CN112386569A - 一种中药凝胶辅料及其应用 - Google Patents
一种中药凝胶辅料及其应用 Download PDFInfo
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Abstract
本发明提供了一种中药凝胶辅料,由下列重量份的原料组成:黏着剂180~300重量份,保湿剂1128~1806重量份,填充剂600~1500重量份,交联剂9.6~24重量份,交联调节剂9.6~19.2重量份,pH调节剂9.6~19.2重量份,水2706~3384重量份。本发明采用的中药凝胶辅料具有膏体质量稳定、不易撕烂的优点,同时对皮肤刺激性小。同时,本发明的中药凝胶辅料使用简单,可直接与处方剂混合制备,易于加工及使用。
Description
技术领域
本发明涉及一种凝胶辅料,特别是涉及一种中药凝胶辅料及其应用,具体为中药凝胶辅料领域。
背景技术
传统的跌打镇痛膏是一种《中华人民共和国药典》记载的皮肤外用橡胶贴膏,具有活血止痛,散瘀消肿,祛风胜湿的功效,用于急、慢性扭挫伤,慢性腰腿痛,风湿关节痛等,其疗效深受广大患者喜爱。
目前的跌打镇痛膏剂型在生产时,需要将中药材粉碎成细粉后,加入橡胶、松香等辅料混合,涂在棉布上制成。橡胶和松香等辅料会导致许多患者皮肤过敏。此外,目前的跌打镇痛膏质量不稳定,在使用过程中容易出现膏体撕烂或贴不牢等问题,严重影响患者的使用体验。
针对上述问题,较好的解决办法是将跌打镇痛膏在药物处方不变的基础上,改变辅料和工艺,由橡胶贴膏升级为凝胶辅料。凝胶辅料以水溶性高分子材料为主要基质,以类似凝胶的状态存在,皮肤刺激性、耐撕扯性和黏附力均优于橡胶贴膏。
但是,跌打镇痛膏依照凝胶辅料领域现有技术,难以制备出符合《中国药典》规定的凝胶辅料。例如,公开号为CN101780169A的专利公开了一种跌打镇痛巴布剂制剂及其制备方法,依照该文件记载的处方和方法制备的凝胶辅料稳定性差,难以交联成型,有严重的渗油现象,此外该工艺存在药材提取纯化步骤操作较复杂。
发明内容
本发明提供了一种中药凝胶辅料及其应用,以获得质量稳定的中药凝胶辅料及中药凝胶。
本发明提供了一种中药凝胶辅料,由下列重量份的原料组成:黏着剂180~300重量份,保湿剂1128~1806重量份,填充剂600~1500重量份,交联剂9.6~24重量份,交联调节剂9.6~19.2重量份,pH调节剂9.6~19.2重量份,水2706~3384重量份。
进一步地,所述黏着剂为聚丙烯酸盐,所述保湿剂为多羟基醇,所述填充剂选自高岭土、硅微粉中的一种或多种,所述交联剂为甘羟铝,所述交联调节剂为EDTA,所述pH调节剂为有机酸。
本发明还提供了一种中药凝胶,由500-700重量份处方剂、5500-6500重量份中药凝胶辅料组成。
进一步地,所述处方剂由350-450重量份中药粉、150-250重量份的油料组成。
更进一步地,所述中药粉由下列重量份原料组成:土鳖虫40-60重量份,生草乌40-60重量份,马钱子40-60重量份,大黄40-60重量份,降香40-60重量份,两面针40-60重量份,黄岑40-60重量份,黄柏40-60重量份,虎杖10-20重量份。
更进一步地,所述油料由下列重量份原料组成:冰片15-30重量份,薄荷素油20-40重量份,樟脑40-80重量份,水杨酸甲酯40-80重量份,薄荷脑20-40重量份。
更进一步地,所述中药粉的制备方法如下:取中药粉的原料粉碎成均匀细粉;所述油料的制备方法如下:取油料原料混合均匀。
更进一步地,所述中药凝胶的制备方法如下:
