CN101175496A - 含有前列腺素F2α衍生物的制品 - Google Patents
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Abstract
本发明涉及一种能够长期稳定地保存水性液体制剂的树脂制容器,所述水性液体制剂含有分子内具有氟原子的前列腺素F2α衍生物。通过将含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂保存于由丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5的丙烯-乙烯共聚物构成的树脂制容器中,能够抑制水性液体制剂中前列腺素F2α衍生物的含有率降低。
Description
技术领域
本发明涉及一种含有前列腺素F2α衍生物的制品,所述含有前列腺素F2α衍生物的制品通过将含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂保存于由丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5的丙烯-乙烯共聚物构成的树脂制容器中,能够抑制水性液体制剂中该前列腺素F2α衍生物的含有率降低。
背景技术
已知分子内具有氟原子的前列腺素F2α衍生物作为青光眼或高眼压症的治疗剂有用(专利文献1、专利文献2)。但是,由于分子内具有氟原子的前列腺素F2α衍生物通常难溶于水且具有易吸附在容器上的性质,所以有必要改善对水的溶解性和对容器的吸附性的问题。
专利文献3公开了一种发明,即通过在水性液体制剂中配合聚山梨酸酯80等非离子表面活性剂改善前列腺素F2α衍生物对水的溶解性及对树脂制容器的吸附性,但没有对保存水性液体制剂的树脂制容器本身进行研究。另一方面,专利文献4公开了以下内容,即,将含有前列腺素和表面活性剂的水性前列腺素组合物保存在全同立构结构或间同立构结构的聚丙烯树脂制容器中比保存在聚乙烯树脂制容器中更稳定,可以抑制残存率降低。
但是,关于树脂制容器的材质,尚无通过改变丙烯-乙烯共聚物的各单体成分比例来研究前列腺素衍生物的稳定化的报道。
专利文献1:特开平10-251225号公报
专利文献2:特开平11-71344号公报
专利文献3:特开2002-161037号公报
专利文献4:特表2002-520368号公报
发明内容
本发明的重要课题在于提供一种能够长期稳定地保存含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂的树脂制容器。
本发明人等在将含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂保存于由各种单体成分比例的丙烯-乙烯共聚物构成的树脂制容器中研究抑制该前列腺素F2α衍生物的含有率降低时,惊奇地发现在由特定的成分比例的共聚物构成的树脂制容器中能够显著地抑制该前列腺素F2α衍生物的含有率降低,从而完成了本发明。
即,本发明涉及,
(1)一种含有前列腺素F2α衍生物的制品,所述含有前列腺素F2α衍生物的制品通过将含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂保存于由丙烯-乙烯共聚物构成的树脂制容器中,抑制了水性液体制剂中该前列腺素F2α衍生物的含有率降低,所述丙烯-乙烯共聚物中的丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5。
(2)如上述(1)所述的含有前列腺素F2α衍生物的制品,其中,所述分子内具有氟原子的前列腺素F2α衍生物为二氟前列腺素F2α衍生物。
(3)如上述(1)所述的含有前列腺素F2α衍生物的制品,其特征为,水性液体制剂中含有非离子表面活性剂。
(4)如上述(1)所述的含有前列腺素F2α衍生物的制品,其中,所述非离子表面活性剂为聚山梨酸酯80。
(5)如上述(1)~(4)中任一项所述的含有前列腺素F2α衍生物的制品,其中,所述水性液体制剂为滴眼液。
(6)一种方法,通过将含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂保存于由丙烯-乙烯共聚物构成的树脂制容器中来抑制水性液体制剂中该前列腺素F2α衍生物的含有率降低,所述丙烯-乙烯共聚物中的丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5。
(7)一种树脂制容器,所述树脂制容器由丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5的丙烯-乙烯共聚物构成,用于保存含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂。
本发明的分子内具有氟原子的前列腺素F2α衍生物通常难溶于水且具有易吸附在容器上的性质。所谓分子内具有氟原子的前列腺素F2α衍生物难溶于水是指为了溶解1g分子内具有氟原子的前列腺素F2α衍生物需要1000ml以上的水(第十三改正日本药典解说书通则A-51(1996)),所谓易吸附在容器上的性质是指将前列腺素衍生物制成水溶液保存于容器中时其含有率(所谓含有率是指相对于溶解的该前列腺素的量,有效地溶解并存在于水溶液中的量)大大降低。
