WO2020073592A1 - 一种普鲁兰多糖空心硬胶囊及其制备方法 - Google Patents

一种普鲁兰多糖空心硬胶囊及其制备方法 Download PDF

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WO2020073592A1
WO2020073592A1 PCT/CN2019/076799 CN2019076799W WO2020073592A1 WO 2020073592 A1 WO2020073592 A1 WO 2020073592A1 CN 2019076799 W CN2019076799 W CN 2019076799W WO 2020073592 A1 WO2020073592 A1 WO 2020073592A1
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pullulan polysaccharide
pullulan
hollow hard
purified water
capsules
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PCT/CN2019/076799
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English (en)
French (fr)
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张轶弛
潘婕
方忠明
刘培勇
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江苏力凡胶囊有限公司
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Priority to EP19871976.7A priority Critical patent/EP3881834A4/en
Priority to US17/429,636 priority patent/US20220105045A1/en
Publication of WO2020073592A1 publication Critical patent/WO2020073592A1/zh

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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
    • A61K9/4816—Wall or shell material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/077—Manufacturing capsule shells
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4883—Capsule finishing, e.g. dyeing, aromatising, polishing

Definitions

  • the invention relates to the technical field of hollow capsules, in particular to a pullulan polysaccharide hollow hard capsule and a preparation method thereof.
  • the hollow capsule is an egg-shaped hollow shell which is refined by specific main materials and auxiliary materials and can be used for holding solid, semi-solid and liquid.
  • Traditional hollow capsules use gelatin as the main material. These hollow capsules have good disintegration performance and fast drug release speed, but there are many problems.
  • Gelatin is made from the hydrolysis of pigs, cows and other animal skins and other materials.
  • the main component is collagen, which is easy to breed various microorganisms. It is a high-protein and high-fat substance, which is not conducive to the diet of patients. It may also be animal Safety problems caused by disease transmission (such as mad cow disease, foot-and-mouth disease, bird flu, etc.).
  • gelatin is derived from animals and is not suitable for vegetarians and ethnic religious groups.
  • Pullulan polysaccharide is an extracellular water-soluble mucopolysaccharide obtained by fermentation of Aureobasidium pullulans, which cannot be gelled by itself. It needs a gelling agent (such as carrageenan, gellan gum, etc.) and a coagulant (such as cation Under the combined action of etc.), an edible film with low oxygen permeability and high solubility is formed.
  • a gelling agent such as carrageenan, gellan gum, etc.
  • a coagulant such as cation Under the combined action of etc.
  • the gel strength becomes weak, and the amount of the gel agent needs to be increased to ensure a faster gel speed.
  • the more the amount of gel is added the longer the capsule disintegration time, and the more unfavorable is the release of the drug in the capsule.
  • the disintegration time of hollow capsules made of raw materials of pullulan pH6-7 is less than 10min. Above this pH range, the viscosity of the glue solution decreases rapidly with the increase of the glue placement time, and the nature of the glue solution is unstable, which has a greater impact on the dipping capsules.
  • the object of the present invention is to provide a pullulan polysaccharide hollow hard capsule and a preparation method thereof.
  • the hard capsule has a short disintegration time and is conducive to drug absorption.
  • a pullulan polysaccharide hollow hard capsule comprising the following components: pullulan polysaccharide with a pH of 6-7 82-89wt%, gelling agent 1-1.4wt%, coagulant 0.8-1.4wt%, moisturizing Agent 0.01-0.04wt%, surfactant 0.01-0.04wt%, purified water 10-14wt%.
  • the above pullulan polysaccharide hollow hard capsules also include a sunscreen agent and food coloring, the content of the sunscreening agent is less than 2.6wt%, and the content of the food coloring is less than 1.7% by weight
  • the gelling agent is carrageenan
  • the moisturizing agent is glycerin
  • the surfactant is sodium lauryl sulfate
  • the sunscreen agent is titanium dioxide
  • the coagulant is a cationic coagulant.
  • the preparation method of the above pullulan polysaccharide hollow hard capsule includes the following steps:
  • Step 1 Weigh out pullulan polysaccharide, gel, coagulant, moisturizer, surfactant, sunscreen, food coloring, purified water;
  • Step 2 Dissolve the gel, coagulant, moisturizer, surfactant, sunscreen, and food coloring in purified water into a sol bucket containing 80-90 ° C, stir until the gel dissolves, stirring Add pullulan polysaccharide with a pH value of 6-7, incubate at 80-90 °C for 2-12h, and stir once every hour. After the pullulan polysaccharide is completely dissolved, cool to 52-58 °C and dip the capsule by dipping method , Drying at 25-40 °C, drying hard capsule water to 10-14% to obtain pullulan polysaccharide hollow hard capsules.
  • the stirring speed in step 2 is 1-5 rpm.
  • step 2 pullulan polysaccharide hollow hard capsules are dried to a moisture content of 12.0-12.1%.
  • the temperature in step 2 is reduced to 55 ° C.
  • the hard capsule provided by the present invention significantly shortens the disintegration time by 6-8 minutes. And the disintegration time of capsules in different batches is stable.
  • the pH value of the pullulan polysaccharide used in the existing hard capsules is 4-8.
  • it is necessary to select the addition amount of the suitable gelling agent according to the pH value of the pullulan polysaccharide, so that the hard capsules The content of the component fluctuates greatly, and the product provided by the present invention limits the pH to a smaller range, so the added gel agent is also within a smaller range, which effectively guarantees the content of the hard capsule. Taking different groups of people provides favorable conditions.
  • the capsules were dipped in a traditional dipping method on the production line and dried at 25-40 ° C to obtain hollow capsules with a transparent appearance of 12.1% moisture and a disintegration time of 7 minutes.
  • the capsules were dipped in a traditional dipping method on the production line and dried at 25-40 ° C to obtain hollow capsules with a transparent appearance of 12.0% moisture and a disintegration time of 7 minutes.
  • the capsules were dipped in a traditional dipping method on the production line and dried at 25-40 ° C to obtain hollow capsules with a transparent appearance of 12.0% moisture and a disintegration time of 7 minutes.
  • the capsules were dipped in a traditional dipping method on the production line and dried at 25-40 ° C to obtain hollow capsules with a transparent appearance of 12.1% moisture and a disintegration time of 7 minutes.
  • the capsules were dipped in a traditional dipping method on the production line and dried at 25-40 ° C to obtain hollow capsules with a transparent appearance of 12.1% moisture and a disintegration time of 7 minutes.

