CN107519312A - 一种治疗白发的中药组合物及其制备方法 - Google Patents

一种治疗白发的中药组合物及其制备方法 Download PDF

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CN107519312A
CN107519312A CN201710916503.7A CN201710916503A CN107519312A CN 107519312 A CN107519312 A CN 107519312A CN 201710916503 A CN201710916503 A CN 201710916503A CN 107519312 A CN107519312 A CN 107519312A
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徐旭东
罗胜勇
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HEFEI HAIDA BIOPHARMACEUTICAL TECHNOLOGY Co Ltd
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HEFEI HAIDA BIOPHARMACEUTICAL TECHNOLOGY Co Ltd
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Abstract

本发明公开了一种治疗白发的中药组合物及其制备方法。该中药组合物由生地、黑芝麻、黑豆、制首乌、熟地、枸杞子、侧柏叶、牛膝、川芎、当归、茯苓、墨汗莲、菟丝子、肉苁蓉、覆盆子等中药为原料，按一定的重量份配比制备而成，它可以制备成任何一种常用口服制剂。本品具有活血化瘀、养血清热、补益肝肾等功效。临床上用于治疗白发。本发明药材采用钠米粉碎、生产工艺采用不加热超声萃取、相对低温快速浓缩，大大地保留了中药的有效成分，是一个显著的创新，并对疗效而言，带来了显著的效果。经临床验证，有效率为87.5％，在治疗过程中，患者未见明显的不良反应。

