CN117120039A - 明胶胶囊剂 - Google Patents
明胶胶囊剂 Download PDFInfo
- Publication number
- CN117120039A CN117120039A CN202280027098.2A CN202280027098A CN117120039A CN 117120039 A CN117120039 A CN 117120039A CN 202280027098 A CN202280027098 A CN 202280027098A CN 117120039 A CN117120039 A CN 117120039A
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- Prior art keywords
- capsule
- gelatin
- film
- acid
- malic acid
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Abstract
本发明提供一种崩解迟缓得到抑制的明胶胶囊剂。一种胶囊剂,以明胶作为基材,且具有含有苹果酸或其盐的胶囊皮膜。
Description
技术领域
本发明涉及一种崩解迟缓得到抑制的明胶胶囊剂。
背景技术
将明胶作为皮膜的胶囊剂具有对人体无害且在体内迅速地溶解等优点,因此,特别是在食品领域中是最常用的剂型。然而,明胶存在由于基于热变性的不溶解或基于氧化的明胶分子的交联结构的形成等而导致崩解迟缓的问题。其中,特别是存在如下问题:在填充内容物中包含DHA、EPA等不饱和脂肪酸、由具有不饱和脂肪酸残基的油脂构成的油成分、维生素类、多酚等的情况下,通过皮膜部明胶分子与填充内容物的相互作用,随时间产生明胶皮膜的不溶解,制剂的崩解显著地延迟的问题。如果产生这样的崩解迟缓,则药物的生物利用度降低,因此无法充分地得到所期待的效果。
作为崩解迟缓防止方法,例如报告了在明胶皮膜中配合氨基酸的方法(专利文献1)、配合柠檬酸的方法(专利文献2)、配合肌醇六磷酸(植酸)的方法(专利文献3)、配合酒石酸的方法(专利文献4)等。
然而,基于这些方法的崩解迟缓防止效果并不一定是充分的,而且,也担心因有机酸的添加而产生由粘度降低导致的皮膜的强度降低、对外观产生影响等问题。
现有技术文献
专利文献
专利文献1:日本特公昭57-30088号公报
专利文献2:日本特开昭59-39834号公报
专利文献3:日本特开2006-328044号公报
专利文献4:日本特许5829607号公报
发明内容
本发明涉及一种崩解迟缓得到抑制的明胶胶囊剂。
本发明人等鉴于上述状况进行了研究,其结果是,发现通过在包含明胶的胶囊皮膜中使苹果酸或其盐存在,从而不会发生粘度的显著降低,能够有效地抑制皮膜对水的溶解性的降低。
即,本发明涉及以下的1)~6)。
1)一种胶囊剂,其以明胶作为基材,且具有含有苹果酸或其盐的胶囊皮膜。
2)根据1)所述的胶囊剂,其中,皮膜中的苹果酸或其盐的含量相对于明胶100质量份为0.5~12质量份。
3)根据1)或者2)所述的胶囊剂,其为软胶囊剂。
