CN111526892A - 眼科用产品和掩蔽方法 - Google Patents
眼科用产品和掩蔽方法 Download PDFInfo
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- CN111526892A CN111526892A CN201880083844.3A CN201880083844A CN111526892A CN 111526892 A CN111526892 A CN 111526892A CN 201880083844 A CN201880083844 A CN 201880083844A CN 111526892 A CN111526892 A CN 111526892A
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- ophthalmic
- ophthalmic composition
- polyoxyethylene
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- 239000011647 vitamin D3 Substances 0.000 description 1
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 1
- 229940021056 vitamin d3 Drugs 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 150000003751 zinc Chemical class 0.000 description 1
- 239000011576 zinc lactate Substances 0.000 description 1
- 235000000193 zinc lactate Nutrition 0.000 description 1
- 229940050168 zinc lactate Drugs 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229960001763 zinc sulfate Drugs 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 0.000 description 1
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- 235000004835 α-tocopherol Nutrition 0.000 description 1
- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
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Abstract
一种眼科用产品,其眼科用组合物收纳在容器中、并将该容器与铁系吸氧剂一起用包围体包围密封而形成,所述眼科用组合物包含(A)易氧化物、(B)清凉剂、(C)非离子型表面活性剂和(D)选自二丁基羟基甲苯、二丁基羟基茴香醚、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上的成分,上述主体的容量为1~25mL,上述主体的透氧度为10cc/(m2·24hr·atm)以上,上述包围体和上述容器之间形成的空间的体积相对于上述容器的体积,为200V/V%以下。
Description
技术领域
本发明涉及吸氧剂的臭味被抑制的眼科用产品和掩蔽方法。
背景技术
作为使易氧化成分稳定的方法,已知有吸氧剂的使用。已知,在滴眼剂领域,通过将收纳在容器中的滴眼剂和吸氧剂封闭在包围体内,容器内的氧气被吸收,可使滴眼剂中的易氧化物质稳定(日本特开平6-40907号公报)。另一方面,脂溶性的维生素A等有效成分在角膜、结膜、鼻粘膜、咽部的治疗中作为有效成分,受到瞩目,但这些有效成分存在特有的臭味,进一步地,随着时间变化臭味增加。
【现有技术文献】
【专利文献】
【专利文献1】日本特开平6-40907号公报
发明内容
【发明要解决的课题】
但是,明确了会产生下述问题:包围体内加入以铁为主成分的吸氧剂(以下,也称为铁系吸氧剂)长期间保存时,产生由脱氧气作用产生的焦糊样的特异性异味,附着在包围体或者充满了包围体内,从而开封时感觉到异味。另一方面,脂溶性的维生素A等有效成分在角膜、结膜、鼻粘膜、咽部的治疗中作为有效成分,受到瞩目。但是,这些有效成分存在特有的臭味,进一步地,随着时间变化臭味增加。包含维生素A的眼科用产品中的吸氧剂的使用,在开封时的臭味的改善方面不充分。从以上的角度考虑,期望:含有维生素A等易氧化物的眼科用组合物收纳于容器中,进一步地,与以铁为主成分的吸氧剂一起,用包围体包围密封而形成的眼科用产品中,抑制由于脱氧气作用产生的包围体开封时的特异性异味的掩蔽方法。
【解决课题的手段】
为了达到上述目的,本发明人深入研究结果,发现:含有维生素A等易氧化物的眼科用组合物收纳在具备主体和盖子的容器中,进一步地,与以铁为主成分的吸氧剂一起用包围体包围密封而形成的眼科用产品中,使主体的容量、主体的透氧度、在上述包围体和上述容器之间形成的空间的体积在特定范围,从而清凉剂从容器内挥发,可以简便且低成本地掩蔽从眼科用组合物进入容器内、进一步地从容器内挥发/滞留在包围体内、开封时产生的异味(来自吸氧剂和来自易氧化物)。
