CN109106736A - 一种含有植物组织的冻干赋形制剂 - Google Patents
一种含有植物组织的冻干赋形制剂 Download PDFInfo
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- CN109106736A CN109106736A CN201710490029.6A CN201710490029A CN109106736A CN 109106736 A CN109106736 A CN 109106736A CN 201710490029 A CN201710490029 A CN 201710490029A CN 109106736 A CN109106736 A CN 109106736A
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- plant tissue
- lyophilized excipient
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Abstract
本发明涉及一种含有植物组织的冻干赋形制剂,特别是一种包含植物组织,并通过溶解于水或配方溶液,从而得到一种含有植物组织的配方溶液的产品的配方与制备方法。
Description
技术领域
本发明涉及一种含有植物组织的冻干赋形制剂,特别是一种包含植物组织,并通过溶解于水或配方溶液,从而得到一种含有植物组织的配方溶液的产品的配方与制备方法。
背景技术
在食品、保健食品以及化妆品中,经常可见包含植物组织的产品,如包含谷粒的饮料、包含花瓣的爽肤水和沐浴产品等。但此种方式由于是液体制剂的形态,一方面为了体系稳定性需要加入大量的防腐体系、一方面花瓣在长期浸泡中也会丧失相应的活性和营养成分,同时这种产品形态也会有一个较高的物流成本,不利于产品的运输。
冻干赋形技术是指在可流动的液体、半固体或固体的活性成分中加入骨架支持剂以及粘结剂,或所述可流动的液体、半固体或固体中本身含有粘结剂及骨架支持剂,然后将其灌注到成型模具中,通过冷冻干燥工艺得以成型的技术,通过冻干赋形技术制备的制剂称作冻干赋形制剂。
由于该类制剂采用冷冻干燥工艺,可以保护不稳定活性成分不被破坏,同时通过水分升华产生大量微孔和孔道,可以具有很快的崩解和溶解速度,因此受到了广泛应用,可以应用于口腔崩解片、速释片、咀嚼片、特殊化妆品、医疗器械、保健品等多个领域。
发明人锐意创新,进行了大量深入的研究和试验工作,基于冻干制剂制造工艺的原理进行工艺优化,并通过对配方的研究,提供了一套加入植物组织的冻干赋形制剂方案,可以保证植物组织既保存了本身的营养成分和活性物质,又可以在遇到溶剂后快速复水,并形成一个包含植物组织的产品的形态,同时其制备和生产过程并不会在冻干赋形制剂的基础上增加成本,又能大大降低物流成本的方案。
发明内容
一种含有植物组织的冻干赋形制剂,包括粘结剂和植物组织。
所述植物组织可以为新鲜的、或是预先干燥的,部位选自植物的整株,或者是花、茎、叶、叶状体、根、果实、种子中的一种或多种组合。
