CN105688066A - 一种用于精神病的制剂及其制备方法 - Google Patents
一种用于精神病的制剂及其制备方法 Download PDFInfo
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- CN105688066A CN105688066A CN201610154694.3A CN201610154694A CN105688066A CN 105688066 A CN105688066 A CN 105688066A CN 201610154694 A CN201610154694 A CN 201610154694A CN 105688066 A CN105688066 A CN 105688066A
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Abstract
本发明属于医药技术领域,公开了一种用于精神病的制剂,其按照如下方法制备而得:取中药提取物15kg,氯氮平15kg,淀粉20kg,糊精20kg,微晶纤维素2kg,50%乙醇27kg,硬脂酸镁1kg,按照常规方法造粒,制备片剂100万片。本发明制剂治疗效果优于常规药物氯氮平片,降低氯氮平的用量,毒副作用小,应用前景广阔。
Description
技术领域
本发明属于医药技术领域,具体涉及一种用于精神病的制剂及其制备方法。
背景技术
精神病指的是大脑机能活动发生率乱,导致认识、情感、行为和意志等精神活动不同程度障碍的疾病的总称。致病因素有多方面:先天遗传、个性特征及体质因素、器质因素、社会性环境因素等。许多精神病人有妄想、幻觉、错觉、情感障碍、哭笑无常、自言自语、行为怪异、意志减退,绝大多数病人缺乏自知力,不承认自己有病,不主动寻求医生的帮助。普通人也存在不承认自己有病现象,所以不能把缺乏自知力和不承认自己有病作为确定精神病的依据。常见的精神病有:精神***症、躁狂抑郁性精神病、更年期精神病、偏执性精神病及各种器质性病变伴发的精神病等。患者及家属应和精神科医生积极配合,及早到医院治疗。精神病患者常表现为精神兴奋,性情急燥,失眠头痛,苦怒,逾坦上屋,骂街叫号,不避亲疏,伤人毁物或精神恐惧或精神疲惫,烦燥,形瘦,面红,多言善惊,舌红苔黄或舌红少苔或无苔,脉象弦滑或细数。诊断以舌红,口腔粘膜、下眼俭粘膜充血,脉数有力为准,病久可见舌红无苔,脉细数。
现有的治疗方法多以西医为主加上辅助疗法,西医诊断复杂,常用治疗的西药有:齐拉西酮、氯氮平、奋乃静、氯丙嗪、利培酮、氟哌啶醇、富马酸喹硫平、舒必利、曲美托嗪、奥氮平等。由于西药治疗伤肝伤胃,疗效差,有些患者需要长期甚至终身服药,大部分患者不能坚持治疗;辅助疗法如电疗,副作用大,对人体伤害大。
精神病在祖国医学中,属于神志病的范畴。本病的病因在中医经典著作内早有论述,如《生气通天论篇》说:阴不胜其阳,则脉流薄疾,并乃狂。《素问,宣明五气论篇》说:邪入于阳则狂,邪入于阴则痹,搏阳则为癫疾。《难经二十难》说:重阳者狂,重阴者癫。《诸病原侯论风狂病候》说:气并阳则狂发。本病用“癫”、“狂”命名,是因其“正性癫倒,狂不识人”,也即现代医学“躁狂型”与“忧郁型”都是由精神刺激而引起的,以致失去理智的控制,不能进行正确地思维、语言错乱、精神失常、癔病、躁狂、登高而歌、弃衣奔走等临床表现。祖国医学认为,天有日、月、星,人有精、气、神,“得神者昌,逆神者亡”,神即人体生命活动的总称,也是精神意识,思维活动以及脏腑、精气、血与津液功能活动的外在表现的高度概括.这就是说,人的气血、津液、思维活动的循环规律,源于自身的调节,而自身调节功能长期失调,则会导致精神的异常。
祖国医学认为精神病的病因病机主要有:1.六淫侵袭。六淫即风、寒、暑、湿、燥、火,是自然界气候的自然发生的现象,一般并不致病,称为六气。只有在气候失常的情况下,才可致病故又称六淫。六淫当中与精神疾病有关的主要是风暑火三种。《素问》有:“伤于风者,上先受之,”和“诸燥狂热皆属于火”的理论。但无论是“风、暑”,还是“燥火”总在人体的虚弱时,才可乘虚而人致病。但“火热过亢”目前仍被视为病因病机的重要方面。2.七情内伤。七情即喜、怒、忧、思、悲、恐、惊,是人精神活动的正常表现,但如果超过了正常限度或受到突然及长久的刺激,而又缺乏心理应激能力和处理技巧,就会导致生理及脏腑功能失调、经络功能紊乱而发生精神疾病。此外,还有痰迷心窍、气血凝滞、阴阳失和、遗传、近亲结婚、脑外伤、脑器质性疾病、中毒等。
