CN1240461A - 用于胶囊的聚合物膜组合物 - Google Patents
用于胶囊的聚合物膜组合物 Download PDFInfo
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- CN1240461A CN1240461A CN97180701A CN97180701A CN1240461A CN 1240461 A CN1240461 A CN 1240461A CN 97180701 A CN97180701 A CN 97180701A CN 97180701 A CN97180701 A CN 97180701A CN 1240461 A CN1240461 A CN 1240461A
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Abstract
本发明涉及适合成膜,特别是形成硬胶囊和软胶囊的非动物性聚合物组合物,含有水溶性纤维素醚、水胶体和螯合剂。
Description
发明背景
1 发明领域
本发明涉及适合成膜，特别是硬胶囊和软胶囊的膜的非动物性聚合物组合物，含有水溶性纤维素醚、水胶体和螯合剂。
2 相关技术的描述
在制药工业和保健品市场广泛使用了胶囊。其主要用途是作为一种剂型用于固体、半固体、液体、丸药或草药制剂。这些剂型的一个主要目的是给药后提供好的崩解性，能在适合的消化器官中使活性物质有效溶解。所以，当在使用前储存成品期间必须保持这种崩解性的稳定。
用于形成胶囊壳的传统的材料是明胶，因为其具有合适的和非常理想的性质。然而，明胶有一些缺点，这就需要得到其它胶囊壁材料。明胶的主要不利方面是其来源于动物。其它的缺点是相对较高的水含量(10-17％)和降低水含量导致的弹性降低带来的不便。另外，明胶胶囊对热和湿气敏感，这会影响产品的实用性。特别是在热和潮湿的条件下软明胶胶囊会聚集。在干燥条件下，明胶膜可产生静电荷积聚，对后继加工有影响。
作为明胶的替代物，在文献中广泛描述了纤维素衍生物形成的水溶性膜的应用。有报道，特别与明胶相比，纤维素衍生物制备的胶囊在体内的崩解性差。为了克服这个缺点，在EP0714656中建议使用在20℃2％水溶液的粘度为2.4-5.4厘沲的羟丙基甲基纤维素(HPMC)，同时使用角叉菜胶作为胶凝剂，用钙离子或钾离子作为共胶凝剂。但是，较低分子量的链生成的HPMC的粘度非常低，导致膜的脆性较高。另外，使用这种组合物导致了膜的透明度的损失，这是不希望的。在EP0592130中公开了改进透明度的尝试，即，在制备胶囊以前对HPMC进行UV辐照。
本发明概述
已经发现了一种用于胶囊的聚合物膜组合物，其中纤维素醚、水胶体和螯合剂的比例为纤维素醚或纤维素醚的混合物占90-99.98重量％，含水量2-10％，水胶体或水胶体混合物0.01-5重量％，螯合剂0.01-5重量％，该组合物没有上述缺点。优选实施方案的详细描述
适用于本发明的纤维素醚是烷基和/或羟烷基取代的纤维素醚，在烷基链中有1-4个碳原子，优选甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟乙基甲基纤维素、羟乙基乙基纤维素、羟丙基甲基纤维素等。特别优选HPMC。纤维素醚或纤维素醚混合物的量优选为95-99.98重量％。在20℃，2％的纤维素醚或其混合物的水溶液的粘度为3-15cps，优选5-10cps，最优选6cps。
适合的水胶体包括合成胶，其无需加入碱金属离子或碱土金属离子就能够凝胶。用于此目的的优选的胶为洁冷胶(gellan gum)。这类胶——特别包括洁冷胶——可在混合物中联合使用，产生协同性能，混合物还可包括天然海藻胶、天然种子胶、天然植物胶、天然果胶、生物合成胶、生物合成加工的淀粉或纤维素材料。更特别地，混合物可包括藻酸盐、琼脂凝胶、瓜尔豆胶、槐树豆胶(角豆胶)、角叉菜胶、刺云实胶、阿拉伯胶、印度胶、Khaya grandifolia gum、黄芪胶、梧桐胶、果胶、阿拉伯糖胶(araban)、汉生胶、洁冷胶、淀粉、魔芋甘露聚糖、半乳甘露聚糖、海萝聚糖(funoran)及其其它细胞外多糖，优选细胞外多糖如汉生胶、acetan、洁冷胶(gellan)、welan、鼠李聚糖、红藻胶、琥珀聚糖、scleroglycan、裂褶菌属(schizophyllan)、罗望籽果胶、产碱杆菌多糖、出芽短梗孢糖、葡聚糖。这些存在胶的量优选为0.01-2重量％，特别优选0.1-1.0％。