步骤1:A相物料制备:将油料与保湿剂混匀;B相物料制备:将pH调节剂溶于水中;C相物料制备:将黏着剂、交联剂、交联调节剂、填充剂混匀;
步骤2:将A相物料投入C相物料中,混匀后再投入B相物料,混匀后投入中药粉中,再次混匀获得中药凝胶。
更进一步地,所述步骤2具体如下:
将A相物料投入C相物料中,研磨至均匀后再缓慢投入B相物料,边投入边研磨,均匀后再投入中药粉的一半并研磨,均匀后再投入另一半中药粉,获得中药凝胶。
本发明还公开一种应用上述中药凝胶的贴膏,所述中药凝胶涂布于载体上。
其中,载体可选为2-4级拒水无纺布。
本发明相对于现有技术,采用的中药凝胶辅料具有膏体质量稳定、不易撕烂的优点,同时对皮肤刺激性小。同时,本发明的中药凝胶辅料使用简单,可直接与处方剂混合制备,易于加工及使用。
具体实施方式
为了使本技术领域的人员更好地理解本发明方案,下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分的实施例,而不是全部的实施例。
本发明实施例中处方剂组份比例及制备方法如下::
中药粉组成如下:土鳖虫48份,生草乌48份,马钱子48份,大黄48份,降香48份,两面针48份,黄岑48份,黄柏48份,虎杖15份;具体制备方法为:将马钱子炒后与土鳖虫、生草乌、大黄、降香、两面、黄岑、黄柏、虎杖粉碎成均匀细粉;
油料组成如下:冰片24份,薄荷素油30份,樟脑60份,水杨酸甲酯60份,薄荷脑30份;具体制备方法为:取油料原料混合均匀。
本发明中药凝胶的制备方法如下:
步骤1:A相物料制备:将油料与保湿剂混匀;B相物料制备:将pH调节剂溶于水中;C相物料制备:将黏着剂、交联剂、交联调节剂、填充剂混匀10分钟;
步骤2:将A相物料投入C相物料中,研磨至均匀后再缓慢投入B相物料,边投入边研磨,均匀后再投入中药粉的一半并研磨,均匀后再投入另一半中药粉,获得中药凝胶。
实施例1-9具体组成如下表所示:
对实施例1-9的中药凝胶进行观察,并涂布,获得结果如下:
实施例1膏体颜色较浅,表面有光泽,无颗粒感,涂布容易,15天尚有黏手,成型最慢;
实施例2表面光泽度低,颗粒感较强,不易涂布,5天成型;
实施例3膏体相对较稀,表面颗粒感较轻,5天成型;
实施例4膏体表面有光泽,颜色较浅,无颗粒感,涂布较难,容易黏住刮刀,5天成型,外观漂亮,膏体弹性,黏附性好;
实施例5表面有光泽,无颗粒感,涂布易黏刀,不易刮平,3天成型;
实施例6表面有光泽,涂布易黏刀,不易刮平,5天成型;
实施例7表面光泽度低,颗粒感较轻,膏体黏稠,涂布易黏刀,不易刮平,3天成型;
实施例8黏稠表面光泽度低,有颗粒感,膏体黏稠,涂布易黏刀,不易刮平,5天成型;
实施例9膏体黏稠,表面无光泽,颗粒感较强,涂布困难,3天成型。
对实施例1-9中药凝胶涂布于无纺布后获得的贴膏进行性能测试,结果如下表所示。
A:涂布3天后观查膏体表面外观性状,有光泽,无颗粒感为最高分9分,有颗粒感,色泽暗淡为最低分1分;
B:涂布3天后手指轻压膏体表面,轻触即有黏附性且黏附力最大者为最高分9分,按压抬起黏附力最小为最低分1分;
C:涂布10天后,依照2020版药典四部通则0952第一法“初黏力的测定”进行测定,倾斜角度为30度;
D:涂布23天后,依照2020版药典四部通则0952第一法“初黏力的测定”进行测定,倾斜角度为30度;
E:涂布9天前后,称重测定;
F:涂布3个月后,依照2020版药典四部通则0122贴膏剂下“含膏量”第一法进行测定;
G:涂布后立即依照2020版药典四部通则0122贴膏剂下“赋形性”进行测定。
