CN104491624A - 一种治疗胆道梗阻的中药制剂及制备方法 - Google Patents
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Abstract
本发明公开了一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份：夏枯草10-16；熟大黄7-10；破布叶6-12；垂盆草9-16；丁香6-15；三棱8-15；地锦草7-15；猪仔笠6-10；淫羊藿10-20；麦饭石9-18；白僵蚕9-16；黄芪20-30；紫厚朴9-15；茯神8-12；金钱草20-30；甘草8-15。本发明的优良效果还表现在：本发明药物所选药材配伍相宜，符合中医及现代药理研究理论，并利用现代先进的制药技术制成，具有消融结石、消炎止痛的功效，本发明所得产品具有扶正祛邪，清热解毒，舒肝利胆，活血化瘀，健胃健脾等功效，能够调理和改善机体脏器功能，提高抗病能力，防治并发症，提高治愈率药源易得，药材成本低廉，能够减轻患者负担。
Description
技术领域
本发明涉及中医中药领域，特别是涉及一种治疗胆道梗阻的中药制剂及制备方法。
背景技术
胆道梗阻性疾病时临床上常见的、多发的一大类疾病。胆道梗住包括原发性胆管腺癌所致胆道梗阻以及胆囊癌、肝细胞癌、壶腹部癌、胰头癌及其它转移癌对肝胆管的侵犯。约70%-90%的患者合并梗阻性黄疸，易并发胆道感染等并发症，病情凶险，预后差。多数患者明确诊断后已失去外科手术机会。
祖国医学认为胆道梗阻性疾病属黄疸范畴，病因为湿热。按其临床症状可归纳为“痛、热、黄、厥”四大症征。临床表现为黄疸、腹痛、恶心、呕吐、发热及皮肤瘙痒等。其发病机制为湿热瘀结，瘀久化热，久热成脓，热毒炽盛，热极而易转为热厥。因胆为六腑之一，宜泻而不藏，性喜疏达，以通为用。故治疗原则应标本兼治，以通为用。中医药是中华民族传统文化的结晶。
授权公告号 CN 103055256 A（申请号 201210565533.5）的中国发明专利文献公开了一种治疗胆管结石中药配方，柴胡9克、白芍9克、郁金9克、姜黄15克、茵陈9克、黄芩9克、木香9克、枳壳9克、大黄6克、芒硝6克。申请公布号 CN 104189675 A（申请号 201410431240.7）的中国发明专利文献公开了一种治疗胆囊癌术后复发的中药制剂，它是由下列配比的原料药组成：龙胆9-12g、三棱4-6g、土木香6-9g、云芝9-12g、五加皮6-9g、天葵子8-12g、水飞蓟6-9g、水红花子8-12g、枫香脂6-9g、仙桃草6-8g、甘草4-6g。公开号 CN 101590195 A （申请号200810113793.2）的中国发明专利文献公开了一种治疗阻塞性黄疸的中药制剂，由下列药材制成：熊胆粉0.5-5g，茵陈5-50g，薏苡仁5-50g，穿山甲3-30g，黄芪5-50g，大黄3-30g。
目前，通常采用外科手术治疗，但是外科引流术的风险大，并发症发生率高达20%-50%，多数患者难以耐受手术。中医药副作用小、无药物依赖性。
发明内容
针对现有技术的不足，本发明的目的是提供一种制备简单、方便服用、安全有效的一种治疗胆道梗阻的中药制剂及制备方法。该药剂疗效确切便于临床使用。
本发明的技术方案是：
一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份：夏枯草10-16；熟大黄7-10；破布叶6-12；垂盆草9-16；丁香6-15；三棱8-15；地锦草7-15；猪仔笠6-10；淫羊藿10-20；麦饭石9-18；白僵蚕9-16；黄芪20-30；紫厚朴9-15；茯神8-12；金钱草20-30；甘草8-15。
优选的方案中，夏枯草12-14；熟大黄8-9；破布叶8-10；垂盆草11-14；丁香9-12；三棱10-13；地锦草10-12；猪仔笠7-9；淫羊藿13-17；麦饭石12-15；白僵蚕11-14；黄芪23-27；紫厚朴11-13；茯神9-11；金钱草23-27；甘草10-13。
更加优选的，夏枯草13；熟大黄8.5；破布叶9；垂盆草12.5；丁香10.5；三棱11.5；地锦草11；猪仔笠8；淫羊藿15；麦饭石13.5；白僵蚕12.5；黄芪25；紫厚朴12；茯神10；金钱草25；甘草11.5。
一种治疗胆道梗阻的中药汤剂的制备方法，步骤如下：
（1）丁香和夏枯草分别捣碎为末；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；