因此,本发明提供下述眼科用产品和掩蔽方法。
[1].一种眼科用产品,其眼科用组合物收纳在具备收纳眼科用组合物的主体和盖子的容器中,该容器与铁系吸氧剂一起用包围体包围密封而形成,
上述眼科用组合物包含:
(A)易氧化物,
(B)清凉剂,
(C)非离子型表面活性剂,和
(D)选自二丁基羟基甲苯、二丁基羟基茴香醚、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上的成分,其中,
上述主体的容量为1~25mL,
上述主体的透氧度为10cc/(m2·24hr·atm)以上,
上述包围体和上述容器之间形成的空间的体积相对于上述容器的体积,为200V/V%以下。
[2].根据[1]记载的眼科用产品,其中,(A)成分为维生素A。
[3].根据[1]或[2]记载的眼科用产品,其中,(B)成分为选自l-薄荷脑、dl-樟脑、d-樟脑、d-冰片、香叶醇和桉叶油中的1种以上。
[4].根据[1]~[3]中任一项记载的眼科用产品,其中,(B)成分在眼科用组合物中的混合量为0.0001w/v%以上。
[5].根据[1]~[4]中任一项记载的眼科用产品,其中,(C)成分为选自聚氧乙烯氢化蓖麻油60、聚氧乙烯氢化蓖麻油40、聚氧乙烯(20)脱水山梨糖醇油酸酯和聚氧乙烯聚氧丙烯二醇中的1种以上。
[6].一种包围体开封时的臭味掩蔽方法,在眼科用组合物收纳在具备收纳眼科用组合物的主体和盖子的容器中、该容器与铁系吸氧剂一起用包围体包围密封而形成的眼科用产品中,
上述眼科用组合物包含:
(A)易氧化物,
(B)清凉剂,
(C)非离子型表面活性剂,和
(D)选自二丁基羟基甲苯、二丁基羟基茴香醚、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上的成分,
使上述主体的容量为1~25mL,
使上述主体的透氧度为10cc/(m2·24hr·atm)以上,
使上述包围体和上述容器之间形成的空间的体积相对于上述容器的体积为200V/V%以下。
【发明效果】
本发明可以提供,将含有易氧化物的眼科用组合物与以铁为主成分的吸氧剂一起用包围体包装的眼科用产品中,包围体开封时的特异性异味被抑制的眼科用产品和掩蔽方法。
具体实施方式
以下,详细说明本发明。
[眼科用组合物]
本发明的眼科用组合物包含(A)易氧化物、(B)清凉剂、(C)非离子型表面活性剂和(D)选自二丁基羟基甲苯、二丁基羟基茴香醚、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上的成分。
[(A)成分]
作为(A)易氧化物,可使用水溶性易氧化物、疏水性易氧化物中的任一种,可以单独使用1种或适当组合使用2种以上。作为水溶性易氧化物,可列举例如薁磺酸钠、维生素B2(黄素腺嘌呤二核苷酸等)、维生素B6(盐酸吡哆醇等)、维生素B12(钴胺素等)、维生素C(抗坏血酸等)等。
作为疏水性易氧化物,可使用日本药局方、日本药局方外医药品规格、医药品添加物事典、医药品添加物规格、化妆品原料基准、化妆品种別配合成分规格和食品添加物公定所收载的成分中对水的溶解性从“稍微难溶”至“几乎不溶”的物质,包括所有经过氧化分解的物质。作为具体的易氧化物质,可列举维生素A、维生素D、维生素E、维生素K、苯海拉明、吲哚美辛、他克莫司(FK506)、利福平等大环内酯系抗生素、佛司可林(forskolin)等,但是,不限于这些。
其中,维生素A具有促进角结膜修复;促进粘蛋白产生;干眼症改善效果;改善视疲劳、眼睛模糊的效果,同时,易于分解,散发出独特的气味,因此,更加能够发挥本发明效果。作为上述维生素A,例如维生素A自身,除此之外,可列举维生素A油等含有维生素A的混合物、维生素A脂肪酸酯等维生素A衍生物等。具体而言,可列举视黄醇棕榈酸酯、视黄醇乙酸酯、视黄醇、视黄酸、类视黄醇、β-胡萝卜素等。其中,优选视黄醇棕榈酸酯、视黄醇乙酸酯,更优选视黄醇棕榈酸酯。
视黄醇棕榈酸酯,通常,市售100~180万国际单位/g(以下,有时简称为IU/g。)的视黄醇棕榈酸酯,具体而言,可列举DSM Nutrition日本株式会社制造的视黄醇棕榈酸酯(174万I.U.)、西格玛奥德里奇制造的视黄醇棕榈酸酯等。
作为维生素D,可列举例如胆骨化醇、1α,25-二羟基胆骨化醇和它们的衍生物等。作为维生素E,可列举例如α-生育酚、d-α-生育酚乙酸酯和它们的衍生物等,作为维生素K,可列举叶绿基甲萘醌(phytylmenadione)和其衍生物等。其中,从作为眼科用物质有用的角度考虑,作为(A)成分,优选视黄醇棕榈酸酯、d-α-生育酚乙酸酯等脂溶性维生素、他克莫司(FK506)、利福平等大环内酯系抗生素、佛司可林等。
(A)成分在眼科用组合物中的混合量优选0.005~2w/v%(质量/体积%,g/100mL,以下相同),更优选0.01~1w/v%。另外,混合维生素A时,优选5,000~300,000IU/100mL,更优选5,000~100,000IU/100mL,进一步优选5,000~50,000IU/100mL。维生素A为高浓度时,更加提高对眼的效果(促进角结膜修复;促进粘蛋白产生;改善干眼症的效果;改善视疲劳、眼睛模糊的效果)。
[(B)成分]
