CN105832693A - 一种抑郁药专用空心胶囊的制备方法 - Google Patents
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Abstract
本发明公开了一种抑郁药专用空心胶囊的制备方法,属于胶囊领域。本发明从新鲜贯叶连翘提取得金丝桃素浓缩液,再制备交联透明质酸钠凝胶,将其与黄原胶、金丝桃素浓缩液表面活性剂、助凝剂、固化剂等混合制备成胶液,将胶液送入胶囊生产线生产成型即可,本发明制备得的空心胶囊的原料流动性好,壁厚均匀,而且提取出金丝桃素添加到囊体中,使得囊体不仅仅只是药剂的外包材料,而且具有抗抑郁的功效,可以应用于抗抑郁药之中,增强药效、延长缓释效果。
Description
技术领域
本发明公开了一种抑郁药专用空心胶囊的制备方法,属于胶囊领域。
背景技术
硬壳空心胶囊是一种重要的药辅材料。它是随制剂一起进入人体消化系统后再被人体所吸收,故食用的安全性与空心胶囊的质量安全标准息息相关。目前市场上的空心胶囊仍以明胶胶囊为主,而明胶胶囊的缺陷也日益明显,研发植物空心胶囊在国内外广受关注。植物空心胶囊的应用市场显现出了极大的发展潜力我国植物空心胶囊制备技术较欧美国家仍较落后,而用于植物空心胶囊制备的材料包括羟甲基纤维素、多糖及淀粉类。
目前,空心胶囊的生产过程中容易发生以下问题:若产品原料的含水低,则原料的流动性差,均质性差,生产出的空心胶囊因各位点的材质、壁厚不一而成品合格率低;若增加产品原料的含水量,原料的流动性提高,则产品的干燥成型过程变长,电耗增加,而且由于失水多,产品成型的不确定性增加,同样影响成品合格率,现有的生产工艺制备的空心胶囊具有壁厚不一,含水量差异大,合格率低,能耗高的缺点。
发明内容
本发明主要解决的技术问题:针对目前空心胶囊具有壁厚不一,含水量差异大,合格率低,能耗高,而且功能单一的问题,提供了一种抑郁药专用空心胶囊的制备方法,本发明从新鲜贯叶连翘提取得金丝桃素浓缩液,再制备交联透明质酸钠凝胶,将其与黄原胶、金丝桃素浓缩液表面活性剂、助凝剂、固化剂等混合制备成胶液,将胶液送入胶囊生产线生产成型即可,本发明制备得的空心胶囊的原料流动性好,壁厚均匀,而且提取出金丝桃素添加到囊体中,使得囊体不仅仅只是药剂的外包材料,而且具有抗抑郁的功效,可以应用于抗抑郁药之中,增强药效、延长缓释效果。
为了解决上述技术问题,本发明所采用的技术方案是:
(1)取60~80g新鲜贯叶连翘,将其烘干后粉碎、过筛得贯叶连翘粉末,按固液比1:8与质量分数90%乙醇混合,混合后在120~140W功率下超声提取20~30min,得到提取液,用质量分数盐酸调节提取液pH为5.0~5.5,调节后离心分离得上清液,将上清液通过大孔树脂柱,用质量分数25%乙醇进行洗脱,收集洗脱液,将洗脱液在50~60℃下蒸发浓缩至30~40mL,得金丝桃素浓缩液,备用;
(2)在500mL三口烧瓶中,加入5~8g己二酸二酰肼和60~70mL质量分数15%盐酸,搅拌溶解后称取55~65g透明质酸钠干粉,将干粉缓慢加入到烧瓶中,在常温和150~200r/min转速下搅拌混合15~20min,搅拌后用浓度0.1mol/L的氢氧化钠或0.1mol/L盐酸调节pH值为4.5~10.5,继续搅拌1~2h,得到稳定的交联透明质酸钠凝胶,再加入50~80mL柠檬酸缓冲溶液,搅拌溶胀至凝胶不粘壁即可;
(3)将20~25g上述交联透明质酸钠凝胶于500mL反应器中,加热至85~90℃,
