CN107865969A - 包衣组合物、包衣制剂及其制造方法 - Google Patents
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Abstract
本发明的目的为提供一种包衣组合物、使用了该包衣组合物的制剂及其制造方法,所述包衣组合物提高在酸性下的耐溶解性(在胃环境下的不溶性),进一步使优异的肠溶性成为可能。解决方法为,包衣组合物含有(A)酯化度为3~40%的果胶、(B)选自钙盐和镁盐中的1种以上、(C)被膜形成成分;由(钙和镁)/(A)表示的质量比为0.002~0.1;由(C)/(A)表示的(A)成分与(C)成分的质量比为0.2~3。
Description
技术领域
本发明涉及包衣组合物、包衣制剂及其制造方法。
背景技术
正在寻求如下的肠溶性制剂:存在如乳酸菌和酶等蛋白质的功能成分这样地,通过防止胃内的分解一直维持结构直至到达肠道,从而发挥高功能性的成分,据此,在胃内不溶解而在肠道内溶解。
作为用于使有效成分直达肠道的保护膜,正在寻求在在胃中的pH条件(酸性)下不溶解、在小肠的pH条件(中性)下溶解的成分,一般地,在医药品中使用甲基丙烯酸系高分子化合物,在食品中使用紫胶和玉米醇溶蛋白,但需要进一步寻求使优异的肠溶性成为可能的包衣组合物。
[现有技术文献]
[专利文献]
专利文献1:日本专利特开第2005-027651号公报
发明内容
[发明所要解决的问题]
本发明鉴于上述情况而完成,其目的在于提供一种包衣组合物、使用该包衣组合物的制剂及其制造方法,所述包衣组合物能够提高在酸性下的耐溶解性(在胃环境下的不溶性),还使优异的肠溶性成为可能。
[解决问题的手段]
本发明人为达到上述目的进行了深入研究,结果发现,在使用果胶的情况下可获得一定的肠溶性的可能性。然而,发现了以下问题:用果胶调制成的薄膜虽然在酸性下(pH1.2)不溶解,但是存在脆弱、容易缺损的问题。对此,本发明人发现,与被膜形成成分组合后,在果胶中选择甲氧基化程度低、酯化度为3~40%、具有大量阴离子性基的果胶,提高在酸性下的耐溶解性,再并用钙盐或镁盐,使果胶交联,可以强化在酸性下的耐溶解性,获得高肠溶性能,进而完成了本发明。
据此,本发明提供下述发明。
[1].一种包衣组合物,其特征在于,含有(A)酯化度为3~40%的果胶、(B)选自钙盐和镁盐中的1种以上、(C)被膜形成成分;由(钙和镁)/(A)表示的质量比为0.002~0.1;由(C)/(A)表示的(A)成分与(C)成分的质量比为0.2~3。
[2].根据[1]所述的包衣组合物,其特征在于,(C)成分选自羟丙基甲基纤维素、聚乙烯醇、阿拉伯胶、羟丙基纤维素、普鲁兰多糖(pullulan)以及凝胶多糖(curdlan)中的1种以上。
[3].根据[1]或[2]所述的包衣组合物,其特征在于,(A)成分是通过(B)成分进行交联而得到的果胶。
[4].一种包衣制剂,其特征在于,在被包衣物的表面上形成有由[1]~[3]中任一项所述的包衣组合物形成的包衣层。
[5].根据[4]所述的包衣制剂,其特征在于,在被包衣物与包衣层之间,具有中间层,所述中间层含有(D)6质量%水溶液在25℃下的粘度小于300mPa·s的高分子化合物。
[6].一种[4]或[5]所述的包衣制剂的制造方法,其特征在于,包括向被包衣物或具有中间层的被包衣物喷雾包覆[1]~[3]中任一项所述的包衣组合物的工序。
[发明效果]
根据本发明,可以提供能够强化在酸性下的耐溶解性、获得高肠溶性能的包衣组合物、使用该包衣组合物的制剂及其制造方法。
具体实施方式
以下,对本发明进行详细说明。
