CN112641751B - 一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊 - Google Patents
一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊 Download PDFInfo
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Abstract
本发明公开了一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，由以下重量份的原料制成：羟丙甲纤维素1000份、卡拉胶5～9份、凝胶剂8.5～12.5份、氯化钾1.0～5份、纯化水4800～5200份、蛋白酶3～5份、林蛙油30～40份、蜂胶100～120份、防溶解内薄衣200～300份，蛋白酶选用内肽酶、枯草杆菌蛋白酶、丝氨酸蛋白酶中的一种，聚乙二醇4000由聚乙二醇于95％酒精中搅拌，再用80℃热水外加热至完全溶解后冷却制得。本发明设计制备的羟丙甲纤维素空心充液胶囊中能够适应多种填充物，胶囊均匀度较好，无异味、韧性高、不易破裂。
Description
技术领域
本发明涉及医药技术领域，尤其涉及一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊。
背景技术
利用动物来源的明胶制作空心胶囊至少已有近200年的历史。由于明胶可掩盖许多药物的不良口感、气味或对胃的刺激性，因此，明胶胶囊很快被推广应用于各种固体制剂的生产中。过去100年来，以明胶为原料的各种胶囊曾长 期畅销于国际医药市场。经检索，授权公告号为CN106074434B的中国专利公开 了一种制备淀粉基质空心胶囊的原料组合物，组合物包括80-97wt％的羟丙基淀 粉、0-3wt％的羟丙基-β-环糊精、0.02-3wt％的羟乙基-β-环糊精、0.5-7wt％的凝胶剂和1-15wt％的增塑补强剂，该设计制备淀粉基质空心胶囊的原料组合物中加入羟丙基-β-环糊精和羟乙基-β-环糊精，促进胶囊的崩解，提高了填充通过率，并且组合物中还加入了增塑补强剂，增加了胶囊的柔韧性及耐填充的性能，降低了凝胶剂用量改善了胶囊崩解过程产生的碎片问题。
但是，不论是常规的动物源明胶空心胶囊还是任何一种植物空心胶囊，都只是可以充填粉末、颗粒及部分固体油状物的内容物。明胶空心胶囊充填水溶性液体或液态油状物，胶囊会吸水膨胀、发软、变形，植物空心胶囊充填水溶性液体或液态油状物，胶囊都会溶解，因此我们提出了一种羟丙甲基纤维素和海藻多糖的填充空心胶囊用于解决上述问题。
发明内容
基于背景技术存在的技术问题，本发明提出了一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊。
本发明提出的一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，所述的填充空心胶囊由以下重量份的原料制成：羟丙甲纤维素1000份、卡拉胶5～9份、凝胶剂8.5～12.5份、氯化钾1.0～5份、纯化水4800～5200份、蛋白酶3～5份、林蛙油30～40份、蜂胶100～120份、防溶解内薄衣200～300份。
优选的，所述防溶解内薄衣由以下重量份的原料制成：丙酮2000～4000份、羟丙基甲基纤维素邻苯二甲酸酯700～900份、Ⅱ树脂100～300份、乙醇溶液 2000～400份、聚乙二醇4000 50～150份、柠檬酸三乙酯6.5～8.5份、醇酯混合物6.5～8.5份、催化剂50～150份。
优选的，所述Ⅱ树脂选用粉末状态的药用聚丙烯酸树脂Ⅱ。
优选的，所述醇酯混合物为丙三醇与聚山梨醇酯-80的任一比例混合物。
优选的，所述蛋白酶选用内肽酶、枯草杆菌蛋白酶、丝氨酸蛋白酶中的一 种。
优选的，所述乙醇溶液选用浓度为95％的药用酒精。
优选的，所述催化剂选用邻苯二甲酸二乙酯。
优选的，所述聚乙二醇4000由聚乙二醇于95％酒精中搅拌，再用80℃热水 外加热至完全溶解后冷却制得。
本发明中所述的一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊的有益效果是：
(1)羟丙甲纤维素空心充液空心胶囊是可以填充水溶性液体的空心胶囊，常规的明胶胶囊和植物空心胶囊只可以填充粉末、颗粒及部分油状物，羟丙甲纤维素空心充液空心胶囊源于欧洲医院的一种需求，通过口服胶囊剂(填充水 溶性针剂液)替代做皮试打针的针剂；
(2)羟丙甲纤维素空心充液空心胶囊可以填充水溶性液体或液态油状物， 该项技术目前研发完善，且已经具备量产条件；防溶解内薄衣配方成分中也可以全部只添加HPMCP，不需要添加Ⅱ树脂，但因HPMCP偏酸性，制备出的内薄衣有酸味，不符中国合药典相关要求；聚乙二醇4000(PEG)，也可以以其他型号替代，但备制的内薄衣韧性差，内薄衣易破裂；
(3)羟丙甲纤维素空心胶囊配方成分凝胶剂中也可以仅添加低酰基结冷胶一种，但添加的量较大，成本高，成型非常快，制备出的胶囊均匀度较差，直接影响客户的上机率；氯化钾(KCL)也可以用乙酸钾替代，但乙酸钾偏酸性，备制出的胶囊有酸味，不符合空心胶囊无异味的标准；
