CN108836948A - 一种利用包衣技术实现营养素可控制释放的产品 - Google Patents
一种利用包衣技术实现营养素可控制释放的产品 Download PDFInfo
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Abstract
本公开提供了一种利用干粉包衣技术实现营养素可控制释放的产品，可控制释放营养素的包衣方法和用于可控制释放营养素包衣的包衣粉末组合物。所述包衣营养素产品包含(a)，含有一种或多种生物活性剂的固形物；和(b)，包裹(a)的一个或多个包衣层。固形物包含一种或多种生物活性剂，并且包含如下其他成分如：粘合剂、填充剂、抗静电剂、流动增强剂或其任意组合。生物活性剂固形物包含一种或多种碳水化合物、蛋白质、维生素、脂肪、氨基酸或其任意组合的营养素。
Description
技术领域
本专利公开了一种可控制释放的包衣营养素产品，可控制释放营养素的包衣方法和用于可控制释放营养素包衣的包衣粉末组合物。
背景技术
营养素是一种生物体用于生存，生长和繁殖的物质。一些营养素在释放能量的过程中最终转化为水和二氧化碳较小分子产物，例如碳水化合物，脂质，蛋白质和发酵产物(乙醇或醋)。动物必需的营养素是其能量的来源，一些氨基酸营养素结合在一起可生成蛋白质、脂肪酸、维生素和某些矿物质。
当人体通过饮食摄入各类营养素时，有20种标准营养素用于合成蛋白质和其他生物分子，或被氧化成尿素和二氧化碳作为能量来源。营养素的氧化过程开始于通过转氨酶除去氨基，然后将氨基供给到尿素循环中。转酰胺化的另一种产物是进入柠檬酸循环的酮酸。葡萄糖类的营养素还可通过糖异生作用转化为葡萄糖。在这20种标准营养素中，有9种氨基酸(组氨酸、异亮氨酸、亮氨酸、赖氨酸、蛋氨酸、苯丙氨酸、苏氨酸、色氨酸和缬氨酸)它们无法通过人体自身合成来满足人体所需，它们需要人体从食物摄取，因而这9种氨基酸被称为人体必需氨基酸。此外，用于代谢合成半胱氨酸、牛磺酸、酪氨酸和精氨酸(尽管牛磺酸从技术角度上说不是氨基酸)的途径在人体内尚未充分形成，因此这些氨基酸被认为是处于孩童状态的半必需氨基酸。
运动营养素在力量体育运动(如：举重和健身)和耐力体育运动(如：骑自行车、跑步、游泳、划船)中颇受欢迎。蛋白质和氨基酸补充剂是常见的可帮助运动员恢复体力的补充剂。但是，如果人体在短时间内消耗过多的蛋白质和氨基酸补充剂，会对人体造成包括：脱水、痛风、钙流失、肝肾损伤、腹泻、腹胀和脱水一系列负作用，其给人体带来负作用可能会比给人体所带来的益处大。
因此，当前有不需要摄取过量食物和零食向人体提供运动营养素(如：氨基酸、维生素、蛋白质和其他营养素)并满足营养素在人体内可延长和可控制释放的需求。
现有技术已经实现液态的可持续释放营养素产品生产。尤其是，已经有些技术尝试通过一些化学反应来使自由基引发剂的聚合物交联产生可持续释放的营养素水凝胶，但该方法对于生产含有不稳定液体的产品是非常复杂的。
因此，提供稳定的可控制释放的包衣固形物营养素产品，可控制释放营养素的包衣方法和用于可控制释放营养素包衣的包衣粉末组合物是非常有前景和优势的。
发明内容
本公开提供了一种利用包衣技术实现营养素可控制释放的产品，该产品包含：(a)，含有一种或多种生物活性剂的固形物；和(b)，包裹(a)的一个或多个包衣层，所述生物活性剂的释放由所述包衣层控制。
另外，本公开还提供了采用包衣实现可控制释放的营养素产品的加工方法，包括如下步骤：
a)制备由成膜聚合物构成的包衣干粉组合物，其中，所述成膜聚合物包括可涂覆在含生物活性剂的固形物颗粒的外表面的一种或多种粉末，所述一种或多种粉末的粒径范围均约1nm-500μm；
b)将含生物活性剂的固形物颗粒放入包衣机的可旋转锅体内部并进行预热；
c)将所述包衣干粉组合物涂覆到上述包衣锅体内部的所述固形物颗粒的外表面；
