CN117100784A - 一种无针注射用中药组合物及其制备方法 - Google Patents
一种无针注射用中药组合物及其制备方法 Download PDFInfo
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- CN117100784A CN117100784A CN202210525637.7A CN202210525637A CN117100784A CN 117100784 A CN117100784 A CN 117100784A CN 202210525637 A CN202210525637 A CN 202210525637A CN 117100784 A CN117100784 A CN 117100784A
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- needleless injection
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- vitiligo
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本发明属于药物制剂技术领域,公开了一种无针注射用斑鸠菊提取物及其制备方法。通过本发明的方法制备得到的一种治疗白癜风的无针注射用中药组合物,经无针注射器械注射后,可直接穿透皮肤表面与皮肤角质层,将斑鸠菊提取物、补骨脂提取物递送入皮肤以发挥药效,适用于白癜风的治疗。通过本发明的方法制备得到的一种治疗白癜风的无针注射用中药组合物可以保护药物长时间滞留皮肤内部,长时间发挥药效,避免了传统皮肤药膏快速清除的缺点。同时,这种治疗方式解决了白癜风目前在临床中需要借助紫外照射的仪器治疗方式,给药方式的特点决定了一种治疗白癜风的无针注射用中药组合物的日常使用安全、便捷,患者无痛感,对于治疗的接受程度高。
Description
技术领域
本发属于药物制剂领域,特别涉及一种治疗白癜风的无针注射用中药组合物及其制备方法。
背景技术
白癜风是一种常见的脱色性皮肤病,估计全球人口的患病率为0.5-2%。该疾病的特征在于黑素细胞的选择性丢失,导致典型的无鳞的、白垩白色的斑疹。近年来,研究者对白癜风的发病机制的理解取得了相当大的进展,现已明确将其归类为自身免疫性疾病。在现实生活中,尽管白癜风对患者的心理上造成着极大的困扰,但通常将其认定为是一种美容问题而没有得到应有的重视。
目前对于白癜风的治疗多采用窄带UV-B光进行照射治疗,也可采用UV-B光照射与其他治疗方式结合使用以促进色素的沉着。以上各种方法尽管在应用中是安全有效的,但由于治疗方式的限制,均需要患者在相应的技术人员指导下接受专业的治疗,这无疑需要患者极大的长时间坚持,也会对患者造成极大的经济压力。因此,一种更为方便便捷,成本低廉的替代治疗方法的开发已迫在眉睫。
发明内容
针对以上现有技术的缺陷,本发明解决的技术问题是提供一种用于治疗白癜风的无针注射用中药组合物,还提出一种用于治疗白癜风的无针注射用中药组合物的制备方法。
为解决本发明的技术问题,本发明解决的技术问题是提供一种用于治疗白癜风的无针注射用中药组合物,其特征在于:
所述治疗白癜风的无针注射用中药组合物为液体形式,所述治疗白癜风的无针注射用中药组合物包括活性物质、改性组分与溶剂组分;
进一步的,所述的活性物质选自斑鸠菊提取物、补骨脂提取物中的一种或多种;
所述的改性组分选自增助潜溶剂,稳定剂,滞留组分与其他组分中的一种或多种;