作为清凉剂,可列举l-薄荷脑、dl-樟脑、d-樟脑、d-冰片、桉叶油、佛手柑油、香叶醇、芳樟醇、桉叶素、小茴香油、留兰香油、胡椒薄荷油、玫瑰油、日本薄荷(Mentha Arvensis)油和薄荷油等,可以单独使用1种或适当组合使用2种以上。其中,优选l-薄荷脑、dl-樟脑、d-樟脑、d-冰片、香叶醇、桉叶油。
从掩蔽的角度考虑,(B)成分在眼科用组合物中的混合量优选0.0001w/v%以上,更优选0.0001~0.5w/v%,进一步优选0.00015~0.2w/v%,特别优选0.0002~0.1w/v%。混合量过多时,有滴眼时的刺激强,损害使用感的可能。
作为本发明的清凉剂,混合(B-1)l-薄荷脑时,优选0.005~0.5w/v%,更优选0.01~0.2w/v%,进一步优选0.02~0.1w/v%,特别优选0.03~0.1w/v%,最优选0.04~0.05w/v%。混合量过多时,有滴眼时的刺激强,损害使用感的可能,混合量过少时,掩蔽效果不充分。
作为本发明的清凉剂,混合(B-2)樟脑时,优选0.002~0.5w/v%,更优选0.005~0.2w/v%,进一步优选0.01~0.1w/v%。混合量过多时,有滴眼时的刺激强,损害使用感的可能,混合量过少时,掩蔽效果不充分。
作为本发明的清凉剂,混合(B-3)d-冰片、香叶醇时,优选0.002~0.5w/v%,更优选0.003~0.2w/v%,进一步优选0.005~0.1w/v%。混合量过多时,有滴眼时的刺激强,损害使用感的可能,混合量过少时,掩蔽效果不充分。
作为本发明的清凉剂,混合(B-4)桉叶油时,优选0.0005~0.5w/v%,更优选0.001~0.2w/v%,进一步优选0.0015~0.1w/v%。混合量过多时,有滴眼时的刺激强,损害使用感的可能,混合量过少时,掩蔽效果不充分。
[(C)成分]
作为非离子型表面活性剂,如果是眼科用组合物中使用的非离子型表面活性剂就无特别限定,可以单独使用1种或适当组合使用2种以上。可列举例如聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油、以聚氧乙烯(20)脱水山梨糖醇油酸酯(聚山梨酯80)为代表的聚氧乙烯脱水山梨糖醇脂肪酸酯(POE脱水山梨糖醇脂肪酸酯)、以泊洛沙姆(poloxamer)为代表的聚氧乙烯聚氧丙烯二醇(聚氧乙烯聚氧丙烯嵌段共聚物、POEPOP二醇)、以聚乙二醇(10)单硬脂酸酯为代表的聚乙二醇单硬脂酸酯等。
聚氧乙烯蓖麻油(POE蓖麻油)为在蓖麻油中加成聚合氧化乙烯(EO)而得到的化合物,已知有氧化乙烯的平均加成摩尔数不同的几种。聚氧乙烯蓖麻油中的氧化乙烯的平均加成摩尔数无特别限定,可例示3~60摩尔。具体而言,可列举聚氧乙烯蓖麻油3(EO平均加成摩尔数3)、聚氧乙烯蓖麻油10(EO平均加成摩尔数10)、聚氧乙烯蓖麻油20(EO平均加成摩尔数20)、聚氧乙烯蓖麻油35(EO平均加成摩尔数35)、聚氧乙烯蓖麻油40(EO平均加成摩尔数40)、聚氧乙烯蓖麻油50(EO平均加成摩尔数50)、聚氧乙烯蓖麻油60(EO平均加成摩尔数60)等。
聚氧乙烯氢化蓖麻油(POE氢化蓖麻油),为在氢化的蓖麻油中加成聚合氧化乙烯而得到的化合物,已知有氧化乙烯的平均加成摩尔数不同的几种聚氧乙烯氢化蓖麻油。聚氧乙烯氢化蓖麻油中的氧化乙烯的平均加成摩尔数无特别限定,可例示5~100摩尔。具体而言,可列举聚氧乙烯氢化蓖麻油5(EO平均加成摩尔数5)、聚氧乙烯氢化蓖麻油10(EO平均加成摩尔数10)、聚氧乙烯氢化蓖麻油20(EO平均加成摩尔数20)、聚氧乙烯氢化蓖麻油30(EO平均加成摩尔数30)、聚氧乙烯氢化蓖麻油40(EO平均加成摩尔数40)、聚氧乙烯氢化蓖麻油50(EO平均加成摩尔数50)、聚氧乙烯氢化蓖麻油60(EO平均加成摩尔数60)、聚氧乙烯氢化蓖麻油80(EO平均加成摩尔数80)、聚氧乙烯氢化蓖麻油100(EO平均加成摩尔数100)等。
作为聚氧乙烯脱水山梨糖醇脂肪酸酯(POE脱水山梨糖醇脂肪酸酯),可列举聚氧乙烯(20)脱水山梨糖醇单月桂酸酯(聚山梨酯20)、聚氧乙烯(20)脱水山梨糖醇单棕榈酸酯(聚山梨酯40)、聚氧乙烯(20)脱水山梨糖醇单硬脂酸酯(聚山梨酯60)、聚氧乙烯(20)脱水山梨糖醇三硬脂酸酯(聚山梨酯65)、聚氧乙烯(20)脱水山梨糖醇单油酸酯(聚山梨酯80)。
聚氧乙烯聚氧丙烯二醇(POEPOP二醇)是由聚氧乙烯链(POE)和聚氧丙烯链(POP)形成的嵌段共聚物,已知有氧化乙烯(EO)和氧化丙烯(PO)的平均加成摩尔数不同的几种。聚氧乙烯聚氧丙烯二醇中的氧化乙烯和氧化丙烯的平均加成摩尔数无特别限定,可例示平均加成摩尔数5~200摩尔。具体而言,可列举聚氧乙烯(200)聚氧丙烯(70)二醇(EO平均加成摩尔数200,PO平均加成摩尔数70)、聚氧乙烯(196)聚氧丙烯(67)二醇(EO平均加成摩尔数196,PO平均加成摩尔数67)、聚氧乙烯(160)聚氧丙烯(30)二醇(EO平均加成摩尔数160,PO平均加成摩尔数30)、聚氧乙烯(120)聚氧丙烯(40)二醇(EO平均加成摩尔数120,PO平均加成摩尔数40)、聚氧乙烯(42)聚氧丙烯(67)二醇(EO平均加成摩尔数42,PO平均加成摩尔数67)、聚氧乙烯(54)聚氧丙烯(39)二醇(EO平均加成摩尔数54,PO平均加成摩尔数39)、聚氧乙烯(20)聚氧丙烯(20)二醇(EO平均加成摩尔数20,PO平均加成摩尔数20)等。
其中,优选聚氧乙烯氢化蓖麻油60、聚氧乙烯氢化蓖麻油40、聚氧乙烯(20)脱水山梨糖醇油酸酯和聚氧乙烯聚氧丙烯二醇。
