CN103830577A - 一种治疗肝胆结石和肾结石的药物组合物及其用途 - Google Patents
一种治疗肝胆结石和肾结石的药物组合物及其用途 Download PDFInfo
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- CN103830577A CN103830577A CN201410113464.3A CN201410113464A CN103830577A CN 103830577 A CN103830577 A CN 103830577A CN 201410113464 A CN201410113464 A CN 201410113464A CN 103830577 A CN103830577 A CN 103830577A
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Abstract
本发明属于医药技术领域，涉及一种治疗肝胆结石或肾结石的药物组合物。为了弥补现有技术的不足，减轻肝胆结石患者的痛苦，本发明提供了一种治疗肝胆结石或肾结石的药物组合物，该治疗药物具有显著的镇痛活性和溶石排石作用，其疗效显著、安全可靠，具有广阔的临床应用前景。
Description
技术领域
本发明属于医药技术领域，涉及一种治疗肝胆结石肾结石的药物组合物及其医药用途。
背景技术
胆石病是胆道系统的常见病，占外科急腹症的20％-30％。近年来，随着人民生活水平的提高以及检查方法的日益完善，特别是B 型超声、CT 等在临床上应用以来，对胆道疾病的诊断和治疗手段，均提供了准确而行之有效的治疗方案。流行病学调查表明，饮食成分对结石的形成和变化占有十分重要的位置。我国胆石病30 年代末至60 年代初的报告系以胆色素结石为主，尤其在农村地区。但是近几年全国胆石标本分析提示我国胆石类型发生了很大的变化，胆固醇结石的比例超过了胆色素结石，这与我国人民饮食结构的变化有关。同时，在动物实验中也证明控制饮食中的脂肪含量或脂肪酸与蛋白质的相对比例，可对结石的数量和成分产生影响。对胆石病的认识，过去一个世纪以来都集中在肝外胆道局部所发生的各种变化，认为肝外胆道是产生结石的场所。然而有了“致石性病理胆汁”这一概念以后，尤其是发现肝外胆道病变经外科处理后仍存在病理胆汁和结石的再发时，人们对胆石病的认识逐渐转向肝内，认为系肝脏通过酶的作用或代谢缺陷而产生致石性病理胆汁，从而形成结石。
近年来不少临床数据表明胆石病是一种与肝脏有关的疾病，胆石病病人都有一定程度的肝脏病损。这些研究结果，与中医治疗胆石病肝胆同治、肝脾同治理论有着异曲同工之妙。祖国医学认为胆附于肝，肝胆互为表里，胆为中精之腑，内藏精汁，胆汁来源于肝之余气。肝司疏泄功能，疏利胆汁，凡影响肝之疏泄、胆气通降功能的因素均可导致胆汁瘀积，煎熬日久，胆汁沉积而形成砂石。肝主疏泄，脾主运化，脾的运化功能必须在肝的疏泄作用协调下得以实现。上工不治已病治未病，见肝之病，知肝传脾，当先实脾。所以，在胆石病的治疗中，应灵活运用肝胆同治、肝脾同治理论，使治疗效果更趋完美。
肝、胆结石属于中医“肋瘤”“腹痛”“胃痛”等病之范畴。病因病机多为肝气郁结、肝失调达，胆附于肝，胆失疏泄、气滞血瘀、湿热阻滞、蕴结石化、煎熬成结石，停滞胆道，肝胆气机不化，故而为患。胆囊炎属中医“胆胀”范畴。主要证候有右胁疼痛、口苦、善太息，同时伴恶心、嗳气、腹胀等，易反复发作，其病变部位在胆，但与肝有密切关系。肝与胆互为表里，“胆为中清之腑，藏胆汁而以转疏通降为顺”，胆汁是“借肝之余气，隅入于胆，积聚而成”，其功能依赖肝之疏泄，又促进脾胃运化。情志不遂、过食油腻、饥饱失常等均可影响肝胆疏泄和脾胃运化，肝胆气滞则胆汁排泄不畅，脾失健运则湿热内蕴，气滞腑闭致胆腑气机通降失常遂成胆囊炎。现代医学对胆囊炎的治疗尚缺乏特效药物和理想手段。大量的临床和实验研究表明，中医药治疗胆囊炎具有较大优势，治胆多以疏肝为达，理脾为和。中医传统理论认为肝失疏泄，胆失通降，胆汁郁积可致结石生成；而湿热、气滞、血瘀又是肝胆结石症的三个主要特征，治疗重在体现“通、降”二字，以疏肝利胆、清热化瘀、利气行滞、攻下排石为原则。
