CN108057056A - 一种自发热中药组合物、自发热中药外敷贴及其制备方法 - Google Patents
一种自发热中药组合物、自发热中药外敷贴及其制备方法 Download PDFInfo
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- CN108057056A CN108057056A CN201810117306.3A CN201810117306A CN108057056A CN 108057056 A CN108057056 A CN 108057056A CN 201810117306 A CN201810117306 A CN 201810117306A CN 108057056 A CN108057056 A CN 108057056A
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Abstract
一种自发热中药组合物,包括自发热组分、中药组分和协同组分,所述自发热组分用于与空气接触产热;所述协同组分包括托玛琳粉和负离子粉,能够在所述自发热组分的加热下与所述中药组分产生协同作用;所述中药组分包括艾叶粉、红花粉和旃那叶粉。本发明的优点在于通过合理配比的艾叶、红花和旃那叶粉能够很好地对女性肥胖患者进行治疗,并且通过添加托玛琳粉和负离子粉,加强药物的治疗效果,而且还能够针对不同体质更有针对性,提高治疗效果。
Description
技术领域
本发明涉及理疗装置技术领域,尤其涉及一种自发热中药减肥外敷贴及其制备方法。
背景技术
随着社会进步及人民生活水平的提高,公共卫生事业的长足发展带来平均寿命进一步延长,我国居民疾病种类发生了较大的变化,曾经严重影响居民平均寿命的感染性疾病现在已经退居二线,心脑血管疾病、恶性肿瘤、糖尿病、高血压等疾病成为危害人类健康的主要因素,而研究表明,这些疾病都和肥胖密切相关,腹型肥胖也称中心性肥胖是导致高血压、高血糖、高血脂的主要原因,也是恶性肿瘤的独立风险因素,控制肥胖对预防和延缓这些疾病的发生和发展有着重要作用。目前治疗肥胖主要通过生活方式干预,药物治疗和外科手术三种治疗方式,而比较严重的肥胖症则需要后两种治疗方式进行治疗,口服给药具有胃肠道对有效成份的破坏、肝脏对药物的"首过效应"和药物副作用等问题,外科手术则具有很大的危险性,因此贴剂给药则成为现在肥胖患者的首选。
如专利号为201610649033.8的中国发明专利,公开了一种减肥贴,包括防粘膜、载体层、防渗圈和药粒,其中,所述的载体层由两层无纺布缝制而成,所述的载体层内部有防渗圈和药粒,所述的载体层一面喷涂胶体,所述的防贴膜覆盖在所述的载体层喷胶面的表面,所述的药粒的配方包括半夏100g、荷叶100g、茯苓150g、泽泻150g、牵牛子50g、槟榔50g、大黄150g、枳壳50g、柴胡50g、肉桂50g、冰片5g。采用上述结构的减肥贴在室温较低时外用贴剂会产生不适感,而且药物起效慢,治疗效果不明显,致敏率高。
发明内容
本发明所要解决的技术问题是提供一种治疗效果好,致敏率低的中药减肥外敷贴。
本发明解决上述技术问题所采用的技术方案为:
一种自发热中药组合物,包括自发热组分、中药组分和协同组分,所述自发热组分用于与空气接触产热;所述协同组分包括托玛琳粉和负离子粉,能够在所述自发热组分的加热下与所述中药组分产生协同作用;所述中药组分包括艾叶粉、红花粉和旃那叶粉。
优选地,所述协同组分按照重量份数包括2~20份托玛琳粉、0.2~2份负离子粉。
优选地,所述所述中药组分按照重量份数包括1~10份艾叶粉、1~10份红花粉和1~10份旃那叶粉。
优选地,所述中药组分按照重量份数包括3~9份艾叶粉、4~9份红花粉和2~8份旃那叶粉。
优选地,所述中药组分按照重量份数包括1~10份香薷粉、1~10份厚朴花粉、1~10份川芎粉、1~10份三七粉、1~10份肉桂粉、1~10份丁香粉中的至少两种。
优选地,所述自发热组分按重量份数包括5~50份还原铁粉、3~25份活性碳粉和1.5~10份无机盐。
