CN108379259A - 一种精神焦虑缓解药物及其制备方法 - Google Patents
一种精神焦虑缓解药物及其制备方法 Download PDFInfo
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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Abstract
本发明属于药物制备技术领域,具体涉及一种缓解精神焦虑的药物及其制备方法。所述药物包括以下原料制得:按重量份数计:γ‑氨基丁酸1‑3份、维生素C 0.5‑1份、花青素0.3‑0.8份、谷氨酰胺1‑2份、黄原胶5‑‑10份、三硬脂酸甘油酯3‑‑8份、乙基纤维素15‑30份、羟丙基纤维素50‑‑80份。本发明制备得到的精神焦虑缓解药物,其缓解焦虑效果更好,安全性高;并且整个制备过程持续时间很短且无须加入水或有机溶剂,不需加热干燥,因此不易发生水解问题;制备效率较高。
Description
技术领域
本发明属于药物制备技术领域,具体涉及一种缓解精神焦虑的药物及其制备方法。
背景技术
γ-氨基丁酸,英文名:γ-aminobutyric acid (GABA),化学名称: 4-氨基丁酸 ,别名:γ-氨基丁酸,氨酪酸,哌啶酸。分子式: C4H9NO2 。分子量: 103.1。GABA是目前研究较为深入的一种重要的抑制性神经递质,它参与多种代谢活动,具有很高的生理活性。具有镇静、抗应激、促进食欲、调节内分泌等多种生物学功能。目前将γ-氨基丁酸应用于保健品、药品,用于缓解精神焦虑等症状是一个热门且意义重大的研究课题。本发明发现将γ-氨基丁酸与花青素、谷氨酰胺联合使用,能够有效增强其功能活性。
而熔融挤压法创造性的将加工技术和药学结合起来,将高分子材料在玻璃化转变温度之上对其进行处理,促使热塑性粘合剂或聚合物、药物活性成分达到分子水平的有效混合。热熔挤出技术结合了固体分散体技术和机械制备的诸多优势,实现了无粉尘、连续化操作、良好的重现性、极高的生产效率和在线监测。不仅可以促进难溶性活性成分溶解从而提高其生物利用度,还可用于制备缓控释、肠溶制剂;此外,这一技术还能用于制备掩味微丸或者其它特殊形状的制剂,如膜剂、棒剂和空心圆柱剂型等。由于整个挤出过程持续时间很短且无须加入水或有机溶剂,不需加热干燥, 因此不易发生水解问题。自从首次被应用于药物制剂领域开始,其完美解决传统制药工艺存在的诸多问题,已经成为国内外研究的热点技术。
发明内容
本发明的目的在于提供一种缓解精神焦虑的药物及其制备方法。本发明以γ-氨基丁酸作为主要功能组分,采用熔融挤压法来制备一种精神焦虑缓解药物。
为实现上述目的,本发明采用如下技术方案:
所述一种精神焦虑缓解药物,其原料包括:按重量份数计:γ-氨基丁酸1-3份;维生素C0.5-1份;花青素 0.3-0.8份;谷氨酰胺1-2份;黄原胶5--10份;三硬脂酸甘油酯3--8份;乙基纤维素15-30份;羟丙基纤维素 50--80份。
所述的一种精神焦虑缓解药物的制备方法,包括以下步骤:
(1)按照原料配比称取各个组分;
(2)将各组分混合后送入热熔挤出机,在热熔挤出机内进行加热熔融、挤出;其中热熔挤出机各区的温度设定为:喂料温度25-40℃,传输区温度35-55℃,混合区一段温度50-90℃,混合区二段温度80-140℃,混合区三段温度70-130℃,脱气区温度70-130℃,挤出区温度70-130℃;最后压片制成600mg片剂。
本发明的显著优点在于:
本发明制备得到的精神焦虑缓解药物,其缓解焦虑效果更好,安全性高;并且整个制备过程持续时间很短且无须加入水或有机溶剂,不需加热干燥,因此不易发生水解问题;制备效率较高。
具体实施方式
为进一步公开而不是限制本发明,以下结合实例对本发明作进一步的详细说明。
实施例1
所述一种精神焦虑缓解药物,其原料包括:按重量份数计:γ-氨基丁酸1份;维生素C 1份;花青素0.5份;谷氨酰胺2份;黄原胶7份;三硬脂酸甘油酯5份;乙基纤维素15份;羟丙基纤维素 68.5份。
所述的一种精神焦虑缓解药物的制备方法,包括以下步骤:
(1)按照原料配比称取各个组分;
(2)将各组分混合后送入热熔挤出机,在热熔挤出机内进行加热熔融、挤出;其中热熔挤出机各区的温度设定为:喂料温度30℃,传输区温度50℃,混合区一段温度75℃,混合区二段温度115℃,混合区三段温度105℃,脱气区温度90℃,挤出区温度90℃;最后压片制成600mg片剂。