d)旋转上述可旋转包衣锅体，使所述包衣干粉组合物中的一种或多种粉末在固形物颗粒的外表面形成均匀包衣；
e)进一步对所述固形物颗粒进行颗粒固化；从而在每颗固形物颗粒的表面上形成基本均匀且包裹每颗固形物颗粒的固化膜。
此外，本公开还提供了可喷涂到固形物颗粒的外表面以实现固形物可控制释放的包衣干粉组合物，包含：
a)一种或多种粉末状的成膜聚合物，其在包衣干粉组合物中占1-100％w/w；
b)一种或多种粉末或液体状的增塑剂，其使用量以能够降低包衣干粉组合物的玻璃化转变温度至30-100℃内为准；
c)一种或多种粉末/液体抗静电剂，其在包衣干粉组合物中占0.1-90％w/w；
d)一种或多种粉末状的流动增强剂，其在包衣干粉组合物中占0.1-20％w/w。
所述增塑剂可包含甘油、丙二醇、PEG 200至PEG 8000、甘油三乙酸酯、邻苯二甲酸二乙酯(DEP)、邻苯二甲酸二丁酯(DBP)、柠檬酸三丁酯(TBC)、柠檬酸三乙酯(TEC)、油醇、蓖麻油、分馏椰子油、乙酰化甘油单酯、甘油单硬脂酸酯、增塑剂，还可以包括低分子量聚合物、低聚物、共聚物、油，有机小分子、具有脂族羟基的低分子多元醇、酯型增塑剂、乙二醇醚、聚丙二醇、多嵌段聚合物、单嵌段聚合物、低分子聚乙二醇和柠檬酸酯型增塑剂。
所述增塑剂也可包含乙二醇、1，2-丁二醇、2，3-丁二醇、苯乙二醇、二甘醇、三甘醇、四甘醇和其他聚(乙二醇)化合物、单丙二醇单异丙基醚、丙二醇单乙醚、乙二醇单乙醚、二甘醇单乙醚、乳酸山梨醇酯、乳酸乙酯、乳酸丁酯、乙醇酸乙酯、癸二酸二丁酯、乙酰基三丁基柠檬酸酯、乙酰基三乙基柠檬酸酯和烯丙基乙醇酸酯。
所述抗静电剂可包含普通盐、炭黑、硬脂酸镁、煅制硅酸盐、三硅酸镁、单硬脂酸甘油酯、高岭土、滑石和液体增塑剂。所述液体增塑剂可包含PEG200至PEG600、丙二醇、甘油、甘油三乙酸酯中的任何一种或其任意组合。常见的盐可以包括氯化钠、氯化钙、氢氧化镁、碳酸钠、碳酸氢钠、磷酸钠、柠檬酸钠、乙酸钠、乙酸钾、柠檬酸钾、氯化钾、硫酸镁中的任何一种或其任意组合。
所选择的增塑剂可将包衣组合物的玻璃化转变温度降低至约45-70℃。
所述流动增强剂可包含硬脂酸钙、胶体二氧化硅、氢化蓖麻油、微晶纤维素、富马酸、山嵛酸甘油酯、甘油单硬脂酸酯、甘油棕榈酸硬脂酸酯、亮氨酸、硬脂酸镁、中链甘油三酯、肉豆蔻酸的任一种或任意组合酸、棕榈酸、泊洛沙姆、聚乙二醇、苯甲酸钾、苯甲酸钠、月桂基硫酸钠、硬脂酰富马酸钠、淀粉、硬脂酸、滑石粉、氢化植物油和硬脂酸锌。
可选一种或多种成膜聚合物以达到防潮、速释、调味、味道改善和味道掩蔽中的任何一种或多种作用，成膜聚合物可包含甲基纤维素、羟乙基纤维素、羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)、聚乙二醇、聚丙二醇、泊洛沙姆、聚维酮、聚乙烯醇的组合物如欧巴代、基于聚乙烯醇的组合物如：AMB、甲基丙烯酸氨烷酯共聚物。
可选一种或多种成膜聚合物以达到延长释放作用，成膜聚合物可包含纤维素醚衍生物，丙烯酸树脂，丙烯酸和甲基丙烯酸酯与季铵基团的共聚物，丙烯酸和甲基丙烯酸的共聚物酯，乙基纤维素和不溶于消化液的聚(甲基)丙烯酸酯聚合物。
不溶于消化液的聚(甲基)丙烯酸酯聚合物可以包括RL聚合物或NE聚合物中的任何一种或任意组合。
可选一种或多种成膜聚合物以达到延长释放作用，成膜聚合物可包含聚环氧乙烷(PEO)、环氧乙烷-环氧丙烷共聚物、聚乙二醇-聚丙二醇(如：泊洛沙姆)、卡波姆、聚乙烯吡咯烷酮(PVP)、聚乙烯醇(PVA)，羟烷基纤维素如羟丙基纤维素(HPC)、羟丙基甲基纤维素、羧甲基纤维素钠、甲基纤维素、羟乙基甲基纤维素、羟丙基甲基纤维素，聚丙烯酸酯如卡波姆、聚丙烯酰胺、藻酸及其衍生物、淀粉和淀粉衍生物、可溶于消化液的明胶。
