CN105920447A - 一种抗抑郁的保健品及其制备方法 - Google Patents
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Abstract
本发明提供了一种抗抑郁的保健品，由下列原料药按重量份计制成：黄花5‑50份、酸枣仁5‑20份、百合5‑30份、白芍5‑20份、当归5‑50份、麦芽5‑20份、藿香5‑30份；七味中药材大多为药食同源药材，无毒安全，各味药药效相辅相成，对治疗抑郁症相关性疾病具有显著的疗效；本发明还提供了一种抗抑郁的饮料，其制备方法简单、食用安全、对抗抑郁具有显著的作用，并且非常适合工业化大生产。
Description
技术领域
本发明属于中药技术领域，具体涉及一种抗抑郁的保健品及其制备方法。
背景技术
抑郁症，属于情感障碍性疾病，是由各种原因引起的以抑郁为主要症状的一组心理障碍或情感性障碍，临床表现为情绪低落、兴趣减退、自我评价过低、对前途悲观失望、不愿主动与人交往等。常伴有相应的思维和行为改变，部分患者会出现幻觉和妄想，严重者伴有自杀行为，严重影响人们的生活质量。多数病例有反复发作的倾向，每次发作大多数可以缓解，部分可有残留症状或转为慢性。
抑郁症至少有10％的患者可出现躁狂发作，此时应诊断为双相障碍。另外我们常说的抑郁症，其实是指临床上的重症抑郁症(major depression)，人群中有16％的人在一生的某个时期会受其影响。患抑郁症除了付出严重的感情和社会代价之外，经济代价也是巨大的。据世界卫生组织统计,抑郁症已成为世界第4大疾患,预计到2020年,可能成为仅次于冠心病的第二大疾病。
随着社会生活节奏的加快，工作压力的增大，抑郁症的发病率呈逐年上升趋势，抑郁症的早期诊断及治疗，越来越受到重视。
目前，现代医学多用西药来治疗抑郁症，但西药治疗周期长、毒副作用大，极大地影响了临床疗效。因此，从中医中药的角度去探讨开发利用传统中药材并制备具有食疗保健作用的产品具有广阔的前景。
发明内容
为了实现本发明的目的，本发明提供了一种抗抑郁的保健品，其特征在于，它是由下列原料药按重量份计制成：黄花5-50份、酸枣仁5-20份、百合5-30份、白芍5-20份、当归5-50份、麦芽5-20份、藿香5-30份；
具体地，上述所述的一种抗抑郁的保健品，它是由下列按重量份计的原料药制成：黄花15-35份、酸枣仁10-15份、百合10-25份、白芍10-15份、当归15-35份、麦芽10-15份、藿香10-25份；
本发明所述的保健品，是将中药材经过本领域常规提取技术提取出活性成分，再与药用辅料或人体可接受的辅料混合，制成各种产品。
所述的保健品可以为片剂、胶囊、糖、饮料等，优选制成液体饮料。
本发明的又一目的是提供了一种抗抑郁的饮料的制备方法，其特征在于：包括以下步骤：
(1).将重量配比的黄花、酸枣仁、百合、白芍、当归、麦芽、藿香加水煎煮，3-4小时，过滤，滤液浓缩至浸膏，加溶剂调至含醇量65-75％，静置过夜，取沉淀或浓缩液，备用；
(2).在沉淀或/和浓缩液内甜味剂、山梨酸钾，溶解，加焦糖色溶液，静置，离心除去沉淀；
(3).加水，加入香精，加10％磷酸溶液调pH值至5-6，灌装、灭菌，即得抗抑郁饮料成品。
本发明使用的各成分特性及功效如下：
黄花：黄花为百合科、萱草属多年生草本宿根植物的花蕾，黄花性平、味甘、微苦，归肝、脾、肾经；有清热利尿，解毒消肿，止血除烦，宽胸膈，养血平肝，利水通乳，利咽宽胸，清利湿热，发奶等功效；主治眩晕耳鸣、心悸烦闷、小便赤涩、水肿、痔疮便血等病症。
酸枣仁：性味：甘，平；归经：心经；脾经；肝经；胆经；功能：宁心安神；养肝；敛汗。主治：虚烦不眠；惊悸怔忡；体虚自汗、盗汗。
百合：甘凉清润，主入肺心，用于清肺润燥止咳，清心安神定惊，为肺燥咳嗽、虚烦不安所常用。