(A)酯化度为3~40%的果胶
本发明的果胶是酯化度(甲氧基)为3~40%的果胶。从初期及保存后的耐胃性(gastro-resistance)、肠道环境中的溶解性的角度考虑,酯化度优选为22~35%,更优选为22~30%。如果酯化度超过40%,则钙或镁的交联不充分,没有充分发挥在酸性下的耐溶解性、在胃环境下的不溶性(以下,统一记为耐胃性)机能。如果酯化度小于3%,则分子量小,无法充分发挥耐胃性机能。另外,酯化度可以通过基于FCC及FAO/WHO中的测定方法的滴定法来测定。另外,果胶根据脱酯化的方法的差异而被大致划分为酸处理型与碱处理型(酰胺果胶),并无特别限定,但从包衣液中的溶解性以及凝胶化实施的角度考虑,优选酸处理型。
(A)成分的含量优选为组合物中的2~10质量%(固体含量),更优选为3~5质量%(固体含量)。另外,优选为包衣层中的30~55质量%,更优选为35~50质量%。
(B)选自钙盐及镁盐中的1种以上,作为钙盐,可列举出氯化钙、乳酸钙、糖精钙等水溶性钙盐;作为镁盐,可列举出氯化镁等水溶性镁盐。从在水中的溶解性高的角度考虑,优选氯化钙、乳酸钙、氯化镁。
(B)成分的含量优选为组合物中的0.02~0.5质量%(固体含量),更优选为0.04~0.2质量%(固体含量)。另外,优选为包衣层中的0.2~6质量%,更优选为0.5~3质量%。
另外,由(钙和镁)/(A)表示的质量比为0.002~0.1,从初期及保存后的耐胃性、肠道环境中的溶解性的角度考虑,优选为0.005~0.05,更优选为0.005~0.02。另外,“钙和镁”的量并不是(B)成分的盐量,而是钙和镁的量的总量,单独存在钙的情况是指钙量,单独存在镁的情况是指镁量。如果上述质量比大于0.1,则包衣组合物将凝胶化,初期和保存后的耐胃性、肠道环境中的溶解性变差,如果小于0.002,则无法充分发挥耐胃性机能。
(C)被膜形成成分
作为被膜形成成分,可使用粘度低的皮膜形成成分,可列举例如羟丙基甲基纤维素(HPMC)、聚乙烯醇(PVA)、阿拉伯胶、羟丙基纤维素(HPC)、普鲁兰多糖、凝胶多糖等,可单独使用1种或者适当组合2种以上使用。其中,优选羟丙基甲基纤维素、聚乙烯醇、普鲁兰多糖,更优选羟丙基甲基纤维素。
(C)成分的含量优选为组合物中的0.5~5质量%(固体含量)),更优选为0.5~2质量%(固体含量)。另外,优选为包衣层中的5~45质量%,更优选为10~30质量%。
由(C)/(A)表示的(A)成分与(C)成分的质量比为0.2~3,从初期及保存后的耐胃性、肠道环境中的溶解性的角度考虑,优选为0.2~0.8,更优选为0.3~0.5。如果上述比率大于3,则无法充分发挥耐胃性机能。另外,如果小于0.2,则膜的形成性降低,无法充分发挥耐胃性机能。
在不妨碍本发明的效果的范围,可以在本发明的包衣组合物中添加任意成分。作为这种成分,可列举出增塑剂、附着防止剂、润滑剂、消泡剂、着色剂等。
作为增塑剂,可列举出蔗糖脂肪酸酯、甘油脂肪酸酯、单甘油脂肪酸酯、聚氧乙烯失水山梨糖醇脂肪酸酯等表面活性剂;甘油、丙二醇、聚乙二醇等多元醇;葡萄糖、果葡糖浆、蔗糖等糖;山梨糖醇、麦芽糖醇、甘露糖醇、赤藓糖醇、木糖醇等糖醇;十二烷醇、十三烷醇、十四烷醇、十五烷醇、十六烷醇(hexadecanol)、十七烷醇、十八烷醇、1-十六烷醇(hexadecyl alcohol)、异硬脂醇、2-辛基十二烷醇等(适宜的为碳原子数6~22)的高级醇;中链脂肪酸酯(适宜的为碳原子数6~12)等油脂。这些可以1种单独使用或适当组合2种以上使用。其中,从包衣膜的增塑效果的角度考虑,优选为甘油,从肠溶性的角度考虑,优选为表面活性剂,更优选为甘油和/或蔗糖脂肪酸酯。相对于包衣组合物,增塑剂的含量优选为0.2~5质量%(固体含量),更优选为0.5~2质量%(固体含量)。另外,包衣层中,优选为2~25质量%,更优选为5~20质量%。
