CN106860695A - 一种治疗心热内扰型夜啼的中药复方制剂 - Google Patents
一种治疗心热内扰型夜啼的中药复方制剂 Download PDFInfo
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Abstract
本发明公开了一种治疗心热内扰型夜啼的中药复方制剂，其特征在于它是由下列药物组成：金银花5〜60份，黄连5〜60份，灯心草5〜60份。本发明的一种治疗夜啼的中药复方制剂，因为处方的科学合理的配伍，不同的提取方法均可达到理想的治疗效果。
Description
技术领域
本发明属于中药技术领域，具体涉及一种治疗心热内扰型夜啼的中药复方制剂的处方、制备工艺及其适应症。
背景技术
足够的睡眠是小儿健康的重要保证，新生儿每天需要睡眠约20小时，到1周岁仍要14〜15小时。夜啼是指1岁以内的哺乳婴儿，因寒热受惊等而致的夜间定时啼哭，甚则 可通宵达旦啼哭的一种疾病。若婴儿夜间饥饿或尿布潮湿、皮带过紧、皮肤瘙痒等以及伤乳伤食、发热或其他疾病而突然引起啼哭者，则不属丁•本病范畴。本病临床比较常见，但实验室检查无异常现象，也无特异性治疗方法。中医认为本病多由心热内扰、脾脏虚寒、暴受惊恐或脾虚肝旺所引起。其中心热内扰可由孕妇内蕴郁热，恣食辛热动火之食；或过服温热药物，蕴蓄之热遗于胎儿；或婴儿将养过温，受火热之气熏灼，心火上炎，心热懊弄难言，烦躁不安而啼。夜间阴盛阳衰，阳入于阴则入静而寐，阴不能潜阳，故夜间不寐而啼哭不止。彻夜啼哭之后阳气耗损，无力抗争，故白天入寐，正气稍复，入夜又啼，周而复始，循环不已。导致孕妇内蕴郁热、婴儿将养过温的情况比比皆是，心经积热极易产生，所以在目前情况下，导致婴幼儿夜啼的诸种因素中，心热内扰是最常见的。因此，研制治疗婴幼儿夜啼的中药，选择针对心热内扰型应该是最有临床意义的。
本制剂处方中以黄连为主药，它具有清热泻火，燥湿、解毒，辅以金银花、灯心草起协同作用，以增加黄连效用。金银花具有清热解毒，近代药理表明，它有抗菌、抗病毒、消炎、解热作用。灯心草在临床上有清热利湿之效，用于烦心失眠、小儿夜啼，既能入心清心火又可利尿泻热，以引导心火下降。三药组方，便能发挥抗菌、抗炎、镇痛、利尿解热、抗血小板凝聚止血等作用。其中黄连药性苦寒、清泻心火、燥湿解毒；银花药性甘寒、散热解毒；灯心草药性甘淡微寒、清心除烦利尿。从清热泻火的角度来看：黄连为苦寒直泻心火；灯心草甘淡渗利，导心火从小便而出；银花之散热作用可使热向外透散而出，这样使心火从三条不同的途径分散而解。全方药味虽少，但构思巧妙，作用集中，针对性强，且方中药味组成甘苦共济，不仅使患儿易于接受，而且可以减缓苦寒败胃之弊。
发明内容
发明目的：本发明的目的在于提供一种组方合理、疗效确切的中药制剂，本发明的另外一个目的是提供该治疗夜啼的中药复方制剂的制备工艺及其在治疗夜啼方面的应用。
技术方案：为了实现以上发明目的，本发明采取一下技术方案：
一种治疗心热内扰型夜啼的中药复方制剂，其特征在于它是由下列药物组成：金 银花5〜60份，黄连5〜60份，灯心草5〜60份。
本发明优选：一种治疗心热内扰型夜啼的中药复方制剂，其处方中各药物重量配比是：金银花6〜40份，黄连6〜40份，灯心草6〜40份。
本发明更加优选：一种治疗心热内扰型夜啼的中药复方制剂，其处方中各药物重
量配比是：金银花40份，黄连40份，灯心草40份。
