CN104398797A - 治疗小儿脑积水的中药组合物及制备方法 - Google Patents
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Abstract
本发明公开了一种治疗小儿脑积水的中药组合物,取下述重量配比的主要原料制备而成:熟地黄5-10份;天香炉4-6份;山药4-8份;山茱萸5-10份;蜘蛛香4-6份;牡丹皮3-5份;茯苓3-7份;白僵蚕4-9份;黄精9-12份;罗布麻叶6-12份;白术(炒)6-9份;郁李仁2-6份;覆盆子6-10份。本发明针对小儿脑积水的病理机制,各原料经辨证配伍,其药效相辅相成,具有温阳化饮、活血化瘀、通窍利水的功效,对小儿脑积水有很好的疗效。
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积水的中药组合物及制备方法。
背景技术
脑积水是因颅内疾病引起的脑脊液分泌过多或循环、吸收障碍而致颅内脑脊液存量增加。如果大量脑脊液积聚在大脑半球表面蛛网膜下腔,则称为硬膜下水囊瘤或硬膜下积液,脑室系统内过多的液体积聚称为脑室内脑积水。小儿脑积水的症状随患儿的发病年龄变化而变化,主要表现为烦躁、发育迟缓、头痛呕吐、嗜睡、癫痫等,体征有头围增大、囟门张力高、上视困难、视乳头水肿和外展神经麻痹等。小儿脑积水多见于新生儿及婴儿,常伴有脑室系统扩大,颅内压增高及头围增大。
儿童脑积水的临床表现是根据病人的发病年龄而变化。在婴儿急性脑积水,通常颅高压症状明显,骨缝裂开,前囟饱满、头皮变薄和头皮静脉清晰可见,并有怒张,用强灯光照射头部时有头颅透光现象。叩诊头顶,呈实性鼓音。病儿易激惹,表情淡漠和饮食差,出现持续高调短促的异常哭泣,双眼球呈下视状态,上眼睑不伴随下垂,可见眼球下半部沉落到下眼睑缘,部分角膜在下睑缘以上,上睑巩膜下翻露白,亦称日落现象。双眼上、下视时出现分离现象,并有凝视麻痹、眼震等,这与导水管周围的脑干核团功能障碍有关。由于脑积水进一步发展,脑干向下移位、展神经和其他脑神经被牵拉,出现眼球运动障碍。在2周岁以内的儿童,由于眼球活动异常,出现弱视。视盘水肿在先天性脑积水中不明显并少见,但视网膜静脉曲张是脑积水的可靠征。运动异常主要有肢体痉挛性瘫,以下肢为主,症状轻者双足跟紧张,足下垂,严重时呈痉挛步态,亦称剪刀步态,有时与脑性瘫痪难以区别。由于三室前部和下视丘、漏斗部受累,可出现各种内分泌功能紊乱,如青春早熟或落后和生长矮小等及其他激素水平下降症状。另外,脊髓空洞症伴有脑积水者多出现下肢活动障碍,而脊髓空洞症状伴脊髓发育不全时,常有脊柱侧弯。
目前,治疗小儿脑积水的药物也有很多,公开号CN 101380376A(申请号200710072787.2)的专利文献公开了一种小儿清开灵分散片,取下列中药为本药配方:胆酸3.25g、猪去氧胆酸3.75g、黄岑苷5g、珍珠母50g、栀子25g、水牛角25g、板兰根200g、金银花60g;取下述辅料为清开灵分散片的制剂配方:原生药材提取的中间体88.5g、内加交联聚乙烯吡咯烷酮57.5g、硫酸钙19g、氯化钠19g、微粉硅胶3.5g、柠檬酸1.5g、阿斯巴甜1.5g、3%PVP无水乙醇溶液适量、外加交联聚乙烯吡咯烷酮7g、硬脂酸镁1g。公开号CN103721001A(申请号201310755486.5)的专利文献公开了一种治疗阳虚水泛型小儿脑积水的中药制剂,该中药制剂由以下重量份的中药制成:铃兰3-9份、风车藤30-40份、艾纳香9-18份、山茴芹6-9份、石菖蒲3-6份、皂荚根皮5-15份、蓼实6-10份、五龙跟15-25份、黄花远志20-24份、花拐藤根9-15份。公开号CN103721003A(申请号201310756188.8)的专利文献公开了一种治疗肾精不足型小儿脑积水的中药制剂,该中药制剂由以下重量份的中药制成:长筒马先蒿6-9份、巴戟天5-7份、鹿药10-14份、菟丝子9-15份、豇豆20-30份、香石藤果6-9份、磨盘根9-15份、三块瓦3-9份、苋10-20份。
