CN111329817A - 一种外用高效祛痘药妆配方与制备方法 - Google Patents
一种外用高效祛痘药妆配方与制备方法 Download PDFInfo
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Abstract
一种外用高效祛痘药妆配方与制备方法，涉及医药领域皮肤外用药技术配方，其由A相、B相、C相组成，其中A相包括水相溶剂38‑60重量份、丙二醇10‑12重量份、甘油5‑8重量份、水相皮肤调理剂2.9‑7.8重量份和增稠剂0.1‑0.2重量份；B相包括溶剂20‑30重量份、皮肤调理剂0.6‑2.3重量份、渗透剂0.5‑1重量份和增溶剂0.3‑0.6重量份；C相包括抑菌防腐剂0.5‑1重量份。包括以下步骤，称重；制备A相；制备B相；混合。该外用高效祛痘药妆配方与制备方法，配方与制备方式工艺简单，易于量化生产，具有一定的抗炎、抑制痤疮丙酸杆菌的繁殖功能，同时能够增强皮肤的水合保湿作用，具备综合效果明显，治疗周期短，且愈后不易复发的特点。
Description
技术领域
本发明涉及医药领域皮肤外用药技术配方，具体为一种外用高效祛痘药妆配方与制备方法。
背景技术
痤疮，俗称“青春痘”、“粉刺”、“暗疮”，医学名为“寻常性痤疮”，其表现是一种皮肤毛囊和皮脂腺的慢性炎症性皮肤病。痤疮主要好发于面部、胸、背部等皮脂腺较丰富，皮脂溢出旺盛部位，皮疹轻重依次表现为粉刺、丘疹、脓疱、结节、囊肿等病理体征。痤疮对于患者虽然无不适感觉，但有碍皮肤美观，常给患者造成一定的心理负担，如果早期处理不当或治疗不及时，会给皮肤造成痘印、凹坑，甚至留下永久性瘢痕。
痤疮的形成过程：是由于皮脂腺功能亢奋，加上表皮角化异常，过度角化物覆盖毛孔，导致皮脂腺分泌的旺盛皮脂排泄不畅，形成黑头或白头粉刺(闭合性粉刺)。同时，毛孔闭塞和过剩的皮脂给厌氧菌类微生物寄生繁殖创造了条件，如痤疮丙酸杆菌、金黄色葡萄球菌、糠秕孢子菌、毛囊虫、螨虫等，造成毛囊和皮脂腺单位受微生物的作用，产生炎症及宿主的免疫反应。受炎症浸润组织时间长短或受累波及范围大小，产生的病理表现依此为丘疹---脓疱---结节---囊肿，严重者形成聚合型痤疮。
针对痤疮治疗的外用药：通过在临床实践中检索大量现有各种文献资料发现，目前市售药物配方制剂原理基本采用的是三个类型药物：⑴、角质溶解剂类药：维甲酸、水杨酸、果酸、过氧化苯甲酰、硫磺；⑵、抗生素类药：克林霉素、红霉素、氯霉素、甲硝唑等；⑶、中草药提取物：金银花、黄柏、黄芩、黄连、苦参、大黄、连翘、丹参、桑白皮、甘草、马齿苋等；以上药物成分其治疗效果原理可归结为二点：角质溶解类药物主要起到溶解角质、改善表皮角化，有利于皮脂排泄；抗生素或中草药提取物主要起到消炎杀菌的功效。所以，以上三类药物成分单独或者联合使用都能取得一定的明显效果。但是，在实际临床运用中也都存在一定的缺陷与问题，中草药提取物见效缓慢，角质溶解剂容易造成皮肤干燥和皮肤屏障受损；抗生素虽然见效快，但长时间使用会产生耐药性，同时也非常容易造成皮肤的正常微生物菌群失衡，痤疮反复发生。
痤疮外用药发明主张：痤疮领域世界顶级医学专家Brigitte博士曾在欧洲皮肤医学大会，发表痤疮丙酸杆菌、微生物组以及皮肤自然免疫在痤疮中的相互作用机理，她提出：“痤疮是一种慢性炎症，温和而有效治疗痤疮在抑菌抗炎的同时，外用护肤药主要用途是维持水合作用与脂质膜，保护皮肤的屏障以及微生物菌群组平衡，防止有害细菌的繁殖，维持肌肤最佳Ph值，提升皮肤免疫力，是健康肌肤的第一准则。所以，要想彻底治疗痤疮，在祛痘外用药护肤制剂方面，本发明主张需从以下几方面着手：1)减少油脂分泌物，调节皮肤水油平衡；2)抑制或杀灭痤疮丙酸杆菌等痤疮致病菌的繁殖，达到抑菌防螨和抗炎作用；3)促进表皮细胞新陈代谢，保证角质层更新脱落正常；4)通过维护正常微生物菌群组来平衡与减少痤疮相关致病菌的繁殖；5)增强皮肤的水合作用与保湿修护效果；6)防治痘痕与色素沉着等并发症。对此，本发明针对痤疮的根本特性，从以上6个方面的功能兼顾设计了新的配方制剂，在临床实践中取得了满意的治疗效果。
