CN106551804B - 一种使用滚模制备冻干赋形制剂的方法及其产品 - Google Patents

一种使用滚模制备冻干赋形制剂的方法及其产品 Download PDF

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CN106551804B
CN106551804B CN201510641264.XA CN201510641264A CN106551804B CN 106551804 B CN106551804 B CN 106551804B CN 201510641264 A CN201510641264 A CN 201510641264A CN 106551804 B CN106551804 B CN 106551804B
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董玲
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Changzhou Pomelo Shield Industrial Investment Co Ltd
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Abstract

本发明涉及一种使用滚模制备得到任意形状的冻干赋形制剂的方法及依该方法制得的产品，特别是涉及一种使用滚模制备得到任意形状的主要含有活性成分和粘结剂的冻干赋形制剂的制备方法及依该方法制得的产品。本发明解决了冻干赋形制剂形态单一的问题，可以根据需要设计模具，将冻干赋形制剂制备成需要的各种形状，让冻干赋形制剂呈现出更加多样的形态、结构(双层片、多层片)并实现连续生产，提高生产效率，将成本有效降低。

Description

一种使用滚模制备冻干赋形制剂的方法及其产品
技术领域
本发明涉及一种使用滚模制备得到任意形状的冻干赋形制剂的方法及依该方法制得的产品，特别是涉及一种使用滚模制备得到任意形状的主要含有活性成分和粘结剂的冻干赋形制剂的制备方法及依该方法制得的产品。
背景技术
冻干赋型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，通过冻干赋型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，可以保护热敏感成分不被破坏，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、特殊化妆品等多个领域。
现在市场上的冻干赋形制剂大多形态单一，所使用的成型模具是传统意义上的模具，即普通的凹槽型模具，这种传统的冻干赋形制剂及其制备方法存在以下缺点：
(1)制剂形状单一，原因在于模具形状都是固定的，且只能不脱模或从单方向脱模，其中不脱模是指直接在一定形状的包装材料中进行成型。
(2)罕见球形、椭球形、不规则球体型等特殊形状，因为传统的制备方法，难以制得特殊形状的冻干赋形制剂。
(3)制得的片剂具有锐角边，脱模后得到的具有锐角边的众多片剂一同进入同一个包装后锐角边之间容易发生磨损，造成药物剂量的不准确。
(4)因为单方向灌装，难以成为多层结构，因此，制剂结构单一。
发明人锐意创新，进行了大量深入的研究和试验工作，提供了一种可以制备得到任意形状的冻干赋形制剂的方法及其依该方法制得的产品，特别是涉及一种使用滚动式模具制备得到任意形状的主要含有活性成分和粘结剂的冻干赋形制剂的制备方法及依该方法制得的产品。本发明解决了冻干赋形制剂形态单一的问题，可以根据需要设计模具，将冻干赋形制剂制备成需要的各种形状，让冻干赋形制剂呈现出更加多样的形态、结构(双层片、多层片)并实现连续生产，提高生产效率，将成本有效降低。
