CN111388602A - 一种灵芝铁皮石斛混悬剂及其制备方法 - Google Patents
一种灵芝铁皮石斛混悬剂及其制备方法 Download PDFInfo
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Abstract
一种灵芝铁皮石斛混悬剂及其制备方法。一种灵芝铁皮石斛混悬剂,各组分的质量百分比为:灵芝提取物粉20~30%,铁皮石斛提取液65~75%,水4.98~4.99%,甜味剂0.01~0.02%,该混悬剂的制备方法:灵芝子实体粉碎,超临界CO2萃取除去脂溶性杂质,乙醇浸提取,过滤,浓缩干燥和超微粉碎,得灵芝提取物粉;铁皮石斛冷冻干燥,低温浸提,浸提液经离心后得到铁皮石斛提取液;灵芝提取物粉与铁皮石斛提取液混悬,甜味剂溶于水,水再与混悬液混匀,无菌灌装,得到成品。成品的灵芝三萜酸含量≥30mg/mL,多糖含量≥35mg/mL。本发明使用灵芝作为功效成分和抑菌剂,铁皮石斛作为功效成分、助悬剂和矫味剂,成品稳定性佳,口感良好无苦味。
Description
技术领域
本发明属于天然产物提取分离、保健食品和制剂领域,特别是一种灵芝铁皮石斛混悬剂及其制备方法。
背景技术
灵芝(Ganoderma lucidum(Leyss.ex Fr.)Karst.)为多孔菌科真菌灵芝中的一种(中国药典2015版一部),味甘性平,扶正固本,主要活性成分为灵芝三萜和灵芝多糖,灵芝三萜具有抗氧化、调节免疫力、抗肿瘤、保肝、降血糖和抑菌等多种药理功效。灵芝三萜在灵芝子实体中含量极低,约占干燥子实体重量的0.5~1%,而且难溶于水,一般制成胶囊剂、片剂和粉剂;这些剂型在服用后,灵芝三萜在消化道内难于溶出吸收,生物利用度低;此外部分灵芝三萜苦,味蕾停留时间长,口感差,影响服用者顺从性。
铁皮石斛为兰科植物铁皮石斛(Dendrobium officinale Kimum et Migo)的干燥茎,味甘微寒,益胃生津,主要活性成分为铁皮石斛多糖,铁皮石斛多糖具有抗氧化、调节免疫力、抗肿瘤、降血糖和促进消化等多种药理功效。铁皮石斛多糖在铁皮石斛中含量25%以上,同时,铁皮石斛中还含有大量果胶等物质,二者同时导致铁皮石斛水提取液粘稠,难于过滤,亦难于干燥成粉,另外铁皮石斛多糖立体结构在高温环境中易损失活,影响其发挥药理活性。
专利“一种铁皮石斛灵芝胶囊”(CN102772313.9),该发明的铁皮石斛灵芝胶囊,是先将铁皮石斛原料用超音速气流粉碎机粉碎,得到粒度为1-75μm的铁皮石斛超颗粒;同时将灵芝原料超颗粒碎,得到粒度小于2μm的灵芝超颗粒。然后将铁皮石斛超颗粒和灵芝超颗粒混合,直接以生药粉形式填充胶囊而制得。由于生药中功效成分含量低,例如灵芝的功效成分灵芝三萜在灵芝原料中含量极低;由于胶囊填充量的限制(0.1~1.0g),常常导致日服用量难以达中国药典下限6g,影响了药理作用。
专利“一种铁皮石斛灵芝超微粉微波真空冷冻干燥方法”(CN109594974A),该发明的铁皮石斛灵芝超微粉仅仅提取了灵芝和铁皮石斛的水溶性成分,仅包含多糖,未包含三萜。但是微波干燥手段中的微波和高温一样会影响多糖空间结构,使灵芝多糖和铁皮石斛多糖易变性失活,影响了药理作用。