所述溶剂组分选自注射用水、磷酸盐缓冲液、生理盐水和葡萄糖溶液中的一种或多种。
更进一步的,所述增助潜溶剂选自二甲基亚砜、甘油、蓖麻油、乙醇、聚山梨酯、聚乙烯吡咯烷酮、聚乙二醇中的一种或多种;
所述稳定剂选自壳聚糖、透明质酸钠、聚氨酯、卡拉胶、明胶、白芨多糖中的一种或多种;
所述滞留组分选自聚乙二醇、蛋黄软磷脂、大豆软磷脂、胆固醇、二硬脂酰基磷脂酰乙醇胺、多巴胺中的一种或多种;
所述其他组分为pH调节剂、渗透压调节剂中的一种或多种,所述pH调节剂选自氢氧化钠、盐酸、磷酸、磷酸二氢钾、磷酸氢二钾、枸橼酸、枸橼酸钠、柠檬酸中的一种或多种,所述渗透压调节剂选自氯化钠、氯化钙、氯化钾、蔗糖中的一种或多种。
所述治疗白癜风的无针注射用中药组合物,其特征还在于,
所述活性物质占0.5-2质量份数,斑鸠菊提取物与补骨脂提取物的质量份数比为0.5-2;
所述增助潜溶剂占0.05-1.5质量份数,所述稳定剂占0.01-1质量份数,所述滞留组分占0.1-8质量份数;
所述pH调节剂占0-1.5质量份数,所述渗透压调节剂占0-1质量份数;
所述溶剂占20-60质量份数。
所述治疗白癜风的无针注射用中药组合物的制备方法,其特征在于,
所述治疗白癜风的无针注射用中药组合物的制备方法包含以下步骤:
①在一部分溶剂中加入增助潜溶剂、稳定剂并充分溶解,得到溶液A;
②将滞留组分溶解于另一部分溶剂中,充分混匀,得溶液B;
③将斑鸠菊提取物与补骨脂提取物按一定制备方法溶解于溶液B,得溶液C,其中,制备方法可以是直接溶解、剪切辅助的溶解、搅拌辅助的溶解超声匀质法、乳化法;
④将上述溶液A缓慢加入至溶液C中,加入过程中二者均保持水浴温度50-60℃,并在3000-5000rpm剪切条件下,加入完成后得溶液D;
⑤将上述溶液D进行pH、渗透压的调整,pH调整至6.7-7.0,渗透压调整至280~320mOsm/kg;
⑥将上述调整好pH、渗透压的治疗白癜风的无针注射用中药组合物经无菌处理、分装后即得;
其中,无菌处理可根据具体条件选择滤膜过滤法、高压灭菌法、无菌灌装法;
其中,所述部分溶剂为总溶剂体积的10%-70%。
所述的治疗白癜风的无针注射用中药组合物的使用方法,其特征在于,
所述治疗白癜风的无针注射用中药组合物装入无针给药国标容器,并配合无针注射器使用;可根据需求,调整每日给药次数,每日最多给药不超过3次;
所述的治疗白癜风的无针注射用中药组合物的使用方法,其特征还在于,
所述的无针注射用中药组合物在制备治疗和/或预防白癜风药物中的应用。
本发明的有益之处在于:
通过本发明的方法制备得到的一种治疗白癜风的无针注射用中药组合物适用于白癜风的治疗,这种治疗方式解决了白癜风目前在临床中需要借助紫外照射的仪器治疗方式,给药方式的特点决定了一种治疗白癜风的无针注射用中药组合物的日常使用安全、便捷,患者无痛感,对于治疗的接受程度高。
通过本发明的方法制备得到的一种治疗白癜风的无针注射用中药组合物经制备后,所得可以保护药物长时间滞留皮肤内部,长时间发挥药效,避免了传统皮肤药膏快速清除的缺点。
附图说明
图1实施例2制备的治疗白癜风的无针注射用中药组合物在皮肤的安全性评价;
图2斑鸠菊提取物与补骨脂提取物的液相图谱;
图3实施例4制备的治疗白癜风的无针注射用中药组合物在皮肤吸收情况与其他给药方式的对比结果图;
图4实施例5制备的治疗白癜风的无针注射用中药组合物在白癜风中的治疗作用与其他给药方式的对比结果图。
具体实施方式
下面通过实施例对本发明作进一步的详细说明,旨在用于说明本发明而非限定本发明。并且,需要特别指出的是,对于本领域技术人员而言,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也同样落入本发明的保护范围之内。