发明内容
本发明所提供的一种使用滚模制备任意形状的冻干赋形制剂的方法，包括如下步骤：
A、使用一种相对旋转式的滚模组合，包括滚模(1)、滚模(2)、灌装头(3)、料盘(4)；其中滚模(1)和滚模(2)的表面具有一定形状的凹模(11)和凹模(12)，在滚动时，两个滚模(1)、(2)相对旋转，其表面的凹模(11)、(12)可以在相对时高度密合形成1个完整形态，其缝隙不超过5mm；
B、将滚模(1)和滚模(2)进行预冷，其预冷温度不高于0℃；
C、将含有水和粘结剂的溶液配制成溶液、乳浊液或悬浊液，制备成冻干赋形制剂原液(5)；
D、将滚模(1)和(2)进行旋转，其表面的凹模(11)和凹模(12)的下边接合时，将冻干赋形制剂原液(5)灌装至凹模(11)和凹模(12)中，其灌装量为凹模(11)和(12)容积的总和或接近其容积的总和；
E、已预冷的滚模(1)和(2)使其中的冻干赋形制剂原液(5)发生冻结固化；
F、继续旋转滚模(1)和(2)，当凹模(11)和(12)旋转开口后，已冻结固化的冻干赋形制剂原液(51)脱离凹模，掉落在料盘(4)中；
G、将料盘(4)中的冻结固化后的冻干赋形制剂原液(51)进行冷冻干燥，除去溶剂，即得到冻干赋形制剂产品。
所述步骤E中，如冻干赋形制剂原液(5)未能完全冻结固化，滚模(1)和(2)可以进一步设有中空管道(6)，并从其中通过或储存制冷剂(7)，使其进一步冷却，直至令原液完全冻结。
制备方法中所述的模具的材料应具有一定硬度且导热性能较好。材料的硬度用压入硬度表示，其压入硬度值在0.1N以上，100000N以下，优选90000N、80000N、70000N、60000N、50000N、40000N、30000N或20000N以下。材料的导热系数需在0.01W/(m.k)以上，其中优选导热系数在0.05W/(m.k)-1000W/(m.k)的材料，最优选导热系数在0.2W/(m.k)-500W/(m.k)的材料。该材料可以是金属、高分子材料、陶瓷、玻璃等其中的一种或由其中的一种以上共同构成。
同时，模具的表面还可以进一步进行表面处理。所述模具表面处理，可以为涂层、电镀、酸碱洗、抛光、拉丝、电泳、PVD及其他表面处理方法，使冻干赋形制剂原液在冷冻后很好的脱离模具。
制得的所述的冻干赋形制剂主要由活性成分和粘结剂组成，其中粘结剂与活性成分的重量配比为粘结剂∶活性成分＝1∶100至100∶1。
粘结剂与活性成分的重量配比可以进一步地优选1∶90至90∶1，1∶80至80∶1，1∶70至70∶1，1∶60至60∶1，1∶50至50∶1，1∶40至40∶1，1∶30至30∶1，更优选1∶20至20∶1，1∶10至10∶1，1∶9至9∶1，1∶8至8∶1，1∶7至7∶1，最优选1∶6至6∶1，1∶5至5∶1。
制备方法中所使用的所述活性成分可以是溶于水也可以是不溶于水的物质，所述的活性成分可以选自化学药物成分、中药成分、天然提取物、生物活性成分、皮肤护理有益成分中的一种或一种以上的组合。
所述活性成分没有特别的限定，可以选自但不限于下列一种或几种成分的组合物。
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。
