CN1102410C - 莫匹罗星钙盐的乳膏组合物 - Google Patents

莫匹罗星钙盐的乳膏组合物 Download PDF

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CN1102410C
CN1102410C CN94194238A CN94194238A CN1102410C CN 1102410 C CN1102410 C CN 1102410C CN 94194238 A CN94194238 A CN 94194238A CN 94194238 A CN94194238 A CN 94194238A CN 1102410 C CN1102410 C CN 1102410C
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H·L·齐默曼
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Abstract

含有乳膏基质的药用或兽用组合物，所述乳膏基质包括矿物油；一种或多种脂肪醇或脂肪酯；聚氧乙烯醚或酯表面活性剂；以及水。

Description

莫匹罗星钙盐的乳膏组合物
本发明涉及用作为治疗用化合物载体的新组合物。尤其是本发明涉及用作为局部应用有效治疗药物(如抗菌素)的通常所说“乳膏”的赋形剂。
EP-A-0 069 423(Gist-Brocades)公开了用作为局部药用组合物的通常所说的”脂肪-乳膏”，它含有50-80％(按重量计)脂肪物质、1.5-5％(按重量计)亲水的非离子型表面活性剂以及治疗药物。优选的组合物基质包括十六烷基硬脂醇、液体石蜡、白色软石蜡和西土马哥1000。
EP-A-0 251 434(Beecham Group)尤其公开了含有抗菌素莫匹罗星的各种乳膏配方。一个具体的实施例含有1-3％(按重量计)莫匹罗星(或其盐)、25-60％(按重量计)液体石蜡、20-50％(按重量计)水以及3-30％(按重量计)乳化剂。其实施例6公开了含有液体石蜡(42％)、硬脂醇(16.4％)和西土马哥1000(3.6％)的乳膏。
含有莫匹罗星的局部用抗菌组合物在英国由Beecham ResearchLaboratories的商品名Bactroban Ointment和Bactroban Nasal进行销售。第一个产品为含有水可溶性聚乙二醇基质的软膏剂，而第二个产品为含有甘油酯的莫匹罗星钙盐的白色软石蜡为基质的软膏剂。
由上述先有技术公开的广泛的组合物中，现在我们发现了与先有技术配方相比具有改进的制剂特性的严格配方。
本发明提供了含有乳膏基质和治疗药物的药用或兽用的组合物，其特征在于该乳膏基质包括
45-60％，优选50-55％按重量计的矿物油；
5-15％，优选5-10％按重量计的一种或多种脂肪醇或脂肪酯；
4-8％，优选5-7％按重量计的聚氧乙烯醚或酯表面活性剂；以及
20-35％，优选25-35％按重量计的水。
上述组合物中的百分比的组合物总重量为基准，该组合物一般还含有1-3％按重量计的治疗药物(如抗菌素)。
矿物油和脂肪醇或酯一起占组合物重量的50-75％是合适的，优选占55-70％，更优选占55-65％。矿物油与脂肪醇或酯的比例为1∶3-1∶12是合适的，优选1∶5-1∶11(按重量计)。
所述治疗药物可以是任一在局部应用有效的药物。作为适合局部应用的抗菌素，尤其可以提到的有莫匹罗星，特别是它的钙盐，尤其是它的二水合物。莫匹罗星或其盐占配方重量的1-3％是合适的，通常为约2％(以游离酸的重量表示)。
这里应用的术语“矿物油”包括适用于局部药用组合物或兽药组合物中的任何一种矿物油，并且包括矿物油(USP)、轻矿物油(NF)、液体石蜡(BP)和轻液体石蜡(BP)。称作为矿物油(USP)的矿物油是尤其适用的。
作为脂肪醇或蜡，可以应用于药用组合物或兽药组合物中的任一脂肪醇或酯，例如硬脂醇、十六烷醇、十六烷基硬脂醇、十四烷基醇和甘油单硬脂酸酯。应用硬脂醇与十六烷基醇的混合物是合适的。
在本发明中应用的聚氧乙烯酯或醇是一种起非离子表面活性剂作用的物质。如上面所引的EP-A-0 069 423中所示，作为表面活性剂它有利于HLB值为14或14以上。合适的物质包括聚乙二醇单鲸蜡基醚，例如以商品名西土马哥1000销售的物质，以及例如以商品名聚山梨醇酯-60销售的聚氧乙烯山梨糖醇单硬脂酸酯和以商品名吐温80销售的聚氧乙烯山梨糖醇单油酸酯。
本发明组合物还可以包括少量的常用添加剂如粘度调节剂例如黄原酸胶，以及防腐剂例如苯氧基乙醇或苄醇(包括它们的混合物)。对于某些治疗药物，为了保持合适的pH值，需要加入缓冲剂。
本发明中优选的组合物包括50-55％(按重量计)矿物油，合适的有矿物油(USP)；5-10％(按重量计)脂肪醇或酯，合适的有十六烷基醇或硬脂醇或它们的混合物；5-7％的聚氧乙烯醚或酯表面活性剂，合适的有聚乙二醇单鲸蜡基醚例如西土马哥1000；25-35％(按重量计)水以及1-3％(约2％是合适的)(按重量计)莫匹罗星钙盐，尤其是其二水合物盐(以游离酸的重量表示)。
该乳膏基质可以按本技术领域熟知的一般方法进行制备。一般来讲，合适的方法包括以合适的相当量按任一方便的顺序将各个乳膏成分混合，然后如果需要，调节pH至最终需要的数值。例如，在一升高的温度(例如60-70℃)，将该基质的各个成分一起混合，直至形成乳状液。在该已乳化的乳膏基质冷却之后加入治疗药物，或者如果应用的温度合适，可以在基质的各个成分混合时加入治疗药物。
本发明组合物供药用或兽药用。在上述步骤中按常用的无菌步骤，可以按无菌条件任意地得到组合物。另外，在无菌条件下使无菌的各成分进行混合。
另一方面，本发明提供了用于治疗的药用或兽用的组合物。
此外，本发明另一方面，该乳膏基质本身可以用作为湿润的乳膏或润肤剂而无需有治疗药物。
下面的实施例详细叙述了本发明的组合物。
实施例1
                         ％(按重量计)
矿物油(USP)                  54.9
聚乙二醇(1000)单鲸蜡基醚*   5.0
硬脂醇(NF)                   3.5
十六烷基醇(NF)               3.5
苯氧基乙醇                   0.5
莫匹罗星钙盐                 2.4
黄原酸胶                     0.2
纯化水                       30.0
*西土马哥1000               30.0
实施例2
                         ％(按重量计)
矿物油(USP)                  51.9
聚乙二醇(1000)单鲸蜡基醚     6.0
硬脂醇(NF)                   3.5
十六烷基醇(NF)               3.5
苯氧基乙醇                   0.5
苄基醇                       1.0
莫匹罗星钙盐                 2.4
黄原酸胶                       0.2
纯化水                         31.0
实施例3
                               ％(按重量计)
矿物油(USP)                    50.9
聚乙二醇(1000)单鲸蜡基醚       6.0
硬脂醇(NF)                     3.5
十六烷基醇(NF)                 3.5
苯氧基乙醇                     0.5
苄基醇                         1.0
莫匹罗星钙盐                   2.4
黄原酸胶                       0.2
纯化水                         32.0