4)根据1)~3)中任一项所述的胶囊剂,其内包选自a)不饱和脂肪酸、b)含有不饱和脂肪酸作为构成脂肪酸的油脂、c)维生素类、d)多酚类、e)含有选自上述a)~d)中的任1种以上的天然材料、f)蕈类、g)发酵提取物、h)香料、i)矿物质类、j)氨基酸、k)蛋白质或者肽以及l)微生物或其代谢物中的1种以上而成。
5)一种胶囊皮膜组合物,含有明胶、苹果酸或其盐、以及增塑剂。
6)一种胶囊剂的崩解迟缓抑制方法,其中,在将明胶作为基材的胶囊剂中,将苹果酸或其盐配合于胶囊皮膜。
根据本发明,可以提供一种在体内的崩解迟缓受到抑制,品质性、稳定性优异的胶囊剂。
具体实施方式
本发明的胶囊剂是将明胶作为基材的胶囊剂(明胶胶囊剂),具有含有苹果酸或其盐的胶囊皮膜。
在本发明中,作为胶囊皮膜的基剂的明胶是对来自于牛、羊、猪、鸡、鱼等的皮、骨、腱等的作为主蛋白质成分的胶原的原料用酸、碱进行处理后用温水提取而得到的胶原的改性物。作为本发明中使用的明胶,胶原的来源、处理方法没有特别限定。
胶囊皮膜中的明胶的含有率没有特别限制,例如相对于胶囊皮膜的总质量,优选为60~90质量%,更优选为65~85质量%。
苹果酸(malic acid)也被称为2-羟基丁二酸(2-hydroxybutanedioic acid),是被分类为羟基酸的有机化合物。苹果酸或其盐多用作饮料、食品的酸味料。
在本发明中,苹果酸可以是D体、L体、DL体(D体与L体的混合物)中的任一种,优选使用DL-苹果酸。另外,苹果酸可以为酸酐,也可以为水合物。
作为苹果酸的盐,可例示钠、钾等碱金属盐、钙等碱土类金属盐、镁盐等,没有特别限定,但优选为钠盐、钾盐,更优选为钠盐。
如后述的实施例所示,将苹果酸配合于皮膜的胶囊剂有效地抑制胶囊对水的溶解性的随时间降低。因此,将苹果酸配合于皮膜的明胶胶囊剂是崩解迟缓受到抑制的胶囊剂。另外,苹果酸或其盐是明胶胶囊剂、特别是软胶囊剂的崩解迟缓抑制剂,在将明胶作为基材的胶囊剂中配合于胶囊皮膜而使用,由此能够抑制胶囊剂的崩解迟缓。
崩解迟缓抑制效果可以通过将胶囊剂在规定的条件(例如40度、湿度75%下,1~3个月)保存后的崩解时间基于第十七改正日本药局方的崩解试验法测定而评价。
胶囊皮膜中的苹果酸或其盐的配合量可以考虑所期待的效果等适当地决定,但作为苹果酸(游离酸),以相对于明胶100质量份为0.5~12质量份来使用是适当的,优选为1~8质量份,更优选为2~6质量份。
胶囊皮膜可以与增塑剂适当地混合以赋予柔软性、弹性。作为增塑剂,可举出甘油类(例如甘油、二甘油、聚甘油等)、糖醇(山梨醇、木糖醇、赤藓糖醇、麦芽糖醇、甘露醇、环糖醇等)、二醇类(丙二醇、二丙二醇、1,3-丁二醇、乙二醇、聚乙二醇等)、二糖类、低聚糖等。
这种增塑剂的配合比率例如可举出相对于明胶100质量份为5~150质量份,优选为10~80质量份,更优选为20~50质量份。
另外,胶囊皮膜在不损害本发明的效果的范围内,可以根据需要包含色素类、附着防止剂(加工淀粉、二氧化硅等)等。
本发明的胶囊剂的形态可以是将内容物填充于胶囊的硬胶囊剂、用胶囊皮膜对内容物进行包被成型的软胶囊剂中的任一者,优选为软胶囊剂。
