CN114948896B - 一种新型软胶囊囊材配方 - Google Patents
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Abstract
本发明公开了一种新型软胶囊囊材配方,属于药用材料技术领域,所述的囊材组分按囊材的总重量计,各组份的重量百分比为:基质30~50%、聚合甘油10~22%、焦磷酸钠0.6~1.6%、纯化水35~55%、附加剂1~5%;所述基质为田菁胶、黄原胶、K型‑卡拉胶、明胶、瓜尔胶、桃胶其中一种以及任意两种或两种以上的组合。本发明的制备工艺简单,原料来源丰富、绿色环保;本发明提供的囊材氧透过率低、保温性能好、崩解速率优异;本发明提供的囊材安全性高、适用性广、稳定性高,利于保护易氧化的软胶囊内容物。
Description
技术领域
本发明属于药用材料技术领域,具体涉及一种新型软胶囊囊材配方。
背景技术
软胶囊剂指将药材提取物、液体药物或与适宜辅料混匀后用滴制法或压制法密封于亲水性软质囊材中制成球形、椭圆形或其他形状的剂型。软胶囊适合于不稳定的药效物质,如对光敏感、挥发性、遇湿热不稳定和易氧化的化学成分,也适合具有不适口味和不良嗅味的药效物质。软胶囊口服后,由于药物被亲水性明胶皮包裹很快在消化道崩解,药物释放较快。软胶囊囊材处方包括胶料、增塑剂、水、附加剂四类物质,胶料是构成囊壳的主要成分,例如明胶以及明胶替代材料等;增塑剂常用甘油、多元醇,单独或混合使用均可;附加剂包括防腐剂、着色剂、崩解剂、遮光剂、抗氧剂等,以保持药物与软胶囊剂型的质量稳定性。传统的软胶囊囊材配方主要包括明胶、水、甘油以及选定色素,由传统配方制成的囊材制作软胶囊,品质一般。
聚合甘油是无色黏稠状的液体或半固体,可溶于水及乙醇,吸湿性比甘油略低,它是一种多元醇。聚合甘油比甘油的黏度与沸点高,挥发性及吸湿性小,保湿性好,并且有提高乳化稳定性的特点。利用其吸湿性和保湿性的特点可用作化妆品的原料;把纤维浸在聚合甘油及其他化合物的水溶液中,可改进疏水性纤维的表面柔韧性和亲水性,同时可作为水不溶性染料的染色助剂。本发明中胶体、聚合甘油、焦磷酸钠交联形成一种全新的交联物质,其韧性更好,以甘油为增塑剂的囊壳其氧气穿透力强,而本发明中提供的交联物质能显著降低氧的穿透力,从而防止囊壳过快老化。
植物软胶囊囊材包括田菁胶、黄原胶、卡拉胶、明胶、瓜尔胶,是以植物多糖代替动物明胶为原料制成的软胶囊囊材,它保留了标准动物胶囊材的全部优点,诸如方便服用、有效掩盖味道和气味、内容物透明可见等。另外,植物胶囊材具有更好的包衣特性,植物本身与大多数高分子材料有较好的亲和性,特别适合缓控释包衣性胶囊剂的制备。植物软胶囊囊材与传统的明胶软胶囊囊材相比具有安全性高、适用性广、稳定性高及不存在交联反应的优点。
发明内容
本发明提供了一种新型软胶囊囊材配方,安全性高、适用性广、稳定性高;氧透过率低、保湿性能好、崩解速率优异。原料来源丰富,绿色环保等优点,制备方法工艺简单,可以用于为对氧敏感的药物活性物质的胶囊填充生产,在胶囊制剂领域中具有很好的应用前景。
本发明提供的一种新型软胶囊囊材配方,所述的囊材组分按囊材的总重量计,各组份的重量百分比为:基质30~50%、聚合甘油10~22%、焦磷酸钠0.6~1.6%、纯化水35~55%、附加剂1~5%;
所述基质为田菁胶、黄原胶、K型-卡拉胶、明胶、瓜尔胶、桃胶其中一种以及任意两种或两种以上的组合。
进一步,所述聚合甘油的聚合度为10~12。
进一步,所述附加剂为遮光剂二氧化钛、崩解剂聚乙二醇-400。
进一步,所述崩解剂占囊材总重量计的2~5%,遮光剂与基质的重量比为0.002~0.01∶1。
进一步,囊材的制备方法为:将基质、聚合甘油、焦磷酸钠混合后加入到50~90℃纯化水中,再加入附加剂,搅拌1~3h后,50~60℃时保温0.5~2h,静置消泡,密闭备用。
进一步,所述纯化水的温度为50~90℃,优选70~85℃;保温时间为0.5~2h,优选1.5~2h。
与现有技术相比,本发明有益效果主要体现在:
(1)制备工艺简单,原料来源丰富、绿色环保。
(2)本发明提供的囊材氧透过率低、保湿性能好、崩解速率优异。
(3)本发明提供的囊材安全性高、适用性广、稳定性高,利于保护易氧化的软胶囊内容物。
具体实施方式