本发明的分子内具有氟原子的前列腺素F2α衍生物(以下称为“含氟前列腺素”)只要是分子内具有一个至数个氟原子的前列腺素F2α衍生物即可,没有特殊的限制,可优选举出特开平10-251225或特开平11-71344中公开的前列腺素F2α衍生物,较优选举出特开平11-71344中公开的二氟前列腺素F2α衍生物,特别优选特开平11-71344中公开的15位具有2个氟原子的二氟前列腺素F2α衍生物。作为特别优选的具体例,可以举出16-苯氧基-15-脱氧-15,15-二氟-17,18,19,20-四去甲前列腺素F2α、16-(3-氯苯氧基)-15-脱氧-15,15-二氟-17,18,19,20-四去甲前列腺素F2α、16-苯氧基-15-脱氧-15,15-二氟-13,14-二氢-17,18,19,20-四去甲前列腺素F2α,或上述物质的烷基酯或上述物质的盐。作为烷基酯的具体例,可以举出甲酯、乙酯、丙酯、异丙酯、叔丁酯、戊酯、己酯等低级烷基酯。
在下述的保存稳定性试验项目中予以详细说明,如果将含有含氟前列腺素的水性液体制剂保存于由丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5的丙烯-乙烯共聚物构成的树脂制容器中,则与将该前列腺素保存于由丙烯均聚物构成的容器中相比显著稳定且可抑制对容器壁吸附。
本发明的树脂制容器通过对丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5的丙烯-乙烯共聚物进行成型加工而制得。作为成型加工的方法,例如可以举出注塑成型法。上述单体成分比例的丙烯-乙烯共聚物可以通过任意聚合方法获得,例如优选通过无规共聚丙烯和乙烯获得的无规共聚物。
本发明可以在水性液体制剂中配合非离子表面活性剂,非离子表面活性剂的作用在于通过提高含氟前列腺素的水溶性抑制水性液体制剂中含氟前列腺素的含有率降低。作为非离子表面活性剂的具体例,可以举出聚山梨酸酯80[聚氧乙烯山梨糖醇酐单油酸酯]、聚山梨酸酯60[聚氧乙烯山梨糖醇酐单硬脂酸酯]、聚山梨酸酯40[聚氧乙烯山梨糖醇酐单棕榈酸酯]、聚氧乙烯山梨糖醇酐单月桂酸酯、聚氧乙烯山梨糖醇酐三油酸酯、聚山梨酸酯65[聚氧乙烯山梨糖醇酐三硬脂酸酯]等聚氧乙烯脂肪酸酯,聚氧乙烯(160)聚氧丙烯(30)二醇[普鲁洛尼克(Pluronic)F68]、聚氧乙烯(42)聚氧丙烯(67)二醇[普鲁洛尼克P123]、聚氧乙烯(54)聚氧丙烯(39)二醇[普鲁洛尼克P85]、聚氧乙烯(196)聚氧丙烯(67)二醇[普鲁洛尼克F127]、聚氧乙烯(20)聚氧丙烯(20)二醇[普鲁洛尼克L-44]等聚氧乙烯聚氧丙烯二醇,硬脂酸聚烃氧40酯、蔗糖脂肪酸酯等,优选举出聚山梨酸酯80[聚氧乙烯山梨糖醇酐单油酸酯]、硬脂酸聚烃氧40酯等。上述非离子表面活性剂可以分别单独使用或2种以上组合使用。作为特别优选的非离子表面活性剂,可以举出作为滴眼液的添加物广泛使用的聚山梨酸酯80[聚氧乙烯山梨糖醇酐单油酸酯]。
本发明的含有前列腺素F2α衍生物的制品优选含氟前列腺素以溶解于水的状态存在。水性液体制剂中的含氟前列腺素的浓度可以根据水性液体制剂的用途等适当地选择。例如滴眼剂,滴眼剂中含氟前列腺素的浓度可以根据对象疾病或症状等适当地选择,优选为0.00005~0.05%。另外,滴眼剂中配合非离子表面活性剂时,也可以根据含氟前列腺素的浓度适当地增减非离子表面活性剂的配合量,但从提高含氟前列腺素的水溶性的观点来看,非离子表面活性剂的浓度优选为含氟前列腺素的浓度的5倍以上,在必须进一步提高水溶性时,特别优选为10倍以上。
本发明的含有前列腺素F2α衍生物的制品为滴眼剂时,除非离子表面活性剂之外,还可以配合乙二胺四乙酸、二丁基羟基甲苯等抗氧化剂,氯化钠、氯化钾、氯化钙、甘油、丙二醇等等渗剂,硼酸、硼砂、柠檬酸、磷酸氢二钠、ε-氨基己酸等缓冲剂,苯扎氯铵、葡萄糖酸氯己定、苯索氯铵、山梨酸、山梨酸钾、对羟基苯甲酸乙酯、对羟基苯甲酸丁酯等防腐剂等制剂上允许的各种添加物。含有含氟前列腺素的滴眼液的配制方法不需要特殊的手段或操作,可以通过广泛使用的方法进行配制,另外滴眼液的pH优选为3~8,特别优选为4~7。
在保存稳定性试验项目中详细地说明,如果将含有含氟前列腺素的水性液体制剂保存于由丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5的丙烯-乙烯共聚物构成的树脂制容器中,则与将该前列腺素保存于由丙烯均聚物构成的树脂制容器中相比,可显著地抑制含氟前列腺素的含有率降低。
附图说明
图1为表示实施例的结果的图,表示各成分比例的丙烯-乙烯无规共聚物制容器及丙烯均聚物制容器中乙烯成分的比例和该化合物的含有率的关系。
具体实施方式
以下,实施保存稳定性试验(40℃、7天),详细地说明本发明,下述试验用于更好地理解本发明,并不限定本发明的范围。
实施例
[保存稳定性试验]
(1)滴眼液的配制
作为分子内具有氟原子的前列腺素F2α衍生物的代表例,使用16-苯氧基-15-脱氧-15,15-二氟-17,18,19,20-四去甲前列腺素F2α异丙基酯(以下称为“该化合物”)。将该化合物(0.0005%)及聚山梨酸酯80(0.05%)溶解于精制水中后,配合乙二胺四乙酸二钠(适量)、浓甘油(适量)及苯扎氯铵(适量)等常用的添加剂等,得到渗透压约为1、pH约为6的滴眼液。
