CN105796886A - 一种治疗慢性便秘的药物组合物 - Google Patents
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Abstract
本发明属于中药领域，涉及一种药物组合物，特别涉及一种治疗慢性便秘的药物组合物及其作为慢性便秘治疗药物的应用，其由如下组分组成：锁阳、肉苁蓉、陈皮、苦杏仁、玉竹、麦冬、香附、大黄。该药物组合物制备简单，作用全面，在起到润肠通便作用的同时，还能够起到补肾健脾、养阴生津的功效，能够从根本上调理慢性便秘患者的体质，且成本低廉，无毒副作用，愈后不易复发，在治疗慢性便秘方面具有很好的应用前景。
Description
技术领域
本发明属于医药领域，具体涉及一种药物组合物及其作为慢性便秘治疗药物的应用。
背景技术
便秘是临床常见的复杂症状，主要是以排便次数减少、粪便量减少、粪便干结、排便费力，或虽有便意而欲排不排，或便后不爽，或肛门坠胀等为临床表现的一种病症。如超过6个月即为慢性便秘。随着社会的发展，工作压力的增加，饮食结构的单一，便秘患者数量逐渐增多，尤其多见于中老年人。中医认为便秘是肠腑传导失常所致，病在大肠与脾胃肾有关。脾虚血少失于襦润或中气不足排送无力，故传导失司，胃热内盛，大肠燥屎内结，大便难行；肾主二便.阴寒内凝则传送不利，排便不畅，阴精不足则大便干燥，失于润滑排出困难。中老年人肝肾亏虚，受风寒湿邪侵袭及劳损外伤，导致局部气血瘀滞，筋骨失养更易发生慢性便秘。便秘形成后，轻则固体内有害物质不能排出产生头晕、恶心、心烦易怒等系列中毒症状，重者引起贫血、直肠溃疡，诱发或加重痔疮、直肠脱垂等病。还可以加重高血压、冠心病、哮喘等许多慢性病。
西药治疗便秘有一定的疗效，但副作用多，疗效不彻底祖国医学对于便秘的治疗记载丰富，历来主张从整体出发，针对病因，调节饮食起居，遵照“保胃气，存津液”的原则，合理用药，辨证施治，标本兼治。专利号为ZL200410073958.X的专利就公开了一种具有通便排毒、减肥降脂功能的组合物及制备方法，它是以何首乌、决明子、芦荟、枸杞子、阿胶、人参等原料制成，虽然有一定的疗效，但是用料贵重，成本较高，普通患者难以承受。
发明内容
针对现有技术不足，本发明公开了一种治疗慢性便秘的药物组合物及其制备方法，本发明药物组合物组方严谨，配伍科学，疗效确切，成本低廉，是一种治疗慢性便秘的有效药物，值得临床推广应用。
本发明的一个目的在于提供一种治疗慢性便秘的药物组合物，包括如下组分：锁阳、肉苁蓉、陈皮、苦杏仁、玉竹、麦冬、香附、大黄。各药物配伍应用，具有显著的补肾健脾、养阴生津、润肠通便的治疗效果。
优选的是，按照重量组分计，它由以下原料药制得：锁阳16-20份、肉苁蓉6-12份、陈皮10-14份、苦杏仁4-6份、玉竹8-12份、麦冬10-14份、香附8-12份、大黄3-5份。
更优选的是，按照重量组分计，它由以下原料药制得：锁阳18份、肉苁蓉9份、陈皮12份、苦杏仁5份、玉竹10份、麦冬12份、香附10份、大黄4份。
锁阳：【性味】甘，温。【归经】归脾、肾、大肠经。【功能主治】补肾阳，益精血，润肠通便。用于腰膝痿软，阳痿滑精，肠燥便秘。
肉苁蓉：【性味】甘、咸，温。【归经】归肾、大肠经。【功能主治】补肾阳，益精血，润肠通便。用于阳痿，不孕，腰膝酸软，筋骨无力，肠燥便秘。
陈皮：【性味】苦、辛，温。【归经】归肺、脾经。【功能主治】理气健脾，燥湿化痰。用于胸脘胀满，食少吐泻，咳嗽痰多。
