CN116327874A - 用于治疗痤疮的药物组合物及外用制剂及其制备方法 - Google Patents
用于治疗痤疮的药物组合物及外用制剂及其制备方法 Download PDFInfo
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- CN116327874A CN116327874A CN202111591214.7A CN202111591214A CN116327874A CN 116327874 A CN116327874 A CN 116327874A CN 202111591214 A CN202111591214 A CN 202111591214A CN 116327874 A CN116327874 A CN 116327874A
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Abstract
提供了一种用于治疗痤疮的药物组合物，包括：莪术油、冰片、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、季铵盐‑73、甘草酸二钾、尿囊素、硅烷二醇水杨酸酯、积雪草总苷和透明质酸。本发明提供的上述药物组合物具有清热解毒，活血化瘀、消炎软坚的功效，用于治疗轻中重度痤疮有很好的疗效。本发明进行了抑菌实验和体外抗炎实验，证明了上述药物组合物不仅能显著抑制痤疮丙酸杆菌，还具有抗炎功效，可用于治疗痤疮。
Description
技术领域
本发明涉及化妆品技术领域，尤其涉及一种用于治疗痤疮的药物组合物及外用制剂及其制备方法。
背景技术
痤疮也称为青春痘，是一种常见的皮肤病，多发于面部，患者没有年龄限制，一般多见于青少年。
痤疮是一种多因素的疾病，其发病主要与性激素水平、皮脂腺大量分泌、痤疮丙酸杆菌增殖，毛囊皮脂腺导管的角化异常及炎症等因素相关。其发病有很多种类型，以面部粉刺、丘疹、脓疱、结节等多形性皮损为主，严重的还会化脓。由于生活、饮食的各种习惯问题，还会导致痘痘反复增长，很大程度影响到了患者面部的美观，甚至会导致自卑的心理因素，因此痤疮需要及时进行治疗。
发明内容
有鉴于此，本发明要解决的技术问题在于提供一种用于治疗痤疮的药物组合物及外用制剂及其制备方法，制备的药物组合物可用于体外治疗痤疮。
本发明提供了一种用于治疗痤疮的药物组合物，包括：
莪术油、冰片、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、季铵盐-73、甘草酸二钾、尿囊素、硅烷二醇水杨酸酯、积雪草总苷和透明质酸。
本发明优选的，所述药物组合物，包括：
进一步优选的，所述药物组合物包括：
本发明中，所述苦参根提取物可以为一般市售的苦参根提取物，本发明对此并无特殊限定。所述苦参根提取物一般为苦参总碱，其主要成分有苦参碱、槐果碱、氧化槐果碱、槐定碱等多种生物碱，以苦参碱、氧化苦参碱含量最高。
其提取方法包括但不限于本领域技术人员熟知的浸泡超声提取法、高温浸泡提取法和碱性醇提取法等。
示例性的，其具体操作如下：
(1)浸泡超声提取法：将苦参根干燥粉碎，粒度60目，1：6～1：10的重量比例与60％乙醇溶液混合，25℃搅拌过夜。以19～200kHz频率超声振荡30min；过滤除去不溶物，提取液于80℃蒸干。
(2)高温浸泡提取法：将苦参根干燥粉碎，粒度60目，1：6～1：10的重量比例与60％乙醇溶液混合，80℃搅拌过夜。过滤除去不溶物，提取液于80℃蒸干。
(3)碱性醇提取法：将苦参根干燥粉碎，粒度60目，1：6～1：10的重量比例与60％乙醇溶液(含有0.02％氨水)混合，80℃搅拌过夜。过滤除去不溶物，提取液于80℃蒸干。