(2)树脂制容器的制备
本发明的树脂制容器是将丙烯-乙烯无规共聚物(丙烯成分/乙烯成分=98.7/1.3、丙烯成分/乙烯成分=97.4/2.6、丙烯成分/乙烯成分=96.4/3.6)及丙烯均聚物分别采用注-吹塑成型进行成型加工而获得的。
(3)试验方法
在加入“(1)滴眼液的配制”中得到的滴眼液(110mL)升温至40℃的玻璃容器中,浸渍“(2)树脂制容器的制备”中得到的树脂制容器(各7个),在温度为40℃的条件下保存7天。采用高效液相色谱法测定保存前后的玻璃容器中该化合物的含量,计算出以保存开始时作为100%时该化合物的含有率(平均值)。试验结果如图1所示。
(4)讨论
从图1可知,如果将该化合物保存于上述各成分比例的丙烯-乙烯无规共聚物制的容器中,则与保存于丙烯均聚物制容器中时相比该化合物的含有率高,前者的容器对该化合物的保存稳定性优异。
Claims (7)
1.一种含有前列腺素F2α衍生物的制品,所述含有前列腺素F2α衍生物的制品通过将含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂保存于由丙烯-乙烯共聚物构成的树脂制容器中来抑制水性液体制剂中该前列腺素F2α衍生物的含有率降低,所述丙烯-乙烯共聚物中的丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5。
2.如权利要求1所述的含有前列腺素F2α衍生物的制品,其中,所述分子内具有氟原子的前列腺素F2α衍生物为二氟前列腺素F2α衍生物。
3.如权利要求1所述的含有前列腺素F2α衍生物的制品,其特征为,水性液体制剂中含有非离子表面活性剂。
4.如权利要求3所述的含有前列腺素F2α衍生物的制品,其中,所述非离子表面活性剂为聚山梨酸酯80。
5.如权利要求1~4中任一项所述的含有前列腺素F2α衍生物的制品,其中,所述水性液体制剂为滴眼液。
6.一种抑制水性液体制剂中前列腺素F2α衍生物的含有率降低的方法,该方法将含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂保存于由丙烯-乙烯共聚物构成的树脂制容器中,抑制水性液体制剂中该前列腺素F2α衍生物的含有率降低,所述丙烯-乙烯共聚物中的丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5。
7.一种树脂制容器,所述树脂制容器由丙烯成分和乙烯成分的比例为丙烯成分/乙烯成分=94.0/6.0~99.5/0.5的丙烯-乙烯共聚物构成,用于保存含有分子内具有氟原子的前列腺素F2α衍生物的水性液体制剂。
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US (1) | US20070244196A1 (zh) |
EP (1) | EP1829545B1 (zh) |
KR (1) | KR101283874B1 (zh) |
CN (1) | CN101175496A (zh) |
AT (1) | ATE555792T1 (zh) |
CA (1) | CA2592474C (zh) |
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ES (1) | ES2386148T3 (zh) |
NO (1) | NO338832B1 (zh) |
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PT (1) | PT1829545E (zh) |
RU (1) | RU2391983C2 (zh) |
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CN106929477A (zh) * | 2017-03-20 | 2017-07-07 | 江南大学 | 一株抗前列腺素F2α的特异性单克隆抗体杂交瘤细胞株WXX‑2及其应用 |
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US2886035A (en) * | 1955-07-29 | 1959-05-12 | Cutter Lab | Venoclysis apparatus |
US2985920A (en) * | 1958-03-26 | 1961-05-30 | Seiberling Rubber Co | Method of making a cored heel |
US4310543A (en) * | 1980-10-09 | 1982-01-12 | Hoffmann-La Roche Inc. | Prostaglandin compositions |
ATE82499T1 (de) * | 1987-09-18 | 1992-12-15 | R Tech Ueno Ltd | Okulare hypotensivagenzien. |
