CN104306748A - 一种治疗小儿脑发育不全的中药组合物及其制备方法 - Google Patents
一种治疗小儿脑发育不全的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗小儿脑发育不全的中药组合物及其制备方法，取下述重量配比的主要原料药制备而成：白芍6-15，一叶萩2-4，鸡血藤9-15，牛藤6-9，甘草4-8，女贞子5-10，天麻4-8，地骨皮6-9，独角莲4-8，菖蒲8-15，槟榔3-6，鹿茸（蜜炙）6-9。本发明组方科学，不仅能促进大脑及体格的生长和发育，而且患儿及家长容易接受，从精神上、经济上减轻患者压力，不用住院治疗，安全、高效。
Description
技术领域
本发明涉及中医中药领域，特别是涉及一种治疗小儿脑发育不全的中药组合物及其制备方法。
背景技术
小儿脑发育不全是一种综合征，可以由于多种病因所引起，临床表现与病因有关。各种先天性原因所致的脑发育障碍，常有不同程度的大脑皮质萎缩和脑室扩大，可有神经细胞减少和胶质细胞增生。早产儿缺血缺氧性脑病可引起室管膜下出血，脑室周围白质软化变性，可有多个坏死或变性区及囊腔形成。小儿脑发育不全病因：脑发育不全病因较为复杂，遗传、母亲孕期感染、中毒或放射线照射过量，产程中外伤、窒息、中毒、脑外伤等都可引起大脑发育障碍。小儿脑发育不全的典型症状表现：1、患儿生后不会吸允、吸允无力或拒乳，或边吃边哭、易呛奶，吸允后疲乏无力，患儿容易发生营养不良，体重不增或增加缓慢，这些都是脑发育不全的症状。2、脑发育不全患儿的常见症状也包括为孩子哭声微弱或无原因持续哭闹，自发运动少，呈无力状态。3、肌张力低下，全身松软，肌肉松弛，患儿特别安静或特别烦躁、易受惊抽搐的脑发育不全患者常见症状。4、脑发育不全患儿的常见症状还有上肢内收、内旋，手握拳，原始反射减弱或增强：如拥抱反射、非对称紧张性颈反射。患上小儿脑发育不全就会导致患者智力下、思维迟钝，小儿脑发育不全给患者的日常生活带来许多不便，让患者无法正常工作和学习。
公开号 CN 1365669A（申请号02103641.1）的中国专利文献公开了一种健骨散，该健骨散由穿山甲、上甲、下甲、鸡内金、全蝎、蜈蚣、海龙等多种纯天然中药组成。公开号CN 1562083A（申请号200410033782.5）的中国专利文献公开了一种主要用于外周神经疾病治疗的注射用麝香粉针剂的制备方法，该麝香粉针剂由麝香的有效成分和注射用水溶性药用辅料组成。公开号 CN 1857718A（申请号200610039106.8）的中国专利文献公开了一种神经生长因子注射剂，该注射剂由活性成分为神经生长因子加工的注射液，维持等渗的生物上可接受的渗透压调节剂，维持该制剂的pH值约为4.0-7.0的缓冲液，以及注射用水制成。
小儿脑发育不全的治疗：1、药物治疗：包括营养脑神经细胞的药物。2、功能训练：其方法较多，但总的目标是促进正常反射通路和运动，抑制异常反射通路和运动，通过功能训练，建立患儿新的条件反射。3、中医手法康复，采用对不同敏感穴位的刺激、按摩，在降低肌张力，矫正异常姿势，使肌体恢复到正常功能位置。
对于小儿脑发育不全，目前尚没有好的治疗方法，也没有特效药，手术治疗费用高、对大脑的创伤极大、风险性极高，而服用西药则会产生药物依赖性。
发明内容
针对现有技术的不足，本发明的目的是提供一种治疗小儿脑发育不全的中药组合物及其制备方法。本发明组方科学，不仅能促进大脑及体格的生长和发育，而且患儿及家长容易接受，从精神上、经济上减轻患者压力，不用住院治疗，安全、高效。
本发明的技术方案是：
一种治疗小儿脑发育不全的中药组合物，取下述重量配比的主要原料药制备而成：白芍6-15，一叶萩2-4，鸡血藤9-15，牛藤6-9，甘草4-8，女贞子5-10，天麻4-8，地骨皮6-9，独角莲4-8，菖蒲8-15，槟榔3-6，鹿茸（蜜炙）6-9。