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  • Veterinary Medicine (AREA)
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  • Animal Behavior & Ethology (AREA)
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Abstract

一种普鲁兰多糖空心硬胶囊及其制备方法。该空心硬胶囊包括以下的组分:pH为6-7的普鲁兰多糖82-89wt%，凝胶剂1-1.4wt%，助凝剂0.8-1.4wt%，保湿剂0.01-0.04wt%，表面活性剂0.01-0.04wt%，纯化水10-14wt%。其制备方法包括：称取各组分，用80-90℃的纯化水溶解凝胶剂，助凝剂，保湿剂，表面活性剂，遮光剂，食用色素转入溶胶桶中，搅拌至凝胶剂溶解，边搅拌边加入pH值为6-7普鲁兰多糖，待普鲁兰多糖完全溶解后，降温，用蘸胶法蘸制胶囊，烘干即可。

Description

一种普鲁兰多糖空心硬胶囊及其制备方法 技术领域
本发明涉及空心胶囊技术领域，具体涉及一种普鲁兰多糖空心硬胶囊及其制备方法。
背景技术
空心胶囊是由特定主料加辅料精制而成的可用于盛装固体、半固体、液体的卵状空心外壳。传统空心胶囊以使用明胶为主料，该类空心胶囊崩解性能较好，药物释放速度快，但存在许多问题。明胶是用猪牛等动物的皮骨等材料水解制成，主要成分为胶原蛋白，容易滋生各种微生物，且其属于高蛋白高脂肪物质，不利于患者的饮食健康，同时可能会存在动物性疾病传染带来的安全问题(如疯牛病、口蹄疫、禽流感等)。此外，明胶来源于动物，不适合素食主义和民族宗教人群。
为解决上述缺陷问题，专业人士经过大量研究，研发出新型植物胶囊以代替明胶胶囊。目前市场占有率最高的是以羟丙甲纤维素等纤维素及其衍生物为主料的植物空心胶囊，但该类胶囊外观透明度较差，存在崩解延迟、透氧率高等缺陷。另一种新型植物空心胶囊以普鲁兰多糖为主料，相比于羟丙甲纤维素空心胶囊，该种胶囊外观透明度好，崩解速度快，透氧率低等优势。
普鲁兰多糖是一种用出芽短梗霉发酵得到的胞外水溶性粘质多糖，自身无法凝胶，需在凝胶剂(如卡拉胶、结冷胶等)、助凝剂(如阳离子等)的共同作用下，形成透氧率低、溶解度高的可食用性膜。在对普鲁兰多糖空心胶囊的研发过程中发现，凝胶剂添加量的多少对胶囊的崩解时间影响最大，添加量越多，胶囊崩解时间越长。普鲁兰多糖的pH值不同影响凝胶剂添加量的多少。国家标准中规定普鲁兰多糖pH值为4-8，而适合制备普鲁兰多糖空心胶囊的普鲁兰多糖pH值为6-7，低于该pH范围的普鲁兰多糖，其与凝胶剂、助凝剂结合的过程中，凝胶强度变弱，需提高凝胶剂的添加量从而保证较快的凝胶速度。而凝胶剂添加量越多，胶囊崩解时间越长，越不利于胶囊中药物的释放。使用pH6-7普鲁兰多糖原料制成的空心胶囊崩解时间低于10min。高于该pH范围，胶液黏度随胶液放置时间增加而下降较快，胶液性质不稳定，对蘸制胶囊影响较大。
发明内容
针对现有技术的不足，本发明的目的在于提供一种普鲁兰多糖空心硬胶囊及其制备方法，该硬胶囊崩解时间短，有利于药物的吸收。
一种普鲁兰多糖空心硬胶囊，包括以下的组分：pH为6-7的普鲁兰多糖82-89wt％，凝胶剂1-1.4wt％，助凝剂0.8-1.4wt％，保湿剂0.01-0.04wt％，表面活性剂0.01-0.04wt％， 纯化水10-14wt％。
作为改进的是，上述普鲁兰多糖空心硬胶囊，还包括遮光剂和食用色素，所述遮光剂的含量低于2.6wt％，所述食用色素的含量低于1.7wt％
作为改进的是，所述凝胶剂为卡拉胶，保湿剂为甘油，表面活性剂为十二烷基硫酸钠，遮光剂为二氧化钛，所述助凝剂为阳离子助凝剂。
上述普鲁兰多糖空心硬胶囊的制备方法，包括以下步骤：
步骤1，称取普鲁兰多糖，凝胶剂，助凝剂，保湿剂，表面活性剂，遮光剂，食用色素，纯化水；