苦杏仁：【性味】苦，微温；有小毒。【归经】归肺、大肠经。【功能主治】降气止咳平喘，润肠通便。用于咳嗽气喘，胸满痰多，血虚津枯，肠燥便秘。
玉竹：【性味】甘，微寒。【归经】归肺、胃经。【功能主治】养阴润燥，生津止渴。用于肺胃阴伤，燥热咳嗽，咽干口渴，内热消渴。
麦冬：【性味】甘，微苦，微寒。【归经】归心、肺、胃经。【功能主治】养阴生津，润肺清心。用于肺燥干咳。虚痨咳嗽，津伤口渴，心烦失眠，内热消渴，肠燥便秘；咽白喉。
香附：【性味】辛、微苦、微甘，平。【归经】归肝、脾、三焦经。【功能主治】行气解郁，调经止痛。用于肝郁气滞，胸、胁、脘腹胀痛，消化不良，胸脘痞闷，寒疝腹痛，乳房胀痛，月经不调，经闭痛经。
大黄：【性味】苦，寒。【归经】归脾、胃、大肠、肝、心包经。【功能主治】泻热通肠，凉血解毒，逐瘀通经。用于实热便秘，积滞腹痛，泻痢不爽，湿热黄疸，血热吐衄，目赤，咽肿，肠痈腹痛，痈肿疔疮，瘀血经闭，跌打损伤，外治水火烫伤；上消化道出血。
本发明还公开上述药物组合物的制备方法，如下：取上述重量组分的各药材，加药材总重量的5-8倍的水，浸泡2-4小时，煎煮1-3次，每次2-3小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.26的浸膏，该相对密度是在60摄氏度下的检测结果，加入乙醇至含醇量为60-80％(v/v)，冷藏静置48小时，滤过，回收乙醇减压浓缩成浸膏。再加入药学上可接受的载体，用常规方法制备成临床可以接受的剂型。
本发明还公开上述药物组合物的一种用途，即上述药物组合物在制备治疗慢性便秘的药物中的用途。通过观察本发明药物组合物对临床慢性便秘患者的治疗实验发现，使用本发明提供的药物组合物按疗程治疗后，患者痊愈率72％、总有效率100％，均优于对照1、2组，且差异性极显著，具有统计学意义(P＜0.01)。对照2组虽然痊愈率优于对照1组，但明显不如治疗组，且差异性极显著治，表明随意改变组方，不能达到本发明的治疗效果。
本发明作为慢性便秘治疗药物使用时，药物作用全面，在起到润肠通便作用的同时，还能够起到补肾健脾、养阴生津的功效，能够从根本上调理慢性便秘患者的体质。并且本发明药物组合物制备简单，基本无毒，原料易得，适于大众化使用。总之，本发明与现有技术相比，对于慢性便秘有较好的治疗效果，且成本低廉，无毒副作用，愈后不易复发，，特别是痊愈率患者，愈后观察半年无一例无复发，具有很好的应用前景。
具体实施方式
以下通过具体实施方式进一步描述本发明，但本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内，对本发明所述的药物组合物进行适当改进、替换功效相同的组分，对于本领域技术人员来说是显而易见的，它们都被视为包括在本发明的范围之内。
实施例1本发明的药物组合物胶囊剂
处方：锁阳18份、肉苁蓉9份、陈皮12份、苦杏仁5份、玉竹10份、麦冬12份、香附10份、大黄4份。
制备方法：取上述重量组分的各药材，加药材总重量的5-8倍的水，浸泡2-4小时，煎煮1-3次，每次2-3小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.26的浸膏，该相对密度是在60摄氏度下的检测结果，加入乙醇至含醇量为60-80％(v/v)，冷藏静置48小时，滤过，回收乙醇减压浓缩成浸膏。再加入药学上可接受的载体，用常规方法制备成胶囊剂。
