WO2016145696A1 - 纤维素胶与红藻卡帕胶复配的植物空心胶囊及制备方法 - Google Patents

纤维素胶与红藻卡帕胶复配的植物空心胶囊及制备方法 Download PDF

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WO2016145696A1
WO2016145696A1 PCT/CN2015/075883 CN2015075883W WO2016145696A1 WO 2016145696 A1 WO2016145696 A1 WO 2016145696A1 CN 2015075883 W CN2015075883 W CN 2015075883W WO 2016145696 A1 WO2016145696 A1 WO 2016145696A1
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kappa
red algae
gum
gel
cellulose
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郭卫强
庄永竞
赵立新
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中华生物科技有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof

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  • the invention relates to the field of medicine, in particular to a plant hollow capsule prepared by compounding cellulose gum and red algae kappa gel and a preparation method thereof.
  • Capsules have been officially listed as pharmaceutical excipients in the country and have been widely used in the hospital field.
  • Capsule-filled drugs are generally powders or granules which are irritating to the esophagus and gastric mucosa, or which are not good in taste, easy to volatilize, easily decomposed by saliva in the oral cavity, and easily inhaled into the trachea. These drugs are encapsulated to protect the drug from damage and protect the digestive organs and respiratory tract.
  • Gelatin capsules are made from animal raw materials, and a large amount of chemical components are added in the process, which also uses a large amount of water resources in the production process, causing serious pollution to the air and water environment. At the same time, due to the existence of certain disease possibilities in animals, the capsules made of animal gelatin have great safety risks.
  • red algae plant capsules Compared with gelatin capsules, red algae plant capsules have the advantage of low water content and are ideal for filling hygroscopic and moisture sensitive drugs. It has the advantages of wide applicability, no risk of cross-linking reaction and high stability; red algae plant capsules are not easy to grow microorganisms, no preservatives; red algae plant capsules are hardly brittle under low humidity conditions, and capsule shell properties are still stable under high temperature.
  • the patent of the present invention aims to design a plant hollow capsule which is prepared by compounding cellulose gum and red algae kappa gel, and a preparation method thereof, which has high disintegration speed, good film forming property and storage stability.
  • a plant hollow capsule made of cellulose gum and red algae kappa gel comprising the following weight percentage components:
  • the cellulose gum and the red algae kappa gum compound are mixed with carboxymethyl cellulose salt SCMC, hydroxypropyl methyl cellulose HPMC and red algae kappa gel at a weight ratio of 8:80:12. to make.
  • red algae kappa gum of the present invention is a red algae KAPPA gel.
  • the invention also provides a preparation method of a plant hollow capsule prepared by compounding cellulose gum and red algae kappa gel, comprising the following steps:
  • Step A mixing carboxymethyl cellulose salt SCMC, hydroxypropyl methylcellulose HPMC and red algae kappa gel in a ratio of 8:80:12 by weight to form cellulose gum and red algae kappa gum compounding gum;
  • Step B weighing 88-90% of cellulose gum and red algae kappa gum compounding glue, adding distilled water, slowly adding the above under rapid stirring conditions
  • the cellulose gum and the red algae Kappa gum compound glue mixed and stirred for 10 minutes, then transferred to a sandwich steam pot, heated to 88 ° C, and fully stirred, the reaction time is 30 minutes, so that it dissolves into a uniform glue;
  • Step C adding 1 to 3% of potassium chloride, 0 to 0.2% of sulfite, 3 to 5% of medicinal glycerin, 2 to 3% of titanium dioxide, and stirring evenly, by weight percentage, to glue
  • the temperature is lowered to 50 ° C, and the stirring is continued for 1 to 2 hours to form a silicone molding solution;
  • step D the capsule blank is prepared by a capsule mold boring method, and the prepared capsule blank is dried, the drying temperature is maintained at 30-35 ° C, the drying time is 1-2 hours, and finally the formed plant is obtained after demolding. Hollow capsules.
  • red algae kappa gum of the present invention is a red algae KAPPA gel.
  • Red algae KAPPA gel is a water-soluble polysaccharide extracted from red algae. It has the characteristics of thickening, gelation and film formation. Especially when cellulose gum and red algae KAPPA glue are compounded, the synergistic effect is the best. Increase the toughness and elasticity of the capsule. Therefore, the red algae KAPPA gel is one of the important raw materials for the production of plant capsule shells.
  • HPMC hydroxypropyl methylcellulose
  • suitable properties such as water solubility, thermogelability, thickening, film forming properties, and emulsifying properties. Its main chemical properties are swelling in cold water and then dissolving. When the temperature reaches 50 ° C or higher, it forms a gel. A thermally stable excipient.
  • the invention adopts the cellulose gum and the red algae KAPPA glue compounding glue as the main raw materials to prepare the plant hollow capsule.
  • the capsule molding process and manufacturing method were studied, and a new substitute of gelatin capsule was found: a plant hollow capsule made of cellulose gum and red algae KAPPA glue.
  • the invention provides a preparation method of a plant hollow capsule prepared by compounding cellulose gum and red algae kappa gum, comprising the following steps:
  • the carboxymethyl cellulose salt SCMC, hydroxypropyl methylcellulose HPMC and red algae kappa gum are mixed in a ratio of 8:80:12 by weight to form cellulose gum and red algae kappa gum compounding glue. ;
  • Capsule blank is prepared by capsule mold boring method, and then the prepared capsule blank is dried, the drying temperature is maintained at 30-35 ° C, the drying time is 1-2 hours, and the final water content of the slab blank is 6-8%;
  • the capsule blank is removed by a special capsule forceps, and the capsule blank is cut into a predetermined length by a capsule cutting machine;
  • the red algae plant hollow capsule prepared by the invention has a disintegration time limit of less than 10 minutes, a viscosity (8% solution, as dry product) of more than 50 mPa.s, and a sulfite content (as SO 2 ) of less than 100 mg/kg.
  • the weight loss on drying is 4 to 10%.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
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Abstract