（2）甘草片置于带盖容器中，加高粱酒没过药面，置蒸锅中蒸制熟透，然后于75-95℃烘箱中烘干至酥脆为度（优选于85℃烘箱中烘干至酥脆为度），取出放冷，研成细粉；麦饭石洗净，砸成小块，置耐火容器中用无烟武火加热，煅至红透，然后倒入老陈醋内淬制，反复三次，捣碎研末，水飞成极细粉备用；
（3）另取一炒锅中火预热，加入大米翻炒5-7分钟，然后加入白僵蚕继续翻炒至大米表面为焦黄色为度（白僵蚕:大米=5:1），停火，筛去米，放凉捣碎，与步骤（1）-（2）所得细粉混合，过50-90目筛（优选过70目筛），置于通透袋中备用；
（4）将剩余中草药洗净，与步骤（3）所得混合细粉一同置于瓦罐中，加入6-10倍量的清水浸泡1.2-1.4小时（优选加入8倍量的清水浸泡1.3小时），大火煮沸，中火煎煮两次，第一次煎煮0.8-1.2小时（优选第一次煎煮1小时），第二次煎煮32-54分钟（优选第二次煎煮43分钟），过滤，合并两次煎液，药渣再加水煎煮13-21分钟（优选的药渣再加水煎煮17分钟），滤液与煎液混合；
（5）将上述所得煎液干燥灭菌，待冷却后，封装，即得。
上述一种治疗胆道梗阻的中药汤剂的制备方法，优选的方案是，步骤（4）中所加清水的温度为33-47℃（优选的清水的温度为38-42℃，更加优选的清水的温度为40℃）。
上述一种治疗胆道梗阻的中药汤剂的制备方法，优选的方案是，步骤（5）中干燥灭菌的温度为100-130℃（优选的干燥灭菌的温度为110-120℃，更加优选的干燥灭菌的温度为115℃）。
上述一种治疗胆道梗阻的中药汤剂的制备方法，优选的方案是，步骤（5）中干燥灭菌的时间为13-29分钟（优选的干燥灭菌的时间为18-24分钟，更加优选的干燥灭菌的时间为21分钟）。
所述稠膏剂的制备方法是：
（1）丁香和夏枯草分别捣碎为末；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；麦饭石洗净，砸成小块，置耐火容器中用无烟武火加热，煅至红透，然后倒入老陈醋内淬制，反复三次，捣碎研末，水飞成极细粉备用；
（2）将三棱放入清水中浸泡3-6小时（优选三棱放入清水中浸泡4.5小时）,捞出,置开水锅内浸没,用微火加热,煮至6成透时,加入15%重量份的米醋,再煮至透心,汤吸净时,捞出放缸中加盖闷润，趁热用铡刀切成薄片,干燥备用；
（3）将剩余药材置于药罐中，加纯净水浸泡73-85分钟（优选纯净水浸泡79分钟），然后加入步骤（1）-（2）处理后的药品，武火加热至沸，文火煎煮3次，每次各煎煮36-54分钟（优选每次各煎煮45分钟），过滤，合并煎液；
（4）将上述煎液蒸发至原体积的1/2，冷却，加入1.5-3.5倍药液量（优选加入2.5倍药液量）的质量浓度为95%的乙醇，充分混匀，放置20-30小时（优选放置25小时），取其上清液，减压回收乙醇后，待浓缩至相对密度为1.30-1.33(85℃)的稠膏，即得。
所述丸剂的制备方法是：
（1）取黄芪片置于铁锅中，武火加热，炒至外表呈焦黑色时，取出放凉，研磨成细粉备用；三棱和猪仔笠分别洗净，与姜汁拌匀（药材:姜汁=6:1）,静置15-23分钟（优选静置19分钟），中火炒至药材酥脆为度，取出放凉，粉碎备用；
（2）丁香和夏枯草分别捣碎为末；取黄柏加水煎汤2次，过滤去渣，合并药液，加入麦饭石碎块，搅匀，待药液吸收完全，于93-97℃恒温箱中烘干，研成细粉备用；
（3）将剩余药材置于药罐中，加纯净水浸泡73-85分钟（优选纯净水浸泡79分钟），然后加入步骤（2）处理后的药材细粉，武火加热至沸，文火煎煮2次，第一次煎煮40-50分钟（优选第一次煎煮45分钟），第二次煎煮25-35分钟（优选第二次煎煮30分钟），煎煮过程中保持清水没过药面，过滤，合并两次煎液；
（4）将上述煎液继续减压浓缩至稠膏状，加入步骤（1）所得药粉，搅拌均匀，然后加入羧甲基纤维素钠和糖粉（稠膏粉:羧甲基纤维素钠:糖粉=6:1.5:1.2），搅匀，加工成丸剂，即得。
所述片剂的制备方法是：
（1）将麻油倒入油锅中，加入淫羊藿丝（淫羊藿:麻油=6:1），小火微炸，待表面呈焦黄色时取出，沥油，捣碎成粉；另取一炒锅中火预热，加入大米翻炒5-7分钟，然后加入白僵蚕继续翻炒至糯米表面为焦黄色为度（白僵蚕:大米=5:1），停火，筛去米，放凉捣碎；
（2）取黄柏加水煎汤2次，过滤去渣，合并药液，加入麦饭石碎块，搅匀，待药液吸收完全，于93-97℃恒温箱中烘干，研成细粉备用；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；
（3）将剩余药材置于96℃热风干燥器中干燥30-50分钟（优选置于96℃热风干燥剂中干燥40分钟），取出放凉，然后投入粉碎机中粉碎；
