CN104474330A - 一种治疗面部色斑的药物组合物 - Google Patents

一种治疗面部色斑的药物组合物 Download PDF

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CN104474330A
CN104474330A CN201410702840.2A CN201410702840A CN104474330A CN 104474330 A CN104474330 A CN 104474330A CN 201410702840 A CN201410702840 A CN 201410702840A CN 104474330 A CN104474330 A CN 104474330A
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柯利佳
韦玲菊
林国友
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Abstract

一种治疗面部色斑的药物组合物，由外用酊剂和口服剂组成，酊剂针对面部色斑产生的机理，依据色斑生成诱因、病理特点，面部色斑收效迅速、疗效确切，对皮肤的刺激作用小，皮肤脱皮程度极为轻微，无明显毒副作用；口服剂调节身体内部环境，达到外擦内服，标本兼治的效果。

Description

一种治疗面部色斑的药物组合物
技术领域
  本发明涉及一种药物，特别涉及外用药物，具体地说是一种治疗面部色斑的药物组合物。
背景技术
黄褐斑俗称“蝴蝶斑”、“肝斑”或者“妊娠斑”。主要发生在面部，以颧部、颊部、鼻、前额、颏部为主。为边界不清楚的褐色或黑色的斑片，多为对称性。黄褐斑的出现多数与内分泌有关，尤其是和女性的雌激素水平有关，月经不调、妊娠、服避孕药或肝功能不好以及慢性肾病都可能出现黄褐斑。
本发明人经过长期实践得出，中药治黄褐斑具有较好作用，取得不错效果。局部治疗多使用中药面膜、SOD霜、氢醌、维甲酸、果酸、壬二酸、酚类化合物及其复方制剂等。全身治疗多内服维生素类、黄酮醇类等药物。此外还有物理疗法、化学疗法和生物疗法、中医疗法等等。多种疗法，各有优势，但都因人而异，有的易复发，有的还有副作用。
     女士和男士的皮肤无论是解剖结构上还是生理功能上，都有显著的不同。通常表现有以下六个方面：(1)女士皮肤真皮层薄而皮肤表皮层略厚，男士则相反；(2)女士皮肤表面携带的细菌种类及数量较男士少；(3)女士的汗液和乳酸分泌较男士少，皮肤表面pH值偏高；(4)女士的皮脂腺腺体平均较男士的小，油脂分泌相对少；(5)女士的毛孔相对细致；(6)在免疫反应中，女士的皮肤伤口愈合时炎症反应比男士的要弱，愈合时间也相对要短。
发明内容
本发明的目的在于克服了上述现有存在问题，提供一种治疗面部色斑的酊剂的制作方法。
    本发明的技术方案是由外用的酊剂和内服的口服剂组成，
    所述酊剂每100体积份中含有15～25重量份复方中药原材的乙醇提取物、1～3重量份冰片和0.05～3重量份水杨酸，
酊剂的复方中药原材有以下重量份的各组分，荷叶10～50份，白果10～50份，苦参10～50份，丹参10～40份，丹皮10～40份，珍珠粉10～40份，紫苏子10～40份，当归10～40份，白芍5～30份，红花10～40份，白茅根10～40份、枳棋子10～40份；
口服剂由以下重量配比的中药原料组成，桑葚 5～10份、枸杞5～10份、桂圆5～10份、莲子5～10份，薄荷 1～4 份、紫苏子 1～4份、白牡丹茶粉1～4份、绞股蓝1～4份。
    进一步的：所述酊剂的复方中药原材混合粉碎过40～60目筛；将上述复方原材粉末投入浸提器中，加入75％体积百分浓度乙醇，乙醇量漫过药物，密闭浸渍7天，每隔一天翻搅一次，过滤分离，用75％乙醇稀释至7500mL，加入冰片150g，水杨酸50g，搅拌均匀，最后调整pH值为5，乙醇含量75％。
    进一步的：所述口服剂中的白牡丹茶粉粉碎、研磨后过80目目筛。
    进一步的：所述口服剂中的绞股蓝为干燥至水分为15%左右的绞股蓝。
体积份取升(L)或毫升(ml)，重量份取千克(kg)或克(g)。
本酊剂使用浸渍法进行制备，也可以用其他公知的稀释法或渗漉法进行制备。
浸渍法是将配比量的复方中药原材粉碎过40～60目筛，在密闭的容器中浸渍5～7天，定期翻搅一次。浸渍结束后分离弃渣，在滤液中加入冰片、水杨酸，最后按药典规定调pH值和乙醇含量。
稀释法是取配比量的复方中药原材经提取、脱溶后的流浸膏，用乙醇稀释，分离弃渣，在滤液加入冰片、水杨酸，最后按药典规定调pH值和乙醇含量。
渗漉法就是将配比量的复方中药原材粉碎后首先加入乙醇使之润湿，密闭一定时间后装入渗漉器中，加入乙醇渗透药粉收集渗漉液再加工本酊剂。
本发明的有益效果：
1.依据面部色斑产生的机理，依据色斑生成诱因、病理特点，优选具有温和祛除角质、高效清除自由基、抗脂质氧化、抑制黑色素生成、抑制脂褐素生成等功能的多种中药材和西药复配而成，加以有促进微循环、新陈代谢的中药及含多种维生素、氨基酸、微量元素等营养物质的中药，利用冰片并结合中药中自身含有的脂肪酸、挥发油等天然皮肤促渗剂，将药物活性成分分阶段、多层次地送达皮肤角质层、表皮层、真皮层及皮下组织等多个作用靶点。本发明15～20天色斑开始明显变淡，一般2～3个疗程色斑可基本消退。
2.采用外擦内服的方式进行对黄褐斑生成因素的抑制，能够减轻黄褐斑的发展趋势，且本发明内服的口服剂为常用的食材和茶组成，不仅对人体副作用小，还能起到一定的保健功效，可以长期服用。
