CN108066578A - 一种睡伴胶囊及其制备方法 - Google Patents

一种睡伴胶囊及其制备方法 Download PDF

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CN108066578A
CN108066578A CN201810088156.8A CN201810088156A CN108066578A CN 108066578 A CN108066578 A CN 108066578A CN 201810088156 A CN201810088156 A CN 201810088156A CN 108066578 A CN108066578 A CN 108066578A
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肖东
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CHONGQING RUEPEAK PHARMACEUTICAL Co Ltd
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Abstract

本发明主要公开了一种睡伴胶囊及其制备方法，由如下重量份的原料组成：酸枣仁4‑10份、五味子3‑8份、远志6‑12份、首乌藤4‑12份、丹参3‑15份、石菖蒲3‑10份、知母3‑8份、甘草2‑8份、茯苓5‑15份；通过药材提取液制备、胶囊填充剂制备、胶囊填充制备等工序，减少给药次数，提高患者服药顺应性，维持血药浓度平稳，具有长效缓释作用，生物利用度高，提高用药安全性和药效，制备工艺简单。

Description

一种睡伴胶囊及其制备方法
技术领域：
本发明涉及一种胶囊领域，特别涉及一种睡伴胶囊及其制备方法，属于医药领域。
背景技术：
用胶囊装的药物，一般都是对食道和胃粘膜有刺激性的粉末或颗粒，或口感不好、易于挥发、在口腔中易被唾液分解，以及易吸入气管的药。这些药装入胶囊，既保护了药物药性不被破坏，也保护了消化器官和呼吸道。去掉胶囊壳可能会造成药物流失、药物浪费、药效降低。另外，有些药物需要在肠内溶解吸收，胶囊保护药物不被胃酸破坏。医药上指用特种成膜材料(如明胶、纤维素、多糖等)制成的囊状物，把内容物(如粉状、液体状各类药物等)或按剂量装入其中，便于吞服。
发明内容：
本发明的目的是克服现有技术的不足之处，提供一种睡伴胶囊及其制备方法，具有对于养血安神，清心除烦的功效，对于心烦不寐，怔忡惊悸，梦多易醒或久卧不眠具有良好的疗效，本发明具有制备工艺简单、使用方便、疗效高、成本低的特点。解决了现有技术中的问题。
为实现上述目的，本发明提供如下技术方案：一种睡伴胶囊，由如下重量份的原料组成：酸枣仁4-10份、五味子3-8份、远志6-12份、首乌藤4-12份、丹参3-15份、石菖蒲3-10份、知母3-8份、甘草2-8份、茯苓5-15份；
一种睡伴胶囊制备方法，包括如下步骤：
步骤1：药材提取液的制备
(1)水煮法提取：将无霉变的酸枣仁10份、五味子5份、远志10份、首乌藤8份、丹参12份、石菖蒲5份、知母5份、甘草5份、茯苓10份充分干燥后投入到提取罐中，向提取罐中加入药物总重量10-15倍重量份的蒸馏水进行加热煮提；
(2)煮提液浓缩：对煮提液进行减压浓缩，浓缩温度为60-65℃，蒸汽压力为0.05-0.08Mpa，真空度为0.06-0.08Mpa，控制药液相对密度在1.10～1.15，形成煮提液浓缩液；
步骤2：胶囊填充剂制备
(1)药材粉碎：将无霉变的酸枣仁5份、五味子3份、远志5份、首乌藤4份、丹参6份、石菖蒲2份、知母2份、甘草3份、茯苓5份充分干燥后投入粉碎机内制得药材粉末；
(2)微球制备，将步骤1中制备的煮提液浓缩液与药材粉末按3:1的比例混合后，加入药物总质量1.5倍的润滑剂，加入适量的纯化水后搅拌均匀放入颗粒机内制备药材微球；将药材微球放入干燥机内进行干燥，控制温度55-60℃，控制药材微球水分含水量低于5％，制得胶囊填充剂，
步骤3：胶囊制备
胶囊填充：将步骤2中制备的胶囊填充剂填充至空心双环胶囊套内，胶囊接口处用明胶液封口后，控制每一粒胶囊质量为0.24g，制得睡伴胶囊。优选的，所述润滑剂为乳糖、滑石粉、微晶纤维素按照2:1:2的比例混合均匀后制备。
优选的，所述药材粉末颗粒大小为100-120目。
优选的，所述明胶液由明胶、纯化水、70％乙醇按照1:2:2的比例混合均匀后制备而成。
本发明的有益效果：
本发明的主要目的在于提供一种睡伴胶囊及其制备方法，减少给药次数，提高患者服药顺应性，维持血药浓度平稳，具有长效缓释作用，生物利用度高，提高用药安全性和药效，制备工艺简单。
具体实施方式：
本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例：一种睡伴胶囊，由如下重量份的原料组成：酸枣仁4-10份、五味子3-8份、远志6-12份、首乌藤4-12份、丹参3-15份、石菖蒲3-10份、知母3-8份、甘草2-8份、茯苓5-15份。
实施例中的睡伴胶囊的制备方法，包括如下步骤：
步骤1：药材提取液的制备
(1)水煮法提取：将无霉变的酸枣仁10份、五味子5份、远志10份、首乌藤8份、丹参12份、石菖蒲5份、知母5份、甘草5份、茯苓10份充分干燥后投入到提取罐中，向提取罐中加入药物总重量10-15倍重量份的蒸馏水进行加热煮提；
(2)煮提液浓缩：对煮提液进行减压浓缩，浓缩温度为60-65℃，蒸汽压力为0.05-0.08Mpa，真空度为0.06-0.08Mpa，控制药液相对密度在1.10～1.15，形成煮提液浓缩液；
步骤2：胶囊填充剂制备
(1)药材粉碎：将无霉变的酸枣仁5份、五味子3份、远志5份、首乌藤4份、丹参6份、石菖蒲2份、知母2份、甘草3份、茯苓5份充分干燥后投入粉碎机内制得药材粉末；
(2)微球制备，将步骤1中制备的煮提液浓缩液与药材粉末按3:1的比例混合后，加入药物总质量1.5倍的润滑剂，加入适量的纯化水后搅拌均匀放入颗粒机内制备药材微球；将药材微球放入干燥机内进行干燥，控制温度55-60℃，控制药材微球水分含水量低于5％，制得胶囊填充剂，
步骤3：胶囊制备
胶囊填充：将步骤2中制备的胶囊填充剂填充至空心双环胶囊套内，胶囊接口处用明胶液封口后，控制每一粒胶囊质量为0.24g，制得睡伴胶囊。
其中，所述润滑剂为乳糖、滑石粉、微晶纤维素按照2:1:2的比例混合均匀后制备，所述药材粉末颗粒大小为100-120目，所述明胶液由明胶、纯化水、70％乙醇按照1:2:2的比例混合均匀后制备而成。
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。