向反应器中依次加入10~15g黄原胶,0.2~0.5g十二烷基硫酸钠,5~10g柠檬酸钾和30~40mL步骤(1)金丝桃素浓缩液,搅拌混合至形成透明溶液,搅拌后降温至45~50℃,并加入5~7g羟丙基甲基纤维素和20~30mL聚乙二醇,保温30~50min,融化为均匀的胶液,并除去液面上的泡沫;
(4)将上述制得的胶液继续保温静置2~2.5h,静置后送入胶囊生产线,将送入胶囊生产线的胶液进行蘸胶,翻转数次后冷却成型,送入烘箱内在45~55℃下烘干得到初囊体;
(5)将初囊体再用交联透明质酸钠凝胶进行一次包衣,然后放入鼓风干燥机中干燥,拔下囊胚,切割成规定长度,即可制成空心胶囊成品。
本发明的应用的方法:采用有机玻璃制成的胶囊板填充,板分上下两层,上层有数百孔洞,先将本发明制得的囊帽、囊身分开,囊身插入胶囊板孔洞中,调节上下层距离,使胶囊口与板面相平,将抑郁药剂颗粒铺于板面,轻轻振动胶囊板,使抑郁药剂颗粒填充均匀,填满每个胶囊后,将板面多余颗粒扫除,顶起囊身,套合囊帽,取出胶囊,即得。
本发明的有益效果是:
(1)本发明制备得的空心胶囊的原料流动性好,壁厚均匀,制备工艺简单,成本低;
(2)本发明提取出金丝桃素添加到囊体中,使得囊体不仅仅只是药剂的外包材料,而且具有抗抑郁的功效,可以应用于抗抑郁药之中,增强药效、延长缓释效果。
具体实施方式
首先取60~80g新鲜贯叶连翘,将其烘干后粉碎、过筛得贯叶连翘粉末,按固液比1:8与质量分数90%乙醇混合,混合后在120~140W功率下超声提取20~30min,得到提取液,用质量分数盐酸调节提取液pH为5.0~5.5,调节后离心分离得上清液,将上清液通过大孔树脂柱,用质量分数25%乙醇进行洗脱,收集洗脱液,将洗脱液在50~60℃下蒸发浓缩至30~40mL,得金丝桃素浓缩液,备用;在500mL三口烧瓶中,加入5~8g己二酸二酰肼和60~70mL质量分数15%盐酸,搅拌溶解后称取55~65g透明质酸钠干粉,将干粉缓慢加入到烧瓶中,在常温和150~200r/min转速下搅拌混合15~20min,搅拌后用浓度0.1mol/L的氢氧化钠或0.1mol/L盐酸调节pH值为4.5~10.5,继续搅拌1~2h,得到稳定的交联透明质酸钠凝胶,再加入50~80mL柠檬酸缓冲溶液,搅拌溶胀至凝胶不粘壁即可;将20~25g交联透明质酸钠凝胶于500mL反应器中,加热至85~90℃,
向反应器中依次加入10~15g黄原胶,0.2~0.5g十二烷基硫酸钠,5~10g柠檬酸钾和30~40mL金丝桃素浓缩液,搅拌混合至形成透明溶液,搅拌后降温至45~50℃,并加入5~7g羟丙基甲基纤维素和20~30mL聚乙二醇,保温30~50min,融化为均匀的胶液,并除去液面上的泡沫;将制得的胶液继续保温静置2~2.5h,静置后送入胶囊生产线,将送入胶囊生产线的胶液进行蘸胶,翻转数次后冷却成型,送入烘箱内在45~55℃下烘干得到初囊体;将初囊体再用交联透明质酸钠凝胶进行一次包衣,然后放入鼓风干燥机中干燥,拔下囊胚,切割成规定长度,即可制成空心胶囊成品。
实例1
首先取60g新鲜贯叶连翘,将其烘干后粉碎、过筛得贯叶连翘粉末,按固液比1:8与质量分数90%乙醇混合,混合后在120W功率下超声提取20min,得到提取液,用质量分数盐酸调节提取液pH为5.0,调节后离心分离得上清液,将上清液通过大孔树脂柱,用质量分数25%乙醇进行洗脱,收集洗脱液,将洗脱液在50℃下蒸发浓缩至30mL,得金丝桃素浓缩液,备用;在500mL三口烧瓶中,加入5g己二酸二酰肼和60mL质量分数15%盐酸,搅拌溶解后称取55g透明质酸钠干粉,将干粉缓慢加入到烧瓶中,在常温和150r/min转速下搅拌混合15min,搅拌后用浓度0.1mol/L的氢氧化钠或0.1mol/L盐酸调节pH值为4.5,继续搅拌1h,得到稳定的交联透明质酸钠凝胶,再加入50mL柠檬酸缓冲溶液,搅拌溶胀至凝胶不粘壁即可;将20g交联透明质酸钠凝胶于500mL反应器中,加热至85℃,