目前，肝、胆结石的发病率正在逐渐上升，国内外对胆石病的治疗多采用手术疗法，但手术后残余结石的去除较为困难。现有中西成药中用于治疗肝、胆结石病及其并发症的药物有：胆康、金胆片、鸡骨草片、消炎利胆片等，多是作用于胆囊体及胆道的炎症改变。经临床观察，这类药物的治疗效果较差，治愈率低，只能缓解症状而不能治愈。
发明内容
为了弥补现有技术的不足，减轻肝胆结石患者的痛苦，本发明提供了一种治疗肝胆结石的药物组合物其疗效显著、安全可靠，具有广阔的临床应用前景。
本发明的技术方案为：一种治疗肝胆结石的药物组合物，该药物组合物由下列重量份的原料制成：栀子10-12、黄芩5-8、牛蒡子6-9、半夏3-5、川芎10-12、淫羊藿3-5、三七3-5、玄参10-12、黄芪8-10、当归6-9、酸枣仁10-12、白芷10-12、延胡索10-12、大蓟12-15、山慈菇9-12。
上述所述的药物组合物中，还可以含有熊去氧胆酸5-8份和白术12-15份。该两中中药可以进一步增强本发明上述药物组合物的镇痛效果和溶石排石效果。
本发明还请求保护上述药物组合物在制备治疗肝胆结石药物中的用途。本发明实施例7显示，小鼠舔足反应潜伏期时间显示，与模型组比较，给药后1h和2h后，本发明药物组合物各个给药组的小鼠添足反应的潜伏期均大于模型组，存在剂量依赖关系，并且高剂量组的潜伏期显著大于模型组（P＜0.05）。说明该本发明药物组合物能够延长小鼠对热板刺激的添足反应潜伏期，有一定的镇痛作用。同样实验条件下，氢化可的松组（P＜0.05）也延长了小鼠添足反应的潜伏期，具有一定的镇痛作用，但其镇痛效果与模型组无显著性差异。本发明实施例8显示，本发明药物组合物各治疗组和阳性对照组具有显著降低胆汁中Ca、TBIL、DBIL水平的作用和升高BA水平的作用。其中阳性对照组的调节作用与本发明组合物低组接近。本发明组合物中组和高组与阳性对照组相比在降低胆汁中Ca、TBIL、DBIL水平和升高BA水平方面具有显著性的差异。基于此，本发明药物组合物对于肾结石也具有一定的治疗效果。
为了更好地表达本发明的药物组合物，本发明的药物组合物可以制备成临床上常用的剂型。比如，粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、口服液、糖浆、片剂、胶囊剂等制剂，所述药物制剂均可按照本领域技术人员所熟知的中药制剂制备方法制备得到。优选地，本发明药物组合物按照常规制备工艺制备成散剂、水剂、片剂或胶囊剂。
本发明还提供了一种上述所述药物组合物的制备方法，其主要包含下述步骤：取处方量上述中药材碎成粗粉，按照粗粉总重量的4-9倍加入体积浓度为40%-95%的乙醇溶液，回流提取三次，回流时间为2-5h，滤过，滤液回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；本领域技术人员可在该制备方法技术上制备得到临床上常用中药药物剂型，如片剂、胶囊剂等。
本发明是发明人经过反复研究，逐步改进，最后成功的一种疗效较好的治疗肝胆结石的药物，为表明本发明药物对肝胆结石的治疗效果，本发明对180 例服用本药物的肝胆结石患者进行了临床观察，并选择具有可比性的肝胆结石患者179 例作为对照组。治疗组患者每天服用本发明药物两次，早晚各一次，一次服用5 克药物，对照组患者服用常规治疗肝胆结石的口服药物。治疗一个月后，治疗结果见表1。
表1 治疗组和对照组治疗结果对照表