（4）将步骤（1）-（3）所得药材细粉混合，过120-160目筛（优选过140目筛），加入硬脂酸镁和糊精（药粉:硬脂酸镁:糊精=9:1.3:1），充分搅拌，压制成片，即得。
本发明组方科学，制备方法简单，服用方便、效果显著。除此之外，本发明的优良效果还表现在：
1、本发明药物所选药材配伍相宜，符合中医及现代药理研究理论，并利用现代先进的制药技术制成，具有消融结石、消炎止痛的功效；
2、本发明所得产品具有扶正祛邪，清热解毒，舒肝利胆，活血化瘀，健胃健脾等功效，能够调理和改善机体脏器功能，提高抗病能力，防治并发症，提高治愈率；
3、药源易得，药材成本低廉，能够减轻患者负担。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案，但保护范围不限于此。
实施例1 一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份（50g/份）：夏枯草10份；熟大黄7份；破布叶6份；垂盆草9份；丁香6份；三棱8份；地锦草7份；猪仔笠6份；淫羊藿10份；麦饭石9份；白僵蚕9份；黄芪20份；紫厚朴9份；茯神8份；金钱草20份；甘草8份。
一种治疗胆道梗阻的中药汤剂的制备方法是：
（1）丁香和夏枯草分别捣碎为末；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；
（2）甘草片置于带盖容器中，加高粱酒没过药面，置蒸锅中蒸制熟透，然后于75℃烘箱中烘干至酥脆为度，取出放冷，研成细粉；麦饭石洗净，砸成小块，置耐火容器中用无烟武火加热，煅至红透，然后倒入老陈醋内淬制，反复三次，捣碎研末，水飞成极细粉备用；
（3）另取一炒锅中火预热，加入大米翻炒5分钟，然后加入白僵蚕继续翻炒至大米表面为焦黄色为度（白僵蚕:大米=5:1），停火，筛去米，放凉捣碎，与步骤（1）-（2）所得细粉混合，过50目筛，置于通透袋中备用；
（4）将剩余中草药洗净，与步骤（3）所得混合细粉一同置于瓦罐中，加入6倍量的33℃清水浸泡1.2小时，大火煮沸，中火煎煮两次，第一次煎煮0.8小时，第二次煎煮32分钟，过滤，合并两次煎液，药渣再加水煎煮13分钟，滤液与煎液混合；
（5）将上述所得煎液于100℃干燥灭菌13分钟，待冷却后，封装，即得。
本发明所得汤剂的服用方法是：每天2次，每次150-200mL，温热服用，15天一疗程。
典型病例：杨XX，女，47岁，临沂人。患者于2010年7月13日来我院治疗。患者自述：一周前，毫无征兆地出现腹胀、腹部按压疼痛，后来服用止痛药无济于事，病情加重，遂来我院治疗。检查：患者厌油、尿黄、大便灰白，舌质红，苔黄腻，脉弦数。血淀粉酶、脂肪酶及尿淀粉酶正常；做胰胆管MR水成像（MRCP)检查，发现肝内胆管轻度扩张，左右肝管及胆总管扩张，最宽处直径约为1.39厘米，胆总管中段截断，胰腺弥漫性增厚，以胰头为著，边缘模糊，胰管显示尚清晰，未见明显扩张。检查结论为：胆道梗阻，胰腺改变。
服用本实施例所得一种治疗胆道梗阻的中药汤剂，服用方法：每天2次，每次150-200mL，温热服用，15天一疗程。治疗两个疗程后，患者腹部疼痛明显减轻，其他体征明显好转，继续用药两个疗程后，MRCP检查肝内胆管回缩，逐渐恢复正常。患者痊愈，无其他副作用，患者身体健康。
实施例2 一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份（30g/份）：夏枯草16份；熟大黄10份；破布叶12份；垂盆草16份；丁香15份；三棱15份；地锦草15份；猪仔笠10份；淫羊藿20份；麦饭石18份；白僵蚕16份；黄芪30份；紫厚朴15份；茯神12份；金钱草30份；甘草15份。
上述一种治疗胆道梗阻的中药稠膏剂的制备方法是：
（1）丁香和夏枯草分别捣碎为末；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；麦饭石洗净，砸成小块，置耐火容器中用无烟武火加热，煅至红透，然后倒入老陈醋内淬制，反复三次，捣碎研末，水飞成极细粉备用；
（2）将三棱放入清水中浸泡4.5小时,捞出,置开水锅内浸没,用微火加热,煮至6成透时,加入15%重量份的米醋,再煮至透心,汤吸净时,捞出放缸中加盖闷润，趁热用铡刀切成薄片,干燥备用；
（3）将剩余药材置于药罐中，加纯净水浸泡79分钟，然后加入步骤（1）-（2）处理后的药品，武火加热至沸，文火煎煮3次，每次各煎煮45分钟，过滤，合并煎液；
（4）将上述煎液蒸发至原体积的1/2，冷却，加入2.5倍药液量的质量浓度为95%的乙醇，充分混匀，放置25小时，取其上清液，减压回收乙醇后，待浓缩至相对密度为1.30-1.33(85℃)的稠膏，即得。
