CN109331156A - 一种生发黑发胶囊及其制备方法 - Google Patents
一种生发黑发胶囊及其制备方法 Download PDFInfo
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- CN109331156A CN109331156A CN201811335053.3A CN201811335053A CN109331156A CN 109331156 A CN109331156 A CN 109331156A CN 201811335053 A CN201811335053 A CN 201811335053A CN 109331156 A CN109331156 A CN 109331156A
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- ethyl acetate
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Abstract
本发明提供一种生发黑发胶囊的制备方法。本发明的方法包括：（1）中药材原料准备；（2）浸泡：将步骤（1）中制成的混合药材粉末加入乙醇、乙酸乙酯，温度控制在25±2℃，浸泡6‑8天后进行固液分离并收集滤液；（3）对步骤（2）中固液分离后的滤渣重新加入乙醇和乙酸乙酯，浸泡1天，再进行固液分离并收集滤液；（4）合并两次滤液，回收乙醇、乙酸乙酯；（5）置换乙酸乙酯，再低温回收溶剂至合并两次滤液量的10%；（6）混合赋形剂；（7）脱除溶媒干燥；（8）制备胶囊膜皮，（9）将步骤（7）中制备的产品采用步骤（8）中制备的胶皮进行包装成胶囊并入库。本发明加大药物有效成分保留，可以明显地提高疗效。
Description
技术领域：
本发明涉及一种生发黑发胶囊及其制备方法，属于中药及其加工方法技术领域。
背景技术：
关于脱发的原因,不同类型的脱发是由不同的 致病因素所造成的,归纳起来,无外乎以下几个方面：
(1)雄性激素有关的毛囊机能低下。头部毛发 严格地受雄性激素的影响,男性激素的睾丸酮,在毛 囊处经5a一还原酶催化变成活性更高的5n一二氢 睾丸酮(DHT),这种变化是不可逆的。DHT是引起 脱发的主要原因,它能与细胞内的受体蛋白质结合, 转移到细胞核内,将特定的基因活化,诱导生成特定 的蛋白质,从而阻碍了毛发的生长,进而产生永久性的脱发或秃发。
(2)毛囊、毛球部及头发生理机能低下。头发 是从毛囊底部长出,而毛囊底部的毛乳头上有许多 分裂的细胞,它们便是毛球,毛球是头发的发端,在毛球的上半球生有色素细胞,它们共同的作用是分 泌油脂,滋润毛发。当油脂分泌过剩,则会导致产生 脂溢性脱发,或引发细菌从而产生糠秕性脱发症。
(3)头皮紧张造成的局部血液循环障碍,引起 毛囊、毛乳头的末梢毛细血管的流量减少,毛乳头和毛母细胞的养料物质供应不足,使头发的生长出现 异常。
(4)营养不良、应激反应和药物副作用。
(5)遗传因素等。
在早期,人们对付脱发,一般是采用中国的传统中草药,以采用 搽、敷、食相结合的多重作用,通过刺激毛囊,促进血 液微循环,提供头发生长养分等手段,从而达到防脱生发的作用。但一般程序较为繁锁,辛辣刺激较重, 目前已很少被采用。
发明内容：
本发明的目的是针对上述存在的问题提供一种生发黑发胶囊及其制备方法，生产的生发黑发胶囊通过高效提取制首乌、生地、熟地、侧柏叶中的有效成分，并且加以高效合成的方式。加大药物有效成分保留，可以明显地提高疗效。
上述的目的通过以下的技术方案实现：
一种生发黑发胶囊的制备方法，该方法包括如下步骤：