包衣干粉组合物中的成膜聚合物除了可以是本公开所述的各种成膜聚合物的具体示例之外，还可以是提供调味、味道改变/掩蔽或防潮作用的任何聚合物，包含但不限于甲基纤维素、羟乙基纤维素、羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)等所列的几个非限制性的例子。
包衣干粉组合物中的成膜聚合物还可包含实现持续或控制药物释放的水不溶性聚合物，包括但不限于乙酸纤维素、乙基纤维素和纤维素衍生物、硝酸纤维素、乙酸纤维素乙酸酯、氨基甲酸乙酯乙酸酯、纤维素乙酸邻苯二甲酸酯、纤维素乙酸甲基氨基甲酸酯、乙酸琥珀酸纤维素、乙酸纤维素二甲基氨基乙酸酯、乙酸纤维素乙基碳酸酯、乙酸纤维素氯乙酸酯、乙酸纤维素乙基草酸乙酯、RL、RS其中一种或任意组合。
包衣干粉组合物还可包含增塑剂、抗粘剂、成孔剂或其它添加剂一种或任意组合。
本公开的发明专利的功效和优势可以通过参考以下详细描述和附图加深理解。
附图说明
以下内容是作为本发明专利申请的附图，这些附图作为本专利申请的一部分详细描述了本专利的申请内容，本发明专利所述内容与这些附图描述相结合将有助于更全面地理解本文公开的实施例，其中：
图1示意了本公开的一个实施例中，含有用乙基纤维素粉末包衣层的支链氨基酸(BCAA)小颗粒的溶解曲线(包衣增重：20％；pH值：7.2)和未包衣的支链氨基酸(BCAA)小颗粒的溶解曲线；
图2示意了本公开的另一个实施例中，含有RS粉末包衣层(包衣增重：20％；pH值：7.2)和未包衣的支链氨基酸(BCAA)小颗粒的溶解曲线。
具体实施方式
下面将对本公开各种实施例细节进行详细描述。以下描述和附图1至2目的是对本公开专利进行说明，不应被理解为是限制本专利。许多具体细节性的描述是为了便于透彻理解本公开内容的各种实施例。然而，在某些情况下，为了实现对本公开实施例的简要讨论，没有对公知或传统概念的细节性内容进行描述。
本文所使用的术语“包括”和“包含”应被理解为包含性的和开放式的，而不具有排他性。具体而言，当在说明书和权利要求书中使用术语“包括”和“包含”及其同义词时，是表示包括指定的特征、步骤或组成部分。这些术语不能被理解为排除其他特征、步骤或组成部分的存在。
本文所使用的术语“示例性”意指“用作示例，实例或说明，并且不应被理解为本文所述内容比其他对应内容更优先或更具优势。
本文所使用的术语“大约”和“近似”意在涵盖诸如属性、参数和尺寸数值在其上限和下限范围内的变化。
术语“固形物”是指含有生命体(包括动物、植物、细菌、真菌和病毒等)生存所必须的生物活性剂如氨基酸、蛋白质、维生素以及任何其他成分的固体营养基质、粘合剂、填充剂、抗静电剂、流动增强剂或其任意组合。
术语“包衣干粉”是指用于在营养素固形物外表面上形成包衣涂层的粉末或其混合物，并且也可以选择其他成分或材料进行包衣，包括本公开所述的各种可选的成膜聚合物。
术语“成孔剂”是可用作药物包衣过程中成孔剂的粉末状聚合物、液体聚合物或具有小分子的聚合物溶液。成孔剂是水溶性材料，可以在包衣过程中与成膜材料粉末一起喷涂，并在固化之后成为包衣层的一部分。经过吞咽与胃肠道接触之后，这些成孔剂被溶解和浸出并在包衣层上留下许多小孔(微孔)，这些小孔使包衣层变得可渗透，从而允许液体流入并溶解内部固形物，最后达到释放活性营养素的目的。
术语“微孔”是指成孔剂包衣过程中在包衣层上形成的孔，其孔径范围为约1nm-100μm，优选10nm-10μm，更优选50nm-5μm。
术语“固化”是指通过施加如：电热器、红外线等热源或紫外线等能量源以提高待包衣固形物的温度，从而固化或部分固化喷洒于固形物表面的包衣粉末。该热源可以是流过包衣滚筒的热空气或者包衣机内部的加热元件。同时，能量源需要足够接近包衣滚筒以确保足够热量能够传递到滚筒内部。
术语“干粉包衣”是指用成膜粉末组合物喷涂固形物的方法，换句话说，它是指在基质表面形成包衣层的方法。
是赢创公司的商标，是卡乐康公司的商标。