在本发明的胶囊剂中,作为胶囊的内容物没有特别限定,可举出作为医药品、医药部外品、化妆品、食品(健康食品、特定保健用食品、功能性食品、补充剂等)使用的各成分、调味料、香料、蕈类、发酵提取物、矿物质类、氨基酸、蛋白质、微生物或其代谢物等一般而言可填充于胶囊中的物质。其中,本发明的胶囊皮膜在内包选自a)不饱和脂肪酸、b)含有不饱和脂肪酸作为构成脂肪酸的油脂、c)维生素类、d)多酚类、以及e)含有上述a)~d)中的任1种以上的天然材料、f)蕈类、g)发酵提取物、h)香料、i)矿物质类、j)氨基酸、k)蛋白质或者肽以及l)选自微生物或其代谢物中的1种以上的情况下,特别有效。
这里,作为不饱和脂肪酸,可举出α-亚麻酸、硬脂酸、二十二碳六烯酸(DHA)、二十碳五烯酸(EPA)等ω3系的多元不饱和脂肪酸、亚油酸、γ-亚麻酸、花生四烯酸等ω6系的多元不饱和脂肪酸、ω9系的一元不饱和脂肪酸即油酸等。
另外,作为含有不饱和脂肪酸作为构成脂肪酸的油脂,例如可举出大豆油、菜籽油、红花油、米油、玉米油、葵花籽油、棉实油、橄榄油、芝麻油、落花生油、蚕蛹油、小麦胚芽油、紫苏油、亚麻油、芝麻油、印加果油、核桃油、猕猴桃种子油、鼠尾草种子油、葡萄种子油、澳洲坚果油、榛果油、南瓜籽油、椿油、茶实油、琉璃苣油、棕榈油、棕榈油精、棕榈硬脂、脂油、棕榈核油、可可脂、娑罗树果仁脂(Shorea(Sal)butter)、乳木果油、藻油等植物性油脂;鱼油、猪油、牛脂、黄油等动物性油脂;或它们的酯交换油、加氢油、分类油等油脂类,其中,优选为包含大量DHA、EPA等的ω3系脂肪酸的鱼油。
作为多酚类,例如可举出黄酮醇、异黄酮、丹宁、儿茶素、槲皮素、花青素、美肤多酚(Flavangenol)、类黄酮等,其中,优选为蓝莓、黑醋栗中包含的花青素、山竹提取物中包含的绕丹酮B。
另外,作为蕈类,例如可举出将姬松茸、裂蹄木层孔菌、亮盖灵芝、金针菇、末广茸、香菇、舞茸、白桦茸(Kabanoanatake)、伞菌、山珍美姬菇、瓦茸、软靴耳、多孔蕈拇茸、冬虫夏草、灵芝等蕈类直接干燥·粉碎而得到的粉末或其提取物。
作为发酵提取物,例如可举出对蔬菜类、果物类、豆类、谷类等植物、海草类、蕈类、糖类等使用酵母、乳酸菌、曲菌、红曲菌、乙酸菌、纳豆菌等微生物发酵而得到的发酵提取物。
作为矿物质类,例如可举出钙、磷、钠、钾、镁、锌、硒、铁以及铜等,这些可以作为无机或者有机盐使用。
作为氨基酸,可举出具有功能性的氨基酸、例如GABA(γ-氨基丁酸)、HMB(3-羟基异戊酸)、茶氨酸、5-ALA(5氨基乙酰丙酸)、β丙氨酸、胱氨酸、麦角硫因、硒氨酸、半胱氨酸、鸟氨酸、瓜氨酸等。
作为蛋白质或肽,可举出具有功能性的蛋白质或者肽、例如可举出弹性蛋白、胶原蛋白、肌肽、鹅肌肽、N-β丙氨酰-1-甲基-L-组氨酸(balenine)、谷胱甘肽等。
作为微生物,例如可举出发酵食品等中利用的属于乳酸杆菌属、乳球菌属、链球菌属、肠球菌属、明串珠菌(leuconostoc)属等的乳酸菌,双歧杆菌属细菌、真杆菌属细菌、丙酸杆菌属细菌,除此之外,还可举出芽孢杆菌属、醋杆菌属等的微生物。
本发明的胶囊剂的制造一般而言可以在胶囊皮膜中填充或封入内容物而制造。
胶囊皮膜通过在上述包含明胶、苹果酸或其盐以及增塑剂的皮膜组合物中添加适量的水,在加热下(70~90℃,优选在80℃左右)进行混合、搅拌,从而制备皮膜液(明胶溶液),成型并干燥,由此形成。