（1）中药材原料准备，按重量份数取制首乌5重量份、生地3重量份、熟地3重量份、侧柏叶3重量份、墨旱莲2重量份、女贞子2重量份、菟丝子2重量份、肉苁蓉2重量份、蛹虫草2重量份、淫羊藿2重量份、黄芪2重量份、黄精2重量份、丹参2重量份、甘草1重量份、干姜4重量份进行粉碎制成混合药材粉末；
（2）浸泡：将步骤（1）中制成的混合药材粉末加入乙醇、乙酸乙酯，加入的量为每重量份混合药材粉末加入10重量份乙醇和3重量份乙酸乙酯，温度控制在25±2℃，浸泡6-8天后进行固液分离并收集滤液；
（3）对步骤（2）中固液分离后的滤渣重新加入乙醇和乙酸乙酯，加入量为每重量份滤渣加入1重量份乙醇和1重量份乙酸乙酯，浸泡1天，温度控制在25±2℃，再进行固液分离并收集滤液；
（4）合并两次滤液，回收乙醇、乙酸乙酯，所述回收乙醇、乙酸乙酯是在真空旋转蒸发器温度控制在40℃之下进行；
（5）回收溶剂至剩余滤液量为合并两次滤液量的10%时，再按照剩余滤液的1:1添加乙醇来置换乙酸乙酯，再低温回收溶剂至合并两次滤液量的10%；
（6）混合赋形剂，加入微晶纤维素，充分搅匀，微晶纤维素加入量是总药材量的10%；
（7）脱除溶媒干燥，在真空烘箱中，-0.1MPA的真空中，温度控制在40℃下，干燥至结晶；
（8）制备胶囊膜皮，所述的胶囊膜皮的制备方法如下：
a.按重量份数取纯化水45-56份、肌醇磷酸3-5份、海藻酸钠1-3份，充分搅拌混合；
b.向步骤a的混合物中加入蜂蜡3～5份、蜂胶粉15-22份、麦芽糖醇4-9份，明胶36-47份充分搅拌混合；
c.将步骤b中制备的混合物在45～53℃的温度下进行化胶6-8小时，得到胶液；
d.将步骤c中制得的胶液制备成胶皮；
（9）将步骤（7）中制备的产品采用步骤（8）中制备的胶皮进行包装成胶囊并入库。
所述的生发黑发胶囊的制备方法，步骤（1）中所述的粉碎制成混合药材粉末，粉碎后药材粉末的粒径75±10微米。
所述的生发黑发胶囊的制备方法，步骤（2）中所述的浸泡过程中，需要加以搅拌达到传质置换的作用，搅拌每天不少于1小时。
所述的生发黑发胶囊的制备方法，步骤（3）中所述的浸泡过程中需要加以搅拌达到传质置换的作用，搅拌不少于1小时。
所述的生发黑发胶囊的制备方法，步骤（5）中所述的低温回收溶剂的温度不超过40℃。
一种用上述方法制备的生发黑发胶囊。
有益效果：
1.本发明采用免加热提取方法不同于传统热蒸煮传质原理，采用动态力学传质机理，通过在密闭容器内机械力作用下与药材相互动力作用，使溶剂在药材组织中进行传质置换。在机械力作用下，所采用的溶媒与药材组织中可溶物质发生传质作用，使得药物中可溶于溶媒物质在反复机械力作用下溶媒与药材组织中可溶物质发生行程反复的传质溶出置换，最终使得可溶于溶媒的药材成分充分溶于溶媒当中，然后通过固液分离，分出溶媒混合液，弃去渣，然后分离溶媒得到可溶成分。采用免加热提取方法可以有效避免二苯乙烯苷类化合物、蒽醌类化合物、聚合原花青素、梓醇、侧柏叶挥发油、黄酮类化合物等一些物质受热分解异构导致降低药效成分活性，从而达到提高药材提取效率的效果。
2.本发明为了获得制首乌中二苯乙烯苷类化合物、蒽醌类化合物、聚合原花青素，地黄中的梓醇，侧柏叶中的挥发油、黄酮类化合物。由于这几类物质在乙醇、乙酸乙酯中溶解性较好，用乙醇、乙酸乙酯作为溶媒，对药材中有效成分进行提取。乙醇乙酸乙酯提取法，提取率高，使得药物中有效成分多且活性高增加疗效。同时可以让患者减少每日服药量，方便服药，提高顺应性。
3.本发明胶囊剂型上优点在于可完全气密封入，胶囊强度和膜遮段性高，内容物可长期保持稳定。据测，本发明的胶囊皮膜对氧遮段性超过聚乙烯膜30倍以上。对空气中氧非常稳定，能防止空气氧化吸湿等摄取后，内容物迅速释放，体内利用率，吸收率高。内容物均一性佳，含量偏差非常低。能遮盖某些内容物异臭，异味，尤对一些功能性健康食品，医药品应用较合适。因其与一般食品不同，异味，异臭成份多。胶囊皮膜的味，色，香，透明度，光泽性均可自由选择，与其他圆形物制品相比，外观光泽好，引人注目。
