CN1195524A - 药物制剂 - Google Patents

药物制剂 Download PDF

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CN1195524A
CN1195524A CN98106364A CN98106364A CN1195524A CN 1195524 A CN1195524 A CN 1195524A CN 98106364 A CN98106364 A CN 98106364A CN 98106364 A CN98106364 A CN 98106364A CN 1195524 A CN1195524 A CN 1195524A
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A·苏珀萨克所
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Abstract

本发明涉及一种新的用于药物局部施用的药物配方,尤其是非甾族的抗炎药(NSAID’s),包括:(a)一种治疗有效量的药物;(b)磷酸钠缓冲剂;和任选的;(c)一种醇溶剂。

Description

药物制剂
本发明涉及一种新的用于药物的局部施用的药物制剂，尤其是非甾族的抗炎药(NSAID’s)。
鉴于与口服制剂相关的药物负作用，NSAID’s日益通过局部的途径给药。对于成功的局部NSAID药物的先决条件是药充分地透过皮肤进入更深层组织如脂膜、筋膜、腱、韧带和肌，来治疗软组织结构的发炎变性的和外伤后的改变。水醇制剂，例如，乙醇/水和1，2-丙二醇/乙醇/水是通常使用的NSAID’s局部施用的制剂。根据本发明，已发现通过加入磷酸钠缓冲剂到这种制剂中可显著地改善NSAID的渗透。
因此，本发明是关于药物局部施用的制剂，尤其是非甾族的抗炎药(NSAID’s)，其制剂包括：
(a)一种治疗有效量的药物；
(b)磷酸钠缓冲剂；和任选的，
(c)一种醇溶剂。
根据本发明的制剂可以任何常规的施用形式给出。这种施用形式的例子是溶液、泡沫、霜剂、软膏、洗剂和凝胶。
根据本发明，制剂中所含的药物可以是任何通常局部施用的药物。在本发明中所用的最感兴趣的药是NSAID’s如萘普生、布洛芬、消炎痛、双氯灭酸、炎痛喜康或氟灭酸酯和其药物可接收的盐。对本发明来说，一种优选的NSAID是萘普生。可使用通常用于NSAID’s的药物制剂中的任何盐。这种盐的例子是碱金属盐如钠和钾盐，和取代的铵盐如与烷基胺和羟烷基胺的盐，例如二乙胺和三乙醇胺。磷酸钠缓冲剂合适的摩尔浓度范围在从约10到300mM，优选约100至约200mM。缓冲溶液的pH值优选在5和7.5之间，更优选6.0到7.5。最优选pH6.0。醇溶剂可以是任何通常用于局部制剂中的这样的溶剂。优选的醇溶剂是乙醇、异丙醇、1，2-丙二醇和其混合物。醇溶剂的另一例子是甘油。优选的醇溶剂是乙醇和1，2-丙二醇3∶1份重量比的混合物。
如果需要一种凝胶制剂，可以使用任何通常用于药物凝胶制剂中的凝胶成形剂。凝胶成形剂的例子是纤维素衍生物如甲基纤维素、羟乙基纤维素、羧甲基纤维素、乙烯基聚合物如聚乙烯醇，聚乙烯吡咯烷酮；和聚丙烯衍生物如聚羧乙烯。根据本发明另外的可用于组合物中的胶凝剂是果胶类、树胶类、如阿拉伯树胶和黄蓍胶、藻酸盐类、角叉酸盐类、琼脂和明胶。优选的用于本发明的胶凝剂是羟丙基甲基纤维素(HPMC)。此外，本发明的凝胶制剂还可含通常用于这种制剂中的辅剂如防腐剂、抗氧化剂、稳定剂、着色剂和香料。
在本发明的制剂中存在的活性成分的量通常与在相应的常规制剂中的相同。如果药物，例如活性成分，是一种NSAID，其量的变化是，例如，每100g制成的制剂中从约0.1到约10g的NSAID，优选0.5-2.5g，最优选每100g制成制剂约1g。磷酸钠缓冲剂的量的变化可从每100g制成的制剂中从约30到约90-99g，优选约30到约70g的100-200mM的溶液。适宜的醇溶剂的量是每100g制成制剂中从约5到约70g。在本发明的一个优选的方面，醇溶剂包含约20到约40g的乙醇和约5到约30g的1，2-丙二醇。在凝胶制剂中，足以获得对在皮肤上施用具有足够的粘度的凝胶制剂的胶凝剂的量取决于所用的特定胶凝剂或介质和所期望的制成的凝胶制剂的粘度，并可通过药物制剂专家根据个别要求确定。
根据本发明的制剂可用常规方式制备。例如，药物，如一种NSAID溶于水缓冲液，和任选地醇共溶剂。然后所得溶液可通过加入胶凝剂，例如羟乙基纤维素或羟丙基甲基纤维素胶凝。
下面的实施例阐述本发明：
实施例1从下面的组分制得一种凝胶；组分                                  〔克〕萘普生钠                               1.1乙醇                                   30.01，2-丙二醇                            10.0pH 6.0的200mM的磷酸钠缓冲水溶液                   50.0羟乙基纤维素                                      1.6水，加至足量                                      100.0
实施例2从下面的组分制得一种凝胶；组分                                             〔克〕萘普生钠                                          1.1乙醇                                              30.01，2-丙二醇                                       10.0pH 6.0的100mM的磷酸钠缓冲水溶液                   50.0羟丙甲基纤维素                                    2.5水，加至足量                                      100.0
实施例3从下面的组分制得一种凝胶：组分                                           〔克〕萘普生(游离酸)                                  1.0三乙醇胺                                        0.65乙醇                                            30.01，2-丙二醇                                     10.0pH 6.0的200mM的磷酸钠缓冲水溶液                 50.0羟乙基纤维素                                    1.6水，加至足量                                    100.0
实施例4从下面的组分制得一种凝胶：组分                                          〔克〕萘普生钠                                       2.74乙醇                                           30.01，2-丙二醇                                10.0pH 6.0的200mM的磷酸钠缓冲水溶液            50.0羟乙基纤维素                               1.6水，加至足量                               100.0
实施例5从下面的组分制得一种凝胶：组分                                      〔克〕萘普生钠                                   5.5乙醇                                       30.01，2-丙二醇                                10.0pH 6.0的200mM的磷酸钠缓冲水溶液            50.0羟乙基纤维素                               1.6水，加至足量                               100.0
实施例6从下面的组分制得一种凝胶：组分                                      〔克〕萘普生钠                                   1.1乙醇                                       30.01，2-丙二醇                                10.0pH 6.0的100mM的磷酸钠缓冲水溶液            50.0羟乙基纤维素                               1.6水，加至足量                               100.0
实施例7从下面的组分制得一种凝胶：组分                                      〔克〕萘普生钠                                   1.1pH 7.25的100mM的磷酸钠缓冲水溶液             50.0羟乙基纤维素                                 1.6水，加至足量                                 100.0
实施例8皮肤渗透研究：
测定了萘普生从根据本发明的制剂(实施例1)、从一相应的非缓冲的制剂(制剂B)和从一先有技术制剂(Naprosyn GELTM，制剂A)的皮肤渗透。制备的制剂A和B具有如下给出的组合物：制剂                     A〔克〕     B〔克〕萘普生(游离酸)           10.0          -萘普生钠                  -           1.1三乙醇胺                 13.0          -乙醇                     30.0         30.01，2-丙二醇               -           10.0羟乙基纤维素              -           1.6卡波沫940(Carbomer 940)  2             -焦亚硫酸钠               0.1           -玫瑰香料                 0.03          -水加至足量               100.0        100.0
将人尸体的腹部皮肤的皮肤样品切成皮板(0.38mm)并在-80℃冷冻。实验的当天，皮肤样品解冻并置于扩散截面1cm2和接受室体积5ml的Franz型扩散小室中。安装有磁搅拌棒的接收室充满1mM、PH7.4的磷酸盐缓冲盐水。然后扩散小室转移至恒温在32℃的加热箱中。随着3-4小时的平衡期后，用微量移液管将5mg/cm2的试验制剂施用到表皮表面上。在非封闭的条件下于32℃孵化45小时后，取出接收溶液并用HPLC测定萘普生的浓度。结果示于图1中。
图1表示萘普生从Naproxyn GEL(A)、1，2-丙二醇/乙醇水(B)和1，2-丙二醇/乙醇/磷酸钠缓冲剂凝胶(实施例1)透过人尸体皮肤的体外透皮实验结果。每个柱代表用得自七个不同供体的皮肤进行的七个实验的几何平均值。***＝P＜0.005，NS＝无显著性；通过“学生”配成对的t-检验与Naprosyn GEL相比较。