软胶囊剂有具有以利用旋转模在两张皮膜片材之间直接填充内容物并成型冲压的方式制造的旋转模式软胶囊、以使用双重喷嘴的滴下方式等制造的无缝胶囊等,但本发明的胶囊剂可以为任意形态。
在旋转模式软胶囊的制造中,由皮膜组合物制备皮膜液,成型为片状后,片材通过二个模辊的旋转而冲压,同时封入内溶液,皮膜被模辊压接而密封。
胶囊剂中的皮膜的干燥例如可以使用旋转鼓式干燥机等进行,干燥的温度、时间等条件可以通过内容物中包含的成分和胶囊皮膜中包含的成分的种类来适当地调整。例如可以举出干燥温度为15℃~35℃左右,湿度为10%RH~50%RH左右,干燥时间为0.5~2天左右。
如此制造的本发明的胶囊剂由于胶囊相对于水的溶解性的随时间降低受到抑制,并且作为皮膜基材的明胶的粘度降低也受到抑制,因此可以说是服用时崩解迟缓受到抑制、且品质和稳定性优异的胶囊剂。
实施例
实施例1软胶囊剂的制造<1>
(1)软胶囊剂A(含维生素C的软胶囊剂)
1)胶囊皮膜液的制备
将表1所示的各成分利用规定的比例混合,以约80℃的水浴,一边加热一边搅拌溶解,制备配合了苹果酸的皮膜的明胶溶液和未配合苹果酸的皮膜的明胶溶液。
[表1]
(质量份)
2)胶囊内容物的制备
如表2所示,将蜜蜡、Poem S-100以及葵花籽油按照规定量混合,以约70℃加热溶解后,冷却至40℃以下,加入维生素C进行搅拌。然后,进行湿式粉碎(胶体磨机)处理、过筛、脱泡,制成胶囊内容物。
[表2]
(mg/粒)
3)软胶囊剂的制造
将1)中制备的明胶溶液在(80℃)脱泡后,约静置10小时,使用旋转模式软胶囊填充机(OVALNo.5),将明胶溶液制成厚度0.8~0.9mm的薄膜,通过冷却而制成明胶片材。将该明胶片材以左右通过辊金属模具,间歇地施加约40℃的热而使明胶片材粘接,并在冲压之前利用泵填充2)中制备的胶囊内容物,冲压并成型,将得到的成型物干燥,制造软胶囊剂A。
(2)软胶囊剂B(含山竹提取物的软胶囊剂)
1)胶囊皮膜液的制备
与上述(1)同样地制备配合了苹果酸的皮膜和未配合苹果酸的皮膜的明胶溶液。
2)胶囊内容物的制备
如表3所示,对蜜蜡、Poem S-100、亚麻仁油、橄榄油在约70℃下加热溶解后,冷却至40℃以下,加入山竹提取物并进行了搅拌。然后,进行湿式粉碎(胶体磨机)处理、过筛、脱泡,制备胶囊内容物。
[表3]
(mg/粒)
3)软胶囊剂的制造
与(1)同样地制成明胶片材。将该明胶片材以左右通过辊金属模,间歇地施加约40℃的热而使明胶片材粘接,并在冲压之前利用泵填充2)中制备的胶囊内容物,冲压并成型,将成型品干燥,由此制造软胶囊剂B。
试验例1崩解性试验
将(1)实施例1中制造的软胶囊剂A和B分别置入玻璃瓶,用金属盖(内衬橡胶)进行密栓,在40℃、75%Rh的恒温恒湿槽内,以1个月为单位保持3个月,比较崩解时间。崩解时间是使用崩解试验器(ERWEKA公司制自动检测式崩解试验器ZT720),基于第十七改正日本药局方的崩解试验法进行测定的。
(2)结果
将结果示于表4。
在皮膜中配合了苹果酸的软胶囊剂A和B均是在40℃·3M的保存下,在“日局”规格的20分钟以内结束崩解,但在皮膜中未配合苹果酸的胶囊剂中,在40℃·1M保存下,需20分钟以上溶解,或者完全不溶解。
[表4.