一种纤维素胶与红藻卡帕拉胶复配制造的植物空心胶囊及其制备方法，包括重量百分比为纤维素胶与红藻卡帕胶复配胶88～90％，氯化钾1～3％，亚硫酸盐0～0.2％，药用甘油3～5％，二氧化钛2～3％的成分，纤维素胶与红藻卡帕胶复配胶为羧甲基纤维素盐SCMC、羟丙基甲基纤维素HPMC和红藻卡帕胶按重量比为8：80：12的比例混合而成。

Description

纤维素胶与红藻卡帕胶复配的植物空心胶囊及制备方法 技术领域
本发明涉及医药领域，特别涉及一种采用纤维素胶与红藻卡帕胶复配制造的植物空心胶囊及其制备方法。
背景技术
胶囊已被国家正式列为药品辅料，在医院领域已被广泛应用。用胶囊装的药物，一般都是对食道和胃粘膜有刺激性的粉末或颗粒，或口感不好、易于挥发、在口腔中易被唾液分解，以及易吸入气管的药。这些药装入胶囊，既保护了药物药性不被破坏，也保护了消化器官和呼吸道。胶囊根据原材料分，胶囊一般包括明胶胶囊和植物胶囊。目前使用的大多数胶囊是由明胶制成，其主要材料是动物源的明胶。采用动物原材料制作明胶胶囊，其过程中添加大量的化学成份，其在生产过程中也会使用大量的水资源，对空气和水环境产生严重的污染。同时，由于动物存在了一定的疾病可能性，因此动物明胶制得的胶囊的存在极大的安全隐患。
与明胶胶囊比较，红藻植物胶囊的优势在于：含水量低，非常适合吸湿性强和对水分敏感的药物的充填。具有适用性广、无交联反应风险和稳定性高的优点；红藻植物胶囊不易生长微生物，无防腐剂；红藻植物胶囊在低湿条件下几乎不脆碎，高温下胶囊壳性状依然稳定。
目前已有众多关于植物硬胶囊的专利申请，但是其提供的植物胶 囊明显存在崩解速度慢的缺陷，同时其植物胶囊体的成膜性和贮藏稳定性差，对胶囊内某些药物存在不良影响。
发明内容
针对以上问题，本发明专利目的在于设计了一种采用纤维素胶与红藻卡帕胶复配制造的植物空心胶囊及其制备方法，其崩解速度快，成膜性和贮藏稳定性好。
一种采用纤维素胶与红藻卡帕胶复配制造的植物空心胶囊，包括如下重量百分比的成分：
纤维素胶与红藻卡帕胶复配胶88～90％，氯化钾1～3％，亚硫酸盐0～0.2％，药用甘油3～5％，二氧化钛2～3％；
所述纤维素胶与红藻卡帕胶复配胶为羧甲基纤维素盐SCMC、羟丙基甲基纤维素HPMC和红藻卡帕胶按重量比为8：80：12的比例混合而成。
进一步，本发明所述红藻卡帕胶为红藻KAPPA胶。
本发明还提供一种纤维素胶与红藻卡帕胶复配制造的植物空心胶囊的制备方法，包括如下步骤：
步骤A，将羧甲基纤维素盐SCMC、羟丙基甲基纤维素HPMC和红藻卡帕胶按重量比为8：80：12的比例混合成纤维素胶与红藻卡帕胶复配胶；
步骤B，按重量百分比计，称取88～90％的纤维素胶与红藻卡帕胶复配胶，加入蒸馏水，在快速搅拌条件下，缓慢添加所述 纤维素胶与红藻卡帕胶复配胶，混合搅拌10分钟，然后移至夹层蒸汽锅中，加热至88℃，并充分搅拌，反应时间30分钟，使其溶化成均匀的胶液；
