CN110448532B - 一种灵芝多糖颗粒及其制备方法和应用 - Google Patents
一种灵芝多糖颗粒及其制备方法和应用 Download PDFInfo
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Abstract
本发明涉及食品和药品技术领域,公开了一种灵芝多糖颗粒及其制备方法和应用。本发明所述灵芝多糖颗粒由灵芝多糖原料、粘合剂、辅料与阿拉伯胶水溶液经由流化床制粒而成,所述辅料选自甲壳胺盐酸盐、淀粉磷酸酯钠和无水磷酸氢钙中的一种或两种以上。本发明通过选择适宜的辅料组合及原辅料配比,结合适宜的流化床制粒工艺,制备得到的灵芝多糖颗粒吸湿性弱、流动性分散性好、收率和载药量高,为灵芝多糖的贮存及后续制剂成型提供了良好的应用前景。而且所述方法对设备要求低、工艺简单,生产周期短,大幅度降低了生产成本,提高了生产效率,适合于大规模生产使用。
Description
技术领域
本发明涉及食品和药品技术领域,特别涉及一种灵芝多糖颗粒及其制备方法和应用。
背景技术
灵芝多糖是灵芝中最有效的成分之一,具有抗氧化、降血糖、降血脂、免疫调节、抗肿瘤、辐射防护等药理活性,在保健食品和药品开发方面具有广阔的应用前景。
灵芝多糖由灵芝水提得到的溶液,经喷雾干燥、真空干燥、带式干燥或者冷冻干燥等方式制备而得,为棕黄色或者褐色粉末,容易吸收空气中的水分,引湿性强,具有易结块、流动性差等缺点,不利于贮藏及后续制剂成型。
目前,灵芝多糖主要采用湿法制粒应用于片剂和胶囊剂的制备中,在湿法制粒过程中,需严格控制制粒环境湿度、灵芝多糖原料的含水量,同时需加入大量的填充剂,导致灵芝多糖的载药量较低,而且制得的颗粒吸湿性和流动性较差,成型率也较低,颗粒粒径大小不一,不利于灵芝多糖的贮藏及后续制剂成型。
发明内容
有鉴于此,本发明的目的在于提供一种灵芝多糖颗粒及其制备方法,降低所述灵芝多糖颗粒吸湿率;
本发明的另外一个目的在于提供一种灵芝多糖颗粒及其制备方法,提高所述灵芝多糖颗粒的临界相对湿度;
本发明的另外一个目的在于提供一种灵芝多糖颗粒及其制备方法,提高所述灵芝多糖颗粒的收率;
本发明的另外一个目的在于一种灵芝多糖颗粒及其制备方法,提高所述灵芝多糖颗粒的流动性;
本发明的另外一个目的在于一种灵芝多糖颗粒及其制备方法,使得所述灵芝多糖颗粒同时满足上述各项有益效果。
为实现上述发明目的,本发明提供如下技术方案:
一种灵芝多糖颗粒,由灵芝多糖原料、粘合剂、辅料与阿拉伯胶水溶液经由流化床制粒而成,所述辅料选自甲壳胺盐酸盐、淀粉磷酸酯钠和无水磷酸氢钙中的一种或两种以上。
流化床制粒指利用气流使粉末底物悬浮呈沸腾状,再喷入雾状粘合剂使粉末结合成粒,再喷入包衣液对颗粒表面包覆改性,最后得到干燥的颗粒。此工艺简单、所得颗粒圆整、溶解性好,颗粒的流动性好。本发明中以灵芝多糖粉末与辅料混合后作为流化床底物,可极大提高制粒成品载药量。加入的粘合剂为灵芝多糖原料水溶液,与传统的湿法制粒中混合制软材、干燥的过程相比,缩短了工艺路线和生产周期,节约了成本。
本发明经过长期深入研究发现,流化床制粒中辅料的选择、原辅料的配比及制备工艺对灵芝多糖颗粒的吸湿性和流动性影响重大,本发明通过衡量各种辅料组合与有效成分灵芝多糖之间的影响,最终确定了能够有效改善灵芝多糖的吸湿性、流动性的适宜的辅料组合,且制得的颗粒成型率和合格率高,为含灵芝多糖的医药保健品提供了良好的应用前景。
本发明中,所述辅料选用甲壳胺盐酸盐、淀粉磷酸酯钠、无水磷酸氢钙或其组合,与灵芝多糖混合制粒后颗粒圆整、溶解性好,可大幅改善颗粒的吸湿性和流动性;在本发明具体实施方式中,所述辅料可选择为淀粉磷酸酯钠、甲壳胺盐酸盐+淀粉磷酸酯钠、甲壳胺盐酸盐+无水磷酸氢钙、淀粉磷酸酯钠+无水磷酸氢钙等几种组合。其中,在多种辅料时,所述甲壳胺盐酸盐、淀粉磷酸酯钠和无水磷酸氢钙的质量比为3:5:1。
作为优选,所述灵芝多糖原料和辅料的质量比为1:(1~3);在本发明具体实施方式中,该配比范围可具体选择为1:1、1:1.6、3:8(近似为1:2.67)、1:2或1:3。
作为优选,所述粘合剂与灵芝多糖原料和辅料两者(在具体制备中称为流化床内物料)总质量的质量比为(2~5):1;在本发明具体实施方式中,该质量比为2:1、40:13(近似为3.08:1)、35:11(近似为3.18:1)、10:3(近似于3.33:1)或5:1。其中,本发明以灵芝多糖水溶液作为粘合剂,溶液质量百分浓度为10~30%,可具体选择为15%、20%或25%。
在本发明中,所述阿拉伯胶水溶液作为包衣液,其与灵芝多糖原料、辅料和粘合剂干质量三者(在具体制备中称为灵芝多糖颗粒中间体)的总质量的质量比为1:2;所述阿拉伯胶水溶液的质量百分比浓度为2%。