作为附着防止剂和润滑剂,可列举出滑石、硬脂酸钙、二氧化硅等,可1种单独使用或者适当组合2种以上使用。微粒的粒径为0.01~50μm,优选为0.1~20μm。另外,粒径的测定使用激光衍射式粒度分布测定装置来进行。相对于包衣组合物,附着防止剂和润滑剂的含量优选为0.1~2质量%(固体含量),更优选为0.2~1.5质量%(固体含量)。另外,优选为包衣层中的1~20质量%,更优选为5~15质量%。
作为消泡剂,可列举出例如甘油脂肪酸酯、二甲基聚硅氧烷、二甲基聚硅氧烷·二氧化硅混合物、含水二氧化硅、二氧化硅等,可单独1种使用或者适当组合2种以上使用。
作为着色剂,可列举出例如儿茶单宁粉末、姜黄提取液、黄氧化铁、柑橙精华、褐色氧化铁、炭黑、焦糖、胭脂红、胡萝卜素液、β-胡萝卜素、甘草提取物、金箔、黑色氧化铁、轻质无水硅酸、氧化钛、氧化铁、食用蓝色1号、食用黄色4号、食用黄色4号铝色淀、食用黄色5号、食用红色2号、食用红色3号、食用红色102号、氢氧化钠、叶绿素铜钠、叶绿素铜、裸麦绿叶提取物、药用炭、核黄素丁酸酯、核黄素、绿茶粉末、核黄素磷酸钠等。
[包衣组合物]
(A)酯化度为3~40%的果胶通过(B)选自于钙盐和镁盐中的1种以上被交联,进一步发挥出耐胃性机能。包衣组合物中的水分含量并无特别的限定,可以适当从50~98质量%中选定。
[包衣制剂]
使用上述包衣组合物,可以制成在被包衣物的表面上形成由包衣组合物形成的包衣层的包衣制剂。
本发明的包衣组合物以及由该包衣组合物形成的包衣膜具有肠溶性,即具有“在胃内不溶解而在肠道内溶解,能使被包衣物到达肠道”的性质。
本发明中,“肠溶性”是指,按照日本药典的溶出试验法,在相当于胃液的溶出试验液(pH1.2)中,2小时的溶出率在20%以下,在相当于肠液的溶出试验液(pH6.8)中,2小时的溶出率在70%以上。
包衣膜的厚度并无特别限定,但优选为5μm~1mm,更优选为10~500μm。另外,相对于包衣制剂,包衣膜优选为0.5~30质量%,更优选为1~25质量%。
相对于包衣膜,包衣膜的水分含量优选为10~30质量%,更优选为15~25质量%。
作为被包衣物,并无特别限定,可列举出食品、医药品等有效成分等。例如,可列举出乳酸菌、半胱氨酸、铁、抗体和乳铁蛋白等蛋白质、肽、ATP-2Na等,这些可以1种单独使用或者适当组合2种以上使用。其中,以蛋白质等高分子量成分和水不溶性成分为宜。从包衣片的外观性以及在肠道环境中的溶出性的角度考虑,优选结晶纤维素40~100mg(1片中)、麦芽糖醇40~80mg(1片中)。
被包衣物的形状、剂型并无特别限定,不特别限定于片剂、粉剂、细颗粒剂、颗粒剂等。片剂既可以是单层也可以是二层以上。其中,从进一步发挥肠溶性的角度考虑,优选制成片剂。片剂的尺寸并无特别限定,从片剂的易处理性与吞咽性的角度考虑,片剂的直径优选为5~14mmΦ,更优选为7~12mmΦ。另外,每片片剂的质量适合为150~700mg左右,片剂的形状并无特别限定,有圆型(R片、2层R片、角平片等)、三角形、四边形、六边形、八边形、椭圆形、橄榄球型等,优选为圆型的R片、2层R片。
