CN113520954A - 一种中药祛痘膏及其生产工艺 - Google Patents

一种中药祛痘膏及其生产工艺 Download PDF

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CN113520954A
CN113520954A CN202110984838.9A CN202110984838A CN113520954A CN 113520954 A CN113520954 A CN 113520954A CN 202110984838 A CN202110984838 A CN 202110984838A CN 113520954 A CN113520954 A CN 113520954A
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traditional chinese
chinese medicine
parts
essential oil
oil
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杨成德
王杨
葛林
朱少晖
方月琴
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Suzhou Chien Shiung Institute of Technology
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Abstract

本发明公开了一种中药祛痘膏的配方及其生产工艺和应用，所述中药祛痘膏，由中药有效成分和药膏基础组分组成，所述中药有效成分包括马齿苋提取物、生大黄粉、菊花精油、金银花精油、金盏花精油、茶树精油、橄榄油；所述药膏基础组分包括甘油硬脂酸酯、矿物油/羊毛脂醇、鲸蜡硬脂醇、硬脂酸、去离子水、丙二醇、羧甲基纤维素、镁铝硅酸盐、三乙醇胺、二氧化钛、颜料、表面活性剂、香料和防腐剂。本发明公开的中药祛痘膏选择地道药材和低温加工，最大可能保留中药有效成分，与西药膏剂基础组分相结合，形成优于西药克林霉素疗效的配方，并且疗效稳定。

Description

一种中药祛痘膏及其生产工艺
技术领域
本发明涉及一种护肤用品，具体涉及一种中药祛痘膏及其生产工艺以及应用。
背景技术
痤疮也称为青春痘，面部痤疮就是脸上长青春痘，这是一种常见的皮肤病，一般多见于青少年。常见症状有炎性丘疹，脓疱，结节等。痤疮是常见的皮肤病之一,有关的流行病学分析显示44.5％的青少年患有痤疮。痤疮常常发生在面部，若不治疗,容易遗留色素沉着或瘢痕,影响病人的容貌。
痘痘的成因是非常复杂的，市面上的祛痘产品不仅仅是通过抑制达到祛痘效果，更是有通过催熟的方式加快痘痘的生长，或者通过祛痘膏的杀菌消炎功效可以帮助痘痘褪红。
常见的祛痘膏蕴含的成分多以酸性和消炎型的成分为主。酸性物质能分解痘痘中的油脂，而消炎型成分则会抑制痘痘生长。比如水杨酸、尿囊素、茶树油等。
治疗痤疮常应用含有激素药物、甲硝唑、抗生素、维A酸、过氧化苯甲酰成分的祛痘产品，但易引发多种不良反应，并且耐药易复发。近年来出现的壳聚糖护创凝胶、芦荟凝胶等祛痘膏，添加了具有祛痘功效的中药提取物成分，治疗痤疮疗效好、毒副作用小，但有效成分吸收不稳定，疗效难以保障。
但是，中药祛痘膏产品采用中药传统方法，煎煮浓缩为膏，没有发挥出中药的独特优势。比如：蒲公英2-4份，高丽参2-4份，车前草2-4份，紫丁花1-2 份，连翘1-2份，金银花1-2份。该方采用煎煮浓缩的传统中药膏剂方法制成，疗效缓慢，膏剂不易储存。
比如CN104940361A一种祛痘膏及其制备方法，该祛痘膏由活性成分和辅料制成，所述的活性成分由如下重量份的中药材原料经水提醇沉制备而得：黄莲花 20-32份、灵香草20-32份、芜菁子12-18份、佛手15-25份、路路通10-18份。该祛痘膏有显著的抑制座疮丙酸杆菌的功效，可抑制座疮的产生。但是，水提醇沉法有效成分收率较低。另外该膏剂稳定性较差，有效期较短，与其基础配方有直接关系。
发明内容