本发明所得稠膏剂的服用方法是：每天2次，每次3勺，温开水冲服，15天一疗程。
典型病例：武XX，男，35岁，东营人。患者于2011年10月12日来我院。主述：半个月前，自觉全身皮肤瘙痒，几日后，发现皮肤发黄，尿液色深，无明显腹痛及发热表现。曾服用消炎利胆片治疗，但黄疸未见消退，并有加重趋势，遂来我院就诊。检查：患者ALT：756U/L，AST：632U/L,TBIL：83mmol/L，DBIL：72mmol/L，B超提示肝内胆管扩张。患者巩膜黄染、右上腹按压后疼痛。诊断为梗阻性黄疸。
服用本实施例所得一种治疗胆道梗阻的中药稠膏剂，服用方法：每天2次，每次3勺，温开水冲服，15天一疗程。用药两个疗程后，患者临床症状及体征明显减轻，黄疸消退；继续用药一个疗程，患者黄疸消失，肝指标检查恢复正常。患者自感痊愈，三个月后回访，患者无复发。
实施例3 一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份（45g/份）：夏枯草12份；熟大黄8份；破布叶8份；垂盆草11份；丁香9份；三棱10份；地锦草10份；猪仔笠7份；淫羊藿13份；麦饭石12份；白僵蚕11份；黄芪23份；紫厚朴11份；茯神9份；金钱草23份；甘草10份。
上述一种治疗胆道梗阻的中药丸剂的制备方法是：
（1）取黄芪片置于铁锅中，武火加热，炒至外表呈焦黑色时，取出放凉，研磨成细粉备用；三棱和猪仔笠分别洗净，与姜汁拌匀（药材:姜汁=6:1）,静置19分钟，中火炒至药材酥脆为度，取出放凉，粉碎备用；
（2）丁香和夏枯草分别捣碎为末；取黄柏加水煎汤2次，过滤去渣，合并药液，加入麦饭石碎块，搅匀，待药液吸收完全，于95℃恒温箱中烘干，研成细粉备用；
（3）将剩余药材置于药罐中，加纯净水浸泡79分钟，然后加入步骤（2）处理后的药材细粉，武火加热至沸，文火煎煮2次，第一次煎煮45分钟，第二次煎煮30分钟，煎煮过程中保持清水没过药面，过滤，合并两次煎液；
（4）将上述煎液继续减压浓缩至稠膏状，加入步骤（1）所得药粉，搅拌均匀，然后加入羧甲基纤维素钠和糖粉（稠膏粉:羧甲基纤维素钠:糖粉=6:1.5:1.2），搅匀，加工成丸剂，即得。
本发明所得丸剂的服用方法是：每天3次，每次3-5丸， 15天一疗程。
典型病例：孙XX，女，57岁,济宁人。 患者于2011年12月11日来我院就诊。主述：右侧腹痛半月余。现病史：患者半个月前无明显诱因出现右侧腹部疼痛不适，初起痛感较轻，后来逐渐加重，半恶心、呕吐和发热症状。经由家人送来我院治疗。检查：患者神志清楚，精神尚可，食欲差，饮食减少，小便色黄，量可；全身皮肤粘膜无黄染，B超及CT等影响学检查提示为：肝外胆道梗阻。
服用本实施例所得一种治疗胆道梗阻的中药丸剂，服用方法：每天3次，每次3-5丸， 15天一疗程。用药两个疗程后，患者临床症状及体征明显减轻，纳量增，精神和体力增强；继续用药一个疗程，患者梗阻现象消失，患者自感痊愈，三个月后回访，患者无复发。
实施例4 一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份（35g/份）：夏枯草14份；熟大黄9份；破布叶10份；垂盆草14份；丁香12份；三棱13份；地锦草12份；猪仔笠9份；淫羊藿17份；麦饭石15份；白僵蚕14份；黄芪27份；紫厚朴13份；茯神11份；金钱草27份；甘草13份。
上述一种治疗胆道梗阻的中药片剂的制备方法是：
（1）将麻油倒入油锅中，加入淫羊藿丝（淫羊藿:麻油=6:1），小火微炸，待表面呈焦黄色时取出，沥油，捣碎成粉；另取一炒锅中火预热，加入大米翻炒6分钟，然后加入白僵蚕继续翻炒至糯米表面为焦黄色为度（白僵蚕:大米=5:1），停火，筛去米，放凉捣碎；
（2）取黄柏加水煎汤2次，过滤去渣，合并药液，加入麦饭石碎块，搅匀，待药液吸收完全，于95℃恒温箱中烘干，研成细粉备用；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；
（3）将剩余药材置于96℃热风干燥器中干燥40分钟，取出放凉，然后投入粉碎机中粉碎；
（4）将步骤（1）-（3）所得药材细粉混合，过140目筛，加入硬脂酸镁和糊精（药粉:硬脂酸镁:糊精=9:1.3:1），充分搅拌，压制成片，即得。
本发明所得片剂的服用方法是：每天3次，每次4-6片， 15天一疗程。
典型病例：肖XX，女，51岁，淄博人。2011年7月21日来我院治疗。主述：腹痛伴恶心、呕吐1天。1天前晚饭后，出现剧烈腹痛，疼痛延及到背部，并伴有恶心、呕吐。呕吐后无缓解，无头晕、胸闷、心悸症状。检查发现：患者血淀粉酶是正常值的3倍，腹部CT显示：腹腔内渗出性改变，B超、CT等影像学检查发现有胆道梗阻并发症。诊断为胰腺炎。