治疗组相比对照组具有更高的治愈率和有效率，由此认为，本发明药物治疗肝胆结石具有较好的效果，并且经过一个月的治疗观察，服用本发明药物没有出现任何毒副作用。
本发明药物组合物在治疗癌症引发的便秘方面，与现有技术相比具有如下优势：
1) 与当前治疗的化学治疗药物相比，本发明药物组合物为天然纯中药制剂，不良反应和副作用显著降低，且本发明药物组合物作用全面，治疗效果更佳，并提高了患者的生活质量。
2) 本发明药物组合物中含有多种药物组分，作用靶点众多，药理实验显示其与现有的胆结石治疗药物在溶石方面具有显著的协同作用，并且可以大幅度减少药物治疗引发的便秘症状，提高病人对于化疗的接受度和用药依从性。
具体实施方式
以下通过具体实施例进一步描述本发明，但本领域技术人员应该知晓，所述实施例并不以任何方式限制本发明。
一)制剂实施例部分
实施例1 本发明药物组合物及制备工艺
中药组分的重量份：栀子10、黄芩5、牛蒡子6、半夏3、川芎10、淫羊藿3、三七3、玄参10、黄芪8、当归6、酸枣仁10、白芷10、延胡索10、大蓟12、山慈菇9。
取处方量上述中药材碎成粗粉，按照粗粉总重量的4-9倍加入体积浓度为40%-95%的乙醇溶液，回流提取三次，回流时间为2-5h，滤过，滤液回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；本领域技术人员可在该制备方法技术上制备得到临床上常用中药药物剂型，如片剂、胶囊剂等。
实施例2 本发明药物组合物及制备工艺
中药组分的重量份：栀子12、黄芩8、牛蒡子9、半夏5、川芎12、淫羊藿5、三七5、玄参12、黄芪10、当归9、酸枣仁12、白芷12、延胡索12、大蓟15、山慈菇12。
制备方法同实施例1。
实施例3 本发明药物组合物及制备工艺
中药组分的重量份：栀子11、黄芩7、牛蒡子7、半夏4、川芎11、淫羊藿4、三七4、玄参11、黄芪9、当归8、酸枣仁11、白芷11、延胡索11、大蓟13、山慈菇10。
制备方法同实施例1。
实施例4 本发明药物组合物及制备工艺
中药组分的重量份：栀子10、黄芩5、牛蒡子6、半夏3、川芎10、淫羊藿3、三七3、玄参10、黄芪8、当归6、酸枣仁10、白芷10、延胡索10、大蓟12、山慈菇9、熊去氧胆酸5、白术13份。
制备方法同实施例1。
实施例5 本发明药物组合物及制备工艺
中药组分的重量份：栀子12、黄芩8、牛蒡子9、半夏5、川芎12、淫羊藿5、三七5、玄参12、黄芪10、当归9、酸枣仁12、白芷12、延胡索12、大蓟15、山慈菇12、熊去氧胆酸8份、白术12。
制备方法同实施例1。
实施例6 本发明药物组合物及制备工艺
中药组分的重量份：栀子11、黄芩7、牛蒡子7、半夏4、川芎11、淫羊藿4、三七4、玄参11、黄芪9、当归8、酸枣仁11、白芷11、延胡索11、大蓟13、山慈菇10、熊去氧胆酸6份、白术15。
制备方法同实施例1。
（二）药效实施例部分
实施例 7 本发明药物组合物对小鼠热板镇痛的影响
1 小鼠热板疼痛模型制作
将体重20g左右雌性小鼠放在热板测痛仪上，筛选合格♀性小鼠90只(舔后足时间＜5s或＞30s弃置，为防止足部烫伤，也应设截止时间，一般为60s) ，以小鼠添后足反应的潜伏期为痛阈指标，取60只雌性动物，分为5组，12只/组，即模型组、氢化可的松组、本发明药物组合物（按实施例1所述药物组合物处方和制备工艺制得）低剂量组、中剂量组和高剂量组。各组均为灌胃给药，1次/天，给药剂量如表10所示，连续给药14d后，测定末次药后60 min、120 min发生添足反应的时间。
2 本发明药物组合物对小鼠热板镇痛实验中舔足反应潜伏期的影响