针对上述问题，本发明公开了一种中药祛痘膏及其生产工艺，吸收传统中药整体调理的思路，以西药膏剂基础配方与传统中药有效成分相结合，避免西药耐药性和中药靶点宽泛的缺点，扬长避短，在制剂工艺上避免中西药相互作用。
本发明包括以下技术方案：
一种中药祛痘膏，由中药有效成分和药膏基础组分组成，所述中药有效成分包括马齿苋提取物、生大黄粉、菊花精油、金银花精油、金盏花精油、茶树精油、橄榄油；所述药膏基础组分包括甘油硬脂酸酯、矿物油/羊毛脂醇、鲸蜡硬脂醇、硬脂酸、去离子水、丙二醇、羧甲基纤维素、铝镁硅酸盐、三乙醇胺、二氧化钛、颜料、表面活性剂、香料和防腐剂。
进一步的，上述一种中药祛痘膏，所述中药有效成分的按质量份数由以下成分组成：
Figure BDA0003226372720000021
进一步的，上述一种中药祛痘膏，所述药膏基础组分按质量分数由以下成分组成：
Figure BDA0003226372720000022
Figure BDA0003226372720000031
进一步的，上述一种中药祛痘膏，所述颜料为氧化铁。
进一步的，上述一种中药祛痘膏，所述表面活性剂选自卵磷脂类，氨基酸型或甜菜碱型中的一种或者多种。
进一步的，上述一种中药祛痘膏，所述表面活性剂为氢化卵磷脂。
进一步的，上述一种中药祛痘膏，所述马齿苋提取物采用超临界CO2流体萃取装置提取：将清洗粉碎后的马齿苋在萃取装置中循环萃取,调节CO2流量,萃取过程温度小于60℃，压强维持40Mpa，保持恒温恒压萃取2小时以上。
进一步的，上述一种中药祛痘膏的制备工艺，包括以下步骤：
S1将马齿苋提取物与生大黄粉混合，混合破碎为20-100μm颗粒，取出置于配料罐，依次加入茶树精油菊花精油、金银花精油、金盏花精油，在配料罐中 500-1500r/min搅拌30分钟，再加入适量橄榄油搅拌10min制成能流动的膏状物A备用，上述制备过程中温度不超过40℃；
S2将羧甲基纤维素在混合器分散于丙二醇和三乙醇胺中，加入60-65℃去离子水搅拌30min，再加入铝镁硅酸盐搅拌至完全混合均匀为止，制成水相；将甘油硬脂酸酯、矿物油/羊毛脂醇、鲸蜡硬脂醇、硬脂酸混合，且加热至60-65℃，制成油相；在500～1000r/min下，在混合器中将水相加入到油相，且不断搅拌，加入颜料搅拌冷却，降温至30℃时加入表面活性剂；随后在均质机中进行均质，制成膏状混合物B；
S3按照A:B为1:1-1:4的比例进行混合，再加入香料、防腐剂和二氧化钛等颜料；在均质机内混合30分钟，包装充填，制成祛痘膏成品。
进一步的，上述一种中药祛痘膏在制备预防或者治疗面部痘痘的化妆品或药品中的的用途。
本发明具有以下有益效果：
1本发明中的中药有效成分具有中药耐药性小、无激素的优点，比常见西药祛痘膏更加温和，治疗后复发率低等优点。
2本发明采用超临界CO2萃取装置低温萃取中药有效成分，比常见中药祛痘膏疗效稳定，各项生产指标确切、质量易控。
3本发明公开了一种中西药配方联合治疗痤疮的方法和应用。
附图说明
附图1为本发明中一种中药祛痘膏的制备工艺的总体流程图；
附图2为本发明实施例4中的抗菌活性测试图。
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。本发明中所述的适量，为本领域内普通技术人员根据国家技术规范和生产实际情况所决定的用量。本发明中所述的原料如无特殊说明，均为商业购得。
(一)中药原料及来源
1.马齿苋提取物(低温)：采用超临界CO2流体萃取装置，将清洗粉碎后的马齿苋,在萃取装置中循环萃取,调节CO2流量,萃取过程温度小于60℃，压强维持40Mpa，保持恒温恒压萃取2小时以上。比一般醇提和水提效果要好。也可采购市场上符合上述条件的马齿苋提取物-西安百川生物科技有限公司。
2.生大黄粉：破碎生大黄(产地甘肃)，100％过80目筛；
3.菊花精油：山东泰安市嘉叶生物科技有限公司
4.金银花精油：江西雪松天然药用油有限公司
5.金盏花精油：江西景旺天然香料有限公司
6.茶树精油：江苏润丰合成科技有限公司
7.橄榄油：甘肃武都田丰油橄榄苗木基地
(二)其他原料及来源(均为医药级或者食品级)
1.甘油硬脂酸酯：浙江物美生物科技有限公司
