CN104415285B - 一种治疗胆结石的中药组合物及其制备方法 - Google Patents
一种治疗胆结石的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗胆结石的中药组合物及其制备方法。它是由金钱草、黄芩、黄连、大黄、木香、枳壳、郁金、川楝子、虎杖、鸡内金、栀子、芦根等药物制成的药剂。本发明的优点在于组方独特，疗效确切、安全、经济、无明显毒副作用，具有疏肝解郁、行气止痛、利胆排石、健脾利湿之功效，适用于胆结石、胆囊炎患者服用。
Description
一、技术领域
本发明涉及一种治疗胆结石的中药组合物及其制备方法，属生物医药领域。
二、背景技术
肝胆结石病是临床上的常见病、多发病，发病率呈逐年增高趋势。目前世界上大约有胆结石患者5000万人，我国大约有800万人，因与胆石有关的疾病而每年都有50多万人的胆囊被切除。胆结石是由多种原因导致胆管树内形成的凝结物的一种疾病，临床表现主要包括发作性腹痛、急性炎症，以右上腹或右胁疼痛，有放射痛，恶心，厌油腻，腹胀，纳差等基本症状，甚则出现剧烈绞痛，寒颤高热，黄疸等，如果结石进入胆总管后可出现下列并发症：黄疸、胆管炎和胰腺炎等。现代医学认为胆结石的发病机理包括几种要素：(1)胆汁中的胆固醇或钙浓度过高，导致胆汁中容易形成固体结晶而沉淀，并聚集和融合形成结石。胆固醇结石形成的基础为胆汁中胆固醇、胆汁酸以及卵磷脂等成分的比例失调，导致胆汁中的胆固醇呈过饱和状态而发生成晶、析出、结聚、成石。大部分胆汁中的胆固醇来源于肝细胞的生物合成，而不是饮食中胆固醇。胆色素结石包括黑色结石和棕色结石两种。黑色结石主要在患有肝硬变或慢性溶血性疾病患者的胆囊内形成，而棕色结石则既可在胆囊，又可在胆道内形成。(2)胆囊排空功能损害，致使胆汁淤滞，促发胆石形成。(3)某些内分泌激素水平也与胆结石形成有关。(4)细菌感染是原发性胆管结石形成的主要原因。原发性胆管结石在亚洲十分常见，感染源可能归咎于寄生虫如华支睾吸虫或其它不太清楚的病因。(5)胆结石患病随年龄增加而增加，且好发于女性。育龄妇女与同龄男性的患病比率超过3：1，而七十岁以后则下降到2：1。怀孕、肥胖、西化的饮食、全胃肠外营养等因素可增加胆结石的患病风险。(6)人种因素亦与发病相关，如美国西部印第安人患病率超过75％，是全球胆石最高发的人群。(7)在饮食习惯中，凡蛋白质、脂肪、或糖类其中任何一类吃得多者，其胆囊结石或胆固醇结石发病率较高。
中医药在防治胆石病方面有较好的疗效。中医认为与胆结石病变关系最密切的为肝、脾、胆三脏。脾气生发之气，运化无力，湿困脾阳，气不得宣散，肝郁气滞，肝失条达所致肝血亏虚、肝郁脾虚者的胆石症危险因素增大。中医认为胆结石病变主要病因病机有以下几个方面：(1)饮食不节：饥饱无常，过食肥甘厚味、辛辣醇酒等，致使脾胃运化功能失常，湿浊内生，阻碍气机，郁而化热，郁热和湿浊相蕴蒸，胆腑失于通降而发病。(2)情志失调。肝主疏泄，性喜条达，疏利气机，使胆汁的分泌、输送、贮存、排泄正常进行，以助脾胃纳化水谷。过度忧思郁怒、情志不畅，致使肝气郁结，疏泄失常，从而使胆汁化生、输送、排泄失常而致病。(3)蛔虫上扰。寄生虫引起胆道感染或胆石症已是事实。“蛔厥”与胆道蛔虫病相似。蛔虫上扰，使肝胆气郁，疏泄失职，胆汁排泄不畅，久而化热，湿热蕴蒸，形成胆石。中医认为肝胆结石症的发生源于肝失疏泄，或脾虚失运导致胆汁淤滞，久则蕴热，湿热熏蒸而出现诸多临床症状。治疗则以舒肝健脾利胆清热为其原则。现代研究表明具有清热利湿、行气止痛、化石解郁的中药对胆结石有一定疗效，可以排石、碎石、消除胆囊的炎症。
综上所述，本发明认为胆结石无论病因为何，其病机以肝胆气郁、胆汁排泄不畅、湿热蕴蒸最为关键，为此，以疏肝解郁、行气止痛、利胆排石、健脾利湿为法创立本方，临床使用收到良好效果。本发明采用纯中药配制而成，具有疗效确切、安全、无明显毒副作用等特点。
三、发明内容
本发明的目的在于提供一种疗效确切、安全、经济、无明显毒副作用的治疗胆结石的中药组合物及其制备方法，适用于胆结石患者服用。