所述的冻干赋形制剂的粘结剂,为人工或天然高分子聚合物、无机物凝胶剂、纤维素醚类、改性淀粉类、透明质酸类、白蛋白、右旋糖酐、壳聚糖及其不同分子量产物、海藻酸钠、PVP、PVA、聚乙二醇、琼脂、聚氨基酸、聚糖或它们的组合。
所述高分子聚合物为海藻酸钠、羊毛脂、琼脂、聚乙烯醇丙烯酸甲酯接枝共聚物、卡波姆、卡波树脂、透明质酸钠、透明质酸、聚乙烯吡咯烷酮、聚乙烯醇、聚乙二醇、聚氧化乙烯、改性石蜡、聚丙烯酰胺、聚丙烯酸钠、聚丙烯酸酯和聚丙烯酸及其衍生物等中的一种或多种。
所述无机物凝胶剂为硅藻土、膨润土、蒙脱石、锂基蒙脱石、硅凝胶中的一种或多种。
所述胶类粘结剂为胶原、明胶、水解明胶、阿拉伯胶、黄原胶、大豆蛋白胶、小核菌胶、生物糖胶、卡拉胶、瓜尔胶、结冷胶、果胶、魔芋胶、角叉菜胶、刺槐豆胶、树胶、槐豆胶等中的一种或多种。
所述的纤维素醚类粘结剂为微晶纤维素、羧甲基纤维素、羧乙基纤维素、羟乙基甲基纤维素、羟丙基甲基纤维素等中的一种或多种。
所述改性淀粉类粘结剂选自聚丙烯酸钠接枝淀粉、普鲁兰糖、羟丙基淀粉、羟丙基甲基淀粉、预胶化淀粉、直链淀粉、羧甲基淀粉、羟乙基淀粉、羟丙基淀粉等中的一种或多种。
所述聚氨基酸选自聚谷氨酸、聚丙氨酸、聚天冬氨酸、聚赖氨酸等中的一种或多种。
所述聚糖选自岩藻多糖、菊糖、葡聚糖等中的一种或多种。
所述的冻干赋形制剂还可以进一步添加活性物、骨架支持剂,肤感改良剂,抗氧化剂,矫味剂,香精,跨黏膜、透皮吸收促进剂和pH调节剂中的一种或几种。
所述活性物,独立的选自为化学药物、中药、天然提取物、生物活性成分、皮肤护理有益成分、消毒杀菌剂、口服食品补充剂和美容药物中的一种或几种。
化学药物(药物活性成分):
解热镇痛抗炎药,例如阿司匹林、二氟尼柳、双水杨酯、对乙酰氨基酚、吲哚美辛、布洛芬、萘普生、酮洛芬、吡洛芬、舒洛芬、氟比洛芬、吡罗昔康、美洛昔康、尼美舒利、苯溴马隆等;
中枢兴奋药,例如匹莫林、阿屈非尼、吡拉西坦等;
治疗偏头痛药,例如琥珀酸舒马普坦;
镇痛药,例如罗通定、丁丙诺啡、喷他佐辛、纳洛酮等;
抗帕金森病和治疗老年痴呆药,例如左旋多巴、复方卡比多巴、复方苄丝肼、盐酸金刚烷胺、吡贝地尔、普罗酚胺、多奈哌齐、石杉碱甲等;
抗精神失常药,例如氯丙嗪、异丙嗪、哌替啶、硫利达嗪、氯普噻吨、氯氮平、舒必利、泰必利、五氟利多、利培酮等;
抗癫痫病和抗惊厥药,例如苯妥英钠、卡马西平、扑米酮、加巴喷丁、拉莫三嗪、丙戊酸钠、氯硝西泮等。
镇静催眠药,例如地西泮、硝西泮、奥沙西泮、劳拉西泮、苯巴比妥等;
胆碱酯酶抑制药,例如东莨菪碱等;
抗心律失常药,例如丙吡啶、妥卡尼、美西律、乙吗噻嗪、苯妥英钠、普罗帕酮、胺碘酮等;
抗心绞痛与抗动脉粥样硬化药,例如普萘洛尔、硝苯地平、吉非贝齐、苯扎贝特、洛伐他汀、辛伐他汀、普伐他汀等;
抗高血压药,例如依拉普利、卡托普利、氢氯噻嗪、氨氯地平等;
肾上腺受体阻断剂,例如醋丁洛尔、阿普洛尔等;
皮质甾类药,例如倍他米松、醋酸可的松等;
抗糖尿病药,例如瑞格列奈等;
抗甲状腺药,例如丙硫氧嘧啶、卡比马唑、甲巯咪唑等;
抗组织胺药,例如盐酸西替利嗪、氯雷他定等;