使用本发明中药制剂治疗小儿便秘时，服用所制备的胶囊剂，每粒含生药量0.3g，每日3次，每次2-4粒，饭后半小时服用。
实施例2本发明的药物组合物颗粒剂
处方：锁阳18份、肉苁蓉9份、陈皮12份、苦杏仁5份、玉竹10份、麦冬12份、香附10份、大黄4份。
制备方法：取上述重量组分的各药材，加药材总重量的5-8倍的水，浸泡2-4小时，煎煮1-3次，每次2-3小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.26的浸膏，该相对密度是在60摄氏度下的检测结果，加入乙醇至含醇量为60-80％(v/v)，冷藏静置48小时，滤过，回收乙醇减压浓缩成浸膏。再加入药学上可接受的载体，用常规方法制备成颗粒剂。
使用本发明中药制剂治疗小儿便秘时，服用所制备的颗粒剂，每袋含生药量1.5g，每日2次，每次1袋，饭后半小时服用。
实施例3本发明药物组合物口服液剂
处方：锁阳18份、肉苁蓉9份、陈皮12份、苦杏仁5份、玉竹10份、麦冬12份、香附10份、大黄4份。
制备方法：取上述重量组分的各药材，加药材总重量的5-8倍的水，浸泡2-4小时，煎煮1-3次，每次2-3小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.26的浸膏，该相对密度是在60摄氏度下的检测结果，加入乙醇至含醇量为60-80％(v/v)，冷藏静置48小时，滤过，回收乙醇减压浓缩成浸膏。再加入药学上可接受的载体，用常规方法制备成口服液剂。
使用本发明中药制剂治疗小儿便秘时，服用所制备的口服液，每瓶含生药量1g，每日3次，每次1瓶，饭后半小时服用。
实施例4本发明药物组合物胶囊剂
处方：锁阳16份、肉苁蓉6份、陈皮10份、苦杏仁4份、玉竹8份、麦冬10份、香附8份、大黄3份。
制备和服用方法同实施例1。
实施例5本发明药物组合物胶囊剂
处方：锁阳20份、肉苁蓉12份、陈皮14份、苦杏仁6份、玉竹12份、麦冬14份、香附12份、大黄5份。
制备和服用方法同实施例1。
对比实施例
处方：肉苁蓉9份、陈皮12份、麻仁5份、玉竹10份、麦冬5份、香附10份、大黄4份。
制备和服用方法同实施例1。
临床观察试验
1.一般资料：
选取医院门诊进行就诊的慢性便秘患者150例(排除肠道器质性病变患者)。采用随机数字法分为治疗组、对照组1组、对照2组，各组患者均为50例。
其中，治疗组，男29例、女21例；年龄35-75岁，平均年龄(51.2±3.26)岁；病程(10.28±4.63)个月，排便间隔时间(4.56±1.78)天。对照1组，男27例、女23例；年龄36-72岁，平均年龄(49.8±3.66)岁；病程(9.75±3.21)个月，排便间隔时间(4.32±1.84)天。对照2组，男30例、女20例；年龄34-71岁，平均年龄(50.6±4.17)岁；病程(9.84±4.75)个月，排便间隔时间(5.15±2.06)天。三组性别比例、年龄、病程等方面经统计学处理，无显著性意义(P＞0.05)，具有可比性。
2.治疗方法：
对照1组：患者服用西沙必利10mg，每日3次，餐前半小时服用。
对照2组：患者服用对比实施例制备的胶囊剂，每粒含生药量0.3g，每日3次，每次2-4粒，饭后半小时服用。
治疗组：患者服用本发明实施例1制备的胶囊剂，每粒含生药量0.3g，每日3次，每次2-4粒，饭后半小时服用。