小鼠舔足反应潜伏期时间显示，与模型组比较，给药后1h和2h后，本发明药物组合物各个给药组的小鼠添足反应的潜伏期均大于模型组，存在剂量依赖关系，并且高剂量组的潜伏期显著大于模型组（P＜0.05）。说明该本发明药物组合物能够延长小鼠对热板刺激的添足反应潜伏期，有一定的镇痛作用。同样实验条件下，阳性对照氢化可的松组（P＜0.05）也延长了小鼠添足反应的潜伏期，具有一定的镇痛作用，但其镇痛效果与模型组无显著性差异。结果见表2。
表2小鼠舔足反应潜伏期时间表（
）
注：与模型组比较，*P＜0.05，** P＜0.01。
实施例 8 本发明对豚鼠胆固醇结石模型的溶石、排石、防石作用
1 材料和方法
1.1 实验动物：溶石、防石实验选用健康豚鼠，雄性，体重200-300g，共100 只，购自辽宁中医药大学实验动物繁育中心，采用笼养方式。
1.2 造模方法：采用食饵诱发法，正常饲料由辽宁中医药大学实验动物饲养中心提供，成石饲料自配，配方为玉米粉15％，黄豆粉10％，面粉10％，鱼粉3％，麸皮10％，食盐1％，酵母粉1％，苜蓿粉40％，酪蛋白2％，猪油2％，蔗糖5％，胆固醇1％。正常组投以普通饲料11 周，模型组和本发明治疗组先投以成石饲料7 周，后投以普通饲料4 周。本发明预防组投以成石饲料7 周。每笼每日投250g，自由饮水( 自来水)，并喂适量胡萝卜。
1.3 实验药物：按实施例1制备的本发明药物组合物制剂。治疗组先投成石饲料7 周，后投普通饲料4 周并灌胃给药；药物均用蒸馏水稀释，分别灌胃给予本发明中药，组合物高组、中组以及低组分别含本发明药物组合物2g、1g、0.5g，阳性对照组每只灌胃鹅脱氧胆酸25mg，正常组和模型组灌胃以相同体积蒸馏水，每日上午8 时一次性给药。
1.4 标本采集方法动物禁食(不禁水)24h，从眼眶处注射空气致死，迅速剖开胸腹，露出心脏，用注射器取心脏血约3ml，然后露出胆囊，用血管钳阻断胆囊管，取下胆囊，先肉眼观察成石情况，并用注射器吸出全部胆汁。胆汁及血液在常温下放置40min，而后2000r/pm 离心10min，取胆汁上清液及血清，放置于-20℃冰箱中保存待测。
1.5 测定指标方法：各种指标测试均采用临床检验试剂盒，于北京市化学试剂公司购买。其中总胆固醇和胆汁酸为酶比色法；总胆红素和直接胆红素为化学比色法；钙离子为乙二胺四乙酸钠法。
1.6 统计方法：本实验所得数据利用SPSS8.0 统计软件进行处理，统计方法采用卡方分析及t 检验。
1.7实验结果
模型制作结果：模型组10 只豚鼠中8 只形成结石，该结石外形不规则，大小不一，灰褐色薄片状，质地松软，易碎。模型组成石率与正常组相比有非常显著差异(P＜0.01)。本发明药物组合物对胆汁中各项成分的影响如表3所示。
表3 本发明药物组合物对胆汁中各项成分的影响
与正常组比较，▲▲P＜0.01；与模型组比较＊P＜0.05，＊＊P＜0.01 ；与阳性对照组比较，△P＜0.05。
由表3可以看出，本发明药物组合物各治疗组和阳性对照组具有显著降低胆汁中Ca、TBIL、DBIL水平的作用和升高BA水平的作用。其中阳性对照组的调节作用与本发明组合物低组接近。本发明组合物中组和高组与阳性对照组相比在降低胆汁中Ca、TBIL、DBIL水平和升高BA水平方面具有显著性的差异。
Claims (6)
1.一种治疗肝胆结石的药物组合物，其特征在于由下列重量份的原料制成：栀子10-12、黄芩5-8、牛蒡子6-9、半夏3-5、川芎10-12、淫羊藿3-5、三七3-5、玄参10-12、黄芪8-10、当归6-9、酸枣仁10-12、白芷10-12、延胡索10-12、大蓟12-15、山慈菇9-12。
2.如权利要求1所述的药物组合物，其特征在于：所述的药物组合物还含有熊去氧胆酸5-8份和白术12-15份。
3.如权利要求1或2所述的治疗肝胆结石的药物组合物，其特征在于所述的药物组合物为散剂、水剂、片剂或胶囊剂。
