CN104258175A - 一种用于治疗肾结石的中药及其制备方法 - Google Patents
一种用于治疗肾结石的中药及其制备方法 Download PDFInfo
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- CN104258175A CN104258175A CN201410599845.7A CN201410599845A CN104258175A CN 104258175 A CN104258175 A CN 104258175A CN 201410599845 A CN201410599845 A CN 201410599845A CN 104258175 A CN104258175 A CN 104258175A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种用于治疗肾结石的中药，属于医药技术领域，所述中药是由以下原料制成：金钱草、海金沙、肉桂、石韦、玉米须、冬葵子、续断、滑石粉、鸡内金、甘草、羌活、薤白、白芷、黄连、石柑子、牡丹皮、鬼针草、苏梗。本发明的药物配伍组合具有清热利湿、行气化瘀、排石止痛的功效，能改变人体的内环境，排出血液内产生结石的有毒物质，溶化结石，随尿液排出体外，有效防止结石感染，保护肝肾功能，有效防止结石的复发。
Description
技术领域
本发明涉及医药技术领域，尤其涉及一种用于治疗肾结石的中药及其制备方法。
背景技术
结石症是一种常见病，它除因受水质等自然因素影响外，主要受患者身体机能和功能下降及高脂肪凝结物等因素导致。随着人们生活水平日益提高和高脂肪食品量的不断增加，结石症患者逐渐增多，该病症病区广，病程长，给患者带来了极大的痛苦。
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，由于人民生活水平提高，其发病率也明显提高。肾结石的临床表现主要为肾绞痛、血尿，可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、海拔等地理环境有关；与患者的性别、遗传因素有关；而日常饮食结构、生活习惯也被认为是可能的重要因素。
祖国传统医学理论认为，尿路结石属于中医“砂石淋”、“尿血”、“腰痛”、“虚损”及“关格”等病的范畴。有关石淋的病因病机，早在唐代以前，祖国医学在《内经》理论的指导下，就有较完整的认识。尤其应该指出的是汉·华佗《中藏经》记载：“砂淋者，此由肾气虚...... 虚伤真气，邪热渐强，结聚而成砂，又如以水煮盐，火大水少，盐渐成石之类，盖肾者，水也，成归于肾，咸积于肾，水留于下，虚热日甚，煎结而生，又非一时之作也”。隋·巢元方《诸病源候论》载：“肾主水，水结则化为石，故肾客砂石，皮肤虚为热所乘，热则 成淋”。认为砂淋是由肾虚邪热煎水而成，非一时之作。且“碱积于肾”、“肾客砂石”指出了结石部位在肾。元·朱震亨《丹溪心法》认为“诸淋所发，皆肾虚膀胱生热也”。清·李中梓《医宗必读》认为“石淋者，有如砂石，膀胱蓄热而成。正如汤瓶久在水中，底结白碱也”。总之历代医家对“砂淋”、“石淋”的发病认为主要是由于肾虚和下焦热引起，病位在肾或在膀胱或在溺窍，而虚为内在因素。肾与膀胱相表里，膀胱气化的动力来自肾脏，肾虚则导致膀胱气化不利，泌尿功能失常，有利于结石的形成。复因湿热蓄积下焦，湿热可由感受外邪而来，也可由多食肥甘引起，使尿液受其煎熬，尿中杂质则结成砂石。小者成砂为“砂淋”，大者成石为“石淋”，热伤血络，迫血妄行则血下溢，出现尿血而为“血淋”。
目前的治疗方法有西医疗法和中医疗法，西医主要是通过手术或用激光碎石的方法来治疗，对病人来说，不到万不得已大都不愿意做手术，有些病人的身体不宜做手术，时常因病情复发而造成疼痛，只能靠服药来止痛和消炎；激光碎石有一定的危险性，一旦治疗失败，后果不堪设想，很多病人都不愿意接受这种疗法。目前，越来越多的病人愿意采用我国传统的中医疗法，即通过服用中药来化石、排石，以达到治疗的目的。
中医对于上尿路结石的治疗主要是根据临床证候进行辨证论治，其大法以通淋排石为主，结合舌脉、症状佐以清热、理气、活血、滋阴、益气及温肾等法，从而对尿石症进行标本兼治。因此，中医药排石以其独特的优势，治疗上尿路结石可以提高自然排石率，减少手术率，改善肾积水、肾功能，且部分中药可溶解草酸盐结石并能预防草酸盐结石的复发。
