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CN105535448B - 一种治疗儿童重症肌无力的中药组合物 - Google Patents

一种治疗儿童重症肌无力的中药组合物 Download PDF

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CN105535448B
CN105535448B CN201610129957.5A CN201610129957A CN105535448B CN 105535448 B CN105535448 B CN 105535448B CN 201610129957 A CN201610129957 A CN 201610129957A CN 105535448 B CN105535448 B CN 105535448B
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乞国艳
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Abstract

本发明公开了一种治疗儿童重症肌无力的中药组合物，该中药组合物由以下重量份配比的中药原料制备而成：黄芪10‑120份、党参10‑30份、白术10‑20份、柴胡5‑8份、升麻5‑8份、当归5‑10份、山萸肉5‑10份、巴戟天5‑10份、菟丝子5‑10份、山药8‑24份、制首乌6‑30份、鸡血藤5‑12份、枸杞5‑12份、甘草3‑6份、陈皮3‑6份、麦冬3‑10份。本发明的中药配伍合理，无毒副作用，加工方便，成本低廉，治疗儿童重症肌无力效果明显，适于在临床上推广使用。

Description

一种治疗儿童重症肌无力的中药组合物
技术领域
本发明属于药物领域，涉及一种治疗儿童重症肌无力的中药组合物。
背景技术
重症肌无力是神经系统难治性病症之一，其病症表现为：单侧或双侧眼睑下垂、四肢软弱无力、吞咽困难和语音不清。
传统上人们使用抗胆碱酯酶药物、胸腺切除、放射治疗三种方法治疗重症肌无力，但是抗胆碱酶药物如新斯的明、吡啶斯的明等是一种暂时性、局部起效的药物，只能短暂的延缓病情的发作，长期用药会导致人体内乙酰胆碱受体破坏，病情更加严重。在医疗应用中采用抗胆碱酶药物出现严重副作用的例子也多有报道。胸腺切除、放射治疗等手术方法一方面治愈效果不理想，五年期以上的效果有待观察；另一方面采用手术方法仅能用于出现了胸腺肿瘤这种症状的重症肌无力患者，适用范围窄。近年新出现的血浆交换法则仅能用于危重重症肌无力患者，其疗效也只能维持两周左右，费用高昂，实用价值低。
中医认为，重症肌无力属于中医范畴中的痿症症状，因此针对性地采用中药治疗应具有一定效果。
发明内容
本发明的目的在于提供一种治疗儿童重症肌无力的中药组合物，本发明的中药组合物制备方法简单，疗效好，使用安全，无副作用，适合在临床上广泛应用。
为了实现上述目的，本发明采用了如下技术方案：
本发明提供了一种治疗儿童重症肌无力的中药组合物，所述中药组合物由以下重量份配比的中药原料制备而成：黄芪(Astragalus membranaceus(Fisch.)Bge.)10-120份、党参(RADIX CODONOPSIS)10-30份、白术(Atractylodes macrocephala)10-20份、柴胡(Radix Bupleuri)5-8份、升麻(RHIZOMA CIMICIFUGAE)5-8份、当归(Angelica sinensis(Oliv.)Diels.)5-10份、山萸肉(Cornus officinalis Sieb.Et Zucc.)5-10份、巴戟天(Morinda)5-10份、菟丝子(Cuscuta chinensis Lam.)5-10份、山药(Dioscorea opposita)8-24份、制首乌(cntRd oa)6-30份、鸡血藤(Millettia reticuiata Benth.)5-12份、枸杞(Fructus Lycii)5-12份、甘草(Glycyrriza Uralensis Fisch.G.Glabra L.)3-6份、陈皮(PERICARPIUM)3-6份、麦冬(Ophiopogon japonicus(Linn.f.)Ker-Gawl.)3-10份。