优选的螯合剂是亚乙基二胺四乙酸、乙酸、硼酸、柠檬酸、葡糖酸、乳酸、磷酸、酒石酸或它们的盐、methaphosphate、二羟基乙基氨基乙酸、卵磷脂或β环糊精和它们的结合。特别优选的是亚乙基二胺四乙酸或其盐或柠檬酸或其盐。优选的量为0.01-3重量％，特别是0.1-2重量％。
通过加入一价或二价阳离子，例如Ca++、Mg++、K+、Na+、Li+、NH4 +等，可调整螯合机理。
本发明聚合物组合物的胶囊或膜可用常规的机械用常规的方法制备，例如挤塑、注塑、浇铸或蘸塑。
胶囊和膜具有非动物性的聚合物组成、改进的溶解性、提高的弹性并表现出较高的透明性。提高的弹性使胶囊对于吸入产品更为有用。另外，该胶囊对于污染填充的例如甲醛不敏感，并且与明胶胶囊相比有更好的温度稳定性，因为在提高温度的储存条件下不发生交联。
本发明的聚合物组合物可含有其它可接受的增塑剂，以纤维素醚的重量为基础计算，其用量在约0-40％范围内。适用的增塑剂是聚乙二醇、甘油、山梨醇、蔗糖、玉米糖浆、果糖、二辛基钠磺基琥珀酸酯、柠檬酸三乙酯、柠檬酸三丁酯、1，2-丙基乙二醇、甘油单乙酯、甘油二乙酯或甘油三乙酯、天然胶等或它们的混合物。
本发明的聚合物组合物另一方面还可含有药学或食品可接受的着色剂，以纤维素醚的重量为基础计算，其用量在约0-10％范围内。着色剂可以选自偶氮、quinophthalone-、三苯基甲烷、黄嘌呤素或靛系染料、铁氧化物或氢氧化物、二氧化钛或天然染料或其混合物。例子是专利蓝V、酸性亮绿BS、红2G、偶氮玉红(azorubine)、食用胭脂红4R、苋菜红、D+C红33、D+C红22、D+C红26、D+C红28、D+C黄10-、黄2G、FD+C黄5、FD+C黄6、FD+C红3、FD+C红40、FD+C蓝1、FD+C蓝2、FD+C绿3、亮黑BN、碳黑、氧化铁黑、氧化铁红、氧化铁黄、二氧化钛、核黄素、胡萝卜素、花青甙、姜黄、胭脂虫提取物、叶绿酸(clorophyllin)、鸡油菌素、焦糖或甜菜红。
本发明成型的聚合物组合物或其最终产品可用合适的包衣剂包衣，提供例如肠溶性，包衣剂是诸如邻苯二甲酸乙酸纤维素、聚醋酸邻苯二甲酸乙烯酯、甲基丙烯酸聚合物、hypromellose邻苯二甲酸酯、邻苯二甲酸羟丙基甲基纤维素、邻苯二甲酸羟烷基甲基纤维素或它们的混合物。
本发明的聚合物组合物可用于制备容器，为例如农用化学品、种子、草药、食物、染料、药品、调味品等提供单位剂型。
本发明的聚合物组合物的改进的弹性使其能用于将药物密封在胶囊中，特别是密封在耐充填式(tamper-proof)胶囊中。优选通过将装填了药物的胶囊各个部分冷缩，进行药物在胶囊中的包封，包括提供空的胶囊的部分，在至少一个所述胶囊的部分中装填一种或多种药物，将所述的胶囊的各个部分合在一起，用冷缩处理合在一起的胶囊部分。
本发明的聚合物组合物还用于密封两半的胶囊，通过将一层或多层组合物施加到胶囊帽和胶囊体的接缝处的方法，或用液体熔合方法，其中装填好的胶囊用水醇(hydroalcoholic)溶液润湿，水醇溶液渗透到胶囊帽与胶囊体交叠的空隙中，然后干燥。
通过下述组合物和比较实施例说明该聚合物组合物的改进的性能。组合物实施例
*根据EP0714656(1)HPMC在50％RH平衡(相当于水含量为5-7％)组合物5：常规的透明硬明胶胶囊组合物6：常规的不透明硬明胶胶囊机械冲击试验
| 组分 | 组合物1 | 组合物2 | 组合物3 | 组合物4* |
| HPMC(1) | 99.26％ | 99.62％ | 99.46％ | 98.1％ |
| 洁冷胶 | 0.54％ | 0.22％ | 0.54％ | 0 |
| 柠檬酸钠 | 0.20％ | 0 | 0 | 0 |
| 柠檬酸 | 0 | 0.16％ | 0 | 0 |
| 角叉菜胶 | 0 | 0 | 0 | 1.3％ |
| KCl | 0 | 0 | 0 | 0.6％ |
对胶囊体施加80mJ的机械冲击应力，检测胶囊的破碎百分比。
吸入器贯穿试验
| 平衡RH | 组合物1 | 组合物2 | 组合物5 | 组合物6 |
| 50％ | 0 | 0 | 0 | 0 |
| 10％ | 0 | 0 | 0 | 5 |
| 2.5％ | 0 | 0 | 10 | 45 |
将胶囊用吸入器装置贯穿，记录裂缝和/或破碎的百分比。
胶囊透明度试验在650nm测试胶囊体的透明度。
溶解试验将胶囊浸入在37℃的去离子水中，对乙酰氨基酚从胶囊溶解出来(USPXXIII)，列出45分钟后对乙酰氨基酚的百分比。
使用交联剂后的溶解试验
| 平衡RH | 组合物1 | 组合物2 | 组合物5 | 组合物6 |
| 50％ | 0 | 0 | 0 | 0 |
| 10％ | 0 | 0 | 95 | 80 |