Claims (5)

1.一种睡伴胶囊，其特征在于，由如下重量份的原料组成：酸枣仁4-10份、五味子3-8份、远志6-12份、首乌藤4-12份、丹参3-15份、石菖蒲3-10份、知母3-8份、甘草2-8份、茯苓5-15份。
2.一种睡伴胶囊的制备方法，其特征在于，制作方法包括如下步骤：
步骤1：药材提取液的制备
(1)水煮法提取：将无霉变的酸枣仁10份、五味子5份、远志10份、首乌藤8份、丹参12份、石菖蒲5份、知母5份、甘草5份、茯苓10份充分干燥后投入到提取罐中，向提取罐中加入药物总重量10-15倍重量份的蒸馏水进行加热煮提；
(2)煮提液浓缩：对煮提液进行减压浓缩，浓缩温度为60-65℃，蒸汽压力为0.05-0.08Mpa，真空度为0.06-0.08Mpa，控制药液相对密度在1.10～1.15，形成煮提液浓缩液；
步骤2：胶囊填充剂制备
(1)药材粉碎：将无霉变的酸枣仁5份、五味子3份、远志5份、首乌藤4份、丹参6份、石菖蒲2份、知母2份、甘草3份、茯苓5份充分干燥后投入粉碎机内制得药材粉末；
(2)微球制备，将步骤1中制备的煮提液浓缩液与药材粉末按3:1的比例混合后，加入药物总质量1.5倍的润滑剂，加入适量的纯化水后搅拌均匀放入颗粒机内制备药材微球；将药材微球放入干燥机内进行干燥，控制温度55-60℃，控制药材微球水分含水量低于5％，制得胶囊填充剂，
步骤3：胶囊制备
胶囊填充：将步骤2中制备的胶囊填充剂填充至空心双环胶囊套内，胶囊接口处用明胶液封口后，控制每一粒胶囊质量为0.24g，制得睡伴胶囊。
3.根据权利要求2所述的一种睡伴胶囊的制备方法，其特征在于：所述润滑剂为乳糖、滑石粉、微晶纤维素按照2:1:2的比例混合均匀后制备。
4.根据权利要求2所述的一种睡伴胶囊的制备方法，其特征在于：所述药材粉末颗粒大小为100-120目。
5.根据权利要求2所述的一种睡伴胶囊的制备方法，其特征在于：所述明胶液由明胶、纯化水、70％乙醇按照1:2:2的比例混合均匀后制备而成。
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