目前,临床上不断有新的治疗精神病的药物(包括西药和中药)出现,但这些均未能达到真正令人满意的效果。开发一种高效低毒、标本兼治的中西药复方新药仍是临床的急切需要。
发明内容
本发明的目的是提供一种标本兼治、副作用小、安全方便的制剂。其目的是为了解决治疗精神病,克服西药副作用、停药反复的问题,达到标本兼治的目的。
本申请发明人根据前人经验及自己多年的医疗实践,通过对传统中药的研究,从整体看,本病主要应归于情志所伤,疏通气机为根本大法,注重脏腑经络的络属、毗邻、传变关系的治疗。从祖国医学宝库中,筛选出益气活血、解痉通络之功效的天然中药,按中医理论组方,结合传统中医技术精心配制成本发明的一种用于精神病的制剂及其制备方法,对精神病的治疗效果显著。
为实现上述目的,本发明采用的技术方案如下:
一种用于精神病的制剂,其按照如下方法制备而得:
取中药提取物15kg,氯氮平15kg,淀粉20kg,糊精20kg,微晶纤维素2kg,50%(体积比)乙醇27kg,硬脂酸镁1kg,按照常规方法造粒,制备片剂100万片。
所述中药提取物由下述重量份的原料制备而得:
麦冬20-25份、菟丝子20-25份、酸枣仁18-22份、大黄18-22份、芦荟15-18份、
知母15-18份、回心草15-18份、桔梗15-18份、枳壳12-15份、前胡12-15份、
茜草12-15份、防风12-15份、葛根12-15份、丹参8-10份、陈皮8-10份、
白芍8-10份、山楂8-10份、枸杞子8-10份、莪术5-7份、肉豆蔻5-7份、伸筋草5-7份、
白芷5-7份、赤芍4-5份、乳香4-5份、地龙4-5份、蒲公英2-3份、桃仁2-3份。
所述中药提取物的制备方法为:
1)按照重量份取各原料备用;
2)取菟丝子、大黄、桔梗、枳壳、前胡、蒲公英以及桃仁混合,加水煎煮,第一次加4倍重量水,煎煮1小时,过滤后得到滤液和药渣,第二次加2倍重量水煎煮15min,过滤后获得滤液,合并两次滤液,将合并后的滤液浓缩成密度为1.2g/ml的浸膏,60℃干燥后,粉碎获得组分A;
3)将地龙研磨成粉末状,过100目筛,得到组分B;
4)取剩余原料,混合,用乙醇浸泡1小时,然后乙醇回流提取1次,提取时间为2小时,收集提取液,浓缩成密度为1.2g/ml的清膏;80℃烘干后,粉碎获得组分C;
5)将组分A、组分B以及组分C混合搅拌均匀,即得。
用法用量:口服,一次1片,一日三次。
注意:高血压患者忌服,温开水送服。服药期间忌食辛辣及寒凉食物,避免情志刺激,生活要有规律。
本发明制剂优良效果在于:
1.本发明的制剂配伍符合中药“君臣佐使”原则,由纯中药制成,各组分符合药政法规定,利用各味中药的综合作用,不含化工成分,不含激素,表里兼治,达到更好的养脑安神、疏肝理气作用;
2.本发明的制剂具有疏肝理气、平肝潜阳、养脑安神、活血导滞、利水消肿、芳香开窍、清热泻火、补气养血、益精补髓的功效,临床实践证明,对精神病尤其是精神***症、狂躁抑郁性精神病、偏执性精神病疗效显著,疗程短,总有效率高,愈后不易复发。
3.本发明制备方法简单可行,降低了生产成本,减轻了患者的经济负担。
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
一种用于精神病的制剂,其按照如下方法制备而得:
取中药提取物15kg,氯氮平15kg,淀粉20kg,糊精20kg,微晶纤维素2kg,50%(体积比)乙醇27kg,硬脂酸镁1kg,按照常规方法造粒,制备片剂100万片。
所述中药提取物由下述重量份的原料制备而得:
麦冬20份、菟丝子20份、酸枣仁18份、大黄18份、芦荟15份、
知母15份、回心草15份、桔梗15份、枳壳12份、前胡12份、
茜草12份、防风12份、葛根12份、丹参8份、陈皮8份、