| 2.5％ | 0 | 0 | 95 | 75 |
| 胶囊 | 透明度 |
| 组合物1 | 74％ |
| 组合物2 | 75％ |
| 组合物4 | 60％ |
| 组合物5 | 81％ |
| 胶囊 | 溶解％ |
| 组合物1 | 90％ |
| 组合物2 | 90％ |
| 组合物3 | 63％ |
| 组合物5 | 91％ |
胶囊用含有40ppmHCHO的乳糖填装，在室内条件下储存1个月，测定45分钟后溶解的对乙酰氨基酚的百分比。
湿气交换试验用干燥的羧甲基纤维素钠盐(CMC)装填胶囊，在室内条件储存在封闭的瓶中。
| 胶囊 | 溶解％ |
| 组合物1 | 90％ |
| 组合物5 | 22％ |
| 胶囊 | 起始水含量 | 最终水含量 | ||
| 胶囊 | 填充物 | 胶囊 | 填充物 | |
| 组合物1 | 6.4％ | 0％ | 1.4％ | 1.1％ |
| 组合物5 | 14％ | 0％ | 4.7％ | 2.0％ |
Claims (25)
1 一种用于形成膜的非动物性聚合物组合物，含有纤维素醚或纤维素醚的混合物、水胶体或水胶体的混合物和螯合剂或其混合物，其中所述的水胶体或水胶体混合物含有单独地或以与其它多糖的混合物的形式的洁冷胶。
2 根据权利要求1的聚合物组合物，其中纤维素醚、水胶体和螯合剂的比例为
a)含水量2-10％的纤维素醚或纤维素醚的混合物90-99.98重量％，
b)水胶体或水胶体混合物0.01-5重量％，
c)螯合剂或螯合剂的混合物0.01-8重量％。
3 根据权利要求1或2的聚合物组合物，其中纤维素醚或纤维素醚的混合物选自烷基和/或羟烷基取代的纤维素醚，在烷基链中有1-4个碳原子。
4 根据权利要求3的聚合物组合物，其中纤维素醚或纤维素醚的混合物选自甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟乙基甲基纤维素、羟乙基乙基纤维素、羟丙基甲基纤维素。
5 根据权利要求4的聚合物组合物，其中纤维素醚是羟丙基甲基纤维素。
6 根据权利要求1或2的聚合物组合物，其中水胶体或水胶体混合物选自多糖。
7 根据权利要求6的聚合物组合物，其中水胶体或水胶体混合物还包括一种或多种藻酸盐、琼脂凝胶、瓜尔豆胶、槐树豆胶(角豆胶)、角叉菜胶、刺云实胶、阿拉伯胶、印度胶、Khaya grandifolia gum、黄芪胶、梧桐胶、果胶、阿拉伯糖胶(araban)、汉生胶、淀粉、魔芋甘露聚糖、半乳甘露聚糖、海萝聚糖或细胞外多糖，诸如acetan、welan、鼠李聚糖、红藻胶、琥珀聚糖、裂褶菌属(scleroglycan)、schizophyllan、罗望籽果胶、产碱杆菌多糖、出芽短梗孢糖或葡聚糖。
8 根据权利要求2的聚合物组合物，其中螯合剂或螯合剂混合物选自亚乙基二胺四乙酸、乙酸、硼酸、柠檬酸、葡糖酸、乳酸、磷酸、酒石酸或它们的盐、methaphosphate、二羟基乙基氨基乙酸、卵磷脂或β环糊精。
9 根据权利要求8的聚合物组合物，其中螯合剂或螯合剂混合物选自亚乙基二胺四乙酸或其盐或柠檬酸或其盐。
10 根据权利要求1的聚合物组合物，其中
a)纤维素醚或纤维素醚的混合物含量为95-99.98重量％，
b)多糖或多糖混合物含量为0.01-2重量％，和
c)螯合剂含量为0.01-3重量％。
11 根据权利要求1的聚合物组合物，其中纤维素醚或纤维素醚的混合物2％的水溶液在20℃的粘度测定为3-15cps。
12 根据权利要求11的聚合物组合物，其中测定的纤维素醚或纤维素醚的混合物2％的水溶液在20℃的粘度为5-10cps，优选6cps。
13 根据权利要求1的聚合物组合物，还含有增塑剂，以纤维素醚的重量为基础计算，其量在约0-40％范围内。
14 根据权利要求13的聚合物组合物，其中增塑剂或增塑剂的混合物选自聚乙二醇、甘油、山梨醇、蔗糖、玉米糖浆、果糖、二辛基钠磺基琥珀酸酯、柠檬酸三乙酯、柠檬酸三丁酯、1，2-丙二醇、甘油单乙酸酯、甘油二乙酸酯或甘油三乙酸酯、或天然树胶。
15 根据权利要求1的聚合物组合物，还含有着色剂，以纤维素醚的重量为基础计算，其量在约0-10％范围内。
16 根据权利要求15的聚合物组合物，其中着色剂或着色剂的混合物选自偶氮、quinophthalone-、三苯基甲烷、黄嘌呤素或靛系染料、铁氧化物或氢氧化物、二氧化钛或天然染料。
17 根据权利要求15的聚合物组合物，其中着色剂或着色剂的混合物选自专利蓝V、酸性亮绿BS、红2G、偶氮玉红(azorubine)、食用胭脂红4R、苋菜红、D+C红33、D+C红22、D+C红26、D+C红28、D+C黄10、黄2G、FD+C黄5、FD+C黄6、FD+C红3、FD+C红40、FD+C蓝1、FD+C蓝2、FD+C绿3或亮黑BN。