公开号为CN101780169A的专利凝胶辅料质量不稳定,难以交联成型,只能使用小号数的钢球进行测试,黏性小。相比之下,本发明实施例1-9交联成型后膏体质量稳定,不易撕烂,赋形性满足药典要求,且膏体具有良好的黏性,在初黏力测试时,最高可采用30-35号钢球进行测试。此外,本发明实施例采用的中药凝胶辅料不含橡胶和松香,对皮肤刺激性较小,且中药凝胶辅料使用简单,可直接与处方剂混合制备,易于加工及使用。
最后应当说明的是,以上实施例仅用以说明本发明的技术方案而非对其限制,尽管参照上述实施例对本发明进行了详细的说明,所属领域的普通技术人员应当理解,技术人员阅读本申请说明书后依然可以对本发明的具体实施方式进行修改或者等同替换,但这些修改或变更均未脱离本发明申请待批权利要求保护范围之内。
Claims (10)
1.一种中药凝胶辅料,其特征在于,所述中药凝胶辅料由下列重量份的原料组成:黏着剂180~300重量份,保湿剂1128~1806重量份,填充剂600~1500重量份,交联剂9.6~24重量份,交联调节剂9.6~19.2重量份,pH调节剂9.6~19.2重量份,水2706~3384重量份。
2.根据权利要求1所述一种中药凝胶辅料,其特征在于,所述黏着剂为聚丙烯酸盐,所述保湿剂为多羟基醇,所述填充剂选自高岭土、微粉硅胶中的一种或多种,所述交联剂为甘羟铝,所述交联调节剂为EDTA,所述pH调节剂为有机酸。
3.一种中药凝胶,其特征在于,所述中药凝胶由500-700重量份处方剂、5500-6500重量份中药凝胶辅料组成。
4.根据权利要求3所述一种中药凝胶,其特征在于,所述处方剂由350-450重量份中药粉、150-250重量份的油料组成。
5.根据权利要求4所述一种中药凝胶,其特征在于,所述中药粉由下列重量份原料组成:土鳖虫40-60重量份,生草乌40-60重量份,马钱子40-60重量份,大黄40-60重量份,降香40-60重量份,两面针40-60重量份,黄岑40-60重量份,黄柏40-60重量份,虎杖10-20重量份。
6.根据权利要求4所述一种中药凝胶,其特征在于,所述油料由下列重量份原料组成:冰片15-30重量份,薄荷素油20-40重量份,樟脑40-80重量份,水杨酸甲酯40-80重量份,薄荷脑20-40重量份。
7.根据权利要求4所述一种中药凝胶,其特征在于,所述中药粉的制备方法如下:取中药粉的原料粉碎成均匀细粉;所述油料的制备方法如下:取油料原料混合均匀。
8.根据权利要求4所述一种中药凝胶,其特征在于,所述中药凝胶的制备方法如下:
步骤1:A相物料制备:将油料与保湿剂混匀;B相物料制备:将pH调节剂溶于水中;C相物料制备:将黏着剂、交联剂、交联调节剂、填充剂混匀;
步骤2:将A相物料投入C相物料中,混匀后再投入B相物料,混匀后投入中药粉中,再次混匀获得中药凝胶。
9.根据权利要求8所述一种中药凝胶,其特征在于,所述步骤2具体如下:
将A相物料投入C相物料中,研磨至均匀后再缓慢投入B相物料,边投入边研磨,均匀后再投入中药粉的一半并研磨,均匀后再投入另一半中药粉,获得中药凝胶。
10.一种应用权利要求3-9任一项所述中药凝胶的贴膏,其特征在于,所述中药凝胶涂布于载体上。
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CN115869360B (zh) * | 2022-12-08 | 2023-12-19 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | 一种跌打镇痛膏及其制备方法 |
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