服用本实施例所得一种治疗胆道梗阻的中药片剂，服用方法：每天3次，每次4-6片， 15天一疗程。治疗两个疗程后，患者恶心、呕吐消失，疼痛和胆道梗阻现象明显减轻；继续用药两个疗程，检查血淀粉酶处于正常范围，胆道梗阻现象基本消失。患者自感痊愈。
实施例5 一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份（40g/份）：夏枯草13份；熟大黄8.5份；破布叶9份；垂盆草12.5份；丁香10.5份；三棱11.5份；地锦草11份；猪仔笠8份；淫羊藿15份；麦饭石13.5份；白僵蚕12.5份；黄芪25份；紫厚朴12份；茯神10份；金钱草25份；甘草11.5份。
上述一种治疗胆道梗阻的中药汤剂的制备方法是：
（1）丁香和夏枯草分别捣碎为末；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；
（2）甘草片置于带盖容器中，加高粱酒没过药面，置蒸锅中蒸制熟透，然后于85℃烘箱中烘干至酥脆为度，取出放冷，研成细粉；麦饭石洗净，砸成小块，置耐火容器中用无烟武火加热，煅至红透，然后倒入老陈醋内淬制，反复三次，捣碎研末，水飞成极细粉备用；
（3）另取一炒锅中火预热，加入大米翻炒6分钟，然后加入白僵蚕继续翻炒至大米表面为焦黄色为度（白僵蚕:大米=5:1），停火，筛去米，放凉捣碎，与步骤（1）-（2）所得细粉混合，过70目筛，置于通透袋中备用；
（4）将剩余中草药洗净，与步骤（3）所得混合细粉一同置于瓦罐中，加入8倍量的40℃清水浸泡1.3小时，大火煮沸，中火煎煮两次，第一次煎煮1小时，第二次煎煮43分钟，过滤，合并两次煎液，药渣再加水煎煮17分钟，滤液与煎液混合；
（5）将上述所得煎液于115℃干燥灭菌21分钟，待冷却后，封装，即得。
本发明汤剂的服用方法是：每天2次，每次150-200mL，温热服用，15天一疗程。
本发明所用主要中药原料的药理如下：
夏枯草：基原：本品为唇形科植物夏枯草的干燥果穗。化学成份：全草含三萜皂甙，其甙元是齐墩果酸，尚含游离的齐墩果酸、熊果酸、芸香甙、金丝桃甙、顺-咖啡酸、反-咖啡酸、维生素B1、维生素C、维生素K、胡萝卜素、树脂、苦味质、鞣质、挥发油、生物碱、水溶性盐类（约3.5％，其中约63％是氯化钾）等。性味：辛、苦，寒。归经：归肝、胆经。药理作用：①降压作用，②抗菌作用。功效：清火，明目，散结，消肿。主治：用于目赤肿痛，目珠夜痛，头痛眩晕，瘰疬，瘿瘤，乳痈肿痛；甲状腺肿大，淋巴结结核，乳腺增生，高血压。
大黄：基原：为蓼科植物掌叶大黄、唐古特大黄或药用大黄的根茎。性味：苦，寒。归经：入胃、大肠、肝经。功能主治：泻热毒，破积滞，行瘀血。治实热便秘，谵语发托，食积痞满，痢疾初起，里急后重，瘀停经闭，症瘕积聚，时行热疫，暴眼赤痛，吐血，衄血，阳黄，水肿，淋浊，溲亦，痈疡肿毒，疔疮，汤火伤。熟大黄（又名：熟军，制军）：取切成小块的生大黄，用黄酒拌匀，放蒸笼内蒸制，或置罐内密封，坐水锅中，隔水蒸透，取出晒干（大黄块100斤用黄酒30-50斤）。亦有按上法反复蒸制2-3次者。
破布叶：基原：为椴树科植物破布叶的叶。性状：干燥的叶或带有幼枝的叶。叶多破碎，枯黄色或淡绿棕色，具短柄，叶片卵形或卵状矩圆形，先端尖，基部浑圆，边缘具小锯齿，主脉3，侧脉羽状，小脉网状，叶柄及主脉被星状柔毛。纸质，易破碎。气香，味淡。性味：酸，平。归经：脾经。功能主治：消热解毒，消食积。治感冒，消化不良，腹胀，黄疸，蜈蚣咬伤。
垂盆草：基原：为景天科植物垂盆草的全草。化学成份：含N-甲基异石榴皮碱二氢-N-甲基异石榴皮碱、景天庚酮糖、葡萄糖、果糖、蔗糖。性味：性凉，味甘、凉。归经：归肝、胆、小肠经。功能主治：清利湿热，有降低谷丙转氨酶作用。用于急性胩炎、迁延性肝炎、慢性肝炎的活动性。
丁香：基原：为桃金娘科植物丁香的花蕾。性味：辛，温。归经：入胃、脾、肾经。功能主治：温中，暖肾，降逆。治呃逆，呕吐，反胃，泻痢，心腹冷痛，痃癖，疝气，癣疾。
三棱：基原：为黑三棱科植物黑三棱或小黑三棱、细叶黑三棱的块茎。化学成份：小黑三棱含挥发油0.05％。性味:苦辛，平。归经：入肝。脾经。功能主治：破血，行气，消积，止痛。治症瘕积聚，气血凝滞，心腹疼痛，胁下胀疼，经闭，产后瘀血腹痛，跌打损伤。疮肿坚硬。
地锦草：基原：为大戟科植物地锦草的全草。化学成份：全草含黄酮类（槲皮紊等）、没食子酸、内消旋肌醇。叶含鞣质12.89％。性味：辛，平。归经：肺；肝；胃；大肠；膀胱经。功能主治：清热解毒，活血，止血，利湿，通乳。治菌痢，肠炎，咳血，吐血，便血，崩漏，外伤出血，湿热黄疸，乳汁不通，痈肿疔疮，跌打肿痛。