白芍：性味，苦酸，凉。入肝、脾经。养血柔肝，缓中止痛，敛阴收汗。治胸腹胁肋疼痛，泻痢腹痛，自汗盗汗，阴虚发热。
当归：甘；辛；苦；性温；归肝；心；脾经；具有补血；活血；调经止痛；润燥滑肠之功效。
麦芽：性：平。归脾、胃经、肝经。行气消食，健脾开胃，退乳消胀。主治：食积不消，脘腹胀痛，脾虚食少，乳汗郁积，乳房胀痛，妇女断乳。
藿香：性味：辛，微温；归脾、胃、肺经。芳香化浊，和中止呕，发表解暑。用于湿浊中阻，脘痞呕吐，暑湿表证，湿温初起，发热倦怠，胸闷不舒，寒湿闭暑，腹痛吐泻，鼻渊头痛。
本发明的有益效果在于：
中医认为：情志病是由七情太过，伤及五脏所引起的功能性心理与情感障碍、睡眠障碍以及脏腑生理功能紊乱的一组症状。中医认为强烈的过度的精神刺激和持久的不良心态和情绪是致病的精神因素。本发明根据中医辨证论治，经过大量处方筛选，获得本发明保健品由黄花、酸枣仁、百合、白芍、当归、麦芽、藿香七味中药材组方，具有理气舒心、平肝定气，温补肾阳，宁心安神之功效，七味中药材大多为药食同源药材，无毒安全，各味药药效相辅相成，对治疗抑郁症相关性疾病具有显著的疗效。本发明还提供了一种抗抑郁的饮料，其制备方法简单、实用安全、对抗抑郁具有显著的作用，非常适合工业化大生产。
为对本发明的有益效果作更好的阐述，本发明还列举了部分试验例，旨在说明本发明的技术效果，绝不限定本发明的范围。
试验例：
一、抗抑郁作用动物实验
本实验采用自主活动实验、强迫悬尾和强迫游泳等实验展开对小鼠抑郁样行为观察、分析,通过一系列指标说明本发明保健品抗抑郁的作用。
1.1实验动物及材料
动物：昆明种小鼠，雌雄兼用，体重18-25g，贵阳医学院动物房提供。
药物：(a)本发明保健品(按照实施例1-6的制备方法制得的成品)；
(b)帕罗西汀(购至中美天津史克制药有限公司)；
(c)专利CN201410628764.5，公开的一种内服治疗抑郁的药物制剂，由白术、海松子、当归、山药、旋复花根、钩藤、香附、回心草、黄花菜、神曲、玉竹、黄芩、连翘、厚朴、积雪草、栀子、酸枣仁、刺五加、红景天、蒲公英、柴胡、川芎、决明子、淫羊藿、枳实、桑椹子、郁金制得的制剂。
1.2实验方法
实验分组135只小鼠随机分为9组：每组15只；
试验组1-6分别给药按照实施例1-6的制备方法制得的成品；药物对照组1给药帕罗西汀；药物对照组2给予专利CN201410628764.5公开的方法制得的制剂；正常对照组：不给于药物，正常饲养，分别进行以下三种实验。
1.2.1小鼠自主活动实验小鼠连续灌胃7天,于末次灌胃1h后放入XZC-4A小动物自主活动测定仪(山东省医学科学院制造)中,适应3min后,观察5min内的活动次数，并记录结果，见表1。
1.2.2小鼠悬尾实验小鼠连续灌胃7天,于末次灌胃1h后将小鼠尾端2cm处固定于水平面上,使其呈倒挂状态,头部离台面约30cm,四周以板隔离动物视线,记录小鼠在6min内的不动时间，见表2。
1.2.3小鼠强迫游泳实验剔除预实验不合格者,连续灌胃7天,并于末次灌胃后1h,将小鼠放入直径22cm，水深10cm的水桶,水温25℃(同预实验条件一致)，适应2min,累计后4min内小鼠的不动时间，见表3。
1.4统计学处理所有实验结果均以x±s表示,采用SPSS统计软件进行单因素方差分析和秩和检验。
2.结果
2.1本发明保健品对小鼠自主活动的影响
本发明保健品组与药物对照组、正常对照组相比均无统计学意义,结果见表1。
表1本发明保健品对小鼠自主活动的影响(x±s)
| 序号 | 组别 | 动物(只) | 5min自主活动时间(s) |
| 1 | 正常对照组 | 15 | 143.56±24.35 |
| 2 | 实施例1(低剂量组) | 15 | 146.81±36.23 |
| 3 | 实施例2 | 15 | 157.47±32.41 |
| 4 | 实施例3 | 15 | 159.78±34.29 |