本发明提供的一种治疗夜啼的中药复方制剂的处方可以制成任何临床上可以接受的剂型，将各原料药的提取物按药学常规方法制备成丸剂、片剂、口服液等口服剂型。
本发明的一种治疗夜啼的中药复方制剂，因为处方的科学合理的配伍，不同的提取方法均可达到理想的治疗效果，这些均在本发明的保护范围之内。
下面结合具体实施例对本发明作进一步说明，下述各实施例仅用于说明本发明而并非对本发明的限制。
实施例1
下列重量份的原料药材制成：金银花20份，黄连40份，灯心草40份。将药材粉碎 后，金银花和灯心草用40倍量水煎煮2次，每次半小时；黄连用10倍20%乙醇浸渍24小 时、渗漉提取。将以上各提取液回收乙醇后浓缩成稠膏，干燥粉碎后用70%乙醇制粒，加入 淀粉100g，微粉硅胶50g，硬脂酸镁1. 5g,混匀后装入胶囊。
实施例2
下列重量份的原料药材制成：金银花40份，黄连60份，灯心草40份。取以上药材 混合后一次用90%乙醇、50%乙醇、水回流提取，提取液合并，浓缩，真空干燥，得到本发明 的药物组合干膏。取其中250g，加入糊精350g，蛋白糖3g，适量70%乙醇制粒，60°C干燥， 得到本发明药物组合颗粒。
实施例3
下列重量份的原料药材制成：金银花25份，黄连30份，灯心草40份。将黄连粉碎 后用70%乙醇回流，提取液浓缩后喷雾干燥为干膏，备用；剩余两味药混合后用水提取，提 取液浓缩，用大孔树脂吸附，60%乙醇洗脱，洗脱液浓缩后喷雾干燥为干膏。两部分干膏混 合后，取其中200g，以90%乙醇为润湿剂，泛制法制成浓缩丸。
实施例4
下列重量份的原料药材制成：金银花30份，黄连60份，灯心草30份。取以上药材 混合后依次用60%乙醇、水提取，提取液合并，浓缩为干膏，备用。取其中250g，加入适量蛋 白糖和尼泊金乙酯，4°C冷藏过夜后过滤，封装于10ml安瓿瓶中，即得本发明药物组合口服液。
Claims (6)
1.一种治疗心热内扰型夜啼的中药复方制剂，其特征在于，它是由下列药物组成：金银花5〜60份，黄连5〜60份，灯心草5〜60份。
2.如权利要求1所述的一种治疗心热内扰型夜啼的中药复方制剂，其特征在于，它的重量配比是：金银花6〜40份，黄连6〜40份，灯心草6〜40份。
3.如权利要求2所述的一种治疗心热内扰型夜啼的中药复方制剂，其特征在于，处方中各药材的重量配比是：金银花40份，黄连6份，灯心草20份。
4.权利要求1所述的一种治疗心热内扰型夜啼的中药复方制剂，其特征在于，与赋形剂混合制成片剂、胶囊、颗粒剂、丸剂、口服液、分散片、口崩片或滴丸。
5.权利要求1-3所述的一种治疗心热内扰型夜啼的中药复方制剂的制备工艺，其特征在于，包括以下步骤：
按权利要求1所述的重量份数取金银花5〜60份，黄连5〜60份，灯心草5〜60 份；
用多倍量水浸泡后煎煮，过滤，水煎液浓缩至稠膏；或粉碎至粗粉，先用10〜50%乙醇浸润，再用50〜80%乙醇渗漉，滤液回收乙醇后浓缩至稠膏；或粉碎取细粉备用，剩余部分用20〜80%乙醇浸泡，加热回流提取，过滤，滤液回收乙醇，浓缩至稠膏；或稠膏与细粉均 匀混合，制成软材，干燥后粉碎，过筛，用20〜80%乙醇制成颗粒，备用；
取步骤（1)得到的软材按药学常规方法制备成颗粒、胶囊、片剂、丸剂、口服液等各 种口服制剂。
6.权利要求1至3任一项所述的治疗心热内扰型夜啼的制剂在治疗夜啼方面的应用。
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