自体活性物质,例如地诺前列酮、前列地尔、倍他司汀等;
消化系统用药,例如丁溴东莨菪碱、盐酸格拉司琼等;
血液系统药,例如EPO、腺苷钴胺等;
泌尿系统药,例如阿佐塞米、呋塞米等;
生殖系统药,例如雌激素、苯丙酸诺龙等;
抗寄生虫药,例如阿苯达唑、坎苯达唑等;
抗肿瘤药,例如氨鲁米特、安吖啶等;
抗微生物药,例如氨苄西林、磺苄西林钠等;
抗生素类药,例如阿莫西林、头孢氨苄、头孢丙烯、头孢呋辛酯、罗红霉素、琥乙红霉素、交沙霉素等。
中药成分:
中药有效成分单体,如:灯盏花素、青蒿素、石杉碱甲、延胡索乙素等;
单味中药材提取物及复方中药提取物,如:丹参酮提取物、丹参总酚酸提取物、复方丹参滴丸提取物、牛黄上清丸复方提取物、人参茎叶总皂苷、北豆根提取物、人参总皂苷、西洋参总皂苷、灯盏花素、肿节风浸膏、三七总皂苷、茵陈提取物、大黄浸膏、穿心莲内酯、山楂叶提取物、积雪草总苷、银杏叶提取物等。
天然植物提取物:
如芦荟提取物、山药提取物、越橘提取物、苦瓜提取物、紫锥菊提取物、小白菊提取物、山竹提取物、松针及松树皮提取物、巴西黑莓提取物、桑葚提取物、接骨木果提取物、蔓越莓提取物、虾青素、番茄红素、绿茶提取物、葡萄籽及葡萄皮提取物、光甘草定、芍药苷、甘草黄酮、丹皮提取物等。
生物活性成分:
EGF、bFGF、aFGF、KGF、IGF、NGF、TGF、HGH、EPO、G-CSF、GM-CSF、各种抗体药物、各种疫苗、类毒素、抗毒素、各种生物酶等。
皮肤护理有益成分:
维生素A、维生素B1、维生素B2、维生素B3、维生素B6、维生素B12、维生素C、维生素D、维生素E、维生素K、辅酶类、蛋白酶、金属硫蛋白、珍珠及其水解物、牛乳及其提取物、花粉及其提取物、蜂王浆、蜂胶等。
消毒杀菌剂:
液氯、高锰酸钾、臭氧、过氧化氢、氯胺、二氧化氯、过氧乙酸、84消毒液、乙醇、来苏尔、苯酚、甲苯酚、福尔马林、红汞、戊二醛、漂白粉、季铵盐类消毒剂(如新洁尔灭、洁尔灭)等。
口服食品补充剂:
氨基酸、多不饱和脂肪酸、矿物质、维生素、膳食成分、草本植物、其它植物成分,或以上成分的浓缩物、提取物或组合物等。
美容药物:
国家食品药品监督管理局发布的化妆品原料名录中的一种或多种具有美容功效的物质。
所述骨架剂选自糖(如麦芽糖、海藻糖等)、糖醇(如甘露醇、山梨醇)、2-12碳原子的氨基酸(如甘氨酸、丙氨酸、谷氨酸等)以及无机盐(如磷酸钠、硅酸铝等)中的任一种或数种混合物。
所述肤感改良剂选自聚甲基硅倍半氧烷、木薯淀粉、二C12-13醇苹果酸酯、二肉豆蔻醇酒石酸酯、PPG-15硬脂醇醚、锦纶-12、欧洲越桔籽油等具有改善肤感的物质中的任一种或数种混合物。
所述的抗氧化剂选自维生素C、维生素E、花青素、白藜芦醇、谷胱甘肽、超氧化物歧化酶、酵母菌/大米发酵产物滤液、植物提取物、白僵菌提取物、白松露菌提取物、果蔬提取物、植物来源的多元酚类化合物等具有抗氧化功效物质中的任一种或数种的混合物。
所述矫味剂和香精选自薄荷味、巧克力味、果蔬味、花草香味、植物香味、香草味、咖啡味、茶味、玉米味、柠檬味、牛奶味等香精或以上一种或几种香味的混合物。
