CN105412204A - 一种治疗老年性便秘的药物组合物及其应用 - Google Patents
一种治疗老年性便秘的药物组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种治疗老年性便秘的药物组合物及其应用，该组合物由如下重量份的中药材原料制备而成：南瓜蒂40-70重量份、上山虎21-30重量份、栝楼皮6-11重量份。本发明可促进胃肠蠕动，显著缩短大便间隔及减轻腹部胀满症状，从而达到治愈老年性便秘的目的。
Description
技术领域
本发明属于中药技术领域，尤其涉及一种治疗老年性便秘的药物组合物及其应用。
背景技术
便秘是老年患者的常见症状，大约有35％的老年人有此症状，便秘患者排便次数明显较正常人少，同时排便困难，粪便干结，肠道疾病及其他全身性疾病都会引起其发生，便秘的发生随着年龄的增加而加重，给老年人带来很多危害，比如肛裂、痔疮、多发性腹痛、直肠癌，严重影响着患者的生活质量，甚至诱发和加重心脑血管疾病，造成猝死。西医对老年性便秘的治疗常选用大黄苏打片、开塞露、莫沙比利等对症治疗，往往能当时见效，但此类药物长期运用易形成药物依耐性便秘，停药后又出现便秘，症状反复。
发明内容
本发明的目的在于提供一种治疗老年性便秘的药物组合物及其应用。该药物组合物疗效确切，能安全、有效地改善患者的便秘症状，愈后不复发，没有药物依耐性的缺点。
本发明的目的是这样实现的：
一种治疗老年性便秘的药物组合物，由如下重量份的中药材原料制备而成：南瓜蒂40-70重量份、上山虎21-30重量份、栝楼皮6-11重量份。
优选地，如上所述的所述的治疗老年性便秘的药物组合物，它由如下重量份的中药材原料制备而成：南瓜蒂57-62重量份、上山虎24-26重量份、栝楼皮7-9重量份。
在本发明一个最优选的实施例中，如上所述的药物组合物由如下重量份的中药材原料制备而成：南瓜蒂60重量份、上山虎25重量份、栝楼皮8重量份。
需要说明的是，本发明治疗老年性便秘的药物组合物中所采用的中药材原料具有如下来源：南瓜蒂为葫芦和植物南瓜Cucurbitamoschata(Duch.ExLam.)Duch.ExPoir.的干燥瓜蒂。栝楼皮为葫芦科植物栝楼TrichosantheskiarlowiiMa-xim.的干燥果皮。上山虎为冬青科植物榕叶冬青IlexficoideaHemsl.的干燥根。
进一步优选地，如上所述的治疗老年性便秘的药物组合物是口服制剂。
再进一步优选地，如上所述的治疗老年性便秘的药物组合物是口服液、颗粒剂、片剂和胶囊剂。
老年性便秘患者机体代谢功能下降，肠蠕动减慢。肠腔内毒素过多吸收、过度用力排便可致发生各类疝，甚至诱发心绞痛、心肌梗死、脑出血、脑中猝死。而长期应用泻药可导致结肠黑变病，长期便秘者还易发生结肠癌。本发明人在动物实验研究阶段发现，南瓜蒂醇提物可提高盲肠切除小鼠的小肠碳末推进率，缩短碳末排出时间；当南瓜蒂醇提物与上山虎、栝楼皮的水提物联合用药时，其能更好地促进肛门排气，消除腹部胀满，从而增强了上山虎栝楼皮在行气导滞方面的效果，适合治疗老年性便秘。因此，本发明的第二个目的在于提供一种制药新用途，即上述的药物组合物在制备润肠通便的药物或保健食品中的应用。
本发明的药物组合物可促进胃肠蠕动，显著缩短大便间隔及减轻腹部胀满症状，从而达到治愈老年性便秘的目的。另外，本发明采用纯中草药材制成，原料来源广泛、成本低，副作用小，有望开发成临床一线用药。
具体实施方式
下面是本发明药物组合物的制备实施例和临床应用例，对本发明做进一步的说明和解释。
实施例1中药提取物的制备
处方：南瓜蒂1.2kg、上山虎0.5kg、栝楼皮0.16kg。
制备工艺：
(1)称取处方量的上山虎，用无水乙醇回流提取3次，每次乙醇用量为8L，时间为2h，滤过，合并滤液，所得滤液在0.07MPa减压浓缩至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，得醇提物；