本公开内容提供一种可控制释放的包衣营养素产品，可控制释放营养素产品的包衣方法和用于可控制释放营养素包衣的包衣干粉组合物。
在一个实例中，可控制释放的包衣营养素产品包含：(a)，一种或多种生物活性剂固形物；和(b)，包封(a)固形物的一个或多个包衣层。
固形物包含一种或多种生物活性剂，并且包含如下其他成分如：粘合剂、填充剂、抗静电剂、流动增强剂或其任意组合。
生物活性剂固形物包含一种或多种碳水化合物、蛋白质、维生素、脂肪、氨基酸或其任意组合的营养素。
氨基酸包括支链氨基酸、L-亮氨酸、L-异亮氨酸、L-缬氨酸、L-谷氨酰胺、其他任何氨基酸或其任意组合。
生物活性剂为包衣或未包衣的颗粒、粉末、丸剂、颗粒剂(即较小单元活性剂聚集体)、片剂、胶囊或其任意组合。
包衣层(i)包含一种或多种成膜聚合物；(ii)包含一种或多种成孔剂；(iii)包含一种或多种增塑剂。
生物活性剂的释放由包衣层控制，释放时间为0.5-8小时，优选释放时间为1-6小时，更优选释放时间为2-4小时。
所述包衣层可由任意一种包衣工艺制备而成，比如流化床喷涂技术(顶喷、侧喷和底喷)、滚筒式包衣锅喷涂包衣技术、热熔包衣技术、光固化包衣技术、超临界流体包衣技术及干粉包衣技术等。
在另一个实例中，提供了生产所述营养素的过程，如下所示：
A)首先是进行包衣粉末的制备，在具体实施方案中，可以使用合适的研磨机如气流研磨机、球磨机、针磨机、锤磨机或其组合来将包衣原材料研磨成粒径在预设范围内的颗粒粉末。包衣粉末的粒径可在约1nm-200μm的范围内，优选约10nm-100μm的范围，并且最佳控制在约20nm-40μm的粒径范围。在包衣材料粒径减小后，将这些不同的包衣材料粉末混合在一起形成包衣干粉组合物。
B)通过对旋转包衣锅体进行预加热而达到对固形物颗粒预热的目的。加载到包衣锅体内的固形物颗粒需加热至接近包衣干粉组合物中所含成膜聚合物的玻璃化转变温度(Tg)，该温度通常在约30℃-100℃的范围内，优选约30℃-80℃，更优选约40℃-60℃。其中，30℃-100℃是目前大多数包衣成膜聚合物的玻璃化转变温度(如EPO的玻璃化转变温度为30℃左右，RS和RL的玻璃化转变温度约为55℃，L系列丙烯酸聚合物的玻璃化转变温度约为100℃)；30℃-80℃是常用包衣成膜聚合物的玻璃化转变温度，40℃-60℃则是最常用包衣成膜聚合物的玻璃化转变温度，也是营养素干粉包衣理想的加热温度。
C)在包衣干粉组合物附着在固形物颗粒表面过程中，可能需要借助适量的干粉增塑剂、液体增塑剂或增塑剂溶液，所述增塑剂、增塑剂溶液的重量比约为成膜包衣粉末重量的0％-200％，优选约5％-100％范围，更优选约10％-80％范围，并且特别优选约20％-60％的范围。使用空气雾化或无气喷嘴/静电喷枪(如：电晕放电喷枪或摩擦静电喷枪)将增塑剂(若存在)和成膜涂料粉末喷涂到固形物颗粒表面上。如果使用电晕放电喷枪，电压可以控制在约20kV-120kV的范围内，优选约25kV一70kV的范围，更优选约40kV-70kV的范围，特别优选在约50kV-70kV的范围内。增塑剂和包衣干粉组合物可以同时或者交替喷洒，其中首先喷洒增塑剂或其他高分子聚合物材料，然后喷涂另一种，并可以不断重复该过程。
或者可以将增塑剂与包衣干粉组合物材料进行混合，然后将该混合物喷洒到固形物表面。如上所述的所有方法中，在喷涂增塑剂和包衣干粉组合物材料时，最好对包衣锅体进行持续加热。
D)在包衣干粉组合物附着在固形物颗粒表面后，需要对包衣干粉组合物进行固化操作以使这些附着在固形物颗粒表面的包衣干粉组合物聚结并形成包衣。固化过程在旋转包衣锅体内进行，固化温度需要控制在约30℃-100℃，优选30℃-80℃，更优选约40℃-60℃范围。固化时间范围约为0-10小时，优选约0-4小时，更优选约1-2小时。