一种治疗小儿脑发育不全的中药组合物，优选的方案是，取下述重量配比的主要原料药制备而成：白芍8-12，一叶萩2.5-3.5，鸡血藤11-13，牛藤7-8.5，甘草5-7，女贞子6-9，天麻5-7，地骨皮7-8.5，独角莲5-6.5，菖蒲10-14，槟榔4-5.5，鹿茸（蜜炙）7-8。
一种治疗小儿脑发育不全的中药组合物，更加优选的方案是，取下述重量配比的主要原料药制备而成：白芍10，一叶萩3，鸡血藤12，牛藤7.5，甘草6，女贞子7，天麻6，地骨皮8，独角莲6，菖蒲12，槟榔5，鹿茸（蜜炙）7.5。
本发明还提供了将前述治疗小儿脑发育不全的中药组合物制成药学上可接受的汤剂和丸剂的制备方法。
所述汤剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的1/5-2/3（优选的，炼蜜的质量为鹿茸质量的1/4-1/2；更加优选的，炼蜜的质量为鹿茸质量的1/3），放置闷润10-28小时（优选的，放置闷润15-25小时；更加优选的，放置闷润20小时），然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过140-190目筛（优选的，过150-180目筛；更加优选的，过160目筛）；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药物总重量的4.5-7倍（优选的，加水量为两种药物总重量的5-6倍；更加优选的，加水量为两种药物总重量的5.5倍），先用大火煮至沸腾，后用小火煎煮1.2-2小时（优选的，后用小火煎煮1.4-1.8小时；更加优选的，后用小火煎煮1.6小时），滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的5.5-8.5倍（优选的，加水量为9种药物总重量的6-8倍；更加优选的，加水量为9种药物总重量的7倍），先用大火煮至沸腾，后用小火煎煮1.5-2.5小时（优选的，后用小火煎煮1.8-2.3小时；更加优选的，后用小火煎煮2.1小时），滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，然后将步骤（1）所得细粉加入到合并后的药液中，即得。
所述丸剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的1/4-4/5（优选的，炼蜜的质量为鹿茸质量的1/3-3/5；更加优选的，炼蜜的质量为鹿茸质量的2/5），放置闷润14-28小时（优选的，放置闷润17-24小时；更加优选的，放置闷润22小时），然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过120-160目筛（优选的，过130-150目筛；更加优选的，过140目筛）；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药材总重量的5.4-7.8倍（优选的，加水量为两种药材总重量的6-7倍；更加优选的，加水量为两种药材总重量的6.5倍），先用大火煮至沸腾，后用小火煎煮1.4-2.6小时（优选的，后用小火煎煮1.8-2.2小时；更加优选的，后用小火煎煮2小时），滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的7-9倍（优选的，加水量为9种药物总重量的7.5-8.5倍；更加优选的，加水量为9种药物总重量的7.8倍），先用大火煮至沸腾，后用小火煎煮1.6-3.3小时（优选的，后用小火煎煮2.2-2.8小时；更加优选的，后用小火煎煮2.3小时），滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，浓缩至相对密度为1.18～1.28的清膏（优选的，浓缩至相对密度为1.20～1.25的清膏；更加优选的，浓缩至相对密度为1.22的清膏），加入辅料炼蜜，每100g清膏加入炼蜜130-180g（优选的，每100g清膏加入炼蜜140-160g；更加优选的，每100g清膏加入炼蜜150g），待冷却后，加入步骤（1）所得细粉，搅拌均匀，制成蜜丸，每丸的重量为0.1-0.3克（优选的，每丸的重量为0.12-0.25克；更加优选的，每丸的重量为0.15克）。
