CN107823358A - 一种治疗肾结石的药物组合物及其制备方法 - Google Patents
一种治疗肾结石的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及中药技术领域，具体涉及一种治疗肾结石的药物组合物，包括如下重量份的中药材或其提取物：金钱草50～150份、瞿麦20～50份、扁蓄20～50份、木通5～20份、泽泻20～40份、车前草20～50份、海金沙40～80份、滑石粉30～60份和茯苓20～50份。本发明还提供了上述药物组合物的制备方法。本发明的药物组合物具有清热利湿、利尿通淋的功效，对肾结石有显著的疗效；本发明的药物组合物中各组分产生协同功能，有效缩短了治疗疗程，复发率低，毒副作用小。
Description
【技术领域】
本发明涉及中药技术领域，具体涉及一种治疗肾结石的药物组合物及其制备方法。
【背景技术】
肾结石是世界范围的常见多发病，也是影响人类健康的一种严重疾病，近年来由于生活水平提高，肾结石的发病率呈上升趋势。肾结石的临床表现为肾绞痛、血尿，引起尿路梗阻或尿路感染。肾结石是一种受多种外界因素影响的疾病，与地区水质、气温、海拔等地理因素有关；与患者的性别、遗传因素有关；日常饮食结构，生活习惯也是重要的影响因素。
肾结石的形成过程，为上述因素造成尿路中晶体物质浓度升高或溶解度降低，呈过饱和状态，析出晶体并在局部生长、聚集，最终形成结石，例如，草酸钙，在我国，以草酸钙为主要成分的结石治愈后的复发率高达60～80％，而且相当一部分患者病因不清，其形成机制尚未完全阐明。
现有技术中肾结石的治疗方法主要包括以下几种：体外震波碎石或非开放性手术取石，或上述几种方法联合使用，但是这些方法不仅治疗费用高，还容易复发；现有技术中也有采用中药治疗肾结石的方法，存在治疗时间长，疗效不理想的缺陷。
鉴于此，克服该现有技术所存在的缺陷是本技术领域亟待解决的问题。
【发明内容】
本发明的目的之一在于提供一种治疗肾结石的药物组合物，解决现有技术中肾结石治疗费用高、治疗效果不理想的技术问题。
本发明的另一个目的在于提供上述中药组合物的制备方法。
本发明的目的可通过以下的技术措施来实现：
一种治疗肾结石的药物组合物，包括如下重量份的中药材或其提取物：金钱草50～150份、瞿麦20～50份、扁蓄20～50份、木通5～20份、泽泻20～40份、车前草20～50份、海金沙40～80份、滑石粉30～60份和茯苓20～50份。
优选地，所述药物组合物包括如下重量份的中药材或其提取物：金钱草80～120份、瞿麦20～50份、扁蓄20～50份、木通5～20份、泽泻20～30份、车前草30～40份、海金沙50～70份、滑石粉40～50份和茯苓30～40份。
优选地，所述药物组合物包括如下重量份的中药材或其提取物：金钱草100份、瞿麦30份、扁蓄30份、木通10份、泽泻28份、车前草38份、海金沙60份、滑石粉46份和茯苓38份。
优选地，所述提取物为醇提取物、水提取物或挥发油。
优选地，所述药物组合物还包括药物上可接受的辅料，所述药物组合物和所述辅料一起被制备成片剂、胶囊剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂、或滴丸剂。
本发明还另外提供了一种治疗肾结石的药物组合物的制备方法，原料包括：金钱草50～150重量份、瞿麦20～50重量份、扁蓄20～50重量份、木通5～20重量份、泽泻20～40重量份、车前草20～50重量份、海金沙40～80重量份、滑石粉30～60重量份和茯苓20～50重量份；
所述制备方法包括如下步骤：
a、将金钱草、瞿麦、扁蓄、木通、泽泻、车前草、海金沙、滑石粉和茯苓进行炮制后粉碎成细粉，置于布袋内，加水浸泡20～40分钟，煎煮三次，第一次和第二次煎煮时间为1小时，第三次煎煮时间为0.5小时，合并煎液；
b、将煎液进行过滤，将过滤后所得滤液进行沉淀；
c、将沉淀后所得上清液浓缩至稠膏状；
