CN107028920A - 布洛芬巴布贴剂 - Google Patents
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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Abstract
一种布洛芬巴布贴剂，其特征是所述巴布贴剂由背衬层、保护层和药物储库组成，所述药物储库由以下重量百分比的组分组成：作为活性成分的布洛芬3％～5％；油相成分5～10％，所述油相成分由质量比为1:0.3～0.4的辛癸酸甘油酯和十八醇组成，布洛芬分散于油相中；作为水相成分的部分中和聚丙烯酸钠5‑10％，甘羟铝0.2％～0.4％，丙三醇10～15％，卡波姆934 1％～1.5％、羧甲基纤维素钠(CMC‑Na)1.5～3％，依地酸钙钠0.1％～0.3％，pH调节剂、吐温80 1％～1.5％、甘露醇10～15％，填充剂1～3％以及余量的水。所述pH调节剂为将水相成分pH调节至5～6.5的氢氧化钠溶液。
Description
技术领域
本发明涉及布洛芬巴布贴剂。
背景技术
布洛芬(CAS：15687-27-1)即α-甲基-4-(2-甲基丙基)苯乙酸，是一种具有抗炎、镇痛、解热作用的非甾体抗炎药。常用于头痛及关节炎的治疗，当用于类风湿性关节炎、骨关节炎等局部炎症治疗时，传统的口服给药方式存在着药物利用度低，肠胃及全身副作用大的缺点。关节炎等慢性局部炎症需要持续进行治疗，但现有的布洛芬外用制剂如乳膏剂等难于持续稳定的释放有效成分而影响了治疗效果，合用药的临床需要。巴布贴剂(Cataplasm)系指将药物溶解或混合于水溶性高分子材料基质中，涂布于被衬材料上,供皮肤贴敷使用的一种新型经皮给药剂型。与普通的外用药物制剂相比巴布贴剂具有载药量大；含水量较高能够加强皮肤中的水合作用以促进药物经皮透过，且对皮肤无过敏反应和刺激作用，剥离时无拉痛感且无残留等优点，但也正是由于巴布贴剂载药量大，敷贴时间较长，在进行处方筛选需要兼顾促进药物透皮吸收与使其药物释放均匀，因此提供一种能够快速起效，并实现持续长时间稳定释药的布洛芬巴布贴剂成为现有技术中亟待解决的问题。
发明内容
为解决前述技术问题，本发明提供了一种布洛芬巴布贴剂，其特征是所述巴布贴剂由背衬层、保护层和药物储库组成，所述药物储库由以下重量百分比的组分组成：
作为活性成分的布洛芬3％～5％；油相成分5～10％，所述油相成分由质量比为1:0.3～0.4的辛癸酸甘油酯和十八醇组成，布洛芬分散于油相中；
作为水相成分的部分中和聚丙烯酸钠5-10％，甘羟铝0.2％～0.4％，丙三醇10～15％，卡波姆934 1％～1.5％、羧甲基纤维素钠(CMC-Na)1.5～3％，依地酸钙钠0.1％～0.3％，pH调节剂、吐温80 1％～1.5％、甘露醇10～15％，填充剂1～3％以及余量的水。所述pH调节剂为将水相成分pH调节至5～6.5的氢氧化钠溶液。
所述部分中和聚丙烯酸钠优选为NP700；所述填充剂为高岭土。
所述的一种布洛芬巴布贴剂，其特征是丙三醇含量优选为10％，甘露醇含量优选为10％。
在研究中发现，发明提供的布洛芬巴布贴剂，通过筛选得到的优选处方可以使制备得到的布洛芬巴布剂贴剂能够兼顾快速释放有效成分和在12h的敷贴时间内持续释放有效成分的两种性能，在对处方进行研究中我们发现，本发明优选的油相成分配比与水相成分中丙三醇和甘露醇配比是决定有效成分释放特性的决定组分。正是上述组分的配合，解决了布洛芬巴布膏在长时间敷贴下的快速起效与长效释放问题。
具体实施方式
本发明实施例中的布洛芬巴布剂按照以下方法制备
1)油相成分配制，将油相成分的原料加热至50-70℃，加入布洛芬微粉，搅拌分散得到油相液(1)
2)将水相成分分散于水得到水凝胶，将水凝胶加热至50～70℃后在用均混器搅拌的同时加入温度为50-70℃的油相液(1)，油相加入后再加入填充剂后搅拌均匀；经静置真空脱气后得到膏状的药物储库；
3)将药物储库涂布于背衬层上，并在上表面贴附保护层。得到布洛芬巴布贴。得到的布洛芬巴布剂的规格为5g药物储库/40cm2背衬层
所有实施例中，所述部分中和聚丙烯酸钠为NP700(Showa Denko kk生产)，填充剂为2％高岭土，保湿剂为丙三醇。
实施例1～6的配方见下表
对照例1～6的配方见下表
与实施例1～6相比，对照例1～6的配方中未加入甘露醇(对照例1、2)或未加入丙三醇(对照例3、4)或改变油相成分两种组分的配比(对照例5、6)