具体实施方式：
实施例1：
一种生发黑发胶囊的制备方法，该方法包括如下步骤：
一种生发黑发胶囊的制备方法，该方法包括如下步骤：
（1）中药材原料准备，按重量份数取制首乌5重量份、生地3重量份、熟地3重量份、侧柏叶3重量份、墨旱莲2重量份、女贞子2重量份、菟丝子2重量份、肉苁蓉2重量份、蛹虫草2重量份、淫羊藿2重量份、黄芪2重量份、黄精2重量份、丹参2重量份、甘草1重量份、干姜4重量份进行粉碎制成混合药材粉末；
（2）浸泡：将步骤（1）中制成的混合药材粉末加入乙醇、乙酸乙酯，加入的量为每重量份混合药材粉末加入10重量份乙醇和3重量份乙酸乙酯，温度控制在25±2℃，浸泡6-8天后进行固液分离并收集滤液；
（3）对步骤（2）中固液分离后的滤渣重新加入乙醇和乙酸乙酯，加入量为每重量份滤渣加入1重量份乙醇和1重量份乙酸乙酯，浸泡1天，温度控制在25±2℃，再进行固液分离并收集滤液；
（4）合并两次滤液，回收乙醇、乙酸乙酯，所述回收乙醇、乙酸乙酯是在真空旋转蒸发器温度控制在40℃之下进行；
（5）回收溶剂至剩余滤液量为合并两次滤液量的10%时，再按照剩余滤液的1:1添加乙醇来置换乙酸乙酯，再低温回收溶剂至合并两次滤液量的10%；
（6）混合赋形剂，加入微晶纤维素，充分搅匀，微晶纤维素加入量是总药材量的10%；
（7）脱除溶媒干燥，在真空烘箱中，-0.1MPA的真空中，温度控制在40℃下，干燥至结晶；
（8）制备胶囊膜皮，所述的胶囊膜皮的制备方法如下：
a.按重量份数取纯化水45-56份、肌醇磷酸3-5份、海藻酸钠1-3份，充分搅拌混合；
b.向步骤a的混合物中加入蜂蜡3～5份、蜂胶粉15-22份、麦芽糖醇4-9份，明胶36-47份充分搅拌混合；
c.将步骤b中制备的混合物在45～53℃的温度下进行化胶6-8小时，得到胶液；
d.将步骤c中制得的胶液制备成胶皮；
（9）将步骤（7）中制备的产品采用步骤（8）中制备的胶皮进行包装成胶囊并入库。
一种用上述方法制备的生发黑发胶囊。每粒装0.3g，【用法用量】口服，一日2-3次，每次2-3粒。建议早晚服用；3个月为一个疗程。
本实施例的提取溶剂选择：
二苯乙烯苷类、梓醇、黄酮类化合物、聚合原花青素在醇类中溶解性较好，而蒽醌类、挥发油常温在水中难溶，所采用溶剂必须选择有机溶剂。溶剂选择必须以低毒性、安全性为前提，通过实验证明，且经过综合评价，选择乙醇、乙酸乙酯作为溶剂提取效果最好。使得药物有效成分溶出度较高、毒性小、成本低、符合先有的提取设备条件。
不同提取工艺比较
| 提取方法 | 优点 | 缺点 |
| 水蒸煮法 | 成本低 | 高温易破坏活性成分 |
| 酸碱法 | 成本低 | 酸碱反应时容易破坏活性成分 |
| 乙醇、乙酸乙酯法 | 工艺温和，能保持活性成分，溶出度高，提取率高 | 需要对于溶媒进行回收，需要真空密闭操作专用设备 |
测定：按照重量份数取制首乌5重量份、生地3重量份、熟地3重量份、侧柏叶3重量份、墨旱莲2重量份、女贞子2重量份、菟丝子2重量份、肉苁蓉2重量份、蛹虫草2重量份、淫羊藿2重量份、黄芪2重量份、黄精2重量份、丹参2重量份、甘草1重量份、干姜4重量份进行粉碎制成混合药材粉末，分别取1000克所述的药材粉末，经过水蒸煮法、酸碱法以及本发明的方法进行提取后，对有效成分进行含量测定，测定方法按照国家药典标准进行测定，测定结果如下：
| 提取方法 | 二苯乙烯苷 | 游离蔥醌 | 梓醇 | 毛蕊花糖苷 | 槲皮苷 |