d、将步骤c所得稠膏状物质加入适量辅料混匀，加水至10体积份；
所述重量份与体积份的关系为g/ml的关系。
优选地，所述步骤a中的加水量分别为步骤a所得细粉的10倍、8倍和8倍。
优选地，所述步骤d之后还包括如下步骤：将步骤d所得药液进行过滤。
与现有技术相比，本发明的有益效果在于，本发明的药物组合物具有清热利湿、利尿通淋的功效，对肾结石有显著的疗效；本发明的药物组合物中各组分产生协同功能，有效缩短了治疗疗程，复发率低，毒副作用小。
【具体实施方式】
为了使本发明的目的、技术方案及优点更加清楚明白，下面结合具体实施例对本发明作进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
因下阴不洁，秽浊之邪从下侵入机体，或由小肠邪热、心经火热等外感之热邪传入膀胱，发为淋证，若湿热久蕴，熬尿成石，遂致石淋。
当机体抵抗力下降或外感湿热，或下阴不洁，秽浊之邪从下侵入机体时则诱发结石发作，病人发作时，往往疼痛难忍，小便频，急，痛，排尿不畅，或排尿时突然中断，少腹拘急，尿中带血等一系列症状。
本发明针上述肾结石症状，提出一种药物组合物，包括如下重量份的中药材或其提取物组成：金钱草50～150份、瞿麦20～50份、扁蓄20～50份、木通5～20份、泽泻20～40份、车前草20～50份、海金沙40～80份、滑石粉30～60份和茯苓20～50份。
本发明实施例的药物组合物中金钱草为主药，具有清利湿热，通淋排石，消肿解毒，用于热淋、沙淋、尿涩作痛、黄疸尿赤、肝胆结石、尿路结石，配合瞿麦、扁蓄、滑石加强清热利尿，通淋止痛；配合小量的木通加强清热，共奏抑制感染的可能；配合茯苓，车前草淡渗利湿，共奏利水渗湿之功。配合海金沙、泽泻加强清利湿热，通淋止痛。诸药配合清热利湿通淋排石止痛。
在本实施例的一个较佳方案中，所述药物组合物包括如下重量份的中药材或其提取物：金钱草80～120份、瞿麦20～50份、扁蓄20～50份、木通5～20份、泽泻20～30份、车前草30～40份、海金沙50～70份、滑石粉40～50份和茯苓30～40份。
在本实施例的一个最优选方案中，所述药物组合物包括如下重量份的中药材或其提取物：金钱草100份、瞿麦30份、扁蓄30份、木通10份、泽泻28份、车前草38份、海金沙60份、滑石粉46份和茯苓38份。
上述中药材的提取物为醇提取物、水提取物或挥发油；上述药物组合物还可包括药物上可接受的辅料，所述药物组合物和所述辅料一起被制备成片剂、胶囊剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂、或滴丸剂。提取物的形式及剂型均为本领域技术人员所熟知。
本发明所述的药物组合物中各药物介绍如下：
金钱草：为报春花科多年生草本植物过路黄Lysimachia christinae Hance的全草。甘、咸、微寒。归肝、胆、肾、膀胱经。具有清利湿热，通淋排石，消肿解毒。用于热淋，沙淋，尿涩作痛，黄疸尿赤，痈肿疔疮，毒蛇咬伤；肝胆结石，尿路结石。用于热淋，尤善治疗石淋病症，可单味浓煎代茶饮服，或与海金沙、鸡内金等同用。现代研究主含黄酮类、甙类、挥发油、鞣质等。有利胆排石和利尿排石作用，并有一定的抑菌作用。
瞿麦：为石竹科多年生草本植物瞿麦Dianthus superbus L和石竹D.chinensisL的带花全草。苦、寒。归心、小肠经。功效利尿通淋，破血通经。用于湿热下注，小便短赤，淋沥涩痛。现代研究主含维生素A样物质、皂甙、糖类。瞿麦煎剂有利尿作用，对平滑肌有显著的兴奋作用。
扁蓄：为蓼科一年生草本植物扁蓄Polygonum aviculare L.的全草。苦、微寒，归膀胱经。具有利尿通淋、清热、杀虫止痒的功效。利水通淋用于湿热淋证，可治疗泌尿系感染、结石、血尿等。现代研究主含萹蓄甙、蒽醌类、鞣质、钾盐、蜡、槲皮甙等。实验证明有利尿、降压作用。
