CN105534996A - 一种治疗银屑病的药物组合物 - Google Patents
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Abstract
本发明公开了一种治疗银屑病的药物组合物，其特征在于该药物组合物处方重量份数计为：卡泊三醇1-10份，羟基脲1-10份，单硬脂酸甘油酯1-20份，脂溶性基质1-20份、乳化剂1-20份，保湿剂5-20份，透皮吸收剂1-8份，纯化水20-70份。组方科学，制备工艺简单，治疗寻常型银屑病、顽固性银屑病疗效显著。
Description
技术领域
本发明属于医药制剂领域，具体涉及一种治疗银屑病的药物组合物。
背景技术
银屑病俗称牛皮癣，俗称“不死癌症”，是一种以表皮过度增生和真皮慢性炎症反应为特征的常见皮肤病，自然人群的患病率约为2%，有逐年升高的趋势。该病发病率较高，病程较长，发病以青壮年为主，对患者的身体健康和精神状况影响较大。临床表现以红斑，鳞屑为主，全身均可发病，以头皮，四肢伸侧较为常见，多在冬季加重。目前大部分治疗银屑病的药膏里面加入了糖皮质类激素，效果虽然好，但在停药后症状反而比原来还严重，甚至可诱发急性脓疱型银屑病或红皮病型银屑病。
卡泊三醇为维生素D衍生物卡泊三醇的外用制剂，能抑制皮肤细胞（角脘细胞）增生和诱导其分化，从而使银屑病皮损的增生和分化异常得以纠正。系1987年由丹麦利昂制药公司合成，其主要作用是通过与角质形成细胞内的核受体结合，调节角质形成细胞的增殖与分化，即抑制细胞增殖，促进细胞分化；对免疫系统具有明显的免疫抑制作用，通过调节角质形成细胞和淋巴细胞（主要是前者）而影响细胞因子的产生和释放，能够抑制皮肤细胞（角朊细胞）增生和诱导其分化，从而使银屑病皮损的增生及分化异常得以纠正。经皮吸收率很低，只有1%-5%，因此使用剂量较大，而其主要副作用为对皮损周围的刺激症状，表现为皮肤烧灼感、瘙痒、红斑、脱屑和干燥，与使用剂量正相关。
羟基脲为核苷酸还原酶抑制剂。其作用机制是抑制核苷二磷酸还原酶，阻止核苷酸还原为脱氧核苷酸，从而抑制脱氧核糖核酸的合成，而不干扰核糖核酸或蛋白质的合成。是细胞周期特异性药物，对分化增殖的细胞较敏感，毒性也较低，口服吸收较快，2小时后血浆浓度达最高水平，6小时后消失。用于顽固性银屑病和脓疱性银屑病均有肯定疗效，能减轻全身性脓疱性银屑病的脓疤、发热和中毒症状。短期用药，其毒性作用较甲氨蝶呤小，对有肝脏损伤不宜应用甲氨蝶呤或用甲氨蝶呤无效的严重银屑病患者，似宜选用本品治疗。
结合卡泊三醇与羟基脲治疗银屑病机理和疗效，联合用药，在不使用糖皮质激素的条件下更好的改善银屑病患者症状，减轻痛苦。
发明内容
本发明旨在提供一种用于毒副作用小，安全性高，治疗寻常型银屑病、顽固性银屑病疗效显著的银屑病的药物组合物。
为实现上述发明目的，本发明一种治疗银屑病的药物组合物，具体实施方案为：
本发明所述一种治疗银屑病的药物组合物，其特征在于该药物组合物处方重量份数计为：卡泊三醇1-10份，羟基脲1-10份，单硬脂酸甘油酯1-20份，脂溶性基质1-20份、乳化剂1-20份，保湿剂5-20份，透皮吸收剂1-8份，纯化水20-70份。
本发明所述一种治疗银屑病的药物组合物，其特征在于该药物组合物处方重量份数计为：卡泊三醇2-8份，羟基脲2-8份，单硬脂酸甘油酯2-15份，脂溶性基质2-18份、乳化剂3-18份，保湿剂8-18份，透皮吸收剂2-6份，纯化水30-60份。
本发明所述一种治疗银屑病的药物组合物，其特征在于该药物组合物脂溶性基质为：石蜡、液状石蜡、白凡士林、羊毛脂、蜂蜡、鲸蜡中的一种或多种组合；乳化剂为：OP乳化剂、平平加O、司盘80、吐温-80、十二烷基硫酸钠中的一种或多种组合；保湿剂为：甘油、丙二醇、山梨醇中的一种或多种组合；透皮吸收剂为：氮酮、薄荷油、松节油中的一种或多种组合。
本发明所述一种治疗银屑病的药物组合物，其特征在于该药物组合物脂溶性基质为液状石蜡、白凡士林，两者比例0.1:1—10:1；乳化剂为司盘80、十二烷基硫酸钠，两者比例0.1:1—10:1。
本发明所述一种治疗银屑病的药物组合物，其特征在于所述制剂由与药学上可接受的载体组成，剂型为软膏剂。
本发明所述一种治疗银屑病的药物组合物，其特征在于其制备方法如下：
1）将处方量的卡泊三醇和羟基脲研细过80-120目筛，加入甘油研和均匀，备用。
2）将液状石蜡、白凡士林、单硬脂酸甘油酯、司盘-80、氮酮于80℃水浴溶解。
3）将十二烷基硫酸钠加入纯化水于78℃水浴溶解。
4）在200-700r/min条件下，将2）缓缓加入3）中，搅拌5-15min，之后冷却降温至40-60℃，加入1）继续搅拌5-15min，冷却至室温即可。