向反应器中依次加入10g黄原胶,0.2g十二烷基硫酸钠,5g柠檬酸钾和30mL金丝桃素浓缩液,搅拌混合至形成透明溶液,搅拌后降温至45℃,并加入5g羟丙基甲基纤维素和20mL聚乙二醇,保温30min,融化为均匀的胶液,并除去液面上的泡沫;将制得的胶液继续保温静置2h,静置后送入胶囊生产线,将送入胶囊生产线的胶液进行蘸胶,翻转数次后冷却成型,送入烘箱内在45℃下烘干得到初囊体;将初囊体再用交联透明质酸钠凝胶进行一次包衣,然后放入鼓风干燥机中干燥,拔下囊胚,切割成规定长度,即可制成空心胶囊成品。
采用有机玻璃制成的胶囊板填充,板分上下两层,上层有数百孔洞,先将本发明制得的囊帽、囊身分开,囊身插入胶囊板孔洞中,调节上下层距离,使胶囊口与板面相平,将抑郁药剂颗粒铺于板面,轻轻振动胶囊板,使药剂颗粒填充均匀,填满每个胶囊后,将板面多余颗粒扫除,顶起囊身,套合囊帽,取出胶囊,即得。
实例2
首先取70g新鲜贯叶连翘,将其烘干后粉碎、过筛得贯叶连翘粉末,按固液比1:8与质量分数90%乙醇混合,混合后在130W功率下超声提取25min,得到提取液,用质量分数盐酸调节提取液pH为5.3,调节后离心分离得上清液,将上清液通过大孔树脂柱,用质量分数25%乙醇进行洗脱,收集洗脱液,将洗脱液在55℃下蒸发浓缩至35mL,得金丝桃素浓缩液,备用;在500mL三口烧瓶中,加入7g己二酸二酰肼和65mL质量分数15%盐酸,搅拌溶解后称取60g透明质酸钠干粉,将干粉缓慢加入到烧瓶中,在常温和175r/min转速下搅拌混合17min,搅拌后用浓度0.1mol/L的氢氧化钠或0.1mol/L盐酸调节pH值为7.0,继续搅拌1.5h,得到稳定的交联透明质酸钠凝胶,再加入65mL柠檬酸缓冲溶液,搅拌溶胀至凝胶不粘壁即可;将23g交联透明质酸钠凝胶于500mL反应器中,加热至87℃,向反应器中依次加入13g黄原胶,0.3g十二烷基硫酸钠,7g柠檬酸钾和35mL金丝桃素浓缩液,搅拌混合至形成透明溶液,搅拌后降温至47℃,并加入6g羟丙基甲基纤维素和25mL聚乙二醇,保温40min,融化为均匀的胶液,并除去液面上的泡沫;将制得的胶液继续保温静置2.3h,静置后送入胶囊生产线,将送入胶囊生产线的胶液进行蘸胶,翻转数次后冷却成型,送入烘箱内在50℃下烘干得到初囊体;将初囊体再用交联透明质酸钠凝胶进行一次包衣,然后放入鼓风干燥机中干燥,拔下囊胚,切割成规定长度,即可制成空心胶囊成品。
采用有机玻璃制成的胶囊板填充,板分上下两层,上层有数百孔洞,先将本发明制得的囊帽、囊身分开,囊身插入胶囊板孔洞中,调节上下层距离,使胶囊口与板面相平,将抑郁药剂颗粒铺于板面,轻轻振动胶囊板,使药剂颗粒填充均匀,填满每个胶囊后,将板面多余颗粒扫除,顶起囊身,套合囊帽,取出胶囊,即得。
实例3