按照本发明所述方法制备灵芝多糖颗粒,其收率为70-85%,24h吸湿率为不高于7.5%,24h临界相对湿度大于65%,休止角介于29.5-34.5°;同时,本发明分别以不添加辅料的灵芝多糖颗粒、不同制粒工艺条件制备的灵芝多糖颗粒以及不同辅料种类配比制备的灵芝多糖颗粒为对照,结果显示,三类对照均无法同时在吸湿性、流动性和收率上保持较高的水平,特别是其他常规可调节制剂吸湿性的辅料种类的对照,其在24h吸湿率、24h临界相对湿度、休止角性能指标均出现了显著下降,这表明不同目标物质的辅料有其适配性。因此,本发明提出了所述灵芝多糖颗粒在制备食品或药品中的应用。
其中,药物包括片剂、颗粒剂、丸剂、胶囊剂、散剂以及其他药学上可接受的剂型。食品包括压片果糖、固体饮料以及其他食品学上可接受的食品形式。所述食品包括保健品,主要制剂为胶囊剂、片剂、粉剂、口服液、颗粒冲剂、茶剂。
此外,本发明还提供了所述灵芝多糖颗粒的制备方法,将灵芝多糖原料与辅料混合均匀,投入流化床制粒机中,加入粘合剂制粒,得到灵芝多糖颗粒中间体,再加入阿拉伯胶水溶液经流化床包衣、干燥得到灵芝多糖颗粒。
本发明采用流化床制粒制备灵芝多糖颗粒的研究中,通过采用适宜的进风温度、物料温度、供液转速和风机频率,有效地提高了灵芝多糖颗粒的成型率,极大地提高了合格产品的收率。
其中,所述制粒的工艺条件为进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz;所述包衣的工艺条件为进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。
由以上技术方案可知,本发明采用流化床制粒制备灵芝多糖颗粒,通过选择适宜的辅料组合及原辅料配比,结合适宜的流化床制粒工艺,制备得到的灵芝多糖颗粒吸湿性弱、流动性分散性好、收率和载药量高,为灵芝多糖的贮存及后续制剂成型提供了良好的应用前景。而且所述方法对设备要求低、工艺简单,生产周期短,大幅度降低了生产成本,提高了生产效率,适合于大规模生产使用。
具体实施方式
本发明公开了一种灵芝多糖颗粒及其制备方法和应用,本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都被视为包括在本发明。本发明所述灵芝多糖颗粒及其制备方法和应用已经通过实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文所述灵芝多糖颗粒及其制备方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。
在本发明具体实施例中,涉及到对比试验,各试验组除了应有的区别外,其余试验环境和原材料等均保持一致。
以下就本发明所提供的一种灵芝多糖颗粒及其制备方法和应用做进一步说明。
实施例1:灵芝多糖的制备
灵芝进行水提或水提醇沉(水温100℃、时间90min、料液比1:20、提取两次)后进行喷雾干燥或带式干燥(喷雾条件:进风温度120℃、雾化压力0.2MPa、出口温度75~80℃),并经粉碎、过60~100目筛制得灵芝多糖。
实施例2:制备本发明灵芝多糖颗粒
取灵芝多糖20份,淀粉磷酸酯钠20份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度20%灵芝多糖水溶液80份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液28份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为74.43%。
吸湿性测定:称取制备得到的颗粒1g,平铺于称量瓶中,精密称定原始样品质量。将称量瓶敞口置于恒温恒湿箱中,条件为:温度为25℃,相对湿度为65%,于不同时间间隔称量样品质量,按如下公式计算24小时的吸湿率。
吸湿率=(吸湿后颗粒质量-吸湿前颗粒质量)/吸湿前颗粒质量×100%
临界相对湿度测定:将底部盛有过饱和盐溶液的干燥器在25℃放置24h,使其内部相对湿度为要求的相对湿度。将上述装有样品的称量瓶精密称重后置于干燥器中(称量瓶盖打开),于24h称量瓶与药物的重量,平行做2份,按下式计算吸湿率,取均值。
吸湿率=(吸湿后颗粒质量-吸湿前颗粒质量)/吸湿前颗粒质量×100%
以相对湿度为横坐标,吸湿率为纵坐标,每组数据前三个数据点一组作线性拟合,后三个数据一组作线性拟合,两条拟合直线交点的横坐标即为该样品的临界相对湿度。
