CN105998481A - 一种镇咳祛痰的中药复方制剂及其制备方法 - Google Patents
一种镇咳祛痰的中药复方制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种镇咳祛痰的中药复方制剂，该制剂由以下重量份的原料制得黄腐酸盐8～14份、甘草6～13份、桑白皮5～7份、紫苏叶5～12份、半夏3～8份、紫菀7～10份、杏仁4～6份、黄岑10～12份；本发明所用的原料容易获得，资源丰富，在传统镇咳祛痰药的基础上创造性地使用黄腐酸盐来治疗咳嗽、痰多的症状。本发明相对其他镇咳祛痰药物有更好的疗效，且含片剂型使用方便，便于携带，能更好地满足临床需求。
Description
技术领域
本发明涉及医药技术领域，具体是一种镇咳祛痰的黄腐酸盐中药复方制剂及其制备方法。
背景技术
咳嗽本身是机体的一种重要的生理性反射，它有利于将进入呼吸道的细菌和异物排出体外。但是过度咳嗽痰多，是呼吸道疾病的常见症状。咳嗽一般由急性和慢性支气管炎、肺炎、上呼吸道感染引起，且易反复。痰是呼吸道分泌出的黏液，痰多容易堵住呼吸道，造成呼吸不畅，严重者引起呼吸困难，危及生命。
老年人作为一个特殊人群，咳嗽发病的情况相当严重，而我国最新的人口普查结果显示，我国老年化的进程在加速。因此，老年人咳嗽的诊断与治疗就成为一个重要的话题，引起了广泛的关注。咳嗽反射弧包括感受器、传入神经、神经中枢、传出神经和效应器。咳嗽中枢位于延髓弧束核附近，咳嗽反射弧的传出神经包括第3～5颈神经(膈神经)、胸神经(肋间神经)、迷走神经(气道)和喉返神经(喉、声门)。咳嗽反射的效应器由气道平滑肌、呼气肌(主要是肋间内肌)、隔肌和声门等组成。咳嗽的目的是为了有效移除痰液和微粒，因此痰液的物理性质也影响咳嗽的有效性。载液的清除与载液的深度成正比，与载液的载滞性、弹性成反比。
冬季是感冒咳嗽多发的季节，老年人体质偏弱，免疫力较差，更易得病。我国地域辽阔，人口复杂，有地域性多发咳嗽的现象。与南方相比，北方冬季更加寒冷，风更加凛冽，近年来北方城市空气也变得更差，雾霾严重，老年人更易患上呼吸道疾病，且病情也更加严重，诊治起来更加困难。
引起咳嗽痰多的病因复杂，由于X线胸片正常，往往不能确定及时明确病因，尤其老年人咳嗽的病因更难确定。临床易误诊、漏诊和误治，部分患者甚至数年得不到确诊和正确治疗。平常的药品治疗咳嗽周期长，使用复杂，临床使用价值不是很高。本发明所提供的一种重要黄腐酸盐复方含片，使用方便，疗效更好，具有更好的临床价值。
发明内容
基于上述背景，针对老年人咳嗽痰多的症状，本发明的目的在于提供一种镇咳祛痰的中药复方制剂，该制剂以下重量份的原料制得黄腐酸盐8～14份、甘草6～13份、桑白皮5～7份、紫苏叶5～12份、半夏3～8份、紫菀7～10份、杏仁4～6份、黄岑10～12份；其药效更好且无毒副作用、不良反应。
本发明制剂中可以添加加入一种或多种药物上可接受的辅料，以提高吸收性能，或制成便于服用的剂型，例如含片、口服液等；制成含片可以添加药用辅料如下：淀粉、糊精、乳糖、微晶纤维素、预胶化淀粉、羧甲基纤维素钠、乙基纤维素或羟丙基甲基纤维素中的一种或者任意几种任意比例的混合物。
所述的黄腐酸盐为食用级或医用级黄腐酸钠和/或黄腐酸钾。
所述黄腐酸盐的制备要求如下：
（1）参照专利200810233669.X“褐煤氧化降解生产腐植酸及其盐的方法”所述的方法利用年青褐煤提出黄腐酸粗品，其中年青褐煤是灰分为5-10%的优质褐煤；