发明内容
(一)解决的技术问题
针对现有技术的不足，本发明提供了一种外用高效祛痘药妆配方与制备方法，解决了中草药提取物见效缓慢，角质溶解剂容易造成皮肤干燥和皮肤屏障受损；抗生素虽然见效快，但长时间使用会产生耐药性，同时也非常容易造成皮肤的正常微生物菌群失衡，痤疮反复发生的问题。
(二)技术方案
为实现以上目的，本发明通过以下技术方案予以实现：一种外用高效祛痘药妆配方，其由A相、B相、C相组成，其中A相包括水相溶剂38-60重量份、丙二醇10-12重量份、甘油5-8重量份、水相皮肤调理剂2.9-7.8重量份和增稠剂0.1-0.2重量份；B相包括溶剂20-30重量份、皮肤调理剂0.6-2.3重量份、渗透剂0.5-1重量份和增溶剂0.3-0.6重量份；C相包括抑菌防腐剂0.5-1重量份。
优选的，所述一种外用高效祛痘药妆配方，其由A相、B相、C相组成，其中A相包括水相溶剂50重量份、丙二醇11重量份、甘油6.5重量份、水相皮肤调理剂6.4重量份和增稠剂0.15重量份；B相包括溶剂25重量份、皮肤调理剂1.5重量份、渗透剂0.75重量份和增溶剂0.5重量份；C相包括抑菌防腐剂0.7重量份。
优选的，所述一种外用高效祛痘药妆配方的制备方法，包括以下步骤，
(1)称重，按照配方比例将A相、B相和C相的组分称重；
(2)制备A相，将水相溶剂加热煮沸后，将丙二醇与增稠剂调成糊状，缓慢加入煮沸的水相溶剂中，边加边搅拌至溶解均匀，然后依次加入甘油和水相皮肤调理剂后搅拌溶解均匀；
(3)制备B相，向油相溶剂内依次将加入油相皮肤调理剂、渗透剂和增溶剂并搅拌均匀；
(4)混合，将A相和B相混合在一起搅拌，最后加入C相搅拌均匀，静置过夜至清澈透明，然后灌装装瓶。
优选的，所述水相溶剂为水，油相溶剂为乙醇。
优选的，所述水相皮肤调理剂包括尿囊素、辛酰甘氨酸、烟酰胺、吡哆素、生育酚磷酸酯、芦荟冻干粉和苦参碱，其中尿囊素、辛酰甘氨酸、烟酰胺、吡哆素、生育酚磷酸酯、芦荟冻干粉和苦参碱的比例为2:20:10：3:7.5:7.5：4，油相皮肤调理剂为水杨酸和薄荷醇，其中水杨酸和薄荷醇的比例为4:1。
优选的，所述增稠剂为黄原胶，渗透剂为氮酮，增溶剂为PEG-40氢化蓖麻油，抑菌防腐剂为o-伞花烃-5醇。
优选的，所述丙二醇与黄原胶加入到煮沸的热水中搅拌至溶解均匀后，依次加入甘油和尿囊素，水温降至50℃以下时再依次加入皮肤调理剂辛酰甘氨酸、苦参碱、芦荟冻干粉、烟酰胺、生育酚磷酸酯和吡哆素。
优选的，所述乙醇中先加入水杨酸搅拌至溶解均匀，然后依次加入薄荷醇、氮酮、PEG-40氢化蓖麻油搅拌均匀。
(三)有益效果
本发明提供了一种外用高效祛痘药妆配方与制备方法。具备以下有益效果：
本发明所解决的技术问题在于提供一种外用祛痘药妆配方与制备方法，配方与制备方式工艺简单，易于量化生产。临床应用能够有效减少皮脂腺油脂分泌和促进表皮细胞的新陈代谢，具有一定的抗炎、抑制痤疮丙酸杆菌的繁殖和维护微生物菌群组平衡功能；同时能够增强皮肤的水合保湿作用以及愈合伤口与淡化祛除痘印的功效。具备综合效果明显，治疗周期短，且愈后不易复发，良好地弥补解决上述背景技术的缺点。