2.矿物油/羊毛脂醇：苏州新亿生物科技有限公司
3.鲸蜡硬脂醇：上海倍特化工有限公司
4.硬脂酸：上海倍特化工有限公司
5.去离子水：自制
6.丙二醇：陶氏化学(上海)有限公司
7.羧甲基纤维素：常州市国宇环保科技有限公司
8.铝镁硅酸盐：斯百全化学(上海)有限公司
9.三乙醇胺(99％)：陶氏化学(上海)有限公司
10.二氧化钛：上海缘江化工有限公司
11.氧化铁：颜料，可以不用。西安天正药用辅料有限公司
12.活性剂：卵磷脂类表面活性剂：河北百味生物科技有限公司
13.香料,防腐剂：苯甲酸钠等，可以不用。山西锦洋药用辅料有限公司
实施例1
中药祛痘膏制备工艺1
表1 实施例1中药有效成分配方表
Figure BDA0003226372720000051
(一)有效成分制备方法：
按照表1将马齿苋提取物与生大黄粉混合，在气流机中破碎为20-100μm 颗粒，取出置于配料罐，依次加入茶树精油菊花精油、金银花精油、金盏花精油，在配料罐中50-100r/min搅拌30分钟，再加入适量橄榄油搅拌10min制成能流动的膏状物A备用，注意在制备过程中温度不超过40℃。
备注：气流机：FQ02气流粉碎机-山东丰力重工有限公司
配料罐：IC-100配料罐-北京博医康实验仪器有限公司
表2 实施例2药膏基础组分(纯度达到医药级)
Figure BDA0003226372720000061
(二)基础组分制备方法：
1.按照表2配方将CMC在混合器A分散于丙二醇和三乙醇胺中，加入去离子水(60-65℃)搅拌30min，再加入veegum搅拌至完全混合均匀为止，制成水相。
2.将1、2、3、4混合，且加热至60-65℃，制成油相。
3.在500-1000r/min下，在混合器B中将水相加入到油相，充分混合。
4.加入氧化铁搅拌冷却，在30℃加入氢化卵磷脂类。
6.在均质机中进行均质，制成混合物B。
(三)混合制备祛痘膏
1.按照A:B为1:1的比例进行混合，再加入香料、防腐剂和二氧化钛等颜料。
2.在均质机内均质30分钟。
3.包装充填。
备注：
混合器A:TJ-Btype双联平行生物反应器-迪必尔生物工程(上海)有限公司
混合器B：SK-7.5/15静态混合器-启东市精博化工设备厂
均质机:JMS-180胶体磨-廊坊市通益机械有限公司
总体制备流程见图1。
实施例2
祛痘膏制备工艺2
表3 实施例2中药有效成分配方表
Figure BDA0003226372720000071
(一)有效成分制备方法：
按照表3将马齿苋提取物与生大黄粉混合，在气流机中破碎为20-100μm 颗粒，取出置于配料罐，依次加入茶树精油菊花精油、金银花精油、金盏花精油，在配料罐中50-100r/min搅拌30分钟，再加入适量橄榄油搅拌10min制成能流动的膏状物A备用，注意在制备过程中温度不超过40℃。
备注：气流机：FQ02气流粉碎机-山东丰力重工有限公司
配料罐：FY30配料罐-温州天兴机械有限公司
表4 实施例2药膏基础组分配方表(纯度达到医药级)
Figure BDA0003226372720000081
(二)基础组分制备方法：
1.按照表4配方将CMC在混合器A分散于丙二醇和三乙醇胺中，加入温水(60-65℃)搅拌30min，再加入铝镁硅酸盐搅拌至完全混合均匀为止，制成水相。
2.将1、2、3、4混合，且加热至60-65℃，制成油相。
3.在500-1000r/min下，在混合器B中将水相加入到油相，充分混合。
4.加入氧化铁搅拌冷却，在30℃加入氢化卵磷脂类。
6.在均质机中进行均质，制成混合物B。
(三)混合制备祛痘膏
1.按照A:B为3:7的比例进行混合，再加入香料、防腐剂和二氧化钛等颜料。
2.在均质机内均质30分钟。
3.包装充填。
备注：
混合器A:TJ-Btype双联平行生物反应器-迪必尔生物工程(上海)有限公司
混合器B：SK-7.5/15静态混合器-启东市精博化工设备厂
均质机:JMS-180胶体磨-廊坊市通益机械有限公司。
实施例3
祛痘膏制备工艺3
表5 实施例3中药有效成分配方表
Figure BDA0003226372720000091
(一)有效成分制备方法：