实施例1:一种治疗白癜风的无针注射用中药组合物的制备
1、处方(1000mL)
2、在500mL溶剂中加入聚山梨酯、透明质酸钠、白芨多糖并充分溶解,得到溶液A;
3、将多巴胺溶解于另500mL溶剂中,充分混匀,得溶液B;
4、将斑鸠菊提取物10g按剪切辅助的溶解方法溶解于溶液B,得溶液C;
5、将上述溶液A缓慢加入至溶液C中,加入过程中二者均保持水浴温度55-57℃,并在3500rpm剪切条件下,加入完成后得溶液D;
6、将上述溶液D进行pH、渗透压的调整,pH调整至6.7-7.0,渗透压调整至280~320mOsm/kg;
7、将上述调整好pH、渗透压的治疗白癜风的无针注射用中药组合物经无菌处理、分装后即得;
使用时,患者借助无针注射器械直接将治疗白癜风的无针注射用中药组合物注射于白癜风发病局部患处。
实施例2:一种治疗白癜风的无针注射用中药组合物的制备
1、处方(1000mL)
2、在800mL溶剂中加入二甲基亚砜、透明质酸钠、壳聚糖并充分溶解,得到溶液A;
3、将二硬脂酰基磷脂酰乙醇胺溶解于另200mL溶剂中,充分混匀,得溶液B;
4、将补骨脂提取物13g按直接溶解的方法溶解于溶液B,得溶液C;
5、将上述溶液A缓慢加入至溶液C中,加入过程中二者均保持水浴温度50-55℃,并在5000rpm剪切条件下,加入完成后得溶液D;
6、将上述溶液D进行pH、渗透压的调整,pH调整至6.7-7.0,渗透压调整至280~320mOsm/kg;
7、将上述调整好pH、渗透压的治疗白癜风的无针注射用中药组合物经无菌处理、分装后即得;
使用时,患者借助无针注射器械直接将治疗白癜风的无针注射用中药组合物注射于白癜风发病局部患处。
实施例3:一种治疗白癜风的无针注射用中药组合物的制备
1、处方(1000mL)
2、在400mL蔗糖溶液中加入甘油、明胶并充分溶解,得到溶液A;
3、将蛋黄软磷脂、胆固醇、二硬脂酰基磷脂酰乙醇胺溶解于600mL注射用水中,充分混匀,得溶液B;
4、将斑鸠菊提取物8g、补骨脂提取物8g按超声匀质法溶解于溶液B,得溶液C;
5、将上述溶液A缓慢加入至溶液C中,加入过程中二者均保持水浴温度55-60℃,并在4500rpm剪切条件下,加入完成后得溶液D;
6、将上述溶液D进行pH、渗透压的调整,pH调整至6.7-7.0,渗透压调整至280~320mOsm/kg;
7、将上述调整好pH、渗透压的治疗白癜风的无针注射用中药组合物经无菌处理、分装后即得;
使用时,患者借助无针注射器械直接将治疗白癜风的无针注射用中药组合物注射于白癜风发病局部患处。
实施例4:一种治疗白癜风的无针注射用中药组合物的制备
1、处方(1000mL)
2、在500mL蔗糖溶液中加入聚乙烯吡咯烷酮、白芨多糖、透明质酸钠并充分溶解,得到溶液A;
3、将聚乙二醇、大豆软磷脂溶解于500mL磷酸盐缓冲液中,充分混匀,得溶液B;
4、将斑鸠菊提取物5g、补骨脂提取物10g按乳化法溶解于溶液B,得溶液C;
5、将上述溶液A缓慢加入至溶液C中,加入过程中二者均保持水浴温度58-60℃,并在4000rpm剪切条件下,加入完成后得溶液D;
6、将上述溶液D进行pH、渗透压的调整,pH调整至6.7-7.0,渗透压调整至280~320mOsm/kg;
7、将上述调整好pH、渗透压的治疗白癜风的无针注射用中药组合物经无菌处理、分装后即得;
使用时,患者借助无针注射器械直接将治疗白癜风的无针注射用中药组合物注射于白癜风发病局部患处。
实施例5:一种治疗白癜风的无针注射用中药组合物的制备