Claims (14)

1.含有乳膏基质以及一种治疗药物莫匹罗星钙盐的药用或兽用组合物，其特征在于所述乳膏基质包括
45-60％按重量计矿物油；
5-15％按重量计一种或多种脂肪醇或酯；
4-8％按重量计聚氧乙烯醚或酯表面活性剂；
少量粘度调节剂，以及
20-35％按重量计水。
2.权利要求1所述的组合物，该组合物含有50-55％按重量计矿物油。
3.权利要求1或2所述的组合物，该组合物含有5-10％按重量计一种或多种脂肪醇或酯。
4.权利要求1至3之一所述的组合物，其中脂肪醇为硬脂醇与十六烷基醇的混合物。
5.权利要求1至4之一所述的组合物，该组合物含有5-7％按重量计聚氧乙烯醚或酯表面活性剂。
6.权利要求1至5之一所述的组合物，其中表面活性剂为聚氧化亚乙基二醇单鲸蜡基醚。
7.权利要求1至6之一所述的组合物，该组合物含有25-35％按重量计水。
8.权利要求1至7之一所述的组合物，该组合物含有1-3％按重量计治疗药物。
9.权利要求1-8之一所述的组合物，其中所述盐为莫匹罗星钙盐二水合物。
10.权利要求1-9之一的组合物，其中的粘度调节剂是黄原酸胶。
11.权利要求10的组合物，其中的黄原酸胶的量是以组合物重量计，约0.2％。
12.权利要求1-11之一所述的组合物还含有选自苯氧基乙醇或苄基醇或为它们混合物的防腐剂。
13.权利要求1-12之一的药用或兽用的组合物，该组合物含有50-55％按重量计矿物油；5-10％按重量计脂肪醇或酯；5-7％的聚氧乙烯醚或酯表面活性剂；30-35％按重量计水以及少量粘度调节剂1-3％按重量计以其游离酸的重量表示莫匹罗星钙盐。
14.权利要求1-12之任一的组合物，包含约2.4％以重量计的莫匹罗星钙盐，约50.9％以重量计的矿物油USP，约6％以重量计的聚氧化亚乙基二醇单鲸腊基醚，约3.5％以重量计的硬脂  醇，约3.5％以重量计的鲸腊基醇，约0.5％以重量计的苯氧基乙醚，约1％以重量计的苄基醇，约0.2％以重量计的黄原酸胶，约32％以重量计的水。
CN94194238A 1993-10-22 1994-10-20 莫匹罗星钙盐的乳膏组合物 Expired - Lifetime CN1102410C (zh)

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GB939321876A GB9321876D0 (en) 1993-10-22 1993-10-22 Novel composition
GB939322288A GB9322288D0 (en) 1993-10-29 1993-10-29 Novel composition
GB9322288.3 1993-10-29

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EP0727979A1 (en) 1996-08-28
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BG100501A (bg) 1996-12-31
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CA2174658C (en) 2000-12-19
GR3036591T3 (en) 2001-12-31
FI961720A (fi) 1996-04-19
OA10361A (en) 2001-11-21
BR9407840A (pt) 1997-05-13
NZ275282A (en) 1996-10-28
WO1995010999A1 (en) 1995-04-27
UA39896C2 (uk) 2001-07-16
NO961588D0 (no) 1996-04-19
FI961720A0 (fi) 1996-04-19
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US6025389A (en) 2000-02-15
NO313446B1 (no) 2002-10-07
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EP0727979B1 (en) 2001-06-27
FI116931B (fi) 2006-04-13
CN1135715A (zh) 1996-11-13
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