进一步，所述中药组合物由以下重量份配比的中药原料配制而成：黄芪60份、党参20份、白术15份、柴胡6份、升麻6份、当归7份、山萸肉7份、巴戟天7份、菟丝子7份、山药16份、制首乌18份、鸡血藤8份、枸杞8份、甘草5份、陈皮4份、麦冬6份。
本发明提供了一种治疗儿童重症肌无力的药物制剂，所述药物制剂包括前面所述的中药组合物。
进一步，所述药物制剂的剂型是药剂学上的常规剂型。所述剂型包括但不限于，片剂、胶囊剂、丸剂、颗粒剂、混悬剂、散剂、滴丸剂、口服液、注射液、输液、冻干粉针剂、软膏剂、凝胶剂、贴剂、栓剂等。优选的剂型是口服剂型，例如片剂、胶囊剂、丸剂、颗粒剂、糖浆剂、合剂等。
进一步，所述药物制剂还包括药剂学上可接受的载体，本发明的药剂学上可接受的载体包括但不限于：
稀释剂：淀粉、糖粉、乳糖、糊精、微晶纤维素、无机盐、糖醇类等。
润湿剂与粘合剂：纯化水、乙醇、明胶、聚乙二醇、纤维素衍生物等。
崩解剂：淀粉、羧甲基淀粉钠、纤维素衍生物、交联聚维酮等。
润滑剂：硬脂酸镁、微粉硅胶、滑石粉、聚乙二醇等。
助溶剂：水、乙醇、甘油、丙二醇、液状石蜡、植物油等。
矫味剂：蔗糖、单糖、芳香剂等。
防腐剂：苯甲酸、山梨酸、甲酯、乙酯、丙酯等。
根据需要，制剂过程中还可以加入其它适宜的辅料，这些辅料的应用是制剂领域所公知的。根据实际制剂的需要，本领域技术人员可以从现有制剂辅料中进行筛选。
本发明的中药组合物可以通过下列方法制备：将药材洗净、烘干后，研磨成细粉混合均匀，加入适当的药用辅料制备成片剂、胶囊、丸剂、颗粒剂等药学可接受的任何药剂类型。
本发明还提供了前面所述的中药组合物的制备方法，该制备方法包括如下步骤：将中药原料洗净、烘干、粉碎后加水、乙醇等常用提取溶剂提取数次，合并提取液，过滤，将滤液浓缩成膏。而后将膏干燥、粉碎然后加入适当的药用辅料备成片剂、胶囊、药丸、冲剂等药学可接受的任何药剂类型。
作为可替换的技术方案，所述制备方法包括如下步骤：将部分中药原料洗净、烘干、粉碎后加水、乙醇等常用提取溶剂提取数次，合并提取液，过滤，将滤液浓缩成膏。而后将膏干燥、粉碎。其余部分中药原料采用研磨粉碎与膏粉混合然后加入适当的药用辅料备成片剂、胶囊、药丸、冲剂等药学可接受的任何药剂类型。
本发明的中药组合物还可以用中药领域最常规的水煮或水煮后醇沉的方法进行制备。
本发明的中药组合物还可以采用如下的制备方法：将中药原料洗净、烘干后，研磨成细粉混合均匀。
本发明提供了前面所述的中药组合物在制备治疗儿童重症肌无力的药物中的应用。
本发明提供了前面所述的药物制剂在制备治疗儿童重症肌无力的药物中的应用。
本发明的优点和有益效果如下：
本发明的中药组合物来源丰富，天然，制备工艺简单、制作费用低、疗效好、安全无副作用，适于在临床上推广使用。
具体实施方式
为了更好地理解和实施，下面结合实施例进一步说明本发明。如无特殊说明，本发明的实施例仅用于解释本发明，并不意味着限定本发明的保护范围。
本发明的中药组合物以及药物制剂在运用中医理论基础的前提下，经科学配方筛选，应用中药材采取科学提取工艺的前提下，精制加工而成。
实施例1中药组合物的制备
1、准确称量以下中药原料：黄芪10份、党参10份、白术10份、柴胡5份、升麻5份、当归5份、山萸肉5份、巴戟天5份、菟丝子5份、山药8份、制首乌6份、鸡血藤5份、枸杞5份、甘草3份、陈皮3份、麦冬3份。
2、将上述中药原料粉碎混合均匀。
实施例2中药组合物的制备
1、准确称量以下中药原料：黄芪120份、党参30份、白术20份、柴胡8份、升麻8份、当归10份、山萸肉10份、巴戟天10份、菟丝子10份、山药24份、制首乌30份、鸡血藤12份、枸杞12份、甘草6份、陈皮6份、麦冬10份。
2、将上述各中药原料用五倍量的水煎煮两次，每次两小时。滤过合并滤液，静置48小时后取其上清液减压浓缩成清膏后粉碎成细粉，或减压浓缩成稠膏。
实施例3中药组合物的制备
