CN105534946A - 一种中药胶囊的制备方法 - Google Patents
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Abstract
本发明公开了一种中药胶囊的制备方法,属于药物胶囊生产技术领域。包括:1)按中药组方,取药材原料,以表面活性剂溶液作为萃取剂,进行超声萃取,过滤,得到萃取液及滤渣;将滤渣用新鲜配制的表面活性剂溶液作为萃取剂,重复萃取2~3次,合并萃取液;2)向萃取液中边搅拌边加入絮凝剂,充分搅拌至絮凝后,静置,再经离心,得到絮状沉淀及上清液;3)将絮状沉淀与药用辅料混合均匀,干燥至恒重,粉碎,制得胶囊芯材颗粒物;4)将胶囊芯材颗粒物与胶囊壳按药物要求,装粒,制得中药胶囊。该方法工艺路线设计合理,节能、快速,能够有效实现中药有效成分的富集。
Description
技术领域
本发明属于药物胶囊生产技术领域,具体涉及一种中药胶囊的制备方法。
背景技术
胶囊始于公元前1500年的埃及,自1730年维也纳药剂师开始用淀粉制造胶囊以来,胶囊进入医药领域,避免了药物对食道、胃粘膜的刺激,避免了胃酸对药物的破坏。胶囊分为硬胶囊和软胶囊,硬胶囊又称空心胶囊,由胶囊、芯材两部分组成;软胶囊是成膜材料和内容物同时加工成产品的,胃康灵、益肾兴阳胶囊属于硬胶囊,包括芯材和胶囊。中药胶囊芯材生产一般采用溶剂浸提,分离、萃取液真空浓缩,制成浸膏,按照一定比例,将浸膏与辅料混合,低温干燥,粉碎的方法生产的。然而,在现有的生产中药胶囊芯材的工艺中,均存在一些缺陷:
一般中药萃取的溶剂为一定浓度的酒精,酒精的浓度、萃取时间、萃取温度、萃取次数是由中药有效成分的浓度决定的。酒精萃取存在残渣中酒精含量过高,浪费大,贮存期间危险性高,成本大的缺点。
一般中药浸膏都是采用真空浓缩(回收酒精)技术生产的,由于中药有效成分的结构与表面活性剂相似,故在真空浓缩时极易起泡,造成有效成分损失及生产时间的延长。絮凝技术在中药生产已经应用多年,一般采用絮凝剂除去中药萃取液中的杂质。
一般中药胶囊的芯材是按照一定比例将浓缩得到的浸膏与一定比例的辅料混合,低温烘干、粉碎。中药含有多种成分,在萃取时多种成分被同时萃取出来,这些成分里面油溶性物质较多,干燥只能得到浸膏。
发明内容
为了克服上述现有技术存在的缺陷,本发明的目的在于提供一种中药胶囊的制备方法,该方法工艺路线设计合理,节能、快速,能够有效实现中药有效成分的富集。
本发明是通过以下技术方案来实现:
一种中药胶囊的制备方法,包括以下步骤:
1)按中药组方,取药材原料,以表面活性剂溶液作为萃取剂,进行超声萃取,过滤,得到萃取液及滤渣;将滤渣用新鲜配制的表面活性剂溶液作为萃取剂,重复萃取2~3次,合并萃取液;
2)向萃取液中边搅拌边加入絮凝剂,充分搅拌至絮凝后,静置,再经离心,得到絮状沉淀及上清液;
3)将絮状沉淀与药用辅料混合均匀,干燥至恒重,粉碎,制得胶囊芯材颗粒物;
4)将胶囊芯材颗粒物与胶囊壳按药物要求,装粒,制得中药胶囊。
超声萃取时,药材原料与萃取剂的用量比为(200~300)g:2000mL。
表面活性剂溶液选用浓度为25.8×10-2~21.5×10-2mol/L的十二烷基硫酸钠。
向药材原料中加入表面活性剂后,在搅拌条件下浸泡3~5h。
超声萃取时间为每次30~40min。
絮凝剂与萃取液的体积比为(2~3):30。
絮凝剂为选用壳聚糖或聚合氯化铁,壳聚糖或聚合氯化铁的质量分数为1%~3%。
步骤2)所述的静置时间为3~4h;离心是在3000r/m的条件下,离心8~12min。
步骤3)所述的干燥是在40~50℃下,干燥10~15h。
与现有技术相比,本发明具有以下有益的技术效果:
本发明公开的一种中药胶囊的制备方法,首先,以食品添加剂级表面活性剂溶液为萃取剂,避免了中药萃取过程中酒精的使用,一方面,降低了中药有效成分萃取的成本及药渣贮存期间的安全隐患;另一方面,中药有效成分一般为大分子物质,表面活性剂在人体内能将大分子有机物进行适当的乳化,提高人体对药物的吸收,增加了药物的疗效。其次,采用絮凝技术,利用电性中和的原理,絮凝中药萃取液中的有效成分,替代传统浓缩富集技术,避免真空浓缩的缺点。最后,将离心分离得到的絮凝物按照一定的比例与辅料混合,低温干燥、粉碎得到胶囊芯材。该方法操作简单,节能快速,能够有效实现中药成分的富集。