本发明所用主要中药原料的药理如下：
白芍：基原：为毛茛科植物芍药的干燥根。药性：苦、酸，微寒。归肝、脾经。功用主治：平肝止痛，养血调经，敛阴止汗。用于头痛眩晕，胁痛，腹痛，四肢挛痛，血虚萎黄，月经不调，自汗，盗汗。
一叶萩：基原：为大戟科叶底珠属植物叶底珠的嫩枝叶或根。成分：全株含生物碱：一叶萩碱，叶底珠碱。叶中含二氢一叶萩碱，一叶萩醇A、B，一叶萩醇C苦味酸盐，别一叶萩碱，一叶萩碱；还含有酚性成分：泽漆鞣质B及11-O-棓酰基去甲岩白菜素。茎中含没食子酸等。药性：辛、苦，微温，有小毒。功用主治：祛风活血，益肾强筋。主治风湿腰痛，阳痿，眩晕，耳鸣，耳聋，面瘫，小儿麻痹后遗症。
鸡血藤：基原：为豆科植物密花豆、白花油麻藤、香花岩豆藤或亮叶岩豆藤等的藤茎。化学成份：香花岩豆藤含鸡血藤醇。药性：苦甘，温。《本草再新》：“入心、脾二经。”功能主治：活血、舒筋。治腰膝酸痛，麻木瘫痪，月经不调。
牛藤：基原：为木通科野木瓜属植物那藤或叶尾那藤的茎和根。药性：苦，凉。功用主治：祛风散瘀，止痛，利尿消肿。主治风湿痹痛，跌打伤痛，各种神经性疼痛，小便不利，水肿。
甘草：基原：为豆科植物甘草的根及根状茎。药性：甘，平。归心、肺、脾、胃经。功用主治：补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
女贞子：基原：为木犀科女贞属植物女贞的果实。成分：果实含三萜类：齐墩果酸，乙酰齐墩果酸，熊果酸，乙酰熊果酸；酚苷类：对羟基苯乙醇，3,4-二羟基苯乙醇，女贞子苷，橄榄苦苷，女贞果苷，女贞酸，女贞苷酸等。药性：甘、苦，凉。归肝、肾经。功用主治：补益肝肾，清虚热，明目。主治头昏目眩，腰膝酸软，遗精，耳鸣，须发早白，骨蒸潮热，目暗不明。宜忌：脾胃虚寒泄泻及阳虚者慎服。
天麻：基原：为天科天麻属植物天麻的块茎。成分：天麻含酚类：天麻苷即称天麻素，天麻醚苷，4-乙氧甲基苯酚，对羟基苯甲醛，3,4-二羟基苯甲醛；芳香族化合物：4-羟苄基甲醚等。药性：甘、辛，平。归肝经。功用主治：熄风止痉，平肝阳，祛风通络。主治急慢惊风，抽搐拘挛，破伤风，眩晕，头痛，半身不遂，肢麻，风湿痹痛。
地骨皮：基原：为茄种植物枸杞等的根皮。化学成分：根皮含桂皮酸和多量酚类物质、甜菜碱。也有报道，甜菜碱只含于枸杞的叶和果实，不存在于根皮。根中尚含抑制硫胺素活性的物质，这种抑制作用可被半胱氨酸及维生素C解除。地骨皮中尚分离得β-谷甾醇、亚油酸、亚麻酸、卅一酸等。药性：甘，寒。入肺、肝、肾经。功用主治：清热，凉血。治虚劳潮热盗汗，肺热咳喘，吐血，衄血，血淋，消渴，高血压，痈肿，恶疮。
独角莲：别名禹白附、牛奶白附、红男星、麻芋子、野半夏、鸡心白附，为天南星科植物独角莲的干燥块茎。药性：辛、甘，温，有毒。归胃，肝经。功用主治：燥湿化痰，祛风止痉，解毒散结。适用于风痰滞络、口眼歪斜、中风痰盛、偏瘫失语、破伤风以及寒湿头痛；外用用于痰核瘰疬，毒蛇咬伤。
菖蒲：别名九节菖蒲、水剑草、粉菖、山菖蒲、溪菖、石蜈蚣、野韭菜。药性：辛，平或微温。归心、肝、脾经。鲜品气味浓郁，辛散之力较之干品更胜，故为宣气通窍之佳品。本品既长于芳香化湿、醒脾健胃，用于治疗湿浊阴滞中焦，气机不畅、胸脘闷胀、不思饮食诸症；且又能芳华痰浊，开窍宁神，用于治疗湿浊蒙蔽清窍所引起的神智昏乱，舌苔白腻之症；并擅治痰热堕滞心包所致的神识不清，抽搐等症。