灵芝和铁皮石斛的在我国已有千年以上的药用历史,被列为“八大仙草之首和之二”,被民间誉为“救命草”。二者各有它的主要药用特征成分,如将二者强强联合,制备成一种混悬剂,其药用成分协同作用,就能进一步增强其药用功效。目前,混悬剂作为一种药物剂型,通常是将难溶性固体原料药物,借助辅料分散在液体介质中制成供口服的混悬液体。混悬剂具有分散度好,起效快,生物利用度高,吞咽困难者易于服用等诸多优点。
发明内容
本发明的目的在于克服上述专利产品的不足,提供了一种苦味较弱、日常携带方便、服用无障碍且功效稳定的灵芝铁皮石斛混悬剂及其制备方法。
本发明采用的技术方案为一种灵芝铁皮石斛混悬剂,其要点在于由灵芝提取物粉、铁皮石斛提取液、甜味剂和水组成,各组分的质量百分比为:灵芝提取物粉20~30%,铁皮石斛提取液65~75%,水4.98~4.99%,甜味剂0.01~0.02%,其中灵芝三萜酸含量≥30mg/mL,多糖含量≥35mg/mL。
一种灵芝铁皮石斛混悬剂,其特征在于该混悬剂的制备方法为:
灵芝提取物粉的制备方法为:采收成熟的灵芝,经清洗、烘干,水分控制在3%以下,粉碎成10目左右的颗粒,用超临界CO2萃取技术除去脂溶性杂质,萃取压力25MPa,萃取温度40℃、分离压力6MPa,分离温度45℃、CO2流量600L/hr,加入重量为灵芝颗粒12倍的95%食用酒精,在85℃搅拌提取2hr得到第一次提取液,再加重量为灵芝颗粒10倍95%食用酒精提取2hr,合并二次提取液,浓缩干燥,超微粉碎,得到灵芝提取物粉,灵芝提取物粉粒径在5~10μm,灵芝三萜酸含量≥15%;
铁皮石斛提取液的制备方法为:采收成熟的铁皮石斛鲜条,切段,冷冻干燥,水分控制在3%以下,粉碎成10~20目颗粒,加入重量为铁皮石斛颗粒15~20倍水,4℃低温搅拌浸提8hr,浸提液经卧螺离心机分离,卧式离心机的转鼓转速为2700r/min,分离因子为1240g,分离出的浊液浊度达到20nut以下,得到铁皮石斛提取液,黏度为8~10mPa·s,多糖含量≥5%;
灵芝铁皮石斛混悬剂的制备为:按各组分的质量百分比为:灵芝提取物粉20~30%,铁皮石斛提取液65~75%,水4.98~4.99%,甜味剂0.01~0.02%,将灵芝提取物与铁皮石斛提取液混悬得混悬液,将甜味剂溶于水混匀,再将水加入混悬液搅拌均匀,无菌灌装,得到成品。
本发明将灵芝和铁皮石斛中抗菌、抗氧化、抗肿瘤和提高人体免疫力的有效成分灵芝三萜和铁皮石斛多糖加以提取利用,同时还可进一步发挥灵芝提取物的抑菌活性;而铁皮石斛提取液的高黏度物理特性即可减轻灵芝三萜的苦味,又可作为混悬材料,将灵芝提取物微粉混悬而制备成日常携带方便、服用无障碍且功效稳定的混悬剂,而不需要加入其他辅料来助悬,本发明混悬剂经经典人群口尝评价方法评价为无苦味。
所述的灵芝为中华人民共和国药典2015版一部所收录的多孔菌科真菌赤芝Ganoderma lucidum(Leyss.ex Fr.)Karst.的干燥子实体,三萜及甾醇以以齐墩果酸(C30H48O3)计,不得少于0.50%。
所述的铁皮石斛为中华人民共和国药典2015版一部所收录的兰科植物铁皮石斛Dendrobium officinale Kimum et Migo的未干燥茎,铁皮石斛多糖以无水葡萄糖(C6H12O6)计,不得少于6.0%。
