CN107375757A - 一种芦笋片剂及其制备方法 - Google Patents
一种芦笋片剂及其制备方法 Download PDFInfo
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L19/00—Products from fruits or vegetables; Preparation or treatment thereof
- A23L19/01—Instant products; Powders; Flakes; Granules
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
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Abstract
本发明公开了一种芦笋片剂,它是以鲜白芦笋为原料,采用真空冷冻、超微粉碎、超声强化提取、萃取、洗脱等方式进行制备,提取出的芦笋皂苷纯度高达96.2%~97.1%,提高了芦笋的生物利用度,降低了加工成本,制备了一种能有效提高机体免疫功能,同时益气生津、杀伤肿瘤细胞、减轻放化疗副作用的药物。
Description
技术领域
本发明涉及药物领域,具体涉及一种芦笋片剂及其制备方法。
背景技术
芦笋是一种质地优良、营养丰富的保健型蔬菜,含有人体不可缺少的氨基酸、矿物质和其它多种营养元素,也含有皂角甙类化合物及黄酮类等多种活性成分,其营养价值高于一般蔬菜水果,在国际市场上被称为“蔬菜之王”。芦笋嫩茎中含有丰富的蛋白质、维生素、矿物质和人体所需的微量元素等,另外芦笋中含有特有的天门冬酰胺,及物质,对心血管病、水肿、膀胱炎、白血病均有疗效,也有抗癌的效果,因此长期食用芦笋有益脾胃,对人体许多疾病有很好的治疗效果。
芦笋食药同源,自古以来备受推崇。《神农本草》将芦笋列为“上品之上”,称“久服不仅能轻身,还有益气延年”的功效。明朝李时珍《本草纲目》记载:芦笋“瘿结热气,利小便”,具润肺、镇咳、祛痰、杀虫之功效,称其能“解诸内毒”。《中华医典》更是详述芦笋内含芦丁、维生素C,能降低血压、软化血管,减少胆固醇吸收,可作为高血压、冠心病人的食疗方剂。芦笋药理上有着增强体质、提高免疫力、抗疲劳、燃烧脂肪、保肝解毒、降血脂、耐缺氧、抗氧化保肝、抗衰老、抗肿瘤、增强记忆力的功效。在临床应用于防癌治癌、治疗高血脂、治银屑病、治乳癌、乳腺增生、高血压、心脏病、心动过速、疲劳、水肿、膀胱炎、结石病、排尿困难、肝硬化等疾病,可以作为各类癌症病人的辅助治疗食品。
目前,我国对芦笋皂苷的提取、纯化的研究还处于起步阶段,CN102511802A公开了一种芦笋片剂,它是以10~50%速溶芦笋粉为原料,添加10~90% 的植物油、适量的食用色素,混合后的液体或悬浊液封闭于片剂壳中,虽然该芦笋片剂中含有芦笋皂苷达到80mg以上,但其制备工艺复杂,植物油和食用色素为常规原料,对芦笋的保健功效并没有加强的作用,营养成分含量有流失,影响了它的保健功效。CN100365011C公开了一种芦笋皂甙的生产方法,该方法中,由于在制备芦笋皂苷时,沉淀剂用***和石油醚,而***和石油醚是一种易挥发、易燃烧的物质,产业化时条件控制不当,容易引发事故,造成难以弥补的损失,不适合工业化生产。CN101474350A公开了一种芦笋总皂苷的提取方法,该方法采用醇水溶剂***提取后直接用大孔吸附树脂处理,所得的皂苷提取物中,总皂苷含量较低。
基于上述不足,一种工艺简单、营养成分保留完整、能益气生津、适用于癌症患者的辅助治疗的芦笋片剂及其制备方法是行业内急需的。