槟榔：基原：为棕榈科植物槟榔的种子。化学成份：槟榔含生物碱0.3～0.6％，缩合鞣质15％，脂肪14％及槟榔红色素。生物碱主为槟榔碱，含量0.1～0.5％；其余有槟榔次碱、去甲基槟榔次碱、去甲基槟榔碱、槟榔副碱、高槟榔碱等。生槟榔含生物碱量比制品为高。槟榔内胚乳含儿茶精、花白素及其聚合物。槟榔含脂肪油14％，槟榔油的组成脂肪酸为：月桂酸19.5％，肉豆蔻酸46.2％，棕榈酸12.7％，硬脂酸1.6％，癸酸0.3％，油酸6.2％，亚油酸5.4％，十二碳烯酸0.3％，十四碳烯酸7.2％。槟榔所含自由氨基酸中脯氨酸超过15％，酪氨酸、苯丙氨酸和精氨酸超过10％，槟榔成熟则非蛋白氮含量减少。药性：苦、辛，温。归脾、胃、大肠经。功用主治：杀虫，破积，下气，行水。治虫积、食滞，脘腹胀痛，泻痢后重，疟疾，水肿，脚气，痰癖，症结。
鹿茸：基原：为鹿科动物梅花鹿或马鹿的雄鹿未骨化密生茸毛的幼角。药性：甘、咸，温。归肾、肝经。功用主治：壮肾阳，益精血，强筋骨，调冲任，托疮毒。用于阳痿滑精，宫冷不孕，羸瘦，神疲，畏寒，眩晕耳鸣耳聋，腰脊冷痛，筋骨痿软，崩漏带下，阴疽不敛。鹿茸（蜜炙）：将净鹿茸切片，取炼蜜与鹿茸拌匀，放置闷润，然后置锅内，用文火炒至颜色加深，不黏手时，取出，摊开放凉。
本发明提供的中药组合物制备方法简单，所得产品服用方便。除此之外，本发明的优良效果还表现在：
（1）组方科学，能促进大脑及体格的生长和发育；
（2）患儿及家长容易接受，从精神上、经济上减轻患者压力，不用住院治疗；
（3）安全、高效；
（4）采用中医辨证论治的原则，利用纯天然的动植物类中药，无任何毒副作用。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案，但保护范围不限于此。
实施例1一种治疗小儿脑发育不全的中药组合物，由下述主要原料药制备而成，以重量份计（每份为50g），其组份为：白芍6份，一叶萩2份，鸡血藤9份，牛藤6份，甘草4份，女贞子5份，天麻4份，地骨皮6份，独角莲4份，菖蒲8份，槟榔3份，鹿茸（蜜炙）6份。
一种治疗小儿脑发育不全的中药组合物丸剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的1/4，放置闷润14小时，然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过120目筛；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药物总重量的5.4倍，先用大火煮至沸腾，后用小火煎煮1.4小时，滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的7倍，先用大火煮至沸腾，后用小火煎煮1.6小时，滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，浓缩至相对密度为1.18的清膏，加入辅料炼蜜，每100g清膏加入炼蜜130g，待冷却后，加入步骤（1）所得细粉，搅拌均匀，制成蜜丸，每丸的重量为0.1克。
本发明丸剂的服用方法：口服，1岁以下每次6～12丸，1～6岁每次15～20丸，7～14岁每次25～30丸，每日3次，1个月为一个疗程。根据具体情况，对于年龄小的患者，患者家长可以把丸药揉碎，用温开水在小勺中烊化成汤液给小儿喂服。
实施例2一种治疗小儿脑发育不全的中药组合物，由下述主要原料药制备而成，以重量份计（每份为50g），其组份为：白芍15份，一叶萩4份，鸡血藤15份，牛藤9份，甘草8份，女贞子10份，天麻8份，地骨皮9份，独角莲8份，菖蒲15份，槟榔6份，鹿茸（蜜炙）9份。
一种治疗小儿脑发育不全的中药组合物丸剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的4/5，放置闷润28小时，然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过160目筛；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药物总重量的7.8倍，先用大火煮至沸腾，后用小火煎煮2.6小时，滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的9倍，先用大火煮至沸腾，后用小火煎煮3.3小时，滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，浓缩至相对密度为1.28的清膏，加入辅料炼蜜，每100g清膏加入炼蜜180g，待冷却后，加入步骤（1）所得细粉，搅拌均匀，制成蜜丸，每丸的重量为0.3克。