4.如权利要求1或2所述的治疗肝胆结石的药物组合物，其特征在于所述的药物组合物的制备方法包含下述步骤：取处方量上述中药材碎成粗粉，按照粗粉总重量的4-9倍加入体积浓度为40%-95%的乙醇溶液，回流提取三次，回流时间为2-5h，滤过，滤液回收乙醇，冷却过滤，用水洗涤，干燥后即得中药浸膏；本领域技术人员可在该制备方法技术上制备得到临床上常用中药药物剂型，如片剂、胶囊剂。
5.权利要求1或2所述的药物组合物在制备治疗肝胆结石药物中的用途。
6.权利要求1或2所述的药物组合物在制备治疗肾结石药物中的用途。
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| CN104548016A (zh) * | 2014-12-30 | 2015-04-29 | 黎细乐 | 一种中药组合物在制备治疗高尿酸血症药物中的用途 |
| CN104587428A (zh) * | 2014-12-30 | 2015-05-06 | 黎细乐 | 治疗高尿酸血症合并肝胆结石的中药组合物及其制备方法 |
| CN105106733A (zh) * | 2015-09-30 | 2015-12-02 | 吴淑芬 | 一种治疗胆囊结石的中药组合物 |
| CN105535408A (zh) * | 2016-01-20 | 2016-05-04 | 青岛云天生物技术有限公司 | 一种治疗胆固醇结石的药物组合物及其用途 |
| CN105770281A (zh) * | 2016-05-13 | 2016-07-20 | 晋利华 | 一种中西药结合治疗胆石症的组合药物 |
| CN106421325A (zh) * | 2016-12-13 | 2017-02-22 | 四川西奈生物科技有限公司 | 软化肝胆结石的组合物 |
| CN108578607A (zh) * | 2018-08-10 | 2018-09-28 | 青岛金丽雅医疗新技术发展有限公司 | 一种治疗肾结石的药物组合物 |
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| CN102949546A (zh) * | 2012-10-29 | 2013-03-06 | 逄瑞莲 | 一种治疗胆囊炎胆结石的中药 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104548016A (zh) * | 2014-12-30 | 2015-04-29 | 黎细乐 | 一种中药组合物在制备治疗高尿酸血症药物中的用途 |
| CN104587428A (zh) * | 2014-12-30 | 2015-05-06 | 黎细乐 | 治疗高尿酸血症合并肝胆结石的中药组合物及其制备方法 |
| CN105106733A (zh) * | 2015-09-30 | 2015-12-02 | 吴淑芬 | 一种治疗胆囊结石的中药组合物 |
| CN105535408A (zh) * | 2016-01-20 | 2016-05-04 | 青岛云天生物技术有限公司 | 一种治疗胆固醇结石的药物组合物及其用途 |
| CN105770281A (zh) * | 2016-05-13 | 2016-07-20 | 晋利华 | 一种中西药结合治疗胆石症的组合药物 |
| CN106421325A (zh) * | 2016-12-13 | 2017-02-22 | 四川西奈生物科技有限公司 | 软化肝胆结石的组合物 |
| CN108578607A (zh) * | 2018-08-10 | 2018-09-28 | 青岛金丽雅医疗新技术发展有限公司 | 一种治疗肾结石的药物组合物 |
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