试验例2明胶皮膜片材溶解试验
(1)明胶皮膜片材的制备
在i)500ml的玻璃烧杯中加入纯化水100g,向其中加入明胶(BCN200S(新田明胶))100g、甘油(食品添加剂甘油)35g并吸水溶胀后,在约80℃的水浴中一边加热一边搅拌溶解,制备明胶溶液。将制备的明胶溶液均匀地扩展到厚度约1mm,在室温25℃下干燥24小时,制成明胶皮膜片材(表5:基准皮膜)。
ii)在500ml的玻璃烧杯中置入纯化水100g,向其中加入明胶(BCN200S(新田明胶)100g、甘油(食品添加剂甘油)35g并吸水溶胀后,加入表5所示的有机酸3g,在约80℃的水浴中一边进行加热一边搅拌溶解,制备配合了有机酸的明胶溶液。与i)同样地制成明胶皮膜片材A~F。
应予说明,在表5中,甘油使用“食品添加剂甘油”、苹果酸使用“苹果酸Soft tapyS(扶桑化学工业)”,植酸使用“食品添加剂植酸(扶桑化学工业)的50%水溶液”,柠檬酸使用“柠檬酸酐”,葡萄糖酸使用“葡萄糖酸液(50%水溶液)”。
[表5]
(g)
(2)溶解试验
假定含有鱼油作为胶囊内容物的胶囊剂,向螺旋管内取10g鱼油(DHA-46G:日本水产),向其中浸渍将各明胶皮膜片材切割成7mm×7mm而成的片材,保存于50℃的恒温槽。
随时间分别取出保存的明胶皮膜片材,擦去附着的鱼油后,置入60℃的温水150ml并利用搅拌器(磁力搅拌器,600rpm)搅拌3分钟后,静置,并目视观察确认是否有不溶物,由此观察直到不溶解为止的天数,按照以下所示的基准进行评价。将结果示于表6。
<评价基准>
皮膜片完全溶解,完全确认不到不溶物的情况:-
皮膜片溶解,但能确认到微量不溶物的情况:±
皮膜片溶解,但能确认到少量不溶性的皮膜的情况:+
皮膜片溶解,但能确认到中量不溶性的皮膜的情况:++
皮膜片溶解,但能确认到大量不溶性的皮膜的情况:+++
皮膜片完全不溶解:++++
[表6]
不溶物的有无
包含葡萄糖酸的皮膜片材D和包含琥珀酸的皮膜片材E与基准皮膜相同,在第5天变为不溶解,没有确认到防止不溶解的效果。在包含苹果酸的皮膜片材A、包含植酸的皮膜片材B、包含柠檬酸的皮膜片材C中,可确认到抑制不溶解的效果,其中,确认到包含苹果酸的皮膜片材A的效果最好。
试验例3明胶皮膜溶液的加温保管时的粘度降低
软胶囊的制造一般而言是如下进行的:1)在明胶中添加甘油、纯化水,一边加温到70~80℃一边搅拌溶解后,进行真空脱泡,制备明胶溶液(粘度调整为20000mPa·s),将该明胶溶液在60℃下加热4~10小时并保管。2)然后,将加热60℃的明胶皮膜溶液供给到胶囊填充机,通过对内容液填充·成型而进行。因此,明胶溶液是从制备到胶囊填充、成型结束为止加热约40小时左右,加热至60℃。另一方面,已知明胶溶液在60℃保管时粘度随时间降低,从初始值20000mPa·s降低至14000mPa·s以下(从初始值起至70%以下),从而产生明胶皮膜强度降低,填充时的机械故障、成型的软胶囊的强度不足所导致的破裂、变形等致命的不良情况。担心通过向明胶溶液中添加有机酸从而可能导致粘度降低。因此,对于该点进行了以下的试验。