猪仔笠：基原：为豆科植物猪仔笠的块根。性状：块根肉质，呈圆锥形，长4-7厘米，直径2-4厘米，末端细长，木质化。表面深棕色，有短横列的突起和少数须状支根。性味：甘，平。归经：肺；大肠；肝经。功能主治：清肺化痰。治肺热咳嗽，烦渴，赤白痢疾。
淫羊藿：基原：为小檗科植物淫羊藿、心叶淫羊藿或箭叶淫羊藿的茎叶。化学成份：淫羊藿茎、叶含淫羊藿甙，叶尚含挥发油、蜡醇、卅一烷、植物甾醇、鞣质、油脂。脂肪油中的脂肪酸有棕榈酸、硬脂酸、油酸、亚油酸。药理作用：①影响性机能；②对微生物有抑制作用；③镇咳、祛痰与平喘作用；④其他作用：淫羊藿提取液对家兔有降压作用，小量使尿分泌增加，大量则反而抑制之，对离体兔肠有抑制作用，离体子宫则先兴奋后抑制，口服能使高血糖大鼠血糖下降。性味：辛甘，温。归经：入肝、肾经。功能主治：补肾壮阳，祛风除湿。治阳痿不举，小便淋沥，筋骨挛急，半身不遂，腰膝无力，风湿痹痛，四肢不仁。
麦饭石：基原：为中酸性火成岩类岩石石英二长斑岩。成分：中华麦饭石主要成分有二氧化硅，氧化铝，氧化铁，氧化亚铁，氧化镁，氧化钙，氧化钠，氧化钾，二氧化钛，五氧化二磷，氧化锰，二氧化碳，以及氟、硫、锶、钡、铜、锌等微量元素。药性：《纲目》：“甘，温，无毒。”功用主治：解毒生肌，祛湿健脾。主治痈疽发背，痤疮，湿疹，脚气，痱子，手指皲裂，黄褐斑，牙痛，口腔溃疡，风湿痹痛，腰背痛，慢性肝炎，胃炎，痢疾，糖尿病，神经衰弱，外伤红肿，高血压病，老年性血管硬化，肿瘤，尿路结石。一般作保健用品。宜忌：外敷时需研极细末，否则易引起疼痛。
白僵蚕：又名僵蚕、天虫、白僵虫，为蚕蛾科蚕属动物家蚕蛾的幼虫感染白僵菌而僵死的全虫。药性：本品略呈圆柱形，多弯曲皱缩，表面灰黄色，质硬而脆，易折断，味辛、咸，性平。成分：白僵蚕含蛋白质、草氨酸，并含赖氨酸，亮氨酸，天冬氨酸等17种氨基酸。根据现代药理研究发现，该药具有祛风止痉、化痰散结、解毒利咽、抗惊厥、降血糖的功效，用于中风，偏正头痛，咽喉肿痛，风疹等。
厚朴：基原：本品为木兰科植物厚朴或凹叶厚朴的干燥干皮、根皮及枝皮。性味：苦、辛，温。归经：归脾、胃、肺、大肠经。功能主治：燥湿消痰，下气除满。用于湿滞伤中，脘痞吐泻，食积气滞，腹胀便秘，痰饮喘咳。紫厚朴的制备方法：厚朴皮置于沸水中微煮后，堆置阴湿处，“发汗”至内表面变紫。
黄芪：基原：本品为豆科植物蒙古黄芪或膜荚黄芪的干燥根。性味：甘，温。归经：归肺、脾经。功效：补气固表，利尿托毒，排脓，敛疮生肌。主治：用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，痈疽难溃，久溃不敛，血虚痿黄，内热消渴；慢性肾炎蛋白尿，糖尿病。
茯神：基原：为多孔菌科植物茯苓菌核中间天然抱有松根（即“茯神木”）的白色部分。药理作用：镇静作用。性味：甘淡，平。归经：入心、脾经。功能主治：宁心，安神，利水。治心虚惊悸，健忘，失眠，惊痫，小便不利。
金钱草：基原：为唇形科植物活血丹的全草或带根全草。化学成份：金钱草有芳香型和非芳香型两类。芳香型含多量单萜酮，其主要成分是l-蒎莰酮、l-薄荷酮和l-胡薄荷酮；尚含α-蒎烯、β-蒎烯、柠檬烯、对-聚伞花素、异薄荷酮、异蒎莰酮、芳樟醇、薄荷醇、α-松油醇。除上述挥发油成分外，尚含熊果酸、β-谷甾醇、棕榈酸、琥珀酸、多种氨基酸、鞣质、苦味质、胆碱、硝酸钾等。地下部分含水苏糖。药理作用：用金钱草煎剂20克（生药）／公斤给大鼠灌胃，有显着的利尿作用，连续应用则利尿作用逐渐降低。性味：苦辛，凉。归经：归肝、胆、肾、膀胱经。功能主治：清热，利尿，镇咳，消肿，解毒。治黄疸，水肿，膀胱结石，疟疾，肺痈，咳嗽，吐血，淋浊，带下，风湿痹痛，小儿疳积，惊痫，痈肿，疮癣，湿疹。
甘草：基原：本品为豆科植物甘草、胀果甘草或光果甘草的干燥报及根茎。性味：甘，平。归经：归心。肺、脾、胃经。功效：补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。主治：用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，院腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
试验例1 本发明所得一种治疗胆道梗阻的中药制剂（实施例5）的临床应用：
1、资料和方法
1.1 一般资料