本发明的技术方案：一种治疗胆结石的中药组合物是由金钱草、黄芩、黄连、大黄、木香、枳壳、郁金、川楝子、虎杖、鸡内金、栀子、芦根等药物制成，其特征在于是由下述原料成分和重量配比制备而成的药剂：金钱草90～360份、黄芩30～90份、黄连10～60份、大黄5～30份、木香30～90份、枳壳30～90份、郁金30～90份、川楝子30～90份、虎杖60～150份、鸡内金30～90份、栀子10～60份、芦根10～60份。
本发明的优选重量配比范围是：金钱草150～300份、黄芩40～80份、黄连20～50份、大黄10～25份、木香40～80份、枳壳40～80份、郁金40～80份、川楝子40～80份、虎杖70～130份、鸡内金40～80份、栀子20～50份、芦根20～50份。
本发明的最佳重量配比范围是：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
一种治疗胆结石的中药组合物制备方法，其特征在于它是采用常规制药工艺制成的药剂，包括以下口服液、散剂、丸剂、颗粒剂、胶囊剂、片剂等剂型。
其中，口服液制备时，按处方量将以上各原料药用水煎煮2～3次，过滤，合并滤液，制成口服液。
散剂制备时，按处方量将以上各原料烘干、粉碎，过80～100目筛，密封包装，即得。
丸剂制备时，按处方量将以上各原料药烘干、粉碎，过80～100目筛，制水泛丸如莱菔子大小，在80℃以下干燥，包装，即得。
颗粒剂制备时，按处方量将以上各原料用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80～100目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为浸润剂，制成颗粒，分装，即得。
胶囊剂制备时，按处方量将以上各原料用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80～100目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为浸润剂，制成颗粒，装胶囊，即得。
片剂制备时，按处方量将以上各原料用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80～100目筛，与0.3～0.5％糊精混匀后，用70-90％乙醇为浸润剂，制成颗粒，加入0.1～0.3硬脂酸镁或0.3～0.5微分硅胶，压片，分装，即得。
本发明的优点在于组方独特，疗效确切、安全、经济、无明显毒副作用，具有疏肝解郁、行气止痛、利胆排石、健脾利湿之功效，适用于胆结石、胆囊炎患者服用。
本发明临床治疗30例胆结石患者，收到良好效果。
1、一般资料：30例患者均为现代医学确诊为胆结石，其中男性11例，女性19例；年龄34～65岁，平均45.2岁。
2、治疗方法：口服3～9g，一日2～3次，一个月为1疗程，平均使用2疗程；基础治疗采用多食用高蛋白食物，促进胆汁排泄，达到更好的效果。
3、疗效评定标准分4级：(1)治愈(临床治愈)：临床症状完全消失，B超显示无结石存在、胆囊壁不厚，无毛糙。(2)显效：临床症状基本消失，B超显示结石体积缩小，或多发结石数量减少，胆囊壁无毛糙。(3)有效：临床症状减轻，B超显示结石结石体积缩小，或多发结石数量减少，胆囊壁毛糙。(4)无效：临床症状无明显改变，B超显示无明显改变。
5、治疗结果：治愈24例，占80％；显效3例，占10％；有效2例，占6.67％；无效1例，占3.33％；总有效率96.67％。临床观察期间未见明显毒副作用。
本发明临床治疗30例胆结石患者疗效情况
四、具体实施方式
下面以具体实施例对本发明作详细说明：
实施例1：
按照下列配比称取原料：金钱草100份、黄芩40份、黄连20份、大黄10份、木香40份、枳壳40份、郁金40份、川楝子40份、虎杖70份、鸡内金40份、栀子20份、芦根20份。
制备方法：采用常规制药工艺制成的药剂，包括以下口服液、散剂、丸剂、颗粒剂、胶囊剂、片剂等剂型。
实施例2：
按照下列配比称取原料：金钱草300份、黄芩80份、黄连50份、大黄20份、木香80份、枳壳80份、郁金80份、川楝子80份、虎杖140份、鸡内金80份、栀子50份、芦根50份。
制备方法：采用常规制药工艺制成的药剂，包括以下口服液、散剂、丸剂、颗粒剂、胶囊剂、片剂等剂型。