典型病例一：孙XX，男，2岁。患儿产后无窒息、状态良好，但运动及语言发育较同龄儿迟缓。患儿3个月能抬头、8个月会翻身、12个月能靠墙坐，至今仍不能独自坐、站，不能维持跪姿及跪行，爬行不能屈髋屈膝，双手灵活性差，头位控制不良，吐字不清，舌及咽喉肌群运动差，不能用吸管吸水，13个月大时于当地医院诊断为“脑发育不全”，康复治疗至今，未见明显好转，遂前来就诊。诊见：患儿四肢主动活动差、双手精细活动差、坐位需用手支撑、双上肢肌力差，手支撑可使胸部离地、不能翻身、下肢力量差，站立支撑无力、双足内翻、下垂，爬行只能缓慢拖行下肢，不能屈髋屈膝。
服用本实施例所得治疗小儿脑发育不全的中药组合物丸剂，每次15丸，每日3次，患儿家长把丸药揉碎，用温开水在小勺中烊化成汤液给患儿喂服。经治疗2个疗程后，患儿四肢活动明显改善、双手精细活动改善，出现对捏动作、坐位稳定提高，可抬起双手玩玩具，而且不用支撑可以独立坐起、双上肢肌力提高，手支撑可使腹部离地、可顺利翻身、下肢肌力明显提高，稍加扶助即可稳定站立、足下垂已消失、爬行灵活，出现屈髋屈膝动作。治疗3个疗程后，患儿可独立站立20余秒，双下肢肌力进一步提高，肌肉明显较前丰满，腰背部肌力提高，爬行灵活；构音较前清晰，愿与人沟通。
实施例3一种治疗小儿脑发育不全的中药组合物，由下述主要原料药制备而成，以重量份计（每份为50g），其组份为：白芍8份，一叶萩2.5份，鸡血藤11份，牛藤7份，甘草5份，女贞子6份，天麻5份，地骨皮7份，独角莲5份，菖蒲10份，槟榔4份，鹿茸（蜜炙）7份。
一种治疗小儿脑发育不全的中药组合物丸剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的2/5，放置闷润22小时，然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过140目筛；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药物总重量的6.5倍，先用大火煮至沸腾，后用小火煎煮2小时，滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的7.8倍，先用大火煮至沸腾，后用小火煎煮2.3小时，滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，浓缩至相对密度为1.22的清膏，加入辅料炼蜜，每100g清膏加入炼蜜150g，待冷却后，加入步骤（1）所得细粉，搅拌均匀，制成蜜丸，每丸的重量为0.15克。
典型病例二：赵XX，女，4岁。患儿反应力差，不能理解大人的语言，仅会无意识发“爸爸、妈妈”，注意力不集中，多动，可独走，生活不能自理，易发脾气。查体：生理反射存在，病理反射未引出。诊断为脑发育不全。服用本实施例所得治疗小儿脑发育不全的中药组合物丸剂，每次20丸，每日3次，家长把丸药揉碎，用温开水在小勺中烊化成汤液给患儿喂服。经过两个疗程的治疗，患儿的反应能力提高，能理解大人言语，注意力集中，精细动作可顺利完成，病情明显好转。后经一个疗程的巩固治疗，言语障碍基本消失，注意力集中，智力测验反应比较的快，达85分。回访调查，患儿已经基本康复，现已入幼儿园中班学习。
实施例4一种治疗小儿脑发育不全的中药组合物，由下述主要原料药制备而成，以重量份计（每份为50g），其组份为：白芍12份，一叶萩3.5份，鸡血藤13份，牛藤8.5份，甘草7份，女贞子9份，天麻7份，地骨皮8.5份，独角莲6.5份，菖蒲14份，槟榔5.5份，鹿茸（蜜炙）8份。
