克”，即与本发明药物的区别为将桑枝和刺五加替换为白芷10克、续断10克；
比较例3的药物组成为“生黄芪30克、赤芍10克、防风15克、穿山龙15克、麸炒芡实15克、金樱子肉15克、白花蛇舌草20克、桑枝5克、刺五加5克”，即与本发明药物的区别为桑枝和刺五加各减至5克，防风加至15克，金樱子肉加至15克；
比较例4的药物组成为“炙黄芪30克、赤芍10克、防风10克、穿山龙15克、芡实15克、金樱子肉10克、白花蛇舌草20克、桑枝10克、刺五加10克”，即与本发明药物的区别为使用了炙黄芪而未使用生黄芪，使用了芡实而未使用麸炒芡实。
药物效果比较实验：
选用SD大鼠80只，分为空白组、模型组、贝那普利组、申请方组、比较例1组、比较例2组、比较例3组、比较例4组，每组各10只。以单次尾静脉注射Fx1A抗体(0.4ml/100g)建立肾炎蛋白尿大鼠模型，造模后两周检测尿蛋白，模型组大鼠尿蛋白显著增多为模型成功。按人体等效剂量制备中药煎剂及贝那普利混悬液。模型建立成功后，分组灌胃干预6周，每2周检测大鼠24小时尿蛋白定量(图1)。实验结果显示，实验第6周末，申请方组24小时尿蛋白定量低于模型组，且低于比较例1-4组，均具有统计学差异，以申请方组疗效最佳。
实验第6周末，大鼠腹主动脉取血，检测血生化指标(结果见图2)。结果显示，各组大鼠的天门冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)以及血肌酐(Scr)相比，无统计学差异；与空白组相比，模型组白蛋白(ALB)显著降低(P<0.01)，经申请方治疗后，ALB有所上升(P<0.05)；与空白组相比，模型组胆固醇(CHO)、甘油三酯(TG)显著升高(分别为P<0.05，P<0.01)，治疗后，贝那普利组及申请方组TG均下降(P<0.05)。
采用HE、Masson染色，光镜下观察各组大鼠肾组织病理改变(结果见图3，图4)。空白组大鼠肾小球以及肾小管形态结构清晰；与空白组相比，模型组大鼠肾小球结构紊乱，体积增大，基底膜可见不同程度增厚，部分肾小管空泡样变性，嗜复红蛋白沉积；与模型组相比，各用药治疗组基底膜厚度减轻，以申请方组效果最显著。透射电镜观察肾组织超微结构病理改变(结果见图5)，与空白组相比，模型组大鼠肾小球基底膜增厚，足细胞的足突排列紊乱，足突部分融合或消失；与模型组相比，各用药治疗组大鼠足细胞足突的排列形态均有不同程度改善，基底膜增厚及足细胞融合有不同程度减轻，以申请方组效果最显著。
综上，虽然上述实验组的中药组合物在减少肾炎大鼠24小时尿蛋白定量，改善肾脏病理损伤方面均有一定效果，但申请方的疗效明显优于比较例1-4。可见对于申请方，改变其中的药味或药物用量均会影响药物的效果，申请方的效果最优。
最后应说明的是：以上实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解；其依然可以对前述实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或替换，并不使相应技术方案的本质脱离本发明实施例技术方案的精神和范围。
Claims (6)
1.一种治疗慢性肾炎气虚血瘀证的中药组合物，其特征在于，由以下重量份的原料药制得：生黄芪9-40重量份、赤芍6-12重量份、防风5-10重量份、穿山龙9-15g、麸炒芡实9-15重量份、金樱子肉6-12重量份、白花蛇舌草15-30重量份、桑枝9-15重量份、刺五加9-27重量份。
2.如权利要求1所述的中药组合物，其特征在于，由以下重量份的原料药制得：生黄芪30重量份、赤芍10重量份、防风10重量份、穿山龙15重量份、麸炒芡实15重量份、金樱子肉10重量份、白花蛇舌草20重量份、桑枝10重量份、刺五加10重量份。
3.如权利要求1或2所述的中药组合物，其特征在于，所述中药组合物是口服制剂。
4.如权利要求3所述的中药组合物，其特征在于，所述口服制剂为汤剂、片剂、胶囊剂或颗粒剂。
5.如权利要求1或2所述的中药组合物的制备方法，其特征在于包括如下步骤：将中药原料放入煎药容器中，加水煎煮2次，第一次加8倍量水煎煮30分钟，第二次加6倍量水煎煮20分钟，滤过，滤液浓缩至相对密度为1.10～1.15的清膏，加入适量辅料，制成口服剂型。
6.如权利要求4所述的中药组合物的制备方法，其特征在于包括如下步骤：将中药原料放入煎药容器中，加水煎煮2次，第一次加8倍量水煎煮30分钟，第二次加6倍量水煎煮20分钟，滤过，所得药汤，即汤剂。
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| CN105853678A (zh) * | 2016-04-21 | 2016-08-17 | 陕西中医药大学附属医院 | 一种治疗膜性肾病的中药组合物及其制备方法 |
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| CN105853678A (zh) * | 2016-04-21 | 2016-08-17 | 陕西中医药大学附属医院 | 一种治疗膜性肾病的中药组合物及其制备方法 |
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| 中药药对治疗糖尿病肾病临证撷菁;杨敏;《辽宁中医杂志》;20060418;第33卷(第4期);462-463 * |
| 张昱运用加味黄芪赤风汤治疗慢性肾炎经验;常美莹；等;《中医药导报 》;20200430;第26卷(第8期);第95页左栏第1-6段 * |
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