流动性测定:取50g制备得到的灵芝多糖颗粒,从上部漏斗慢慢加入,使辅料经过漏斗的缓冲逐渐堆积在底盘上,形成锥体,直至得到最高的锥体为止。测定锥体的高H,按下式计算休止角:α=arctg(H/R)其中,α为休止角,R为底盘半径。其中,休止角小于40°表明流动性符合生产过程中制剂成型的要求。
按照上述方法对实施例2制得的灵芝多糖颗粒的吸湿率、临界相对湿度和休止角进行测定,结果为:24小时吸湿率为7.43%,将灵芝多糖颗粒按照临界相对湿度的测定方法进行检测,得到的24h临界相对相对湿度结果为:68.52%,相对于灵芝多糖的临界相对湿度36.65%有大幅提高,表明本发明制得的灵芝多糖颗粒的吸湿性好。经测定休止角为33.1°。
实施例3:制备本发明灵芝多糖颗粒
取灵芝多糖10份,甲壳胺盐酸盐6份,淀粉磷酸酯钠10份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度15%灵芝多糖水溶液130份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液22.75份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为75.52%。按照实施例2的测定方法测得24小时吸湿率为6.37%,24h临界相对相对湿度结果为:73.63%,休止角为31.1°。
实施例4:制备本发明灵芝多糖颗粒
取灵芝多糖10份,甲壳胺盐酸盐12份,无水磷酸氢钙4份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度25%灵芝多糖水溶液80份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液23份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为72.71%。按照实施例2的测定方法测得24小时吸湿率为6.93%,24h临界相对相对湿度结果为:67.34%,休止角为31.8°。
实施例5:制备本发明灵芝多糖颗粒
取灵芝多糖12份,甲壳胺盐酸盐12份,淀粉磷酸酯钠20份,无水磷酸氢钙4份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度15%灵芝多糖水溶液140份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液34.5份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为84.04%。按照实施例2的测定方法测得24小时吸湿率为5.03%,24h临界相对相对湿度结果为:77.82%,休止角为34.1°。
实施例6:制备本发明灵芝多糖颗粒
甲壳胺盐酸盐12份,淀粉磷酸酯钠20份,无水磷酸氢钙4份混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度20%灵芝多糖水溶液120份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液30份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为80.41%。按照实施例2的测定方法测得24小时吸湿率为4.94%,24h临界相对相对湿度结果为:78.68%,休止角为29.8°。
对比例1:不添加辅料对灵芝多糖颗粒吸湿性和收率的影响
实施例1制得灵芝多糖20份投入流化床制粒机,粘合剂为质量百分浓度20%灵芝多糖水溶液20份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为45.31%。按照实施例2的测定方法测得24小时吸湿率为17.58%,24h临界相对相对湿度结果为:34.26%,休止角为46.8°。该制粒工艺制得的灵芝多糖颗粒收率低,吸湿现象严重,流动性差,不能满足生产需求。
对比例2:制粒条件对灵芝多糖颗粒收率的影响
取灵芝多糖10份,甲壳胺盐酸盐6份,淀粉磷酸酯钠10份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度15%灵芝多糖水溶液130份,制粒条件设定为:进风温度为90℃,物料温度80℃,供液转速:18rpm,风机频率20Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液22.75份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为48.37%。按照实施例2的测定方法测得24小时吸湿率为6.12%,24h临界相对相对湿度结果为:71.28%,休止角为33.5°。