1、准确称量以下中药原料：黄芪60份、党参20份、白术15份、柴胡6份、升麻6份、当归7份、山萸肉7份、巴戟天7份、菟丝子7份、山药16份、制首乌18份、鸡血藤8份、枸杞8份、甘草5份、陈皮4份、麦冬6份。
2、将上述中药原料用三倍量的85％的乙醇回流三次，每次一小时。合并滤液，减压浓缩成清膏后粉碎成细粉，或减压浓缩成稠膏。
实施例4药物制剂的制备
1、口服液的制备
(1)按照实施例1-实施例3中的方法制备中药组合物清膏；
(2)加入20％苯甲酸乙醇溶液5ml和24％山梨酸钾溶液5ml，搅匀，冷藏48h以上，滤过，加水调整至每毫升含有生药5.5g，搅匀，灌封，即得口服液。
2、糖浆剂的制备
(1)按照实施例1-实施例3中的方法制备中药组合物清膏；
(2)加入辅料蔗糖、山梨酸、水搅拌均匀，制得糖浆剂。
3、片剂的制备
(1)按照实施例1-实施例3中的方法制备中药组合物清膏；
(2)加入辅料淀粉、乙醇、滑石粉，制得片剂。
4、胶囊剂的制备
(1)按照实施例1-实施例3中的方法制备中药组合物清膏；
(2)加入辅料淀粉、乙醇、糊精、硬脂酸镁，装入胶囊壳、制得胶囊剂。
5、颗粒剂的制备
(1)按照实施例1-实施例3中的方法制备中药组合物清膏；
(2)加入辅料糖粉、淀粉、糊精、乙醇，制得颗粒剂。
6、所述丸剂的制备方法包括以下步骤：
(1)按照实施例2-实施例3中的方法制备中药组合物稠膏；
(2)将膏状物团成丸状，即得。
7、所述合剂的制备方法包括以下步骤：
(1)按照实施例1-实施例3中的方法制备中药提取物稠膏；
(2)加入辅料蔗糖、乙酯、水、山梨酸搅拌均匀，制得合剂。
实施例5中药组合物的疗效
1、实验用药的制备
对比药物A制备：称取黄芪60份，党参20份，白术15份，茯苓10～30份，升麻10份，柴胡10份，枸杞子10份，当归10份，陈皮10份，炙甘草5份，菟丝子10份、薏苡仁10份、麦芽10份，淮山10份，山萸肉10份。用五倍量的水煎煮两次，每次两小时，滤过合并滤液，静置48小时后取其上清液减压浓缩成清膏；加入20％苯甲酸乙醇溶液5ml和24％山梨酸钾溶液5ml，搅匀，冷藏48h以上，滤过，加水调整至每毫升含有生药5.5g，搅匀，灌封，即得口服液。
对比药物B制备：称取黄芪120份，太子参20份，党参60份，白术20份，柴胡6份，升麻6份，当归7份，山药20份，合欢皮6份，制首乌18份，巴戟天7份，桑葚6份，甘草5份，陈皮4份，枳壳3份，鸡血藤20份，枸杞10份，麦冬6份。用五倍量的水煎煮两次，每次两小时，滤过合并滤液。静置48小时后取其上清液减压浓缩成清膏；加入20％苯甲酸乙醇溶液5ml和24％山梨酸钾溶液5ml，搅匀，冷藏48h以上，滤过，加水调整至每毫升含有生药5.5g，搅匀，灌封，即得口服液。
本发明的中药组合物制备：称取黄芪60份、党参20份、白术15份、柴胡6份、升麻6份、当归7份、山萸肉7份、巴戟天7份、菟丝子7份、山药16份、制首乌18份、鸡血藤8份、枸杞8份、甘草5份、陈皮4份、麦冬6份。用五倍量的水煎煮两次，每次两小时，滤过合并滤液，静置48小时后取其上清液减压浓缩成清膏；加入20％苯甲酸乙醇溶液5ml和24％山梨酸钾溶液5ml，搅匀，冷藏48h以上，滤过，加水调整至每毫升含有生药5.5g，搅匀，灌封，即得口服液。
2、试验人群：儿童患者人数为120人，随机分为3组，所有患者均经过下述诊断标准确诊为重症肌无力患者：
(1)新斯的明试验呈阳性：肌电图检查重复神经电刺激动作电位呈衰减。
(2)血清抗乙酰胆碱抗体阳性。
分别给予对比药物A、对比药物B、本发明的中药组合物，
剂量为每次150-200ml，日服用三次。连续服用一个月后观察治疗效果。
3、疗效评定标准：
治愈：临床症状和体征全部消失，，三个月无复发；
有效：临床症状和体征有所改善；
无效：临床症状和体征均无改善。
4、疗效结果
使用本发明的中药组合物的有效率达100％，效果好于对比药物A、对比药物B，具体数据参见表1所示。
表1 疗效结果统计
Figure BDA0000936269930000071
以上内容是结合具体的优选实施方式对本发明所作的进一步详细说明，不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干简单推演或替换，都应当视为属于本发明的保护范围。