包括上述专利文献在内的现有技术在治疗小儿脑积水方面还存在很多不足之处,目前较严重的脑积水多采用手术的方法来治疗,其价格昂贵,患儿需要承受很大的痛苦;而较轻的脑积水患者目前多采用药物缓解的方式,但目前的一些药物的疗效并不理想,而且会存在很强的副作用,对患儿的成长带来很大的负面影响。
发明内容
针对现有技术的不足,本发明的目的之一在于提供一种治疗小儿脑积水的中药组合物,采用地方上较为多见的中药材作为原料,无副作用;而且各原料药的药效相辅相成,针对小儿脑积水的病理机制,具有温阳化饮、活血化瘀、通窍利水的功效,其治疗效果显著。本发明的另一目的就是提供上述治疗小儿脑积水的中药组合物的制备方法。
本发明的上述目的是通过以下技术方案来实现的:
治疗小儿脑积水的中药组合物,取下述重量配比的主要原料制备而成:熟地黄5-10份;天香炉4-6份;山药4-8份;山茱萸5-10份;蜘蛛香4-6份;牡丹皮3-5份;茯苓3-7份;白僵蚕4-9份;黄精9-12份;罗布麻叶6-12份;白术(炒)6-9份;郁李仁2-6份;覆盆子6-10份。
治疗小儿脑积水的中药组合物,优选的方案为,取下述重量配比的主要原料制备而成:熟地黄6-9份;天香炉4.5-5.5份;山药5-7份;山茱萸6-9份;蜘蛛香4.5-5.5份;牡丹皮3.5-4.5份;茯苓4-6份;白僵蚕5-8份;黄精10-11份;罗布麻叶8-10份;白术(炒)7-8份;郁李仁3-5份;覆盆子7-9份。
治疗小儿脑积水的中药组合物,更加优选的方案为,取下述重量配比的主要原料制备而成:熟地黄8份;天香炉5份;山药6份;山茱萸7份;蜘蛛香5份;牡丹皮4份;茯苓5份;白僵蚕6份;黄精10.5份;罗布麻叶9份;白术(炒)7.5份;郁李仁4份;覆盆子8份。
本发明还提供了将上述治疗小儿脑积水的中药组合物制成药学上可接受的糖浆剂、颗粒剂、滴剂和口服液的制备方法。
所述治疗小儿脑积水的中药组合物糖浆剂的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中,煎煮30-50分钟(优选35-45分钟,更加优选40分钟),将天香炉和罗布麻叶于烘干机中烘干,粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于砂锅中,继续煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置3-5小时(优选的,静置3.5-4.5小时,更加优选的,静置4小时),取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置6-9小时(优选的,静置7-8小时,更加优选的,静置7.5小时),过滤,滤液回收乙醇并浓缩至相对密度1.10-1.20(优选的,浓缩至相对密度1.12-1.18,更加优选的,浓缩至相对密度1.15),加入单糖浆(单糖浆的用量为药膏质量的20%-40%,优选的,单糖浆的用量为药膏质量的25%-35%,更加优选的,单糖浆的用量为药膏质量的30%)和苯甲酸钠(苯甲酸钠的用量为药膏质量的0.04%-0.08%,优选的,苯甲酸钠的用量为药膏质量的0.05%-0.07%,更加优选的,苯甲酸钠的用量为药膏质量的0.06%),混合均匀,无菌封装。
根据上面所述的制备方法,优选的方案在于:步骤(1)渗漉时优选每小时流出液相当于渗漉容器被利用容积的1/48-1/24。
服用方法:每次2-3ml,随后喂适量的奶水或者温开水,每日3次,5天一个疗程。
所述治疗小儿脑积水的中药组合物颗粒剂的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将天香炉和罗布麻叶烘干,粉碎,过80-120 目筛(优选的,过90-110目筛,更加优选的,过100目筛),用水浸泡(优选的,水的用量为药粉质量的3-5倍,更加优选的,水的用量为药粉质量的4倍),置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌4-8min(优选的,杀菌5-7min,更加优选的,杀菌6min),得挥发油;