于2010年7月-2012年12月，在5所医院收集232例临床疑诊为胆道梗阻性疾病而选择B超、CT、MRI及磁共振胰胆管造影检查且最终确诊为胆道梗阻性疾病的患者。其中男性127例，女性105例，年龄为29-68岁，平均年龄45.5±4.5岁。良性胆道梗阻性疾病共156例，其中胆管结石53例，胆管炎性狭窄34例，慢性胰腺炎48例、梗阻性黄疸21例。恶性胆道梗阻性疾病共76例，其中肝门胆管癌19例，胰头癌25例，壶腹癌15例，胆囊癌17例。
1.2 症状表现：
临床症状主要表现为右上腹痛、恶心、呕吐、发热、皮肤巩膜黄染等。
B超、CT、MRI及磁共振胰胆管造影检查表现：（1）恶性胆道梗阻性疾病表现：①、胆管狭窄范围长，胆管狭窄部内腔不规则；②、管壁偏心性增厚；③、壁厚明显且明显强化；④、壁外缘不规则或壁外受累；⑤动脉和门静脉受累；（2）良性胆道梗阻性疾病表现：①、未见明显原发性肿瘤；②、狭窄范围短；③、壁厚较轻、壁外无侵犯④、无动脉和门静脉受累。
1..3 治疗方法
治疗组服用本发明所得产品；对照组服用其他药品（如胆舒胶囊、消炎利胆胶囊、托尼萘酸片等常规药品），共观察治疗三个疗程。
1.4 疗效判断标准
临床治愈：临床治愈：治疗后，症状和体征消失，B超、MRI及磁共振胰胆管造影检查：胆道梗阻完全消失。
显效：症状和体征减轻、B超、MRI及磁共振胰胆管造影检查：胆道梗阻范围减小1/2以上。
有效：症状和体征减轻、B超、MRI及磁共振胰胆管造影检查：胆道梗阻范围较前减少或变小。
无效：症状、体征、胆道梗阻现象均无变化。
1.5 治疗结果
治疗结果如表1所示。
表1：治疗组和对照组患者治疗结果比较
治疗效果：治愈71例（53.8%）， 显效34例（25.8%），有效25例（18.9%），无效2例（1.5%），总有效率98.5%。效果明显优于对照组。
本发明选择夏枯草、熟大黄、破布叶、垂盆草、丁香、三棱、地锦草、猪仔笠、淫羊藿、麦饭石和白僵蚕等16味中草药混合而成。方中夏枯草具有清火，明目，散结，消肿的作用；破布叶、地锦草治黄疸；垂盆草清利湿热；三棱主治破血，行气，消积，止痛。麦饭石解毒生肌，祛湿健脾；白僵蚕化痰散结；茯神宁心，安神；金钱草治黄疸，水肿，膀胱结石。诸药合用，以调和肝、胆、脾胃，标本兼治，效得益彰。治疗三个疗程后，治疗组有效率可达98.5%，而对照组仅为74%。
应当指出的是，具体实施方式只是本发明比较有代表性的例子，显然本发明的技术方案不限于上述实施例，还可以有很多变形。本领域的普通技术人员，以本发明所明确公开的或根据文件的书面描述毫无异议的得到的，均应认为是本专利所要保护的范围。
Claims (10)
1.一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份：夏枯草10-16；熟大黄7-10；破布叶6-12；垂盆草9-16；丁香6-15；三棱8-15；地锦草7-15；猪仔笠6-10；淫羊藿10-20；麦饭石9-18；白僵蚕9-16；黄芪20-30；紫厚朴9-15；茯神8-12；金钱草20-30；甘草8-15。
2.如权利要求1所述的一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份：夏枯草12-14；熟大黄8-9；破布叶8-10；垂盆草11-14；丁香9-12；三棱10-13；地锦草10-12；猪仔笠7-9；淫羊藿13-17；麦饭石12-15；白僵蚕11-14；黄芪23-27；紫厚朴11-13；茯神9-11；金钱草23-27；甘草10-13。
3.如权利要求1所述的一种治疗胆道梗阻的中药制剂，其特征在于，由下列原料药制备而成，均为重量份：夏枯草13；熟大黄8.5；破布叶9；垂盆草12.5；丁香10.5；三棱11.5；地锦草11；猪仔笠8；淫羊藿15；麦饭石13.5；白僵蚕12.5；黄芪25；紫厚朴12；茯神10；金钱草25；甘草11.5。
4.如权利要求1-3任一所述的一种治疗胆道梗阻的中药制剂，其特征在于，将其制成药学上可接受的汤剂，制备方法如下：
（1）丁香和夏枯草分别捣碎为末；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；
（2）甘草片置于带盖容器中，加高粱酒没过药面，置蒸锅中蒸制熟透，然后于75-95℃烘箱中烘干至酥脆为度（优选于85℃烘箱中烘干至酥脆为度），取出放冷，研成细粉；麦饭石洗净，砸成小块，置耐火容器中用无烟武火加热，煅至红透，然后倒入老陈醋内淬制，反复三次，捣碎研末，水飞成极细粉备用；
（3）另取一炒锅中火预热，加入大米翻炒5-7分钟，然后加入白僵蚕继续翻炒至大米表面为焦黄色为度（白僵蚕:大米=5:1），停火，筛去米，放凉捣碎，与步骤（1）-（2）所得细粉混合，过50-90目筛（优选过70目筛），置于通透袋中备用；