1、处方(1000mL)
2、在700mL注射中加入聚乙二醇、聚氨酯、卡拉胶并充分溶解,得到溶液A;
3、将二硬脂酰基磷脂酰乙醇胺溶解于另300mL注射用水中,充分混匀,得溶液B;
4、将斑鸠菊提取物12g、补骨脂提取物6g按超声匀质法溶解于溶液B,得溶液C;
5、将上述溶液A缓慢加入至溶液C中,加入过程中二者均保持水浴温度50-55℃,并在3000rpm剪切条件下,加入完成后得溶液D;
6、将上述溶液D进行pH、渗透压的调整,pH调整至6.7-7.0,渗透压调整至280~320mOsm/kg;
7、将上述调整好pH、渗透压的治疗白癜风的无针注射用中药组合物经无菌处理、分装后即得;
使用时,患者借助无针注射器械直接将治疗白癜风的无针注射用中药组合物注射于白癜风发病局部患处。
实验例1:本发明一种治疗白癜风的无针注射用中药组合物皮肤穿透能力与皮下扩散能力的研究
使用SD大鼠腹部皮肤评估治疗白癜风的无针注射用中药组合物皮肤穿透能力与皮下扩散能力,本实验例使用的治疗白癜风的无针注射用中药组合物样品为实施例3制备得到的治疗白癜风的无针注射用中药组合物,搭配的无针注射器械为北京某企业已上市的无针注射器械。首先,取下SD大鼠腹部皮肤,除毛,并将其固定在泡沫板上。将本发明的治疗白癜风的无针注射用中药组合物经无针注射器械紧贴皮肤,并注射至大鼠皮肤内。随后,取走无针注射器械,滤纸吸取大鼠皮肤表面残留液体,借助放大镜观察注射针口。而后将注射部位大鼠皮肤经0.6cm角膜环钻取下,组织处理后借助高效液相色谱仪进行含量分析。
结果显示,本发明实施例3的治疗白癜风的无针注射用中药组合物注射入皮肤后,大鼠皮肤表面无残留液体发现,借助放大镜观察结果显示大鼠皮肤仅有一微小创口,其创口远小于1mL注射器针头造成的皮肤创口,说明本方法下治疗白癜风的无针注射用中药组合物全部注射进入体内,促进了药物经皮传递。
实验例2:本发明一种治疗白癜风的无针注射用中药组合物的大鼠个体安全性与组织刺激性的研究
本实验例使用的治疗白癜风的无针注射用中药组合物样品为实施例2制备得到的治疗白癜风的无针注射用中药组合物,搭配的无针注射器械为北京某企业已上市的无针注射器械。雄性SD大鼠(体重200~250g)按数字随机表法设置分组,给药后观察大鼠生存状态与大鼠与大鼠组织的病理状态。
结果显示,各组SD大鼠在给药后均未出现死亡的情况,说明本发明实施例2的治疗白癜风的无针注射用中药组合物安全性良好。组织病理学结果显示,本发明实施例2的无针注射用斑鸠菊提取物在给药后,未见明显的淋巴细胞浸润,未见组织损伤或坏死,同样表明本发明的无针注射用斑鸠菊提取物具有良好的安全性。实验例3:本发明一种治疗白癜风的无针注射用中药组合物在皮肤中的药物分布研究
本实验例使用的治疗白癜风的无针注射用中药组合物样品为实施例4制备得到的治疗白癜风的无针注射用中药组合物,搭配的无针注射器械为北京某企业已上市的无针注射器械。雄性SD大鼠(体重200~250g)按数字随机表法设置分组,(1)有针注射给药组、(2)无针注射给药组、(3)皮肤涂抹组。每组30只,分别使用下述分组设置中的药物对大鼠进行给药,给药后饲养4h,取大鼠皮肤组织,借助高效液相色谱法测定皮肤中斑鸠菊提取物与补骨脂提取物的含量,高效液相色谱谱图如图2所示。
结果如图3所示:有针注射组和无针注射组可以在皮肤中检测到更高的斑鸠菊提取物与补骨脂提取物,二者均高于皮肤涂抹给药组,而且无针给药组的药物含量更高。
实验例4:本发明一种治疗白癜风的无针注射用中药组合物的药效学的研究