本发明中，所述马齿苋提取物可以为一般市售的马齿苋提取物，本发明对此并无特殊限定。一般为采用低温方法从马齿苋的茎和叶中萃取获得具有生物活性的提取物，并溶解在一定浓度的丁二醇溶液中。
本发明提供了上述药物组合物在制备痤疮外用制剂中的应用。
本发明提供了一种痤疮外用制剂，包括：
莪术油、冰片、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、季铵盐-73、甘草酸二钾、尿囊素、硅烷二醇水杨酸酯、积雪草、透明质酸和辅剂。
本发明对所述辅剂的种类并无特殊限定，本领域技术人员可以根据剂型需求选用合适的辅剂，在本发明的一些具体实施例中，所述辅剂选自乙醇、吐温-80、丙二醇、水、防腐剂、香精等。
优选的，所述痤疮外用制剂，包括：
进一步优选的，所述痤疮外用制剂，包括：
本发明优选的，所述制剂的剂型为凝胶剂或膏剂。
本发明中，为了产品的使用舒适性，所述痤疮外用制剂还可以包括香精。
本发明对上述防腐剂、香精的种类并无特殊限定，可以为本领域技术人员熟知的适用防腐剂和香精。
本发明提供了上述痤疮外用制剂的制备方法，包括以下步骤：
S1)将处方量的莪术油、冰片、乙醇、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、硅烷二醇水杨酸酯、防腐剂、香精混合、溶解，得到第一溶液；
S2)将第一溶液与甘草酸二钾、尿囊素和积雪草总苷的水溶液混合，得到第二溶液；
S3)将第二溶液和透明质酸的水溶液混合，得到第三溶液；
S4)将第三溶液和季铵盐-73的丙二醇溶液混合，得到痤疮外用制剂。
与现有技术相比，本发明提供了一种用于治疗痤疮的药物组合物，包括：莪术油、冰片、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、季铵盐-73、甘草酸二钾、尿囊素、硅烷二醇水杨酸酯、积雪草总苷和透明质酸。本发明提供的上述药物组合物具有清热解毒，活血化瘀、消炎软坚的功效，用于治疗轻中重度痤疮有很好的疗效。
本发明进行了抑菌实验和体外抗炎实验，证明了上述药物组合物不仅能显著抑制痤疮丙酸杆菌，还具有体外抗炎功效，可用于体外治疗痤疮。
具体实施方式
为了进一步说明本发明，下面结合实施例对本发明提供的用于治疗痤疮的药物组合物及外用制剂及其制备方法进行详细描述。
以下实施例中的苦参根提取物、马齿苋提取物购买于广州宏众生物科技有限公司。
实施例1
按照表1的配比，制备祛痘凝胶：
表1 祛痘凝胶处方
制备：
1、称取处方量的透明质酸，加入500g纯化水中，搅拌溶解化开直至澄清，备用；
2、称取处方量的季铵盐-73，加入100.0g的丙二醇溶解并搅拌均匀，备用；
3、将处方量的莪术油、冰片、乙醇、吐温-80、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、硅烷二醇水杨酸酯、苯氧乙醇、薰衣草油加入配液罐中，开启搅拌，在450-550转/分钟搅拌状态下继续搅拌10-20分钟使其完全溶解；
5、将处方量的甘草酸二钾、尿囊素、积雪草总苷加入约315g纯化水中，450-550转/分钟搅拌状态下溶解澄清后加入上述配液罐中，搅拌10-20分钟至完全溶解；
6、然后将5加入1中混匀，搅拌15min，直至澄清；
7、将3加入到6中，混匀，再加入2，再搅拌混匀直至澄清，真空脱气，即得。
实施例2 祛痘凝胶对痤疮杆菌的抑制作用
一、材料来源
痤疮丙酸杆菌ATCC11827，购买于中国广东省微生物菌种保藏中心；PhosphateBuffered Saline(PBS)缓冲液购买于Gibco公司；梭菌增菌培养基、技术琼脂粉购买于广东环凯微生物科技有限公司。祛痘凝胶为实施例1制备的祛痘凝胶。
二、试验方法