(2)称取处方量的南瓜蒂和栝楼皮合并，加水煎煮提取2次，第一次加水8L，煎煮1.5h，第二次加水7L，煎煮1h，滤过，合并滤液，所得滤液在0.07MPa减压浓缩至65℃时相对密度为1.25，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，得水提物；
(3)将步骤(1)所得醇提物干粉与步骤(2)所得水提物干粉混匀，得中药提取物。
实施例2
制备工艺：将处方中的中药提取物干粉(实施例1制备)、维生素K2、羧甲基纤维素钠、西黄蓍胶、蔗糖和枸橼酸钠，分别过100目筛，按处方量称取，混匀，加10％淀粉浆制成软材，以14目筛制粒后，置80℃左右干燥后用12目筛整粒，按每包15g分装即可。临床应用例
按照1999年9月国际RomeⅡ协作委员会在RomeⅠ基础上制订RomeⅡ功能性胃肠疾病的-系列诊断标准中有关慢性便秘的诊断标准，经确诊的老年性便秘患者94例，年龄55-72岁，平均(63.7±8.6)岁，男74例，女20例。随机分为实验组47例和对照组47例。两组的性别、年龄、便秘程度、病程等差异均无统计学意义，具有可比性。
实验组患者采用本发明实施例1制备的中医颗粒剂治疗，1包/次，3次/d，开水冲服，治疗2周。对照组患者采用莫沙必利片(5mg/片，江苏豪森药业股份有限公司，生产批号11102303)治疗，5mg/次，3次/d，治疗2周。治疗结束后，按症状轻、中、重分别计1、3、5分，统计两组患者的各种症状得分情况。大便质地：大便硬为轻度，大便很硬为中度，大便呈硬球形为重度；大便间隔时间：大便间隔不多于3d为轻度，大便间隔多于3d，但不超过6d为中度，大便间隔9d或9d以上定为重度；腹部胀满：腹部胀满感轻微者为轻度，腹部胀满可忍受者中度，腹部胀满难忍受者为重度。
两组症状缓解情况见表1、表2、表3。根据表1、表2、表3的试验统计结果可以看出，实验组在治疗前大便质地、间隔及腹部胀满症状与对照组相近(P＞0.05)，治疗后较对照组明显改善(P＜0.05)，其中以大便间隔改善最为显著(P＜0.01)。
表1两组患者大便质地得分比较
*与对照组比较，P＜0.05。
表2两组患者大便间隔得分比较
**与对照组比较，P＜0.01。
表3两组患者腹部胀满得分比较
*与对照组比较，P＜0.05。
Claims (6)
1.一种治疗老年性便秘的药物组合物，其特征在于，所述的药物组合物由如下重量份的中药材原料制备而成：南瓜蒂40-70重量份、上山虎21-30重量份、栝楼皮6-11重量份。
2.根据权利要求1所述治疗老年性便秘的药物组合物，其特征在于，所述的药物组合物由如下重量份的中药材原料制备而成：南瓜蒂57-62重量份、上山虎24-26重量份、栝楼皮7-9重量份。
3.根据权利要求2所述治疗老年性便秘的药物组合物，其特征在于，所述的药物组合物由如下重量份的中药材原料制备而成：南瓜蒂60重量份、上山虎25重量份、栝楼皮8重量份。
4.根据权利要求1-3任一项所述治疗老年性便秘的药物组合物，其特征在于，所述的药物组合物是口服制剂。
5.根据权利要求4所述的治疗老年性便秘的药物组合物，其特征在于，所述的口服制剂是口服液、颗粒剂、片剂或胶囊剂。
6.权利要求1-3任一项所述药物组合物在制备润肠通便的药物或保健食品中的应用。
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| CN1533805A (zh) * | 2004-04-07 | 2004-10-06 | 金建文 | 以南瓜为主要原料制备的治疗便秘的胶囊配方及配制方法 |
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| CN1533805A (zh) * | 2004-04-07 | 2004-10-06 | 金建文 | 以南瓜为主要原料制备的治疗便秘的胶囊配方及配制方法 |
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| 韦丰: "皮的药用(十九)", 《开卷有益(求医问药)》 * |
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