所述粘结剂是可食用或者可药用的一种水溶性高分子材料，可以是多糖、多肽、蛋白质、也可能是人工聚合高分子，或者是经过改型的天然高分子材料或其混合物。所述的粘结剂包括但不限于，明胶类(明胶、鱼明胶、鸟明胶、水解明胶等)、纤维素醚类(甲基纤维素、羧甲基纤维素、羟丙基甲基纤维素、羧乙基甲基纤维素等)、改性淀粉(普鲁兰糖、羟甲基淀粉等)、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，阿拉伯胶、瓜尔豆胶、黄原胶、魔芋胶、卡拉胶、卡波姆、琼脂、角叉菜胶、果胶或它们的组合等。其特征在于所述的胶类粘结剂为胶原、明胶、水解明胶、阿拉伯胶、黄原胶、卡拉胶、果胶、魔芋胶、角叉菜胶、刺槐豆胶、树胶、槐豆胶；所述的纤维素醚类粘结剂为羧甲基纤维素，羧乙基纤维素、羟乙基甲基纤维素、羟丙基甲基纤维素等；所述的改性淀粉类粘结剂选自普鲁兰糖、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；所述的聚氨基酸选自聚谷氨酸、聚丙氨酸、聚赖氨酸等；所属聚糖选自岩藻多糖、菊糖等。
所述的冻干赋形制剂还可进一步包含其它辅料，例如骨架支持剂、抗氧化剂、矫味剂及香精、跨黏膜或透皮吸收促进剂、PH调节剂等，这些其它辅料的含量范围可以是占制备得到的冻干赋形制剂的总含量的0.1-5％，优选0.1-3％。
所述骨架支持剂包含并不限于糖(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)等物质。
所述抗氧化剂包括但不限于维生素C及其衍生物、花青素、白藜芦醇、植物来源的多元酚类化合物中的一种或数种的混合物；
所述矫味剂和香精包括但不限于薄荷味、巧克力味、果味、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；
所述跨黏膜或透皮吸收促进剂包括但不限于卵磷脂、皂苷、月桂醇酸钠、氮酮、吐温、司盘中的任一种或数种的混合物；
所述pH调节剂包括但不限于柠檬酸、酒石酸、碳酸氢钠、碳酸盐、碳酸钠、磷酸盐中的任何一种或数种的混合物。
使用本发明的方法制备得到的产品，根据模具所围成的空腔的不同，其形状可以为任意形状。优选的，其形状为片剂形状、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。使用本发明的方法制备得到的产品，根据模具的形状，可以没有锐角边。
使用本发明的方法制备冻干赋形制剂，其优势在于：(1)可以在模具任意部位上刻上文字或者图案，相应地，在制得的产品的任意部位上也会出现文字或者图案，其可以是产品名称或者商标，这是现有冻干赋形制剂产品所不能具备的。(2)制得的产品可以设计出在包装内不易破碎的任意形状，减少药品损失和使药品服用剂量准确。(3)本发明的方法制备冻干赋形制剂采用脱模冻干的形式，模具不再进入冻干工序，提高了生产效率，降低了生产成本，节能环保。(4)本发明的方法使用的模具可连续生产，大幅度提高了生产效率，模具寿命长，进一步降低生产成本，节能环保。
附图说明
图1为滚模生产装置各组件剖面图。
图2-4为使用滚模法制备冻干赋形制剂的生产流程图。
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：
A、使用相对旋转式的滚模组合，包括滚模(1)、滚模(2)、灌装头(3)、料盘(4)；其中滚模(1)和滚模(2)的表面具有一定形状的凹模(11)和凹模(12)，其形状为半球形，当凹模(11)和凹模(12)对接时可形成完整球形，缝隙1mm；
B、将滚模(1)和滚模(2)使用其中的中空管道(6)注入液氮(7)进行预冷，预冷后滚膜温度为-20℃；
C、越橘提取物∶普鲁兰＝5∶1，加水配制成溶液，离心脱气，制得冻干赋形制剂原液；
D、将滚模(1)和(2)进行旋转，其表面的凹模(11)和凹模(12)的下边接合时，将冻干赋形制剂原液(5)灌装至凹模(11)和凹模(12)中，其灌装量为凹模(11)和(12)容积的总和或接近其容积的总和；
E、已预冷的滚模(1)和(2)使其中的冻干赋形制剂原液(5)发生冻结固化；
F、继续旋转滚模(1)和(2)，当凹模(11)和(12)旋转开口后，已冻结固化的球形冻干赋形制剂原液(51)脱离凹模，掉落在料盘(4)中；