本发明配方中采用的功能成分：①水杨酸用作角质溶解剂，可以加速老废角质细胞脱落，增进上皮细胞新陈代谢的速度，促使肌肤更新，因此可以改善表皮层的过度角化、粗糙暗沉、以及发炎後之色素沉淀或异常，使皮肤变得光滑明亮。②辛酰甘氨酸首先它具有抑菌效果，对于表皮金色葡萄球菌和痤疮丙酸杆菌等均有较强的抑制作用,同时还可抑制皮脂的过剩分泌，调节皮肤的菌群微生态体系。③苦参碱具有清热解毒凉血，祛风利湿止痒，杀螨虫作用，是古代名医推崇的治疗皮肤疾患的主药。④芦荟冻干粉是现代美容护肤较推崇的绿色原料，具有良好的愈合伤口、抑菌修复、保湿与美白作用。⑤吡哆素即维生素B6，能调节皮脂分泌，有效抑制痘痘的产生发展与防治皮肤粗糙作用；⑥生育酚磷酸酯和烟酰胺作为一种抗炎剂和抗氧化剂，具有清除氧自由基，抗炎、美白和活化皮肤细胞，预防与消除痘印的作用。⑦薄荷醇具有清凉止痒、抗炎止痛、抑菌防腐的作用；⑧尿囊素具有促进细胞生长，加快伤口愈合，软化角质蛋白等生理功能，是皮肤创伤的良好愈合剂和抗溃疡药剂，可用作缓解和治疗皮肤干燥症、鳞屑性皮肤疾患、皮肤溃疡、痤疮均有较好疗效。由于尿囊素是一种两性化合物，能结合多种物质形成复盐，具有避光、杀菌防腐、止痛、抗氧化作用，同时能使皮肤保持水份，滋润和柔软。⑨氮酮作为透皮吸收剂，能促进功能成分药物的有效吸收从而发挥最佳效果。⑩o-伞花烃-5-醇是一种非常安全、可接触粘膜的广谱高效抗真菌抑菌剂，已经被证实是对改善油性和痤疮易发肌肤具有卓越功效的活性物，并且可抑制产品氧化，从而延长产品的保质期。
配方中乙醇和PEG-40氢化蓖麻油作为水杨酸和其它功能成分的助溶剂。
黄原胶作为混悬剂和增稠剂，有助于药物配方体系的稳定与调节液体的稠度。
具体实施方式
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体实施例，进一步阐述本发明。
实施例一：
按比例准备下列物料：
A相：水加热煮沸后，将丙二醇与黄原胶调成糊状，缓慢加入煮沸的热水中，边加边搅拌至溶解均匀，然后依次加入甘油、尿囊素，水温降至50℃时依次加入辛酰甘氨酸、苦参碱、芦荟冻干粉、烟酰胺、生育酚磷酸酯、吡哆素等搅拌溶解均匀；
B相：按配方比例准备好乙醇，先将称重好的水杨酸加入乙醇中搅拌至溶解，然后依次加入薄荷醇、氮酮、PEG-40氢化蓖麻油等搅拌均匀；将A相和B相混合在一起适当搅拌，最后加入C相搅拌均匀，静置过夜至清澈透明，灌装装瓶。
实施例二：
按比例准备下列物料：
A相：水加热煮沸后，将丙二醇与黄原胶调成糊状，缓慢加入煮沸的热水中，边加边搅拌至溶解均匀，然后依次加入甘油、尿囊素，水温降至40℃时依次加入辛酰甘氨酸、苦参碱、芦荟冻干粉、烟酰胺、生育酚磷酸酯、吡哆素等搅拌溶解均匀；
B相：按配方比例准备好乙醇，先将称重好的水杨酸加入乙醇中搅拌至溶解，然后依次加入薄荷醇、氮酮、PEG-40氢化蓖麻油等搅拌均匀；将A相和B相混合在一起适当搅拌，最后加入C相搅拌均匀，静置过夜至清澈透明，灌装装瓶。
实施例三：
按比例准备下列物料：
A相：水加热煮沸后，将丙二醇与黄原胶调成糊状，缓慢加入煮沸的热水中，边加边搅拌至溶解均匀，然后依次加入甘油、尿囊素，水温降至45时依次加入辛酰甘氨酸、苦参碱、芦荟冻干粉、烟酰胺、生育酚磷酸酯、吡哆素等搅拌溶解均匀；
B相：按配方比例准备好乙醇，先将称重好的水杨酸加入乙醇中搅拌至溶解，然后依次加入薄荷醇、氮酮、PEG-40氢化蓖麻油等搅拌均匀；将A相和B相混合在一起适当搅拌，最后加入C相搅拌均匀，静置过夜至清澈透明，灌装装瓶。
本发明的临床使用效果观察：
1)、临床测试：通过在自营医疗美容门诊部的临床使用，对自2015年3月至2018年3月，三年期间接诊的痤疮病例患者进行临床治疗效果测试，统计数据显示，该时间段实际接诊治疗1320例，其中女938人，男382人，均具有典型痤疮临床表现，符合寻常性痤疮临床诊断标准，均进行了4-6周的使用周期治疗效果追踪观察。