所述的跨黏膜或透皮吸收促进剂选自卵磷脂、吐温、司盘中的任一种或数种的混合物。
所述的PH调节剂选自柠檬酸、山梨酸、酒石酸、乳酸、苹果酸、碳酸氢钠、碳酸钠,磷酸氢二钠、磷酸钙、磷酸钾、磷酸三镁等中的任何一种或数种的混合物。
所述预先干燥的植物组织,其处理方式可以为自然干燥法、加温干燥法、低温干燥法、减压干燥法、重压干燥法、干燥剂包埋法、液剂干燥法、真空冷冻干燥法中的一种或多种组合。
本发明还涉及所述冻干赋形制剂的制备方法,为:
A、方法1
a)将水、植物组织、粘结剂和/或辅料形成的溶液、乳液或者悬浊液,定容、脱气;
b)使用定量灌装泵,将a)注入到定量成型模具中,进行脱气;
c)将b)冷冻干燥,除去溶剂,得到含有植物组织的冻干赋形制剂,并可以脱离模具,进行内包装。
B、方法2
a)将水、植物组织、粘结剂和/或辅料形成的溶液、乳液或者悬浊液,定容、脱气;
b)使用定量灌装泵,其滴注口的尺寸可以使植物组织通过,在内部温度处于溶液共晶点以下的舱体内进行滴注,使其滴液时迅速冻结;
c)将已冻结的溶液进行冷冻干燥,得到含有植物组织的冻干赋形制剂。
所述预先干燥的植物组织,可以在方法1和方法2的a)步骤之前进行柔化处理。
所述柔化处理方式可以为水浸泡或配方液体浸泡,其配方液体优选为不易挥发的多元醇溶解液、油剂、包含油或多元醇的乳液、组织培养固定液中的一种或多种组合。
上述方式所涉及的配方和/或制备方法制备得到的产品,其为任意形状。
可以为片剂形状、胶囊剂形状、软胶囊形状、球形、椭球形或者各种人物、动物、植物、食物、图形标识或卡通形象。
在使用时,可以将其溶于水或者是配方溶液中使用,进一步得到一种包含植物组织的配方溶液体系。
所述配方溶液,可以进一步加入增稠成分,使溶解后的植物组织悬浮在配方溶液中,从而得到更加美观的视觉效果。所述的增稠成分,可以选自人工或天然高分子聚合物、无机物凝胶剂、胶类、纤维素醚类、改性淀粉类、透明质酸类、壳聚糖及其不同分子量产物、海藻酸钠、PVA、聚乙二醇、琼脂、聚氨基酸、聚糖或它们的组合;优选高分子聚合物、无机物凝胶剂、胶类、透明质酸类、壳聚糖及其不同分子量产物、海藻酸钠、PVA、琼脂;最优选高分子聚合物、无机物凝胶剂、胶类、透明质酸类。
具体实施方式
以下通过实施例进一步说明本发明,但本发明并不仅仅限于此。
实施例1
水、0.5%卡波姆、0.2%三乙醇胺、5%甘露醇混合形成溶液,灌装入片状模具中,灌装时取新鲜茉莉花,清洁后加入灌装模具中,数量为1-2朵/片;将茉莉花和溶液一并进行冷冻干燥、脱去水分,形成包含茉莉花的冻干赋形制剂。
使用时,数片溶于水后,形成包含茉莉花的外用护肤精华。
实施例2
取新鲜茉莉花瓣预先冷冻干燥。
水,0.5%卡波姆、0.2%三乙醇胺、0.2%透明质酸钠、8%甘露醇、0.3%聚谷氨酸形成溶液,混合冻干后的茉莉花瓣,灌装入球状模具中,数量为3-5瓣/片,将茉莉花瓣和溶液一并进行冷冻干燥、脱去水分,形成包含茉莉花瓣的冻干赋形制剂。
使用时,数粒溶于水后,形成包含茉莉花瓣的外用护肤精华。
实施例3
取预先干燥的茉莉花瓣,使用纯水浸泡至回软。