发明内容
本发明提供了一种用于治疗肾结石的中药及其制备方法。
本发明采取的技术方案是：
本发明用于治疗肾结石的中药是由以下重量份的原料制成：金钱草120-260份、海金沙110-230份、肉桂130-210份、石韦100-200份、玉米须100-220份、冬葵子90-180份、续断80-190份、滑石粉80-170份、鸡内金70-160份、甘草100-180份、羌活50-150份、薤白60-120份、白芷80-150份、黄连70-130份、石柑子40-100份、牡丹皮50-90份、鬼针草30-80份、苏梗20-50份。
优选的本发明中药是由以下重量份的原料制成：金钱草180份、海金沙190份、肉桂170份、石韦150份、玉米须160份、冬葵子130份、续断140份、滑石粉120份、鸡内金110份、甘草120份、羌活100份、薤白90份、白芷110份、黄连100份、石柑子60份、牡丹皮70份、鬼针草60份、苏梗40份。
本发明用于治疗肾结石的中药的剂型是汤剂、颗粒剂、丸剂、片剂、粉针剂或注射剂中的一种。
本发明用于治疗肾结石的中药的制备方法具体步骤如下：
（1）首先按配比称取中药材原料，然后分别放入中药粉碎机中进行粉碎，粉碎后过80-200目筛，再进行混合得到药物细粉备用；
（2）然后将步骤（1）制备的药物细粉加入煎煮锅中，加水煎煮，加水量为药材重量的5-12倍，煎煮时间为2-5h，煎煮完成后过滤；
（3）过滤完毕，对滤液进行加热浓缩，浓缩成60℃下相对密度为1.10-1.15的清膏，然后加入无水乙醇，无水乙醇加入量为清膏体积的1-3倍，然后搅拌均匀后，静置24h，取上清液并回收乙醇，并浓缩至60℃下相对密度为1.05-1.10；
（4）按常规工艺，加入辅料，喷雾干燥得细粉，制粒，干燥，包装。
步骤（1）中，优选粉碎后过100目筛。
步骤（2）中，优选加水量为药材重量的8倍，煎煮时间为4h。
步骤（3）中，优选对滤液进行加热浓缩，浓缩成60℃下相对密度为1.12的清膏。
步骤（3）中，优选无水乙醇加入量为清膏体积的2倍。
步骤（3）中，优选取上清液并回收乙醇，并浓缩至60℃下相对密度为1.08。
本发明在中医辩证的基础上，根据中医君臣佐使的组方原则，选取金钱草、海金沙、肉桂、石韦、玉米须作为君药；金钱草具有清热利尿、祛风止痛、止血生肌、消炎解毒的功效；海金沙具有清热解毒，利水通淋的功效；肉桂具有补元阳，暖脾胃，除积冷，通血脉的功效；石韦具有利水通淋，清肺泄热的功效；玉米须具有利尿消肿、止血、利胆的功效。
选取冬葵子、续断、滑石粉、鸡内金、甘草为臣药；冬葵子具有清热利湿、消肿的功效；续断具有补肝肾，续筋骨，调血脉的功效；滑石粉具有清热，渗湿，利窍的功效；鸡内金具有化坚消石的功效；甘草具有清热解毒的功效。
选取羌活、薤白、白芷、黄连为佐药；羌活具有散风寒湿，止痛的功效；薤白具有通阳散结，行气导滞的功效；白芷具有祛病除湿、排脓生肌、活血止痛的功效；黄连具有清热燥湿，泻火解毒的功效。
选取石柑子、牡丹皮、鬼针草、苏梗为使药；石柑子具有祛风除湿，活血散瘀的功效；牡丹皮具有清热凉血；活血散瘀的功效；鬼针草具有清热解毒、散瘀活血的功效；苏梗具有 理气宽中，止痛的功效。
本发明的药物配伍组合具有清热利湿、行气化瘀、排石止痛的功效，能改变人体的内环境，排出血液内产生结石的有毒物质，溶化结石，随尿液排出体外，有效防止结石感染，保护肝肾功能，有效防止结石的复发。
具体实施方式
下面的实施例是对本发明的进一步详细描述。
实施例1
1.1原料组成(g)：
金钱草120、海金沙230、肉桂130、石韦200、玉米须100、冬葵子180、续断80、滑石粉170、鸡内金70、甘草180、羌活50、薤白120、白芷80、黄连130、石柑子40、牡丹皮90、鬼针草30、苏梗50。
1.2制备方法：
（1）首先按配比称取中药材原料，然后分别放入中药粉碎机中进行粉碎，粉碎后过80目筛，再进行混合得到药物细粉备用；
（2）然后将步骤（1）制备的药物细粉加入煎煮锅中，加水煎煮，加水量为药材重量的5倍，煎煮时间为2h，煎煮完成后过滤；