G、将料盘(4)中的冻结固化后的冻干赋形制剂原液(51)进行冷冻干燥，除去溶剂，得到越橘速溶固体饮料产品。
实施例2：
A、使用相对旋转式的滚模组合，包括滚模(1)、滚模(2)、灌装头(3)、料盘(4)；其中滚模(1)和滚模(2)的表面具有一定形状的凹模(11)和凹模(12)，其形状各为胶囊型，当凹模(11)和凹模(12)对接时可形成完整胶囊形，缝隙0.5mm；
B、将滚模(1)和滚模(2)进行预冷，预冷温度为0℃；
C、将GTCC∶维生素D∶卵磷脂＝5∶1∶1充分搅拌、真空脱气后配制成组分一；将水解明胶∶普鲁兰＝1∶1加水充分搅拌、离心脱气后配制成组分二；
D、将滚模(1)和(2)进行旋转，其表面的凹模(11)和凹模(12)的下边接合时，将组分一、组分二依次灌装至凹模(11)和凹模(12)中，其灌装量为凹模(11)和(12)容积的总和或接近其容积的总和；
E、已预冷的滚模(1)和(2)使其中的冻干赋形制剂原液(5)发生冻结固化；
F、继续旋转滚模(1)和(2)，当凹模(11)和(12)旋转开口后，已冻结固化的胶囊形冻干赋形制剂原液(51)脱离凹模，掉落在料盘(4)中；
G、将料盘(4)中的冻结固化后的冻干赋形制剂原液(51)进行冷冻干燥，除去溶剂，得到口服营养补充剂产品。
实施例3：
A、使用相对旋转式的滚模组合，包括滚模(1)、滚模(2)、灌装头(3)、料盘(4)；其中滚模(1)和滚模(2)的表面具有一定形状的凹模(11)和凹模(12)，其整体形状为芒果形，凹模(11)和凹模(12)各自的形状并不对称，对接时可形成完整芒果形，缝隙0.3mm；
B、将滚模(1)和滚模(2)进行预冷，预冷温度为-10℃；
C、浓缩芒果汁∶海藻糖＝3∶1，加水配制成溶液，离心脱气，制得冻干赋形制剂原液；
D、将滚模(1)和(2)进行旋转，其表面的凹模(11)和凹模(12)的下边接合时，将冻干赋形制剂原液(5)灌装至凹模(11)和凹模(12)中，其灌装量为凹模(11)和(12)容积的总和或接近其容积的总和；
E、已预冷的滚模(1)和(2)使其中的冻干赋形制剂原液(5)发生冻结固化；
F、继续旋转滚模(1)和(2)，当凹模(11)和(12)旋转开口后，已冻结固化的芒果形冻干赋形制剂原液(51)脱离凹模，掉落在料盘(4)中；
G、将料盘(4)中的冻结固化后的冻干赋形制剂原液(51)进行冷冻干燥，除去溶剂，得到芒果味糖果产品。
实施例4：
A、使用相对旋转式的滚模组合，包括滚模(1)、滚模(2)、灌装头(3)、料盘(4)；其中滚模(1)和滚模(2)的表面具有一定形状的凹模(11)和凹模(12)，凹模(11)和凹模(12)对接时可形成完整水滴型，缝隙0.2mm；
B、将滚模(1)和滚模(2)使用其中的中空管道(6)注入制冷剂(7)进行预冷，预冷温度为-30℃；
C、将维生素C∶普鲁兰＝10∶1加水充分搅拌、真空脱气后配制成冻干赋形制剂原液；
D、将滚模(1)和(2)进行旋转，其表面的凹模(11)和凹模(12)的下边接合时，将冻干赋形制剂原液(5)灌装至凹模(11)和凹模(12)中，其灌装量为凹模(11)和(12)容积的总和或接近其容积的总和；
E、已预冷的滚模(1)和(2)使其中的冻干赋形制剂原液(5)发生冻结固化；
F、继续旋转滚模(1)和(2)，当凹模(11)和(12)旋转开口后，已冻结固化的水滴形冻干赋形制剂原液(51)脱离凹模，掉落在料盘(4)中；
G、将料盘(4)中的冻结固化后的冻干赋形制剂原液(51)进行冷冻干燥，除去溶剂，得到维生素护肤品。
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 (8)

1.一种使用滚模制备任意形状冻干赋形制剂的生产方法，其特征在于，包括如下步骤：