1)明胶溶液的制备
向500ml玻璃烧杯中加入纯化水112g,对称量的表7所示的有机酸7g进行搅拌溶解(酒石酸和琥珀酸是投入纯化水后,在约80℃的水浴中一边进行加热一边进行溶解)。接着,加入明胶(BCN200S(新田明胶))140g、甘油(“食品添加剂甘油”)49g并吸水溶胀后,在约80℃的水浴中一边进行加热一边搅拌溶解,制成明胶溶液。应予说明,表7中,苹果酸使用“苹果酸Soft tapy S(扶桑化学工业)”,酒石酸使用“L-酒石酸S(扶桑化学工业)”,柠檬酸使用“无水柠檬酸”(盘田化学工业),琥珀酸使用“琥珀酸(扶桑化学工业)”。
[表7]
(g)
2)粘度测定
制成的明胶溶液利用B型粘度计(转子转速12rpm)测定粘度后,向规格10号玻璃瓶各分装90g,保存于60℃的恒温槽。
在48小时后分别取出保存的明胶溶液,测定粘度。将结果示于表8。
[表8]
60℃保管时的明胶溶液的粘度
包含苹果酸的明胶溶液F在60℃·48hr保管下粘度降低到70%,但以与未配合的基准溶液同等的粘度降低率,而仍处于目标下限值的14000mPa·s以内。在包含酒石酸的明胶溶液G、包含柠檬酸的明胶溶液H、包含琥珀酸的明胶溶液I中,粘度降低率为30%以上、且小于14000mPa·s,担心可能会对胶囊成型、胶囊强度等产生影响。
实施例2软胶囊剂的制造<2>
(1)软胶囊剂C(含蕈提取物的软胶囊)
1)胶囊皮膜液的制备
按照规定的比例将表9所示的各成分混合,在约80℃的水浴中一边进行加热一边搅拌溶解,得到配合了苹果酸的皮膜和未配合苹果酸的皮膜的明胶溶液。
[表9]
(重量份)
2)胶囊内容物的制备
对表10所示的葵花籽油、蜜蜡、乳化剂在约70℃下加热溶解后,冷却至40℃以下,加入灵芝并进行了搅拌。然后,进行湿式粉碎(胶体磨机)处理、过筛、脱泡,制备胶囊内容物。
[表10]
(mg/粒)
3)软胶囊剂的制造
与实施例1的(1)同样地制成明胶片材。将该明胶片材以左右通过辊金属模具,间歇地施加约40℃的热而使明胶片材粘接,并在冲压之前利用泵填充2)中制备的胶囊内容物,冲压并成型,并对其进行干燥,由此制造软胶囊剂C。
(2)软胶囊剂D(含活菌的软胶囊)
1)胶囊皮膜液的制备
与上述(1)同样地制备配合了苹果酸的皮膜和未配合苹果酸的皮膜的明胶溶液。
[表11]
(重量份)
2)胶囊内容物的制备
对表12所示的葵花籽油、蜜蜡、乳化剂在约70℃下加热溶解后,冷却至40℃以下,加入双歧杆菌和纳豆菌并进行了搅拌。然后,进行湿式粉碎(胶体磨机)处理、过筛、脱泡,制备胶囊内容物。
[表12]
(mg/粒)
3)软胶囊剂的制造
与(2)同样地制成明胶片材。将该明胶片材以左右通过辊金属模具,间歇地施加约40℃的热而使明胶片材粘接,并在冲压之前利用泵填充2)中制备的胶囊内容物,冲压并成型,将得到的成型体干燥,制造软胶囊剂D。
(3)软胶囊剂E(含有氨基酸的软胶囊)
1)胶囊皮膜液的制备
与上述(1)同样地制备配合了苹果酸的皮膜和未配合苹果酸的皮膜的明胶溶液。
[表13]
(重量份)
2)胶囊内容物的制备