3组患者均连续服药2个月，2个月后进行疗效判断。患者在用药期间。禁止食油腻、辛辣、生冷食物，保证治疗效果。在治疗期间，不服用其他治疗该病的中西药。
3.疗效标准：
痊愈：排便正常，伴随症状全部消失；
显效：便秘明显改善、间隔时间及便质接近正常，或排便稍平、间隔时间在72h以内，伴随症状大部分消失；
有效：排便时间间隔缩短1天，或便质干结改善，伴随症状均好转；
无效：便秘及伴随症状均无改善。
4.统计学方法
用统计学软件SPSS20.0对数据进行统计学分析，计数资料采用x2检验；计量资料用均数±标准差表示，进行t检验；P＜0.05表示两组之间差异性显著。
5.治疗结果
1)试验各组患者的具体治疗结果如表1所示。
表1：三组患者临床效果比较(n，％)
注：治疗组痊愈率与对照1组比较，*P＜0.01，与对照2组比较，◎P＜0.01。
三组在治疗过程中无脱落病例，均完成临床观察。治疗2个疗程后总疗效比较，从表1比较可以看出，治疗组中痊愈率72％、总有效率100％，均优于对照1或2组，且痊愈率差异性极显著。对照2组虽然痊愈率优于对照1组，但明显不如治疗组，且差异性极显著，表明随意改变组方，不能达到本发明的治疗效果。
通过观察患者的安全性检查结果，治疗期间治疗组未出现与用药有关的不良反应，治疗前后肝肾功能各项指标及心电图均未出现较大波动，说明本发明药物安全可靠。
综上，本发明提供了一种药物组合物及其制备方法，该药物组合物制备简单，作用全面，在起到润肠通便作用的同时，还能够起到补肾健脾、养阴生津的功效，能够从根本上调理慢性便秘患者的体质，且成本低廉，无毒副作用，愈后不易复发，特别是痊愈率患者，愈后观察半年无一例无复发，在治疗慢性便秘方面具有很好的应用前景。
Claims (7)
1.一种治疗慢性便秘的药物组合物，其特征在于，它由以下原料药制得：锁阳、肉苁蓉、陈皮、苦杏仁、玉竹、麦冬、香附、大黄。
2.如权利要求1所述的药物组合物，其特征在于，它由以下重量份的原料药制得：锁阳16-20份、肉苁蓉6-12份、陈皮10-14份、苦杏仁4-6份、玉竹8-12份、麦冬10-14份、香附8-12份、大黄3-5份。
3.如权利要求1所述的药物组合物，其特征在于，它由以下重量份的原料药制得：锁阳18份、肉苁蓉9份、陈皮12份、苦杏仁5份、玉竹10份、麦冬12份、香附10份、大黄4份。
4.如权利要求1所述的药物组合物，其特征在于，所述药物组合物制备成口服制剂。
5.如权利要求4所述的药物组合物，其特征在于，所述口服制剂为胶囊剂、颗粒剂或口服液剂。
6.一种制备如权利要求1-3所述的药物组合物的方法，其特征在于，它包括以下步骤：取上述重量组分的各药材，加药材总重量的5-8倍的水，浸泡2-4小时，煎煮1-3次，每次2-3小时，滤过，合并滤液，滤液减压浓缩至相对密度1.11-1.26的浸膏，该相对密度是在60摄氏度下的检测结果，加入乙醇至含醇量为60-80％(v/v)，冷藏静置48小时，滤过，回收乙醇减压浓缩成浸膏，再加入药学上可接受的载体，用常规方法制备成临床可以接受的剂型。
7.如权利要求1-3任一所述的药物组合物在制备治疗慢性便秘的药物中的用途。
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| CN101129770A (zh) * | 2007-08-27 | 2008-02-27 | 尹克华 | 治疗慢性便秘的中药 |
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