混合聚氧乙烯聚氧丙烯二醇时,(C)成分在眼科用组合物中的混合量优选0.001~5.0w/v%,更优选0.001~2.0w/v%,进一步优选0.001~1.0w/v%。混合聚氧乙烯聚氧丙烯二醇以外的(C)成分的情况下,(C)成分的混合量优选0.001~0.5w/v%,更优选0.001~0.3w/v%,进一步优选0.001~0.2w/v%。(C)成分的混合量过多时,有清凉剂内含于活性剂胶束中,挥发被抑制的可能,过少时,有清凉剂、脂溶性易氧化物分离的可能。
[(D)成分]
(D)成分是选自二丁基羟基甲苯(BHT)、二丁基羟基茴香醚(BHA)、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上的成分。其中,优选二丁基羟基甲苯。作为(D)成分,可以单独使用1种或适当组合使用2种以上。(D)成分,其溶解度比(B)成分低,易于内含于活性剂胶束中,因此,更加促进(B)清凉剂的挥发,提高(B)清凉剂带来的臭味掩蔽效果。
混合二丁基羟基甲苯、二丁基羟基茴香醚时,从掩蔽效果的角度考虑,(D)成分在眼科用组合物中的混合量优选0.001w/v%以上,更优选0.002w/v%以上,进一步优选0.003w/v%以上。该混合量的上限无特别限定,可为0.01w/v%以下。
混合对羟基苯甲酸丙酯、对羟基苯甲酸丁酯时,从掩蔽效果的角度考虑,(D)成分在眼科用组合物中的混合量优选0.03w/v%以上,更优选0.05w/v%以上,进一步优选0.1w/v%以上。该混合量的上限无特别限定,可为1w/v%以下。
混合氯丁醇时,从掩蔽效果的角度考虑,(D)成分在眼科用组合物中的混合量优选0.03w/v%以上,更优选0.05w/v%以上,进一步优选0.1w/v%以上。该混合量的上限无特别限定,可为3w/v%以下。
(B)/(D)表示的混合比(质量比)的优选范围如下所述。另外,该比率为w/v%比,但是与质量比相同(以下相同)。分别说明(D)成分为(D-I)二丁基羟基甲苯或二丁基羟基茴香醚的情况,为(D-II)对羟基苯甲酸丙酯或对羟基苯甲酸丁酯的情况,为(D-III)氯丁醇的情况。
(I)(D)成分为二丁基羟基甲苯(BHT)或二丁基羟基茴香醚(BHA)时,该比率优选0.05~500,更优选0.1~200,进一步优选0.1~100。
作为(B)成分,混合l-薄荷脑时,该比率优选1.0~200,更优选2.0~100,进一步优选3.0~50,特别优选4.0~50。
作为(B)成分,混合樟脑(dl-樟脑,d-樟脑)时,该比率优选0.4~200,更优选1.0~100,进一步优选2.0~50。
作为(B)成分,混合d-冰片或香叶醇时,该比率优选0.4~200,更优选0.6~100,进一步优选1.0~50。
作为(B)成分,混合桉叶油时,该比率优选0.1~200,更优选0.2~100,进一步优选0.3~50。
(II)(D)成分为对羟基苯甲酸丙酯或对羟基苯甲酸丁酯时,该比率优选0.001~200,更优选0.003~100,进一步优选0.01~50。
作为(B)成分,混合l-薄荷脑时,该比率优选0.1~100,更优选0.2~50,进一步优选0.4~10。
作为(B)成分,混合樟脑(dl-樟脑,d-樟脑)时,该比率优选0.05~100,更优选0.15~50,进一步优选0.2~10。
作为(B)成分,混合d-冰片或香叶醇时,该比率优选0.05~100,更优选0.1~50,进一步优选0.15~10。
作为(B)成分,混合桉叶油时,该比率优选0.01~100,更优选0.02~50,进一步优选0.05~10。
(III)(D)成分为氯丁醇时,该比率优选0.0001~100,更优选0.0003~50,进一步优选0.0005~20以上。
作为(B)成分,混合l-薄荷脑时,该比率优选0.01~50,更优选0.02~20,进一步优选0.04~10。
作为(B)成分,混合樟脑(dl-樟脑,d-樟脑)时,该比率优选0.05~50,更优选0.15~20,进一步优选0.2~10。
作为(B)成分,混合d-冰片或香叶醇时,该比率优选0.0005~50,更优选0.001~20,进一步优选0.0015~10。
作为(B)成分,混合桉叶油时,该比率优选0.001~50,更优选0.002~20,进一步优选0.005~10。
((B)+(D))/(C)表示的混合比(质量比)的优选范围如下所述。另外,分别记载(A)成分为维生素A的情况,(C)成分为(C-I)聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油或聚氧乙烯脱水山梨糖醇脂肪酸酯的情况,(C)成分为(C-II)聚氧乙烯聚氧丙烯二醇的情况。
(A)成分为维生素A时,((B)+(D))/(C)表示的混合比(质量比)优选0.01~30,更优选0.02~10。((B)+(D))/(C)过小时,有清凉剂包含于胶束中,挥发被抑制的可能,过大时,有清凉剂、脂溶性易氧化物分离的可能。
(C)成分为(C-I)聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油或聚氧乙烯脱水山梨糖醇脂肪酸酯时:
作为(B)成分,混合l-薄荷脑,作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.05~15,更优选0.1~10,进一步优选0.15~5。