一种治疗小儿脑发育不全的中药组合物汤剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的2/3，放置闷润28小时，然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过190目筛；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药物总重量的7倍，先用大火煮至沸腾，后用小火煎煮2小时，滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的8.5倍，先用大火煮至沸腾，后用小火煎煮2.5小时，滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，然后将步骤（1）所得细粉加入到合并后的药液中，即得。
典型病例三：张XX，男，1岁。患儿的父母都是80后，宝贝儿子的降生为这个家庭增添了不少乐趣。虽然患儿早产，但在一家人的精心呵护下，也出落得白白胖胖。但到了半岁大的时候，患儿的双手就无法再张开，不仅紧握僵硬，而且大拇指内收的现象越来越严重。他也不会像其他同龄的孩子那样主动伸手去抓东西。患儿的父母担心起来，他们带着孩子到当地的医院检查。医生说，可能是孩子发育比较迟缓，建议再观察一段时间。可是，半年过去了，患儿还是依然如故。这时，患儿的父母再也坐不住了，他们带着患儿再次到医院检查，被确诊为“脑发育不全”，由于早产所致。
服用本实施例所得治疗小儿脑发育不全的中药组合物汤剂，每次5mL，每日4次。汤药中加入白糖再煮沸5分钟，患儿家长喂服。经2个疗程的治疗后，患儿上肢肌张力明显下降，能主动抓东西。又经两个疗程的治疗，患儿可以很自由的抓放东西，治疗效果大大超出他们的想象。症状较之前大为改观，上肢不仅恢复了自由支配的能力，并且患儿的智力反应也较为迅速，说话也较之前改善了很多，患儿的爸爸说患儿他在高兴的时候可以讲很多话了，可以清楚的表达自己的意思。
实施例5一种治疗小儿脑发育不全的中药组合物，由下述主要原料药制备而成，以重量份计（每份为50g），其组份为：白芍10份，一叶萩3份，鸡血藤12份，牛藤7.5份，甘草6份，女贞子7份，天麻6份，地骨皮8份，独角莲6份，菖蒲12份，槟榔5份，鹿茸（蜜炙）7.5份。
一种治疗小儿脑发育不全的中药组合物汤剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的1/3，放置闷润20小时，然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过160目筛；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药物总重量的5.5倍，先用大火煮至沸腾，后用小火煎煮1.6小时，滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的7倍，先用大火煮至沸腾，后用小火煎煮2.1小时，滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，然后将步骤（1）所得细粉加入到合并后的药液中，即得。
试验例1 实施例5所得治疗小儿脑发育不全的中药组合物汤剂的临床应用：2009年8月-2012年1月，在8所医院筛选284例小儿脑发育不全患者进行临床观察。并随机分为两组，实验组和对照组（每组142人）。实验组使用本实施例5所得产品，服用方法：口服，1岁以下每次5mL～10mL，1～6岁每次15mL～25mL，7～14岁每次30mL～40mL，每日3～4次。根据具体情况，汤药中可加适量白糖、蜂蜜或冰糖，若加入白糖或冰糖，加入后再煮沸5分钟，以杀灭糖中的杂菌等。对照组使用常规治疗小儿脑发育不全的药品（如脑神经节苷脂注射液、脑蛋白水解物、鼠神经生长因子、奥拉西坦注射液等）。疗效情况判定标准：显效：经治疗3-5个疗程后，临床症状及体征基本消失；好转：经治疗3-5个疗程后，临床症状及体征明显好转；无效：经治疗3-5个疗程后，临床症状及体征略有改善或无改善。总有效包括显效和好转。结果如表1所示。