优选本发明的包衣制剂在被包衣物与包衣层之间,具有含有(D)6质量%水溶液在25℃下的粘度小于300mPa·s的高分子化合物的中间层。通过设置该中间层,进一步提高耐胃性机能。作为6质量%水溶液在25℃下的粘度小于300mPa·s的高分子化合物,可使用粘度低的皮膜形成成分,例如可列举出羟丙基甲基纤维素(HPMC)、聚乙烯醇(PVA)、阿拉伯胶、羟基丙基纤维素(HPC)、普鲁兰多糖、凝胶多糖等,可单独使用1种或者适当组合2种以上使用。其中,优选为羟丙基甲基纤维素(HPMC)、聚乙烯醇(PVA)、羟丙基纤维素(HPC),更优选为羟丙基甲基纤维素(HPMC)。相对于形成中间层的包衣组合物,(C)成分的含量优选为1~20质量%(固体含量),更优选为2~10质量%(固体含量)。另外,优选为中间层中的20~80质量%,更优选为30~70质量%。
在中间层中,除了(D)成分以外,还可以含有甘油、蔗糖脂肪酸酯等成分。相对于形成中间层的包衣组合物,这些成分的含量优选为0.1~10质量%(固体含量),更优选为0.5~5质量%(固体含量);相对于中间层,这些成分的含量优选为1~40质量%,更优选为5~30质量%。
相对于包衣层的量,中间层的量优选为5~50质量%,更优选为10~50质量%。通过在5质量%以上,可以获得经时的充分的耐胃性。另外,可获得平滑的包衣片。另外,通过在50质量%以下,在肠道环境下的溶出性变良好。另外,(D)成分在包衣中间层中的含量优选为10~80质量%,更优选为20~70质量%。
相对于中间层,中间层的水分含量优选为5~40质量%,更优选为10~30质量%。
[包衣制剂的制造方法]
包衣组合物可以通过混合上述必要成分而获得;包衣制剂可通过如下方法获得:通过向被包衣物,直接喷雾包衣组合物、或者喷雾添加有水的包衣溶液,进行干燥,从而在被包衣物的表面上形成包衣膜。本发明的包衣组合物由于为水性,故而使用了水的包衣是可行,能形成水溶性膜。
包衣溶液含有包衣组合物及水,包衣溶液的水分含量优选为50~98质量%,更优选为70~96质量%。另外,在不损及本发明的效果范围内,还可以添加乙醇等有机溶剂。
包衣机并无特别限定,可使用锅式包衣机(pan coating machine)、流动层式包衣机、滚动式包衣机等。
包衣方法并无特别的限定,例如可列举出以下方法:通过向被包衣物喷雾包衣溶液,通过加温使其干燥,从而使被包衣的表面薄膜化的方法。包衣溶液可以适当加温,温度优选为30~80℃,干燥温度优选为40~80℃。相对于干燥风量1m3/min,包衣溶液的添加速度优选为1~5g/min。另外,还可以采用将被包衣物浸渍于包衣溶液中、使其干燥的浸涂方法。干燥优选使其干燥直至将包衣制剂中的水分含量为上述适宜范围内。
设置中间层的情况下,只要在进行上述包衣之前,调制(D)6质量%水溶液在25℃下的粘度小于300mPa·s的高分子化合物溶液,以与上述同样的方法进行包衣即可。中间层溶液的水分含量优选为50~99质量%,更优选为80~99质量%。
实施例
以下,给出实施例和比较例,对本发明进行具体说明,但本发明不限制于下述实施例。另外,下述的例子中如无特别说明,则组成的“%”表示质量%,比率表示质量比。
[实施例、比较例]
混合以下原料,使用打片机进行打片以变成片剂(300mg、Φ9.0mm、厚度5.3mm、2层R片(R1=3.6mm、R2=10.5、H=1.5mm)),调制素片。调制下述表1~4所示的组成的包衣溶液、下述表1所示的中间层溶液,按照下述方法包衣素片,调制包衣片(表2~4中无中间层)。对所获得的包衣片进行下述评价。结果一并记载于表中。
[素片]
每1片的质量
乳铁蛋白:110mg
荜拔提取物粉末:50mg
麦芽糖醇:50mg
结晶纤维素:80.5mg
羧甲基纤维素钙(CMC-Ca):6.0mg
硬脂酸钙:0.5mg
微粒二氧化硅:3.0mg