Claims (10)

1.一种治疗儿童重症肌无力的中药组合物，其特征在于，所述中药组合物由以下重量份配比的中药原料制备而成：黄芪10-120份、党参10-30份、白术10-20份、柴胡5-8份、升麻5-8份、当归5-10份、山萸肉5-10份、巴戟天5-10份、菟丝子5-10份、山药8-24份、制首乌6-30份、鸡血藤5-12份、枸杞5-12份、甘草3-6份、陈皮3-6份、麦冬3-10份。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药组合物由以下重量份配比的中药原料配制而成：黄芪60份、党参20份、白术15份、柴胡6份、升麻6份、当归7份、山萸肉7份、巴戟天7份、菟丝子7份、山药16份、制首乌18份、鸡血藤8份、枸杞8份、甘草5份、陈皮4份、麦冬6份。
3.一种治疗儿童重症肌无力的药物制剂，其特征在于，所述药物制剂包括权利要求1或2所述的中药组合物。
4.根据权利要求3所述的药物制剂，其特征在于，所述药物制剂的剂型是药剂学上的常规口服剂型。
5.根据权利要求4所述的药物制剂，其特征在于，所述口服剂型是口服液、糖浆剂、颗粒剂、丸剂、片剂、胶囊、合剂。
6.权利要求1或2所述的中药组合物的制备方法，其特征在于，所述制备方法如下：将中药原料洗净、烘干后，研磨成细粉混合均匀。
7.权利要求1或2所述的中药组合物的制备方法，其特征在于，所述制备方法如下：将中药原料洗净、烘干、粉碎后提取数次，合并提取液，过滤，将滤液浓缩成膏，干燥后粉碎混合均匀。
8.权利要求1或2所述的中药组合物的制备方法，其特征在于，所述制备方法包括将中药原料水煮或水煮醇沉的步骤。
9.权利要求1或2所述的中药组合物在制备治疗儿童重症肌无力的药物中的应用。
10.权利要求3-5中任一项所述的药物制剂在制备治疗儿童重症肌无力的药物中的应用。
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