CN108310097A - 一种用于抑郁症的药物制剂 - Google Patents
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Abstract
本发明属于药物制备技术领域，公开了一种用于抑郁症的药物制剂，其包括盐酸米安色林、人参提取物以及陈皮提取物。本发明采用人参和陈皮两种药物提取物能够与盐酸米安色林产生协同效果，提高了药效。
Description
技术领域
本发明属于药物制备技术领域，具体涉及一种用于抑郁症的药物制剂。
背景技术
抑郁症或抑郁障碍是全球性主要精神卫生问题，其病因很复杂，至今尚未完全阐明，随着现代社会竟争日趋加剧，人们的心理压力不断增加，情志性疾病成为当代的主要疾病，世界卫生组织指出二十一世纪人们面临的最大疾病是精神疾病。WHO估计，全球患抑郁性疾病者有1.2亿到2亿人。1996年，WHO公布的一项关于“疾病负担”的调查表明：以因病造成伤残(功能缺损)统计，抑郁症占第二位，占全部疾病总负担的6.2％。这类病人情绪低落，联想缓慢，言语动作减少，内心体验十分痛苦，常有轻生念头和自杀行为，据报导国外仅抑郁症自杀死亡率就高达15％。抑郁症终生患病率为6.1-9.5％，约13-20％的人一生曾有过一次或一次以上抑郁体验。随着社会的发展、生活节奏加快，抑郁症呈逐年增长，估计在25年后，将占疾病总负担10％左右。
抑郁症作为一种发病率较高的精神障碍，药物治疗是主要的治疗方法。传统异环类抗抑郁药治疗指数窄、耐受性差，合并用药时易发生相互作用，影响药效及病人依从性；新型抗抑郁药，如选择性五羟色胺再摄取抑制剂相对副作用较小、耐受性较好，但价格较为昂贵。为寻求更安全、有效、不良反应更小、价格低廉的抗抑郁药，越来越多的研究者将眼光投向资源丰富的天然植物，尤其是中草药方面。
CN201510336203和CN201510336115均采用西药盐酸米安色林为主辅以中草药制成复方药物来治疗抑郁症，其减少了西药产生的副作用以及依赖性，疗效显著，但是中药组份较多，药理作用不明确，而且增大了原料获取的难度，一旦一种或者少数几种原料供应不足，企业会停产，从而造成较大的损失。
选择合适的中草药与西药进行配伍，可以减少副作用和不良反应，降低对西药的依赖。人参具有大补元气、补脾益肺、安神增智等功效。人参的主要有效成分是人参皂甙，含量约为4％，对中枢神经系统、免疫系统、心血管系统、内分泌系统、血液系统、延缓衰老等多方面均具有一定的药理作用。陈皮为芸香科植物橘及其栽培变种的干燥成熟果皮，陈皮提取物中含有丰富黄酮类物质，具有抗氧化、消除自由基抑菌等功效，还能提高抑郁症患者的认知功能，改善非快速眼动相睡眠。
发明内容
为了克服现有技术的缺陷，本发明提供了一种用于抑郁症的药物制剂。
为实现上述目的，本发明采用的技术方案如下：
一种用于抑郁症的药物制剂，其包括盐酸米安色林、人参提取物以及陈皮提取物。
进一步地，
所述药物制剂按照如下方法制备而得：
分别称取盐酸米安色林30g、人参提取物5g、陈皮提取物5g、淀粉42g、微晶纤维素14g、羧甲淀粉钠3g，过80目筛，混匀，然后加入10%聚维酮K30乙醇液 28g，20目筛制粒，55-60℃烘干至水分含量为3.0%，20目筛整粒，加硬脂酸镁1.3g，压片制成1000片，包薄膜衣即得。
进一步地，
所述人参提取物的制备方法包括：将人参投入到粉碎机中粉碎，过100目筛，然后添加到10倍重量的水中，加热至65℃，保温1小时，收集滤液；将滤液置于真空浓缩机内，真空浓缩到滤液体积的三分之一；加入酒精，使得浓缩液中的酒精含量达75%（v/v），静置1小时，过滤收集滤液，滤液采用减压旋转蒸发去除乙醇,低温干燥得到人参提取物。
进一步地，
所述陈皮提取物的制备方法包括：取陈皮，粉碎，过200目筛，得到陈皮粉，置于反应釜中，然后添加五倍重量的85%的乙醇浸提三次，每次6h，然后合并三次浸提液，减压浓缩至无醇，最后低温冷冻干燥，得到陈皮提取物。
本发明的立足点以及有益效果主要包括但是并不限于以下几个方面：