[中间层(第1层)]
〈中间层包衣液的调制〉
<包衣液的调制>
将全部原料混合搅拌,使其溶解,获得中间层包衣液。
<包衣>
使用包衣机(Freund产业(株)制造的HICOATER FZ-Lab),对素片200g,喷雾45g的中间层包衣液,使其干燥至水分残留量变为约20%,获得包衣片。
[包衣层(第2层)]
<包衣液的调制>
将(A)成分与(B)成分分散于一部分的水中,加热至80℃,使其溶解。将其它原料分散于剩余的水中,与上述液体混合,获得包衣液。
<包衣>
使用包衣机(Freund产业(株)制造的HICOATER FZ-Lab),对素片200g,喷雾300g的中间层包衣液,使其干燥至水分残留量变为约15~20%,获得包衣片。
<溶出性试验>
以乳铁蛋白的溶出性来评价包衣膜的溶解性。
评价刚刚包衣好的包衣片、包衣后在40℃、75%RH下保存4个月后的试样。
<试样溶液的调制>
使用日本药典1液(pH1.2),进行按照日本药典一般试验法的溶出试验。
使用日本药典2液(pH6.8),进行按照日本药典一般试验法的溶出试验。
<乳铁蛋白定量>
乳铁蛋白的定量法按照第9版食品添加剂规定和标准草案的方法。
<定量>
以上述溶出试验2小时后的采样溶液为试样溶液。分别各量取20μL的试样溶液以及3浓度的标准溶液,在以下操作条件下,进行液体色谱法由该校准曲线与试样溶液的乳铁蛋白面积,求出试样溶液中的乳铁蛋白浓度,按照下式,求出乳铁蛋白相对于乳铁蛋白100mg/片的溶出率。测定各自的标准液的乳铁蛋白峰面积,制作校准曲线。由该校准曲线与试样溶液的乳铁蛋白面积,求出试样溶液中的乳铁蛋白浓度,按照下式,求出相对于乳铁蛋白100mg/片的乳铁蛋白溶出率。
乳铁蛋白溶出率(%)=试样溶液中的乳铁蛋白浓度(mg/mL)×900(mL)×定量用乳铁蛋白的纯度(%)×1/100×1/100(mg)×100
色谱法条件
检测器:紫外吸光光度计(测定波长:280nm)
柱填料:5μm的液体色谱法用丁基化聚乙烯醇聚合物凝胶(Shodex Asahipak C4P-504D)
柱管:内径4.6mm、长度15cm的不锈钢管
保护柱:Shodex Asahipak C4P-50G 4A
柱温:35℃
移动相A
含0.03w/v%三氟乙酸的乙腈/氯化钠溶液(3→100)混液(10:90)
移动相B
含0.03w/v%三氟乙酸的乙腈/氯化钠溶液(3→100)混液(50:50)
浓度梯度进行了25分钟的从A:B(50:50)到(0:100)为止的直线浓度梯度。
流量:0.8mL/分钟
定量用乳铁蛋白:和光纯药工业(株)制造的生物化学用“乳铁蛋白、来自牛奶”
定量用乳铁蛋白的纯度(%):使用和光纯药工业(株)检查成绩书的含量(HPLC)的数值
根据溶出率,以下述基准表示结果。
日本药典1液(pH1.2);
2小时的溶出性在5%以下:◎
2小时的溶出性大于5%、在10%以下:○
2小时的溶出性大于10%%、在20%以下:●
2小时的溶出性大于20%:×
日本药典2液(pH6.8);
2小时的溶出性在90%以上:◎
2小时的溶出性在70%以上、小于90%:○
2小时的溶出性在30以上、小于70%:△
2小时的溶出性小于30%:×
日本药典1液的试验中,◎、○、●的情形为肠溶性,并且日本药典2液中,◎、○的情形为肠溶性。
[表1]
[表2]
[表3]
[表4]
调制实施例及比较例时所使用的原料如下所示。另外,表中的量为纯度换算量。
[表5]
Claims (6)
1.一种包衣组合物,其特征在于,
含有(A)酯化度为3~40%的果胶、(B)选自钙盐和镁盐中的1种以上、(C)被膜形成成分;