Description

一种治疗白发的中药组合物及其制备方法
技术领域
本发明是涉及一种中药组合物，具体的说，涉及一种治疗白发的中药组合物及其制备方法。
背景技术
毛发全部或部分变白成为白发，可为先天性或后天性。《素问·上古天真论》载“女子……六七，三阳脉衰于上，面皆焦，发始白。……丈夫……六八，阳气衰竭于上，面焦，发鬓颁白”，揭示了人体生理性白发开始于40岁。现代人们由于生活节奏快、工作压力大、饮食及作息不规律等原因，过早出现白发，对生活质量造成一定影响。
现代医学认为，酪氨酸酶活性降低、黑色素合成减少、色素沉着减少均可导致毛发变白，其中酪氨酸酶活性降低是影响毛发色素生成与沉着减少的主要因素。但目前白发的现代医学确切病理机制尚未明了，治疗方法也相对局限。中医药在白发的预防、治疗等方面均有独特的优势。
但是中药提取工艺常采用水或乙醇长时间高温加热，浓缩也是长时间高温，致使中药部分有效成分失去相应的治疗作用，疗效受到一定的限制。本发明人在中医药理论的指导下，发明的经验方，并运用创新的生产工艺，临床应用安全性好，疗效高，很值得临床推广θ用。
发明内容
本发明的目的是提供治疗一种白发的中药组合物。
本发明的目的还在于提供一种治疗白发的中药组合物及其制备方法。
本发明解决的方案是发明人，在中医药理论的指导下，多年来结合自己的临床经验，运用创新的生产工艺，精心研制而成的，本品具有活血化瘀、养血清热、补益肝肾等功效。临床上用于治疗白发。
本发明是通过下列方案实现的，本发明药物主要是由下述重量份配比的原料药制成的：
本发明药物主要各原料的优选重量份配比是：
本发明药物主要各原料的最佳重量份配比是：
生地2份、黑芝麻4份、黑豆4份、制首乌4份、熟地3份、枸杞子2份、侧柏叶3份、牛膝2份、川芎1份、当归2份、茯苓3份、墨汗莲2份、菟丝子2份、肉苁蓉2份、覆盆子2份、补骨脂2份、桑葚2份、女贞子2份、桃仁1.5份、丹参1.5份、黄芪2份、白芍2份、甘草1份。
本发明药物的制备方法，其方法步骤如下：
(1)将配方中所述重量份配比的生地、黑芝麻、黑豆、制首乌、熟地、枸杞子、侧柏叶、牛膝、川芎、当归、茯苓、墨汗莲、菟丝子、肉苁蓉、覆盆子、补骨脂、桑葚、女贞子、桃仁份、丹参、黄芪、白芍、甘草纳米粉碎，加6-8倍量50-95％的乙醇浸泡12-24小时；
(2)采用不加热，超声循环萃取1-2次，每次15-30分钟，合并静置，取上清液用旋转蒸发设备，相对低温快速浓缩至相对密度为1.30～1.35(80℃)的浸膏，冷藏，用于制备各种制剂。
本发明提取的浓缩液中可以加入制备不同剂型时所需要的辅料，再以常规的中药制剂方法制备成常用口服剂型，如胶囊、颗粒剂、糖浆剂等。
具体实施方式
实施例1：本发明的治疗白发胶囊剂的制备方法，其步骤如下：
生地2份、黑芝麻4份、黑豆4份、制首乌4份、熟地3份、枸杞子2份、侧柏叶3份、牛膝2份、川芎1份、当归2份、茯苓3份、墨汗莲2份、菟丝子2份、肉苁蓉2份、覆盆子2份、补骨脂2份、桑葚2份、女贞子2份、桃仁1.5份、丹参1.5份、黄芪2份、白芍2份、甘草1份。
(1)将配方中所述重量份配比的生地、黑芝麻、黑豆、制首乌、熟地、枸杞子、侧柏叶、牛膝、川芎、当归、茯苓、墨汗莲、菟丝子、肉苁蓉、覆盆子、补骨脂、桑葚、女贞子、桃仁份、丹参、黄芪、白芍、甘草纳米粉碎，加8倍量95％的乙醇浸泡24小时；
(2)采用不加热，超声循环萃取1次，每次30分钟，合并静置，取上清液用旋转蒸发设备，相对低温快速浓缩至相对密度为1.30～1.35(80℃)的浸膏，加微晶纤维素制粒，干燥，粉碎，过筛，装入胶囊，即制成胶囊剂。
实施例2：本发明的治疗白发颗粒剂的制备方法，其步骤如下：
生地2份、黑芝麻3份、黑豆3份、制首乌3份、熟地3份、枸杞子2份、侧柏叶2份、牛膝2份、川芎1份、当归2份、茯苓3份、墨汗莲2份、菟丝子2份、肉苁蓉2份、覆盆子2份、补骨脂2份、桑葚2份、女贞子2份、桃仁1份、丹参1份、黄芪2份、白芍2份、甘草1份。
(1)将配方中所述重量份配比的生地、黑芝麻、黑豆、制首乌、熟地、枸杞子、侧柏叶、牛膝、川芎、当归、茯苓、墨汗莲、菟丝子、肉苁蓉、覆盆子、补骨脂、桑葚、女贞子、桃仁份、丹参、黄芪、白芍、甘草纳米粉碎，加6倍量55％的乙醇浸泡18小时；
(2)采用不加热，超声循环萃取2次，每次15分钟，合并静置，取上清液用旋转蒸发设备，相对低温快速浓缩至相对密度为1.30～1.35(80℃)的浸膏，加入糊精、甜菊素、混匀，制粒，干燥，包装，即制成颗粒剂。
实施例3：本发明的治疗白发糖浆剂的制备方法，其步骤如下：
生地3份、黑芝麻3份、黑豆3份、制首乌3份、熟地3份、枸杞子2份、侧柏叶3份、牛膝2份、川芎1份、当归2份、茯苓3份、墨汗莲2份、菟丝子2份、肉苁蓉2份、覆盆子2份、补骨脂2份、桑葚2份、女贞子2份、桃仁1份、丹参1份、黄芪2份、白芍2份、甘草1份。
(1)将配方中所述重量份配比的生地、黑芝麻、黑豆、制首乌、熟地、枸杞子、侧柏叶、牛膝、川芎、当归、茯苓、墨汗莲、菟丝子、肉苁蓉、覆盆子、补骨脂、桑葚、女贞子、桃仁份、丹参、黄芪、白芍、甘草纳米粉碎，加8倍量75％的乙醇浸泡12小时；
(2)采用不加热，超声循环萃取2次，每次20分钟，合并静置，取上清液用旋转蒸发设备，相对低温快速浓缩至相对密度为1.30～1.35(80℃)的浸膏，加入蔗糖、山梨酸钾及适量蒸馏水，搅匀，滤过，包装，即制成糖浆剂。
实验例
以下均选用同一处方：
治疗组：采用本发明实施例1：制成的胶囊剂。
对照组1：采用水加热提取，每次加8倍量的水，煎煮2次，每次2小时，合并煎液，滤过，浓缩至相对密度为1.30～1.35(80℃)的浸膏，加微晶纤维素制粒，干燥，粉碎，过筛，装入胶囊，即制成胶囊剂。
对照组2：采用70％乙醇加热提取，每次加8倍量的醇，每次2小时，合并醇液，滤过，浓缩至相对密度为1.30～1.35(80℃)的浸膏，加微晶纤维素制粒，干燥，粉碎，过筛，装入胶囊，即制成胶囊剂。
选择22例白发患者，年龄21-53岁，随机分为治疗组、对照组1和对照组2，一日3次，一次2-3粒。3个月一个疗程，治疗2个疗程后，评定结果，结果如表：
疗效判定标准 治愈：治疗后头发由白变黄，由黄变黑，不复发者；显效：白发数目明显减少，新生头发全变黑者；无效：治疗时间短而未按医嘱坚决执行，头发无任何变化，白发症状无改善者。以治愈+显效计算总有效率。
临床疗效观察图
采用本发明实施例1：制成的胶囊剂，药材采用钠米粉碎、生产工艺采用不加热超声萃取、相对低温快速浓缩，大大地保留了中药的有效成分，是一个显著的创新，并对疗效而言，带来了显著的效果。经临床验证，有效率为87.5％，在治疗过程中，患者未见明显的不良反应。
虽然，上文中已经用一般性说明及具体实施方案对本发明做了详尽的描述，但在本发明基础上，可以对之作一些修改或改进，这对本领域技术人员而言是显而易见的。因此，在不偏离本发明精神的基础上所做的这些修改或改进，均属于本发明要求保护的范围。