本发明所述一种治疗银屑病的药物组合物，适用于寻常型银屑病、顽固性银屑病治疗。
具体实施方式
下面实施例只为进一步说明本发明，不以任何形式限制本发明。
实施例1
卡泊三醇2g，羟基脲1.5g，单硬脂酸甘油酯10g，液状石蜡9g，白凡士林6g、氮酮2g，司盘-806g，十二烷基硫酸钠2g，甘油16g，纯化水50g
制备方法：
1）将处方量的卡泊三醇和羟基脲研细过80目筛，加入甘油研和均匀，备用。
2）将液状石蜡、白凡士林、单硬脂酸甘油酯、司盘-80、氮酮于80℃水浴溶解。
3）将十二烷基硫酸钠加入纯化水于78℃水浴溶解。
4）在500r/min条件下，将2）缓缓加入3）中，搅拌10min，之后冷却降温至40-60℃，加入1）继续搅拌8min，冷却至室温即可。
实施例2
卡泊三醇2g，羟基脲1.5g，单硬脂酸甘油酯10g、液状石蜡7g、白凡士林8g、氮酮2g，司盘-805g，十二烷基硫酸钠3g，甘油16g，纯化水50g
制备方法：
1）将处方量的卡泊三醇和羟基脲研细过80目筛，加入甘油研和均匀，备用。
2）将液状石蜡、白凡士林、单硬脂酸甘油酯、司盘-80、氮酮于80℃水浴溶解。
3）将十二烷基硫酸钠加入纯化水于78℃水浴溶解。
4）在500r/min条件下，将2）缓缓加入3）中，搅拌10min，之后冷却降温至40-60℃，加入1）继续搅拌8min，冷却至室温即可。
实施例3
卡泊三醇2g，羟基脲1.5g，单硬脂酸甘油酯10g，液状石蜡5g，白凡士林10g、氮酮2g，司盘-807g，十二烷基硫酸钠1g，甘油16g，纯化水50g
制备方法：
1）将处方量的卡泊三醇和羟基脲研细过80目筛，加入甘油研和均匀，备用。
2）将液状石蜡、白凡士林、单硬脂酸甘油酯、司盘-80、氮酮于80℃水浴溶解。
3）将十二烷基硫酸钠加入纯化水于78℃水浴溶解。
4）在500r/min条件下，将2）缓缓加入3）中，搅拌10min，之后冷却降温至40-60℃，加入1）继续搅拌8min，冷却至室温即可。
实施例4
银屑病的主要病理改变为表皮增殖过快、细胞有丝分裂数增加和角化不全。采用小鼠阴道上皮细胞有丝分裂模型和鼠尾鳞片颗粒层模型等2种动物模型，对比市售卡泊三醇软膏与本发明软膏外用对上皮细胞有丝分裂及表皮细胞分化的影响，结果见表1,2。
判断标准：小鼠尾部颗粒层的鳞片数越多表示效果越好，有丝分裂细胞数越少表示效果越好。
表1不同实验药物组对小鼠鼠尾颗粒层细胞形成的影响
表2不同实验药物组对小鼠阴道上皮细胞有丝分裂的影响
由实验结果看，本发明软膏对鼠尾颗粒层细胞分化具有促进作用，对小鼠阴道上皮细胞有丝分裂有明显抑制作用，治疗银屑病药效优于卡泊三醇软膏。
Claims (7)
1.一种治疗银屑病的药物组合物，其特征在于该药物组合物处方重量份数计为：卡泊三醇1-10份，羟基脲1-10份，单硬脂酸甘油酯1-20份，脂溶性基质1-20份、乳化剂1-20份，保湿剂5-20份，透皮吸收剂1-8份，纯化水20-70份。
2.根据权利要求1所述一种治疗银屑病的药物组合物，其特征在于该药物组合物处方重量份数计为：卡泊三醇2-8份，羟基脲2-8份，单硬脂酸甘油酯2-15份，脂溶性基质2-18份、乳化剂3-18份，保湿剂8-18份，透皮吸收剂2-6份，纯化水30-60份。
3.根据权利要求1所述一种治疗银屑病的药物组合物，其特征在于该药物组合物脂溶性基质为：石蜡、液状石蜡、白凡士林、羊毛脂、蜂蜡、鲸蜡中的一种或多种组合；乳化剂为：OP乳化剂、平平加O、司盘80、吐温-80、十二烷基硫酸钠中的一种或多种组合；保湿剂为：甘油、丙二醇、山梨醇中的一种或多种组合；透皮吸收剂为：氮酮、薄荷油、松节油中的一种或多种组合。
4.根据权利要求所述脂溶性基质为液状石蜡、白凡士林，两者比例0.1:1—10:1；乳化剂为司盘80、十二烷基硫酸钠，两者比例0.1:1—10:1。
5.根据权利要求1所述一种治疗银屑病的药物组合物，其特征在于所述制剂由与药学上可接受的载体组成，剂型为软膏剂。
6.根据权利要求1所述一种治疗银屑病的药物组合物，其特征在于其制备方法如下：
1）将处方量的卡泊三醇和羟基脲研细过80-120目筛，加入甘油研和均匀，备用；
2）将液状石蜡、白凡士林、单硬脂酸甘油酯、司盘-80、氮酮于80℃水浴溶解；
3）将十二烷基硫酸钠加入纯化水于78℃水浴溶解；
4）在200-700r/min条件下，将2）缓缓加入3）中，搅拌5-15min，之后冷却降温至40-60℃，加入1）继续搅拌5-15min，冷却至室温即可。
7.根据权利要求1-5所述一种治疗银屑病的药物组合物，适用于寻常型银屑病、顽固性银屑病治疗。
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