所述的甜味剂为甜菊糖苷、罗汉果苷、索马甜、纽甜或四者不同配比的组合。
所述的水为无菌纯化水。
本发明采用的技术方案,采用精心的工艺设计,选用灵芝提取物粉、铁皮石斛提取液、甜味剂和水,经过科学配比制备,其有益效果为:
1.灵芝子实体中含有少量脂溶性杂质,提取时易溶于95%食用酒精,加入混悬剂体系时会破坏混悬液稳定性,导致分层,超临界CO2萃取技术可除去灵芝子实体内脂溶性杂质。使灵芝提取物粉在混悬剂体系中保持稳定。
2.灵芝提取物粉中的灵芝三萜具有抑制细菌生长的药理活性,可作为天然有机的抑菌剂代替化学合成抑菌剂,延长混悬剂的保质期的同时避免消费者的负面认知(消费者在有选择的情况下更愿意购买不含有食品添加剂的食品)。
3.铁皮石斛富含水分和多糖,不及时干燥则易滋生细菌,导致微生物指标异常。同时铁皮石斛多糖的复杂空间结构遇热易变性失活,高温干燥的同时导致铁皮石斛多糖药理活性下降。本发明采用冷冻干燥技术,延长了原料的储存期限,采用4℃的低温搅拌浸提技术和卧式离心机的分离技术,在获得铁皮石斛多糖的同时,有效保留了铁皮石斛的药理活性。
4.铁皮石斛富含多糖和果胶等天然高分子聚合物,其浸提液极难过滤分离,但是其黏度较高,可替代化学合成药用辅料如羟丙甲纤维素等,作为天然有机的混悬剂可避免消费者的负面认知。同时铁皮石斛浸提液可有效阻滞灵芝三萜在口腔中的扩散,降低灵芝提取物粉作用于味蕾的时间,继而减轻灵芝提取物粉的苦味。
5.本发明采用天然有机的甜味剂,甜度极高,降低成本的同时,极大降低了混悬剂中的单糖含量,使本发明的混悬剂的升糖值(GI)接近于无;同时混悬剂中的灵芝三萜和铁皮石斛多糖具有辅助降血糖的药理作用,适宜血糖偏高者和和糖尿病患者服用。
6.本发明采用灵芝三萜和铁皮石斛多糖作为功效成分协同发挥:抗菌、抗氧化、调节免疫力、抗肿瘤、保肝和促进消化等诸多药理功效。
7.本发明采用的技术方案为一种灵芝铁皮石斛混悬剂,其中灵芝三萜酸含量≥30mg/mL,多糖含量≥35mg/mL,采用经典人群口尝评价方法评价为无苦味。日常携带方便,服用无障碍,功效稳定,分散度好,起效快,生物利用度高,吞咽困难者易于服用。
具体实施例
以下实施例进一步说明本发明的内容,但不应理解为对本发明的限制,在不背离本发明的精神和实质的情况下,对本发明方法、步骤或条件所做的修改或替换,均属于本发明的范围。
本发明所述的灵芝三萜酸的检测方法为团体标准T/CCCMHPIE 1.49-2019植物提取物灵芝提取物(醇提)中灵芝三萜的检测方法。
本发明所述的黏度的检测方法为中华人民共和国药典2015版四部通则0633黏度测定法第三法。
本发明所述的粗多糖的检测方法为中华人民共和国药典2015版一部所收录的铁皮石斛的含量测定中多糖的检测方法。
一种灵芝铁皮石斛混悬剂,由灵芝提取物粉、铁皮石斛提取液、甜味剂和水组成,各组分的质量百分比为:灵芝提取物粉20~30%,铁皮石斛提取液65~75%,水4.98~4.99%,甜味剂0.01~0.02%,其中灵芝三萜酸含量≥30mg/mL,多糖含量≥35mg/mL,其中:
灵芝提取物粉的制备:采收成熟的灵芝,经清洗、烘干,水分控制在3%以下,粉碎成10目左右的颗粒,用超临界CO2萃取技术除去脂溶性杂质,萃取压力25MPa,温度40℃、分离压力6MPa,温度45℃、CO2流量600L/hr,加入12倍95%食用酒精,在85℃搅拌提取2hr得到一次提取液,再加10倍95%食用酒精提取2hr,合并二次提取液,浓缩干燥,超微粉碎,得到灵芝提取物粉,灵芝提取物粉粒径在5~10μm,灵芝三萜酸含量≥15%;
铁皮石斛提取液的制备:采收成熟的铁皮石斛鲜条,切段,冷冻干燥,水分控制在3%以下,粉碎成10~20目颗粒,加入15~20倍水,低温搅拌浸提,提取温度4℃,提取时间8h,提取液经过卧式离心机离心,卧式离心机的转鼓转速为2700r/min,分离因子为1240g,分离出的浊液浊度达到20nut以下,得到铁皮石斛提取液,黏度为8~10mPa·s,多糖含量≥5%;
灵芝铁皮石斛混悬剂的制备为:按各组分的质量百分比为:灵芝提取物粉20~30%,铁皮石斛提取液65~75%,水4.98~4.99%,甜味剂0.01~0.02%,将灵芝提取物与铁皮石斛提取液混悬得混悬液,将甜味剂溶于水混匀,再将水加入混悬液搅拌均匀,无菌灌装,得到成品。
实施例1
灵芝提取物粉的制备:采收成熟的灵芝,经清洗、烘干,水分控制在3%以下,粉碎成10目左右的颗粒,用超临界CO2萃取技术除去脂溶性杂质,萃取压力25MPa,温度40℃、分离压力6MPa,温度45℃、CO2流量600L/hr,取100kg脱脂后的颗粒加入1200kg95%食用酒精,在85℃搅拌提取2hr得到一次提取液,再加1000kg 95%食用酒精提取2hr,合并二次提取液,浓缩干燥,超微粉碎,得到约5kg灵芝提取物粉,灵芝提取物粉粒径在5~10μm,灵芝三萜酸含量15.9%;
铁皮石斛提取液的制备:采收成熟的铁皮石斛鲜条,切段,冷冻干燥,水分控制在3%以下,粉碎成10~20目颗粒,取10kg颗粒加入20倍水,低温搅拌浸提,提取温度4℃,提取时间8h,提取液经过卧式离心机离心,卧式离心机的转鼓转速为2700r/min,分离因子为1240g,分离出的浊液浊度达到20nut以下,得到铁皮石斛提取液,黏度为8.4mPa·s,多糖含量5.07%;
灵芝铁皮石斛混悬剂的制备为:按各组分的质量百分比为:灵芝提取物粉20%,铁皮石斛提取液75%,水4.99%,甜味剂0.01%,先将灵芝提取物分和铁皮石斛提取液混悬得到混悬液,将甜味剂溶于水混匀,再将水与混悬液混匀,无菌灌装,得到样品1,经检测灵芝三萜酸含量为31.4mg/ml,多糖含量35.0mg/mL。
实施例2
灵芝提取物粉的制备:采收成熟的灵芝,经清洗、烘干,水分控制在3%以下,粉碎成10目左右的颗粒,用超临界CO2萃取技术除去脂溶性杂质,萃取压力25MPa,温度40℃、分离压力6MPa,温度45℃、CO2流量600L/hr,取100kg脱脂后的颗粒加入1200kg95%食用酒精,在85℃搅拌提取2hr得到一次提取液,再加1000kg 95%食用酒精提取2hr,合并二次提取液,浓缩干燥,超微粉碎,得到约5kg灵芝提取物粉,灵芝提取物粉粒径在5~10μm,灵芝三萜酸含量15.9%;
铁皮石斛提取液的制备:采收成熟的铁皮石斛鲜条,切段,冷冻干燥,水分控制在3%以下,粉碎成10~20目颗粒,取10kg颗粒加入18倍水,低温搅拌浸提,提取温度4℃,提取时间8h,提取液经过卧式离心机离心,卧式离心机的转鼓转速为2700r/min,分离因子为1240g,分离出的浊液浊度达到20nut以下,得到铁皮石斛提取液,黏度为9.0mPa·s,多糖含量5.47%;
