CN114288231A - 一种养颜美容祛斑胶囊的制备方法 - Google Patents
一种养颜美容祛斑胶囊的制备方法 Download PDFInfo
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Abstract
本发明公开了一种养颜美容祛斑胶囊的制备方法。所述制备方法包括如下步骤：采用乙醇水溶液回流提取红景天、何首乌和当归的混合物至少三次，合并提取液，过滤，回收乙醇，得到含有提取物的溶液；采用水蒸气蒸馏法处理红花和杜鹃花的混合物，得到挥发油和药渣；将所述药渣、枸杞子和黄芪合并，加水煎煮至少三次，合并煎液，过滤得滤液；将所述滤液与所述含有提取物的溶液合并，浓缩成稠膏；将珍珠粉碎成珍珠粉；将所述稠膏与珍珠粉混匀，然后经干燥后粉碎得到细粉；将所述细粉与挥发油混匀，装入胶囊即得。本发明以红花和杜鹃花替代了原配方中的生地黄和熟地黄，以红花和杜娟挥发油入药，进一步缩短了药物起效时间，并提高了治疗的有效率。
Description
本申请是申请日为2018年11月21日、申请号为201811391289.9、发明名称为《一种养颜美容祛斑胶囊的制备方法》的发明专利的分案申请。
技术领域
本发明涉及一种养颜美容祛斑胶囊的制备方法，属于化妆品技术领域。
背景技术
黄褐斑是发生在面部的获得性不规则褐色色素沉着，一般认为其与内分泌紊乱、日晒、情绪等因素有关，近年来发病率呈上升趋势，发病年龄趋于年轻化。
本病目前尚无特效的治疗方法。氢醌霜、维甲酸类药物有一定效果，但也存在不足：氢醌霜高浓度时疗效提高，但刺激性加重，长期应用可导致外源性黄褐斑；维甲酸起效缓慢，需持续用药半年左右才能逐渐显效。晶珠景天祛斑胶囊选自高原药材，以红景天、黄芪、红花、珍珠等组成，具有活血行气、祛斑消痤的功效，用于治疗黄褐斑取得了确切疗效，且患者耐受性良好，但部分患者使用后疗效不甚明显，或起效时间缓慢，因此需要对现有配方加以调整，以期缩短从用药到起效的时间，并提高治疗的有效率。
发明内容
本发明的目的是提供一种养颜美容祛斑胶囊的制备方法，本发明采用了水蒸气蒸馏法提取的红花和杜鹃花的挥发油，所制备的祛斑胶囊的疗效显著提高。
本发明所提供的祛斑胶囊的制备方法，包括如下步骤：
(1)采用乙醇水溶液回流提取红景天、何首乌和当归的混合物至少三次，合并提取液，过滤，回收乙醇，得到含有提取物的溶液；
(2)采用水蒸气蒸馏法处理红花和杜鹃花的混合物，得到挥发油和药渣；
所述水蒸气蒸馏法包括如下步骤：
将所述红花和杜鹃花的混合物经粉碎过筛，采用水回流提取得水提液，然后采用正己烷萃取所述水提液，得到水相和有机相；
所述有机相为透明油状液体，经干燥即得所述挥发油；所述水相经过滤得到所述药渣；
所述回流提取的条件为：采用4～8倍体积的水回流提取3～7小时；
(3)将所述步骤(2)得到的药渣、枸杞子和黄芪合并，加水煎煮至少三次，合并煎液，过滤得滤液；
(4)将所述步骤(3)得到的滤液与步骤(1)得到的含有提取物的溶液合并，浓缩成稠膏；
(5)将珍珠粉碎成珍珠粉；
(6)将所述步骤(4)得到的稠膏与所述步骤(5)得到的珍珠粉混匀，然后经干燥后粉碎得到细粉；
(7)将所述步骤(6)得到的细粉与所述步骤(2)得到的挥发油混匀，装入胶囊即得；
制备所述祛斑胶囊的各原料的质量配比如下：
所述祛斑胶囊的各原料的质量配比如下：
优选的，步骤(1)中，所述乙醇水溶液中乙醇的体积百分含量为65％～75％，进一步优选为70％。
优选的，步骤(1)中，所述乙醇水溶液回流提取的条件如下：
采用所述乙醇水溶液回流提取所述混合物三次；
