CN114601911A - 一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂 - Google Patents
一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂 Download PDFInfo
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Abstract
本发明公开了一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其原料成分组成按质量组计份，包括以下成分吸收促进剂12份、稳定剂1.5份、防风6份、防腐剂0.5份、白芷7份、等渗调节剂1份、荆芥5份、制附子7份、氢溴酸东茛菪碱15份、干姜9份、苍耳子5份、H102肽16份、辛夷花6份、炒子芩4份；防风、白芷、荆芥、制附子、干姜等中药需要先进行煎煮，再进行过滤杂质处理，以添加至药剂中。在鼻内喷雾剂的西药成分中添加了大量的中药成分，使中药配置入喷雾剂成分内，降低了较多的副作用缺陷，达到了在保持较高药效速度同时兼顾低刺激药性反应的效果，实现了在保障安全性的基础上极大提高生物利用性的效果。
Description
技术领域
本发明涉及医用喷雾技术领域，尤其涉及一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂。
背景技术
神经系统疾病包括脑血管疾病、周期性麻痹、进行性肌营养不良、强直性肌营养不良、共济失调。在对神经系统进行疾病治疗的过程中，常常采用鼻内喷雾的形式进行治疗。喷雾剂，系指原料药物或与适宜辅料填充于特制的装置中，使用时借助手动泵的压力、高压气体、超声振动或其他方法将内容物呈雾状物释出，用于肺部吸入或直接喷至腔道黏膜及皮肤等的制剂。有别于气雾剂，气雾剂喷出药物的动力为抛射剂，如氟氯烷烃(现多不用)、氢氟烷烃、二甲醚等。
目前现有的鼻内喷雾剂大多为西药成分，存在较多的副作用缺陷，而中药又难以配置入喷雾剂成分内，难以在保持较高药效见效速度兼顾低刺激性的药效反应，生物利用性也较差。
发明内容
针对现有技术的不足，本发明提供了一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂及其制备方法与流程，解决了目前现有的鼻内喷雾剂大多为西药成分，存在较多的副作用缺陷，而中药又难以配置入喷雾剂成分内，难以在保持较高药效见效速度兼顾低刺激性的药效反应，生物利用性也较差的问题。
为了实现上述目的，本发明采用了如下技术方案：一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其原料成分组成按质量组计份，包括以下成分吸收促进剂12份、稳定剂1.5份、防风6份、防腐剂0.5份、白芷7 份、等渗调节剂1份、荆芥5份、制附子7份、氢溴酸东茛菪碱15份、干姜9 份、苍耳子5份、H102肽16份、辛夷花6份、炒子芩4份。
优选的，所述原料防风、白芷、荆芥、制附子、干姜、苍耳子、辛夷花和炒子芩等中药需要先进行煎煮，再进行过滤杂质处理，以添加至药剂中。
优选的，喷雾剂配方溶液的pH值为6。
优选的，所述稳定剂为甘露醇和山梨醇的混合物，且甘露醇和山梨醇之比为 1:1.5。
优选的，所述防腐剂为苯扎溴铵与醋酸氯己啶的混合物，且苯扎溴铵与醋酸氯己啶之比为1:2.25。
优选的，所述等渗调节剂为氯化钠与葡萄糖的混合物，且氯化钠与葡萄糖的混合比例为1:5.5。
优选的，所述H102肽的浓度为0.002％～10.5％w/v，即每1mL鼻腔喷雾剂中含H102肽20mg～105mg。
优选的，所述吸收促进剂为自壳聚糖、环糊精和聚山梨酯的混合体，且自壳聚糖、环糊精和聚山梨酯的混合比例为1:2.75:1.5。
优选的，所述吸收促进剂中的环糊精，为b-环糊精和二甲基-b-环糊精的混合体，且b-环糊精和二甲基-b-环糊精的混合比例为2:1。
优选的，所述吸收促进剂中的壳聚糖的用量为0.25％～6％w/v。
与现有技术相比，本发明的有益效果是：该用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，通过设置原料成分组成按质量组计份，为吸收促进剂12份、稳定剂1.5份、防风6份、防腐剂0.5份、白芷7份、等渗调节剂 1份、荆芥5份、制附子7份、氢溴酸东茛菪碱15份、干姜9份、苍耳子5份、 H102肽16份、辛夷花6份、炒子芩4份，在鼻内喷雾剂的西药成分中添加了大量的中药成分，使中药配置入喷雾剂成分内，降低了较多的副作用缺陷，达到了在保持较高药效速度同时兼顾低刺激药性反应的效果，实现了在保障安全性的基础上极大提高生物利用性的效果。
具体实施方式
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实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例：一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其原料成分组成按质量组计份，包括以下成分吸收促进剂12份、稳定剂1.5 份、防风6份、防腐剂0.5份、白芷7份、等渗调节剂1份、荆芥5份、制附子 7份、氢溴酸东茛菪碱15份、干姜9份、苍耳子5份、H102肽16份、辛夷花6 份、炒子芩4份。
本发明中，原料防风、白芷、荆芥、制附子、干姜、苍耳子、辛夷花和炒子芩等中药需要先进行煎煮，再进行过滤杂质处理，以添加至药剂中。