步骤2，用纯化水溶解凝胶剂，助凝剂，保湿剂，表面活性剂，遮光剂，食用色素转入装有80-90℃的溶胶桶中，搅拌至凝胶剂溶解，边搅拌边加入pH值为6-7普鲁兰多糖，80-90℃下保温2-12h，每小时搅拌一次，待普鲁兰多糖完全溶解后，降温至52-58℃，用蘸胶法蘸制胶囊，25-40℃烘干，将硬胶囊水分烘干至10-14％即得普鲁兰多糖空心硬胶囊。
作为改进的是，步骤2中搅拌速度为1-5rpm。
作为改进的是，步骤2中普鲁兰多糖空心硬胶囊烘干至水分含量为12.0-12.1％。
作为改进的是，步骤2中降温至55℃。
有益效果：
与现有技术相比，本发明的优点在于：
1、针对现有的普鲁兰多糖胶囊产品常出现的崩解时间长，不同批次崩解时间波动范围大的问题，本发明提供的硬胶囊，明显缩短了崩解用时6-8分钟，且不同批次的胶囊崩解时间稳定。
2、现有硬胶囊所使用的普鲁兰多糖的pH值在4-8，为了满足生产需要，需要根据普鲁兰多糖的pH值得大小选择适应的凝胶剂的添加量，使得硬胶囊的组分含量波动较大，而本发明所提供的产品，因限定了pH在更小的范围内，所以添加的凝胶剂也在更小的范围内，有效保证硬胶囊的组分含量，为不同体质人群服用提供了有利的条件。
具体实施方式
下面通过具体实施例对本发明作进一步详细介绍。
实施例1
在溶胶桶中加入40kg的85℃纯化水，另取8kg纯化水溶解卡拉胶192g、氯化钾144g、 十二烷基硫酸钠3.2g、甘油5.25g，并倒入溶胶桶中，搅拌至卡拉胶溶解后，边搅拌边缓慢加入pH值为6.72的普鲁兰多糖12kg。然后胶液于85℃保温4h左右，每小时搅拌一次，后降至55℃保温消泡待用。
在生产线上使用传统蘸胶法蘸制胶囊，25-40℃烘干，得到水分为12.1％的透明外观空心胶囊，崩解时间为7min。
实施例2
在溶胶桶中加入40kg的80℃纯化水，另取8kg纯化水溶解溶解卡拉胶192g、氯化钾144g、十二烷基硫酸钠3g、甘油4.25g，并倒入溶胶桶中溶胶桶，搅拌至卡拉胶溶解后，边搅拌边缓慢加入pH值为6.63的普鲁兰多糖12kg。然后胶液于85℃保温4h左右，每小时搅拌一次，后降至55℃保温消泡待用。
在生产线上使用传统蘸胶法蘸制胶囊，25-40℃烘干，得到水分为12.0％的透明外观空心胶囊，崩解时间为7min。
实施例3
在溶胶桶中加入40kg的88℃纯化水，另取8kg纯化水溶解溶解辅料卡拉胶192g、氯化钾144g、十二烷基硫酸钠2.3g、甘油4.25g并倒入溶胶桶中溶胶桶，搅拌至卡拉胶溶解后，边搅拌边缓慢加入pH值为6.35的普鲁兰多糖12kg。然后胶液于85℃保温4h左右，每小时搅拌一次，后降至55℃保温消泡待用。
在生产线上使用传统蘸胶法蘸制胶囊，25-40℃烘干，得到水分为12.0％的透明外观空心胶囊，崩解时间为7min。
实施例4
在溶胶桶中加入40kg的90℃纯化水，另取8kg纯化水溶解溶解辅料卡拉胶192g、氯化钾144g、十二烷基硫酸钠2.3g、甘油3.25g并倒入溶胶桶中溶胶桶，搅拌至卡拉胶溶解后，边搅拌边缓慢加入pH值为6.83普鲁兰多糖12kg。然后胶液于85℃保温4h左右，每小时搅拌一次，后降至55℃保温消泡待用。
在生产线上使用传统蘸胶法蘸制胶囊，25-40℃烘干，得到水分为12.1％的透明外观空心胶囊，崩解时间为7min。
实施例5
在溶胶桶中加入40kg的83℃纯化水，另取8kg纯化水溶解溶解卡拉胶192g、氯化钾144g、十二烷基硫酸钠3.2g、甘油3.25g并倒入溶胶桶中溶胶桶，搅拌至卡拉胶溶解后，边搅拌边缓慢加入pH值为6.17普鲁兰多糖12kg。然后胶液于85℃保温4h左右，每小时搅 拌一次，后降至55℃保温消泡待用。
在生产线上使用传统蘸胶法蘸制胶囊，25-40℃烘干，得到水分为12.1％的透明外观空心胶囊，崩解时间为7min。
以上所述，仅为本发明较佳的具体实施方式，本发明的保护范围不限于此，任何熟悉本技术领域的技术人员在本发明披露的技术范围内，可显而易见地得到的技术方案的简单变化或等效替换均落入本发明的保护范围内。

