CN110302183B - 复方消炎痛凝胶贴膏及其制备方法 - Google Patents
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Abstract
本发明属于中药制剂技术领域,具体涉及复方消炎痛凝胶贴膏及其制备方法。本发明为一种消炎痛复方制剂,由吲哚美辛、白芍、当归、半夏、大黄、药用辅料及纯净水组成。制备过程主要包括:药材前处理、提取、过滤、浓缩、制膏、混合、涂布、盖膜。本发明的消炎痛复方制剂具有降低主药不良反应、增加药效时间,使用方便、疗效确切。
Description
技术领域
本发明属于中药制剂技术领域,具体涉及一种复方消炎痛凝胶贴膏及其制备方法。
背景技术
疼痛是临床疾病中常见的症状,比如类风湿性关节炎痛、运动损伤等。目前,阿片类和非甾体类抗炎药是最常用的镇痛药,由于阿片类药物有很强的成瘾性在临床使用中被严格限制;而非甾体类抗炎药容易引起消化道反应,很大程度上限制了其使用。为得到副作用少和镇痛效果好的制剂,采用中西药结合的复方贴膏。
凝胶贴膏,原名巴布剂,系指原料药物与适宜的亲水性基质(骨架材料、交联剂、交联调节剂、增粘剂、保湿剂等和水)混匀后涂布于背衬材料上制成的贴膏剂,属于经皮给药系统。凝胶贴膏相比与传统的中药贴膏剂有显著的优点:水溶性聚合物材料与皮肤相容性好,几乎不产生致敏刺激;载药量大,尤其适于中药制剂;保水性强且透气性好;高含水量,利于药物透皮吸收;剂量准确,血药浓度平稳;具有反复揭帖性;适用范围广,克服了口服给药及直肠给药的缺点,避免肝脏的首过效应,从而增加了药物吸收率。
发明内容
针对现有技术中存在的问题,本发明设计的目的在于提供一种复方消炎痛凝胶贴膏及其制备方法。该贴膏基于复方消炎痛乳膏的基础,在已有的消炎痛巴布剂的基础上,加入4味临床经验优选而来的中药,采用中西药相结合的方式既保留了西药的速效、中药长效的作用,又降低了非甾体抗炎药的不良反应。
本发明通过以下技术方案加以实现:
所述的复方消炎痛凝胶贴膏,其特征在于该贴膏由主药、中药乙醇提取液、辅料组成,所述主药为吲哚美辛,所述中药乙醇提取液为白芍、当归、半夏、大黄混合物的醇提液,所述辅料包括聚丙烯酸钠、氮酮、甘油、甘羟铝、EDTA-2Na、聚维酮、酒石酸、薄荷脑、尼泊金乙酯。
所述的复方消炎痛凝胶贴膏,其特征在于每50g膏体中,
主药的用量为0.1~0.5g;
中药乙醇提取液所需的中药组分及用量为:白芍8~10g、当归8~10g、半夏8~10g、大黄10~16g;
辅料的成分及用量为:聚丙烯酸钠3~5g、氮酮1~3g、甘油10~30g、甘羟铝0.1~0.5g、EDTA-2Na 0.1~0.5g、聚维酮1~3g、酒石酸0.1~0.5g、薄荷脑0.1~0.5g、尼泊金乙酯0.1~0.5g。
所述的复方消炎痛凝胶贴膏的制备方法,其特征在于包括以下步骤:
1)白芍、当归、大黄、半夏分别粉碎后过筛,分别取配方量的白芍粉末、当归粉末、大黄粉末、半夏粉末混合均匀得混合粉末,加入混合粉末8~20倍量的乙醇加热回流2~4小时,过滤得提取液,将提取液浓缩至相对密度为1.2得药液,
2)取配方量的吲哚美辛溶于5~15ml无水乙醇中得主药液,将主药液与步骤1)制得的药液混合得混合药液,备用;
3)取配方量氮酮、甘羟铝、EDTA-2Na、聚丙烯酸钠、尼泊金乙酯,加甘油溶解制得油相,备用;
4)取配方量的聚维酮、酒石酸、薄荷脑加水引湿后,制得水相,备用;
5)油相及水相混合后,将步骤2)~4)制得的混合药液加入,真空搅拌,涂布到无纺布上,盖上保护膜,即得复方消炎痛凝胶贴膏。