具体实施方式
下面结合实施例对本发明做进一步说明：
实施例1
   以浸渍法为例，非限定实施例叙述如下：
   A、制备酊剂：取荷叶300g、白果300g、丹参200g、丹皮200g、珍珠粉200g、紫苏子150g、当归400g、白芍300g、红花400g，白茅根100g，枳棋子100g，混合粉碎过40～60目筛。将复方原材粉末投入浸提器中，加入75％(体积百分浓度)乙醇，乙醇量漫过药物，密闭浸渍7天，每隔一天翻搅一次。过滤分离。用75％乙醇稀释至7500ml，加入冰片150g，水杨酸50g，搅拌均匀，最后调整pH值为5，乙醇含量75％。
    B、制备口服剂：
    取桑葚50克、枸杞50克、桂圆50克、莲子50克，薄荷10克、紫苏子10克、白牡丹茶粉10克、绞股蓝10克，洗净后，放入电高压锅内，锅内放入适量纯化水，将温度控制在110℃左右，高压隔水蒸10分钟，冷却至室温，晒干后粉碎成粗末备用；按然后将粉碎后备用的中药混合粉碎成80目粉末，混合均匀后，按每袋20g的用量装入袋状包装袋，即得成品。
实施例2
   以浸渍法为例，非限定实施例叙述如下：
   A、制备酊剂：取荷叶500g、白果500g、苦参500g、丹参400g、丹皮500g、珍珠粉200g、紫苏子150g、当归150g、白芍100g、红花100g，白茅根100g，枳棋子100g，混合粉碎过40～60目筛。将复方原材粉末投入浸提器中，加入75％(体积百分浓度)乙醇，乙醇量漫过药物，密闭浸渍7天，每隔一天翻搅一次。过滤分离。用75％乙醇稀释至7500ml，加入冰片150g，水杨酸50g，搅拌均匀，最后调整pH值为5，乙醇含量75％。
B、制备口服剂：
    取桑葚50克、枸杞50克、桂圆50克、莲子50克，薄荷40克、紫苏子40克、白牡丹茶粉40克、绞股蓝40克，洗净后，放入电高压锅内，锅内放入适量纯化水，将温度控制在110℃左右，高压隔水蒸10分钟，冷却至室温，晒干后粉碎成粗末备用；按然后将粉碎后备用的中药混合粉碎成80目粉末，混合均匀后，按每袋20g的用量装入袋状包装袋，即得成品。
实施例3
 以浸渍法为例，非限定实施例叙述如下：
 A、制备酊剂：取荷叶100g、白果100g、苦参100g、丹参100g、丹皮100g、珍珠粉200g、紫苏子150g、当归150g、白芍100g、红花400g，白茅根400g，枳棋子400g混合粉碎过40～60目筛。将复方原材粉末投入浸提器中，加入75％(体积百分浓度)乙醇，乙醇量漫过药物，密闭浸渍7天，每隔一天翻搅一次。过滤分离。用75％乙醇稀释至7500ml，加入冰片150g，水杨酸50g，搅拌均匀，最后调整pH值为5，乙醇含量75％。
B、制备口服剂：
    取桑葚10克、枸杞10克、桂圆10克、莲子10克，薄荷10克、紫苏子10克、白牡丹茶粉10克、绞股蓝10克，洗净后，放入电高压锅内，锅内放入适量纯化水，将温度控制在110℃左右，高压隔水蒸10分钟，冷却至室温，晒干后粉碎成粗末备用；按然后将粉碎后备用的中药混合粉碎成80目粉末，混合均匀后，按每袋20g的用量装入袋状包装袋，即得成品。
本酊剂应用于治疗黄褐斑的临床试验结果如下：
   本品经临床应用，并与3％复方氢醌乳膏(氢醌、果酸、地塞米松)作对照，治疗6周后观察，临床结果如下：
 （1）一般资料：180例验证病人均为门诊黄褐斑女性患者，其中验证组110例，对照组70例。验证组110例中：年龄20～29岁38例，31～39岁53例，40～49岁19例。对照组70例中：年龄20～29岁24例，31～39岁37例，40～49岁9例。治疗组与对照组在性别、年龄、临床分型，经统计学处理，P＞0.05，具有可比性。
（2）病例选择
排除病例：排除其他疾病(如颧部褐青色痣、Riehl黑变病及色素性光化性扁平苔藓等)引起的色素沉着。
  （3）治疗方法：按1∶1的配对原则，验证组和对照组各70例，验证组扩大40例，共180例。验证组：使用本发明实施例1。对照组：使用3％复方氢醌乳膏。
  疗程：两者连续用药2周为1个疗程，计观察3个疗程。
  （4）疗程判断标准：
    参照“中国中西医结合学会皮肤性病专业委员会色素病学组”制定的“黄褐斑的临床诊断和疗效标准(2003年修订稿)”，划分为“基本治愈”、“显效”、“好转”、“无效”4种。
①基本治愈：(1)肉眼视色斑面积消退＞90％，颜色基本消失；(2)评分法计算治疗后下降指数≥0.8
   ②显效：(1)肉眼视色斑面积消退＞60％，颜色明显变淡；(2)评分法计算治疗后下降指数≥0.5
③好转：(1)肉眼视色斑面积消退＞30％，颜色变淡；(2)评分法计算治疗后下降指数≥0.3
   ④无效：(1)肉眼视色斑面积消退＜30％，颜色变化不明显；(2)评分法计算治疗后下降指数≤0
⑤评分方法和标准：
皮损面积评分：0为无皮损；1为皮损面积＜2cm2，2为皮损面积2～4cm2；3为皮损面积＞4cm2
   皮损颜色评分：0为正常肤色；1为淡褐色；2为褐色；3为深褐色。
总积分＝面积评分+颜色评分。
 （5）治疗结果：表一本品用于治疗面部黄褐斑的临床试验结果
  由表一可知，本品临床总有效率为92.73％，对照组为81.43％，两者统计学处理，X2＝4.26，P＜0.05，差异显著。验证组总显效率为82.73％，对照组为61.43％，X2＝10.20，P＜0.01，差异极显著。
本发明不局限于以上所述的具体实施方式，以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (4)