本发明配方合适，通过添加两种中草药提取物和盐酸米安色林配伍，提高了药效，同时还可以根据药效减少盐酸米安色林的用量，从而降低西药产生的毒副作用；本发明制成的片剂剂型大小合适，外观平整光滑，成本低，硬度、崩解较好，质量稳定；本发明通过多因素分析以及具体试验发现，采用人参和陈皮的提取物与盐酸米安色林进行配伍，协同性能好，避免采用多种中药与盐酸米安色林进行配伍，成本低廉，药理作用相对清晰，同时避免了由于大量原料种类中的一种或者几种原料药断货，造成的生产停滞；人参采用加热水提工艺，能够获得含量较高的皂苷类物质；陈皮采用简易的乙醇浸提工艺，较为简单，提取物中含有大量黄酮类物质。
具体实施方式
为了使本技术领域的人员更好地理解本申请中的技术方案，下面将结合本申请具体实施例，对本发明进行更加清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都应当属于本发明保护的范围。
实施例1
一种用于抑郁症的药物制剂，其按照如下方法制备而得：
分别称取盐酸米安色林30g、人参提取物5g、陈皮提取物5g、淀粉42g、微晶纤维素14g、羧甲淀粉钠3g，过80目筛，混匀，然后加入10%聚维酮K30乙醇液 28g，20目筛制粒，55-60℃烘干至水分含量为3.0%，20目筛整粒，加硬脂酸镁1.3g，压片制成1000片，包薄膜衣即得。
所述人参提取物的制备方法包括：将人参投入到粉碎机中粉碎，过100目筛，然后添加到10倍重量的水中，加热至65℃，保温1小时，收集滤液；将滤液置于真空浓缩机内，真空浓缩到滤液体积的三分之一；加入酒精，使得浓缩液中的酒精含量达75%（v/v），静置1小时，过滤收集滤液，滤液采用减压旋转蒸发去除乙醇,低温干燥得到人参提取物；其中皂苷类化合物的含量为75.1%；
所述陈皮提取物的制备方法包括：取陈皮，粉碎，过200目筛，得到陈皮粉，置于反应釜中，然后添加五倍重量的85%的乙醇浸提三次，每次6h，然后合并三次浸提液，减压浓缩至无醇，最后低温冷冻干燥，得到陈皮提取物；其中，黄酮类化合物含量为37.8%。
对比例1
一种用于抑郁症的药物制剂，其按照如下方法制备而得：
分别称取盐酸米安色林30g、人参提取物10g、淀粉42g、微晶纤维素14g、羧甲淀粉钠3g，过80目筛，混匀，然后加入10%聚维酮K30乙醇液 28g，20目筛制粒，55-60℃烘干至水分含量为3.0%，20目筛整粒，加硬脂酸镁1.3g，压片制成1000片，包薄膜衣即得。
所述人参提取物的制备方法包括：将人参投入到粉碎机中粉碎，过100目筛，然后添加到10倍重量的水中，加热至65℃，保温1小时，收集滤液；将滤液置于真空浓缩机内，真空浓缩到滤液体积的三分之一；加入酒精，使得浓缩液中的酒精含量达75%（v/v），静置1小时，过滤收集滤液，滤液采用减压旋转蒸发去除乙醇,低温干燥得到人参提取物。
对比例2
一种用于抑郁症的药物制剂，其按照如下方法制备而得：
分别称取盐酸米安色林30g、淀粉48g、微晶纤维素18g、羧甲淀粉钠3g，过80目筛，混匀，然后加入10%聚维酮K30乙醇液 28g，20目筛制粒，55-60℃烘干至水分含量为3.0%，20目筛整粒，加硬脂酸镁1.3g，压片制成1000片，包薄膜衣即得。
实施例2
急性毒性实验：首先将实施例1的片剂溶解到生理盐水中，搅拌均匀，浓度控制在0.5mg/mL。选用昆明小鼠40只，雌雄各半，进行急性毒性试验。小鼠随机分为两组，每组20只；实验前禁食12小时，给予实施例1的药液灌胃给药，对照组给予等量生理盐水，按照25ml/kg给药；一天给药2次，给药后连续观察两星期，并记录小鼠的毒性反应及死亡数。实验结果表明：与对照组比较，给药后小鼠未见明显差异，实验连续观察两周，小鼠全身状况、饮食、饮水、体重增长无明显异常。
长期毒性实验：首先将实施例1的片剂溶解到生理盐水中，搅拌均匀，浓度控制在0.1mg/mL。选用昆明小鼠20只，将本发明实施例1的药液按照25ml/kg的剂量对小鼠连续用药15周及停药5周后，给药为每天两次，间隔12小时，结果表明：实施例1对小鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响，小鼠各脏器均无明显改变；说明本发明实施例1的片剂对小鼠长期用药后毒性小，安全性高。
实施例3
试验动物：昆明小白鼠，雄性，体重 20±2g。
一、迫小鼠游泳实验