发明内容
鉴于上述分析,本发明提供了一种工艺简单、营养成分保留完整、益气生津,适用于癌症的辅助治疗及放、化疗后口干舌燥,食欲不振,全身倦怠患者芦荟片剂。
一种芦笋片剂,由以下重量份配比的原料制成:
鲜芦笋14000~16000份,淀粉100~140份,乳糖70~90份,微晶纤维素75~110份,低取代羟丙基纤维素5~20份,糊精10~30份,硬脂酸镁0.5~0.7份。
进一步的,该芦笋片剂由以下重量份配比的原料制成:
鲜芦笋15000份,淀粉120份,乳糖80份,微晶纤维素92.5份,低取代羟丙基纤维素12.5份,糊精20份,硬脂酸镁0.6份。
一种芦笋片剂及其制备方法,具体步骤如下:
(1)原料处理:取新鲜芦笋以流动清水洗净、沥干、切断、切片;
(2)真空冷冻:将切片后的芦笋置于抽真空装置中,抽真空2min,使用液氮进行喷淋,保持芦笋中心温度-20℃,并转入-30℃的冻库中储存备用;
(3)超微粉碎:将冷冻后的芦笋置入机械超微粉碎机中粉碎,获得600目以上超微粉a,再将超微粉a通过气流粉碎,获得1000目以上的超微粉b;
(4)超声强化提取:将超微粉b加入60%~80%的乙醇溶液进行浓缩提取,乙醇溶液与芦笋破壁粉的液固比为5:1~10:1,功率400~600w,回流3次,每次2h,合并回流液,获得回流液与残渣,将回流液减压浓缩得浓缩液a,回收乙醇,浓缩液a中包含芦笋皂苷;
(5)萃取:将浓缩液a加入体积比为10倍的饱和正丁醇水溶液萃取3-5次,合并萃取液,减压浓缩,烘干,得粗粉,回收正丁醇;
(6)洗脱:将粗粉溶于质量比为5倍的蒸馏水中,溶解后加入高径比为6~8:1的大孔吸附树脂中,上样2~3倍柱体积的样品,首先以6~10倍柱体积的去离子水以每小时0.5~1倍柱体积的流速洗脱并收集水洗脱液b,然后用4~5倍柱体的含量为30%~50%的乙醇溶液以每小时0.5~1倍柱体积的流速洗脱并收集洗脱液c,合并洗脱液,并减压浓缩,回收乙醇,浓缩成浸膏,总皂苷含量为96.2%~97.1%;
(7)混合制粒:按重量份配比取芦笋浸膏、淀粉、乳糖、微晶纤维素、低取代羟丙基纤维素、糊精混合均匀,再加入原料总量18%的乙醇,制粒、干燥、整粒;
(8)压片:取上述颗粒将加入重量份的硬脂酸镁,混合均匀,压片,即得一种芦笋片剂。
进一步的,步骤(2)所述真空冷冻真空度86.13kPa。
进一步的,步骤(6)所述减压浓缩真空度0.07MPa,搅拌转速60r/min。
进一步的,步骤(7)所述乙醇浓度为55%。
本发明还提供了一种芦笋片剂在辅助治疗癌症的药物中的用途。
本发明的有益效果在于:
(1)采用真空冷冻处理,能让植物细胞中的纤维晶度下降,聚合度提高,剥离部分木素,将原料撕裂为细小纤维,同时最大程度的保留了芦笋中皂苷及其他营养物质的活性,提高了芦笋的发酵成分和利用效果。
(2)采用大孔吸附树脂进行两次洗脱,有效提高了芦笋皂苷的纯度,可达96.2%~97.1%,经正丁醇纯化后的皂苷可回收利用,无需在大孔树脂中使用***进行脱色,不仅利于化工业的生产,同时节约生产成本。
(3)采用两级超微粉碎制得的超微粉,能提高芦笋提取物的溶解和吸收利用,最终大大提高了提取物的利用率。
(4)采用低温冷冻干燥法,提高了物料收得率和有效成分转移率,从而提高了中间品和成品的质量。
(5)通过对原料药进行精制,去除无效成分与杂质,在保证药效的前提下,减少服用量,有利于剂型的制备和药物的应用,提升了中药的现代化水平。