按照表5将马齿苋提取物与生大黄粉混合，在气流机中破碎为20-100μm 颗粒，取出置于配料罐，依次加入茶树精油菊花精油、金银花精油、金盏花精油，在配料罐中50-100r/min搅拌30分钟，再加入适量橄榄油搅拌10min制成能流动的膏状物A备用，注意在制备过程中温度不超过40℃。
备注：气流机：FQ02气流粉碎机-山东丰力重工有限公司
配料罐：FY30配料罐-温州天兴机械有限公司
表6 实施例3药膏基础组分配方表(纯度达到医药级)
Figure BDA0003226372720000092
(二)基础组分制备方法：
1.按照表6配方将CMC在混合器A分散于丙二醇和三乙醇胺中，加入温水 (60-65℃)搅拌30min，再加入铝镁硅酸盐搅拌至完全混合均匀为止，制成水相。
2.将1、2、3、4混合，且加热至60-65℃，制成油相。
3.在500-1000r/min下，在混合器B中将水相加入到油相，充分混合。
4.加入氧化铁搅拌冷却，在30℃加入药用氨基酸。
6.在均质机中进行均质，制成混合物B。
(三)混合制备祛痘膏
1.按照A:B为2:8的比例进行混合，再加入香料、防腐剂和二氧化钛等颜料。
2.在均质机内均质30分钟。
3.包装充填。
备注：
混合器A:TJ-Btype双联平行生物反应器-迪必尔生物工程(上海)有限公司
混合器B：SK-7.5/15静态混合器-启东市精博化工设备厂
均质机:JMS-180胶体磨-廊坊市通益机械有限公司。
实施例4
祛痘膏抗菌活性测试研究
经抗菌测试，本祛痘膏具有明显的抑制痤疮丙酸杆菌的功效，可以抑制痤疮的产生，对痤疮丙酸杆菌的最低抑菌质量浓度为0.3-0.4mg/mL，优于克林霉素乳膏的最低抑菌浓度，见图2。
实施例5
祛痘膏的临床应用研究
面部痤疮患者64例，男性27例，女性37例；年龄最小13岁，最大42岁；病程最短20d，最长10年。随机分为观察组和对照组。观察组32例，男性15 例，女性17例；年龄最小14岁，最大42岁；病程最短20d，最长10年，使用实施例2处方工艺制备的祛疻膏治疗。对照组32例，男性12例，女性20 例；年龄最小13岁，最大41岁；病程最短25d，最长9年，使用0.8％克林霉素乳膏治疗。两组病例在性别、年龄、病程等方面经统计学处理无显著差异，P>0.05，具有可比性。
使用方法：用清水清洗面部，取适量药膏，均匀涂抹于患处，每日2-3次，连续使用2周以上。
疗效标准：经2周治疗，皮损消退70％以上为显效；皮损消退30％以上为有效；皮损消退30％以下为无效。总有效率＝(显效例数+有效例数)/总例数×100％。
治疗结果：如表7所示，观察组32例中显效13例，有效16例，无效3例，总有效率90.6％。对照组32例中显效10例，有效18例，无效4例，总有效率84.3％，汇总在表4-3中。复诊时观察组复发为0，对照组5例复发。显然，本发明的中药祛疻膏治疗痤疮效果略优于克林霉素乳膏。
表7 治疗有效率表
Figure BDA0003226372720000111
以上实施例1-5可知，本发明公开了一种中药祛痘膏及其生产工艺，吸收传统中药整体调理的思路，以西药膏剂基础配方与传统中药有效成分相结合，避免西药耐药性和中药靶点宽泛的缺点，扬长避短，在制剂工艺上避免中西药相互作用。
以上仅为本发明的较佳实施例而已，不能以此限定本发明的保护范围，即大凡依本发明权利要求书及发明内容所做的简单的等效变化与修改，皆仍属于本发明专利申请的保护范围。

Claims (9)

1.一种中药祛痘膏，其特征在于，由中药有效成分和药膏基础组分组成，所述中药有效成分包括马齿苋提取物、生大黄粉、菊花精油、金银花精油、金盏花精油、茶树精油、橄榄油；所述药膏基础组分包括甘油硬脂酸酯、矿物油/羊毛脂醇、鲸蜡硬脂醇、硬脂酸、去离子水、丙二醇、羧甲基纤维素、铝镁硅酸盐、三乙醇胺、二氧化钛、颜料、表面活性剂、香料和防腐剂。
2.根据权利要求1所述的一种中药祛痘膏，其特征在于，所述中药有效成分的按质量份数由以下成分组成：
马齿苋提取物 1-2份
生大黄粉 2-4份
菊花精油 1-3份
金银花精油 1-3份
金盏花精油 1-3份
茶树精油 1-2份
橄榄油 适量。