作为(B)成分,混合樟脑(d-樟脑、dl-樟脑),作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.04~5,更优选0.05~4,进一步优选0.08~3。
作为(B)成分,混合d-冰片或香叶醇,作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.03~5,更优选0.04~4,进一步优选0.05~3,特别优选0.06~3。
作为(B)成分,混合桉叶油,作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.02~5,更优选0.03~3,进一步优选0.04~3,特别优选0.045~3。
(C)成分为(C-II)聚氧乙烯聚氧丙烯二醇时:
作为(B)成分,混合l-薄荷脑,作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.005~1.5,更优选0.015~1.0,进一步优选0.025~0.5。
作为(B)成分,混合樟脑(d-樟脑,dl-樟脑),作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.007~0.5,更优选0.01~0.4,进一步优选0.015~0.3。
作为(B)成分,混合d-冰片或香叶醇,作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.007~0.5,更优选0.008~0.4,进一步优选0.01~0.3。
作为(B)成分,混合桉叶油,作为(D)成分,混合二丁基羟基甲苯或二丁基羟基茴香醚时,((B)+(D))/(C)表示的混合比(质量比)优选0.005~0.5,更优选0.006~0.4,进一步优选0.007~0.3。
上述(B)/(D)比、((B)+(D))/(C)表示的混合比中,混合多种(B)成分时,将(B)成分的总量视为各成分的浓度。掩蔽效果,按照桉叶油、香叶醇、d-冰片、樟脑(d-樟脑,dl-樟脑)、l-薄荷脑的顺序依次增高,因此,上述比按照混合的成分中的掩蔽效果高的成分的范围。混合多种(C)和(D)成分时,将各成分的总量视为各成分的浓度。上述比按照混合量多的成分的范围。
[任意成分]
根据需要,可在不损害本发明效果的范围,在本发明的眼科用组合物中,混合眼科用组合物中使用的各种成分。作为优选的混合成分,可列举药物、缓冲剂、稳定剂、增粘剂、等张剂、抗氧化剂、防腐剂、pH调节剂、多元醇等。
作为药物,可列举例如充血去除成分、眼肌调节药成分、抗炎症药成分或收敛药成分、抗组胺药成分或抗过敏药成分、氨基酸、抗菌药成分或杀菌药成分、糖类、多糖类或其衍生物、局部麻醉药成分、类固醇(steroid)成分、青光眼治疗成分、白内障治疗成分、散瞳成分等。具体例如下所述。
充血去除成分:可列举例如α-肾上腺素兴奋剂,例如咪唑啉衍生物(萘甲唑啉、四氢唑啉等)、β-苯乙胺衍生物(苯肾上腺素、肾上腺素、麻黄碱、甲基麻黄碱等),和它们的药学上或生理上可允许的盐(例如盐酸萘甲唑啉、硝酸萘甲唑啉、盐酸四氢唑啉、硝酸四氢唑啉、盐酸苯肾上腺素、肾上腺素盐酸盐、麻黄碱盐酸盐、甲基麻黄碱盐酸盐等无机酸盐;肾上腺素酒石酸氢盐等有机酸盐等)等。
眼肌调节药成分:可列举例如具有与乙酰胆碱类似的活性中心的胆碱酯酶抑制剂(例如,新斯的明甲基硫酸盐等)、托吡卡胺、硫酸阿托品等。
抗炎症药成分或收敛药成分:可列举例如普拉洛芬、塞来昔布、罗非昔布、吲哚美辛、双氯芬酸、双氯芬酸钠、吡罗昔康、美洛昔康、阿司匹林、甲芬那酸、吲哚美辛法呢酯、阿西美辛、布洛芬、噻洛芬酸、洛索洛芬钠、盐酸噻拉米特、锌盐(例如硫酸锌、乳酸锌等)、溶菌酶、氯化溶菌酶、水杨酸甲酯、尿囊素、ε-氨基己酸、氯化小檗碱、硫酸小檗碱、甘草酸和药理学上可允许的盐(例如甘草酸二钾、甘草酸铵等)等。
抗组胺药成分或抗过敏药成分:可列举例如酮替芬、阿扎司特、氯苯那敏、苯海拉明、左卡巴斯汀、色甘酸、曲尼司特、异丁司特、氨来呫诺、吡嘧司特和它们的药学上或生理上可允许的盐(苯海拉明盐酸盐、酮替芬富马酸盐、色甘酸钠等)等。
氨基酸:可列举例如亮氨酸、异亮氨酸、缬氨酸、蛋氨酸、苏氨酸、丙氨酸、苯基丙氨酸、色氨酸、赖氨酸、甘氨酸、丝氨酸、脯氨酸、酪氨酸、半胱氨酸、组氨酸、鸟氨酸、羟基脯氨酸、羟基赖氨酸、甘氨酰甘氨酸、γ-氨基丁酸、谷氨酸、天冬氨酸钠、天冬氨酸钾、天冬氨酸镁、氨基乙基磺酸(牛磺酸)或其盐(例如盐酸半胱氨酸等)等。
抗菌药成分或杀菌药成分:可列举例如磺酰胺类(例如磺胺甲恶唑、磺胺二甲异恶唑、磺胺索嘧啶和药理学上可允许的盐(磺胺甲恶唑钠、磺胺索嘧啶钠等)、利凡诺(acrinol)、烷基聚氨基乙基甘氨酸、新喹诺酮剂(洛美沙星、左氧氟沙星、环丙沙星、氧氟沙星、诺氟沙星、盐酸环丙沙星等)、β内酰胺系抗菌药(磺苄西林、头孢甲肟等)、氨基糖苷系抗菌药(卡那霉素、庆大霉素、妥布霉素、西索米星、地贝卡星、卡那霉素B、小诺霉素等)、四环素系抗菌药(土霉素等)、大环内酯系抗菌药(红霉素等)、氯霉素系抗菌药(氯霉素等)、多肽系抗菌药(粘菌素等)等。此外,可列举抗病毒药(碘苷、阿昔洛韦、阿糖腺苷(adeninearabinoside)、更昔洛韦、膦甲酸、伐昔洛韦、三氟胸腺嘧啶核苷(trifluorothymidine)、西多福韦、carbocyclic oxetanocin G等)、抗真菌药(匹马霉素、氟康唑、伊曲康唑、咪康唑、氟胞嘧啶、两性霉素B等)等。