（3）过滤完毕，对滤液进行加热浓缩，浓缩成60℃下相对密度为1.10的清膏，然后加入无水乙醇，无水乙醇加入量为清膏体积的1倍，然后搅拌均匀后，静置24h，取上清液并回收乙醇，并浓缩至60℃下相对密度为1.05；
（4）按常规工艺，加入辅料，喷雾干燥得细粉，制粒，干燥，包装，每袋10g含生药3g。
实施例2
2.1原料组成(g)：
金钱草260、海金沙110、肉桂210、石韦100、玉米须220、冬葵子90、续断190、滑石粉80、鸡内金160、甘草100、羌活150、薤白60、白芷150、黄连70、石柑子100、牡丹皮50、鬼针草80、苏梗20。
2.2制备方法：
（1）首先按配比称取中药材原料，然后分别放入中药粉碎机中进行粉碎，粉碎后过200目筛，再进行混合得到药物细粉备用；
（2）然后将步骤（1）制备的药物细粉加入煎煮锅中，加水煎煮，加水量为药材重量的12倍，煎煮时间为5h，煎煮完成后过滤；
（3）过滤完毕，对滤液进行加热浓缩，浓缩成60℃下相对密度为1.15的清膏，然后加入无水乙醇，无水乙醇加入量为清膏体积的3倍，然后搅拌均匀后，静置24h，取上清液并回收乙醇，并浓缩至60℃下相对密度为1.10；
（4）按常规工艺，加入辅料，喷雾干燥得细粉，制粒，干燥，包装，每袋10g含生药3g。
实施例3
3.1原料组成(g)：
金钱草180、海金沙190、肉桂170、石韦150、玉米须160、冬葵子130、续断140、滑石粉120、鸡内金110、甘草120、羌活100、薤白90、白芷110、黄连100、石柑子60、牡丹皮70、鬼针草60、苏梗40。
3.2制备方法：
（1）首先按配比称取中药材原料，然后分别放入中药粉碎机中进行粉碎，粉碎后过100目筛，再进行混合得到药物细粉备用；
（2）然后将步骤（1）制备的药物细粉加入煎煮锅中，加水煎煮，加水量为药材重量的8倍，煎煮时间为4h，煎煮完成后过滤；
（3）过滤完毕，对滤液进行加热浓缩，浓缩成60℃下相对密度为1.12的清膏，然后加入无水乙醇，无水乙醇加入量为清膏体积的2倍，然后搅拌均匀后，静置24h，取上清液并回收乙醇，并浓缩至60℃下相对密度为1.08；
（4）按常规工艺，加入辅料，喷雾干燥得细粉，制粒，干燥，包装，每袋10g含生药3g。
药效学研究
1实验动物
ICR小鼠，雌雄兼用，体重22-29g，由中国医学科学研究院动物中心繁育场提供。
2实验药品
本发明实施例3制备的颗粒剂。
3实验方法
按常规方法建立小鼠的肾结石模型，然后按照生药量10g/Kg、20/Kg、30g/Kg给药。
结果表明：小鼠肾组织中草酸和钙含量以及草酸钙结晶的面积明显减少，说明本发明的药物对草酸钙有较强的溶解能力，并且对肾结石中的钙盐具有明显的助溶作用。本发明的药物对水负荷大鼠具有明显的利尿作用，并明显增加大鼠尿液草酸钙的溶解度，而且还具有一定的抗炎和镇痛作用。
长期毒性试验研究
1实验动物
SD大鼠，雌雄兼用，体重98-132g，由中国医学科学研究院动物中心繁育场提供。
2实验药品
本发明实施例3制备的颗粒剂。
3实验方法
将120只SD大鼠随即分成四组，每组30只，雌雄各半，其中三组使用本发明实施例3制备的药物连续灌胃给药26周，剂量分别为每天80、40和20g/Kg（含生药24、12、6g/ Kg），另外一组为对照组。
4实验结果
给药12周时，药物对大鼠血常规指标与对照物无明显差异。
给药15周时，给药组与对照物的大鼠血清主要生化指标无明显差异。
给药26周时，给药组和对照组大鼠的主要脏器重量无明显差异。
给药过程中，大鼠的主要脏器、包括心、肝、肾、脾、大脑、胃、胸腺、肾上腺、睾丸、附睾、前列腺、精囊腺、子宫和卵巢均无明显差异，说明药物对大鼠重要脏器的形态结构无明显不良影响。
上述结果表明，本发明的药物在本实验条件和剂量下对大鼠无明显的毒性反应。
临床疗效
1入选病例诊断标准
有不同程度的腰痛或典型的肾绞痛和血尿，经B超检查确诊的肾结石患者。
2一般资料
选取478例经确诊的肾结石患者，其中男性310例，女性168例，排除妊娠、肾功能不全的患者。
3治疗方法
服用本发明实施例3制备的颗粒剂，每次1袋，一天三次，三个月一个疗程，观察3年为远期疗效。
治疗期间，增加饮水量，每日尿量保持2000ml左右，以利于小结石排出；适当增加运动量，进行慢跑、下蹲、跳跃等活动，以利于结石排出。
4 临床疗效评价标准
疗效判断参照《中医病证诊断疗效标准》中石淋的疗效判断标准：