2)效果评价标准为：痊愈(皮疹完全消退，皮肤光洁无痤疮印痕)，基本治愈(皮疹消退80％以上，偶尔会出现极少量红色丘疹)，好转(皮疹消退50％以上，红色丘疹脓疱基本控制)，无效(皮疹消退10％以下)。
3)使用后结果数据统计：以下表数据统计结果显示，本发明一种外用祛痘药妆对痤疮的治疗效果显著，有效率达到98.87％，具有见效快、治疗周期短，且在使用中未发现明显不良反应症状的反馈。
| 评价 | 痊愈 | 基本治愈 | 好转 | 无效 |
| 人数 | 330 | 630 | 345 | 15 |
| 百分比 | 25％ | 47.73％ | 26.14％ | 1.13％ |
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (9)
1.一种外用高效祛痘药妆配方，其特征在于，其由A相、B相、C相组成，其中A相包括水相溶剂38-60重量份、丙二醇10-12重量份、甘油5-8重量份、水相皮肤调理剂2.9-7.8重量份和增稠剂0.1-0.2重量份；B相包括溶剂20-30重量份、皮肤调理剂0.6-2.3重量份、渗透剂0.5-1重量份和增溶剂0.3-0.6重量份；C相包括抑菌防腐剂0.5-1重量份。
2.根据权利要求1所述的一种外用高效祛痘药妆配方，其特征在于，其由A相、B相、C相组成，其中A相包括水相溶剂50重量份、丙二醇11重量份、甘油6.5重量份、水相皮肤调理剂6.4重量份和增稠剂0.15重量份；B相包括溶剂25重量份、皮肤调理剂1.5重量份、渗透剂0.75重量份和增溶剂0.5重量份；C相包括抑菌防腐剂0.7重量份。
3.根据权利要求1所述的一种外用高效祛痘药妆配方的制备方法，其特征在于，包括以下步骤，
(1)称重，按照配方比例将A相、B相和C相的组分称重；
(2)制备A相，将水相溶剂加热煮沸后，将丙二醇与增稠剂调成糊状，缓慢加入煮沸的水相溶剂中，边加边搅拌至溶解均匀，然后依次加入甘油和水相皮肤调理剂后搅拌溶解均匀；
(3)制备B相，向溶剂内依次将加入皮肤调理剂、渗透剂和增溶剂并搅拌均匀；
(4)混合，将A相和B相混合在一起搅拌，最后加入C相搅拌均匀，静置过夜至清澈透明，然后灌装装瓶。
4.根据权利要求1所述的一种外用高效祛痘药妆配方，其特征在于，所述A相溶剂为水，B相溶剂为乙醇。
5.根据权利要求4所述的一种外用高效祛痘药妆配方，其特征在于，所述A相皮肤调理剂包括尿囊素、辛酰甘氨酸、烟酰胺、吡哆素、生育酚磷酸酯、芦荟冻干粉和苦参碱，其中尿囊素、辛酰甘氨酸、烟酰胺、吡哆素、生育酚磷酸酯、芦荟冻干粉和苦参碱的比例为2:20:10：3:7.5:7.5：4，B相皮肤调理剂为水杨酸和薄荷醇，其中水杨酸和薄荷醇的比例为4:1。
6.根据权利要求5所述的一种外用高效祛痘药妆配方，其特征在于，所述增稠剂为黄原胶，渗透剂为氮酮，增溶剂为PEG-40氢化蓖麻油，抑菌防腐剂为o-伞花烃-5醇。
7.根据权利要求6所述的一种外用高效祛痘药妆配方的制备方法，其特征在于，所述丙二醇与黄原胶加入到煮沸的热水中搅拌至溶解均匀后，依次加入甘油和尿囊素，水温降至50℃以下时再依次加入辛酰甘氨酸、苦参碱、芦荟冻干粉、烟酰胺、生育酚磷酸酯和吡哆素。
8.根据权利要求6所述的一种外用高效祛痘药妆配方的制备方法，其特征在于，所述乙醇中先加入水杨酸搅拌至溶解均匀，然后依次加入薄荷醇、氮酮、PEG-40氢化蓖麻油搅拌均匀。
9.根据权利要求6所述的一种外用高效祛痘药妆配方的制备方法，其特征在于，所述将A相和B相混合在一起搅拌，最后加入C相搅拌均匀，静置过夜至清澈透明，然后灌装装瓶。
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