钙和镁/(A)表示的质量比为0.002~0.1;
由(C)/(A)表示的(A)成分与(C)成分的质量比为0.2~3。
2.根据权利要求1所述的包衣组合物,其特征在于,(C)成分选自羟丙基甲基纤维素、聚乙烯醇、阿拉伯胶、羟丙基纤维素、普鲁兰多糖以及凝胶多糖中的1种以上。
3.根据权利要求1或2所述的包衣组合物,其特征在于,(A)成分是通过(B)成分进行交联而得到的果胶。
4.一种包衣制剂,其特征在于,在被包衣物的表面上形成有由权利要求1~3中任一项所述的包衣组合物形成的包衣层。
5.根据权利要求4所述的包衣制剂,其特征在于,在被包衣物与包衣层之间具有中间层,所述中间层含有(D)6质量%水溶液在25℃下的粘度小于300mPa·s的高分子化合物。
6.一种权利要求4或5所述的包衣制剂的制造方法,其特征在于,包括向被包衣物或具有中间层的被包衣物喷雾包覆权利要求1~3中任一项所述的包衣组合物的工序。
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KR (1) | KR20180035136A (zh) |
CN (1) | CN107865969A (zh) |
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CN108543072A (zh) * | 2018-04-09 | 2018-09-18 | 鲍引健 | 一种包衣用组合物及其相关用途 |
CN112272991A (zh) * | 2020-10-28 | 2021-01-29 | 青岛市农业科学研究院 | 一种花生用抗黄曲霉侵染的新型绿色植物多糖包衣及其应用方法 |
CN112336850A (zh) * | 2019-08-06 | 2021-02-09 | 狮王株式会社 | 含乳铁蛋白的肠溶片和其制造方法 |
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SG11202000445TA (en) * | 2017-08-09 | 2020-02-27 | Lion Corp | Coating composition, coating film, and coating preparation and method for producing same |
JP7149169B2 (ja) * | 2018-09-21 | 2022-10-06 | 株式会社Screenホールディングス | 錠剤印刷装置および錠剤印刷方法 |
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CN112336850A (zh) * | 2019-08-06 | 2021-02-09 | 狮王株式会社 | 含乳铁蛋白的肠溶片和其制造方法 |
CN112272991A (zh) * | 2020-10-28 | 2021-01-29 | 青岛市农业科学研究院 | 一种花生用抗黄曲霉侵染的新型绿色植物多糖包衣及其应用方法 |
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JP2018053059A (ja) | 2018-04-05 |
TW201813633A (zh) | 2018-04-16 |
JP6780412B2 (ja) | 2020-11-04 |
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