实施例3：
按照下列配比称取原料：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
制备方法：采用常规制药工艺制成的药剂，包括以下口服液、散剂、丸剂、颗粒剂、胶囊剂、片剂等剂型。
实施例4：口服液制备
按照下列配比称取原料：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
制备方法：按处方量将以上各原料药用水煎煮2～3次，过滤，合并滤液，制成口服液。
实施例5：散剂制备
按照下列配比称取原料：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
制备方法：按处方量将以上各原料药烘干、粉碎，过80～100目筛，密封包装，即得。
实施例6：丸剂制备
按照下列配比称取原料：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
制备方法：按处方量将以上各原料药烘干、粉碎，过80～100目筛，制水泛丸如莱菔子大小，在80℃以下干燥，包装，即得。
实施例7：颗粒剂制备
按照下列配比称取原料：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
制备方法：按处方量将以上各原料药用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为湿润剂，制成颗粒，分装，即得。
实施例8：胶囊剂制备
按照下列配比称取原料：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
制备方法：按处方量将以上各原料药用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为湿润剂，制成颗粒，装胶囊，即得。
实施例9：片剂制备
按照下列配比称取原料：金钱草180份、黄芩60份、黄连30份、大黄20份、木香60份、枳壳60份、郁金60份、川楝子60份、虎杖90份、鸡内金60份、栀子30份、芦根30份。
制备方法：按处方量将以上各原料药用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为湿润剂，制成颗粒，加入0.1～0.3％硬脂酸镁或0.3～0.5％微分硅胶，压片，分装，即得。
Claims (1)
1.一种治疗胆结石的药物组合物的制备方法，其特征在于原料药及其用量为：金钱草90～360份、黄芩30～90份、黄连10～60份、大黄5～30份、木香30～90份、枳壳30～90份、郁金30～90份、川楝子30～90份、虎杖60～150份、鸡内金30～90份、栀子10～60份、芦根10～60份，所述的制备方法按以下步骤：
(1)将以上各原料药用水煎煮1～3次，过滤，合并滤液，制成口服液；
(2)将以上各原料药烘干、粉碎，过80～100目筛，密封包装，即得散剂；
(3)将以上各原料药烘干、粉碎，过80～100目筛，制水泛丸如莱菔子大小，在80℃以下干燥，包装，即得丸剂；
(4)将以上各原料药用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80～100目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为湿润剂，制成颗粒，分装，即得颗粒剂；
(5)将以上各原料药用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80～100目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为湿润剂，制成颗粒，装胶囊，即得胶囊剂；
(6)将以上各原料药用水煎煮2～3次，过滤，合并滤液，减压浓缩至流浸膏，烘干，粉碎，过80～100目筛，与0.3～0.5％糊精混匀后，用70～90％乙醇为湿润剂，制成颗粒，加入0.1～0.3％硬脂酸镁或0.3～0.5％微粉硅胶，压片，分装，即得片剂。
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