CN104491560B - 一种治疗产后神经性肠梗阻的口服药物 - Google Patents
一种治疗产后神经性肠梗阻的口服药物 Download PDFInfo
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Abstract
本发明公开了一种治疗产后神经性肠梗阻的口服药物，以解决产后神经性肠梗阻的治疗问题。其特征在于，将九香虫、阿利藤、海茜、七叶莲、香构、茖葱、桑葚子、猫爪草、络石藤、柳叶藓、桂枝、焦谷芽混合加水煎煮，30分钟后取滤液，药渣加水继续煎煮20分钟后取滤液，两次滤液合并。临床实验证明：本发明治疗产后神经性肠梗阻具有疗效好和安全性较高的特点，值得临床应用、推广。
Description
技术领域
本发明为发明专利申请《一种治疗产后神经性肠梗阻的敷脐颗粒及其制备方法》（申请号：2013104855729；申请日2013年10月17日）的分案，涉及中药领域，具体涉及一种治疗产后神经性肠梗阻的敷脐颗粒及其制备方法。
背景技术
神经性肠梗阻（Neurosis Intestinal Obstruction，NIO）按照症状分为麻痹性神经性肠梗阻和痉挛性神经性肠梗阻，其发病原因多在于腹腔刺激。无论是自然分娩还是剖腹产，对于腹腔而言都是一种状态的巨大的改变，使之成为NIO的始发因素，继之发生肠肌肉活动障碍。
产后NIO与常见的术后麻痹性肠梗阻不同。其一在于：该病变可以发生在任何分娩方式后，并且与患者体质明确相关，其发生的根源在于该患者对腹腔环境变化的高敏感。其二在于：产后NIO表现为麻痹和痉挛交替发作，症状不稳定，而术后麻痹性肠梗阻则为肠道麻痹造成动力不足。
目前该病变出现后的处理同术后麻痹性肠梗阻，即使用促进肠蠕动的药物。但是由于二者病理基础不同，部分病例为肠道痉挛状态，使用促肠蠕动的药物反而加重症状。而自然分娩后出现的NIO尚未有恰当的治疗方案。
发明内容
本发明的技术任务是针对以上现有技术的不足，提供一种疗效肯定且副作用小的治疗产后神经性肠梗阻的敷脐颗粒及其制备方法。
本发明解决其技术问题的技术方案是：一种治疗产后神经性肠梗阻的口服药物，其特征在于，将九香虫、阿利藤、海茜、七叶莲、香构、茖葱、桑葚子、猫爪草、络石藤、柳叶藓、桂枝、焦谷芽混合加水煎煮，30分钟后取滤液，药渣加水继续煎煮20分钟后取滤液，两次滤液合并。
其中所述的：九香虫，为蝽科昆虫九香虫Aspongopus chinensis Dallas 的干燥体。性味咸，温。归肝、脾、肾经。功可理气止痛，温中助阳。
阿利藤，为夹竹桃科植物链珠藤的全草及根。苦辛，平。入肺、肝、脾三经。功可祛风利湿，活血通络。
海茜，为马尾藻科植物马尾藻Sargassum enerve C.Ag.、亨氏马尾藻Sargassumhenslowianum C.Ag.、鼠尾藻Sargassum thunbergii（Mert.）O.Kuntze或铜藻argassumhorneri（Turn.）C. Ag的藻体。性味咸；寒。归肝；胃；肾经。功可软坚散结；清热化痰。
七叶莲，为五加科鹅掌柴属植物鹅掌藤Scheffleva arboricola Hayata 和密脉鹅掌柴S.venulosa （Wight et Arn.）Harms，以茎及叶入药。性味苦、甘，温。功可止痛散瘀，消肿。
香构，为瑞香科植物小黄构Wikstroemia micrantha Hemsl.的茎皮和根。味甘；性平。归肺经。功可止咳化痰；消热解毒。
茖葱，为百合科植物茖葱Allium victorialis L.的鳞茎。归肺经。功可散瘀；止血；解毒。
桑葚子，为桑科植物桑Morus alba L. 的干燥果穗。性味甘、酸，寒。归心、肝、肾经。功可补血滋阴，生津润燥。
猫爪草，为毛茛科植物小毛茛Ranunculus ternatus Thunb. 的干燥块根。性味甘、辛，温。归肝、肺经。功可散结，消肿。
络石藤，为夹竹桃科植物络石Trachelospermum jasminoides （Lindl.）Lem.的干燥带叶藤茎。苦，微寒。归肾、肝、肾经。功可祛风通络，凉血消肿。