本发明设计制备的羟丙甲纤维素空心充液空心胶囊中能够适应多种填充物，胶囊均匀度较好，无异味、韧性高、不易破裂。
具体实施方式
下面结合具体实施例对本发明作进一步解说。
实施例一
本发明提出了一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，所述的填充空心胶囊由以下重量份的原料制成：羟丙甲纤维素1000份、卡拉胶5份、凝胶剂8.5份、氯化钾1.0份、纯化水4800份、蛋白酶3份、林蛙油30份、蜂胶100份、防溶解内薄衣200份。
本实施例中，所述防溶解内薄衣由以下重量份的原料制成：丙酮2000份、羟丙基甲基纤维素邻苯二甲酸酯700份、Ⅱ树脂100份、乙醇溶液200份、聚乙二醇4000 50份、柠檬酸三乙酯6.5份、醇酯混合物6.5份、催化剂50份。
本实施例中，所述Ⅱ树脂选用粉末状态的药用聚丙烯酸树脂Ⅱ，所述醇酯混合物为丙三醇与聚山梨醇酯-80的任一比例混合物，所述蛋白酶选用内肽酶、枯草杆菌蛋白酶、丝氨酸蛋白酶中的一种。
本实施例中，所述乙醇溶液选用浓度为95％的药用酒精，所述催化剂选用邻苯二甲酸二乙酯，所述聚乙二醇4000由聚乙二醇于95％酒精中搅拌，再用80℃热水外加热至完全溶解后冷却制得。
实施例二
本发明提出了一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，所述的填充空心胶囊由以下重量份的原料制成：羟丙甲纤维素1000份、卡拉胶8份、凝胶剂10份、氯化钾4份、纯化水5000份、蛋白酶4份、林蛙油35份、蜂胶110 份、防溶解内薄衣250份。
本实施例中，所述防溶解内薄衣由以下重量份的原料制成：丙酮3000份、羟丙基甲基纤维素邻苯二甲酸酯800份、Ⅱ树脂200份、乙醇溶液300份、聚乙二醇4000 100份、柠檬酸三乙酯8份、醇酯混合物7份、催化剂100份。
本实施例中，所述Ⅱ树脂选用粉末状态的药用聚丙烯酸树脂Ⅱ，所述醇酯 混合物为丙三醇与聚山梨醇酯-80的任一比例混合物，所述蛋白酶选用内肽酶、 枯草杆菌蛋白酶、丝氨酸蛋白酶中的一种。
本实施例中，所述乙醇溶液选用浓度为95％的药用酒精，所述催化剂选用邻苯二甲酸二乙酯，所述聚乙二醇4000由聚乙二醇于95％酒精中搅拌，再用80℃ 热水外加热至完全溶解后冷却制得。
实施例三
本发明提出了一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，所述的填 充空心胶囊由以下重量份的原料制成：羟丙甲纤维素1000份、卡拉胶9份、凝胶剂12.5份、氯化钾5份、纯化水5200份、蛋白酶5份、林蛙油40份、蜂胶120份、防溶解内薄衣300份。
本实施例中，所述防溶解内薄衣由以下重量份的原料制成：丙酮4000份、 羟丙基甲基纤维素邻苯二甲酸酯900份、Ⅱ树脂300份、乙醇溶液400份、聚乙二醇4000 150份、柠檬酸三乙酯8.5份、醇酯混合物8.5份、催化剂150份。
本实施例中，所述Ⅱ树脂选用粉末状态的药用聚丙烯酸树脂Ⅱ，所述醇酯混合物为丙三醇与聚山梨醇酯-80的任一比例混合物，所述蛋白酶选用内肽酶、 枯草杆菌蛋白酶、丝氨酸蛋白酶中的一种。
本实施例中，所述乙醇溶液选用浓度为95％的药用酒精，所述催化剂选用邻 苯二甲酸二乙酯，所述聚乙二醇4000由聚乙二醇于95％酒精中搅拌，再用80℃ 热水外加热至完全溶解后冷却制得。
通过对上述实施例制作的填充空心胶囊的各项性能测试，结果记录如下：
采用本发明设计制备的羟丙甲纤维素空心充液空心胶囊中能够适应多种填充物，胶囊均匀度较好，无异味、韧性高、不易破裂。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。
Claims (3)
1.一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，其特征在于，所述的填充空心胶囊由以下重量份的原料制成：羟丙甲纤维素1000份、卡拉胶5～9份、凝胶剂8.5～12.5份、氯化钾1.0～5份、纯化水4800～5200份、蛋白酶3～5份、林蛙油30～40份、蜂胶100～120份、防溶解内薄衣200～300份；所述防溶解内薄衣由以下重量份的原料制成：丙酮2000～4000份、羟丙基甲基纤维素邻苯二甲酸酯700～900份、Ⅱ树脂100～300份、乙醇溶液2000～400份、聚乙二醇4000 50～150份、柠檬酸三乙酯6.5～8.5份、醇酯混合物6.5～8.5份、催化剂50～150份；所述Ⅱ树脂选用粉末状态的药用聚丙烯酸树脂Ⅱ；所述醇酯混合物为丙三醇与聚山梨醇酯-80的任一比例混合物；所述蛋白酶选用内肽酶、枯草杆菌蛋白酶、丝氨酸蛋白酶中的一种；所述催化剂选用邻苯二甲酸二乙酯。
2.根据权利要求1所述的一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，其特征在于，所述乙醇溶液选用浓度为95％的药用酒精。
3.根据权利要求1所述的一种羟丙甲基纤维素和卡拉胶的填充空心充液胶囊，其特征在于，所述聚乙二醇4000由聚乙二醇于95％酒精中搅拌，再用80℃热水外加热至完全溶解后冷却制得。
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