3.根据权利要求1所述的一种中药祛痘膏，其特征在于，所述药膏基础组分按质量分数由以下成分组成：
甘油硬脂酸酯 20-40份
矿物油/羊毛脂醇 30-60份
鲸蜡硬脂醇 5-20份
硬脂酸 10-30份
去离子水 适量
丙二醇 20-40份
羧甲基纤维素 1-3份
铝镁硅酸盐 1-20份
三乙醇胺 2-20份
二氧化钛 80-150份
颜料 适量
表面活性剂 30-80份
香料和防腐剂 适量。
4.根据权利要求1所述的一种中药祛痘膏，其特征在于，所述颜料为氧化铁。
5.根据权利要求1所述的一种中药祛痘膏，其特征在于，所述表面活性剂选自卵磷脂类，氨基酸型或甜菜碱型中的一种或者多种。
6.根据权利要求1所述的一种中药祛痘膏，其特征在于，所述表面活性剂为氢化卵磷脂。
7.根据权利要求1所述的一种中药祛痘膏，其特征在于，所述马齿苋提取物采用超临界CO2流体萃取装置提取：将清洗粉碎后的马齿苋在萃取装置中循环萃取,调节CO2流量,萃取过程温度小于60℃，压强维持40Mpa，保持恒温恒压萃取2小时以上。
8.如权利要求1-7任一项所述的中药祛痘膏的制备工艺，其特征在于，包括以下步骤：
S1将马齿苋提取物与生大黄粉混合，混合破碎为20-100μm颗粒，取出置于配料罐，依次加入茶树精油菊花精油、金银花精油、金盏花精油，在配料罐中500-1500r/min搅拌30分钟，再加入适量橄榄油搅拌10min制成能流动的膏状物A备用，上述制备过程中温度不超过40℃；
S2将羧甲基纤维素在混合器分散于丙二醇和三乙醇胺中，加入60-65℃去离子水搅拌30min，再加入铝镁硅酸盐搅拌至完全混合均匀为止，制成水相； 将甘油硬脂酸酯、矿物油/羊毛脂醇、鲸蜡硬脂醇、硬脂酸混合，且加热至60-65℃，制成油相；在500~1000r/min下，在混合器中将水相加入到油相，且不断搅拌，加入颜料搅拌冷却，降温至30℃时加入表面活性剂；随后在均质机中进行均质，制成膏状混合物B；
S3按照A:B为1:1-1:4的比例进行混合，再加入香料、防腐剂和二氧化钛等颜料；在均质机内混合30分钟，包装充填，制成祛痘膏成品。
9.如权利要求1-7任一项所述的中药祛痘膏在制备预防或者治疗面部痘痘的化妆品或药品中的的用途。
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102219669A (zh) * 2010-04-13 2011-10-19 徐德钦 一种采用超临界co2流体萃取马齿苋亚麻酸的方法
CN103169641A (zh) * 2013-03-14 2013-06-26 金红叶纸业集团有限公司 祛痘淡印组合物及应用其的纸巾
CN103463212A (zh) * 2013-09-27 2013-12-25 罗成 一种中药祛痘、除印面膜及其制备方法
CN104940361A (zh) * 2015-06-04 2015-09-30 青岛大学附属医院 一种祛痘膏及其制备方法
CN107929227A (zh) * 2017-12-15 2018-04-20 柳州市汉象教育咨询有限责任公司 一种祛痘除印的药膏及其制备方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102219669A (zh) * 2010-04-13 2011-10-19 徐德钦 一种采用超临界co2流体萃取马齿苋亚麻酸的方法
CN103169641A (zh) * 2013-03-14 2013-06-26 金红叶纸业集团有限公司 祛痘淡印组合物及应用其的纸巾
CN103463212A (zh) * 2013-09-27 2013-12-25 罗成 一种中药祛痘、除印面膜及其制备方法
CN104940361A (zh) * 2015-06-04 2015-09-30 青岛大学附属医院 一种祛痘膏及其制备方法
CN107929227A (zh) * 2017-12-15 2018-04-20 柳州市汉象教育咨询有限责任公司 一种祛痘除印的药膏及其制备方法

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