木通：为马兜铃科藤本植物东北马兜铃Aristolochia manshuriensis Kom.的藤茎。淡、苦、寒。归心、肺、小肠、膀胱经。功效清热利尿，通经下乳。用于膀胱湿热，小便短赤、淋沥涩痛，或心火上炎、口舌生疮。现代研究含马兜铃酸、鞣质和钙质、皂碱素、脂肪油等。
泽泻：为泽泻科多年生沼泽植物泽泻Alisma orientalis(Sam.)Juzep.块茎。甘、寒。归归服、膀胱经。功效：利小便，清湿热。用于水湿停滞，小便不利，水肿，现代研究主含三萜类化合物、挥发油、生物碱、天门冬素树脂等。泽泻有降血脂，抗脂肪肝的作用。亦报道有降血糖、利尿作用。
车前草：为车前科多年生草本植物车前Plantago asiatica L.或平车前P.depressa Willd.r全草。甘、微寒。归肝、肾、肺、小肠经。功效：利水通淋，清热明目，袪痰止咳。用于热结膀胱而致的小便不利，淋沥涩痛者，车前草尚能清热解毒、凉血。现代研究主含粘液质、琥珀酸、车前烯醇、腺嘌呤、胆碱、车前子碱、脂肪油、维生素A和B等。试验证明有袪痰、镇咳作用，有抗病原微生物的作用。
海金沙：为海金沙科多年生攀援蕨类植物海金沙Lygodium japonicum(Thunb.)Sw.的成熟孢子。甘、咸、寒。归膀胱、小肠经。功效清利湿热，通淋止痛。用于热淋、石淋、血淋等小便短赤、淋沥涩痛，可单用，或与其它药配用。现代研究含脂肪油。对金黄色葡萄球菌、绿脓杆菌、痢疾杆菌、伤寒杆菌有抑制作用。
滑石粉：为硅酸盐类矿物滑石族滑石。甘、淡、寒。归膀胱、肺、胃经。功效：利尿通淋，清热解暑，祛湿敛疮。用于膀胱湿热之热淋、小便短涩疼痛等。现代研究含硅酸镁、氧化铝、氧化镍等。
茯苓：为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的菌核。甘、淡、平。归心、肺、脾、肾经。功效：利水渗湿，健脾宁心。用于水湿停滞的水肿、小便不利等三。现代研究菌核主含β－茯苓聚糖、茯苓酸等。蛋白质、卵磷脂、尚含麦角固醇、胆碱、组氨酸及钾盐等。动物试验有利尿作用。茯苓煎剂对金黄色葡萄球菌、结核杆菌等有抑制作用。
本发明还提供了上述药物组合物的制备方法，其中，原料包括：金钱草50～150重量份、瞿麦20～50重量份、扁蓄20～50重量份、木通5～20重量份、泽泻20～40重量份、车前草20～50重量份、海金沙40～80重量份、滑石粉30～60重量份和茯苓20～50重量份；
所述制备方法包括如下步骤：
步骤1：将金钱草、瞿麦、扁蓄、木通、泽泻、车前草、海金沙、滑石粉和茯苓进行炮制后粉碎成细粉，置于布袋内，加水浸泡20～40分钟，煎煮三次，第一次和第二次煎煮时间为1小时，第三次煎煮时间为0.5小时，合并煎液；
步骤2：将煎液进行过滤，将过滤后所得滤液进行沉淀；
步骤3：将沉淀后所得上清液浓缩至稠膏状；
步骤4：将步骤3所得稠膏状物质加入适量辅料混匀，加水至10体积份；
上述步骤中重量份与体积份的关系为g/ml的关系。
在本实施例的一个优选方案中，步骤1中三次煎煮的加水量分别为步骤1所得细粉的10倍、8倍和8倍。
进一步地，步骤4之后还包括如下步骤：将步骤4所得药液进行过滤。
实施例1
本实施例提供了一种乙肝的药物组合物包括：金钱草10kg、瞿麦3kg、扁蓄3kg、木通1kg、泽泻2.8kg、车前草3.8kg、海金沙6kg、滑石粉4.6kg和茯苓3.8kg；
本实施例的药物组合物按照如下制备方法进行制备：
步骤S101：将金钱草、瞿麦、扁蓄、木通、泽泻、车前草、海金沙、滑石粉和茯苓进行炮制后粉碎成细粉，置于布袋内，加水浸泡20～40分钟，煎煮三次，第一次和第二次煎煮时间为1小时，第三次煎煮时间为0.5小时，合并煎液；
步骤S102：将煎液进行过滤，将过滤后所得滤液进行沉淀；
步骤S103：将沉淀后所得上清液浓缩至稠膏状，其中，所述稠膏状的相对密度为1.25～1.35；
步骤S104：将步骤S103所得稠膏状物质加入适量辅料混匀，加水至1000ml；
本实施例的药物组合物为深褐色液体；气微，味甜中带苦涩。
实施例2～实施例18