(6)实验表明本发明提取的活性部位有明显的抗肿瘤功能,又由于芦笋本身就可食用,所以其具有无毒、安全等特点,以此活性部位作为活性成分可以得到有效的抗肿瘤新药和/或抗肿瘤保健品,具有高效、无毒且原料廉价易得的特点。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
附图说明
图1为芦笋片剂制备工艺流程图。
具体实施方式
实施例1
一种芦笋片剂(制备工艺流程如图1所示)
(1)原料处理:取15000kg新鲜芦笋以流动清水洗净、沥干、切断、切片;
(2)真空冷冻:将切片后的芦笋置于抽真空装置中,抽真空2min,使用液氮进行喷淋,保持芦笋中心温度-20℃,并转入-30℃的冻库中储存备用,真空冷冻真空度86.13kPa;
(3)超微粉碎:将冷冻后的芦笋置入机械超微粉碎机中粉碎,获得600目以上超微粉a,再将超微粉a通过气流粉碎,获得1000目以上的超微粉b;
(4)超声强化提取:将超微粉b加入60%~80%的乙醇溶液进行浓缩提取,乙醇溶液与芦笋破壁粉的液固比为5:1~10:1,功率400~600w,回流3次,每次2h,合并回流液,获得回流液与残渣,将回流液减压浓缩得浓缩液a,回收乙醇,浓缩液a中包含芦笋皂苷;
(5)萃取:将浓缩液a加入体积比为10倍的饱和正丁醇水溶液萃取3-5次,合并萃取液,减压浓缩,烘干,得粗粉,回收正丁醇;
(6)洗脱:将粗粉溶于质量比为5倍的蒸馏水中,溶解后加入高径比为6~8:1的大孔吸附树脂中,上样2~3倍柱体积的样品,首先以6~10倍柱体积的去离子水以每小时0.5~1倍柱体积的流速洗脱并收集水洗脱液b,然后用4~5倍柱体的含量为30%~50%的乙醇溶液以每小时0.5~1倍柱体积的流速洗脱并收集洗脱液c,合并洗脱液,并减压浓缩,回收乙醇,浓缩成浸膏,总皂苷含量为96.2%~97.1%,减压浓缩真空度0.07MPa,搅拌转速60r/min;
(7)混合制粒:取芦笋浸膏702kg,淀粉120kg,乳糖80kg,微晶纤维素92.5kg,低取代羟丙基纤维素12.5kg,糊精20kg,混合均匀,再加入原料总量18%、浓度为55%的乙醇,制粒、干燥、整粒;
(8)压片:取上述颗粒将加入硬脂酸镁0.6kg,混合均匀,压片,即得一种芦笋片剂。
实施例2
一种芦笋片剂
制备方法同实施例1,只是由如下重量份配比的原料制成:鲜芦笋14000kg,淀粉100kg,乳糖70kg,微晶纤维素75kg,低取代羟丙基纤维素5kg,糊精10kg,硬脂酸镁0.5kg。14000kg鲜芦笋制备得到的芦笋提取物655.2kg。
实施例3
一种芦笋片剂
制备方法同实施例1,只是由如下重量份配比的原料制成:鲜芦笋16000kg,淀粉140kg,乳糖90kg,微晶纤维素110kg,低取代羟丙基纤维素20kg,糊精30kg,硬脂酸镁0.7kg。
试验例1
本发明涉及的工艺流程为:原料处理、真空冷冻、超微粉碎、超声强化提取、萃取、洗脱、混合制粒、压片。其中真空冷冻、超微粉碎、洗脱为本发明的关键工艺,我们将新鲜白芦笋作为原料,以提取物得率、提取物皂苷含量及皂苷提取率作为指标,在保证除关键工艺外的其他工艺相同的情况下,对不同的关键工艺进行评价,具体详见表1。
表1不同生产工艺对芦笋提取的影响
。
由表1可知,只有在真空冷冻、超微粉碎、二次洗脱共同作用下,才能获得芦笋皂苷含量96.94%,远高于单纯使用常规冷冻、破壁粉碎、单次洗脱制备工艺,说明本发明中的工艺密不可分,相互协同,是不可缺少的一个整体工艺,只有在本发明配方和工艺条件下,才能获得皂苷含量96%以上的芦笋提取物。
试验例2
结合以下实验数据和记录,对本发明的疗效做进一步说明,以下所述的药物,用的是实施例1中的配方。