选用痤疮丙酸杆菌ATCC11827作为供试菌种，参照GB15797-2002一次性使用卫生用品卫生标准中“溶出性抗(抑)菌产品抑菌性能试验方法”进行试验，用受试物对痤疮丙酸杆菌的抑制菌落数目来评估受试物的药敏效果。抑菌效果分级为：极敏：菌落数≤10CFU/mL；高敏：菌落数10-100CFU/mL；中敏：菌落数100-1000CFU/mL；低敏：菌落数1000-106CFU/mL；不敏：菌落数＞106CFU/mL。
将痤疮丙酸杆菌接种于加有琼脂粉的梭菌增菌培养基斜面上，在37℃环境下厌氧培养48～72h。待菌落长满后用5mL梭菌增菌培养基将菌落进行洗脱。收集洗脱液并将其浓度调整为106CFU/mL，并用平板法进行活菌计数。称取祛痘凝胶样品1g加入到上述0.1mL菌悬液中，并加入9ml PBS混合后，取1mL置于3个平行平皿内，再加入梭菌增菌培养基在37℃环境下厌氧培养48～72h后菌落计数，以上实验重复3次，取其平均数，同时设置生理盐水为空白对照。
结果如表2所示：
表2 体外抑制痤疮杆菌效果
实施例3 祛痘凝胶的抗炎作用
一、材料来源
1.细胞株：
RAW264.7细胞株，购买于武汉普诺赛生命科技有限公司；
2.主要试剂：
祛痘凝胶为实施例1制备的祛痘凝胶；Phosphate Buffered Saline(PBS)缓冲液、胰蛋白酶及青-链霉素溶液购买于Gibco公司；RAW264.7细胞专用培养基及胎牛血清购买于武汉普诺赛生命科技有限公司；脂多糖(LPS)购买于上海源叶生物科技有限公司；CCK-8试剂盒购买于Glpbio公司；一氧化氮(NO)检测试剂盒购买于碧云天生物技术有限公司；
二、试验方法
1.细胞培养
RAW264.7细胞生长于含有10％胎牛血清、100U/mL青霉素和100mg/L链霉素的RAW264.7细胞专用培养基中，于37℃、5％CO2的培养箱中培养。待细胞生长至80％-90％汇合度时，细胞传代，收集对数生长期细胞接种于96孔细胞板继续培养。
2.药物浓度选择
精量称取250mg祛痘凝胶样品，溶于DMSO中，制成200mg/mL储备液，置于-20℃冰箱保存备用。根据预试验结果，实验组最终加入的祛痘凝胶浓度分别为62.5μg/mL、125μg/mL及250μg/mL。
3.细胞活力检测
收集对数生长期细胞以每孔15000个细胞的密度接种于96孔培养板，于培养箱中继续培养24h后，移去培养液，PBS缓冲液洗涤1次，然后每孔加入100μL含不同浓度祛痘凝胶的无血清培养液，每组设8个复孔。置于培养箱中继续培养24h后，去除原培养液，加入100μL无血清培养液及10μLCCK-8，放入孵箱培养3小时后，使用酶标仪于450nm波长处检测吸光值并计算细胞增殖活力。细胞活力(％)＝实验组吸光值/对照组吸光值×100％。
4.NO含量检测
细胞以每孔15000个细胞的密度接种于96孔培养板，于培养箱中继续培养24h后，移去培养液，PBS缓冲液洗涤1次，然后每孔加入100μL含不同浓度祛痘凝胶的无血清培养基预孵育细胞1h，然后加入LPS，并使LPS的终质量浓度100ng/mL。置于培养箱中继续培养24h后，收集培养液，用NO检测试剂盒测定各组NO含量。
5.统计学方法
所有数据采用GraphPad Prism9.0软件进行统计学分析，采用均数±标准差表示计量资料，计数资料使用率表示。多组间比较使用单因素方差分析，两组间比较使用Student’t检验。P<0.05表示差异具有统计学意义。
三.试验结果
1.祛痘凝胶对RAW264.7细胞活力的影响
如表3所示，作用24h后，祛痘凝胶在剂量为62.5μg/mL、125μg/mL及250μg/mL时对RAW264.7细胞活力皆无明显影响，可用于后续实验。
表3 祛痘凝胶对RAW264.7细胞活力的影响
2.祛痘凝胶对LPS刺激RAW264.7细胞释放NO含量的影响