（4）将剩余中草药洗净，与步骤（3）所得混合细粉一同置于瓦罐中，加入6-10倍量的清水浸泡1.2-1.4小时（优选加入8倍量的清水浸泡1.3小时），大火煮沸，中火煎煮两次，第一次煎煮0.8-1.2小时（优选第一次煎煮1小时），第二次煎煮32-54分钟（优选第二次煎煮43分钟），过滤，合并两次煎液，药渣再加水煎煮13-21分钟（优选的药渣再加水煎煮17分钟），滤液与煎液混合；
（5）将上述所得煎液干燥灭菌，待冷却后，封装，即得。
5.如权利要求4所述汤剂的制备方法，其特征在于，步骤（4）中所加清水的温度为33-47℃（优选的清水的温度为38-42℃，更加优选的清水的温度为40℃）。
6.如权利要求4所述汤剂的制备方法，其特征在于，步骤（5）中干燥灭菌的温度为100-130℃（优选的干燥灭菌的温度为110-120℃，更加优选的干燥灭菌的温度为115℃）。
7.如权利要求4所述汤剂的制备方法，其特征在于，步骤（5）中干燥灭菌的时间为13-29分钟（优选的干燥灭菌的时间为18-24分钟，更加优选的干燥灭菌的时间为21分钟）。
8.如权利要求1-3任一所述的一种治疗胆道梗阻的中药制剂，其特征在于，将其制成药学上可接受的稠膏剂，制备方法如下：
（1）丁香和夏枯草分别捣碎为末；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；麦饭石洗净，砸成小块，置耐火容器中用无烟武火加热，煅至红透，然后倒入老陈醋内淬制，反复三次，捣碎研末，水飞成极细粉备用；
（2）将三棱放入清水中浸泡3-6小时（优选三棱放入清水中浸泡4.5小时）,捞出,置开水锅内浸没,用微火加热,煮至6成透时,加入15%重量份的米醋,再煮至透心,汤吸净时,捞出放缸中加盖闷润，趁热用铡刀切成薄片,干燥备用；
（3）将剩余药材置于药罐中，加纯净水浸泡73-85分钟（优选纯净水浸泡79分钟），然后加入步骤（1）-（2）处理后的药品，武火加热至沸，文火煎煮3次，每次各煎煮36-54分钟（优选每次各煎煮45分钟），过滤，合并煎液；
（4）将上述煎液蒸发至原体积的1/2，冷却，加入1.5-3.5倍药液量（优选加入2.5倍药液量）的质量浓度为95%的乙醇，充分混匀，放置20-30小时（优选放置25小时），取其上清液，减压回收乙醇后，待浓缩至相对密度为1.30-1.33(85℃)的稠膏，即得。
9.如权利要求1-3任一所述的一种治疗胆道梗阻的中药制剂，其特征在于，将其制成药学上可接受的丸剂，制备方法如下：
（1）取黄芪片置于铁锅中，武火加热，炒至外表呈焦黑色时，取出放凉，研磨成细粉备用；三棱和猪仔笠分别洗净，与姜汁拌匀（药材:姜汁=6:1）,静置15-23分钟（优选静置19分钟），中火炒至药材酥脆为度，取出放凉，粉碎备用；
（2）丁香和夏枯草分别捣碎为末；取黄柏加水煎汤2次，过滤去渣，合并药液，加入麦饭石碎块，搅匀，待药液吸收完全，于93-97℃恒温箱中烘干，研成细粉备用；
（3）将剩余药材置于药罐中，加纯净水浸泡73-85分钟（优选纯净水浸泡79分钟），然后加入步骤（2）处理后的药材细粉，武火加热至沸，文火煎煮2次，第一次煎煮40-50分钟（优选第一次煎煮45分钟），第二次煎煮25-35分钟（优选第二次煎煮30分钟），煎煮过程中保持清水没过药面，过滤，合并两次煎液；
（4）将上述煎液继续减压浓缩至稠膏状，加入步骤（1）所得药粉，搅拌均匀，然后加入羧甲基纤维素钠和糖粉（稠膏粉:羧甲基纤维素钠:糖粉=6:1.5:1.2），搅匀，加工成丸剂，即得。
10.如权利要求1-3任一所述的一种治疗胆道梗阻的中药制剂，其特征在于，将其制成药学上可接受的片剂，制备方法如下：
（1）将麻油倒入油锅中，加入淫羊藿丝（淫羊藿:麻油=6:1），小火微炸，待表面呈焦黄色时取出，沥油，捣碎成粉；另取一炒锅中火预热，加入大米翻炒5-7分钟，然后加入白僵蚕继续翻炒至糯米表面为焦黄色为度（白僵蚕:大米=5:1），停火，筛去米，放凉捣碎；
（2）取黄柏加水煎汤2次，过滤去渣，合并药液，加入麦饭石碎块，搅匀，待药液吸收完全，于93-97℃恒温箱中烘干，研成细粉备用；取吴茱萸加水煎煮2次，过滤除渣，将黄芪片与煎液拌匀，稍加闷润，待药液吸收完全后，取出，置炒锅内，文火加热，炒干，放凉，研磨成粉备用；
（3）将剩余药材置于96℃热风干燥器中干燥30-50分钟（优选置于96℃热风干燥剂中干燥40分钟），取出放凉，然后投入粉碎机中粉碎；
（4）将步骤（1）-（3）所得药材细粉混合，过120-160目筛（优选过140目筛），加入硬脂酸镁和糊精（药粉:硬脂酸镁:糊精=9:1.3:1），充分搅拌，压制成片，即得。
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