表1：实施例5所得一种治疗小儿脑发育不全的中药组合物汤剂效果验证
治疗效果：显效99例（69.72%），好转40例（28.17%），无效3例（2.11%），总有效率97.89%。效果明显优于对照组。
本发明选择白芍、一叶萩、鸡血藤和牛藤等进行配伍，组方科学合理，能够更好地治疗小儿脑发育不全。方中白芍平肝止痛，养血调经，敛阴止汗。一叶萩祛风活血，益肾强筋。鸡血藤活血、舒筋。牛藤祛风散瘀，止痛，利尿消肿。甘草补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。女贞子补益肝肾，清虚热，明目。天麻熄风止痉，平肝阳，祛风通络。地骨皮清热，凉血。独角莲燥湿化痰，祛风止痉，解毒散结。菖蒲宣气通窍。槟榔杀虫，破积，下气，行水。鹿茸壮肾阳，益精血，强筋骨，调冲任，托疮毒。诸药合用，能促进大脑及体格的生长和发育。采用中医辨证论治的原则，利用纯天然的动植物类中药，无任何毒副作用，安全、高效。
最后应说明的是，实施例只是本发明最优的具体实施方式而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
1.一种治疗小儿脑发育不全的中药组合物，其特征在于，取下述重量配比的主要原料药制备而成：白芍6-15，一叶萩2-4，鸡血藤9-15，牛藤6-9，甘草4-8，女贞子5-10，天麻4-8，地骨皮6-9，独角莲4-8，菖蒲8-15，槟榔3-6，鹿茸（蜜炙）6-9。
2.根据权利要求1所述的治疗小儿脑发育不全的中药组合物，其特征在于，取下述重量配比的主要原料药制备而成：白芍8-12，一叶萩2.5-3.5，鸡血藤11-13，牛藤7-8.5，甘草5-7，女贞子6-9，天麻5-7，地骨皮7-8.5，独角莲5-6.5，菖蒲10-14，槟榔4-5.5，鹿茸（蜜炙）7-8。
3.根据权利要求1所述的治疗小儿脑发育不全的中药组合物，其特征在于，取下述重量配比的主要原料药制备而成：白芍10，一叶萩3，鸡血藤12，牛藤7.5，甘草6，女贞子7，天麻6，地骨皮8，独角莲6，菖蒲12，槟榔5，鹿茸（蜜炙）7.5。
4.根据权利要求1-3任一所述的治疗小儿脑发育不全的中药组合物，其特征在于，将该治疗小儿脑发育不全的中药组合物制成汤剂，所述汤剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的1/5-2/3，放置闷润10-28小时，然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过140-190目筛（优选的，过150-180目筛；更加优选的，过160目筛）；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药材总重量的4.5-7倍，先用大火煮至沸腾，后用小火煎煮1.2-2小时，滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的5.5-8.5倍，先用大火煮至沸腾，后用小火煎煮1.5-2.5小时（优选的，后用小火煎煮1.8-2.3小时；更加优选的，后用小火煎煮2.1小时），滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，然后将步骤（1）所得细粉加入到合并后的药液中，即得。
5.根据权利要求4所述的治疗小儿脑发育不全的中药组合物汤剂的制备方法，其特征在于，步骤（1）中炼蜜的质量为鹿茸质量的1/4-1/2（优选炼蜜的质量为鹿茸质量的1/3）。
6.根据权利要求4所述的治疗小儿脑发育不全的中药组合物汤剂的制备方法，其特征在于，步骤（1）中放置闷润15-25小时（优选放置闷润20小时）。
7.根据权利要求4所述的治疗小儿脑发育不全的中药组合物汤剂的制备方法，其特征在于，步骤（2）中加水量为两种药材总重量的5-6倍（优选加水量为两种药材总重量的5.5倍）。