(4)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置3-5小时(优选的,静置3.5-4.5小时,更加优选的,静置4小时),取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置6-9小时(优选的,静置7-8小时,更加优选的,静置7.5小时),过滤,滤液回收乙醇并浓缩至相对密度1.10-1.20(优选的,浓缩至相对密度1.12-1.18,更加优选的,浓缩至相对密度1.15),加入步骤(3)所得的挥发油,加入单糖浆和糊精,混匀,制成均匀的颗粒,辅以药学上可接受的载体包装,每小包的质量为2g。
根据上面所述的制备方法,优选的方案在于:步骤(4)单糖浆和糊精的用量比为1:1,且均为浓缩液质量的5%-7%(优选为浓缩液质量的6%)。
服用方法:每次1小包,用35-45℃的温开水溶化后服用,每日3次,5天一个疗程。
所述治疗小儿脑积水的中药组合物滴剂的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将天香炉和罗布麻叶打碎,用水浸泡(优选的,水的用量为药粉质量的3-5倍,更加优选的,水的用量为药粉质量的4倍),置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌4-8min(优选的,杀菌5-7min,更加优选的,杀菌6min),得挥发油;
(4)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置3-5小时(优选的,静置3.5-4.5小时,更加优选的,静置4小时),取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置6-9小时(优选的,静置7-8小时,更加优选的,静置7.5小时),过滤,滤液回收乙醇并浓缩为混悬液,加入步骤(3)所得的挥发油,加入甜味剂和矫味剂,混匀,采用高剪切设备剧烈高速搅拌,在搅拌状态下,以小气泡的形式通入氮气来排除药液中的氧气,无菌封装。
服用方法:每次2-3ml,随后喂适量的奶水或者温开水,每日3次,5天一个疗程。
所述治疗小儿脑积水的中药组合物口服液的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将天香炉和罗布麻叶打碎,用水浸泡(优选水的用量为药粉质量的3-5倍,更加优选4倍),置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌4-8min(优选5-7min,更加优选6min),得挥发油;
(4)步骤(3)提取挥发油后的水溶液滤过,与步骤(1)所得的渗漉液和步骤(2)所得的水煎液混合均匀,浓缩至原体积的1/2,加入步骤(3)所得的挥发油,加入苯甲酸钠和矫味剂,混匀,杀菌10-20分钟(优选13-17分钟,更加优选15分钟),以每支3ml的剂量进行无菌封装。
根据上面所述的制备方法,优选的方案在于:步骤(4)苯甲酸钠的用量为浓缩液质量的0.1%-0.3%(优选0.2%),矫味剂使用蔗糖,用量为浓缩液质量的6%-8%(优选7%)。
服用方法:每次3-4ml,随后喂适量的奶水或者温开水,每日3次,5天一个疗程。
各原料药的药理功效分别为:
熟地黄:味甘,性微温。归肝、肾经。为生地黄的炮制加工品,而生地黄为玄参科植物地黄的新鲜或干燥块根。具有滋阴补血,益精填髓的功效。用于肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早白。
天香炉:味辛、淡,性平。归肺、脾、肝、大肠经。为野牡丹科植物金锦香的带根全草或根。含金锦香酸、熊果酸、琥珀酸、胡萝卜甙、槲皮素、山柰酚,全草还含酚类成分及氨基酸。具有化痰利湿,祛瘀止血,解毒消肿的功效。用于咳嗽,哮喘,痢疾,泄泻,吐血,咯血,便血,经闭,疳积,风湿骨痛,跌打损伤。
山药:味甘,性平。归脾、肺、肾经。为薯蓣科植物薯蓣的干燥根茎。具有补脾养胃,生津益肺,补肾涩精的功效。用于脾虚食少,久泻不止,肺虚喘咳,肾虚遗精,带下,尿频,虚热消渴。麸炒山药补脾健胃。用于脾虚食少,泄泻便溏,白带过多。