第一次提取的条件如下：采用4～8倍体积的所述乙醇水溶液回流提取1～6小时，进一步优选为采用6倍体积的所述乙醇水溶液回流提取3小时；
第二次提取的条件如下：采用2～6倍体积的所述乙醇水溶液回流提取1～3小时，进一步优选为采用4倍体积的所述乙醇水溶液回流提取2小时；
第三次提取的条件如下：采用2～6倍体积的所述乙醇水溶液回流提取0.5～1.5小时，进一步优选为采用4倍体积的所述乙醇水溶液回流提取1小时。
优选的，步骤(2)中，所述干燥的方式为加入无水硫酸钠进行干燥。
优选的，步骤(3)中，所述煎煮的条件如下：
采用水煎煮三次；
第一次煎煮的条件如下：采用4～8倍体积的水煎煮1～5小时，进一步优选为采用6倍体积的水煎煮3小时；
第二次煎煮的条件如下：采用2～6倍体积的水煎煮1～3小时，进一步优选为采用4倍体积的水煎煮2小时；
第三次煎煮的条件如下：采用2～6倍体积的水煎煮0.5～1.5小时，进一步优选为采用4倍体积的水煎煮1小时。
优选的，步骤(4)中，所述稠膏的相对密度为1.30～1.35(50℃)。
优选的，步骤(5)中，所述珍珠粉的粒径为70～80μm(200目)。
优选的，步骤(6)中，所述干燥的条件如下：
采用微波真空干燥法，中低火力，前13分钟为间歇式加热(开1分钟停1分钟)，之后为连续加热，控制温度24℃～39℃，真空度-0.084MPa。
所述细粉的粒径为70～80μm(200目)。
本发明提供的养颜美容祛斑胶囊的制备方法，与原制备方法相比，优势与特点在于：
(1)以红花和杜鹃花替代了原配方中的生地黄和熟地黄。红花具有活血通经、化瘀止痛、活血解毒的功能，用于治疗痛经、跌打损伤、关节疼痛、冠心病等疾病。杜鹃花含有黄酮类、二萜类等有效成分，具有镇咳、祛痰、平喘、抗炎、镇痛等作用，此外还对心血管、神经系统发挥多种作用。
(2)以红花和杜娟挥发油入药，进一步缩短了药物起效时间，并提高了治疗有效率。目前红花挥发油已鉴定出48种挥发性化学成分，包括7,9-二十二烷酮、石竹烯氧化物等，通过构建疾病网络模型发现这些成分在肿瘤、肝硬化、高血脂、心肌缺血等疾病的治疗中发挥重要作用。目前杜鹃花挥发油已鉴定出62种挥发性成分，已知其中δ-杜松烯、γ-杜松烯、异愈创木醇和α-杜松醇具有祛痰作用，愈创木醇和异愈创木醇具有镇咳作用。
具体实施方式
下述实施例中所使用的实验方法如无特殊说明，均为常规方法。
下述实施例中所用的材料、试剂等，如无特殊说明，均可从商业途径得到。
实施例1
按照下述配方称取各组分：
按照下述方法进行制备：
1)将红景天、何首乌、当归用70％乙醇水溶液(体积)回流提取三次，第一次使用用药材体积6倍的乙醇提取3小时，第二次使用药材体积4倍的乙醇提取2小时，第三次使用药材体积4倍的乙醇提取1小时，合并提取液，滤过，回收乙醇，所得溶液备用；
2)采用水蒸气蒸馏法处理红花和杜鹃花，取干燥的红花80g和杜鹃花200g，用普通粉碎机粉碎并过50目筛，然后混合均匀，用6倍体积的水煮沸回流提取5小时，采用正己烷萃取水提液，得到水相和有机相，所述有机相为具有芳香气味的透明油状液体，经干燥即得挥发油；水相经过滤得到药渣。
3)将步骤2)得到的药渣与枸杞子、黄芪合并，加水煎煮三次，第一次使用药材体积6倍的水煎煮3小时，第二次使用药材体积4倍的水煎煮2小时，第三次使用药材体积4倍的水煎煮1小时，合并煎液，滤过得滤液。
4)将步骤3)所得滤液与步骤1)所得溶液合并，浓缩至相对密度为1.30～1.35(50℃)的稠膏备用；
5)将珍珠粉碎后筛成细粉，粒径为70μm～80μm(200目)；
