CN103142886A - 一种和胃健脾的颗粒剂 - Google Patents
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Abstract
本发明提供一种治疗脾胃不合以及厌食症的药物颗粒剂，药物组成为厚朴，菊花，枳壳，薏苡仁，稻芽，山楂，淡竹叶，甘草，蔗糖粉，乳糖。对药物组成和辅料的筛选增加了制剂的安全性和用药顺应性。
Description
技术领域
本发明涉及一种药物组合物及其制备方法，特别涉及一种治疗厌食症的颗粒制剂及其制备方法。
背景技术
脾胃虚弱、脾胃不和多会引起厌食症，临床主要表现为较长时间的食欲减退、食量减少。桑莉等人根据厌食症临床表现分为六型：1.脾失健运型，治宜健脾助运，开胃增食，2.脾胃气虚型，治宜益气健脾、渗湿和胃，3.肝气郁结型，治宜疏肝理气，运脾开胃，4.食滞内阻型，治宜消食导滞，健脾助运，5.胃阴不足型，宜养胃生津、育阴润燥，6.虫积伤脾型，治宜驱虫去积、健运脾胃，本病的主要原因在脾胃，治疗上分别采用运脾、健胃、温中、燥湿等原则。
目前，对于儿童厌食症的治疗常用药方多包括了钩藤和蝉蜕两味药物，这两种药物均具有镇静作用，对于高热惊痫者适宜，再者蝉蜕已发生服药后腹胀、肠鸣和腹痛的副作用，这也不利于小儿患者服药的安全性。并且现有技术多采用口服液、糖浆剂等，剂型比较单一，不利于中药制剂的对外发展。而本发明经过对大量药物及辅料的筛选，除了对组方进行改进外，还提供了一种尤其适合老年和儿童用药的颗粒剂型。
发明内容
本发明所要解决的技术问题是提供一种疗效好、生物利用度高的和胃健脾颗粒制剂，发明人通过大量实验发现，当选择蔗糖粉和乳糖作为辅料时，本发明的颗粒剂疗效好、生物利用度高，本发明的颗粒剂由如下主要成分制备而成，厚朴600g-700g，菊花600g-700g，枳壳800g-900g，薏苡仁800g-900g，稻芽800g-900g，山楂400g-500g，淡竹叶600g-700g，甘草1000g-1100g，蔗糖粉800g-900g，乳糖200g-240g，还可以加入其它赋形剂。
更有选蔗糖粉与乳糖的比例为4:1。
本发明的颗粒剂通过如下制备步骤得到：1）按重量份称取厚朴、菊花、枳壳、薏苡仁、山楂、稻芽、淡竹叶、甘草进行粉碎，浸泡，加入4-5倍水进行煎煮3次，每次45-60min，合并煎煮液，浓缩，加70%乙醇静置，过滤，旋转蒸发除去乙醇，干燥得到粉末；2）按重量称取蔗糖粉、乳糖，与1）得到的粉末混合；以70％乙醇水溶液为粘合剂，制粒，干燥，整粒，灭菌，装入袋中即得。
厚朴、枳壳均具有促进胃功能、消积实的作用，而积实生“火”，用菊花有降火功效，其合用也产生一定的协同作用，再与其它成分并用，对厌食有相当的疗效，尤其对于小儿厌食症的治疗，颗粒剂便于携带和运输，微粉化超微粉碎也增加了药物的利用率，乳糖辅料的筛选以及用水作为粘合剂的使用，利用中药本身的粘性制粒，也为本发明的颗粒剂带来了优良的性能。
具体实施方式
以下实施例是对本发明的进一步说明，但绝不是对本发明范围的限制。下面参照实施例进一步详细阐述本发明，但是本领域技术人员应当理解，本发明并不限于这些实施例以及使用的制备方法。而且，本领域技术人员根据本发明的描述可以对本发明进行等同替换、组合、改良或修饰，但这些都将包括在本发明的范围内。
实施例1
厚朴600g，菊花600g，枳壳800g，薏苡仁800g，稻芽800g，山楂400g，淡竹叶600g，甘草1000g，蔗糖粉800g，乳糖200g。