18 根据权利要求15的聚合物组合物，其中着色剂或着色剂的混合物选自碳黑、氧化铁黑、氧化铁红、氧化铁黄、二氧化钛、核黄素、胡萝卜素、花青甙、姜黄、胭脂虫提取物、叶绿酸、鸡油菌素、焦糖或甜菜红。
19 由根据权利要求1的聚合物组合物制备的为农用化学品、种子、草药、食物、染料、药品或调味品等提供单位剂型的容器。
20 根据权利要求19的容器，是药用胶囊的形式。
21 根据权利要求19的容器，其中容器有包衣。
22 根据权利要求21的有包衣的容器，其中包衣选自邻苯二甲酸乙酸纤维素、聚醋酸邻苯二甲酸乙烯酯、甲基丙烯酸聚合物、hypromellose邻苯二甲酸酯、邻苯二甲酸羟丙基甲基纤维素、邻苯二甲酸羟烷基甲基纤维素或它们的混合物。
23 在根据权利要求1的聚合物组合物中包封的药物。
24 根据权利要求20的胶囊，其中用一层或多层根据权利要求1的聚合物组合物将两半的胶囊密封。
25 根据权利要求20的胶囊，其中用液体熔合方法将两半的胶囊密封。
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| FR96/15580 | 1996-12-17 | ||
| FR9615580A FR2757173A1 (fr) | 1996-12-17 | 1996-12-17 | Compositions polymeres d'origine non-animale pour la formation de films |
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| EP (2) | EP1057862B1 (zh) |
| JP (3) | JP2001506692A (zh) |
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| FR (1) | FR2757173A1 (zh) |
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- 1996-12-17 FR FR9615580A patent/FR2757173A1/fr not_active Withdrawn
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1997
- 1997-12-05 EP EP00119624A patent/EP1057862B1/en not_active Expired - Lifetime
- 1997-12-05 PT PT00119624T patent/PT1057862E/pt unknown
- 1997-12-05 PT PT97950816T patent/PT946637E/pt unknown
- 1997-12-05 AT AT00119624T patent/ATE365188T1/de active
- 1997-12-05 ES ES00119624T patent/ES2285985T3/es not_active Expired - Lifetime
- 1997-12-05 AT AT97950816T patent/ATE198612T1/de active
- 1997-12-05 KR KR10-1999-7005385A patent/KR100502383B1/ko not_active IP Right Cessation
- 1997-12-05 WO PCT/US1997/022177 patent/WO1998027151A1/en active IP Right Grant
- 1997-12-05 ES ES97950816T patent/ES2155703T3/es not_active Expired - Lifetime
- 1997-12-05 EP EP97950816A patent/EP0946637B1/en not_active Expired - Lifetime
- 1997-12-05 AU AU53714/98A patent/AU5371498A/en not_active Abandoned
- 1997-12-05 DK DK00119624T patent/DK1057862T3/da active