白芍8份、山楂8份、枸杞子8份、莪术5份、肉豆蔻5份、伸筋草5份、
白芷5份、赤芍4份、乳香4份、地龙4份、蒲公英2份、桃仁2份。
所述中药提取物的制备方法为:
1)按照重量份取各原料备用;
2)取菟丝子、大黄、桔梗、枳壳、前胡、蒲公英以及桃仁混合,加水煎煮,第一次加4倍重量水,煎煮1小时,过滤后得到滤液和药渣,第二次加2倍重量水煎煮15min,过滤后获得滤液,合并两次滤液,将合并后的滤液浓缩成密度为1.2g/ml的浸膏,60℃干燥后,粉碎获得组分A;
3)将地龙研磨成粉末状,过100目筛,得到组分B;
4)取剩余原料,混合,用乙醇浸泡1小时,然后乙醇回流提取1次,提取时间为2小时,收集提取液,浓缩成密度为1.2g/ml的清膏;80℃烘干后,粉碎获得组分C;
5)将组分A、组分B以及组分C混合搅拌均匀,即得。
用法用量:口服,一次1片,一日三次。
实施例2
一种用于精神病的制剂,其按照如下方法制备而得:
取中药提取物15kg,氯氮平15kg,淀粉20kg,糊精20kg,微晶纤维素2kg,50%(体积比)乙醇27kg,硬脂酸镁1kg,按照常规方法造粒,制备片剂100万片。
所述中药提取物由下述重量份的原料制备而得:
麦冬25份、菟丝子25份、酸枣仁22份、大黄22份、芦荟18份、
知母18份、回心草18份、桔梗18份、枳壳15份、前胡15份、
茜草15份、防风15份、葛根15份、丹参10份、陈皮10份、
白芍10份、山楂10份、枸杞子10份、莪术7份、肉豆蔻7份、伸筋草7份、
白芷7份、赤芍5份、乳香5份、地龙5份、蒲公英3份、桃仁3份。
所述中药提取物的制备方法为:
1)按照重量份称取各原料备用;
2)取菟丝子、大黄、桔梗、枳壳、前胡、蒲公英以及桃仁混合,加水煎煮,第一次加4倍重量水,煎煮1小时,过滤后得到滤液和药渣,第二次加2倍重量水煎煮15min,过滤后获得滤液,合并两次滤液,将合并后的滤液浓缩成密度为1.2g/ml的浸膏,60℃干燥后,粉碎获得组分A;
3)将地龙研磨成粉末状,过100目筛,得到组分B;
4)取剩余原料,混合,用乙醇浸泡1小时,然后乙醇回流提取1次,提取时间为2小时,收集提取液,浓缩成密度为1.2g/ml的清膏;80℃烘干后,粉碎获得组分C;
5)将组分A、组分B以及组分C混合搅拌均匀,即得。
用法用量:口服,一次1片,一日三次。
实施例3
急性毒性实验:应用小鼠90只,雌雄各半,体重30~40g,进行急性毒性试验。小鼠随机分为两组,即对照组、实施例1组以及实施例2组,每组30只,实验前禁食12小时,给药组分别给予本发明的实施例1、实施例2的制剂溶解在水中灌胃给药,对照组给予等量生理盐水,一天给药2次,给药间隔时间6小时,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、体重增长均正常。因此本发明的制剂毒性较低,临床用药相对安全。
长期毒性实验:将本发明实施例1的制剂对小鼠连续用药15周及停药3周后,结果表明:本发明制剂对小鼠的毛发、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,脏器肉眼没有发现异样变化和组织学检查结果表明,用药15周及停药3周后,小鼠各脏器均无明显改变。说明本发明制剂对小鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
实施例4
临床资料
临床资料选取98例临床患者,其中男性53人,女性45人,年龄最小者26岁,最大者67岁,病程平均2.6年。随机分成两组,每组49人,对照组(氯氮平片,25mg/片,一日100-200mg)和实施例2组(一次1片,一日三次),两组患者性别、年龄、病程、经统计学处理,无显著差异(P>0.05),具有可比性。两组患者治疗同时均配合体针、鬼门十三针、腕踝针治疗治疗。
诊断标准:急性期:精神兴奋,彻夜不眠,头痛躁狂,两目怒视,面红耳赤,躁狂症多不避亲疏,狂乱莫制,骂人毁物,逾坦上屋,高歌狂呼,久病则阳性症状稍缓,神呆,语无伦次,多话,多动,惊恐不安,烦燥失眠,舌红苔黄或舌红无苔或花苔,脉象滑数有力或脉细数。
疗效判定标准:
痊愈:语言、举止、神情均恢复正常,能正常处理日常事务。
显效:症状消失,语言、举止基本正常,能做简单家务,生活能够自理。
有效:神情安定,语言、举止基本正常或有所改善,有精神刺激时神情不稳定。
无效:语言、举止、神情均无好转。
两组治疗前后效果比较见表1:
表1
组别 | 例次 | 痊愈 | 显效 | 有效 | 无效 | 总有效率(%) |
对照组 | 49 | 16 | 16 | 7 | 10 | 79.6 |
实施例2组 | 49 | 26 | 15 | 6 | 2 | 95.9 |
结论:本发明制剂治疗效果优于常规药物氯氮平片,有效降低有效成分氯氮平的用量,毒副作用小,应用前景广阔。
最后,还需要注意的是,以上列举的仅是本发明的若干个具体实施例。显然,本发明不限于以上实施例,还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形,均应认为是本发明的保护范围。
Claims (4)
1.一种用于精神病的制剂,其按照如下方法制备而得:
取中药提取物15kg,氯氮平15kg,淀粉20kg,糊精20kg,微晶纤维素2kg,50%(体积比)乙醇27kg,硬脂酸镁1kg,按照常规方法造粒,制备片剂100万片。
2.根据权利要求1所述的制剂,其特征在于,所述中药提取物由下述重量份的原料制备而得:
麦冬20-25份、菟丝子20-25份、酸枣仁18-22份、大黄18-22份、芦荟15-18份、
知母15-18份、回心草15-18份、桔梗15-18份、枳壳12-15份、前胡12-15份、
茜草12-15份、防风12-15份、葛根12-15份、丹参8-10份、陈皮8-10份、
白芍8-10份、山楂8-10份、枸杞子8-10份、莪术5-7份、肉豆蔻5-7份、伸筋草5-7份、
白芷5-7份、赤芍4-5份、乳香4-5份、地龙4-5份、蒲公英2-3份、桃仁2-3份。
3.根据权利要求1-2所述的制剂,其特征在于,所述中药提取物的制备方法包括如下步骤:
1)按照重量份取各原料备用;
2)取菟丝子、大黄、桔梗、枳壳、前胡、蒲公英以及桃仁混合,加水煎煮,第一次加4倍重量水,煎煮1小时,过滤后得到滤液和药渣,第二次加2倍重量水煎煮15min,过滤后获得滤液,合并两次滤液,将合并后的滤液浓缩成密度为1.2g/ml的浸膏,60℃干燥后,粉碎获得组分A;
3)将地龙研磨成粉末状,过100目筛,得到组分B;
4)取剩余原料,混合,用乙醇浸泡1小时,然后乙醇回流提取1次,提取时间为2小时,收集提取液,浓缩成密度为1.2g/ml的清膏;80℃烘干后,粉碎获得组分C;
5)将组分A、组分B以及组分C混合搅拌均匀,即得。
4.权利要求1-3所述制剂的用途。
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CN1198942A (zh) * | 1998-03-04 | 1998-11-18 | 王昌运 | 清心解烦胶囊及配制方法 |
CN101979039A (zh) * | 2010-10-26 | 2011-02-23 | 山西省长治精神病院 | 一种用于治疗精神病的药物 |
CN105327287A (zh) * | 2015-12-05 | 2016-02-17 | 翔宇药业股份有限公司 | 一种治疗精神病的药物组合物及其制备工艺 |
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CN1198942A (zh) * | 1998-03-04 | 1998-11-18 | 王昌运 | 清心解烦胶囊及配制方法 |
CN101979039A (zh) * | 2010-10-26 | 2011-02-23 | 山西省长治精神病院 | 一种用于治疗精神病的药物 |
CN105327287A (zh) * | 2015-12-05 | 2016-02-17 | 翔宇药业股份有限公司 | 一种治疗精神病的药物组合物及其制备工艺 |
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