实施例2
所述一种精神焦虑缓解药物,其原料包括:按重量份数计:γ-氨基丁酸2份;维生素C1份;花青素 0.5份;谷氨酰胺1.5份;黄原胶8份;三硬脂酸甘油酯3份;乙基纤维素25份;羟丙基纤维素 59份。
所述的一种精神焦虑缓解药物的制备方法,包括以下步骤:
(1)按照原料配比称取各个组分;
(2)将各组分混合后送入热熔挤出机,在热熔挤出机内进行加热熔融、挤出;其中热熔挤出机各区的温度设定为:喂料温度25℃,传输区温度45℃,混合区一段温度70℃,混合区二段温度120℃,混合区三段温度110℃,脱气区温度100℃,挤出区温度85℃;最后压片制成600mg片剂。
实施例3
所述一种精神焦虑缓解药物,其原料包括:按重量份数计:γ-氨基丁酸3份;维生素C0.5份;花青素0.8份;谷氨酰胺1份;黄原胶7份;三硬脂酸甘油酯4份;乙基纤维素20份;羟丙基纤维素 63.7份。
所述的一种精神焦虑缓解药物的制备方法,包括以下步骤:
(1)按照原料配比称取各个组分;
(2)将各组分混合后送入热熔挤出机,在热熔挤出机内进行加热熔融、挤出;其中热熔挤出机各区的温度设定为:喂料温度25℃,传输区温度45℃,混合区一段温度65℃,混合区二段温度125℃,混合区三段温度125℃,脱气区温度105℃,挤出区温度95℃;最后压片制成600mg片剂。
对比例
所述一种精神焦虑缓解药物,其原料包括:按重量份数计:γ-氨基丁酸2份;维生素C1份;黄原胶8份;三硬脂酸甘油酯3份;乙基纤维素25份;羟丙基纤维素 59份。
所述的一种精神焦虑缓解药物的制备方法,包括以下步骤:
(1)按照原料配比称取各个组分;
(2)将各组分混合后送入热熔挤出机,在热熔挤出机内进行加热熔融、挤出;其中热熔挤出机各区的温度设定为:喂料温度25℃,传输区温度45℃,混合区一段温度70℃,混合区二段温度120℃,混合区三段温度110℃,脱气区温度100℃,挤出区温度85℃;最后压片制成600mg片剂。
选择20g~25克昆明种小鼠为实验对象,分三组,每组10只小鼠。试验组每天喂食实施例2所述片剂2次,每次喂食量为0.4mg/10g小鼠体重,连续喂食5天。对比例组喂食对比例所述片剂2次,每次喂食量为0.4mg/10g小鼠体重,连续喂食5天。对照组喂食等量饲料。进行小鼠高架十字迷宫实验,记录5min内小鼠开放臂进入次数(必须有两只前瓜进入臂内),开放臂停留时间,闭合臂进入次数,闭合臂停留时间。计算开放臂停留时间比例,开放臂进入次数比例,高架十字迷宫中总进入次数。实验组平均进入开放臂次数(实验组开放臂次数百分率22.52±7.58%;)和停留时间(实验组开放臂时间百分率为9.29±7.45%)显著大于对比例组(对比例组开放臂次数百分率15.50±4.14%;对照组开放臂时间百分率为5.69±4.23%)、对照组(对照组开放臂次数百分率12.50±6.13%;对照组开放臂时间百分率为4.51±3.15%)。进入开放臂次数及停留时间与大鼠的焦虑情绪成负相关,进入开放臂次数越少,停留时间越短,说明老鼠的焦虑情绪越严重。
以上所述仅为本发明的较佳实施例,凡依本发明申请专利范围所做的均等变化与修饰,皆应属本发明的涵盖范围。
Claims (3)
1.一种精神焦虑缓解药物,其特征在于:所述药物包括以下原料制得:按重量份数计:γ-氨基丁酸1-3份、维生素C 0.5-1份、花青素 0.3-0.8份、谷氨酰胺1-2份、黄原胶5--10份、三硬脂酸甘油酯3--8份、乙基纤维素15-30份、羟丙基纤维素 50--80份。
2.根据权利要求1所述的一种精神焦虑缓解药物,其特征在于:所述药物包括以下原料制得:按重量份数计:γ-氨基丁酸2份、维生素C 1份、花青素 0.5份、谷氨酰胺1.5份、黄原胶8份、三硬脂酸甘油酯3份、乙基纤维素25份、羟丙基纤维素 59份。
3.一种制备如权利要求1所述的精神焦虑缓解药物的方法,其特征在于:包括以下步骤:
(1)按照原料配比称取各个组分;
(2)将各组分混合后送入热熔挤出机,在热熔挤出机内进行加热熔融、挤出;其中热熔挤出机各区的温度设定为:喂料温度25-40℃,传输区温度35-55℃,混合区一段温度50-90℃,混合区二段温度80-140℃,混合区三段温度70-130℃,脱气区温度70-130℃,挤出区温度70-130℃;最后压片制成600mg片剂。
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