山茱萸:味酸、涩,性微温。归肝、肾经。为山茱萸英科植物山茱萸的干燥成熟果肉,别名山萸肉、药枣等。具有补益肝肾,涩精固脱的功效。用于眩晕耳鸣,腰膝酸痛,阳屡遗精。遗尿尿频,崩漏带下,大汗虚脱,内热消渴。
蜘蛛香:味辛、微苦,性温。为败酱科缬草属植物蜘蛛草,以根状茎及根入药。根和根茎含挥发性成分,主要为α-蒎烯、柠檬烯、1,8-桉叶素、对-聚伞花素、乙酸龙脑酯、龙脑、橙花叔醇、橄榄醇、二十烷酸甲酯、乙酰缬草三酯、缬草三酯等有效成分。具有理气和中,散寒除湿,活血消肿的功效。用于脘腹胀痛,哎吐泄泻,小儿疳积,风寒湿痹,肢气水肿,月经不调,跌打损伤,疮疖。
牡丹皮:味苦、辛,性微寒。归心、肝、肾经。为毛茛科植物牡丹的干燥根皮。具有清热凉血,活血化瘀的功效。用于温毒发斑,吐血衄血,夜热早凉,无汗骨蒸,经闭痛经,痈肿疮毒,跌扑伤痛。
茯苓:味甘、淡,性平。归心、肺、脾、肾经。为多孔菌科真菌茯苓的干燥菌核。具有利水渗湿,健脾宁心的功效。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
白僵蚕:味辛、咸,性平。归肝、肺、胃经。为蚕蛾科昆虫家蚕蛾的幼虫感染白僵菌而僵死的干燥全虫。含蛋白质、草酸铵,并含赖氨酸,亮氨酸,天冬氨酸等17种氨基酸,镁、钙、锌等28种元素,以及变态活性融激素、促脱皮甾酮和一种色素3-羟基犬尿素,6-N-羟乙基腺嘌呤。具有祛风解痉,化痰散结的功效。用于中风失音、中风口嘴眼斜、惊痫抽搐、头风、喉风、咽喉肿痛、瘰疬、痄腮、风疹、疮毒喉痹、瘰疬结核、风疮瘾疹、丹毒、乳腺炎。
黄精:味甘,性平。归脾、肺、肾经。为百合科植物滇黄精、黄精或多花黄精的干燥根茎。具有补气养阴,健脾,润肺,益肾的功效。用于脾胃虚弱,体倦乏力,口干食少,肺虚燥咳,精血不足,内热消渴。
罗布麻叶:味甘、苦,性凉。归肝经。为夹竹桃科植物罗布麻的干燥叶。具有平肝安神,清热利水的功效。用于肝阳眩晕.心悸失眠,浮肿尿少,高血压,神经衰弱,肾炎浮肿。
白术(炒):味苦、甘,性温。归脾、胃经。白术为菊科植物白术的干燥根茎。具有健脾益气,燥湿利水,止汗,安胎的功效。用于脾虚食少,腹胀泄泻,痰饮眩悸、水肿,自汗,胎动不安。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便清,胎动不安。用沙土或者麦麸拌炒之后称为炒白术,其中麸炒白术是先将麸皮撒于热锅内,候烟冒出时,将白术片倒入微炒至淡黄色,取出,筛去麸皮后放凉(每100斤白术片用麸皮10斤)。
郁李仁:味辛、苦、甘,性平。归脾、大肠、小肠经。为蔷薇科植物欧李、郁李或长柄扁桃的干燥成熟种子。具有润燥滑肠,下气,利水的功效。用于津枯肠燥.食积气滞,腹胀便秘,水肿,脚气,小便不利。
覆盆子:味甘、酸,性温。归肾、膀胱经。为蔷薇科植物华东覆盆子的干燥果实。具有益肾,固精,缩尿的功效。用于肾虚遗尿,小便频数,阳痿早泄,遗精滑精。
本发明治疗小儿脑积水的中药组合物,针对小儿脑积水的病理机制,符合中医关于治疗小儿脑积水的理论,本发明在总结前人经验的基础上,采用纯天然草本中药独特配方和工艺精制而成,各原料药的药效相辅相成,具有温阳化饮、活血化瘀、通窍利水的功效,本品组分相互配伍,疗效显著。
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,但保护范围不被此限制。
实施例1 治疗小儿脑积水的中药组合物,取下述主要原料制备而成(每份取30g):熟地黄5份;天香炉4份;山药4份;山茱萸5份;蜘蛛香4份;牡丹皮3份;茯苓3份;白僵蚕4份;黄精9份;罗布麻叶6份;白术(炒)6份;郁李仁2份;覆盆子6份。
上述治疗小儿脑积水的中药组合物糖浆剂的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的2倍的60%的乙醇做溶剂,浸渍25小时,装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡15小时,倒入砂锅中,煎煮40分钟,将天香炉和罗布麻叶于烘干机中烘干,粉碎,装入灭菌过的700目的纱布袋中,置于砂锅中,继续煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置4小时,取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置7.5小时,过滤,滤液回收乙醇并浓缩至相对密度1.15,加入相当于药膏质量的30%的单糖浆和相当于药膏质量的0.06%的苯甲酸钠,混合均匀,无菌封装。