（2）将黄腐酸粗品加入其质量4-6倍的超纯水中常温溶解后离心分离，取上清液过滤，将所得滤液加入质量百分比浓度为15%的食用级的氢氧化钾或氢氧化钠溶液调节pH值至9-10，并在85-95℃条件下搅拌并反应30分钟，然后浓缩至体积为原液体积的三分之一后再次离心分离，取上清液进行透析，最后将所得透析液浓缩后干燥得到黄腐酸盐。
本发明制剂的制备方法如下：
1、取黄腐酸盐、甘草、桑白皮、紫苏叶、半夏、紫菀、杏仁、黄岑晒干，加入原料总质量4～6倍的水，煎煮4～5小时，过滤，滤液即为镇咳祛痰的中药复方制剂；
2、根据所需要制备的剂型添加常规制剂辅料，按常规工艺制备得到不同的剂型。
本发明制备的中药复方含片为纯天然产品，无毒副作用，工艺简单，疗效显著，携带方便，口感微甜无刺激性味道和气味，更加适合老年人和小孩使用，且原材料来源丰富，价格低廉，有更好的临床价值的同时也适合大规模工业化生产。
具体实施方式
下面通过实施例对本发明作进一步详细说明，但本发明保护范围不局限于所述内容。
实施例1：本镇咳祛痰的中药复方制剂与常规片剂辅料混合制得含片，其由以下原料制备得到：黄腐酸钠12g、甘草9g、桑白皮5g，紫苏叶8g、半夏7g、紫菀9g、杏仁6g、黄岑10g；
制备时，黄腐酸钠、甘草、桑白皮、紫苏叶、半夏、紫菀、杏仁、黄岑晒干，加原料总质量5倍的水，煎煮4小时，过滤，滤液中按常规剂量添加山梨醇、甘露醇、蔗糖、淀粉，按常规含片制备工艺制得每粒1.5g的口服含片。本发明的中药复方含片中的黄腐酸钠的制备方法参照专利200810233669.X“褐煤氧化降解生产腐植酸及其盐的方法”，服用方法为口服，一日三次，每次一片，餐后服用，视患者病情选用剂量。
实施例2：本镇咳祛痰的中药复方制剂与常规片剂辅料混合制得含片，其由以下质量的原料制备得到：黄腐酸钾8g、甘草13g、桑白皮6g、紫苏叶6g、半夏3g、紫菀10g、杏仁4g、黄岑11g；
制备时，黄腐酸钾、甘草、桑白皮、紫苏叶、半夏、紫菀、杏仁、黄岑晒干，加原料总质量4倍的水，煎煮5小时，过滤，滤液中按常规剂量添加蔗糖、淀粉，按常规含片制备工艺制得每粒1.5g的口服含片。本发明的中药复方含片中的黄腐酸钠的制备方法参照专利200810233669.X“褐煤氧化降解生产腐植酸及其盐的方法”，服用方法为口服，一日三次，每次一片，餐后服用，视患者病情选用剂量。
实施例3：本镇咳祛痰的中药复方制剂与常规片剂辅料混合制得含片，其由以下质量的原料制备得到：黄腐酸钠7g、黄腐酸钾7g、甘草6g、桑白皮7g、紫苏叶12g、半夏5g、紫菀7g、杏仁5g、黄岑12g；
制备时，黄腐酸钠、黄腐酸钾、甘草、桑白皮、紫苏叶、半夏、紫菀、杏仁、黄岑晒干，加原料总质量5倍的水，煎煮4小时，过滤，滤液中按常规剂量添加蔗糖、淀粉，按常规含片制备工艺制得每粒1.5g的口服含片。本发明的中药复方含片中的黄腐酸钠的制备方法参照专利200810233669.X“褐煤氧化降解生产腐植酸及其盐的方法”，服用方法为口服，一日三次，每次一片，餐后服用，视患者病情选用剂量。
本发明药效学实验：
镇咳试验方法：氨水喷雾引咳法
将实验动物随机分为5组，每组10只，体重在20-25g，雌雄各半，依次灌胃给予0.2mL/10g生理盐水为空白对照组，黄腐酸盐0.2mL/10g（黄腐酸盐浓度为80mg/mL，用生理盐水配制），黄腐酸盐中药复方含片组实施例1-3、0.2mL/10g（黄腐酸盐中药复方含片浓度为80mg/mL，用生理盐水配制），愈美片0.2mL/10g（愈美片浓度为80mg/mL，用生理盐水配制）作为阳性对照组。每天给药1次，连续给药3天，最后一次给药后1小时，分别将小鼠放入用一定浓度氨水喷雾喷过的容器内，一段时间后取出小鼠，观察有没有咳嗽反应，如果出现4次以上咳嗽典型症状（嘴张大）为阳性症状，如若没有出现就为阴性。记录3分钟内小鼠咳嗽的次数，统计各组同生理盐水组的差异。根据一下公式计算镇咳的百分率。