固形物至少含有一种营养素(生物活性剂)。典型的生物活性剂包括但不限于碳水化合物、蛋白质、维生素、脂肪、氨基酸或其任意组合。所述氨基酸包含如：支链氨基酸、L-亮氨酸、L-异亮氨酸、L-缬氨酸、L-谷氨酰胺、任何其他氨基酸或任何氨基酸的组合。
固形物可以是任何粉末，丸剂或颗粒剂(即较小单元的活性剂聚集体)、小片剂或其任意组合的状态形式。
固形物还可以包括一种或多种功能性赋形剂，例如压缩剂、润滑剂、热润滑剂、抗氧化剂、粘合剂、稀释剂、渗透剂、甜味剂、螯合剂、着色剂、调味剂、表面活性剂、增溶剂、润湿剂、稳定剂、亲水聚合物、疏水性聚合物、蜡、亲脂性物质、吸收促进剂、蛋白酶抑制剂、防腐剂、吸收剂、交联剂、生物粘附聚合物、阻燃剂和香料。
成膜聚合物可以选择充当调味剂、味道改变/掩蔽或阻隔湿气的聚合物，包括但不限于甲基纤维素、羟乙基纤维素、羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)等一些非限制性的实例。
成膜聚合物可以包括但不限于甲基纤维素、羟乙基纤维素、羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)、聚(乙烯吡咯烷酮)(PVP)水溶性聚合物、包含但不限于聚乙二醇如PVP、PEG 400、PEG 600、PEG 3350、聚丙二醇、泊洛沙姆、聚维酮或其任意组合。
成膜聚合物可以包括水不溶性聚合物，该水不溶性聚合物包括但不限于醋酸纤维素、乙基纤维素和纤维素衍生物，纤维素衍生物包括但不限于硝酸纤维素、醋酸纤维素乙酸氨基甲酸酯、醋酸纤维素邻苯二甲酸酯、醋酸纤维素乙酸甲酯、琥珀酸乙酸纤维素、乙酸纤维素二甲基氨基乙酸酯、醋酸纤维素乙酯、醋酸氯乙酸纤维素、醋酸纤维素乙酯草酸盐、RL、RS或其任意组合。
成膜聚合物可以包括pH值低于5.5时不溶于水性介质的pH值依赖性聚合物，其中包括但不限于醋酸邻苯二甲酸纤维素、醋酸纤维素三马来酸酯、羟丙基甲基纤维素邻苯二甲酸酯、聚乙酸乙烯邻苯二甲酸酯、丙烯酸聚合物、聚乙烯醇缩乙二胺基乙酸酯、醋酸羟丙基甲基纤维素琥珀酸酯、醋酸偏苯三酸纤维素、虫胶、甲基丙烯酸共聚物、L30D、L100、FS30D、S I00、羟丙基甲基纤维素醋酸琥珀酸酯或其任意组合。
包衣干粉组合物还可以包括成孔剂、增塑剂、抗粘剂、颜料和其它添加剂如：涂料粉末助流剂或其任意组合。
所述成孔剂包括水溶性聚合物如甲基纤维素、羟乙基纤维素、羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)、聚(乙烯吡咯烷酮)(PVP)、聚乙二醇如：包含但不限于PVP、PEG400、PEG 600、PEG 3350、聚丙二醇、泊洛沙姆和聚维酮；粘合剂，如：乳糖、硫酸钙、磷酸钙等；盐，如：氯化钠、氯化镁等所列出的实例，以及它们的任意组合和本领域中被广为认知的其他类似或等同的材料。
增塑剂用来降低包衣聚合物的玻璃化转变温度。增塑剂可以是固体增塑剂、液体增塑剂或增塑剂的溶液。当增塑剂为液体聚合物或聚合物溶液时，它也可用于降低待包衣颗粒表面电阻率，从而达到提高包衣粉末的附着性并提高包衣效率。此外，通过使用液体聚合物增塑剂或聚合物增塑剂溶液，可在包衣粉末与固形物表面之间形成强大的毛细作用力，进而增强包衣粉末的附着力。适用于本发明的增塑剂包括但不限于甘油、丙二醇、PEG200-PEG 600、甘油三乙酸酯、邻苯二甲酸二乙酯(DEP)、邻苯二甲酸二丁酯(DBP)、柠檬酸三丁酯(TBC)、柠檬酸三乙酯(TEC)等。
在如下另一个实施例中，其展示了依据本发明对支链氨基酸(BCAA)进行干粉包衣的过程。表1表述了该包衣氨基酸制剂的组成。图1展示了含有包衣层的BCAA小颗粒的溶出曲线。
表1含有乙基纤维素包衣层的可控制释放支链氨基酸(BCAA)组成成分
加工含有粉末包衣层的BCAA小颗粒的方法如下：先将BCAA与羟丙基甲基纤维素混合均匀；然后将混合物在湿法造粒机中进行造粒；接下来，将颗粒在流化床中干燥；干燥过后，使用合适的研磨设备(例如空气磨机)将大颗粒研磨至粒径小于约20μm的颗粒。