实施例2～实施例18提供的治疗肾结石的药物组合物中各组分的具体含量如表1所示，实施例2～实施例18的制备方法与实施例1相同。
表1所示为治疗肾结石的药物组合物中各组分的具体含量
应用例1
采用本发明实施例1-18的药物组合物治疗肾结石
病例选择
从本院选择102例肾结石患者，平均年龄40岁，平均病程36个月，采用本发明实施例1-18(根据病情的情况对中药的用量进行调整)的药物组合物。
诊断标准
本发明应用例1中所述的肾结石的诊断标准：
所有病例均有不同程度的腰痛，或典型的肾绞痛和血尿，经B超检查确诊。
治疗方法
按实施例1-18的配比和方法制成片剂，一日两次，一般每次80ml；60天为一疗程，共观察2-3个疗程。
治疗期间，禁食酒、海鲜等辛辣刺激食物。
治疗标准和结果
显效：2-3个疗程内自觉症状消失，尿常规正常，B超或X线摄片证实结石排出；
有效：2-3个疗程内自觉症状消失或减轻，尿常规RBC(0～+)，WBC(0～+)，B超或X线摄片证实结石部分排出或向下移动；
无效：经2-3个疗程的治疗，疼痛有所减轻，尿常规RBC(±～+++)，WBC(0～+)，B超或X线摄片证实结石位置、数量与治疗前对比无明显改变。
治疗结果
临床显效62例，有效27例，无效13例；
临床显效率为60.7％，总有效率为87.4％。
以上所述本发明的具体实施方式，并不构成对本发明保护范围的限定。任何根据本发明的技术构思所做出的各种其他相应的改变与变形，均应包含在本发明权利要求的保护范围内。
Claims (8)
1.一种治疗肾结石的药物组合物，其特征在于，包括如下重量份的中药材或其提取物：金钱草50～150份、瞿麦20～50份、扁蓄20～50份、木通5～20份、泽泻20～40份、车前草20～50份、海金沙40～80份、滑石粉30～60份和茯苓20～50份。
2.根据权利要求1所述的药物组合物，其特征在于，包括如下重量份的中药材或其提取物：金钱草80～120份、瞿麦20～50份、扁蓄20～50份、木通5～20份、泽泻20～30份、车前草30～40份、海金沙50～70份、滑石粉40～50份和茯苓30～40份。
3.根据权利要求2所述的药物组合物，其特征在于，包括如下重量份的中药材或其提取物：金钱草100份、瞿麦30份、扁蓄30份、木通10份、泽泻28份、车前草38份、海金沙60份、滑石粉46份和茯苓38份。
4.根据权利要求1至3任一项所述的药物组合物，其特征在于，所述提取物为醇提取物、水提取物或挥发油。
5.根据权利要求1至3任一项所述的药物组合物，其特征在于，所述药物组合物还包括药物上可接受的辅料，所述药物组合物和所述辅料一起被制备成片剂、胶囊剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂、或滴丸剂。
6.一种治疗肾结石的药物组合物的制备方法，其特征在于，原料包括：金钱草50～150重量份、瞿麦20～50重量份、扁蓄20～50重量份、木通5～20重量份、泽泻20～40重量份、车前草20～50重量份、海金沙40～80重量份、滑石粉30～60重量份和茯苓20～50重量份；
所述制备方法包括如下步骤：
a、将金钱草、瞿麦、扁蓄、木通、泽泻、车前草、海金沙、滑石粉和茯苓进行炮制后粉碎成细粉，置于布袋内，加水浸泡20～40分钟，煎煮三次，第一次和第二次煎煮时间为1小时，第三次煎煮时间为0.5小时，合并煎液；
b、将煎液进行过滤，将过滤后所得滤液进行沉淀；
c、将沉淀后所得上清液浓缩至稠膏状；
d、将步骤c所得稠膏状物质加入适量辅料混匀，加水至10体积份；
所述重量份与体积份的关系为g/ml的关系。
7.根据权利要求6所述的制备方法，其特征在于，所述步骤a中的加水量分别为步骤a所得细粉的10倍、8倍和8倍。
8.根据权利要求6所述的制备方法，其特征在于，所述步骤d之后还包括如下步骤：将步骤d所得药液进行过滤。
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