Claims (4)

1.一种治疗白发的中药组合物，其特征在于它主要是由下列重量份配比的原料药制成：
2.根据权利要求1所述的治疗白发的中药组合物，其特征在于它主要是由下列优选的重量份配比的原料药制成：
3.根据权利要求1所述的治疗白发的中药组合物，其特征在于它主要是由下列最佳重量份配比的原料药制成：
生地2份、黑芝麻4份、黑豆4份、制首乌4份、熟地3份、枸杞子2份、侧柏叶3份、牛膝2份、川芎1份、当归2份、茯苓3份、墨汗莲2份、菟丝子2份、肉苁蓉2份、覆盆子2份、补骨脂2份、桑葚2份、女贞子2份、桃仁1.5份、丹参1.5份、黄芪2份、白芍2份、甘草1份。
4.一种制备权利要求1或2或3所述药物的方法，其特征在于它包括下列步骤：
(1)将配方中所述重量份配比的生地、黑芝麻、黑豆、制首乌、熟地、枸杞子、侧柏叶、牛膝、川芎、当归、茯苓、墨汗莲、菟丝子、肉苁蓉、覆盆子、补骨脂、桑葚、女贞子、桃仁份、丹参、黄芪、白芍、甘草纳米粉碎，加6-8倍量50-95％的乙醇浸泡12-24小时；
(2)采用不加热，超声循环萃取1-2次，每次15-30分钟，合并静置，取上清液用旋转蒸发设备，相对低温快速浓缩至相对密度为1.30～1.35(80℃)的浸膏，加入不同口服制剂的相关辅料，可制成胶囊剂、颗粒剂、糖浆剂等各种口服制剂。
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