自发热中药外敷贴,包括功效层、保温层和黏贴层,所述功效层位于保温层和黏贴层之间,所述功效层和所述保温层设于无纺布内,所述黏贴层设于所述无纺布的外表面,所述功效层的原料包括所述自发热中药组合物和制成用于载药的基体的原料。
优选地,所述保温层的原料和所述功效层的原料按照重量份数1份保温层的原料和3~6份功效层的原料进行配比,所述功效层的原料中按照重量份数1份自发热中药组合物和0.2~1份所述基体的原料进行配比。
自发热中药外敷贴的制备方法,包括下述步骤:1)、功效层和保温层的制作:取所述自发热中药组合物和所述基体混合,均匀涂布于大孔无纺布上形成所述功效层,当所述功效层成型后在其表面均匀布散所述保温层的原料,干燥,得到所述功效层和所述保温层复合在一起的复合层;2)、成品的制作:将步骤1)得到的所述复合层的保温层面上覆盖无纺布,将无纺布边缘缝合,并在该缝合后的复合层的无纺布上添加黏贴层,得到所述自发热中药外敷贴。
步骤1)的所述干燥的条件为压强0.04~0.09Mpa,温度为20~30℃,干燥时间为2~8分钟。
与现有技术相比,本发明的优点在于通过合理配比的艾叶、红花和旃那叶粉能够很好地对女性肥胖患者进行治疗,并且通过添加托玛琳粉和负离子粉,加强药物的治疗效果,而且还能够针对不同体质更有针对性,提高治疗效果。
具体实施方式
以下结合实施例对本发明作进一步详细描述。
实施例1
本发明的自发热中药组合物包括自发热组分、中药组分和协同组分,其中自发热组分用于与空气接触产热,中药组分为减重降脂的中药原料,协同组分能够在自发热组分的加热下与中药组分产生协同作用,进一步发挥中药组分减重降脂的治疗作用,上述三种组分优选为粉末状态,易于混合均匀。
自发热组分按重量份数包括5~50份还原铁粉、3~25份活性碳粉和1.5~10份无机盐,这三种原料混合后能够和空气反应产生热量。
中药组分按重量份数包括1~10份艾叶粉、1~10份红花粉和1~10份旃那叶粉,优选比例为3~9份艾叶粉、4~9份红花粉和2~8份旃那叶粉。艾叶粉、红花粉和旃那叶粉能够很好地针对肥胖患者的湿热夹瘀的体质,而且女性在肥胖患者中的比例较高,湿热夹瘀的体质会导致这些女性患者具有月经不调、痛经、闭经等病症,艾叶粉和红花粉的活血调经功效能够对这些女性肥胖患者产生很好的治疗效果。为了使治疗效果更具有针对性,上述中药组分还针对不同体质按照重量份数包括1~10份香薷粉、1~10份厚朴花粉、1~10份川芎粉、1~10份三七粉、1~10份肉桂粉、1~10份丁香粉中的至少两种,如针对湿热体质,中药组分中可以添加香薷粉和厚朴花粉,针对血瘀体质,中药组分中可以添加川芎粉和三七粉,针对寒湿体质,中药组分中可以添加肉桂粉和丁香粉。
协同组分按重量份数包括2~10份托玛琳粉和0.5~2份负离子粉,托玛琳粉在加热后产生电磁波改善人体的微循环,负离子粉在加热后产生的负离子能够促进血液携氧能力,将托玛琳粉、负离子粉和自发热组分、中药组分混合后能够协同促进各中药粉末的渗透和吸收,大大提高该自发热中药组合物的治疗效果。
实施例2
本实施例为采用实施例1中的自发热中药组合物制成的自发热中药外敷贴,该自发热中药外敷贴包括功效层、保温层和黏贴层,功效层位于保温层和黏贴层之间,并且功效层和保温层设于无纺布内,黏贴层设置在无纺布的外表面上,黏贴层可贴于皮肤上,保温层用于减少功效层的热量散失。其中,制成保温层的原料和制成功效层的原料按照重量份数1份保温层的原料和3~6份功效层的原料进行配比,功效层的原料包括自发热中药组合物和制成用于载药的基体的原料,并且按照重量份数1份自发热中药组合物和0.2~1份基体的原料进行配比,按照上述重量份数配比的自发热中药减肥外敷贴能够促进药物吸收的同时节省费用。优选地,自发热中药外敷贴按照重量份数由1份保温层和4份功效层组成,其中功效层按照重量份数包括1份自发热中药组合物和0.5份基体。本实施例的自发热中药组合物优选地包括25g还原铁粉、14g活性碳粉、6g无机盐、5g托玛琳粉、1.7g负离子粉、5g艾叶粉、7g红花粉、5g旃那叶粉,不包括针对体质的中药粉末,适用于各种体质。
该自发热中药外敷贴的制备方法包括下述步骤:
1)、功效层和保温层的制作:取按照上述重量份数的自发热中药组合物并过80目筛后搅拌均匀,然后按照重量份数将1份自发热中药组合物和0.5份基体混合,均匀涂布于大孔无纺布上形成功效层,无纺布可以维持功效层的形状并且便于操作;当功效层成型后在其表面均匀布散保温层原料,如蛭石粉,保温层原料的重量为功效层的1/4,冲压切割为合适的形状,置于0.04~0.09Mpa、20~30℃的真空干燥箱中干燥2~8分钟,优选地在0.09Mpa、20℃的真空干燥箱中干燥8分钟,得到功效层和保温层复合在一起的复合层。
2)、成品的制作:将步骤1)得到的复合层的无纺布面上添加黏贴层,并在复合层的保温层面上覆盖无纺布,将无纺布边缘缝合,得到本实施例的自发热中药外敷贴。
本实施例的自发热中药外敷贴能够在温度40度以上发热时间持续13.8小时,检测负离子浓度显著增加。
实施例3
本实施例同样地采用实施例1中的自发热中药组合物制成的自发热中药外敷贴,并且本实施例与实施例2的自发热中药外敷贴结构相同,其区别仅在于原料的用量和制备工艺条件的选取不同,而且本实施例针对湿热体质的肥胖患者。
自发热中药组合物包括50g还原铁粉、25g活性碳粉、10g无机盐、10g托玛琳粉、2g负离子粉、9g艾叶粉、9g红花粉、8g旃那叶粉、10g香薷粉和10g厚朴花粉。
本实施例的自发热中药外敷贴的制备方法为:
1)、功效层和保温层的制作:取按照上述重量份数的自发热中药组合物并过80目筛后搅拌均匀,然后按照重量份数将1份自发热中药组合物和1份基体混合,均匀涂布于大孔无纺布上形成功效层,当功效层成型后在其表面均匀布散保温层原料,如蛭石粉,保温层原料的重量为功效层的1/3,冲压切割为合适的形状,置于0.07Mpa、23℃的真空干燥箱中干燥6分钟,得到功效层和保温层复合在一起的复合层。
2)、成品的制作:将步骤1)得到的复合层的无纺布面上添加黏贴层,并在复合层的保温层面上覆盖无纺布,将无纺布边缘缝合,得到本发明的自发热中药外敷贴。
本实施例的自发热中药外敷贴能够在温度40度以上发热时间持续13.8小时,检测负离子显著增加。
实施例4
本实施例同样地采用实施例1中的自发热中药组合物制成的自发热中药外敷贴,并且本实施例与实施例2的自发热中药外敷贴结构相同,其区别仅在于原料的用量和制备工艺条件的选取不同,而且本实施例针对血瘀体质的肥胖患者。
自发热中药组合物包括5g还原铁粉、3g活性碳粉、1.5g无机盐、2g托玛琳粉、0.5g负离子粉、3g艾叶粉、4g红花粉、2g旃那叶粉、1g川芎粉、1g三七粉。
本实施例的自发热中药减肥外敷贴的制备方法为:
1)、功效层和保温层的制作:取按照上述重量份数的自发热中药组合物并过80目筛后搅拌均匀,然后按照重量份数将1份自发热中药组合物和0.2份基体混合,均匀涂布于大孔无纺布上形成功效层,当功效层成型后在其表面均匀布散保温层原料,如蛭石粉,保温层原料的重量为功效层的1/6,冲压切割为合适的形状,置于真空干燥箱中0.05Mpa、26℃干燥4分钟,得到功效层和保温层复合在一起的复合层。
2)、成品的制作:将步骤1)得到的复合层的无纺布面上添加黏贴层,并在复合层的保温层面上覆盖无纺布,将无纺布边缘缝合,得到本发明的自发热中药外敷贴。
本实施例的自发热中药外敷贴能够在温度40度以上发热时间持续12.8小时,检测负离子显著增加。
实施例5
本实施例同样地采用实施例1中的自发热中药组合物制成的自发热中药外敷贴,并且本实施例与实施例2的自发热中药外敷贴结构相同,其区别仅在于原料的用量和制备工艺条件的选取不同,而且本实施例针对寒湿体质的肥胖患者。
自发热中药组合物包括40g还原铁粉、20g活性碳粉、9g无机盐、8g托玛琳粉、1g负离子粉、10g艾叶粉、10g红花粉、10g旃那叶粉、10g肉桂粉、10g丁香粉。
本实施例的自发热中药外敷贴的制备方法为:
1)、功效层和保温层的制作:取按照上述重量份数的自发热中药组合物并过80目筛后搅拌均匀,然后按照重量份数将1份自发热中药组合物和0.8份基体混合,均匀涂布于大孔无纺布上形成功效层,当功效层成型后在其表面均匀布散保温层原料,如蛭石粉,保温层原料的重量为功效层的1/5,冲压切割为合适的形状,置于真空干燥箱中0.04Mpa、30℃干燥2分钟,得到功效层和保温层复合在一起的复合层。