步骤C，按重量百分比计依次加入1～3％的氯化钾，0～0.2％的亚硫酸盐，3～5％的药用甘油，2～3％的二氧化钛，并搅拌均匀，将胶液温度降至50℃，继续保温搅拌l～2小时，形成蘸胶成型溶液；
步骤D，用胶囊模具蘸模法制备胶囊毛坯，再将所制备的胶囊毛坯进行干燥处理，干燥温度保持在30～35℃，干燥时间1～2小时，最后进行脱模后即得到成形的植物空心胶囊。
进一步，本发明所述红藻卡帕胶为红藻KAPPA胶。
具体实施例
下面结合附图和具体实施例对本发明作进一步的详细说明。
红藻KAPPA胶是一种从红藻中提取出来的水溶性多糖，具有增粘、凝胶和成膜等特性，特别是当纤维素胶与红藻KAPPA胶复配时协同效应最好，能增加胶囊的坚韧性和弹性，因此，红藻KAPPA胶就成为植物性胶囊壳的重要生产原料之一。
使用羟丙基甲基纤维素HPMC的有利方面在于：HPMC的强度、柔软性都十分稳定，基本无吸湿作用。HPMC具有适合的水溶性、热凝胶性、增稠性、成膜性以及乳化性等特性。其主要的化学性质是在冷水中溶胀而后溶解，在温度达到50℃以上时则形成凝胶，是最具 热稳定性的赋形剂。
本发明采用采用纤维素胶与红藻KAPPA胶复配胶为主要原料，制备植物空心胶囊。同时研究胶囊的成型工艺和制造方法，寻找出一种明胶胶囊新的替代品：以纤维素胶与红藻KAPPA胶复配胶为原料的植物空心胶囊。
本发明提出了一种纤维素胶与红藻卡帕胶复配制造的植物空心胶囊的制备方法，包括如下步骤：
1、将羧甲基纤维素盐SCMC、羟丙基甲基纤维素HPMC和红藻卡帕胶按重量比为8：80：12的比例混合成纤维素胶与红藻卡帕胶复配胶；
2、按重量百分比计，称取88～90％的纤维素胶与红藻卡帕胶复配胶，加入蒸馏水，在快速搅拌条件下，缓慢添加所述纤维素胶与红藻卡帕胶复配胶，混合搅拌10分钟，然后移至夹层蒸汽锅中，加热至88℃，并充分搅拌，反应时间30分钟，使其溶化成均匀的胶液；
3、按重量百分比计依次加入1～3％的氯化钾，0～0.2％的亚硫酸盐，3～5％的药用甘油，2～3％的二氧化钛，并搅拌均匀，将胶液温度降至50℃，继续保温搅拌l～2小时，形成蘸胶成型溶液；
4、用胶囊模具蘸模法制备胶囊毛坯，再将所制备的胶囊毛坯进行干燥处理，干燥温度保持在30～35℃，干燥时间1～2小时，囊坯最终含水量为6～8％；
5、用特制的胶囊钳把囊坯拔下，将囊坯用胶囊截割机截成规定的长度；
6、将已制成的空心胶囊置于特制的工作台上，台面为玻璃，下面装日光灯。在此台上检查，剔除不合格品，将胶囊上下两节套合。盛装于密闭容器中，贮存于阴凉干燥处，即得到成形的红藻植物空心胶囊。
经测试，本发明制备的红藻植物空心胶囊其崩解时限小于10分钟，粘度(8％溶液，以干燥品计)大于50mpa.s，亚硫酸盐含量(以SO2计)小于100mg/kg，干燥失重为4～10％。
以上所述本发明的具体实施方式，并不构成对本发明保护范围的限定。任何根据本发明的技术构思所做出的各种其他相应的改变与变形，均应包含在本发明权利要求的保护范围内。