显效：经治疗后患者腰腹部隐痛等自觉症状完全消失，尿检恢复正常，复查泌尿系B 超未见结石、积水。
有效：患者尿检正常，复查泌尿系B 超显示肾结石已经通过第1 狭窄，并且降入到了输尿管上段，或者原多发性结石已有部分结石排出。
无效：患者尿检正常，但患者自觉症状及泌尿系B 超复查均无改善，肾结石位置无移动，肾积水无好转甚至加重。
5治疗结果
经过1个疗程的治疗后，治疗结果如表1所示。
表1
总有效率=（显效+有效）/总例数X100%
上述治疗有效的患者在远期疗效观察期间没有出现复发病例。
尽管已经示出和描述了本发明的实施例，对于本领域的普通技术人员而言，可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由所附权利要求及其等同物限定。
Claims (9)
1.一种用于治疗肾结石的中药，其特征在于由以下重量份的原料制成：金钱草120-260份、海金沙110-230份、肉桂130-210份、石韦100-200份、玉米须100-220份、冬葵子90-180份、续断80-190份、滑石粉80-170份、鸡内金70-160份、甘草100-180份、羌活50-150份、薤白60-120份、白芷80-150份、黄连70-130份、石柑子40-100份、牡丹皮50-90份、鬼针草30-80份、苏梗20-50份。
2.如权利要求1所述用于治疗肾结石的中药，其特征在于由以下重量份的原料制成：金钱草180份、海金沙190份、肉桂170份、石韦150份、玉米须160份、冬葵子130份、续断140份、滑石粉120份、鸡内金110份、甘草120份、羌活100份、薤白90份、白芷110份、黄连100份、石柑子60份、牡丹皮70份、鬼针草60份、苏梗40份。
3.如权利要求1或2所述用于治疗肾结石的中药，其特征在于：所述中药为汤剂、颗粒剂、丸剂、片剂、粉针剂或注射剂。
4.一种制备如权利要求1或2所述用于治疗肾结石的中药的方法，其特征在于包括如下工艺步骤：
（1）首先按配比称取中药材原料，然后分别放入中药粉碎机中进行粉碎，粉碎后过80-200目筛，再进行混合得到药物细粉备用；
（2）然后将步骤（1）制备的药物细粉加入煎煮锅中，加水煎煮，加水量为药材重量的5-12倍，煎煮时间为2-5h，煎煮完成后过滤；
（3）过滤完毕，对滤液进行加热浓缩，浓缩成60℃下相对密度为1.10-1.15的清膏，然后加入无水乙醇，无水乙醇加入量为清膏体积的1-3倍，然后搅拌均匀后，静置24h，取上清液并回收乙醇，并浓缩至60℃下相对密度为1.05-1.10；
（4）按常规工艺，加入辅料，喷雾干燥得细粉，制粒，干燥，包装即可。
5.如权利要求4所述制备用于治疗肾结石的中药的方法，其特征在于：步骤（1）中，粉碎后过100目筛。
6.如权利要求4所述制备用于治疗肾结石的中药的方法，其特征在于：步骤（2）中，加水量为药材重量的8倍，煎煮时间为4h。
7.如权利要求4所述制备用于治疗肾结石的中药的方法，其特征在于：步骤（3）中，对滤液进行加热浓缩，浓缩成60℃下相对密度为1.12的清膏。
8.如权利要求4所述制备用于治疗肾结石的中药的方法，其特征在于：步骤（3）中，无水乙醇加入量为清膏体积的2倍。
9.如权利要求4所述制备用于治疗肾结石的中药的方法，其特征在于：步骤（3）中，取上清液并回收乙醇，并浓缩至60℃下相对密度为1.08。
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| CN106729301A (zh) * | 2016-11-30 | 2017-05-31 | 四川旭华制药有限公司 | 一种溶化结石的中药配方 |
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| CN103263460A (zh) * | 2013-04-27 | 2013-08-28 | 潘首德 | 一种制备复方石淋通片的新方法 |
| CN103830316A (zh) * | 2012-11-21 | 2014-06-04 | 青岛康地恩动物药业有限公司 | 一种用于治疗宠物肾结石的中药 |
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