本发明中，喷雾剂配方溶液的pH值为6。
本发明中，稳定剂为甘露醇和山梨醇的混合物，且甘露醇和山梨醇之比为 1:1.5。
本发明中，防腐剂为苯扎溴铵与醋酸氯己啶的混合物，且苯扎溴铵与醋酸氯己啶之比为1:2.25。
本发明中，等渗调节剂为氯化钠与葡萄糖的混合物，且氯化钠与葡萄糖的混合比例为1:5.5。
本发明中，H102肽的浓度为0.002％～10.5％w/v，即每1mL鼻腔喷雾剂中含 H102肽20mg～105mg。
本发明中，吸收促进剂为自壳聚糖、环糊精和聚山梨酯的混合体，且自壳聚糖、环糊精和聚山梨酯的混合比例为1:2.75:1.5。
本发明中，吸收促进剂中的环糊精，为b-环糊精和二甲基-b-环糊精的混合体，且b-环糊精和二甲基-b-环糊精的混合比例为2:1。
本发明中，吸收促进剂中的壳聚糖的用量为0.25％～6％w/v。
综上所述，该用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，通过设置原料成分组成按质量组计份，为吸收促进剂12份、稳定剂1.5份、防风6份、防腐剂0.5份、白芷7份、等渗调节剂1份、荆芥5份、制附子7 份、氢溴酸东茛菪碱15份、干姜9份、苍耳子5份、H102肽16份、辛夷花6 份、炒子芩4份，在鼻内喷雾剂的西药成分中添加了大量的中药成分，使中药配置入喷雾剂成分内，降低了较多的副作用缺陷，达到了在保持较高药效速度同时兼顾低刺激药性反应的效果，实现了在保障安全性的基础上极大提高生物利用性的效果，解决了目前现有的鼻内喷雾剂大多为西药成分，存在较多的副作用缺陷，而中药又难以配置入喷雾剂成分内，难以在保持较高药效见效速度兼顾低刺激性的药效反应，生物利用性也较差的问题。
需要说明的是，在本文中，诸如术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。
尽管已经示出和描述了本发明的实施例，对于本领域的普通技术人员而言，可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由所附权利要求及其等同物限定。
Claims (10)
1.一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，其原料成分组成按质量组计份，包括以下成分吸收促进剂12份、稳定剂1.5份、防风6份、防腐剂0.5份、白芷7份、等渗调节剂1份、荆芥5份、制附子7份、氢溴酸东茛菪碱15份、干姜9份、苍耳子5份、H102肽16份、辛夷花6份、炒子芩4份。
2.根据权利要求1所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述原料防风、白芷、荆芥、制附子、干姜、苍耳子、辛夷花和炒子芩等中药需要先进行煎煮，再进行过滤杂质处理，以添加至药剂中。
3.根据权利要求1所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，喷雾剂配方溶液的pH值为6。
4.根据权利要求1所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述稳定剂为甘露醇和山梨醇的混合物，且甘露醇和山梨醇之比为1:1.5。
5.根据权利要求1所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述防腐剂为苯扎溴铵与醋酸氯己啶的混合物，且苯扎溴铵与醋酸氯己啶之比为1:2.25。
6.根据权利要求1所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述等渗调节剂为氯化钠与葡萄糖的混合物，且氯化钠与葡萄糖的混合比例为1:5.5。
7.根据权利要求1所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述H102肽的浓度为0.002％～10.5％w/v，即每1mL鼻腔喷雾剂中含H102肽20mg～105mg。
8.根据权利要求1所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述吸收促进剂为自壳聚糖、环糊精和聚山梨酯的混合体，且自壳聚糖、环糊精和聚山梨酯的混合比例为1:2.75:1.5。
9.根据权利要求8所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述吸收促进剂中的环糊精，为b-环糊精和二甲基-b-环糊精的混合体，且b-环糊精和二甲基-b-环糊精的混合比例为2:1。
10.根据权利要求8所述的一种用于治疗神经系统疾病的热敏水凝胶投递外泌体的鼻内喷雾剂，其特征在于，所述吸收促进剂中的壳聚糖的用量为0.25％～6％w/v。
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| CN101780061A (zh) * | 2010-03-24 | 2010-07-21 | 朱秀青 | 一种鼻腔喷雾剂 |
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| CN101780061A (zh) * | 2010-03-24 | 2010-07-21 | 朱秀青 | 一种鼻腔喷雾剂 |
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