进一步地,絮凝剂为选用壳聚糖或聚合氯化铁,壳聚糖或聚合氯化铁的质量分数为1%~3%。中药萃取液一般带负电荷,在水溶液中极易形成水化层,成为热力学不稳定胶体体系,当与带正电荷的絮凝剂(壳聚糖或聚合氯化铁)结合时,本身的负电被中和,体系不带电,在重力及分子力的作用下形成沉淀,有效成分得以富集。
具体实施方式
下面结合具体的实施例对本发明做进一步的详细说明,所述是对本发明的解释而不是限定。
本发明公开的中药胶囊的制备方法,包括以下步骤:
1)中药有效成分的萃取
按照中药组方称取一定量的中药材,总重为200~300g于3000mL的烧杯中(如:胃康灵中白芍,白芨,甘草,茯苓,醋延胡索,海螵蛸,三七;益肾兴阳胶囊中的颠茄;人参、鹿茸、菟丝子、淫羊藿、蚕蛾(去足翅)、黄芪、炙肉苁蓉、炙驴肾、炙狗肾),再加25.8×10-2~21.5×10-2mol/L的十二烷基硫酸钠2000mL,不断搅拌下浸泡3~5h,然后使用TGCXZ-2B的超声循环提取机中,打开超声波萃取电源,萃取30~40min,过滤,得第一道萃取液及药渣,按照同样操作给药渣中加入萃取剂萃取2次,得二道、三道萃取液,合并三道萃取液。
2)中药有效成分的絮凝及富集
取中药萃取液3000mL,不断搅拌下加入200~300mL质量分数为1%~3%的壳聚糖或质量分数为1%~3%的聚合氯化铁,先快速搅拌5~8min,混合均匀后,再慢速搅拌25~30min,待絮团完全形成后,静置3~4h,在3000r/m下离心8~12min,收集絮状沉淀及上清液。
中药萃取液一般带负电荷,在水溶液中极易形成水化层,成为热力学不稳定胶体体系,当与带正电荷的絮凝剂结合时,本身的负电被中和,体系不带电,在重力及分子力的作用下形成沉淀,有效成分得以富集。
3)芯材制备
按照用药需求,将絮状沉淀与辅料(淀粉/糊精)进行混合,在40~50℃的烘箱中干燥10~15h,去除粉碎,得到中药芯材。
4)胶囊制备
按照每个胶囊中原药量(胃康灵0.4g/益肾兴阳0.48g)装入胶囊中,再按照30粒装/60粒装包装。
以下实施例以中药胃康灵中白芍胶囊以及益肾兴阳胶囊中的颠茄进行举例说明:
胃康灵中白芍胶囊,按组方要求取:白芨、甘草、茯苓、醋延胡索、海螵蛸及三七;
益肾兴阳胶囊颠茄,按组方要求取:人参、鹿茸、菟丝子、淫羊藿、蚕蛾(去足翅)、黄芪、炙肉苁蓉、炙驴肾及炙狗肾。
实施例1
中药胃康灵中白芍胶囊的制备方法,包括以下步骤:
1)中药有效成分的萃取
按照中药组方称取300g的中药材,置于3000mL的烧杯中,再加25.8×10-2mol/L的十二烷基硫酸钠2000mL,不断搅拌下浸泡4h,将其加入TGCXZ-2B的超声循环提取机中,打开超声波萃取电源,萃取35min,过滤,得第一道萃取液及药渣,按照同样操作给药渣中加入萃取剂萃取2次,得二道、三道萃取液,合并三道萃取液。
2)中药有效成分的絮凝及富集
取中药萃取液3000mL,不断搅拌下加入200mL质量分数为1%的壳聚糖,先快速搅拌5min,混合均匀后,再慢速搅拌25min,待絮团完全形成后,静置3h,在3000r/m下离心10min,收集絮状沉淀及上清液。
3)芯材制备
按照一定比例将絮状沉淀与辅料(淀粉/糊精)进行混合,在40℃的烘箱中干燥15h,去除粉碎,得到中药胶囊芯材颗粒物。
4)胶囊制备
将胶囊芯材颗粒物,按照每个胶囊中原药量(胃康灵0.4g)装入胶囊壳中,再按照30粒装/60粒装包装。
实施例2
益肾兴阳胶囊颠茄的制备方法,包括以下步骤:
1)中药有效成分的萃取
按照中药组方称取250g的中药材,置于3000mL的烧杯中,再加入21.5×10-2mol/L的十二烷基硫酸钠2000mL,不断搅拌下浸泡5h,将其加入TGCXZ-2B的超声循环提取机中,打开超声波萃取电源,萃取40min,过滤,得第一道萃取液及药渣,按照同样操作给药渣中加入萃取剂萃取2次,得二道、三道萃取液,合并三道萃取液。