对比例3:辅料种类对灵芝多糖颗粒吸湿性、休止角和收率的影响
取灵芝多糖10份,麦芽糊精10份,微晶纤维素10份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度15%灵芝多糖水溶液80份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:12rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液21份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为68.86%。按照实施例2的测定方法测得24小时吸湿率为9.95%,24h临界相对相对湿度结果为:62.52%,休止角为35.5°。
对比例4:辅料种类对灵芝多糖颗粒吸湿性、休止角和收率的影响
取灵芝多糖20份,乳糖20份,甘露醇20份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度20%灵芝多糖水溶液120份,制粒条件设定为:进风温度为65℃,物料温度55℃,供液转速:12rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液42份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为65.12%。按照实施例2的测定方法测得24小时吸湿率为13.02%,24h临界相对相对湿度结果为:51.31%,休止角为41.9°。
对比例5:辅料种类对灵芝多糖颗粒吸湿性、休止角和收率的影响
取灵芝多糖20份,糊精29份,微粉硅胶1份,混合均匀后投入流化床制粒机中,粘合剂为质量百分浓度20%灵芝多糖水溶液100份,制粒条件设定为:进风温度为60℃,物料温度50℃,供液转速:12rpm,风机频率15Hz,供液结束30min后再加入为质量百分浓度2%阿拉伯胶水溶液35份,包衣条件设定为:进风温度为50℃,物料温度45℃,供液转速:8rpm,风机频率15Hz。用20-80目整粒筛进行整粒,收率为63.86%。按照实施例2的测定方法测得24小时吸湿率为14.28%,24h临界相对相对湿度结果为:49.52%,休止角为42.5°。
实施例7:各实施例和对比例的数据对比
将实施例2-6以及对比例1-5的收率、休止角、吸湿性等结果汇总对比,结果见表1。
表1
由上表可知,不添加任何辅料的灵芝多糖颗粒,在吸湿性、流动性和收率上均表现较差;而制备工艺参数不同的灵芝多糖颗粒,在收率上受到了明显影响;剩余不同辅料制备的灵芝多糖颗粒,吸湿性、流动性和收率相比本发明颗粒有着明显不足;综上说明,工艺参数的不同和辅料的不同可以显著影响灵芝多糖颗粒的收率、流动性和吸湿性,只有恰当合适的辅料和工艺参数才能够获得预期的效果。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (9)
1.一种灵芝多糖颗粒,其特征在于,由灵芝多糖原料、粘合剂、辅料与阿拉伯胶水溶液经由流化床制粒而成,所述辅料选择为淀粉磷酸酯钠、甲壳胺盐酸盐+淀粉磷酸酯钠、淀粉磷酸酯钠+无水磷酸氢钙或甲壳胺盐酸盐+淀粉磷酸酯钠+无水磷酸氢钙;在多种辅料时,所述甲壳胺盐酸盐、淀粉磷酸酯钠和无水磷酸氢钙的质量比为3:5:1。
2.根据权利要求1所述灵芝多糖颗粒,其特征在于,所述灵芝多糖原料和辅料的质量比为1:(1~3)。
3.根据权利要求1所述灵芝多糖颗粒,其特征在于,所述粘合剂与灵芝多糖原料和辅料两者总质量的质量比为(2~5):1。
4.根据权利要求1或3所述灵芝多糖颗粒,其特征在于,所述粘合剂为灵芝多糖水溶液。
5.根据权利要求1所述灵芝多糖颗粒,其特征在于,所述阿拉伯胶水溶液与灵芝多糖原料、辅料和粘合剂干质量三者的总质量的质量比为1:2。
6.根据权利要求1或5所述灵芝多糖颗粒,其特征在于,所述阿拉伯胶水溶液的质量百分比浓度为2%。
7.权利要求1-6任意一项所述灵芝多糖颗粒在制备食品或药品中的应用。
8.权利要求1所述灵芝多糖颗粒的制备方法,其特征在于,将灵芝多糖原料与辅料混合均匀,投入流化床制粒机中,加入粘合剂制粒,得到灵芝多糖颗粒中间体,再加入阿拉伯胶水溶液经流化床包衣、干燥得到灵芝多糖颗粒。
9.根据权利要求8所述制备方法,其特征在于,所述制粒的工艺条件为进风温度为60℃,物料温度50℃,供液转速:10rpm,风机频率15Hz。
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