服用方法:每次2-3ml,随后喂适量的奶水或者温开水,每日3次,5天一个疗程。
典型病例一姜XX,男,1岁2个月,山东省菏泽市单县人。宝宝出生后不久,头就显得比其他孩子大很多。由于农村里都流行头大聪明的说法,所以妈妈一直认为这是孩子“聪明”的表现。但孩子一岁后,常常出现喂食困难,眼睛一直往下看。去医院就诊,头颅CT检查提示:脑积水。当时医生建议要么直接手术治疗,要么靠药物缓解,妈妈不忍心宝贝这么小就经受这种痛苦,于是选用药物治疗。服用一段时间后,宝宝的症状好转得很快,妈妈非常高兴,但没过多久就再一次出现之前的情况。
妈妈在朋友建议下带孩子咨询了中医,服用了实施例1所得治疗小儿脑积水的中药组合物糖浆剂2个疗程后,喂食困难、眼睛一直往下看的症状均得到缓解;继续服用1个疗程后,智力和运动发育逐渐跟上了同龄儿,头围也变得跟其他同龄儿相似,再也没有出现四肢抽搐。随访至今已痊愈,未复发。
实施例2 治疗小儿脑积水的中药组合物,取下述主要原料制备而成(每份取25g):熟地黄6份;天香炉4.5份;山药5份;山茱萸6份;蜘蛛香4.5份;牡丹皮3.5份;茯苓4份;白僵蚕5份;黄精10份;罗布麻叶8份;白术(炒)7份;郁李仁3份;覆盆子7份。
所述治疗小儿脑积水的中药组合物颗粒剂的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的2倍的60%的乙醇做溶剂,浸渍25小时,装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡15小时,倒入砂锅中煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将天香炉和罗布麻叶烘干,粉碎,过100目筛,用水浸泡,置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌6min,得挥发油;
(4)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置4小时,取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置7.5小时,过滤,滤液回收乙醇并浓缩至相对密度1.15,加入步骤(3)所得的挥发油,加入分别相当于浓缩液质量的6%的单糖浆和糊精,混匀,制成均匀的颗粒,辅以药学上可接受的载体包装,每小包的质量为2g。
服用方法:每次1小包,用35-45℃的温开水溶化后服用,每日3次,5天一个疗程。
典型病例二韩XX,男,3岁,山东省滨州市博兴县人。孩子出生时被确诊为先天性脑积水,但是家长一直抱着幻想希望脑积水可以自行痊愈,所以一直没有加以治疗。直到宝贝3岁时,发现孩子发育迟缓,语言表达能力弱,孩子发育也较为迟缓,行走不如同龄儿童,头颅稍微大于一般孩子。其父母这才意识到问题的严重性。
经多方打听,了解到本发明治疗小儿脑积水的中药组合物的疗效不错,于是决定尝试一下。服用实施例2所得治疗小儿脑积水的中药组合物颗粒剂2个疗程后,孩子的行走状况明显改善,也能够基本表达自己的想法。继续服用1个疗程后,孩子的语言表达能力。行走状况以及身体发育情况均与同龄儿童差不多,各不适症状也消失。随访知未复发。
实施例3 治疗小儿脑积水的中药组合物,取下述主要原料制备而成(每份取20g):熟地黄9份;天香炉5.5份;山药7份;山茱萸9份;蜘蛛香5.5份;牡丹皮4.5份;茯苓6份;白僵蚕8份;黄精11份;罗布麻叶10份;白术(炒)8份;郁李仁5份;覆盆子9份。