试验方法： 小鼠120只, 随机分为4组，在实验前12h禁食不禁水饲养, 并在实验前1h移入实验室, 使小鼠适应环境。首先将片剂溶解到生理盐水中，搅拌均匀，浓度控制在0.1mg/mL，然后按照25ml/kg的剂量灌胃给药或生理盐水（空白对照组），1h后将小鼠置于玻璃水缸中游泳(内盛10cm高的水,水温25±1℃)。前2min为小鼠适应游泳, 记录后8min内小鼠游泳停止漂浮不动的累计时间(秒)。统计方法数据以X士S表示,并采用组间t检验。具体结果见表1（注: 与空白对照组比较 ** p< 0.01，* p< 0.05 ; 与对比例2比较，△△P <0.01，△P < 0.05）：
表1
| 组别 | 剂量ml/kg | 不动时间（s） |
| 空白对照组 | 25 | 161.3±33.4 |
| 实施例1 | 25 | 97.8±26.7**△ |
| 对比例1 | 25 | 109.1±33.9*△ |
| 对比例2 | 25 | 118.4±32.7* |
结论：实施例1和对比例1－2均能够明显降低小鼠游泳停止漂浮不动的时间，实施例1在对比例2的基础上，添加了人参和陈皮两种药物提取物，效果明显优于对比例2，也优于添加人参提取物（添加量与实施例1两种提取物添加量之和相同）的对比例1，缩短了10％左右，上述结果提示，实施例1中的人参和陈皮两种药物提取物能够与盐酸米安色林产生协同效果，提高药效。
二、小鼠尾悬挂试验
80只雄性小鼠随机分成4组，每组20只。首先将片剂溶解到生理盐水中，搅拌均匀，浓度控制在0.1mg/mL，然后按照25ml/kg的剂量灌胃给药或生理盐水（空白对照组），每天1次，共3天；然后将小鼠尾部距末端约2cm处用夹子固定，使其呈倒挂状态，四周以板隔离动物视线, 动物为克服不正常体位而挣扎活动，但活动一段时间后，出现间断性不动，显示失望状态。
悬挂时间为6min，累计后4min内的小鼠不动时间，计为失望时间（秒）。统计方法数据以X士S表示,并采用组间t检验。具体结果见表2（注: 与空白对照组比较 ** p< 0.01，*p< 0.05 ; 与对比例2比较，△△P < 0.01，△P < 0.05）：
表2
| 组别 | 剂量ml/kg | 不动时间（s） |
| 空白对照组 | 25 | 113.2±25.7 |
| 实施例1 | 25 | 65.4±17.2**△ |
| 对比例1 | 25 | 78.1±27.4** |
| 对比例2 | 25 | 84.7±20.5* |
结论：如表2所示，实验组1和对比例1与空白对照组相比比较有非常显著性差异，失望时间分别缩短了40％以上、30％以上；对比例2与空白对照组相比比较有显著性差异；实验组1和对比例2比较有显著性差异，失望时间缩短了30％左右。上述结果表明，每一药物组分单独应用时抗抑郁作用都偏弱，实施例1的药物实现的抗抑郁作用是多种成分共同作用的结果。
虽然，上文中已经用一般性说明、具体实施方式及试验，对本发明作了详尽的描述，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)
1.一种用于抑郁症的药物制剂，其包括盐酸米安色林、人参提取物以及陈皮提取物。
2.根据权利要求1所述的药物制剂，其特征在于，所述药物制剂按照如下方法制备而得：
分别称取盐酸米安色林30g、人参提取物5g、陈皮提取物5g、淀粉42g、微晶纤维素14g、羧甲淀粉钠3g，过80目筛，混匀，然后加入10%聚维酮K30乙醇液 28g，20目筛制粒，55-60℃烘干至水分含量为3.0%，20目筛整粒，加硬脂酸镁1.3g，压片制成1000片，包薄膜衣即得。
3.根据权利要求1或2所述的药物制剂，其特征在于，所述人参提取物的制备方法包括：将人参投入到粉碎机中粉碎，过100目筛，然后添加到10倍重量的水中，加热至65℃，保温1小时，收集滤液；将滤液置于真空浓缩机内，真空浓缩到滤液体积的三分之一；加入酒精，使得浓缩液中的酒精含量达75%（v/v），静置1小时，过滤收集滤液，滤液采用减压旋转蒸发去除乙醇,低温干燥得到人参提取物。
4.根据权利要求1或2所述的药物制剂，其特征在于，所述陈皮提取物的制备方法包括：取陈皮，粉碎，过200目筛，得到陈皮粉，置于反应釜中，然后添加五倍重量的85%的乙醇浸提三次，每次6h，然后合并三次浸提液，减压浓缩至无醇，最后低温冷冻干燥，得到陈皮提取物。
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