本实验样品均为片剂剂,内容物为棕色或棕黄色的颗粒,具芦笋特异香,味微苦。人体推荐剂量为每天2.7g/60kg,本次实验设低、中、高三个剂量组,分别相当于人体剂量的5倍、10倍和30倍,经口给样品28天。实验结果表明:样品对小鼠S180实体瘤瘤重有明显抑制作用,而对小鼠体重无明显影响,并能提高小鼠巨噬细胞吞噬百分数和吞噬指数以及NK细胞活性而未见抑制作用。
结论:适用于癌症的辅助治疗及放、化疗后口干舌燥,食欲不振,全身倦怠患者。
抑制肿瘤作用测定:
1.对移植性肿瘤的影响:
1.1样品处理
样品为褐色内容物的片剂,用水配成所需浓度的混悬液供试。
1.2实验动物
昆明种雌性小白鼠,体重范围20~22克,由上海医科大学动物房提供。
1.3实验瘤株
小鼠肉瘤180(s180),由四川省肿瘤医院提供。
1.4剂量设计
样品人每日推荐剂量为2.7g/60kg,低剂量组为0.225g/kg,中剂量组为0.45g/kg,高剂量组为1.35g/kg,阳性对照组为25mg/kg环磷酰胺,阴性对照组给以蒸馏水。
1.5实验方法和结果
动物连续给样三周后,抽取健康的腹水型S180小鼠腹水,进行计数后,根据活细胞数用生理盐水稀释腹水至细胞数为10个/ml,每只小鼠腹部皮下接种0.2ml。接种后继续给样,环磷酰胺组于接种后一天开始给样(1g)。接种10天后,将小鼠称重,颈椎脱臼处死,取皮下瘤块称重,结果详见表2.
表2 肿瘤抑制实验
注:中剂量组和高剂量组的实体瘤瘤重明显轻于阴性对照组(P<0.05
),差异有统计学意义;但低剂量组的实体瘤瘤重与阴性对照组则无明显差异(P>0.05)。低剂量组、中剂量组和高剂量组的小鼠体重与阴性对照组无明显差异。
2.对免疫功能的影响
2.1样品处理
样品为褐色内容物的片剂,用水配成所需浓度的混悬液供试。
2.2动物来源
昆明种小白鼠,由四川省肿瘤医院提供。
2.3剂量设计
样品人每日推荐剂量为2.7g/60kg,低剂量组为0.225g/kg,中剂量组为0.45g/kg,高剂量组为1.35g/kg,对照组给以蒸馏水。
2.4实验方法与结果
2.4.1小鼠腹腔巨噬细胞吞噬鸡红细胞试验
动物连续给样四周后,每鼠腹腔注射20g鸡红细胞悬液1ml,间隔30分钟,颈椎脱臼处死,固定于鼠板上,剪开腹壁皮肤,注射生理盐水2ml,转动鼠板1分钟,吸出腹腔洗液1ml,分滴于2片玻片上,37℃孵箱湿孵30分钟,用生理盐水漂洗,晾干,以1∶1丙酮甲醇溶液固定,4%Giemsa~磷酸缓冲液染色3分钟,再用蒸馏水漂洗晾干,用油镜镜检,计算吞噬百分数和吞噬指数,结果详见表3.
表3 巨噬细胞吞噬试验
。
注:给以样品28天,四组动物吞噬率和吞噬指数均有所升高,但中剂量组和高剂量组相比对照组,其升高的吞噬率和吞噬指数差异更显著(P<0.05),低剂量组与对照组之间则无明显差异。
2.4.2NK细胞活性测定
动物连续给样四周后:颈椎脱臼处死,取脾脏,制成脾细胞悬液,取传代后24hYAC~1细胞加3H~TdR 10u Ci/1×106/ml,37℃培养2小时,每30分钟震荡1次,用培养液洗涤3次,配制成1×105/ml YAC~1靶细胞加入96孔培养板,每孔加100ul,试验孔加入100ul1×107/ml小鼠脾细胞悬液,空白对照孔加入100ul培养液,最大释放孔加入100ul2.5%TritonX~100,每个样品设3个复孔,37℃培养4h后用多头细胞收集器将细胞收集在49型玻璃纤维滤纸上,60℃烤干后浸入闪烁液过夜,用液体闪烁仪测量CPM,结果详见表4.