通过对实施例1～6得到的巴布剂进行考察，可知其外观平整、均匀，药物储库膏体光滑；成型性、含膏量、初粘力、粘附性以及膜残留量均符合要求。
药理实施例1体外释放实验
按照中国药典2010版第二部附录XD中释放度测定法中第三法(桨碟法，用于透皮贴剂)中提供的方法对实施例1～6得到的巴布贴紧急释放度测定。具体方法如下
试验以生理盐水为释放介质，将释放介质加入溶出杯内，预温至(32±0.5℃)将巴布膏除去保护层，裁剪成2.5cmx7.5cm大小，平放入透析袋(截留分子量14,000)中，释放面朝上,置于两层碟片之间，使碟片边缘夹住透析袋两端，再用皮筋缠绕固定,以固定碟片。于10min、20min、30min、45min、60min、90min、2h、2.5h、3h和4h分别从溶出杯内取样6mL，并补充等体积(32+0.5)℃新鲜释放介质，平行试验6片，取平均值计算。经过检测表明，本申请实施例中的巴布膏的体外释放度均在2h达到90％以上。
药理实施例2，体外透皮实验
采用改良Franz扩散池法，以离体3月龄大鼠腹部皮肤为屏障，用实施例1～6及对照例1～6制备得到的巴布贴剂进行进行体外透皮试验。具体实验方法为：
取3月龄健康大鼠麻醉处死后，用剪刀除尽腹部毛，取下无损伤的皮肤，除去皮下组织，洗净后分别固定于Franz扩散池的释放口，接受室中加入pH7.4磷酸缓冲液作释放介质，保持内皮层与溶液密切接触。将揭去保护层的巴布剂贴于皮肤上，调节水浴使外层套层温度恒定于(32±0.5)℃，搅拌速度为100rpm，分别于0、1h、2h、4h、6h、8h、12h小时吸取释放介质4ml，同时补加等量PBS液。计算累计吸收百分数(即累计透过的布洛芬占药物储库中布洛芬总量的百分比分数)结果如下表
上述结果表明，本发明提供的布洛芬巴布膏，在进行体外透皮吸收实验时，12h的累计药物透过率均高于80％，且药物释放率随时间增加速度较为均匀、说明本发明采用的技术方案中，通过分别优选油相成分与水相成分的组成，既提高了布洛芬巴布剂的透皮吸收速度，又能够控制药物在整个敷贴时间段内较为均匀的释放，实现了两种特性的平衡。在处方筛选时我们发现优选了辛癸酸甘油酯与十八醇的配比，并在水相中同时加入处方量的丙三醇和甘露醇后，才能实现布洛芬快速均匀释放的效果。通过以对比例的对照实验表明，改变油相成分中的两种组分的配比，或者单独加入丙三醇或甘露醇均会影响的布洛芬释放效果，且在进一步实验中我们还发现，该辅料配方与布洛芬均有关联性，当改变活性成分时，即使采用同样的辅料配方，也会无法产生本发明提供的布洛芬巴布剂具有的快速均匀释药效果。
Claims (3)
1.一种布洛芬巴布贴剂，其特征是所述巴布贴剂由背衬层、保护层和药物储库组成，所述药物储库由以下重量百分比的组分组成：
作为活性成分的布洛芬3％～5％；油相成分5～10％，所述油相成分由质量比为1:0.3～0.4的辛癸酸甘油酯和十八醇组成，布洛芬分散于油相中；
作为水相成分的部分中和聚丙烯酸钠5-10％，甘羟铝0.2％～0.4％，丙三醇10～15％，卡波姆934 1％～1.5％、羧甲基纤维素钠(CMC-Na)1.5～3％，依地酸钙钠0.1％～0.3％，pH调节剂、吐温80 1％～1.5％、甘露醇10～15％，填充剂1～3％以及余量的水。
2.如权利要求1所述的一种一种布洛芬巴布贴剂，其特征是所述部分中和聚丙烯酸钠优选为NP700；所述填充剂为高岭土。
3.如权利要求1所述的一种布洛芬巴布贴剂，其特征是丙三醇含量优选为10％，甘露醇含量优选为10％。
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| CN101502499A (zh) * | 2009-03-13 | 2009-08-12 | 北京化工大学 | 一种布洛芬经皮释放贴剂及其制备方法 |
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| WO1995031193A1 (fr) * | 1994-05-11 | 1995-11-23 | Laboratoires D'hygiene Et De Dietetique | Systeme matriciel pour administration transdermique d'ibuprofene et procede de preparation |
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