糖类:可列举例如乳果糖、棉子糖、普鲁兰多糖、葡萄糖、麦芽糖、海藻糖、蔗糖、环糊精、木糖醇、甘露糖醇、山梨糖醇等。
多糖类或其衍生物:可列举例如阿拉伯胶、刺梧桐胶、黄原胶、角豆树胶(carobgum)、瓜尔胶、愈创树脂、榅桲籽、达玛胶(dammar gum)、黄芪胶、安息香胶、刺槐豆胶(locust bean gum)、酪蛋白、琼脂、海藻酸、糊精、葡聚糖、卡拉胶、明胶、胶原蛋白、果胶、淀粉、聚半乳糖醛酸(海藻酸)、甲壳质(chitin)和其衍生物、壳聚糖(chitosan)和其衍生物、弹性蛋白、透明质酸、硫酸软骨素或其盐(海藻酸钠、软骨素硫酸钠等)等。
局部麻醉药成分:可列举例如利多卡因、奥布卡因、地布卡因、普鲁卡因、氨基苯甲酸乙酯、美普卡因(meprylcaine)、甲哌卡因、布比卡因、可卡因和它们的盐(盐酸利多卡因、奥布卡因盐酸盐等)等。
类固醇成分:可列举例如氢化可的松、泼尼松龙、皮质醇、甲基泼尼松龙、曲安缩松、帕拉米松、倍他米松和它们的盐等。
青光眼治疗成分:可列举例如溴地斯的明(distigmine bromide)、马来酸噻吗洛尔、盐酸卡替洛尔、盐酸倍他洛尔、拉坦前列素、乌诺前列酮异丙酯、盐酸地匹福林、盐酸安普乐定、盐酸匹鲁卡品、卡巴胆碱、盐酸多佐胺、乙酰唑胺、醋甲唑胺和它们的盐等。
白内障治疗成分:可列举例如吡诺克辛、谷胱甘肽、唾液腺激素、硫普罗宁、二氢氮杂并五苯二磺酸盐(Dihydro azapentacene disulfonate)和它们的盐(例如5,12-二氢并五苯二磺酸钠(Sodium 5,12-dihydro azapentacene disulfonate)等)等。
散瞳成分:可列举例如盐酸环喷托酯、托吡卡胺等。
混合药物时,其混合量,可选择各药物的有效的适当量,但是,从对眼的刺激性、组合物的稳定性等角度考虑,优选在眼科用组合物中为0.001~5w/v%范围。
作为缓冲剂,可列举例如柠檬酸、柠檬酸钠、硼酸、硼砂、磷酸、磷酸氢二钠、磷酸二氢钠、磷酸二氢钾、乙酸、乙酸钠、冰醋酸、氨丁三醇、碳酸钠、碳酸氢钠等。混合缓冲剂时,其混合量优选在眼科用组合物中为0.003~4w/v%的范围。
作为稳定剂,可列举例如乙二胺乙酸衍生物或其盐(例如,依地酸(乙二胺四乙酸等)、依地酸钠(乙二胺四乙酸钠)等)、α-环糊精、β-环糊精、γ-环糊精等。混合稳定剂时,其混合量优选在眼科用组合物中为0.003~2w/v%的范围。
作为增粘剂,可列举例如甲基纤维素、羟丙基甲基纤维素、羟乙基纤维素等纤维素系高分子化合物、聚乙烯吡咯烷酮、聚乙烯醇等聚乙烯基系高分子化合物;液体石蜡;羧基乙烯基聚合物;聚乙二醇等。混合增粘剂时,其混合量优选在眼科用组合物中为0.003~3w/v%的范围。
作为等张剂,可列举例如氯化钾、氯化钠、氯化钙、氯化镁、乙酸钾、乙酸钠、碳酸钠、硫酸镁、磷酸氢二钠、磷酸二氢钠、亚硫酸氢钠等。混合等张剂时,其混合量优选在眼科用组合物中为0.001~3w/v%的范围。
作为抗氧化剂,可列举例如氢醌、没食子酸丙酯、亚硫酸氢钠等。混合抗氧化剂时,其混合量优选在眼科用组合物中为0.001~1w/v%的范围。
作为防腐剂,可列举例如苯扎氯铵、苄索氯铵、葡萄糖酸氯己定、山梨酸、山梨酸钾、泊利氯铵、烷基二氨基乙基甘氨酸盐酸盐、聚六亚甲基双胍等。混合防腐剂时,其混合量优选在眼科用组合物中为0.001~0.5w/v%的范围。
作为pH调节剂,可列举例如盐酸、硫酸、磷酸、氢氧化钠、氢氧化钾、氢氧化镁、氢氧化钙等。本发明的眼科用组合物的pH(20℃)为3.5~8.0,优选5.0~7.5,更优选6.0~7.3。pH过低或过高,均有增强刺激感的可能性。另外,在20℃下使用pH渗透压计(HSMO-1,东亚DKK株式会社)进行pH的测定。作为pH调节剂,优选氢氧化钠、氢氧化钾、盐酸等。
作为多元醇,可列举例如丙三醇、丙二醇、丁二醇、聚乙二醇等。
[制造方法]
例如,可使余量为水,用公知的制造方法制造本发明的眼科用组合物。例如将上述各成分溶解于灭菌纯化水、离子交换水等水的混合溶剂等中后,调节pH,进一步地,根据需要,通过pH调节剂、等张剂适当地调节渗透压等,可得到眼科用组合物。
[眼科用产品]
本发明的眼科用产品为一种收纳在具备收纳眼科用组合物的主体和盖子的容器中、并将该容器与铁系吸氧剂一起用包围体包围密封而形成的眼科用产品,
上述主体的容量为1~25mL,
上述主体的透氧度为10cc/(m2·24hr·atm)以上,
上述包围体和上述容器之间形成的空间的体积相对于上述容器的体积,为200V/V%以下。
容器为具备收纳眼科用组合物的主体和盖子的容器。更具体而言,主体上设置有滴眼口,具有密闭主体的螺旋式、一键式等盖子。另外,主体中可设置具有滴眼口的密封圈,滴眼口可设置在盖子上,可将盖子直接设置在容器上使得能够密闭。优选主体上设置有具有滴眼口的内塞。本发明中,称呼为容器时,是指主体上安装有盖子的状态的容器。
<主体>
为了使眼科用组合物中的清凉剂挥发入包围体内,收纳眼科用组合物的主体的透氧度为10cc/(m2·24hr·atm)以上。透氧度的上限无特别限定,可为200cc/(m2·24hr·atm)以下。作为具有这样的透氧度的主体,具体而言,可列举例如由聚乙烯、聚对苯二甲酸乙二醇酯、聚丙烯、聚丁烯、聚碳酸酯、聚芳酯、氯乙烯等材质形成的主体。更具体而言,聚对苯二甲酸乙二醇酯制得的多剂量滴眼用容器等的稳定性高,更适宜。可用基于JIS-K7126-2塑料膜和片材-透气度试验方法B法(附录B)的方法测定透氧度。