将研磨后的BCAA小颗粒放置于可旋转的无孔包衣锅中并预热至约50℃。
将增塑剂以约0.5克/分钟的速度喷洒到滚动的BCAA小颗粒表面上。然后，使用电晕喷枪以1-1.5克/分钟的速度将包衣粉末喷涂在BCAA小颗粒表面。重复循环喷涂增塑剂和包衣粉末，直到达到目标包衣层厚度。
含有包衣的BCAA小颗粒需在设定温度为50℃条件下固化60-90分钟。
USP溶出度实验是在模拟人体饮用水溶液来吞咽口服制剂时的肠内环境条件下进行的，所述肠内环境的pH值范围控制在7.2±0.05(最佳pH值为7.2)。
如图1所示，与未包衣的BCAA小颗粒相比，含有包衣层的BCAA小颗粒在相对恒定的释放速率下具有更长的释放时间曲线。
在如下另一个实施例中，通过使用本发明公开的粉末包衣方法和表2中提供的包衣粉末组合物，实现了对BCAA小颗粒进行包衣并达到BCAA小颗粒可控制释放的目的。
表2本实施例中使用的包衣粉末组成成分
如图2所示的曲线，使用本实施例所述的包衣粉末对BCAA颗粒包衣，可以实现BCAA以接近于零级的速率释放长达120分钟。
以上所述本发明的优选实施例仅用于说明本发明的技术原理而非将本发明限制于所述实施例。其目的在于通过以下权利要求及其包含的所有类似实施例来限定本发明的范围。
Claims (34)
1.一种利用包衣技术实现营养素可控制释放的产品，该产品包含：(a)，含有一种或多种生物活性剂的固形物；和(b)，包裹(a)的一个或多个包衣层，所述生物活性剂的释放由所述包衣层控制。
2.根据权利要求1所述的产品，其中，优选的，所述的固形物含有一种或多种生物活性剂，并且包含如下成分：粘合剂、填充剂、抗静电剂、流动增强剂或其任意组合。
3.根据权利要求1所述的产品，其中，所述一种或多种生物活性剂是一种或多种营养素，其包括碳水化合物、蛋白质、维生素、脂肪、氨基酸或其任意组合。
4.根据权利要求3所述的产品，其中，所述氨基酸包括支链氨基酸、L-亮氨酸、L-异亮氨酸、L-缬氨酸、L-谷氨酰胺在内的任何其他氨基酸或其任意组合。
5.根据权利要求1所述的产品，其中，所述一种或多种生物活性剂的固形物为包衣或未包衣的颗粒、或粉末、或丸剂、或颗粒剂(即较小单元活性剂聚集体)、或片剂、或胶囊或其任意组合。
6.根据权利要求1所述的产品，其中，所述一个或多个包衣层包含：(i)一种或多种成膜聚合物；(ii)一种或多种成孔剂；(iii)一种或多种增塑剂。
7.根据权利要求1所述的产品，其中，所述生物活性剂的释放时间为0.5-8小时，优选1-6小时，更进一步优选2-4小时。
8.根据权利要求1所述的产品，其中，所述一个包衣层或多个包衣层中的任一层通过如下任意一种适合的工艺加工而成：流化床喷涂技术、滚筒式包衣锅喷涂包衣技术、热熔包衣技术、光固化包衣技术、超临界流体包衣技术及干粉包衣技术。
9.一种采用包衣实现可控制释放的营养素产品的加工方法，包括如下步骤：
a)制备由成膜聚合物构成的包衣干粉组合物，其中，所述成膜聚合物包括可涂覆在含生物活性剂的固形物颗粒的外表面的一种或多种粉末，所述一种或多种粉末的粒径范围均约1nm-500μm；
b)将含生物活性剂的固形物颗粒放入包衣机的可旋转锅体内部并进行预热；
c)将所述包衣干粉组合物涂覆到上述包衣锅体内部的所述固形物颗粒的外表面；
d)旋转上述可旋转包衣锅体，使所述包衣干粉组合物中的一种或多种粉末在固形物颗粒的外表面形成均匀包衣；
e)进一步对所述固形物颗粒进行颗粒固化；从而在每颗固形物颗粒的表面上形成基本均匀且包裹每颗固形物颗粒的固化膜。
10.根据权利要求9所述的方法，其中，步骤b)中，将所述固形物颗粒预热至接近所述成膜聚合物的玻璃化转变温度(Tg)，其中所述成膜聚合物的玻璃化转变温度在约20-200℃范围内，优选玻璃化转变温度在约30-100℃范围内，更优选在约40-60℃范围内。