6)将步骤4)得到的稠膏与步骤5)得到的细粉，混匀，微波真空干燥(采用中低火力，前13分钟为间歇式加热，开1分钟停1分钟，之后为连续加热，控制温度24℃～39℃，真空度-0.084MPa)，粉碎成细粉，粒度为70μm～80μm(200目)；
7)将步骤6)得到的细粉喷上由步骤2)制得的挥发油，混匀，装入胶囊即得。
对比例1
按照下述配方称取各组分：
按照下述方法进行制备：
1)将红景天、何首乌和当归用70％乙醇水溶液(体积)回流提取三次(第一次使用用药材体积6倍的70％乙醇提取3小时，第二次使用药材体积4倍的70％乙醇提取2小时，第三次使用药材体积4倍的70％乙醇提取1小时)，合并三次提取液，减压回收乙醇，浓缩成膏，烘干、粉碎成细粉备用，粒径为70μm～80μm(200目)；
2)将枸杞子、生地黄、熟地黄和黄芪水煮三次(第一次使用药材体积6倍的水煎煮3小时，第二次使用药材体积4倍的水煎煮2小时，第三次使用药材体积4倍的水煎煮1小时)，合并三次提取液过滤、浓缩、微波真空干燥(采用中低火力，前13分钟为间歇式加热，开1分钟停1分钟，之后为连续加热，控制温度24℃～39℃，真空度-0.084MPa)得细粉，粒径为70μm～80μm(200目)；
3)将珍珠粉碎后筛成细粉，粒度为70μm～80μm(200目)；
4)将步骤1)、步骤2)和步骤3)所得细粉加辅料充分混匀，灭菌，加药用淀粉辅料灌装胶囊即得。
实施例2
将实施例1和对比例1分别制备的胶囊用于临床，并对其针对原有疾病的疗效进行比较
为了比较本发明制备的晶珠景天祛斑胶囊与原方法制备的晶珠景天祛斑胶囊的疗效，北京晶珠中医医院纳入120例黄褐斑患者，并随机分为A组和B组，各60例。其中A组使用本发明制备的晶珠景天祛斑胶囊治疗(实施例1)，B组使用原方法制备的晶珠景天祛斑胶囊治疗(对比例1)。两组均为一日2次，一次4粒，3个月为一个疗程。
疗效判定标准为：以皮损面积和皮肤颜色得分之和计算积分。皮损面积评分：面积≤5cm2得1分，5cm2＜面积≤10cm2得2分，面积＞10cm2得3分；皮肤颜色评分：浅褐色得1分，深褐色得2分，黑褐色得3分。
疗效指数(％)＝(治疗前总积分-治疗后总积分)/治疗前总积分×100％。疗效指数＞90％为治愈，疗效指数60％～90％为显效，疗效指数30％～59％为进步，疗效指数＜30％为无效。起效时间＝从开始用药到疗效指数为30％的时间。总显效率＝(痊愈例数+显效例数)/总例数×100％，总有效率＝(痊愈例数+显效例数+有效例数)/总例数×100％。
两组平均起效时间和疗效对比如表1所示。
表1A、B两组的平均起效时间和疗效对比
由表1中的数据可知，A组的平均起效时间仅为(12.7±3.2)天，显著短于B组的(28.5±2.6)天(P＜0.05)，表明本发明制备的晶珠景天祛斑胶囊起效更快，这对于患者树立治疗信心，增强治疗依从性具有重要意义。
此外，A、B两组的总有效率分别为86.6％和80.0％，差别尚未达到统计学意义(P＞0.05)，但A组的显效率为60.0％，远远高于B组的36.6％(P＜0.05)，这表明本发明制备的晶珠景天祛斑胶囊其显效率优于原方法制备的晶珠景天祛斑胶囊，而后者治疗结果仅呈现进步的占比更高。
在不良反应方面，A组和B组各有1例出现短暂胃肠道反应，但均为轻度，不影响治疗，并均完成了一个疗程的治疗。
实施例3
将实施例1和对比例1分别制备的胶囊用于临床，并对其针对新适应症的疗效进行比较
北京晶珠中医医院在以本发明制备的晶珠景天祛斑胶囊用于黄褐斑治疗的过程中，发现该药对气滞血瘀型原发性痛经的女性患者亦具有疗效，故对此进行了初步观察。将60例气滞血瘀型原发性痛经患者随机分为治疗组和对照组，每组各30例。治疗组采用本发明制备的晶珠景天祛斑胶囊治疗，对照组采用原方法制备的晶珠景天祛斑胶囊治疗，共治疗3个月，观察疗效及治疗前后视觉模拟评分(VAS)。