US5565492A (en) * | 1988-07-18 | 1996-10-15 | Alcon Laboratories, Inc. | Prostaglandin combinations in glaucoma therapy |
JPH06285135A (ja) * | 1993-03-31 | 1994-10-11 | Kyoraku Co Ltd | 薬液用プラスチック容器 |
US5486540A (en) * | 1993-10-28 | 1996-01-23 | Allergan, Inc. | Cyclopentane heptanoic or heptenoic acid, 2-arylalkyl or arylalkenyl and derivatives as therapeutic agents |
ATE285795T1 (de) * | 1998-07-14 | 2005-01-15 | Alcon Mfg Ltd | Polypropylenbasierte behälter für prostaglandin- enthaltende produkte |
US6235781B1 (en) * | 1998-07-14 | 2001-05-22 | Alcon Laboratories, Inc. | Prostaglandin product |
JP3876355B2 (ja) * | 2000-09-13 | 2007-01-31 | 参天製薬株式会社 | 点眼液 |
EP1321144B1 (en) * | 2000-09-13 | 2010-12-08 | Santen Pharmaceutical Co., Ltd. | Eye drops |
WO2002022106A2 (en) * | 2000-09-14 | 2002-03-21 | Novartis Ag | Stable ophthalmic preparation |
TW586946B (en) * | 2000-12-22 | 2004-05-11 | Novartis Ag | Process to improve stability |
JP2003138074A (ja) * | 2001-10-30 | 2003-05-14 | Japan Polychem Corp | 医療用延伸ブロー容器 |
ATE450264T1 (de) * | 2003-07-31 | 2009-12-15 | Santen Pharmaceutical Co Ltd | Prostaglandin enthaltendes produkt |
US20050049311A1 (en) * | 2003-09-03 | 2005-03-03 | Pharmacia & Upjohn Company | Medicinal products comprising prostaglandin compositions and methods of packaging such compositions |
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CN106929477A (zh) * | 2017-03-20 | 2017-07-07 | 江南大学 | 一株抗前列腺素F2α的特异性单克隆抗体杂交瘤细胞株WXX‑2及其应用 |
CN106929477B (zh) * | 2017-03-20 | 2020-01-10 | 江南大学 | 一株抗前列腺素F2α的特异性单克隆抗体杂交瘤细胞株WXX-2及其应用 |
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RU2391983C2 (ru) | 2010-06-20 |
ES2386148T3 (es) | 2012-08-10 |
NO338832B1 (no) | 2016-10-24 |
CA2592474A1 (en) | 2006-06-29 |
EP1829545B1 (en) | 2012-05-02 |
PT1829545E (pt) | 2012-05-21 |
US20070244196A1 (en) | 2007-10-18 |
WO2006068266A1 (ja) | 2006-06-29 |
KR20070093997A (ko) | 2007-09-19 |
CA2592474C (en) | 2013-08-13 |
PL1829545T3 (pl) | 2012-09-28 |
ATE555792T1 (de) | 2012-05-15 |
SI1829545T1 (sl) | 2012-08-31 |
EP1829545A1 (en) | 2007-09-05 |
DK1829545T3 (da) | 2012-07-23 |
KR101283874B1 (ko) | 2013-07-08 |
NO20073767L (no) | 2007-09-14 |
EP1829545A4 (en) | 2009-07-22 |
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