11.根据权利要求9所述的方法，其中，还包括将适量的增塑剂喷入包衣锅体内，所述适量的增塑剂用来降低所述包衣干粉组合物中成膜聚合物的玻璃化转变温度(Tg)至约30-100℃范围。
12.根据权利要求11所述的方法，其中，在喷洒所述包衣干粉组合物之前，需要将所述增塑剂喷洒到包衣锅体中。
13.根据权利要求11所述的方法，其中，所述包衣干粉组合物与所述增塑剂同时喷洒到包衣锅体中。
14.根据权利要求11所述的方法，其中，所述包衣干粉组合物与所述增塑剂预混合之后喷洒到包衣锅中。
15.根据权利要求11所述的方法，其中，所述增塑剂为液体纯增塑剂、增塑剂溶液和干粉增塑剂中的任何一种或其任意组合。
16.根据权利要求9所述的方法，其中，所述涂覆有包衣干粉组合物的固形物颗粒在包衣锅体内固化期间，固化温度控制在30-100℃范围内，固化时间最长持续至约4小时。
17.根据权利要求16所述的方法，其中，所述固化温度控制在约40-60℃范围内。
18.一种可喷涂到固形物颗粒的外表面以实现固形物可控制释放的包衣干粉组合物，包含：
a)一种或多种粉末状的成膜聚合物，其在包衣干粉组合物中占1-100％w/w；
b)一种或多种粉末或液体状的增塑剂，其使用量以能够降低包衣干粉组合物的玻璃化转变温度至30-100℃内为准；
c)一种或多种粉末/液体抗静电剂，其在包衣干粉组合物中占0.1-90％w/w；
d)一种或多种粉末状的流动增强剂，其在包衣干粉组合物中占0.1-20％w/w。
19.根据权利要求18所述的组合物，其中，所述一种或多种成膜聚合物以10-80％w/w范围内的占比存在于所述组合物中。
20.根据权利要求18所述的组合物，其中，所述一种或多种流动增强剂以0.25-20％w/w范围内的占比存在于所述组合物中。
21.根据权利要求18所述的组合物，其中，所述一种或多种流动增强剂以0.5-3.0％w/w范围内的占比存在于所述组合物中。
22.根据权利要求18至21中任意一项中所述的组合物，其中，所述一种或多种抗静电剂以1-50％w/w的范围内的占比存在于所述组合物中。
23.根据权利要求18至21中任意一项中所述的组合物，其中，所述一种或多种增塑剂包括如下任一或其任意组合：甘油、丙二醇、PEG 200至PEG 8000、三乙酸甘油酯、邻苯二甲酸二乙酯(DEP)、邻苯二甲酸二丁酯(DBP)、三丁基柠檬酸盐(TBC)、柠檬酸三乙酯(TEC)、蓖麻油、分馏椰子油、乙酰化单甘油酯、甘油单硬脂酸酯、低聚物、共聚物、油、有机小分子，具有脂族羟基的低分子多元醇、酯型增塑剂、聚丙二醇、多嵌段聚合物、单嵌段聚合物、低分子聚乙二醇和柠檬酸酯型增塑剂。
24.根据权利要求18至21中任意一项中所述的组合物，其中，所述一种或多种增塑剂包括如下任一或其任意组合：乙二醇、1，2-丁二醇、2，3-丁二醇、苯乙烯乙二醇、二甘醇、三甘醇、二甘醇、三甘醇、四甘醇、其他聚乙二醇化合物、单丙二醇单异丙基醚、丙二醇单乙基醚、乙二醇单乙基醚、二甘醇单乙基醚、乳酸山梨醇酯、乳酸乙酯、乳酸丁酯、乙醇酸乙酯、癸二酸二丁酯、乙酰基三丁基柠檬酸酯、乙酰基三乙基、柠檬酸盐和烯丙基甘醇酸酯。
25.根据权利要求18至24中任一项所述的组合物，其中，所述一种或多种抗静电剂包括如下任一或其任意组合：普通盐、炭黑、硬脂酸镁、煅制硅酸盐、三硅酸镁、甘油单硬脂酸酯、高岭土、滑石和液体增塑剂。
26.根据权利要求25所述的组合物，其中，所述液体增塑剂包括PEG200至PEG 600、丙二醇、甘油、甘油三乙酸酯中的任何一种或其任意组合。
27.根据权利要求25所述的组合物，其中，所述的普通盐包括如下任一或其任意组合：氯化钠、氯化钙、氢氧化镁、碳酸钠、碳酸氢钠、磷酸钠、柠檬酸钠、乙酸钠、乙酸钾、柠檬酸钾、氯化钾和硫酸镁。
