CN103768529B - 一种治疗胆囊切除术后综合征的中药组合物及其应用 - Google Patents
一种治疗胆囊切除术后综合征的中药组合物及其应用 Download PDFInfo
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Abstract
本发明涉及一种治疗胆囊切除术后综合征中药组合物及其应用，该组合物由如下重量份的中药材原料制备而成：马齿笕17-24份、郁金9-16份、茵陈9-16份、鸡内金15-22份、黄芩17-24份、厚朴15-22份、金钱草6-13份、白术6-13份。本发明的中药组合物可以减轻胆囊术后综合征患者的主要临床症状，明显改善手术后病人的健康状况，从而促进患者术后的恢复。
Description
技术领域
本发明涉及一种治疗胆囊切除术后综合征的中药组合物及其应用，属于中医药技术领域。
背景技术
急慢性胆道疾患如胆石症、胆囊炎、胆囊息肉等是普外科临床的常见病、多发病，大多需手术切除胆囊，但是很多患者于手术切除胆囊后会出现胆囊切除术后综合征，发病率占胆囊切除术后的l0％-27％，临床主要症状有心窝部胀满、恶心、嗳气、吐苦水、食欲减退、食量减少、黄疸、低烧、肝功能异常等，多于胆囊切除术后数周或数月内发生，女性多于男性，症状可由精神刺激、酒精、进食油腻性食物等因素所诱发。在其发病机理上与胆汁淤积、胆道感染及胆固醇代谢失调密切相关。
发明内容
本发明根据传统中医理论，经过对药物组分的大量筛选、重组、尝试、又通过大量实验研究作出的。因此，本发明的目的在于通过对传统中药材的药理进行研究后重新组方，提供一种疗效稳定、复发率低、无毒副作用的治疗胆囊切除术后综合征的中药组合物。
本发明的目的是这样实现的：
一种治疗胆囊切除术后综合征的中药组合物，该中药组合物由如下重量份的中药材制备而成：马齿苋17-24份、郁金9-16份、茵陈9-16份、鸡内金15-22份、黄芩17-24份、厚朴15-22份、金钱草6-13份、白术6-13份；
优选地，如上所述治疗胆囊切除术后综合征的中药组合物，其中所述的中药组合物由如下重量份的中药材制备而成：马齿苋19-21份、郁金11-13份、茵陈11-13份、鸡内金17-19份、黄芩19-21份、厚朴17-19份、金钱草8-10份、白术8-10份；
进一步优选地，如上所述治疗胆囊切除术后综合征的中药组合物，其中所述的中药组合物由如下重量份的中药材制备而成：马齿苋20份、郁金12份、茵陈12份、鸡内金18份、黄芩20份、厚朴18份、金钱草9份、白术9份；
本发明所述治疗胆囊切除术后综合征的中药组合物，优选制备的剂型为口服制剂，进一步优选该口服制剂为颗粒剂。
通过大量实验证明，本发明的中药组合物治疗胆囊切除术后综合征的疗效稳定，复发率低，基本无毒副作用。因此，本发明还提供了一种产品用途，即：上述的中药组合物在制备治疗胆囊切除术后综合征的药物中的应用。
将上述各中药材制备成本发明的复方颗粒剂的制备方法，包括如下步骤：称取清洗干净的马齿苋17-24份、郁金9-16份、茵陈9-16份、鸡内金15-22份、黄芩17-24份、厚朴15-22份、金钱草6-13份和白术6-13份，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：1-3的重量比称取清膏粉、糊精与适量55%乙醇，其中55%乙醇是指体积浓度为55%的乙醇水溶液，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂。
通过试验研究结果表明，本发明的中药组合物具有调节机体免疫功能、增强机体防御能力、改善心肺功能、改善微循环、调节体液电解质平衡、促进消化液分泌、改善消化功能、促进人体物质代谢、降低交感神经兴奋性等作用，可以减轻胆囊术后综合征患者的主要临床症状，明显改善手术后病人的健康状况，从而促进患者胆囊切除术后的恢复。另外，由于治疗胆囊切除术后综合征疗效较为理想，因此本发明的中药组合物具有廉价、有效、毒副作用低的优点，能节约有限的卫生资源，减轻社会和家庭经济负担。
具体实施方式
根据中医药史料记载，本发明采用的中药材原料的药理活性和来源如下：
马齿苋：具有清热解毒，止血通淋等功效；主治急性、亚急性皮炎和肠炎、细菌性痢疾、疗疮肿毒、虫蛀咬伤、湿疹、阑尾炎、钩虫病、带状孢疹及功能性子宫出血；选用苋科植物马齿苋的干燥幼嫩茎叶；
郁金：行气化瘀，清心解郁，利胆退黄。用于经闭痛经,胸腹胀痛、刺痛，热病神昏，癫痫发狂，黄疸尿赤；选用姜科植物姜黄的干燥块根；
茵陈：清湿热，退黄疸。用于黄疸尿少，湿疮瘙痒；传染性黄疸型肝炎；选用菊科植物茵陈蒿ArtemisiacapillarisThunb.的干燥地上部分；
鸡内金：健胃消食，涩精止遗。用于食积不消，呕吐泻痢，小儿疳积，遗尿，遗精；选用雉科动物家鸡GallusgallusdomesticusBrisson的干燥沙囊内壁；
黄芩：清热燥湿，泻火解毒，止血，安胎，降血压；用于湿温、暑温胸闷呕恶，湿热痞满，泻痢，黄疸，肺热咳嗽，高热烦渴，血热吐衄，痈肿疮毒，胎动不安；选用唇形科植物黄芩ScutellariabaicalensisGeorgi的干燥根；