主体的容量(主体充满眼科用组合物时的体积)为1~25mL,优选5~20mL。进一步地,可根据产品和其使用方法适当地选择收纳的眼科用组合物的量,例如多剂量滴眼剂时,该量为1~25mL,优选1~20mL,更优选5~20mL。眼科用组合物的量过少时,有滴眼剂容器内的清凉剂的挥发量不充分、臭味掩蔽效果不充分的可能。
<盖子、内塞>
内塞、盖子可使用公知的眼科用产品的容器中使用的材质的盖子。作为内塞的材质,优选为熔体流动速率在2.0以下(优选1.2~1.8)的聚乙烯、聚丙烯。作为盖子的材质,优选聚乙烯、聚丙烯。
容器的透氧性优选0.01%以上,更优选0.1%以上,进一步优选0.2%以上。透氧性的上限无特别限定,例如可为5%以下。另外,透氧性的测定方法为后述的实施例记载的方法。如果透氧性高,那么清凉剂易于挥发,更加可以得到臭味掩蔽效果。
眼科用组合物相对于容器体积的充填率(安装有盖子、内塞的容器中,相对于主体的空壁的容器总容量的体积率)优选50%以上,更优选70%以上,进一步优选80%以上。收纳率过低时,有清凉剂充满在空壁内,包围体内的臭味的掩蔽效果不充分的可能。
[吸氧剂]
本发明的吸氧剂为铁系吸氧剂,具体而言,为市售的三菱瓦斯化学株式会社制造的AGELESS(FX,SA,Z-PT,GL,G)、株式会社常盤产业制造的Vitalon等。使用充分吸收包围体内氧气的规格的吸氧剂。通常,医药品、食品业界广泛使用吸氧剂,因此,可以低成本地使用吸氧剂。另外,吸氧剂,使用能够完全吸收枕包内存在的氧气的能力的物质。如果在该能力以下,那么就不能充分吸收氧气,易氧化物氧化分解的可能,如果在该能力以上,那么就有枕包收缩、容器凹陷的可能。
[包围体]
眼科用组合物与吸氧剂一起用包围体包围密封。作为包围体的材料,可列举例如聚乙烯;聚对苯二甲酸乙二醇酯;聚丙烯;聚丁烯;聚碳酸酯;聚酯;尼龙;玻璃纸;聚氯乙烯膜;铝箔或蒸镀有铝的聚乙烯醇系膜、聚酰胺系膜;蒸镀有氧化铝的聚对苯二甲酸乙二醇酯;蒸镀有氧化硅的聚对苯二甲酸乙二醇酯;涂布有聚偏1,1-二氯乙烯的膜或层叠膜等;它们的复合膜、多层膜等。其中,优选聚对苯二甲酸乙二醇酯/聚乙烯多层膜、蒸镀有氧化铝的聚对苯二甲酸乙二醇酯/聚乙烯多层膜。透氧度优选10cc/(m2·24hr·atm)以下(即,0~10cc/(m2·24hr·atm))。另外,包围体的透氧度优选低于主体的透氧度,更优选小于10cc/(m2·24hr·atm),进一步优选0~3cc/(m2·24hr·atm)、0~1cc/(m2·24hr·atm)、0.01~0.3cc/(m2·24hr·atm),特别优选0.01~0.1cc/(m2·24hr·atm),最优选0.01~0.02cc/(m2·24hr·atm)。
相对于上述容器的体积,上述包围体和上述容器(在主体安装有盖子的状态)之间形成的空间(内部空间)的体积为200V/V%以下,优选150V/V%以下,更优选120V/V%以下。其大于200V/V%时,不能充分得到包围体内的臭味的掩蔽效果。其下限无特别限定,可为20V/V%以上。
[掩蔽方法]
本发明提供包围体开封时的臭味掩蔽方法,
在包含:
(A)易氧化物,
(B)清凉剂,
(C)非离子型表面活性剂,和
(D)选自二丁基羟基甲苯、二丁基羟基茴香醚、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上的成分的眼科用组合物收纳在具备收纳眼科用组合物的主体和盖子的容器中、并将该容器与铁系吸氧剂一起用包围体包围密封而形成的眼科用产品中,
使上述主体的容量为1~25mL,
使上述主体的透氧度为10cc/(m2·24hr·atm)以上,
使上述包围体和上述容器之间形成的空间的体积相对于上述容器的体积为200V/V%以下。优选成分、范围等与上述相同。
【实施例】
以下,示出实施例和比较例,具体地说明本发明,但是,本发明并不限定于下述实施例。另外,下述例中,除非另有特别说明,否则,组成的“%”表示w/v%(g/100mL),比率表示质量比。
[实施例、比较例]
按照通常的方法制造下述表所示的组成的眼科用组合物,收纳于下述容器后,使吸氧剂(AGELESS(型号:Z-PT15),三菱瓦斯化学株式会社制造)在同包装内,用下述包围体实施膜包装,密封,得到眼科用产品。将该眼科用产品在40℃·75%RH环境下保存1个月。保存后,开封膜包装,实施下述臭气的感官评价。
除了实施例2、比较例3、比较例4和比较例5以外,使用下述的容器、包围体。
<容器>
·主体
材质:聚对苯二甲酸乙二醇酯:透氧度10cc/(m2·24hr·atm)
主体的容量:17mL
·盖子
螺旋式
·内塞
<包围体>
材质:蒸镀有氧化铝的聚对苯二甲酸乙二醇酯/聚乙烯多层膜(透氧度0.2cc/(m2·24hr·atm))
尺寸:W9.0×L6.5(cm)
使用上述容器、包围体时的各条件如下。
·眼科用组合物的量:15mL
·容器透氧性:0.7%
·眼科用组合物相对于容器体积的充填率:88%
·容器体积:22mL
·上述包围体和上述容器之间形成的空间(内部空间):23mL
·内部空间相对于容器体积之比:105%
实施例2和比较例4中,变更包围体的尺寸,使其达到表中的内部空间相对于容器体积之比,比较例3中,取表中的组合物量(mL)/主体容量(mL),使其达到空间比,比较例5中,使用非透氧性物质作为主体。