A、使用一种相对旋转式的滚模组合，包括第一滚模(1)、第二滚模(2)、灌装头(3)、料盘(4)；其中
第一滚模(1)和第二滚模(2)的表面分别具有一定形状的第一凹模(11)和第二凹模(12)，在滚动时，第一滚模(1)和第二滚模(2)相对旋转，其表面的第一凹模(11)和第二凹模(12)在相对时高度密合形成1个完整形态，其缝隙不超过5mm；
B、将第一滚模(1)和第二滚模(2)进行预冷，其预冷温度不高于0℃；
C、将含有水和粘结剂的溶液配制成溶液、乳浊液或悬浊液，制备成冻干赋形制剂原液(5)，其中，所述的含有水和粘结剂的溶液进一步含有活性成分，所述活性成分包括对人体和动物有益的化学药物成分、中药成分、天然提取物、生物活性成分、口服食品补充剂和对皮肤护理有益成分中的一种或一种以上的组合；
D、将第一滚模(1)和第二滚模(2)进行旋转，其表面的第一凹模(11)和第二凹模(12)的下边接合时，将冻干赋形制剂原液(5)灌装至第一凹模(11)和第二凹模(12)中，其灌装量为第一凹模(11)和第二凹模(12)容积的总和或接近其容积的总和；
E、已预冷的第一滚模(1)和第二滚模(2)使其中的冻干赋形制剂原液(5)发生冻结固化；
F、继续旋转第一滚模(1)和第二滚模(2)，当第一凹模(11)和第二凹模(12)旋转开口后，已冻结固化的冻干赋形制剂原液(51)脱离凹模，掉落在料盘(4)中；
G、将料盘(4)中的冻结固化后的冻干赋形制剂原液(51)进行冷冻干燥，除去溶剂，即得到冻干赋形制剂产品。
2.根据权利要求1所述的生产方法，其特征在于，步骤C所述含有水和粘结剂的溶液进一步含有其它辅料，其它辅料为骨架支持剂、抗氧化剂、矫味剂和香精、跨黏膜或者透皮吸收促进剂、pH调节剂中的一种或一种以上。
3.根据权利要求2所述的生产方法，其特征在于，所述的骨架支持剂包含糖、糖醇、2-12碳原子的氨基酸以及无机盐；所述的抗氧化剂选自维生素C及其衍生物、花青素、白藜芦醇、植物来源的多元酚类化合物中的一种或数种的混合物；所述的矫味剂和香精选自薄荷味、巧克力味、果味、香草味、咖啡味、茶味、玉米味、柠檬味、牛奶味香精的一种或几种的混合物；所述的跨黏膜或透皮吸收促进剂选自卵磷脂、皂苷、月桂醇酸钠、氮酮、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、酒石酸、碳酸氢钠、碳酸盐、碳酸钠、磷酸盐中的任何一种或数种的混合物。
4.根据权利要求1所述的生产方法，其特征在于，所述步骤E所述已预冷的第一滚模(1)和第二滚模(2)中进一步设有中空管道(6)，并于其中通过或储存制冷剂(7)。
5.根据权利要求1所述的生产方法，其特征在于，所述的第一滚模(1)和第二滚模(2)由压入硬度在0.1N以上、导热系数在0.01W/(m.k)以上的材料制成，所述材料选自金属、高分子材料、陶瓷、玻璃中的一种或由所述材料中的一种以上共同构成。
6.根据权利要求1所述的生产方法，其特征在于，所述第一滚模(1)和第二滚模(2)的表面进一步进行表面处理。
7.根据权利要求1所述的生产方法，其特征在于，所述的粘结剂是可食用或者可药用的一种水溶性高分子材料或其混合物，所述的水溶性高分子材料是多糖、多肽、蛋白质。
8.根据权利要求1所述的生产方法，其特征在于，所述的粘结剂包括明胶类、纤维素醚类、改性淀粉、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，阿拉伯胶、瓜尔豆胶、黄原胶、魔芋胶、卡拉胶、卡波姆、琼脂、角叉菜胶、果胶或它们的组合，以及含有水溶性高分子的天然材料。
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