所述治疗小儿脑积水的中药组合物滴剂的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的2倍的60%的乙醇做溶剂,浸渍25小时,装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡15小时,倒入砂锅中煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将天香炉和罗布麻叶打碎,用水浸泡,置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌6min,得挥发油;
(4)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置4小时,取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置7.5小时,过滤,滤液回收乙醇并浓缩为混悬液,加入步骤(3)所得的挥发油,加入甜味剂和矫味剂,混匀,采用高剪切设备剧烈高速搅拌,在搅拌状态下,以小气泡的形式通入氮气来排除药液中的氧气,无菌封装。
服用方法:每次2-3ml,随后喂适量的奶水或者温开水,每日3次,5天一个疗程。
典型病例三杨XX,女,2岁半,山东省聊城市东昌府区人。在孩子差不多2岁时,其父母发现孩子常常有肚子痛和呕吐的现象,妈妈总是用止痛药帮孩子止住暂时的疼痛。但在接下来的日子里,孩子的头颅又开始一天天的变大,常常出现喂食困难,高音调的啼哭,大运动和精细运动的发育都落后于同龄儿。这让妈妈非常害怕,去医院检查后才知道孩子患上了小儿脑积水。
服用实施例3所得治疗小儿脑积水的中药组合物滴剂1个疗程后,孩子肚子痛和呕吐的现象明显减少;继续服用1个疗程,孩子基本不再哭闹,喂食也变的明显容易了很多;又坚持服用1个疗程来巩固,服用完后,诸症消失,孩子的运动能力及头颅大小已经与同龄儿童一般,无其他不适症状。随访至今,未见复发。
实施例4治疗小儿脑积水的中药组合物,取下述主要原料制备而成(每份取10g):熟地黄8份;天香炉5份;山药6份;山茱萸7份;蜘蛛香5份;牡丹皮4份;茯苓5份;白僵蚕6份;黄精10.5份;罗布麻叶9份;白术(炒)7.5份;郁李仁4份;覆盆子8份。
上述治疗小儿脑积水的中药组合物口服液的制备方法,步骤如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的2倍的60%的乙醇做溶剂,浸渍25小时,装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡15小时,倒入砂锅中煎煮两次,每次煮沸30分钟,两次滤液合并,静置5小时,取上清液;
(3)将天香炉和罗布麻叶打碎,用水浸泡,置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌6min,得挥发油;
(4)步骤(3)提取挥发油后的水溶液滤过,与步骤(1)所得的渗漉液和步骤(2)所得的水煎液混合均匀,浓缩至原体积的1/2,加入步骤(3)所得的挥发油,加入相当于浓缩液质量的0.2%的苯甲酸钠和相当于浓缩液质量的7%的蔗糖,混匀,杀菌15分钟,以每支3ml的剂量进行无菌封装。
服用方法:每次3-4ml,随后喂适量的奶水或者温开水,每日3次,5天一个疗程。
试验例:为了验证实施例4所得的治疗小儿脑积水的中药组合物口服液的疗效,我们进行了对比试验。实验选病人250人,随机地分为对照组和实验组,其中实验组有150人,对照组有100人。试验之前1周,对该人群进行连续观察,记录症状及变化。实验组:服用实施例4所得治疗小儿脑积水的中药组合物口服液,每次3粒,用40℃左右的温开水送服,每日3次,5天一个疗程。对照组:采用其他治疗方案,比如口服呋塞米片、注射甘露醇等。我们每天同等时间,同等情况下用药,并同时观察、记录每小组病人的身体状况。疗效情况判定标准:治愈:头颅明显减少,行走状况以及身体发育情况均正常,不适症状完全消失。显效:脑积水基本消失,头颅大小、智力及活动基本正常,不适症状减轻或部分消失。无效:脑积水,头颅大小、行走状况以及身体发育情况没有得到缓解,不适症状无变化以及症状复发。其中有效包括痊愈和显效。采用其他治疗方案的对照组和使用实施例4所得治疗小儿脑积水的中药组合物口服液的实验组的疗效对比,结果如表1所示:
表1