水,8%甘露醇,0.5%瓜尔豆胶,0.5%水溶性油,1.75%PVP形成溶液,混合回软后的茉莉花瓣,灌装入球状模具中,数量为3-5瓣/片,将茉莉花瓣和溶液一并进行冷冻干燥、脱去水分,形成包含茉莉花瓣的冻干赋形制剂。
使用时,数粒溶于水后,形成包含茉莉花瓣的外用护肤精华。
实施例4
取预先干燥的茉莉花瓣,使用7%甘油水溶液浸泡至回软。
水,0.2%透明质酸钠,5%普鲁兰,0.5%油,0.5%乳化剂形成乳浊液,混合回软后的茉莉花瓣,灌装入球状模具中,数量为3-5瓣/片,将茉莉花瓣和溶液一并进行冷冻干燥、脱去水分,形成包含茉莉花瓣的冻干赋形制剂。
使用时,数粒溶于水后,形成包含茉莉花瓣的外用护肤精华。
实施例5
取新鲜的玫瑰花瓣,使用加热干燥法烘干,并使用油脂浸泡柔化。
水,0.5%卡波姆、0.2%三乙醇胺、0.2%透明质酸钠、8%甘露醇、0.3%聚谷氨酸形成溶液,混合回软后的玫瑰花瓣,灌装入立方体型状模具中,数量为3-5瓣/片,将玫瑰花瓣和溶液一并进行冷冻干燥、脱去水分,形成包含玫瑰花瓣的冻干赋形制剂。
使用时,数粒溶于水后,形成包含玫瑰花瓣的外用护肤精华。
实施例6
取新鲜的桂花整花,自然干燥法干燥。
使用10%的甘油水溶液,进行柔化。
水,8%甘露醇,0.5%瓜尔豆胶,0.5%水溶性油,1.75%PVP形成溶液,加入柔化的桂花,使用定量灌装泵,其滴注口的尺寸可以使植物组织通过,在内部温度处于溶液共晶点以下的舱体内进行滴注,使其滴液时迅速冻结;将已冻结的溶液进行冷冻干燥,得到含有桂花的冻干赋形制剂。
使用时,数粒溶于包含2.5%锂基蒙脱石的配方溶液,形成包含桂花的外用护肤精华。
实施例7
取新鲜的勿忘我花瓣,真空干燥法干燥。
使用10%的组织培养定型液溶液,进行柔化。
水,8%甘露醇,0.5%瓜尔豆胶,0.5%水溶性油,1.75%PVP形成溶液,加入柔化的勿忘我花瓣,使用定量灌装泵,其滴注口的尺寸可以使植物组织通过,在内部温度处于溶液共晶点以下的舱体内进行滴注,使其滴液时迅速冻结;将已冻结的溶液进行冷冻干燥,得到含有勿忘我花瓣的冻干赋形制剂。
使用时,数粒溶于包含3%硅酸铝镁的配方溶液,形成包含勿忘我花瓣的外用护肤精华。
实施例8
取预先干燥的谷粒。
使用2%甘露醇,3%普鲁兰,1%海藻糖,3%乳清蛋白形成乳液,加入干燥的谷粒,灌装到片装模具中,将谷粒和乳液一并进行冷冻干燥、脱去水分,形成包含谷粒的冻干赋形制剂。
使用时,数片溶于水后,形成包含谷粒的乳清蛋白饮料。
实施例9
取预先干燥的三七根须,使用纯化水泡至回软。
使用2%甘露醇,3%普鲁兰,1%海藻糖,5%铁皮石斛多糖形成溶液,加入回软后的三七根须,灌装到球装模具中,将三七根须和溶液一并进行冷冻干燥、脱去水分,形成包含三七根须的冻干赋形制剂。
使用时,直接口服包含三七根须的铁皮石斛含片。
实施例10
取越橘鲜果,进行冷冻干燥。
使用2%甘露醇,3%普鲁兰,1%海藻糖,60%越橘提取物,形成溶液,加入冻干后的越橘果,使用定量灌装泵,其滴注口的尺寸可以使植物组织通过,在内部温度处于溶液共晶点以下的舱体内进行滴注,使其滴液时迅速冻结;将已冻结的溶液进行冷冻干燥,得到含有越橘果的冻干赋形制剂。