28.根据权利要求18所述的组合物，其中，所述增塑剂的选择应当能将所述包衣干粉组合物的玻璃化转变温度降低至40-70℃。
29.根据权利要求18至28中任一条所述的组合物，其中，所述一种或多种流动增强剂包括如下任一或其任意组合：硬脂酸钙、胶态二氧化硅、氢化蓖麻油、微晶纤维素、富马酸、山嵛酸甘油酯、甘油单硬脂酸酯、棕榈硬脂酸甘油酯、亮氨酸、硬脂酸镁、中链甘油三酯、肉豆蔻酸、棕榈酸、泊洛沙姆、聚乙二醇、苯甲酸钾、苯甲酸钠、月桂基硫酸钠、硬脂富马酸钠、淀粉、硬脂酸、滑石、氢化植物油和硬脂酸锌。
30.根据权利要求18至29中任一条所述的组合物，其中，所述一种或多种成膜聚合物是用来达到防潮、速释、调味、味道改善和掩味其中一种或其中多种目的，其中，所述成膜聚合物包括甲基纤维素、羟乙基纤维素、羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)、聚乙二醇、聚丙二醇、泊洛沙姆和聚维酮中的任何一种或其多种组合、聚乙烯醇基组合物。
31.根据权利要求18至30中任一项所述的组合物，其中，所述一种或多种起到延长释放作用的成膜聚合物包括如下任一或其任意组合：纤维素醚衍生物、丙烯酸树脂、丙烯酸和甲基丙烯酸的共聚物、具有季铵基团的酯、丙烯酸和甲基丙烯酸酯的共聚物、乙基纤维素和不溶于消化液的聚(甲基)丙烯酸酯聚合物。
32.根据权利要求31的组合物，其中，不溶于消化液中的聚(甲基)丙烯酸酯聚合物包括RS聚合物、RL聚合物、NE聚合物中的任何一种或其任意组合。
33.根据权利要求18至29中任一项所述的组合物，其中，所述一种或多种起到延长释放作用的成膜聚合物包括如下任一或其任意组合：聚环氧乙烷(PEO)、环氧乙烷-环氧丙烷共聚物、聚乙烯吡咯烷酮(PVP)、聚乙烯醇(PVA)、羟烷基纤维素如羟丙基纤维素(HPC)、羟丙基甲基纤维素、羧甲基纤维素钠、甲基纤维素、羟乙基甲基纤维素、羟丙基甲基纤维素、聚丙烯酸酯类如：卡波姆、聚丙烯酰胺、海藻酸及其衍生物、淀粉和淀粉衍生物、可溶于消化液的明胶。
34.根据权利要求18至33中任一项所述的组合物，其中，可多次涂覆不同种类的所述包衣粉末组合物，从而达到固体制剂多种预设定的功效。
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| CN110141531B (zh) * | 2019-06-06 | 2022-04-19 | 周大凯 | 一种包裹活性组分的组合物及其应用 |
| CN113117008A (zh) * | 2021-04-30 | 2021-07-16 | 贵州汉方药业有限公司 | 一种知柏地黄丸的制备方法 |
| CN113117008B (zh) * | 2021-04-30 | 2022-10-21 | 贵州汉方药业有限公司 | 一种知柏地黄丸的制备方法 |
| CN114315467A (zh) * | 2022-01-17 | 2022-04-12 | 上海诺同农业科技有限公司 | 水稻专用多级控释复合微生物肥料及其制备方法 |
| CN115532224A (zh) * | 2022-09-20 | 2022-12-30 | 中国科学院上海高等研究院 | 用于血液灌流的植物胶包膜活性炭、制备方法及其应用 |
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| Publication number | Publication date |
|---|---|
| JP2019216706A (ja) | 2019-12-26 |
| CN108836948B (zh) | 2024-04-12 |
| US20190389785A1 (en) | 2019-12-26 |
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