1.一种治疗面部色斑的药物组合物，其特征在于：由外用的酊剂和内服的口服剂组成，
   所述酊剂每100体积份中含有15～25重量份复方中药原材的乙醇提取物、1～3重量份冰片和0.05～3重量份水杨酸，
所述酊剂的复方中药原材有以下重量份的各组分，荷叶10～50份，白果10～50份，苦参10～50份，丹参10～40份，丹皮10～40份，珍珠粉10～40份，紫苏子10～40份，当归10～40份，白芍5～30份，红花10～40份，白茅根10～40份、枳棋子10～40份；
所述口服剂由以下重量配比的中药原料组成，桑葚 5～10份、枸杞5～10份、桂圆5～10份、莲子5～10份，薄荷 1～4 份、紫苏子 1～4份、白牡丹茶粉1～4份、绞股蓝1～4份。
2.根据权利要求1所述的一种治疗面部色斑的药物组合物，其特征在于：所述酊剂的复方中药原材混合粉碎过40～60目筛；将上述复方原材粉末投入浸提器中，加入75％体积百分浓度乙醇，乙醇量漫过药物，密闭浸渍7天，每隔一天翻搅一次，过滤分离，用75％乙醇稀释至7500mL，加入冰片150g，水杨酸50g，搅拌均匀，最后调整pH值为5，乙醇含量75％。
3.根据权利要求1所述的一种治疗面部色斑的药物组合物，其特征在于：所述口服剂中的白牡丹茶粉粉碎、研磨后过80目目筛。
4.根据权利要求1所述的一种治疗面部色斑的药物组合物，其特征在于：所述口服剂中的绞股蓝为干燥至水分为15%左右的绞股蓝。
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