CN115025180B - 一种养血生发药物组合物 - Google Patents
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Abstract
本发明公开了一种养血生发药物组合物，该组合物由以下重量份的组分制成：熟地黄200‑250重量份、制何首乌150‑200重量份、当归50‑80重量份、川芎30‑50重量份、五加皮100‑120重量份、天麻30‑50重量份、白芍30‑60重量份、桑椹40‑60重量份。本发明养血生发药物组合物采用中国传统药食两用的中药材，原料来源易得，服用量少。本发明治疗脱发具有全面兼顾、安全有效、消费者接受程度高等优势，在养血生化产品方面具有良好的前景。
Description
技术领域
本发明属于中药技术领域，具体涉及一种养血生发药物组合物。
背景技术
脱发是一种常见现象，分为生理性脱发和病理性脱发两种。生理性脱发指头发正常的脱落，而病理性脱发则是一种常见的毛发疾病。据不完全统计，目前中国约有2.5亿脱发人群，其中男女比例约为3∶2，近年来随着社会的进步和人们工作生活节奏的加快，脱发现象已呈现普遍化早龄化的趋势。脱发虽不属于严重疾病，但对人们的精神状态和心理健康会产生较大的影响。脱发现象已经成为现代人的一项重要烦恼，防治脱发的相关产品也是市场的热点。
中医认为，发为血之余。人体如果长期气虚血亏，肝肾亏虚，则容易造成头发枯黄易脱落。所以，防治脱发应从补气养血着手，补肝肾配方，通过中医药调理人体内阴阳平衡。目前市场也有在产生发的中药，其中疗效公认的是养血生发胶囊，但随着近年来对中药不良反应认识水平的提高，对该组方中羌活、菟丝子等药材的毒副反应有较多报道，长期服用有肝肾损伤等潜在风险。
因此，开发一种安全、有效的养血生发中药组合物仍是现代中医药研究的热点问题。
发明内容
本发明的目的是克服上述不足之处，采用药食两用且可用于保健食品的药材，提供一种方便服用并且安全有效的养血生发药物组合物。
本发明另一目的是提供上述养血生发药物组合物的制备方法。
本发明还有一个目的是提供上述组合物在制备养血生发的药物中的应用。
本发明的目的是通过以下方式实现的：
一种养血生发药物组合物，该组合物由以下重量份的组分制成：熟地黄200-250重量份、制何首乌150-200重量份、当归50-80重量份、川芎30-50重量份、五加皮100-120重量份、天麻30-50重量份、白芍30-60重量份、桑椹40-60重量份。
优选上述组合物由以下重量份的组分制成：熟地黄200重量份、制何首乌200重量份、当归80重量份、川芎50重量份、五加皮100重量份、天麻30重量份、白芍60重量份、桑椹60重量份。
上述药物组合物可与药学可接受的辅料制成制剂，优选制剂为颗粒剂、片剂、胶囊剂、丸剂。
上述养血生发药物组合物的制备方法包括以下步骤：将当归、川芎、制何首乌、天麻粉碎成细粉；其余四味混合加水煎煮三次，第一、二次每次2小时，第三次1小时，合并煎液，滤过，滤液浓缩，与上述细粉混匀。
方中，熟地黄补血滋阴，益精填髓为君药；制何首乌养精血、乌须发；当归补血，活血，为血中之气药；白芍养血调经，敛阴止汗，柔肝止痛，平抑肝阳；五加皮祛风除湿，补益肝肾，倶为臣药；川芎行气活血；天麻祛风通络；桑椹滋阴补血，生津润燥，以上为佐药。诸药物相配伍，可达滋阴养血、补益肝肾、兼顾脾胃，从而生发防脱。
上述组合物在制备养血生发的药物中应用具有显著的效果。
与现有技术比较本发明的有益效果：本发明养血生发药物组合物采用中国传统药食两用的中药材，原料来源易得，服用量少。本发明治疗脱发具有全面兼顾、安全有效、消费者接受程度高等优势，在生产养血生发产品方面具有良好的前景。
具体实施方式
以下通过具体实施例对本发明进行进一步解释说明：
实施例1
组方：熟地黄200重量份、制何首乌200重量份、当归80重量份、川芎50重量份、五加皮100重量份、天麻30重量份、白芍60重量份、桑椹60重量份。