1、新型软胶囊囊材的制备
实施例1
一种新型软胶囊囊材配方:
K型-卡拉胶 52.5g;
聚合甘油 19.8g;
焦磷酸钠 1.2g;
纯化水 72g;
聚乙二醇-400 4.05g;
二氧化钛 0.45g。
制备步骤:将72g纯化水加热到75℃时,将52.5gK型-卡拉胶、19.8g聚合甘油(聚合度为10)、1.2g焦磷酸钠混合后加入到纯化水中,再加入0.45g二氧化钛、4.05g聚乙二醇-400,搅拌2h后,55℃时保温2h,静置消泡,密闭备用。
实施例2
一种新型软胶囊囊材配方:
田菁胶 60g;
聚合甘油 22.22g;
焦磷酸钠 1.78g;
纯化水 60g;
聚乙二醇-400 5.7g;
二氧化钛 0.3g。
制备步骤:将60g纯化水加热到80℃时,将60g田菁胶、22.22g聚合甘油(聚合度为10)、1.78g焦磷酸钠混合后加入到纯化水中,再加入0.3g二氧化钛、5.7g聚乙二醇-400,搅拌2h后,55℃时保温1.5h,静置消泡,密闭备用。
实施例3
一种新型软胶囊囊材配方:
明胶 67.5g;
聚合甘油 17.04g;
焦磷酸钠 1.71g;
纯化水 60g;
聚乙二醇-400 3.6g;
二氧化钛 0.15g。
制备步骤:将60g纯化水加热到60℃时,将67.5g明胶、17.04g聚合甘油(聚合度为10)、1.71g焦磷酸钠混合后加入到纯化水中,再加入0.15g二氧化钛、3.6g聚乙二醇-400,搅拌2h后,55℃时保温0.5h,静置消泡,密闭备用。
实施例4
一种新型软胶囊囊材配方:
桃胶 60g;
聚合甘油 18.09g;
焦磷酸钠 1.26g;
纯化水 67.5g;
聚乙二醇-400 3g;
二氧化钛 0.15g。
制备步骤:将67.5g纯化水加热到85℃时,将60g桃胶、18.09g聚合甘油(聚合度为11)、1.26g焦磷酸钠混合后加入到纯化水中,再加入0.15g二氧化钛、3g聚乙二醇-400,搅拌2h后,55℃时保温1.5h,静置消泡,密闭备用。
实施例5
一种新型软胶囊囊材配方:
黄原胶 45g;
聚合甘油 18.42g;
焦磷酸钠 0.93g;
纯化水 82.5g;
聚乙二醇-400 3g;
二氧化钛 0.15g。
制备步骤:将82.5g纯化水加热到50℃时,将45g黄原胶、18.42g聚合甘油(聚合度为12)、0.93g焦磷酸钠混合后加入到纯化水中,再加入0.15g二氧化钛、3g聚乙二醇-400,搅拌1h后,55℃时保温1h,静置消泡,密闭备用。
实施例6
一种新型软胶囊囊材配方:
瓜尔胶 60g;
聚合甘油 27.78g;
焦磷酸钠 2.22g;
纯化水 52.5g;
聚乙二醇-400 7.35g;
二氧化钛 0.15g。
制备步骤:将52.5g纯化水加热到70℃时,将60g瓜尔胶、27.78g聚合甘油(聚合度为11)、2.22g焦磷酸钠混合后加入到纯化水中,再加入0.15g二氧化钛、7.35g聚乙二醇-400,搅拌3h后,55℃时保温1h,静置消泡,密闭备用。
对比例1
一种新型软胶囊囊材配方:
明胶 67.5g;
甘油 18.75g;
纯化水 60g;
聚乙二醇-400 3.6g;
二氧化钛 0.15g。
制备步骤:将60g纯化水加热到60℃时,将67.5g明胶、18.75g甘油混合后加入到纯化水中,再加入0.15g二氧化钛、3.6g聚乙二醇-400,搅拌2h后,55℃时保温0.5h,静置消泡,密闭备用。
2、软胶囊囊材的氧透过率评价
将实施例1-6与对比例1用胶囊机分别制成湿胶皮:厚度分别为0.25mm(干燥后约0.15mm)与0.75mm(干燥后约0.50mm);干燥至水分9.0%-12.0%的囊材后,分别用氧透过率测试仪测定其氧透过率(注:RH是相对湿度,h是小时,cc是容积/体积计量单位立方厘米,cc/m2.24h是氧透过率的单位)。
表1实施例1-6与对比例1软胶囊囊材的氧透过率
上述表1的数据结果显示:本发明实施例的软胶囊囊材氧透过率显著降低。
3、软胶囊的崩解时限评价
同一内容物的软胶囊制备:将上述实施例1-6与对比例1胶液分别导入压制式软胶囊机中压制,形成的胶皮进入滚模中,内容物(例如:尼莫地平药液)从两片胶皮中注入,洗丸干燥后分别得到实施例1-6与对比例1的软胶囊各100粒。