| 5 | 实施例4 | 15 | 160.17±32.41 |
| 6 | 实施例5 | 15 | 158.22±33.15 |
| 7 | 实施例6(高剂量组) | 15 | 160.29±33.12 |
| 8 | 药物对照组1(帕罗西汀) | 15 | 156.67±32.44 |
| 9 | 药物对照组2(专利) | 15 | 150.67±38.23 |
2.2本发明保健品对小鼠悬尾实验不动时间的影响
本发明保健品均能明显缩短悬尾实验中小鼠不动时间(P<0.05或0.01),并且优于对照试验组，结果见表2。
表2本发明保健品对小鼠悬尾实验不动时间的影响(x±s)
| 序号 | 组别 | 动物(只) | 6min自主活动时间(s) |
| 1 | 正常对照组 | 15 | 115.11±45.35 |
| 2 | 实施例1(低剂量组) | 15 | 81.33±40.10 |
| 3 | 实施例2 | 15 | 63.93±42.23●● |
| 4 | 实施例3 | 15 | 60.33±45.10●● |
| 5 | 实施例4 | 15 | 61.57±43.02●● |
| 6 | 实施例5 | 15 | 62.63±41.23●● |
| 7 | 实施例6(高剂量组) | 15 | 60.13±46.22●● |
| 8 | 药物对照组1(帕罗西汀) | 15 | 63.33±44.10●● |
| 9 | 药物对照组2(专利) | 15 | 71.93±46.32● |
与正常对照组比较,●P<0.05,●●P<0.01,下表同。
2.3本发明保健品对小鼠强迫游泳实验不动时间的影响
本发明保健品组均能明显缩短悬尾实验中小鼠不动时间，高剂量组效果更好，结果见表3。
表3本发明保健品对小鼠强迫游泳实验不动时间的影响(x±s)
| 序号 | 组别 | 动物(只) | 6min自主活动时间(s) |
| 1 | 正常对照组 | 15 | 82.33±63.24 |
| 2 | 实施例1(低剂量组) | 15 | 50.25±43.44 |
| 3 | 实施例2 | 15 | 36.11±40.82 |
| 4 | 实施例3 | 15 | 34.33±43.24 |
| 5 | 实施例4 | 15 | 33.25±43.44 |
| 6 | 实施例5 | 15 | 35.45±41.42 |
| 7 | 实施例6(高剂量组) | 15 | 33.45±47.42 |
| 8 | 药物对照组1(帕罗西汀) | 15 | 35.25±48.44 |
| 9 | 药物对照组2(专利) | 15 | 52.45±54.42 |
小鼠悬尾实验和强迫游泳实验是行为药理实验中用于筛选和观察抗抑郁药物的可靠的实验方法。以上实验数据表明，与药物对照组及正常对照组实验相比，本发明保健品组均能明显缩短悬尾及强迫游泳实验中小鼠的不动时间,并且对其自主活动无显著影响,并且试验组2-5效果最优，表明本发明保健品具有较好的抗抑郁作用,且无中枢兴奋性作用。
具体实施方式：
实施例1：抗抑郁饮料(低组分)
处方：黄花4g、酸枣仁3g、百合3.5g、白芍3g、当归4g、麦芽3g、藿香3.5g；
制备方法：
(1).将配方量的黄花、酸枣仁、百合、白芍、当归、麦芽、藿香混合加水煎煮，3小时，过滤，滤液浓缩至浸膏，加溶剂调至含醇量65-75％，静置过夜，取沉淀或浓缩液，备用；
(2).在浓缩液内加入甜味剂、山梨酸钾，溶解，加1％焦糖色溶液，静置，离心除去沉淀；
(3).加水，加入香精，加10％磷酸溶液调pH值至5-6，灌装、灭菌，制得100瓶饮料，每瓶200ml。
实施例2：抗抑郁片剂
处方：黄花5g、酸枣仁20g、百合5g、白芍20g、当归5g、麦芽20g、藿香5g；
制备方法：