对如表14所示的葵花籽油、蜜蜡、乳化剂在约70℃下加热溶解后,冷却至40℃以下,加入GABA并搅拌。然后,进行湿式粉碎(胶体磨机)处理、过筛、脱泡,制备胶囊内容物。
[表14]
(mg/粒)
3)软胶囊剂的制造
与(2)同样地制成明胶片材。使该明胶片材以左右通过辊金属模,间歇地施加约40℃的热而使明胶片材粘接,并在冲压之前利用泵填充2)中制备的胶囊内容物,冲压并成型,将得到的成型体干燥,由此制造软胶囊剂E。
(4)软胶囊剂F、G、H(含蓝莓和DHA的软胶囊剂)
1)胶囊皮膜液的制备
与上述(1)同样地分别制备配合了苹果酸的皮膜和未配合苹果酸的皮膜的明胶溶液。
[表15]
(重量份)
2)胶囊内容液的调整
对如表16所示的DHA、蜜蜡、乳化剂在约70℃下加热溶解后,冷却至40℃以下,加入蓝莓并进行了搅拌。然后,进行湿式粉碎(胶体磨机)处理、过筛、脱泡,制备胶囊内容物。
[表16]
(mg/粒)
3)软胶囊剂的制造
与(2)同样地制成明胶片材。使该明胶片材以左右通过辊金属模,间歇地施加约40℃的热而使明胶片材粘接,并在冲压之前利用泵填充2)中制备的胶囊内容物,进行冲压而成型,将所得到的成型品干燥,由此制造软胶囊剂。苹果酸皮膜中,将使用苹果酸3重量份的明胶溶液的皮膜作为软胶囊F,将使用苹果酸5重量份的明胶溶液的皮膜作为软胶囊G,将使用苹果酸8重量份的明胶溶液的皮膜作为软胶囊H,将使用未配合苹果酸的明胶溶液的皮膜作为软胶囊I。
试验例4崩解性试验
(1)试验方法
将实施例2中制造的软胶囊F、G以及H分别置入玻璃瓶,利用金属盖(内衬橡胶)进行密封,在40℃、75%Rh的恒湿恒温槽中以1个月为单位保存4个月,并比较崩解时间。崩解时间是使用崩解试验(ERWEKA公司制,自动检测式崩解试验机ZT720),基于第十七改正日本药局方的崩解试验法进行测定的。
(2)结果
将结果示于表17。
在皮膜中配合了苹果酸的软胶囊剂F、G和H均是在40℃·3M的保存下,在“日局”规格的20分钟以内结束崩解,但在皮膜内没有配合苹果酸的软胶囊剂I中,在40℃·2M保存下,需20分钟以上溶解,或者完全不溶解。
[表17]
/>
Claims (6)
1.一种胶囊剂,其以明胶为基材,且具有含有苹果酸或其盐的胶囊皮膜。
2.根据权利要求1所述的胶囊剂,其中,皮膜中的苹果酸或其盐的含量相对于明胶100质量份为0.5~12质量份。
3.根据权利要求1或2所述的胶囊剂,其为软胶囊剂。
4.根据权利要求1~3中任一项所述的胶囊剂,其内包选自a)不饱和脂肪酸、b)含有不饱和脂肪酸作为构成脂肪酸的油脂、c)维生素类、d)多酚类、e)含有上述a)~d)中的任1种以上的天然材料、f)蕈类、g)发酵提取物、h)香料、i)矿物质类、j)氨基酸、k)蛋白质或者肽、以及l)微生物或其代谢物中的1种以上而成。
5.一种胶囊皮膜组合物,含有明胶、苹果酸或其盐、以及增塑剂。
6.一种胶囊剂的崩解迟缓抑制方法,在将明胶作为基材的胶囊剂中,将苹果酸或其盐配合于胶囊皮膜。
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