表4 NK细胞活性测定
。
注:给以样品28天,四组动物NK细胞活性均有所升高,但低剂量组、中剂量组、高剂量组相比对照组的NK细胞活性,差异具有统计学意义(P<0.05)。
综上所述,口服芦笋片剂用于有实体瘤的小鼠的体重并无明显影响,但实体瘤瘤重却显著减轻,巨噬细胞吞噬率和吞噬指数也显著升高,用药后的NK细胞活性也明显提升,说明芦笋片剂能有效抑制肿瘤的生长,同时还能提高免疫功能。
Claims (7)
1.一种芦笋片剂,其特征在于,该芦笋片剂由以下重量份配比的原料制成:
鲜芦笋14000~16000份,淀粉100~140份,乳糖70~90份,微晶纤维素75~110份,低取代羟丙基纤维素5~20份,糊精10~30份,硬脂酸镁0.5~0.7份。
2.根据权利要求1所述的芦笋片剂,其特征在于,该芦笋片剂由以下重量份配比的原料制成:
鲜芦笋15000份,淀粉120份,乳糖80份,微晶纤维素92.5份,低取代羟丙基纤维素12.5份,糊精20份,硬脂酸镁0.6份。
3.一种根据权利要求1或2所述的芦笋片剂的制备方法,其特征在于,该方法包含以下步骤:
(1)原料处理:取新鲜芦笋以流动清水洗净、沥干、切断、切片;
(2)真空冷冻:将切片后的芦笋置于抽真空装置中,抽真空2min,使用液氮进行喷淋,保持芦笋中心温度-20℃,并转入-30℃的冻库中储存备用;
(3)超微粉碎:将冷冻后的芦笋置入机械超微粉碎机中粉碎,获得600目以上超微粉a,再将超微粉a通过气流粉碎,获得1000目以上的超微粉b;
(4)超声强化提取:将超微粉b加入60%~80%的乙醇溶液进行浓缩提取,乙醇溶液与芦笋破壁粉的液固比为5:1~10:1,功率400~600w,回流3次,每次2h,合并回流液,获得回流液与残渣,将回流液减压浓缩得浓缩液a,回收乙醇,浓缩液a中包含芦笋皂苷;
(5)萃取:将浓缩液a加入体积比为10倍的饱和正丁醇水溶液萃取3-5次,合并萃取液,减压浓缩,烘干,得粗粉,回收正丁醇;
(6)洗脱:将粗粉溶于质量比为5倍的蒸馏水中,溶解后加入高径比为6~8:1的大孔吸附树脂中,上样2~3倍柱体积的样品,首先以6~10倍柱体积的去离子水以每小时0.5~1倍柱体积的流速洗脱并收集水洗脱液b,然后用4~5倍柱体的含量为30%~50%的乙醇溶液以每小时0.5~1倍柱体积的流速洗脱并收集洗脱液c,合并洗脱液,并减压浓缩,回收乙醇,浓缩成浸膏,总皂苷含量为96.2%~97.1%;
(7)混合制粒:按重量份配比取芦笋浸膏、淀粉、乳糖、微晶纤维素、低取代羟丙基纤维素、糊精混合均匀,再加入原料总量18%的乙醇,制粒、干燥、整粒;
(8)压片:取上述颗粒将加入重量份的硬脂酸镁,混合均匀,压片,即得一种芦笋片剂。
4.根据权利要求3所述的芦笋片剂的制备方法,其特征在于,步骤(2)所述真空冷冻真空度86.13kPa。
5.根据权利要求3所述的芦笋片剂的制备方法,其特征在于,步骤(6)所述减压浓缩真空度0.07MPa,搅拌转速60r/min。
6.根据权利要求3所述的芦笋片剂的制备方法,其特征在于,步骤(7)所述乙醇浓度为55%。
7.根据权利要求1-6任意一项所述的芦笋片剂在辅助治疗癌症的药物中的用途。
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CN1840067A (zh) * | 2006-01-17 | 2006-10-04 | 山东轻工业学院 | 芦笋咀嚼片及其生产工艺 |
CN101559157A (zh) * | 2009-05-18 | 2009-10-21 | 华东师范大学 | 一种利用芦笋渣分级提取芦笋皂苷和芦笋多糖的方法 |
CN101791371A (zh) * | 2009-12-22 | 2010-08-04 | 沈阳亿灵医药科技有限公司 | 芦笋皂苷提取制备方法 |
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