两组疗效比较如表2所示，治疗前后VAS评分如表3所示。
表2治疗组和对照组的临床疗效比较
表3治疗组和对照组在治疗前后VAS评分比较
注：*表示与同组治疗前比较，P＜0.05；#表示与对照组治疗后比较，P＜0.05。
由于是初步观察，故未设安慰剂对照组。但从上述结果仍然可见，本发明制备的晶珠景天祛斑胶囊，其总有效率83.3％显著高于原方法制备的晶珠景天祛斑胶囊(60.0％)，同时对治疗前后VAS评分亦有显著改善，且优于原方法制备的晶珠景天祛斑胶囊。
本发明制备的晶珠景天祛斑胶囊与原方法制备的晶珠景天祛斑胶囊相比，主要变化在于以红花和杜鹃花替代了原方法中的生地黄和熟地黄，并且用水蒸汽蒸馏法提取了红花和杜鹃花的挥发油。
尽管上述实施例对本发明做出了详尽的描述，但它仅仅是本发明一部分实施例，而不是全部实施例，还可以根据本实施例在不经创造性前提下获得其他实施例，这些实施例都属于本发明保护范围。
Claims (6)
1.一种祛斑胶囊的制备方法，包括如下步骤：
(1)采用乙醇水溶液回流提取红景天、何首乌和当归的混合物至少三次，合并提取液，过滤，回收乙醇，得到含有提取物的溶液；
(2)采用水蒸气蒸馏法处理红花和杜鹃花的混合物，得到挥发油和药渣；
所述水蒸气蒸馏法包括如下步骤：
将所述红花和杜鹃花的混合物经粉碎过筛，采用水回流提取得水提液，然后采用正己烷萃取所述水提液，得到水相和有机相；
所述有机相为透明油状液体，经干燥即得所述挥发油；所述水相经过滤得到所述药渣；
所述回流提取的条件为：采用4～8倍体积的水回流提取3～7小时；
(3)将所述步骤(2)得到的药渣、枸杞子和黄芪合并，加水煎煮至少三次，合并煎液，过滤得滤液；
(4)将所述步骤(3)得到的滤液与所述步骤(1)得到的含有提取物的溶液合并，浓缩成稠膏；
(5)将珍珠粉碎成珍珠粉；
(6)将所述步骤(4)得到的稠膏与所述步骤(5)得到的珍珠粉混匀，然后经干燥后粉碎得到细粉；
(7)将所述步骤(6)得到的细粉与所述步骤(2)得到的挥发油混匀，装入胶囊即得；
制备所述祛斑胶囊的各原料的质量配比如下：
2.根据权利要求1所述的制备方法，其特征在于：步骤(1)中，所述乙醇水溶液中乙醇的体积百分含量为65％～75％。
3.根据权利要求1或2所述的制备方法，其特征在于：步骤(1)中，所述乙醇水溶液回流提取的条件如下：
采用所述乙醇水溶液回流提取所述混合物三次；
第一次提取的条件如下：采用4～8倍体积的所述乙醇水溶液回流提取1～5小时；
第二次提取的条件如下：采用2～6倍体积的所述乙醇水溶液回流提取1～4小时；
第三次提取的条件如下：采用2～6倍体积的所述乙醇水溶液回流提取0.5～1.5小时。
4.根据权利要求1所述的制备方法，其特征在于：步骤(3)中，所述煎煮的条件如下：
采用水煎煮三次；
第一次煎煮的条件如下：采用4～8倍体积的水煎煮1～5小时；
第二次煎煮的条件如下：采用2～6倍体积的水煎煮1～4小时；
第三次煎煮的条件如下：采用2～6倍体积的水煎煮0.5～1.5小时。
5.根据权利要求1所述的制备方法，其特征在于：步骤(5)中，所述珍珠粉的粒径为70～80μm。
6.根据权利要求1所述的制备方法，其特征在于：步骤(6)中，所述干燥的条件如下：
采用微波真空干燥法，中低火力，前13分钟为间歇式加热，之后为连续加热，控制温度为24℃～39℃，真空度为-0.084MPa。
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