灵芝铁皮石斛混悬剂的制备为:按各组分的质量百分比为:灵芝提取物粉20%,铁皮石斛提取液75%,水4.99%,甜味剂0.01%,先将灵芝提取物分和铁皮石斛提取液混悬得到混悬液,将甜味剂溶于水混匀,再将水与混悬液混匀,无菌灌装,得到样品2,经检测灵芝三萜酸含量为34.5mg/ml,多糖含量35.1mg/ml。
实施例3
灵芝提取物粉的制备:采收成熟的灵芝,经清洗、烘干,水分控制在3%以下,粉碎成10目左右的颗粒,用超临界CO2萃取技术除去脂溶性杂质,萃取压力25MPa,温度40℃、分离压力6MPa,温度45℃、CO2流量600L/hr,取100kg脱脂后的颗粒加入1200kg95%食用酒精,在85℃搅拌提取2hr得到一次提取液,再加1000kg 95%食用酒精提取2hr,合并二次提取液,浓缩干燥,超微粉碎,得到大约5kg灵芝提取物粉,灵芝提取物粉粒径在5~10μm,灵芝三萜酸含量16.1%;
铁皮石斛提取液的制备:采收成熟的铁皮石斛鲜条,切段,冷冻干燥,水分控制在3%以下,粉碎成10~20目颗粒,取10kg颗粒加入15倍水,低温搅拌浸提,提取温度4℃,提取时间8h,提取液经过卧式离心机离心,卧式离心机的转鼓转速为2700r/min,分离因子为1240g,分离出的浊液浊度达到20nut以下,得到铁皮石斛提取液,黏度为9.5mPa·s,多糖含量5.81%;
灵芝铁皮石斛混悬剂的制备为:按各组分的质量百分比为:灵芝提取物粉30%,铁皮石斛提取液65%,水4.98%,甜味剂0.02%,先将灵芝提取物分和铁皮石斛提取液混悬得到混悬液,将甜味剂溶于水混匀,再将水与混悬液混匀,无菌灌装,得到样品3,经检测灵芝三萜酸含量为41.3mg/ml,多糖含量35.8mg/ml。
实验检测例1
稳定性的测定:
取样品1,2,3按照中华人民共和国药典2015版四部通则0123口服混悬剂的沉降体积比方法进行稳定性考察:用具塞量筒量取供试品50ml,密塞,用力振摇1min,记下混悬物的开始高度H0,静置3h,记下混悬物的最终髙度H,按下式计算:
结果如下:
表1灵芝铁皮石斛混悬剂沉降体积比
样品1,2,3沉降体积比均大于0.90,判定合格
实验检测例2
目前对苦味的评价方法主要包括体内和体外2类方法。前者包括人群试验、动物电生理试验等,后者可采用释放试验、生化实验和味觉传感器等。体内口感评价方法中最常用的是经典人群口尝评价方法(简称口尝法)。它是最直接的评价方法,同时也是体外方法中评价体内外相关性的基础。
经典人群口尝评价法实验材料:盐酸小檗碱对照品,纯化水,样品1,2,3
实验方法:
1,苦度评价等级和各级评分范围的确定:
表2苦度值(I)的定性描述,等级及定量范围
2,阳性,阴性溶液的制备:
阳性溶液的制备:精密称取盐酸小檗碱对照品500mg置于100mL量瓶中,加水50mL,摇匀溶解,转移至1000mL量瓶中,加水至刻度,即为5号液;另分别取5号液200,100,20mL置于1000mL量瓶中,加水至刻度,并将其分别标记为4,3,2号液。阴性溶液取纯水1 000mL置于l000 mL烧杯中,即为1号液,没有苦味。1,2,3,4和5号参比溶液中盐酸小檗碱的质量浓度分别为0.00,0.01,0.05,0.10和0.50g/L,其对应的苦度等级分别为I,Ⅱ,Ⅲ,Ⅳ,V,其对应的I值分别为1.0,2.0,3.0,4.0和5.0。