使用时,1粒溶于水中,形成包含越橘果的越橘饮料。
本发明所涉及的成分组成、形态和制备方式并不限于实施例中所列举的形式,实施例仅为本发明的较佳实施例而已,不能以此限定保护范围。凡以本发明的权利要求范围所述的简单的或等效的变化及修饰,皆属于本发明的保护范围。
Claims (11)
1.一种含有植物组织的冻干赋形制剂,其特征在于,该冻干赋形制剂的配方包括粘结剂和植物组织;所述植物组织可以为新鲜的、或是预先干燥的,部位选自植物的整株,或者是花、茎、叶、叶状体、根、果实、种子中的一种或多种组合。
2.根据权利要求1所述的冻干赋形制剂,其特征在于,所述的冻干赋形制剂的粘结剂,为人工或天然高分子聚合物、无机物凝胶剂、纤维素醚类、改性淀粉类、透明质酸类、白蛋白、右旋糖酐、壳聚糖及其不同分子量产物、海藻酸钠、PVP、PVA、聚乙二醇、琼脂、聚氨基酸、聚糖或它们的组合。
3.根据权利要求1所述的冻干赋形制剂,其特征在于,所述的冻干赋形制剂还可以进一步添加活性物、骨架支持剂,肤感改良剂,抗氧化剂,矫味剂,香精,跨黏膜、透皮吸收促进剂和pH调节剂中的一种或几种。
4.根据权利要求3所述的冻干赋形制剂,其特征在于,所述活性物,独立的选自为化学药物、中药、天然提取物、生物活性成分、皮肤护理有益成分、消毒杀菌剂、口服食品补充剂和美容药物中的一种或几种。
5.根据权利要求1所述的冻干赋形制剂,其特征在于,所述预先干燥的植物组织,其处理方式可以为自然干燥法、加温干燥法、低温干燥法、减压干燥法、重压干燥法、干燥剂包埋法、液剂干燥法、真空冷冻干燥法中的一种或多种组合。
6.根据权利要求1所述的冻干赋形制剂,其制备方法为:
A、方法1
a)将水、植物组织、粘结剂和/或辅料形成的溶液、乳液或者悬浊液,定容、脱气;
b)使用定量灌装泵,将a)注入到定量成型模具中,进行脱气;
c)将b)冷冻干燥,除去溶剂,得到含有植物组织的冻干赋形制剂,并可以脱离模具,进行内包装。
B、方法2
a)将水、植物组织、粘结剂和/或辅料形成的溶液、乳液或者悬浊液,定容、脱气;
b)使用定量灌装泵,其滴注口的尺寸可以使植物组织通过,在内部温度处于溶液共晶点以下的舱体内进行滴注,使其滴液时迅速冻结;
c)将已冻结的溶液进行冷冻干燥,得到含有植物组织的冻干赋形制剂。
7.根据权利要求1和5所述的冻干赋形制剂,其特征在于,所述预先干燥的植物组织,可以在方法1和方法2的a)步骤之前进行柔化处理。
8.由权利要求1-7中任意一项配方和/或制备方法制备得到的产品。
9.根据权利要求1-8所述的冻干赋形制剂,其特征在于,其为任意形状。
10.根据权利要求9所述的产品,其特征在于,其为片剂形状、胶囊剂形状、软胶囊形状、球形、椭球形或者各种人物、动物、植物、食物、图形标识或卡通形象。
11.根据权利要求1-10所述的冻干赋型制剂产品,其特征在于,在使用时,可以将其溶于水或者是配方溶液中使用,进一步得到一种包含植物组织的配方溶液体系。
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