(1).将配方量的黄花、酸枣仁、百合、白芍、当归、麦芽、藿香混合加水煎煮，4小时，过滤，滤液浓缩，加溶剂调至含醇量65-75％，静置过夜，取上清液，备用；
(2).将上清液浓缩至60℃时相对密度为1.1-1.2，干燥后粉碎，加入片剂常用辅料，混合、制粒、干燥、压片，制成片剂100片。
用法用量：口服，每次1片，每日1次。
实施例3：抗抑郁饮料
处方：黄花35g、酸枣仁10g、百合25g、白芍10g、当归35g、麦芽10g、藿香25g。
制备方法：
(1).将配方量的黄花、酸枣仁、百合、白芍、当归、麦芽、藿香混合加水煎煮，4小时，过滤，滤液浓缩至浸膏，加溶剂调至含醇量65-75％，静置过夜，取沉淀或浓缩液，备用；
(2).在浓缩液内加入甜味剂、山梨酸钾，溶解，加1％焦糖色溶液，静置，离心除去沉淀；
(3).加水，加入香精，加10％磷酸溶液调pH值至6，灌装、灭菌，制得100瓶饮料，每瓶200ml。
实施例4：抗抑郁胶囊
处方：黄花15g、酸枣仁15g、百合10g、白芍15g、当归15g、麦芽15g、藿香10g。
制备方法：
(1).将配方量的黄花、酸枣仁、百合、白芍、当归、麦芽、藿香混合加水煎煮，4小时，过滤，滤液浓缩，加溶剂调至含醇量65-75％，静置过夜，取上清液，备用；
(2).将上清液浓缩至60℃时相对密度为1.1-1.2，干燥后粉碎，加入胶囊剂常用辅料，混合、制粒、干燥、装入胶囊，制成胶囊剂100粒。
用法用量：口服，每次1粒，每日1次。
实施例5：抗抑郁硬糖
处方：黄花50g、酸枣仁5g、百合30g、白芍5g、当归50g、麦芽5g、藿香30g。
制备方法：
(1).将准确称取处方量的黄花、酸枣仁、百合、白芍、当归、麦芽、藿香混合加水煎煮，4小时，过滤，滤液浓缩至浸膏，加溶剂调至含醇量65-75％，静置过夜，取上清液，备用；
(2).将上清液浓缩至60℃时相对密度为1.1-1.2，加入甜味剂、糖果常用辅料，成型，制成硬糖200粒；
实施例6：抗抑郁饮料(高组分)
处方：黄花55g、酸枣仁25g、百合35g、白芍25g、当归55g、麦芽25g、藿香35g。
制备方法：
(1).将准确称取处方量的黄花、酸枣仁、百合、白芍、当归、麦芽、藿香混合加水煎煮，4小时，过滤，滤液浓缩至浸膏，加溶剂调至含醇量65-75％，静置过夜，取沉淀或浓缩液，备用；
(2).在浓缩液内加入甜味剂、山梨酸钾，溶解，加1％焦糖色溶液，静置，离心除去沉淀；
(3).加水，加入香精，加10％磷酸溶液调pH值至6，灌装、灭菌，制得100瓶饮料，每瓶200ml。
Claims (5)
1.一种抗抑郁的保健品，其特征在于，它是由下列原料药按重量份计制成：黄花5-50份、酸枣仁5-20份、百合5-30份、白芍5-20份、当归5-50份、麦芽5-20份、藿香5-30份。
2.根据权利要求1所述的一种抗抑郁的保健品，其特征在于：它是由下列按重量份计的原料药制成：黄花15-35份、酸枣仁10-15份、百合10-25份、白芍10-15份、当归15-35份、麦芽10-15份、藿香10-25份。
3.根据权利要求1或2所述的保健品，是将中药材经过本领域常规提取技术提取出活性成分，再与药用辅料或人体可接受的辅料混合，制成各种产品。
4.根据权利要求3所述的保健品，其特征在于：产品为片剂、胶囊、糖、饮料。
5.一种抗抑郁的饮料的制备方法，其特征在于：包括以下步骤：
(1).将上述所述的重量份黄花、酸枣仁、百合、白芍、当归、麦芽、藿香的中药材加水煎煮，3-4小时，过滤，滤液浓缩至浸膏，加溶剂调至含醇量65-75％，静置过夜，取沉淀或浓缩液，备用；
(2).在沉淀或/和浓缩液内甜味剂、山梨酸钾，溶解，加焦糖色溶液，静置，离心除去沉淀；
(3).加水，加入香精，加10％磷酸溶液调PH值至5-6，灌装、灭菌，即得抗抑郁饮料成品。
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