镇咳百分率（%）=（N0-N） / N0×100%
N0：生理盐水组咳嗽次数平均值；N：给药组咳嗽次数平均值；
试验结果见表1：本发明所述的黄腐酸盐组，黄腐酸盐中药复方含片与生理盐水组相比有显著性差异，黄腐酸盐中药复方含片组与愈美片相比效果更好，所以黄腐酸盐中药复方含片有更好的镇咳效果。
表1：黄腐酸盐中药复方含片的镇咳作用（n=10）
。
祛痰试验方法：酚红法
将实验动物随机分为5组，每组10只，体重在20-25g，雌雄各半，依次灌胃给予0.2mL/10g生理盐水为空白对照组，黄腐酸盐组0.2mL/10g（黄腐酸盐浓度为80mg/ mL,用生理盐水配制），黄腐酸盐中药复方含片组实施例1-3，0.2mL/10g（黄腐酸盐中药复方含片浓度为80mg/ mL，用生理盐水配制），市售复方甘草含片0.2mL/10g（市售复方甘草含片浓度为80mg/ mL，用生理盐水配制）作为阳性对照组。每天给药1次，连续给药3天，最后一次给药后30分钟，腹腔注射0.5%酚红溶液0.5mL/只，30分钟后处死小鼠，在实验台上剖开颈部皮肤，剥离气管周围组织，去甲状软骨至气管分支的一段气管，置于含有2mL生理盐水的试管中，然后每管滴加0.1mol/L的氢氧化钠0.1mL，酶标仪546nm出测出吸光度A值，与酚红的标准曲线进行比较，求出酚红的含量。按下列公式计算酚红排泄增加率。
酚红排泄增加率（%）=（N-N0） / N×100%
N0： 生理盐水组酚红排泄量平均值，N：给药组酚红排泄量平均值
试验结果：本发明所述的黄腐酸盐组，黄腐酸盐中药复方含片组、氯化铵组与生理盐水组相比均有显著性差异，所以黄腐酸盐中药复方含片有良好的祛痰效果（见表2）。
表2： 黄腐酸盐中药复方含片的祛痰作用（n=10）
。
临床试验：
临床对象选择：选择咳嗽痰多，喉咙干痒有异物的患者103例，其中男58例，女45例，年龄18-70岁，给病人服用实施例1的黄腐酸盐中药复方含片，每天3次，一次一片，按一周为一个疗程，连续服用2个疗程。三个疗程内，疗效评价标准：治愈：症状与体征完全消退；好转：症状消失或减轻；无效：症状无变化。疗效调查结果见下表。
由上表可以看出，本发明所述的黄腐酸盐中药复方含片对于咳嗽痰多，喉咙干痒有异物的患者有显著的疗效，虽然临床试验例数比较有限，但是可以在一定程度上体现出疗效较一般市售镇咳祛痰药有更好的疗效。
Claims (4)
1.一种镇咳祛痰的中药复方制剂，其特征在于由以下重量份的原料制得：黄腐酸盐8～14份、甘草6～13份、桑白皮5～7份、紫苏叶5～12份、半夏3～8份、紫菀7～10份、杏仁4～6份、黄岑10～12份。
2.根据权利要求1所述的镇咳祛痰的中药复方制剂，其特征在于：所述的黄腐酸盐为食用级或医用级黄腐酸钠和/或黄腐酸钾。
3.根据权利要求1所述的镇咳祛痰的中药复方制剂，其特征在于：还包括薄荷。
4.根据权利要求1所述的镇咳祛痰的中药复方制剂的制备方法，其特征在于：取黄腐酸盐、甘草、桑白皮、紫苏叶、半夏、紫菀、杏仁、黄岑晒干，加入原料总质量4～6倍的水，煎煮4～5小时，过滤，滤液即为镇咳祛痰的中药复方制剂。
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