所述的复方消炎痛凝胶贴膏的制备方法,其特征在于步骤1)中乙醇浓度为60~90%。
所述的复方消炎痛凝胶贴膏的制备方法,其特征在于5)中真空搅拌是抽真空至-0.5MPa,转速为500~1500rpm,搅拌温度为40℃,搅拌时间为10min。
本发明在已有主药的基础上,改进基质的配方和制备工艺,以制备出黏附性适宜、不透水、膏体外观优良、释药性能及疗效较好的复方消炎痛凝胶贴膏,用来减轻或解除局部软组织损伤、风湿关节炎患者的疼痛。
本发明采用中西药相结合的方式,经过科学合理的配比,既保留了西药的速效、中药长效的作用,又降低了非甾体抗炎药的不良反应。临床研究验证,复方消炎痛凝胶贴膏起效快,持续时间长。克服了其他制剂依从性差、消化道副作用的缺点。四位中药都具有消肿止痛的功效,进一步增强治疗效果。
附图说明
图1为本发明制得的复方消炎痛凝胶贴膏样品。
具体实施方式
以下结合实施例对本发明做进一步详细描述,并给出具体实施方式。
本发明提供了一种复方消炎痛凝胶贴膏,以亲水性材料为基质,该基质中含有白芍、半夏、大黄、当归的抗炎镇痛活性成分。以聚丙烯酸钠(可选择NP-600、NP-700或NP-800)为骨架材料、甘羟铝为交联剂构成网状结构进行载药。
实施例1
大黄、白芍、当归、半夏粉碎过10目筛,取大黄10g、白芍8g、当归10g、半夏12g;药材粉末加15倍量70%乙醇加热回流3小时,过滤后,78℃浓缩药液约为15mL,取350mg吲哚美辛溶于8mL无水乙醇后加入,混匀;取3g氮酮、0.5g甘羟铝、0.5g EDTA-2Na、7g聚丙烯酸钠NP800、0.1g尼泊金乙酯,加30g甘油溶解;取4g聚维酮、0.1g酒石酸、0.3g薄荷脑加水引湿;将上述各溶液投入真空搅拌锅中,抽真空至-0.5MPa,以500~1500rpm、40℃搅拌10min,将膏体倒入水凝胶涂布机中涂布于无纺布上、加保护膜,放入异形膏贴滚切机裁剪,真空包装机包装完成,得到复方消炎痛凝胶贴膏。
上述制备方法及配方制得的凝胶贴膏见图1,粘附性适宜,外衬易剥离无残留,膏体均匀,皮肤相容性适中,保湿度好。
实施例2
改良Franz扩散池。向接收池中加入磷酸缓冲液,取处理好的离体鼠皮剪裁成合适的大小,角质层向上置于扩散池中,分别取裁剪好的复方消炎痛凝胶贴膏(自制)、消炎痛凝胶贴膏(自制)和消炎痛巴布剂(市售)贴在离体皮肤表面,将扩散池置于恒温水浴锅(温度37±1℃,转速200rpm)中。24h内分别于8个时间点取接受液,并向扩散池补等量的已加热到37℃的磷酸缓冲液。
各时间点取得的接受液分别经0.45μm微孔滤膜过滤,精密量取稀释后流动相定容,HPLC检测。按计算不同时间单位面积的累积渗透量Q(μg·cm-2),式中Cn为第n个取样点测得的药物浓度(μg·mL-1),V为接收液体积(mL),Ci为第i(i≤n-1)个取样点测得的药物浓度(μg·mL-1),Vi为取样体积(mL),A为扩散面积(cm2)。以时间(X)为横坐标,累积渗透量Q(Y)为纵坐标进行线性回归。取上述三种制剂各三贴,分别从不同贴的不同位置剪下面积相同的圆形贴膏,分别置于烧杯中,加入10mL甲醇超声置换20min,溶液全部倒出后,加入5mL甲醇继续超声置换20min,如此置换两次,合并置换液于量筒,精密读取体积,测定吲哚美辛的含量,按计算单位面积载药量Q(mg·cm-2),式中,V为精密读取合并置换液的体积(mL),c为测得吲哚美辛含量(μg·mL-1),A’为从贴膏上剪下的面积。按计算累积透过率T%。式中,A为扩散面积,Qn为n时的累积渗透率,Q为单位面积载药量。结果显示三种制剂24h累积透过率分别为40.85%、40.69%和47.09%。表明复方消炎痛凝胶贴膏较普通消炎痛凝胶贴膏有更优越的透皮性能。