[容器透氧性的测定方法]
(1)在室温(20~30℃)下,将空的容器放入包围体中。容器中,安装有内塞、盖子。关于包围体的透氧性,使用透氧度为0.2cc/(m2·24hr·atm)以下的低透氧性的包围体。包围体的尺寸为150×65mm(内部尺寸)。
(2)在容器和包围体之间充满氮气,密封。此时的氮气置换率为90体积%以上(氧气浓度2体积%以下)。
(3)通过热封将包围体划分为2个空间,使包围体的尺寸为85×65mm(内部尺寸)。测定无容器侧的包围体的空间的氧气浓度,作为初期值。使用残留氧气浓度计(饭岛电子株式会社)测定氧气浓度。
(4)在40℃·75%RH的条件下保存3天,取出,在室温下放置后,测定包围体内的氧气浓度。
将用以下的计算式计算的值定义为透氧性。
透氧性的计算式:
透氧性(%)=保存后的包围体内氧气浓度(%)-初期的包围体内氧气浓度(%)
[臭气的评价]
按照下述4个等级,由专业评判员对臭气进行感官评价(n=6)。
0:感觉到非常有异味
1:感觉到异味
2:感觉到少许异味
3:几乎感觉不到异味
4:完全感觉不到异味
5:无异味,感觉到清凉剂气味
一并记载了得到的结果(平均值)和基于此结果的下述评价标准。●、〇、◎为合格。
<评价标准>
×:小于1.5
●:1.5以上且小于2.0
〇:2.0以上且小于3.0
◎:3.0以上
【表1】
【表2】
【表3】
【表4】
【表5】
【表6】
【表7】
【表8】
另外,将包围体的材质变更为聚乙烯(透氧度3cc/(m2·24hr·atm))时,也可得到与上述相同的结果。
上述例中使用的原料如下述所示。另外,除非另有说明,否则表中各组分的量为纯成分换算量。
视黄醇棕榈酸酯:(商品名:棕榈酸视黄醇酯,DSM Nutrition日本株式会社制造,174万I.U/g)
l-薄荷脑:(商品名:l-薄荷脑(薄荷脳),铃木薄荷株式会社制造)
dl-樟脑:(商品名:日本药局方dl-樟脑,日本精化株式会社制造)
d-樟脑(商品名:日本药局方d-樟脑,日本精化株式会社制造)
d-冰片:(商品名:特沸龙脑(d-冰片),株式会社柳沢正巳商店制造)
桉叶油:(商品名:日本药局方桉叶油,小川香料株式会社)
香叶醇:(商品名:香叶醇EX MIX,高砂香料工业株式会社制造)
聚氧乙烯氢化蓖麻油60:(商品名:HCO-60(医用),日本Surfactant工业株式会社制造)
聚氧乙烯氢化蓖麻油40:(商品名:HCO-40(医用),日本Surfactant工业株式会社制造)
聚氧乙烯(20)脱水山梨糖醇油酸酯(聚山梨酯80):(商品名:RHEODOL TW-O120V,花王株式会社制造)
聚氧乙烯聚氧丙烯二醇(聚氧乙烯(196)聚氧丙烯(67)二醇):(商品名:KolliphorP407,BASF日本株式会社制造)
聚乙二醇单硬脂酸酯(聚氧乙烯40硬脂酸酯):(商品名:NIKKOL MYS-40MV,日本Surfactant工业株式会社制造)
二丁基羟基甲苯:(商品名:二丁基羟基甲苯,和光纯药工业株式会社制造)
对羟基苯甲酸丙酯:(商品名:MEKKINSU-P,上野制药株式会社制造)
对羟基苯甲酸丁酯:(商品名:MEKKINSU-B,上野制药株式会社制造)
氯丁醇:(商品名:氯丁醇,JSC Olainfarm)
Claims (6)
1.一种眼科用产品,其通过将眼科用组合物收纳在具备收纳眼科用组合物的主体和盖子的容器中、并将该容器与铁系吸氧剂一起用包围体包围密封而形成,
所述眼科用组合物包含:
(A)易氧化物,
(B)清凉剂,
(C)非离子型表面活性剂,和
(D)选自二丁基羟基甲苯、二丁基羟基茴香醚、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上成分,
其特征在于,
所述主体的容量为1~25mL,
所述主体的透氧度为10cc/(m2·24hr·atm)以上,
所述包围体和所述容器之间形成的空间的体积相对于所述容器的体积,为200V/V%以下。
2.根据权利要求1所述的眼科用产品,其中,(A)成分为维生素A。
3.根据权利要求1或2所述的眼科用产品,其中,(B)成分为选自l-薄荷脑、dl-樟脑、d-樟脑、d-冰片、香叶醇和桉叶油中的1种以上。
4.根据权利要求1~3中任一项所述的眼科用产品,其中,(B)成分在眼科用组合物中的混合量为0.0001w/v%以上。
5.根据权利要求1~4中任一项所述的眼科用产品,其中,(C)成分为选自聚氧乙烯氢化蓖麻油60、聚氧乙烯氢化蓖麻油40、聚氧乙烯(20)脱水山梨糖醇油酸酯和聚氧乙烯聚氧丙烯二醇中的1种以上。
6.一种包围体开封时的臭味掩蔽方法,在将眼科用组合物收纳在具备收纳眼科用组合物的主体和盖子的容器中、并将该容器与铁系吸氧剂一起用包围体包围密封而成的眼科用产品中,
所述眼科用组合物包含:
(A)易氧化物,
(B)清凉剂,
(C)非离子型表面活性剂,和
(D)选自二丁基羟基甲苯、二丁基羟基茴香醚、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯和氯丁醇中的1种以上成分,
使所述主体的容量为1~25mL,
使所述主体的透氧度为10cc/(m2·24hr·atm)以上,
并使所述包围体和所述容器之间形成的空间的体积相对于所述容器的体积为200V/V%以下。
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