2)、成品的制作:将步骤1)得到的复合层的无纺布面上添加黏贴层,并在复合层的保温层面上覆盖无纺布,将无纺布边缘缝合,得到本发明的自发热中药外敷贴。
本实施例的自发热中药外敷贴能够在温度40度以上发热时间持续13.2小时,检测负离子显著增加。
验证实验:
1、样本制作:
收集12岁至80岁之间的无其他系统严重疾病的肥胖患者90例,这些肥胖患者的体重指数(BMI=体重/身高2,kg/m2)≥24kg/m2,并且排除哺乳期妇女、孕妇、备孕期妇女。
首先,将上述肥胖患者的分为对照组、中药组和核心组方组,每组30例,分别采集三组中的肥胖患者的基线信息,基线信息为年龄、性别、职业、身高、体重、腰围、臀围、ALT(谷丙转氨酶)、AST(谷草转氨酶)、Scr(血清肌酐)、TG(甘油三酯)、TC(总胆固醇),统计学分析基线信息两组无显著差异。
2、实施方案:
按照双盲原则,核心组方组给予上述实施例2的工艺流程制作自发热中药减肥外敷贴,中药组给予按照实施例2的工艺流程制作的,但不含有托玛琳粉和负离子粉的自发热中药减肥外敷贴,对照组给予有相同外观,不含有功效成分的空白自发热中药减肥外敷贴,将贴剂贴于肚脐两侧天枢穴,每贴使用三天,实验8周,两组中各肥胖患者的其余作息均相同。实验结束后,分别采集肥胖患者的基线信息并作统计学分析,即将三组基线信息采用均数±标准差(mean±std)表达,符合正态分布的计量资料,采用t检验,不符合正态分布的计量资料,采用Mann-Whitney检验,结果用P值表示,以P<0.05为有统计学差异,P<0.01为有显著差异。
3、结果及其分析:
①治疗结束时,对照组中有2例出现过敏,核心组方组中有1例出现过敏,上述3人持续使用后缓解,其余均完成治疗,无不良反应。
②分别将对照组、中药组和核心组方组的治疗前后的基线信息进行计算并对比,具体如表1-3所示。
表1治疗前后治疗组和对照组的体重(Weight)、腰围(Waist)、臀围(Hip)
**P<0.01,表示有显著统计学差异。
表2治疗前后治疗组和对照组的血清ALT、AST、TG、TC浓度
*P<0.05,表示有统计学差异,**P<0.01,表示有显著统计学差异。
如表1所示,治疗前,对照组、中药组和核心组方组在体重、腰围、臀围基本一致;治疗后,中药组和核心组方组的体重、腰围、臀围相比于对照组显著下降,同时核心组方组的体重和腰围低于中药组。由此可知,本发明的中药组分对于肥胖患者的体重、腰围和臀围具有显著的治疗效果,并且在中药组分中添加托玛琳粉和负离子粉能够进一步提高中药组分的治疗效果。
如表2所示,治疗前,对照组、中药组和核心组方组在血清ALT、AST、TG、TC浓度基本一致;治疗后,中药组和核心组方组的血清ALT、AST、TG、TC浓度和对照组相比有显著下降,同时核心组方组的本发明的中药组分对于肥胖患者的体重、腰围和臀围具有显著的治疗效果,并且在中药组分中添加托玛琳粉和负离子粉能够进一步提高中药组分的治疗效果和中药组基本一致,并且在治疗前后,对照组、中药组和核心组方组的Scr的含量也均无显著差异,且均处于正常范围内。由此可知,本发明的中药组分能够有效降低肥胖患者的血清ALT、AST、TG、TC浓度,同时对于Scr含量无影响,安全有效。并且,中药组分中添加的托玛琳粉和负离子粉能够提高中药组分的治疗效果,进一步降低肥胖患者的血清ALT、AST、TG、TC浓度。
由表1-2可知,首先,本发明的自发热中药减肥外敷贴可以明显降低肥胖患者的体重、腰围、臀围,直观地治疗肥胖。然后,本发明的自发热中药减肥外敷贴改善肥胖患者的肝功能指标ALT、AST,同时降低血脂指标TG、TC,改善脂质代谢,调节脂代谢紊乱。其次,本发明的自发热中药减肥外敷贴可以在后续中添加针对体质的中药,更进一步增强减重降脂的功效。最后,本发明的自发热中药减肥外敷贴对肥胖患者的肝肾功能没有影响,致敏率低,致敏反应轻,持续用药可以缓解,不良反应少。