疗效分析:从表1可以看出,服用本发明实施例4所得治疗小儿脑积水的中药组合物口服液的无效率仅为2%,治愈率高达76%,有效率高达98%,而采用其他治疗方案的有18%的无效率,治愈率只达到40%,有效率也仅为82%。实验表明服用实施例4所得治疗小儿脑积水的中药组合物口服液与采用其他治疗方案(比如口服呋塞米片、注射甘露醇等)相比,其疗效大幅度提高,且治愈率高,并且无效率低。
通过观察可以看出:服用实施例4所得治疗小儿脑积水的中药组合物口服液的各症状得到缓解的比例明显高于使用其它药品(比如口服呋塞米片、注射甘露醇等),服用1个疗程,实验组有43%的患儿有所好转,且3个疗程后,实验组的各症状缓解率都达到了94%以上;而服用其他药物的对照组1个疗程后,只有32%的患者的各症状有所改善, 3个疗程后也只有75%的患者的各症状得到缓解。由此,可断定出本发明治疗小儿脑积水的中药组合物口服液对小儿脑积水有更好的疗效。
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. 治疗小儿脑积水的中药组合物,其特征是,取下述重量配比的主要原料制备而成:熟地黄5-10份;天香炉4-6份;山药4-8份;山茱萸5-10份;蜘蛛香4-6份;牡丹皮3-5份;茯苓3-7份;白僵蚕4-9份;黄精9-12份;罗布麻叶6-12份;白术(炒)6-9份;郁李仁2-6份;覆盆子6-10份。
2.根据权利要求1所述的中药组合物,其特征是,取下述重量配比的主要原料制备而成:熟地黄6-9份;天香炉4.5-5.5份;山药5-7份;山茱萸6-9份;蜘蛛香4.5-5.5份;牡丹皮3.5-4.5份;茯苓4-6份;白僵蚕5-8份;黄精10-11份;罗布麻叶8-10份;白术(炒)7-8份;郁李仁3-5份;覆盆子7-9份。
3.根据权利要求1所述的中药组合物,其特征是,取下述重量配比的主要原料制备而成:熟地黄8份;天香炉5份;山药6份;山茱萸7份;蜘蛛香5份;牡丹皮4份;茯苓5份;白僵蚕6份;黄精10.5份;罗布麻叶9份;白术(炒)7.5份;郁李仁4份;覆盆子8份。
4.根据权利要求1-3任一所述的中药组合物,其特征在于,可将该中药组合物制成药学上可接受的糖浆剂,制备方法如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中,煎煮30-50分钟(优选35-45分钟,更加优选40分钟),将天香炉和罗布麻叶于烘干机中烘干,粉碎,装入灭菌过的600-800目(优选650-750目,更加优选700目)的纱布袋中,置于砂锅中,继续煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置3-5小时(优选的,静置3.5-4.5小时,更加优选的,静置4小时),取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置6-9小时(优选的,静置7-8小时,更加优选的,静置7.5小时),过滤,滤液回收乙醇并浓缩至相对密度1.10-1.20(优选的,浓缩至相对密度1.12-1.18,更加优选的,浓缩至相对密度1.15),加入单糖浆(单糖浆的用量为药膏质量的20%-40%,优选的,单糖浆的用量为药膏质量的25%-35%,更加优选的,单糖浆的用量为药膏质量的30%)和苯甲酸钠(苯甲酸钠的用量为药膏质量的0.04%-0.08%,优选的,苯甲酸钠的用量为药膏质量的0.05%-0.07%,更加优选的,苯甲酸钠的用量为药膏质量的0.06%),混合均匀,无菌封装。
5.根据权利要求4所述的制备方法,其特征是:步骤(1)渗漉时优选每小时流出液相当于渗漉容器被利用容积的1/48-1/24。
6.根据权利要求1-3任一所述的中药组合物,其特征在于,可将该中药组合物制成药学上可接受的颗粒剂,制备方法如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将天香炉和罗布麻叶烘干,粉碎,过80-120 目筛(优选的,过90-110目筛,更加优选的,过100目筛),用水浸泡(优选的,水的用量为药粉质量的3-5倍,更加优选的,水的用量为药粉质量的4倍),置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌4-8min(优选的,杀菌5-7min,更加优选的,杀菌6min),得挥发油