Claims (4)

  1. 一种纤维素胶与红藻卡帕胶复配的植物空心胶囊，其特征在于，包括如下重量百分比的成分：
    纤维素胶与红藻卡帕胶复配胶88～90％，氯化钾1～3％，亚硫酸盐0～0.2％，药用甘油3～5％，二氧化钛2～3％；
    所述纤维素胶与红藻卡帕胶复配胶为羧甲基纤维素盐SCMC、羟丙基甲基纤维素HPMC和红藻卡帕胶按重量比为8：80：12的比例混合而成。
  2. 根据权利要求1所述的纤维素胶与红藻卡帕胶复配的植物空心胶囊，其特征在于，红藻卡帕胶为红藻KAPPA胶。
  3. 一种纤维素胶与红藻卡帕胶复配的植物空心胶囊的制备方法，其特征在于，包括如下步骤：
    步骤A，将羧甲基纤维素盐SCMC、羟丙基甲基纤维素HPMC和红藻卡帕胶按重量比为8：80：12的比例混合成纤维素胶与卡拉胶复配胶；
    步骤B，按重量百分比计，称取88～90％的纤维素胶与红藻卡帕胶复配胶，加入蒸馏水，在快速搅拌条件下，缓慢添加所述纤维素胶与红藻卡帕胶复配胶，混合搅拌10分钟，然后移至夹层蒸汽锅中，加热至88℃，并充分搅拌，反应时间30分钟，使其溶化成均匀的胶液；
    步骤C，按重量百分比计依次加入1～3％的氯化钾，0～0.2％的亚硫酸盐，3～5％的药用甘油，2～3％的二氧化钛，并搅拌均匀，将胶液温度降至50℃，继续保温搅拌l～2小时，形成蘸胶成 型溶液；
    步骤D，用胶囊模具蘸模法制备胶囊毛坯，再将所制备的胶囊毛坯进行干燥处理，干燥温度保持在30～35℃，干燥时间1～2小时，最后进行脱模后即得到成形的植物空心胶囊。
  4. 根据权利要求3所述的纤维素胶与红藻卡帕胶复配的植物空心胶囊制备方法，其特征在于，红藻卡帕胶为红藻KAPPA胶。
PCT/CN2015/075883 2015-03-16 2015-04-03 纤维素胶与红藻卡帕胶复配的植物空心胶囊及制备方法 WO2016145696A1 (zh)

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