Claims (7)

  1. 一种普鲁兰多糖空心硬胶囊，其特征在于，包括以下的组分：pH为6-7的普鲁兰多糖82-89wt％，凝胶剂1-1.4wt％，助凝剂0.8-1.4wt％，保湿剂0.01-0.04wt％，表面活性剂0.01-0.04wt％，纯化水10-14wt％。
  2. 根据权利要求1所述的一种普鲁兰多糖空心硬胶囊，其特征在于，还包括遮光剂和食用色素，所述遮光剂的含量低于2.6wt％，所述食用色素的含量低于1.7wt％。
  3. 根据权利要求1所述的一种普鲁兰多糖空心硬胶囊，其特征在于，所述凝胶剂为卡拉胶，保湿剂为甘油，表面活性剂为十二烷基硫酸钠，遮光剂为二氧化钛，所述助凝剂为阳离子助凝剂。
  4. 基于权利要求1所述的普鲁兰多糖空心硬胶囊的制备方法，其特征在于，包括以下步骤：步骤1，称取普鲁兰多糖，凝胶剂，助凝剂，保湿剂，表面活性剂，遮光剂，食用色素，纯化水；步骤2，用纯化水溶解凝胶剂，助凝剂，保湿剂，表面活性剂，遮光剂，食用色素转入装有80-90℃纯化水的溶胶桶中，搅拌至凝胶剂溶解，边搅拌边加入pH值为6-7普鲁兰多糖，保温2-12h，每小时搅拌一次，待普鲁兰多糖完全溶解后，降温至52-58℃，用蘸胶法蘸制胶囊，25-40℃烘干，将硬胶囊水分烘干至10-14％即得普鲁兰多糖空心硬胶囊。
  5. 根据权利要求4所述的一种普鲁兰多糖空心硬胶囊的制备方法，其特征在于，步骤2中搅拌速度为1-5rpm。
  6. 根据权利要求4所述的普鲁兰多糖空心硬胶囊的制备方法，其特征在于，步骤2中普鲁兰多糖空心硬胶囊烘干至水分含量为12.0-12.1％。
  7. 根据权利要求4所述的普鲁兰多糖空心硬胶囊的制备方法，其特征在于，步骤2中降温至55℃。
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