柳叶藓，柳叶藓，为柳叶藓科植物柳叶藓Amblystegium serpens（Hedw.）B.S.G.的植物体。性味涩；平。功可收敛止血。
桂枝，为樟科植物肉桂 Cinnamomum cassia Presl的细枝。性味辛、甘，温。入心、肺、膀胱经。功可发汗解表，温通经脉，通阳化气。
焦谷芽，为禾本科植物粟Setaria italica （L.） Beauv.的成熟果实经发芽干燥，照清炒法炒至焦褐色。性味甘，温。归脾、胃经。功可消食和中，健脾开胃。
与现有技术相比较，本发明具有以下特点。
1、立论独特：从通络入手，以恢复肠壁神经修复为目的，避免使用泻下药物，因为泻下药物虽然能解决一时的腹胀，但是对肠壁又造成了新的刺激，久生他变，迁延不愈。且刺激性泻药，对于母乳喂养的患者，大多导致婴儿大便次数增多而停止哺乳。
2、以九香虫、阿利藤为君：发明人临床经验所得，神经性肠梗阻是术中肠壁神经受到刺激后的一种反射性表现，而九香虫理气止痛，阿利藤活血通络，可以减少这种刺激性反射给肠道带来的不良反应。基础药理试验证实：不完全性小肠梗阻模型大鼠九香虫（20g生药/kg/d）和阿利藤（10g生药/kg/d）混合水煎液灌胃，可以降低小肠粘膜损伤，对不完全肠梗阻大鼠肠粘膜具有保护作用；并用炭末法观察大鼠肠蠕动的推进作用，九香虫、阿利藤联合用药组的推进率（84.42±13.24）%明显高于空白组（59.33±15.62）%。
3、以海茜软坚散结、香构消化有形之痰、络石藤疏风通络、七叶莲止痛、茖葱散瘀、猫爪草散结消肿作为臣药辅助君药：气息不达，久之则会痰积阻滞，故而选香构、海茜去除肠道脉络中的有形之痰，络石藤、猫爪草增加药物行走脉络的能力。七叶莲可以降低肠道高张力状态，缓解肠道痉挛，但同时并不影响肠道蠕动节律，这个特点是其他止痛药物所没有的，尤其适合于本病使用。茖葱具有散瘀不耗气的特点，尤其适合于产后虚实夹杂使用。
4、产后大量使用补益药物会影响胃肠道运化，故本发明组方仅仅以一味桑葚子补血滋阴。
5、小剂量的柳叶藓、桂枝为反佐药，对抗本组方中寒凉药物过多而有耗气伤阴之虞，且其通阳化气的作用也与九香虫呼应，有助于行散。而柳叶藓的使用，是防止本发明配方中的活血药物动血生风。
6、焦谷芽性味甘温，归脾胃经，取护阳卫中之意，且所含的焦化成分有收敛作用，散中有收之意。
7、方中所取药物均一药多效，有助于减少药物种类和用量，不增加肝肾负担。
8、本发明药物原料用量是经发明人进行大量摸索总结得出的，各原料用量为在下述重量份范围都具有较好的疗效。
9、采用敷脐剂型，服用方便，依从性好，便于接受。
具体实施方式
以下结合实际情况，对本发明的具体实施方式作详细说明。
实施例1，原料药重量配比：九香虫20份、阿利藤10份、海茜6份、七叶莲10份、香构6份、茖葱10份、桑葚子10份、猫爪草10份、络石藤10份、柳叶藓2份、桂枝6份、焦谷芽20份。
实施例1的制备方法是：将九香虫、阿利藤、海茜、七叶莲、香构、茖葱、桑葚子、猫爪草、络石藤、柳叶藓、桂枝、焦谷芽混合加水煎煮，30分钟后取滤液，药渣加水继续煎煮20分钟后取滤液，两次滤液合并，分成两份早晚服用。
实施例2，原料药重量配比：九香虫10份、阿利藤6份、海茜3份、七叶莲6份、香构3份、茖葱6份、桑葚子6份、猫爪草6份、络石藤6份、柳叶藓1份、桂枝3份、焦谷芽10份。
实施例3，原料药重量配比：九香虫20份、阿利藤10份、海茜6份、七叶莲10份、香构6份、茖葱10份、桑葚子10份、猫爪草10份、络石藤10份、柳叶藓2份、桂枝6份、焦谷芽20份。
实施例4，原料药重量配比：九香虫30份、阿利藤12份、海茜10份、七叶莲12份、香构10份、茖葱12份、桑葚子12份、猫爪草12份、络石藤12份、柳叶藓5份、桂枝10份、焦谷芽25份。
实施例2~4的中药可按下列方法制备而成：
（1）将桑葚子、阿利藤、香构粗粉各自浸泡4小时后以水蒸气蒸馏提取挥发油6小时，并收集后混合备用，药渣备用；
（2）将柳叶藓、焦谷芽粉碎过150目筛，成细粉备用；