实施例3
通过注射刺激性化学物质使小鼠扭体,从而观察复方消炎痛凝胶贴膏的镇痛效果:选取18只ICR雌性小鼠,分别为空白组、消炎痛组、复方消炎痛组。将每只小鼠进行称重,记录各自重量,然后用剪刀及刮毛刀对小鼠的臀背部进行脱毛处理,避免剪伤小鼠,之后在臀背部脱毛处理的位置贴上相应的贴膏(空白组贴空白基质的凝胶贴膏,消炎痛组贴市售的消炎痛巴布剂,复方消炎痛组贴自制的复方消炎痛凝胶贴膏,凝胶贴膏的大小均裁剪成适宜的面积),连续给药一周,最后一次给药后1h,在每只小鼠的腹腔注射醋酸溶液,使产生腹膜炎疼痛,观察出现扭体反应的时间和15min内小鼠出现的扭体次数(腹部明显收缩内凹,后肢不停伸展蠕行,臀部会抬高),然后计算各组的镇痛率(=(空白组小鼠扭体次数—实验组小鼠扭体次数)/空白组小鼠扭体次数×100%)醋酸扭体实验结果如表1所示。
表1复方消炎痛凝胶贴膏与消炎痛巴布剂的镇痛作用比较 (n=6)
通过醋酸扭体实验结果分析可以得出:复方消炎痛组与消炎痛组的小鼠扭体次数明显少于空白组,且复方消炎痛组扭体次数最少但与消炎痛组的数据差异不明显;说明复方消炎痛凝胶贴膏的局部应用能有效地降低醋酸所致的小鼠疼痛扭体次数,延长小鼠出现扭体反应的时间,复方消炎痛凝胶贴膏具有较好的镇痛效果。
最后应说明的是:以上所述仅为本发明的优选实施例而已,并不用于限制本发明,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换。
凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (2)
1.复方消炎痛凝胶贴膏,其特征在于该贴膏由主药、中药乙醇提取液、辅料组成,所述主药为吲哚美辛,所述中药乙醇提取液为白芍、当归、半夏、大黄混合物的醇提液,所述辅料包括聚丙烯酸钠、氮酮、甘油、甘羟铝、EDTA-2Na、聚维酮、酒石酸、薄荷脑、尼泊金乙酯,乙醇浓度为60~90%;
其中,每50g膏体中,主药的用量为0.1~0.5g;中药乙醇提取液所需的中药组分及用量为:白芍 8~10g、当归 8~10g、半夏 8~10g、大黄 10~16g;辅料的成分及用量为:聚丙烯酸钠3~5g、氮酮1~3g、甘油10~30g、甘羟铝0.1~0.5g、EDTA-2Na 0.1~0.5g、聚维酮1~3g、酒石酸0.1~0.5g、薄荷脑0.1~0.5g、尼泊金乙酯0.1~0.5g;
所述复方消炎痛凝胶贴膏采用以下步骤制备:
1)白芍、当归、大黄、半夏分别粉碎后过筛,分别取配方量的白芍粉末、当归粉末、大黄粉末、半夏粉末混合均匀得混合粉末,加入混合粉末8~20倍量的乙醇加热回流2~4小时,过滤得提取液,将提取液浓缩至相对密度为1.2,得药液;
2)取配方量的吲哚美辛溶于5~15ml无水乙醇中得主药液,将主药液与步骤1)制得的药液混合得混合药液,备用;
3)取配方量氮酮、甘羟铝、EDTA-2Na、聚丙烯酸钠、尼泊金乙酯,加甘油溶解制得油相,备用;
4)取配方量的聚维酮、酒石酸、薄荷脑加水引湿后,制得水相,备用;
5)油相及水相混合后,将步骤2)制得的混合药液加入,真空搅拌,涂布到无纺布上,盖上保护膜,即得复方消炎痛凝胶贴膏。
2.如权利要求1所述的复方消炎痛凝胶贴膏,其特征在于步骤5)中真空搅拌是抽真空至-0.5MPa,转速为500~1500rpm,搅拌温度为40℃,搅拌时间为10min。
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