厚朴：主温中，益气，消痰下气，治霍乱及腹痛，胀满，胃中冷逆，胸中呕逆不止，泄痢，淋露，除惊，去留热，止烦满，厚肠胃；选用木兰科植物厚朴MagnoliaofficinalisRehd.etWils.或凹叶厚朴MagnoliaofficinalisRehd.etWils.var.bilobaRehd.etWils.的干燥干皮、根皮及枝皮；
金钱草：清利湿热，通淋，消肿。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；选用报春花科植物过路黄LysimachiachristinaeHance的干燥全草；
白术：健脾益气，燥湿利水，止汗，安胎；用于脾虚食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安；选用菊科植物白术AtractylodesmacrocephalaKoidz.的干燥根茎；
以下是本发明的具体实施例，对本发明的技术方案做进一步作描述，但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例1中药颗粒剂的制备
称取清洗干净的马齿苋20份、郁金12份、茵陈12份、鸡内金18份、黄芩20份、厚朴18份、金钱草9份和白术9份，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：3的重量比称取清膏粉、糊精与适量55%乙醇，其中55%乙醇是指体积浓度为55%的乙醇水溶液，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂，按每袋20g包装。
实施例2中药颗粒剂的制备
称取清洗干净的马齿苋23份、郁金9份、茵陈10份、鸡内金22份、黄芩24份、厚朴15份、金钱草8份和白术12份，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：3的重量比称取清膏粉、糊精与适量55%乙醇，其中55%乙醇是指体积浓度为55%的乙醇水溶液，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂，按每袋20g包装。
实施例3中药颗粒剂的制备
称取清洗干净的马齿苋17份、郁金16份、茵陈15份、鸡内金15份、黄芩18份、厚朴20份、金钱草12份和白术8份，合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15的浸膏，加95%(v/v)乙醇使含醇量达75%(v/v)，搅拌，静置24小时，过滤，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥（条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。），粉碎过80目筛，得到清膏粉；按照清膏粉：糊精1：2.5的重量比称取清膏粉、糊精与适量55%乙醇，其中55%乙醇是指体积浓度为55%的乙醇水溶液，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65-75℃干燥2小时，取出，放凉即得所述的颗粒剂，按每袋20g包装。
实施例4中药颗粒剂对胆囊切除术后综合征患者的疗效研究
胆囊切除患者47例，男19例，女28例；年龄33-70岁，平均51.6±4.9岁。开腹切除胆囊16例，腹腔镜切除胆囊31例。胆囊切除术后3个月以上，术后反复出现右上腹部或右胁疼痛或胀闷不适感，以及反复出现厌油腻、腹胀、肠鸣、便秘等消化不良症状，被诊断为胆囊术后综合征。所有患者随机分为试验组24例，对照组共23例。两组性别、年龄、病程、生化指标、影像学、手术方法等方面比较无显著性差异，具有可比性。
试验组患者确诊后开始服用中药颗粒剂（按本发明实施例1的处方工艺制备而成），每天于早餐前及晚餐前各服用一包。对照组用胆维他片25mg，日服3次。两组均4周为一个疗程，治疗一个疗程后统计疗效。
两组疗效比较的结果是：试验组24例患者中显效(胁痛、腹痛及其他不适症状消失，未发现明显阳性体征，理化检查正常)19例，有效(胁痛、腹痛及其他不适症状减轻、阳性体征及理化检查改善)3例，无效(症状、体征均无变化)2例，总有效率为91.7％；对照组23例患者中显效12例，有效4例，无效7例，总有效率为69.6％。
Claims (3)
1.一种治疗胆囊切除术后综合征的中药组合物，其特征在于：所述的中药组合物由如下重量份的中药材制备而成：马齿苋20份、郁金12份、茵陈12份、鸡内金18份、黄芩20份、厚朴18份、金钱草9份、白术9份。
2.根据权利要求1所述治疗胆囊切除术后综合征的中药组合物，其特征在于：所述的中药组合物为口服制剂。
3.根据权利要求2所述治疗胆囊切除术后综合征的中药组合物，其特征在于：所述的口服制剂为颗粒剂。
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