（3）将九香虫、海茜、七叶莲、茖葱、猫爪草、络石藤、桂枝和步骤1中所得药渣混匀以5倍量80％乙醇提取2次，每次2小时，合并两次乙醇提取液，滤过，回收乙醇并减压浓缩成60℃时相对密度为1.25～1.30的浸膏；
（4）将步骤2中所得细粉加入步骤3中所得浸膏混匀，60℃烘干，粉碎成细粉，加入聚山梨酯-80制成颗粒，烘干，整粒，喷入步骤1中所得挥发油，混匀，分装，即得。
上述药物的有效组合，互相协调，有效达到治疗产后神经性肠梗阻之目的，且副作用较少。上述结果为临床资料充分证明，有关资料如下。
1 对象与方法。
1.1 对象 。
1.1.1 病例选择：病例选自2009年1月~2013年9月产后7天内出现神经性肠梗阻的病例73例。其中自然分娩24例，剖腹产分娩49例。
1.1.2 神经性肠梗阻诊断标准：（1）腹痛：阵发性腹痛；（2）呕吐：高位梗阻呕吐较频繁，低位梗阻呕吐次数较少，呕吐物带有粪臭；（3）腹胀：低位梗阻全腹膨胀，常伴肠型，高位梗阻腹胀不明显；（4）排气与排便停止；（5）体征：膨胀的肠管有压痛、反跳痛；肠鸣音微弱或消失或气过水声；（6）X线诊断肠梗阻有重要价值。并排除机械性肠梗阻。
1.1.3随机分为三组：对照组25例，汤药组23例，敷脐组25例。三组患者治疗前在年龄、妊娠周数上比较，差异无统计学意义（P>0.05），具有可比性。
1.2 方法。
1.2.1治疗方法：对照组采取胃肠减压、补液、纠正酸碱平衡失调，抗感染治疗，汤药组在对照组用药基础上加用实施例1所得汤药，2次/d；敷脐组在对照组用药基础上加入所述的实施例3所得敷脐剂醋调敷，2次/d，共5d。
1.2.2依据《中药新药临床研究指导原则》中肠梗阻的疗效标准判定。痊愈：临床症状体征消失，正常肛门排气排便，肠鸣音恢复，腹部X线检查肠管充气扩张消失，可以拔除胃肠减压管。显效：临床症状体征明显减轻，肠鸣音基本恢复，腹部X线检查肠管充气扩张明显减轻，可以关闭胃肠减压管观察。有效：腹部胀痛有所减轻，排气、排便不畅，腹部听诊肠鸣音弱，腹部X线检查肠管充气扩张减轻，仍需留置胃肠减压管。无效：用药72 h后仍无排气、排便，临床症状体征无缓解或加重。
1.2.3 统计学分析：SPSS 13.0进行统计学分析。计量资料用t检验，计数资料用χ2检验。
2 结果。
2.1 三组临床疗效比较：见下表。结果显示，汤药组和敷脐组的治愈率明显高于对照组（汤药组P<0.01；敷脐组P<0.05）；汤药组和敷脐组的总有效率高于对照组（P<0.05）。
| 组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
| 对照组 | 25 | 2（8.00%） | 8（32.00%） | 8（32.00%） | 7（28.00%） | 72.00% |
| 汤药组 | 23 | 12（52.17%） | 6（26.09%） | 4（17.39%） | 1（4.35%） | 95.65% |
| 敷脐组 | 25 | 8（32.00%） | 11（44.00%） | 5（20.00%） | 1（4.00%） | 96.00% |
2.2三组患者不良反应发生率比较：三组均未出现明显不良反应记录。汤药组有4.35%（1/23）患者出现因婴儿大便次数 > 6次/天而停止母乳喂养情况，对照组和敷脐组均未出现。
3．结论。
本研究结果显示，使用本发明的汤药或者敷脐后，产后神经性肠梗阻患者治愈率、总有效率明显高于对照组，且未出现明显不良反应记录，说明本发明方法制备的药物组合物在治疗产后神经性肠梗阻方面拥有疗效好、不良反应较轻的优点。
Claims (1)
1.一种治疗产后神经性肠梗阻的口服药物，其特征在于，原料药重量配比：九香虫20份、阿利藤10份、海茜6份、七叶莲10份、香构6份、茖葱10份、桑葚子10份、猫爪草10份、络石藤10份、柳叶藓2份、桂枝6份、焦谷芽 20 份；将九香虫、阿利藤、海茜、七叶莲、香构、茖葱、桑葚子、猫爪草、络石藤、柳叶藓、桂枝、焦谷芽混合加水煎煮，30分钟后取滤液，药渣加水继续煎煮 20 分钟后取滤液，两次滤液合并。
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