制备方法为：1）按重量份称取厚朴、菊花、枳壳、薏苡仁、山楂、稻芽、淡竹叶、甘草进行粉碎，浸泡，加入4倍水进行煎煮3次，每次45min，合并煎煮液，浓缩，加70%乙醇静置，过滤，旋转蒸发除去乙醇，干燥得到粉末；2）按重量称取蔗糖粉、乳糖，与1）得到的粉末混合；以70％乙醇水溶液为粘合剂，制粒，干燥，整粒，灭菌，装入袋中即得，每袋7g。
实施例2
厚朴700g，菊花700g，枳壳900g，薏苡仁900g，稻芽900g，山楂500g，淡竹叶700g，甘草1100g，蔗糖粉900g，乳糖180g。
制备方法同实施例1
实施例3
厚朴650g，菊花650g，枳壳850g，薏苡仁850g，稻芽850g，山楂450g，淡竹叶650g，甘草1050g，蔗糖粉600g，乳糖220g。
制备方法同实施例1
临床研究
本发明共观察符合纳入标准的120例厌食症患者，病程未结束而出现过敏反应或严重不良反应者，应终止研究，但已超过1/2疗程者应统计有效。
疗效判定标准：
临床痊愈：食欲与食量均恢复到正常水平；
显效：食欲明显恢复，食量恢复到原水平的3/4；
有效：食欲有所改善，食量有所恢复，但未达到原水平的3/4；
无效：食欲与食量无改善。
将患者随机分为治疗组1-3、对照组1，治疗组分别给予实施例1-3制备的颗粒剂，对照组1给予市售广州王老吉药业股份有限公司生产小儿七星茶糖浆，每日三次，给药三天，结果如表1。
表1治疗效果
| 有效率 | |
| 治疗组1 | 92% |
| 治疗组2 | 90% |
| 治疗组3 | 91% |
| 对照组1 | 78% |
Claims (7)
1.一种和胃健脾颗粒剂，由如下成分制备而成，厚朴600g-700g，菊花600g-700g，枳壳800g-900g，薏苡仁800g-900g，稻芽800g-900g，山楂400g-500g，淡竹叶600g-700g甘草1000g-1100g，蔗糖粉800g-900g，乳糖200g-240g。
2.如权利要求1所述的和胃健脾颗粒剂，还可以加入其它赋形剂。
3.如权利要求1所述的和胃健脾颗粒剂，其由如下成分制备而成，厚朴600g，菊花600g，枳壳800g，薏苡仁800g，稻芽800g，山楂400g，淡竹叶600g，甘草1000g，蔗糖粉800g，乳糖200g。
4.如权利要求1所述的和胃健脾颗粒剂，其由如下成分制备而成，厚朴700g，菊花700g，枳壳900g，薏苡仁900g，稻芽900g，山楂500g，淡竹叶700g，甘草1100g，蔗糖粉900g，乳糖240g。
5.如权利要求1所述的和胃健脾颗粒剂，其由如下成分制备而成，厚朴650g，菊花650g，枳壳850g，薏苡仁850g，稻芽850g，山楂450g，淡竹叶650g，甘草1050g，蔗糖粉850g，乳糖220g。
6.如权利要求1-5之一所述的和胃健脾颗粒剂的制备方法，其特征是通过如下制备步骤得到：1）按重量份称取厚朴、菊花、枳壳、薏苡仁、山楂、稻芽、淡竹叶、甘草进行粉碎，浸泡，加入4-5倍水进行煎煮3次，每次45-60min，合并煎煮液，浓缩，加70%乙醇静置，过滤，旋转蒸发除去乙醇，干燥得到粉末；2）按重量称取蔗糖粉、乳糖，与1）得到的粉末混合；以70％乙醇水溶液为粘合剂，制粒，干燥，整粒，灭菌，装入袋中即得。
7.如权利要求1-5之一所述的和胃健脾颗粒剂在制备健脾和胃以及治疗厌食症的药物中的应用。
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| CN101856473A (zh) * | 2010-06-22 | 2010-10-13 | 中山市恒生药业有限公司 | 小儿七星茶口服液及其制备方法 |
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