首先取80g新鲜贯叶连翘,将其烘干后粉碎、过筛得贯叶连翘粉末,按固液比1:8与质量分数90%乙醇混合,混合后在140W功率下超声提取30min,得到提取液,用质量分数盐酸调节提取液pH为5.5,调节后离心分离得上清液,将上清液通过大孔树脂柱,用质量分数25%乙醇进行洗脱,收集洗脱液,将洗脱液在60℃下蒸发浓缩至40mL,得金丝桃素浓缩液,备用;在500mL三口烧瓶中,加入8g己二酸二酰肼和70mL质量分数15%盐酸,搅拌溶解后称取65g透明质酸钠干粉,将干粉缓慢加入到烧瓶中,在常温和200r/min转速下搅拌混合20min,搅拌后用浓度0.1mol/L的氢氧化钠或0.1mol/L盐酸调节pH值为10.5,继续搅拌2h,得到稳定的交联透明质酸钠凝胶,再加入80mL柠檬酸缓冲溶液,搅拌溶胀至凝胶不粘壁即可;将25g交联透明质酸钠凝胶于500mL反应器中,加热至90℃,向反应器中依次加入15g黄原胶,0.5g十二烷基硫酸钠,10g柠檬酸钾和40mL金丝桃素浓缩液,搅拌混合至形成透明溶液,搅拌后降温至50℃,并加入7g羟丙基甲基纤维素和30mL聚乙二醇,保温50min,融化为均匀的胶液,并除去液面上的泡沫;将制得的胶液继续保温静置2.5h,静置后送入胶囊生产线,将送入胶囊生产线的胶液进行蘸胶,翻转数次后冷却成型,送入烘箱内在55℃下烘干得到初囊体;将初囊体再用交联透明质酸钠凝胶进行一次包衣,然后放入鼓风干燥机中干燥,拔下囊胚,切割成规定长度,即可制成空心胶囊成品。
采用有机玻璃制成的胶囊板填充,板分上下两层,上层有数百孔洞,先将本发明制得的囊帽、囊身分开,囊身插入胶囊板孔洞中,调节上下层距离,使胶囊口与板面相平,将抑郁药剂颗粒铺于板面,轻轻振动胶囊板,使药剂颗粒填充均匀,填满每个胶囊后,将板面多余颗粒扫除,顶起囊身,套合囊帽,取出胶囊,即得。
Claims (1)
1.一种抑郁药专用空心胶囊的制备方法,其特征在于具体制备步骤为:
(1)取60~80g新鲜贯叶连翘,将其烘干后粉碎、过筛得贯叶连翘粉末,按固
液比1:8与质量分数90%乙醇混合,混合后在120~140W功率下超声提取20~30min,得到提取液,用质量分数盐酸调节提取液pH为5.0~5.5,调节后离心分离得上清液,将上清液通过大孔树脂柱,用质量分数25%乙醇进行洗脱,收集洗脱液,将洗脱液在50~60℃下蒸发浓缩至30~40mL,得金丝桃素浓缩液,备用;
(2)在500mL三口烧瓶中,加入5~8g己二酸二酰肼和60~70mL质量分数15%
盐酸,搅拌溶解后称取55~65g透明质酸钠干粉,将干粉缓慢加入到烧瓶中,在常温和150~200r/min转速下搅拌混合15~20min,搅拌后用浓度0.1mol/L的氢氧化钠或0.1mol/L盐酸调节pH值为4.5~10.5,继续搅拌1~2h,得到稳定的交联透明质酸钠凝胶,再加入50~80mL柠檬酸缓冲溶液,搅拌溶胀至凝胶不粘壁即可;
(3)将20~25g上述交联透明质酸钠凝胶于500mL反应器中,加热至85~90℃,
向反应器中依次加入10~15g黄原胶,0.2~0.5g十二烷基硫酸钠,5~10g柠檬酸钾和30~40mL步骤(1)金丝桃素浓缩液,搅拌混合至形成透明溶液,搅拌后降温至45~50℃,并加入5~7g羟丙基甲基纤维素和20~30mL聚乙二醇,保温30~50min,融化为均匀的胶液,并除去液面上的泡沫;
(4)将上述制得的胶液继续保温静置2~2.5h,静置后送入胶囊生产线,将送入胶囊生产线的胶液进行蘸胶,翻转数次后冷却成型,送入烘箱内在45~55℃下烘干得到初囊体;
(5)将初囊体再用交联透明质酸钠凝胶进行一次包衣,然后放入鼓风干燥机中干燥,拔下囊胚,切割成规定长度,即可制成空心胶囊成品。
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