本实验例使用的治疗白癜风的无针注射用中药组合物样品为实施例5制备得到的治疗白癜风的无针注射用中药组合物,搭配的无针注射器械为北京某企业已上市的无针注射器械。本实验例全部志愿者为招募自由自愿加入,并充分阅读知晓知情同意书,实验过程符合伦理福利要求。所有志愿者均在教授使用方法后自行给药,连续给药一个月后追踪药物作用效果,结果显示,无针给药组患者极少反应给药方式与有针没有变化,而白癜风患处的皮肤变化结果显示,无针给药组具有更好的治疗效果,如图4。
Claims (8)
1.一种无针注射用中药组合物,其特征在于,
所述无针注射用中药组合物为液体形式,其包括活性物质、改性组分与溶剂组分;
所述的活性物质选自斑鸠菊提取物、补骨脂提取物中的一种或多种;
所述的改性组分选自增助潜溶剂,稳定剂,滞留组分与其他组分中的一种或多种;
所述溶剂组分选自注射用水、磷酸盐缓冲液、生理盐水和葡萄糖溶液中的一种或多种。
2.根据权利要求1所述的无针注射用中药组合物,其特征在于,
所述增助潜溶剂选自二甲基亚砜、甘油、蓖麻油、乙醇、聚山梨酯、聚乙烯吡咯烷酮、聚乙二醇中的一种或多种;
所述稳定剂选自壳聚糖、透明质酸钠、聚氨酯、卡拉胶、明胶、白芨多糖中的一种或多种;
所述滞留组分选自聚乙二醇、蛋黄软磷脂、大豆软磷脂、胆固醇、二硬脂酰基磷脂酰乙醇胺、多巴胺中的一种或多种;
所述其他组分为pH调节剂、渗透压调节剂中的一种或多种。
3.根据权利要求2所述的无针注射用中药组合物,其特征在于,
所述pH调节剂选自氢氧化钠、盐酸、磷酸、磷酸二氢钾、磷酸氢二钾、枸橼酸、枸橼酸钠、柠檬酸中的一种或多种,所述渗透压调节剂选自氯化钠、氯化钙、氯化钾、蔗糖中的一种或多种。
4.根据权利要求1-3任一项所述的无针注射用中药组合物,其特征在于,
其中,所述活性物质占0.5-2质量份数,斑鸠菊提取物与补骨脂提取物的质量份数比为1:0.5-1:2;
所述增助潜溶剂占0.05-1.5质量份数,所述稳定剂占0.01-1质量份数,所述滞留组分占0.1-8质量份数;
所述pH调节剂占0-1.5质量份数,所述渗透压调节剂占0-1质量份数;
所述溶剂占20-60质量份数。
5.权利要求1-4任一项所述的无针注射用中药组合物的制备方法,其特征在于,
所述无针注射用中药组合物的制备方法包含以下步骤:
①在一部分溶剂中加入增助潜溶剂、稳定剂并充分溶解,得到溶液A;
②将滞留组分溶解于另一部分溶剂中,充分混匀,得溶液B;
③将斑鸠菊提取物与补骨脂提取物按一定制备方法溶解于溶液B,得溶液C,其中,制备方法可以是直接溶解、剪切辅助的溶解、搅拌辅助的溶解超声匀质法、乳化法;
④将上述溶液A缓慢加入至溶液C中,加入过程中二者均保持水浴温度50-60℃,并在3000-5000rpm剪切条件下,加入完成后得溶液D;
⑤将上述溶液D进行pH、渗透压的调整,pH调整至6.7-7.0,渗透压调整至280~320mOsm/kg;
⑥将上述调整好pH、渗透压的治疗白癜风的无针注射用中药组合物经无菌处理、分装后即得;
其中,无菌处理可根据具体条件选择滤膜过滤法、高压灭菌法、无菌灌装法。
6.根据权利要求5所述的无针注射用中药组合物的制备方法,其特征在于,
所述部分溶剂为总溶剂体积的10%-70%。
7.权利要求1-6任一项所述的无针注射用中药组合物的使用方法,其特征在于,
其中,所述治疗白癜风的无针注射用中药组合物装入无针给药国标容器,并配合无针注射器使用;可根据需求,调整每日给药次数,每日最多给药不超过3次。
8.根据权利要求1-7任一项所述的无针注射用中药组合物在制备治疗和/或预防白癜风药物中的应用。
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