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- 1997-12-05 DK DK97950816T patent/DK0946637T3/da active
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- 1997-12-05 JP JP52776198A patent/JP2001506692A/ja active Pending
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2000
- 2000-05-30 HK HK00103187A patent/HK1024013A1/xx not_active IP Right Cessation
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2001
- 2001-03-15 GR GR20010400429T patent/GR3035585T3/el unknown
- 2001-09-26 JP JP2001293558A patent/JP3822810B2/ja not_active Expired - Fee Related
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2002
- 2002-05-28 US US10/157,428 patent/US6517865B2/en not_active Expired - Lifetime
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- 2007-06-26 JP JP2007167528A patent/JP4838202B2/ja not_active Expired - Lifetime
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100358510C (zh) * | 2005-04-27 | 2008-01-02 | 中国科学院海洋研究所 | 一种红藻多糖植物膳食纤维药用硬胶囊的制备方法 |
| CN101203213B (zh) * | 2005-06-21 | 2011-06-15 | 玛奈·菲尔萨公司 | 吉兰糖无缝易碎胶囊及其制造方法 |
| CN104814878A (zh) * | 2007-05-21 | 2015-08-05 | 高露洁-棕榄公司 | 不渗透性胶囊 |
| CN105230576A (zh) * | 2015-11-06 | 2016-01-13 | 天津拓华生物科技有限责任公司 | 一种利用脱皮绿豆大规模生产绿豆象幼虫的方法 |
| CN105230576B (zh) * | 2015-11-06 | 2017-12-26 | 天津拓华生物科技有限责任公司 | 一种利用脱皮绿豆大规模生产绿豆象幼虫的方法 |
| CN113993508A (zh) * | 2019-05-15 | 2022-01-28 | 赢创运营有限公司 | 用胶囊填充机制备具有基于纤维素或淀粉的包衣的填充硬壳胶囊的方法 |
| CN110507629A (zh) * | 2019-09-02 | 2019-11-29 | 广东广发制药有限公司 | 一种植物纤维素软胶囊胶皮及其制备方法 |
| CN110507629B (zh) * | 2019-09-02 | 2021-02-23 | 广东广发制药有限公司 | 一种植物纤维素软胶囊胶皮及其制备方法 |
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Assignee: Suzhou capsule Co Ltd Assignor: WARNER-LAMBERT Co. Contract fulfillment period: 2008.9.24 to 2017.12.5 Contract record no.: 2008990000688 Denomination of invention: Polymer film composition for capsules Granted publication date: 20020724 License type: Exclusive license Record date: 20081013 |
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