苦味值的确定:先对参比溶液进行测试,分别取30mL各浓度的参比溶液于口尝纸杯中,由20名志愿者(11名男性,9名女性,年龄23~51岁)含于口中,计时10s,此间口腔做漱口动作,以使舌的苦味感受区能够感受药物苦味,并被告知该溶液的苦度分级和具体苦度值,吐出,漱口5次,至口腔内无苦味,20min后测定另一浓度的参比溶液。
样品的测定:志愿者根据自己的口尝感受,并结合与参比溶液的对比,首先参照表1中的苦味表述确定苦度等级,记录与事先设计好的“药物苦味描述表”中;然后再根据同一级别内各药液的相对苦度大小,在该级别的苦度值允许的取值范围内,给所尝样品赋予一个具体的苦度值。并填入上述“药物苦味描述表”中;漱口5次,至口腔内无苦味,20min后测定另一样品。此外,实验中受试人员对样品测试时,均采用低苦度向高苦度的方法对样品进行逐步测试。结果如下:
表3灵芝铁皮石斛混悬剂苦度值
样品1,2,3苦度值比均小于1.5,判定为无苦味
实验检测例3
微生物指标检测
将样品1,2,3放置于恒温恒湿箱90d,温度37±1℃,湿度75±5%,取样检测微生物指标,检测结果如下:
表4微生物指标结果
样品1,2,3微生物检测指标合格,说明该混悬剂中的灵芝提取物中的灵芝三萜有明显的抑菌功效。
Claims (2)
1.一种灵芝铁皮石斛混悬剂,其特征在于,由灵芝提取物粉、铁皮石斛提取液、甜味剂和水组成,各组分的质量百分比为:灵芝提取物粉20~30%,铁皮石斛提取液65~75%,水4.98~4.99%,甜味剂0.01~0.02%,其中灵芝三萜酸含量≥30mg/mL,多糖含量≥35mg/mL。
2.一种制作灵芝铁皮石斛混悬剂的方法,其特征在于,灵芝提取物粉的制备方法为:采收成熟的灵芝,经清洗、烘干,水分控制在3%以下,粉碎成10目左右的颗粒,用超临界CO2萃取技术除去脂溶性杂质,萃取压力25MPa,萃取温度40℃、分离压力6MPa,分离温度45℃、CO2流量600L/hr,加入重量为灵芝颗粒12倍的95%食用酒精,在85℃搅拌提取2hr得到第一次提取液,再加重量为灵芝颗粒10倍95%食用酒精提取2hr,合并二次提取液,浓缩干燥,超微粉碎,得到灵芝提取物粉,灵芝提取物粉粒径在5~10μm,灵芝三萜酸含量≥15%;铁皮石斛提取液的制备方法为:采收成熟的铁皮石斛鲜条,切段,冷冻干燥,水分控制在3%以下,粉碎成10~20目颗粒,加入重量为铁皮石斛颗粒15~20倍水,4℃低温搅拌浸提8hr,浸提液经卧螺离心机分离,卧式离心机的转鼓转速为2700r/min,分离因子为1240 g,分离出的浊液浊度达到20 nut以下,得到铁皮石斛提取液,黏度为8~10mPa·s,多糖含量≥5%;灵芝铁皮石斛混悬剂的制备为:按各组分的质量百分比为:灵芝提取物粉20~30%,铁皮石斛提取液65~75%,水4.98~4.99%,甜味剂0.01~0.02%,将灵芝提取物与铁皮石斛提取液混悬得混悬液,将甜味剂溶于水混匀,再将水加入混悬液搅拌均匀,无菌灌装,得到成品。
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