制备方法：将当归、川芎、制何首乌、天麻粉碎成细粉；其余四味混合加水煎煮三次，第一、二次每次2小时，第三次1小时，合并煎液，滤过，滤液浓缩，与上述细粉混匀。
实施例2
组方：熟地黄220重量份、制何首乌180重量份、当归60重量份、川芎40重量份、五加皮120重量份、天麻40重量份、白芍40重量份、桑椹40重量份。
制备方法：将当归、川芎、制何首乌、天麻粉碎成细粉；其余四味混合加水煎煮三次，第一、二次每次2小时，第三次1小时，合并煎液，滤过，滤液浓缩，与上述细粉混匀，制粒。
对比例1
组方：熟地黄200重量份、制何首乌120重量份、当归100重量份、川芎50重量份、天麻30重量份、五加皮100重量份、白芍60重量份、桑椹60重量份。
制备方法：将当归、川芎、制何首乌、天麻粉碎成细粉；其余四味混合加水煎煮三次，第一、二次每次2小时，第三次1小时，合并煎液，滤过，滤液浓缩，与上述细粉混匀，制粒。
对比例2
组方：熟地黄250重量份、制何首乌200重量份、当归30重量份、川芎10重量份、天麻30重量份、五加皮100重量份、白芍60重量份、桑椹60重量份。
制备方法：将当归、川芎、制何首乌、天麻粉碎成细粉；其余四味混合加水煎煮三次，第一、二次每次2小时，第三次1小时，合并煎液，滤过，滤液浓缩，与上述细粉混匀，制粒。
试验例1
促进毛发生长作用试验
1.小鼠脱毛模型建立
健康成年雌性SD小鼠50只，自由取食、饮水，每天给予光照12h，进行5天的适应性饲养后，开始实验操作将松香与石蜡按1∶1混合加热溶化，冷却至合适的温度后(以免烫伤小鼠皮肤)，在小鼠麻醉条件下均匀涂于其背部，涂抹面积约为2cm×3cm；待凝固变硬后剥去，拔掉所有的终止期毛发，诱导高度同步的生长期毛囊的发育，该毛囊与自发形成的生长期毛囊在形态上无差别。
2.试验动物分组及给药
选取脱毛区光滑且无皮肤破损的小鼠，随机分为5组，每组10只，具体分组情况见表1。
组1：空白对照组；组2：实施例1产品；组3：对比例1产品；
组4：对比例2产品：组5：对比例3产品：市售养血生发胶囊(含熟地黄、当归、羌活、木瓜、川芎、白芍、菟丝子、天麻、制何首乌)
表1试验分组情况
3.试验小鼠从脱毛后第2天起对其进行灌胃给药，每天1次，连续给药15天。
4.结果与分析
4.1促进毛发生长作用试验结果及分析
实施例1组在给药第5天时，在灯下仔细观察可发现其背部有少量细小的绒毛出现；对比例2组和对比例3组小鼠在给药第6天时，可发现其背部也出现少量细小的绒毛；而空白对照组和对比例1组则在第7天出现细小绒毛；实施例1组在给药后第7天时细小绒毛覆盖量明显多于其他4组；在第8天，实施例1组小鼠毛发生长良好，其他3组出现较明显毛发；第10天，5组小鼠毛发皆生长良好，但实施例1组和对比例3组覆盖量明显多于其他3组；第11天，实施例1组毛发生长最明显；第12天，空白对照组小鼠发生长与其他3组基本相同，实施例1组毛发覆盖量依旧最显著。由试验结果可以看出，实施例1组对促进毛发生长作用较明显，与其他各组比较，效果有显著性差别。
表2试验结果
注:“－”代表无毛发生长；“+”代表少量细小绒毛出现；“++”代表代表较明显毛发出现；“+++”代表毛发生长良好；“++++”代表毛发生长同正常小鼠无异；“*”代表所述状况显著。
通过建立小鼠松香石蜡脱毛模型对实施例1组、对比例1组、对比例2组和对比例3组对正常毛发生长的促进作用结果可以看出，实施例1组对毛发生长促进作用显著。
试验例2
一、急性经口毒性试验
1.实验动物：SPF级健康小鼠20只，雌雄各半。
2.剂量选择：用最大耐受量法进行小鼠急性毒性试验，剂量为15000mg/kg·bw。试验前动物禁食16小时，自由饮水，实施例1样品用无菌水配制，配制浓度为0.25g/ml，按最大灌胃量灌胃给样，间隔4小时三次给样，连续观察14天，记录中毒表现及死亡情况。