崩解时限的评价方法:取本品6粒,照崩解时限检查法(胶囊剂法:将崩解仪的吊篮通过上端的不锈钢轴悬挂于金属支架上,浸入1000ml烧杯中,并调节吊篮位置使其下降时筛网距烧杯底部25mm,烧杯内盛有温度为37℃±1℃的水,调节水位高度使吊篮上升时筛网在水面下15mm处。),加挡板,启动崩解仪进行检查,软胶囊应在1小时内全部崩解,如有1粒不能完全崩解,应另取6粒复试,均应符合规定。
表2实施例1-6与对比例1软胶囊的崩解时限
实施例 | 崩解时限(min) |
实施例1 | 8.3 |
实施例2 | 8 |
实施例3 | 9.3 |
实施例4 | 8.5 |
实施例5 | 9.7 |
实施例6 | 9 |
对比例1 | 15.2 |
上述表2的数据结果显示:本发明实施例的软胶囊有优异的崩解速率。
4、软胶囊稳定性实验
将上述导入内容物的实施例1-6与对比例1软胶囊作为测试样品,测试样品在不同条件下的稳定性。其中室温干燥存储条件为25℃、相对湿度20%,高温高湿储存条件为60℃、相对湿度90%,震荡条件为100次/分钟摇晃震荡,每项测试取样品20粒。
表3实施1-6与对比例1软胶囊在不同条件下的稳定性
注:高温高湿测试中无明显变化为3个月后软胶囊表面有吸湿软化现象,但不变形,晾干后与初始状态无变化。
上述表3的数据结果显示:本发明实施例的软胶囊的稳定性高。
Claims (6)
1.一种软胶囊囊材,其特征在于,所述的囊材组分按囊材的总重量计,各组份的重量百分比为:基质30~50%、聚合甘油10~22%、焦磷酸钠0.6~1.6%、纯化水35~55%、附加剂1~5%;
所述基质为田菁胶、黄原胶、K型-卡拉胶、明胶、瓜尔胶、桃胶其中一种以及任意两种或两种以上的组合。
2.根据权利要求1所述的一种软胶囊囊材,其特征在于,所述聚合甘油的聚合度为10~12。
3.根据权利要求1所述的一种软胶囊囊材,其特征在于,所述附加剂为遮光剂二氧化钛、崩解剂聚乙二醇-400。
4.根据权利要求3所述的一种软胶囊囊材,其特征在于,所述崩解剂占囊材总重量计的2~5%,所述遮光剂与基质的重量比为0.002~0.01:1。
5.一种如权利要求1-4任意一项所述的一种软胶囊囊材的制备方法,其特征在于,所述制备方法为:将基质、聚合甘油、焦磷酸钠混合后加入到50~90℃纯化水中,再加入附加剂,搅拌1~3h后,50~60℃时保温0.5~2h,静置消泡,密闭备用。
6.如权利要求5所述的制备方法,其特征在于,所述纯化水的温度为70~85℃,保温时间为1.5~2h。
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DE102016110089A1 (de) * | 2016-06-01 | 2017-12-07 | Christine Konert | Kapsel für die portionsweise Zubereitung eines Getränks |
CN111265712A (zh) * | 2020-03-27 | 2020-06-12 | 浙江工业大学 | 一种负载植物精油的水凝胶及其制备方法 |
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EP1045022A1 (de) * | 1999-04-15 | 2000-10-18 | Greither, Peter | Verwendung von Gelatine in Waschmitteln |
CN102499910A (zh) * | 2011-12-15 | 2012-06-20 | 山西吉呈生物技术有限公司 | 一种基于普鲁兰多糖的硬壳胶囊 |
DE102016110089A1 (de) * | 2016-06-01 | 2017-12-07 | Christine Konert | Kapsel für die portionsweise Zubereitung eines Getränks |
CN111265712A (zh) * | 2020-03-27 | 2020-06-12 | 浙江工业大学 | 一种负载植物精油的水凝胶及其制备方法 |
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