8.根据权利要求4所述的治疗小儿脑发育不全的中药组合物汤剂的制备方法，其特征在于，步骤（2）中后用小火煎煮1.4-1.8小时（优选后用小火煎煮1.6小时）。
9.根据权利要求4所述的治疗小儿脑发育不全的中药组合物汤剂的制备方法，其特征在于，步骤（3）中加水量为9种药物总重量的6-8倍（优选加水量为9种药物总重量的7倍）。
10.根据权利要求1-3任一所述的治疗小儿脑发育不全的中药组合物，其特征在于，将该治疗小儿脑发育不全的中药组合物制成丸剂，所述丸剂的制备方法是：
（1）将净鹿茸切片，取炼蜜与鹿茸拌匀，炼蜜的质量为鹿茸质量的1/4-4/5（优选的，炼蜜的质量为鹿茸质量的1/3-3/5；更加优选的，炼蜜的质量为鹿茸质量的2/5），放置闷润14-28小时（优选的，放置闷润17-24小时；更加优选的，放置闷润22小时），然后置锅内，用文火炒至颜色加深，不黏手时，取出，待凉后，将其研成细粉，过120-160目筛（优选的，过130-150目筛；更加优选的，过140目筛）；
（2）将女贞子和槟榔两种药材放入砂锅中，加水，加水量为两种药材总重量的5.4-7.8倍（优选的，加水量为两种药材总重量的6-7倍；更加优选的，加水量为两种药材总重量的6.5倍），先用大火煮至沸腾，后用小火煎煮1.4-2.6小时（优选的，后用小火煎煮1.8-2.2小时；更加优选的，后用小火煎煮2小时），滤出药液；
（3）将除鹿茸、女贞子和槟榔外的其余9味中药放入砂锅中，加水，加水量为9种药物总重量的7-9倍（优选的，加水量为9种药物总重量的7.5-8.5倍；更加优选的，加水量为9种药物总重量的7.8倍），先用大火煮至沸腾，后用小火煎煮1.6-3.3小时（优选的，后用小火煎煮2.2-2.8小时；更加优选的，后用小火煎煮2.3小时），滤出药液；
（4）将步骤（2）以及步骤（3）所得药液合并，浓缩至相对密度为1.18～1.28的清膏（优选的，浓缩至相对密度为1.20～1.25的清膏；更加优选的，浓缩至相对密度为1.22的清膏），加入辅料炼蜜，每100g清膏加入炼蜜130-180g（优选的，每100g清膏加入炼蜜140-160g；更加优选的，每100g清膏加入炼蜜150g），待冷却后，加入步骤（1）所得细粉，搅拌均匀，制成蜜丸，每丸的重量为0.1-0.3克（优选的，每丸的重量为0.12-0.25克；更加优选的，每丸的重量为0.15克）。
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| CN101062362A (zh) * | 2007-06-06 | 2007-10-31 | 谷瑞起 | 一种治疗中风偏瘫及后遗症的中药制剂 |
| CN101524493A (zh) * | 2009-03-24 | 2009-09-09 | 范永昌 | 一种多功能中药蜜丸 |
| CN101757572A (zh) * | 2010-01-19 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | 一种治疗小儿脑瘫的中药组合物及其制备方法 |
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| CN101062362A (zh) * | 2007-06-06 | 2007-10-31 | 谷瑞起 | 一种治疗中风偏瘫及后遗症的中药制剂 |
| CN101524493A (zh) * | 2009-03-24 | 2009-09-09 | 范永昌 | 一种多功能中药蜜丸 |
| CN101757572A (zh) * | 2010-01-19 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | 一种治疗小儿脑瘫的中药组合物及其制备方法 |
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