如表4所示，LPS作用于RAW264.7细胞，细胞上清液中的NO分泌量明显增加，达到52.42μmol/L，与正常对照组(2.63μmol/L)比较，差异皆具有统计学意义(p＜0.01)，提示LPS诱导RAW264.7细胞炎症模型建立成功。祛痘凝胶在剂量为62.5μg/mL、125μg/mL及250μg/mL时皆能显著降低LPS刺激的RAW264.7细胞上清液NO释放量，分别为31.65μmol/L、25.28μmol/L及16.69μmol/L，与LPS组比较，差异皆具有统计学意义(p＜0.01、p＜0.01、p＜0.01)。
表4 祛痘凝胶对LPS刺激的RAW264.7细胞释放NO含量的影响
注：与对照组比较：#p<0.01，与LPS组比较：**p<0.01
以上试验表明，本发明提供的祛痘凝胶具有体外抗炎功效。
以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。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，这些改进和修饰也落入本发明权利要求的保护范围内。
Claims (9)
1.一种用于治疗痤疮的药物组合物，包括：
莪术油、冰片、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、季铵盐-73、甘草酸二钾、尿囊素、硅烷二醇水杨酸酯、积雪草总苷和透明质酸。
2.根据权利要求1所述的药物组合物，其特征在于，包括：
3.根据权利要求2所述的药物组合物，其特征在于，包括：
4.权利要求1～3任一项所述的药物组合物在制备痤疮外用制剂中的应用。
5.一种痤疮外用制剂，包括：
莪术油、冰片、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、季铵盐-73、甘草酸二钾、尿囊素、硅烷二醇水杨酸酯、积雪草、透明质酸和辅剂。
6.根据权利要求5所述的痤疮外用制剂，其特征在于，包括：
7.根据权利要求6所述的痤疮外用制剂，其特征在于，包括：
8.根据权利要求5所述的痤疮外用制剂，其特征在于，所述制剂的剂型为凝胶剂或膏剂。
9.权利要求5～8任一项所述的痤疮外用制剂的制备方法，包括以下步骤：
S1)将处方量的莪术油、冰片、乙醇、吐温-80、苦参根提取物、马齿苋提取物、页岩油磺酸酯钠、硅烷二醇水杨酸酯、防腐剂、香精混合、溶解，得到第一溶液；
S2)将第一溶液与甘草酸二钾、尿囊素和积雪草总苷的水溶液混合，得到第二溶液；
S3)将第二溶液和透明质酸的水溶液混合，得到第三溶液；
S4)将第三溶液和季铵盐-73的丙二醇溶液混合，得到痤疮外用制剂。
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| CN108158972A (zh) * | 2018-03-28 | 2018-06-15 | 湖南御家化妆品制造有限公司 | 组合物及含有该组合物的抑制痤疮炎症的化妆品 |
| CN111388523A (zh) * | 2020-04-15 | 2020-07-10 | 贵州得轩堂护康药业股份有限公司 | 一种治疗痤疮的制剂及其制备方法 |
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| CN108158972A (zh) * | 2018-03-28 | 2018-06-15 | 湖南御家化妆品制造有限公司 | 组合物及含有该组合物的抑制痤疮炎症的化妆品 |
| CN111388523A (zh) * | 2020-04-15 | 2020-07-10 | 贵州得轩堂护康药业股份有限公司 | 一种治疗痤疮的制剂及其制备方法 |
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