2)中药有效成分的絮凝及富集
取中药萃取液3000mL,不断搅拌下280mL加入质量分数为3%的聚合氯化铁,先快速搅拌5min,混合均匀后,再慢速搅拌30min,待絮团完全形成后,静置4h,在3000r/m下离心8min,收集絮状沉淀及上清液。
3)芯材制备
按照一定比例将絮凝物与辅料(淀粉/糊精)进行混合,在50℃的烘箱中干燥12h,去除粉碎,得到中药胶囊芯材颗粒物。
4)胶囊制备
将胶囊芯材颗粒物,按照每个胶囊中原药量(益肾兴阳0.48g)装入胶囊中,再按照30粒装/60粒装包装。
实施例3
中药胃康灵中白芍胶囊的制备方法,包括以下步骤:
1)中药有效成分的萃取
按照中药组方称取200g的中药材,于3000mL的烧杯中,再加23.4×10-2mol/L的十二烷基硫酸钠2000mL,不断搅拌下浸泡3h,将其加入TGCXZ-2B的超声循环提取机中,打开超声波萃取电源,萃取30min,过滤,得第一道萃取液及药渣,按照同样操作给药渣中加入萃取剂萃取2次,得二道、三道萃取液,合并三道萃取液。
2)中药有效成分的絮凝及富集
取中药萃取液3000mL,不断搅拌下加入质量分数为2%的壳聚糖300mL,先快速搅拌6min,混合均匀后,再慢速搅拌30min,待絮团完全形成后,静置3.5h,在3000r/m下离心12min,收集絮状沉淀及上清液。
3)芯材制备
按照用药需求,将絮状沉淀与辅料(淀粉/糊精)进行混合,在45℃的烘箱中干燥12h,去除粉碎,得到中药芯材。
4)胶囊制备
按照每个胶囊中原药量(胃康灵0.4g)装入胶囊中,再按照30粒装/60粒装包装。
综上所述,本发明以食品添加剂级表面活性剂溶液为萃取剂,避免了中药萃取过程中酒精的使用,节约中药的萃取成本,有利于中药有效成分的吸收,提高了药效。采用絮凝技术,利用电性中和的原理,絮凝中药萃取液中的有效成分,替代传统浓缩富集技术,避免真空浓缩的缺点。将离心分离得到的絮凝物按照一定的比例与辅料混合,低温干燥、粉碎得到芯材。
本发明保护中药有效成分萃取,萃取液絮凝工艺,这一工艺避免了真空浓缩过程中能耗大,浓缩物因起泡造成得损失及浓缩时间长等缺点,实现了中药有效成分的富集,是一种节能、快速的中药有效成分萃取、浓缩技术。
Claims (9)
1.一种中药胶囊的制备方法,其特征在于,包括以下步骤:
1)按中药组方,取药材原料,以表面活性剂溶液作为萃取剂,进行超声萃取,过滤,得到萃取液及滤渣;将滤渣用新鲜配制的表面活性剂溶液作为萃取剂,重复萃取2~3次,合并萃取液;
2)向萃取液中边搅拌边加入絮凝剂,充分搅拌至絮凝后,静置,再经离心,得到絮状沉淀及上清液;
3)将絮状沉淀与药用辅料混合均匀,干燥至恒重,粉碎,制得胶囊芯材颗粒物;
4)将胶囊芯材颗粒物与胶囊壳按药物要求,装粒,制得中药胶囊。
2.根据权利要求1所述的一种中药胶囊的制备方法,其特征在于,步骤1)中,超声萃取时,药材原料与萃取剂的用量比为(200~300)g:2000mL。
3.根据权利要求1或2所述的一种中药胶囊的制备方法,其特征在于,表面活性剂溶液选用浓度为25.8×10-2~21.5×10-2mol/L的十二烷基硫酸钠。
4.根据权利要求1所述的一种中药胶囊的制备方法,其特征在于,步骤1)中,向药材原料中加入表面活性剂后,在搅拌条件下浸泡3~5h。
5.根据权利要求1所述的一种中药胶囊的制备方法,其特征在于,超声萃取时间为每次30~40min。
6.根据权利要求1所述的一种中药胶囊的制备方法,其特征在于,步骤2)中,絮凝剂与萃取液的体积比为(2~3):30。
7.根据权利要求1或6所述的一种中药胶囊的制备方法,其特征在于,絮凝剂为选用壳聚糖或聚合氯化铁,壳聚糖或聚合氯化铁的质量分数为1%~3%。
8.根据权利要求1所述的一种中药胶囊的制备方法,其特征在于,步骤2)所述的静置时间为3~4h;离心是在3000r/m的条件下,离心8~12min。
9.根据权利要求1所述的一种中药胶囊的制备方法,其特征在于,步骤3)所述的干燥是在40~50℃下,干燥10~15h。
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