本发明中各中药原料的作用为:艾叶具有理气血,逐寒湿,温经,止血,安胎的功效,可以显著降低肥胖患者的体重、体重指数、腰围、腰臀比、脂肪百分率,降低多囊卵巢综合症患者的黄体生成素、黄体生成素/卵泡生成素,同时对兼有多囊卵巢综合症和肥胖的患者体重、腰围均有控制作用;红花具有活血通经,散淤止痛的功效,显著降低肥胖小鼠的体质量、体脂含量、脂肪细胞面积、肝脏重量及血脂水平,并且明显减轻肥胖小鼠肝脏脂肪变性程度,同时可显著改善肥胖小鼠的糖耐量异常,增强胰岛素的敏感性,增加腺嘌呤苷酸依赖的AMPK(蛋白激酶)的mRNA的表达、提高p-AMPK蛋白表达水平,从而抑制前脂细胞增殖分化的作用,有效地降低血清中的TG、TC、LDL、AST、ALT、丙二醛的含量,提高肝脏组织中超过氧化物歧化酶、过氧化氢酶、亚铁还原能力活力,具有较好的降血脂和抗氧化活力。旃那叶具有泻热行滞,通便,利水的功效,对脂联素启动子有调控作用,可以上调脂联素mRNA浓度,促进脂肪细胞分泌脂联素,改善胰岛素抵抗指数,治疗肥胖。因此,混合了上述中药成分及合理配比的自发热中药外敷贴,能够提高降脂减肥的治疗效果,并且致敏率低,操作简单,成本低。
以上仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明技术原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种自发热中药组合物,其特征在于:包括自发热组分、中药组分和协同组分,所述自发热组分用于与空气接触产热;所述协同组分包括托玛琳粉和负离子粉,能够在所述自发热组分的加热下与所述中药组分产生协同作用;所述中药组分包括艾叶粉、红花粉和旃那叶粉。
2.根据权利要求1所述的一种自发热中药组合物,其特征在于:所述协同组分按照重量份数包括2~20份托玛琳粉、0.2~2份负离子粉。
3.根据权利要求1所述的一种自发热中药组合物,其特征在于:所述所述中药组分按照重量份数包括1~10份艾叶粉、1~10份红花粉和1~10份旃那叶粉。
4.根据权利要求3所述的一种自发热中药组合物,其特征在于:所述中药组分按照重量份数包括3~9份艾叶粉、4~9份红花粉和2~8份旃那叶粉。
5.根据权利要求1所述的一种自发热中药组合物,其特征在于:所述中药组分按照重量份数包括1~10份香薷粉、1~10份厚朴花粉、1~10份川芎粉、1~10份三七粉、1~10份肉桂粉、1~10份丁香粉中的至少两种。
6.根据权利要求1所述的一种自发热中药组合物,其特征在于:所述自发热组分按重量份数包括5~50份还原铁粉、3~25份活性碳粉和1.5~10份无机盐。
7.由权利要求1~7任一项所述的自发热中药组合物制成的自发热中药外敷贴,其特征在于:包括功效层、保温层和黏贴层,所述功效层位于保温层和黏贴层之间,所述功效层和所述保温层设于无纺布内,所述黏贴层设于所述无纺布的外表面,所述功效层的原料包括所述自发热中药组合物和制成用于载药的基体的原料。
8.根据权利要求7所述的自发热中药外敷贴,其特征在于:所述保温层的原料和所述功效层的原料按照重量份数1份保温层的原料和3~6份功效层的原料进行配比,所述功效层的原料中按照重量份数1份自发热中药组合物和0.2~1份所述基体的原料进行配比。
9.如权利要求8所述的自发热中药外敷贴的制备方法,其特征在于:包括下述步骤:1)、功效层和保温层的制作:取所述自发热中药组合物和所述基体混合,均匀涂布于大孔无纺布上形成所述功效层,当所述功效层成型后在其表面均匀布散所述保温层的原料,干燥,得到所述功效层和所述保温层复合在一起的复合层;2)、成品的制作:将步骤1)得到的所述复合层的保温层面上覆盖无纺布,将无纺布边缘缝合,并在该缝合后的复合层的无纺布上添加黏贴层,得到所述自发热中药外敷贴。
10.如权利要求9所述的自发热中药外敷贴的制备方法,其特征在于:步骤1)的所述干燥的条件为压强0.04~0.09Mpa,温度为20~30℃,干燥时间为2~8分钟。
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