Claims (9)

1.一种用于药物局部施用的药物制剂，该制剂包含：
(a)一种治疗有效量的药物；
(b)磷酸钠缓冲剂；和任选的，
(c)一种醇溶剂。
2.一种如在权利要求1中的制剂，其中的药物是一种非甾族抗炎药(NSAID)。
3.一种如在权利要求2中的制剂，其中的NSAID是萘普生、布洛芬、消炎痛、双氯灭酸、炎痛喜康或氟灭酸酯或其药物可接收的盐。
4.一种如在权利要求1到3中任何一个中的制剂，其中的磷酸钠缓冲剂是10到300mM的pH 5到7.5的磷酸钠缓冲水溶液。
5.一种如在权利要求1-4中任何一个中的制剂，其中存在一种醇溶剂，包括乙醇、异丙醇、和1，2-丙二醇或一种它们的混合物。
6.一种如在权利要求1-5中任何一个中的凝胶制剂，每100g的制剂包含：
(a)约0.1到约10g的NSAID；
(b)约30到约70g的100-200mM的pH 6-7.5的磷酸钠缓冲剂；
(c1)约20到约40g的乙醇和/或异丙醇；
(c2)约5到约30g的1，2-丙二醇；和
(d)至少一种胶凝剂，其量为足以获得一种具有足够的粘度以施用于皮肤上的凝胶制剂。
7.一种如在权利要求6中的凝胶制剂，其中的胶凝剂是羟丙基甲基纤维素。
8.一种如在权利要求1-7中任何一个中的制剂，其中的药物是萘普生钠。
9.一种权利要求8的制剂，其中的药物是约1％的萘普生钠。
CNB981063640A 1997-04-10 1998-04-09 药物制剂 Expired - Fee Related CN1191826C (zh)

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US6420394B1 (en) 2002-07-16
DE69815585T2 (de) 2004-04-29
EP0872247B1 (en) 2003-06-18
CN1191826C (zh) 2005-03-09
TR199800631A2 (xx) 1998-10-21
EP0872247A1 (en) 1998-10-21
DK0872247T3 (da) 2003-09-29
CA2232855C (en) 2007-10-09
ZA982872B (en) 1998-10-12
AR012376A1 (es) 2000-10-18
TR199800631A3 (tr) 1998-10-21
DE69815585D1 (de) 2003-07-24
PT872247E (pt) 2003-10-31
CA2232855A1 (en) 1998-10-10
BR9803300A (pt) 2000-01-11
JPH10287588A (ja) 1998-10-27
KR19980081238A (ko) 1998-11-25
KR100554811B1 (ko) 2006-05-25
JP4580476B2 (ja) 2010-11-10
ATE243043T1 (de) 2003-07-15
ES2201361T3 (es) 2004-03-16

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