3.结果：
试验观察期间，各组动物饮食和活动正常，生长良好，未见任何中毒表现，无死亡。结果见表3
表3对急性经口毒性试验的影响
经口给予动物实施例1样品后未见明显中毒表现，对动物体重增长无明显影响，观察期内无动物死亡。实施例1产品雌、雄性小鼠急性经口MTD大于15000mg/kg·bw，根据急性毒性剂量分级标准，该样品属无毒级。
二、30天喂养试验
1.实验动物：SPF级健康大鼠80只，雌雄各半。按体重随机分为对照组、低剂量组、中剂量组、高剂量组，每组20只，雌雄各半。
2.试验剂量：实施例1样品推荐剂量为3.6g/人/日，设1.8g/kg·bw/d、3.90g/kg·bw/d、6.0g/kg·bw/d三个剂量组，分别相当于人体推荐剂量的30倍、65倍、100倍，另设一个空白对照组0g/kg·bw/d。连续喂养30天。
3.试验方法
3.1一般情况观察给药后每周进行1次体重测定和进食量统计；给药期间每天观察动物精神状态、食欲、行为活动、排便情况等。
3.2血液学检查进行血常规指标检测。
3.3血液生化指标检测进行血液生化指标检测。
4结果
4.1一般情况检查试验期间大鼠的精神状态、皮肤、毛发、眼睛、黏膜、粪便、呼吸和四肢活动等均无异常变化，也无大鼠死亡，实施例1组和对照组无差别。对大鼠的体重增加无显著性影响(P＞0.05)，结果见表4
表4对大鼠体重的影响
4.2血液学检查实施例1给药组各组大鼠血常规检测结果与对照组大鼠相比均无显著差异(P＞0.05)，结果见表5。
表5对大鼠血常规的影响
续表5实施例1对大鼠血常规的影响
4.3血液生化指标检测
实施例1给药组各组大鼠血液生化指标结果与对照组大鼠相比均无显著差异(P＞0.05)，结果见表6。
表6实施例1对大鼠部分血生化的影响
续表6实施例1对大鼠部分血生化的影响
结论：大鼠连续喂养30天本发明实施例1药物组合物，精神状态、皮肤、毛发、眼睛、黏膜、粪便、呼吸和四肢活动均无异常情况，各剂量组均未出现中毒和死亡情况；大鼠血液指标和生化指标是评价药物毒性的常用指标，可在一定程度上反映药物对动物脏器的影响程度。试验结果显示低、中、高3个药物剂量组的血液指标和生化指标与对照组无显著性差异(P＞0.05)。
Claims (6)
1.一种养血生发药物组合物，其特征在于该组合物由以下重量份的组分制成：熟地黄200-250重量份、制何首乌150-200重量份、当归50-80重量份、川芎30-50重量份、五加皮100-120重量份、天麻30-50重量份、白芍30-60重量份、桑椹40-60重量份。
2.根据权利要求1所述的养血生发药物组合物，其特征在于该组合物由以下重量份的组分制成：熟地黄200重量份、制何首乌200重量份、当归80重量份、川芎50重量份、五加皮100重量份、天麻30重量份、白芍60重量份、桑椹60重量份。
3.根据权利要求1或2所述的养血生发药物组合物，其特征在于该组合物与药学可接受的辅料制成制剂。
4.根据权利要求3所述的养血生发药物组合物，其特征在于所述的制剂为颗粒剂、片剂、胶囊剂、丸剂。
5.一种权利要求1或2所述的养血生发药物组合物的制备方法，其特征在于该方法包括以下步骤：将当归、川芎、制何首乌、天麻粉碎成细粉；其余四味混合加水煎煮三次，第一、二次每次2小时，第三次1小时，合并煎液，滤过，滤液浓缩，与上述细粉混匀。
6.权利要求1或2所述的组合物在制备养血生发的药物中的应用。
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| CN103751564A (zh) * | 2011-11-08 | 2014-04-30 | 郭德胜 | 一种治疗脱发的中药配方 |
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