| 水蒸煮法 | 2.32克 | 0.24克 | 0.56克 | 0.14克 | 0.22克 |
| 酸碱法 | 2.56克 | 0.23克 | 0.76克 | 0.12克 | 0.25克 |
| 本发明的方法 | 3.53克 | 0.42克 | 1.09克 | 0.23克 | 0.39克 |
经过测定可以看出，采用本发明的方法提取以后，各种主要成分的含量，明显高于传统的水蒸煮方法、酸碱方法或者超临界法，达到显著差异。
以上仅是本发明的最佳实施例，本发明的方法包括但不限于上述实施例，本发明的未尽事宜，属于本领域技术人员的公知常识。
Claims (6)
1.一种生发黑发胶囊的制备方法，其特征是：该方法包括如下步骤：
一种生发黑发胶囊的制备方法，该方法包括如下步骤：
（1）中药材原料准备，按重量份数取制首乌5重量份、生地3重量份、熟地3重量份、侧柏叶3重量份、墨旱莲2重量份、女贞子2重量份、菟丝子2重量份、肉苁蓉2重量份、蛹虫草2重量份、淫羊藿2重量份、黄芪2重量份、黄精2重量份、丹参2重量份、甘草1重量份、干姜4重量份进行粉碎制成混合药材粉末；
（2）浸泡：将步骤（1）中制成的混合药材粉末加入乙醇、乙酸乙酯，加入的量为每重量份混合药材粉末加入10重量份乙醇和3重量份乙酸乙酯，温度控制在25±2℃，浸泡6-8天后进行固液分离并收集滤液；
（3）对步骤（2）中固液分离后的滤渣重新加入乙醇和乙酸乙酯，加入量为每重量份滤渣加入1重量份乙醇和1重量份乙酸乙酯，浸泡1天，温度控制在25±2℃，再进行固液分离并收集滤液；
（4）合并两次滤液，回收乙醇、乙酸乙酯，所述回收乙醇、乙酸乙酯是在真空旋转蒸发器温度控制在40℃之下进行；
（5）回收溶剂至剩余滤液量为合并两次滤液量的10%时，再按照剩余滤液的1:1添加乙醇来置换乙酸乙酯，再低温回收溶剂至合并两次滤液量的10%；
（6）混合赋形剂，加入微晶纤维素，充分搅匀，微晶纤维素加入量是总药材量的10%；
（7）脱除溶媒干燥，在真空烘箱中，-0.1MPA的真空中，温度控制在40℃下，干燥至结晶；
（8）制备胶囊膜皮，所述的胶囊膜皮的制备方法如下：
a.按重量份数取纯化水45-56份、肌醇磷酸3-5份、海藻酸钠1-3份，充分搅拌混合；
b.向步骤a的混合物中加入蜂蜡3～5份、蜂胶粉15-22份、麦芽糖醇4-9份，明胶36-47份充分搅拌混合；
c.将步骤b中制备的混合物在45～53℃的温度下进行化胶6-8小时，得到胶液；
d.将步骤c中制得的胶液制备成胶皮；
（9）将步骤（7）中制备的产品采用步骤（8）中制备的胶皮进行包装成胶囊并入库。
2.根据权利要求1所述的生发黑发胶囊的制备方法，其特征是：步骤（1）中所述的粉碎制成混合药材粉末，粉碎后药材粉末的粒径75±10微米。
3.根据权利要求1所述的生发黑发胶囊的制备方法，其特征是：步骤（2）中所述的浸泡过程中，需要加以搅拌达到传质置换的作用，搅拌每天不少于1小时。
4.根据权利要求1所述的生发黑发胶囊的制备方法，其特征是：步骤（3）中所述的浸泡过程中需要加以搅拌达到传质置换的作用，搅拌不少于1小时。
5.根据权利要求1所述的生发黑发胶囊的制备方法，其特征是：步骤（5）中所述的低温回收溶剂的温度不超过40℃。
6.一种用上述方法制备的生发黑发胶囊。
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| CN115737512A (zh) * | 2022-11-18 | 2023-03-07 | 深圳市熙雨中医药研究有限公司 | 一种具有防脱生发功能的精华液及其制备方法 |
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