(4)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置3-5小时(优选的,静置3.5-4.5小时,更加优选的,静置4小时),取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置6-9小时(优选的,静置7-8小时,更加优选的,静置7.5小时),过滤,滤液回收乙醇并浓缩至相对密度1.10-1.20(优选的,浓缩至相对密度1.12-1.18,更加优选的,浓缩至相对密度1.15),加入步骤(3)所得的挥发油,加入单糖浆和糊精,混匀,制成均匀的颗粒,辅以药学上可接受的载体包装,每小包的质量为2g。
7.根据权利要求6所述的制备方法,其特征是:步骤(4)单糖浆和糊精的用量比为1:1,且均为浓缩液质量的5%-7%(优选为浓缩液质量的6%)。
8.根据权利要求1-3任一所述的中药组合物,其特征在于,可将该中药组合物制成药学上可接受的滴剂,制备方法如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将天香炉和罗布麻叶打碎,用水浸泡(优选的,水的用量为药粉质量的3-5倍,更加优选的,水的用量为药粉质量的4倍),置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌4-8min(优选的,杀菌5-7min,更加优选的,杀菌6min),得挥发油;
(4)将步骤(1)所得渗漉液和步骤(2)所得水煎液合并,混合均匀,静置3-5小时(优选的,静置3.5-4.5小时,更加优选的,静置4小时),取上清液,余液滤除沉淀后与上清液合并,加入乙醇,静置6-9小时(优选的,静置7-8小时,更加优选的,静置7.5小时),过滤,滤液回收乙醇并浓缩为混悬液,加入步骤(3)所得的挥发油,加入甜味剂和矫味剂,混匀,采用高剪切设备剧烈高速搅拌,在搅拌状态下,以小气泡的形式通入氮气来排除药液中的氧气,无菌封装。
9.根据权利要求1-3任一所述的中药组合物,其特征在于,可将该中药组合物制成药学上可接受的口服液,制备方法如下:
(1)将山药、白术(炒)、山茱萸、覆盆子、白僵蚕和郁李仁置于烘干机中烘干,粉碎成粗粉,置于玻璃容器中,加入相当于药粉质量的1-3倍的50%-70%的乙醇做溶剂(优选的,加入相当于药粉质量的1.5-2.5倍的55%-65%的乙醇做溶剂,更加优选的,加入相当于药粉质量的2倍的60%的乙醇做溶剂),浸渍20-30小时(优选的,浸渍22-28小时,更加优选的,浸渍25小时),装入渗容器中进行渗漉;
(2)将熟地黄、蜘蛛香、牡丹皮、茯苓和黄精置于非铁质容器中浸泡10-20小时(优选的,浸泡12-18小时,更加优选的,浸泡15小时),倒入砂锅中煎煮两次,每次煮沸20-40分钟(优选的,每次煮沸25-35分钟,更加优选的,每次煮沸30分钟),两次滤液合并,静置3-7小时(优选的,静置4-6小时,更加优选的,静置5小时),取上清液;
(3)将天香炉和罗布麻叶打碎,用水浸泡(优选水的用量为药粉质量的3-5倍,更加优选4倍),置于蒸馏器中,通入水蒸气蒸馏,收集蒸馏液,冷却,分取油层,油层加热到100℃,杀菌4-8min(优选5-7min,更加优选6min),得挥发油;
(4)步骤(3)提取挥发油后的水溶液滤过,与步骤(1)所得的渗漉液和步骤(2)所得的水煎液混合均匀,浓缩至原体积的1/2,加入步骤(3)所得的挥发油,加入苯甲酸钠和矫味剂,混匀,杀菌10-20分钟(优选13-17分钟,更加优选15分钟),以每支3ml的剂量进行无菌封装。
10.根据权利要求9所述的制备方法,其特征是:步骤(4)苯甲酸钠的用量为浓缩液质量的0.1%-0.3%(优选0.2%),矫味剂使用蔗糖,用量为浓缩液质量的6%-8%(优选7%)。
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