CN115025193B - 一种治疗肿瘤相关性失眠的中药组合物及其应用 - Google Patents
一种治疗肿瘤相关性失眠的中药组合物及其应用 Download PDFInfo
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Abstract
本发明涉及中药技术领域,具体是一种治疗肿瘤相关性失眠的中药组合物及其应用,所述中药组合物是由以下重量份的原料药组成:黄芪9~30份、酸枣仁9~30份、郁金6~12份、重楼3~9份。本发明还包括所述中药组合物在制备治疗肿瘤相关性失眠的药物中的应用。其优点表现在:本发明优选各原料药及其之间的重量份,全方以调神、扶正、抗癌、祛邪4味药物为核心,安寐调神,扶正治癌为治疗原则,符合“君臣佐使”配伍原则,协同作用,共奏调神、扶正、抗癌、祛邪之效,并通过实验证实其疗效,有很好的应用前景。
Description
技术领域
本发明涉及中药技术领域,具体地说,是一种治疗肿瘤相关性失眠的中药组合物及其应用。
背景技术
失眠症是一种以失眠为主的睡眠质量不满意状况,随着社会竞争的加剧,工作压力的增加,本症的发病正呈日益增多的趋势。失眠在临床上发病率很高,严重困扰着患者的生活和工作。失眠可引起病人焦虑,抑郁或恐惧心理,导致精神活动障碍,妨碍身心健康。目前现代医学治疗失眠症多采用镇静催眠药物,诸如巴比妥类,苯二氮卓类,非苯二氮卓类,但药物治疗具有耐药性,依赖性及成瘾性等,鉴于西药的副作用,中医药治疗显示出强大的优势,特别是其中的针灸疗法,更因其无毒副作用而被广泛使用。
CRI(肿瘤相关性失眠)是肿瘤患者伴发的一种以入睡困难,和(或)睡眠保持障碍的主观体验,且肿瘤患者往往因担忧病情而情绪焦虑、思虑过多,从而出现失眠。历代医家多认为不寐病因在于内邪所干、外邪侵袭、禀赋不足、年老体虚,病机为气血、阴阳失调以致阴阳不交,阳不入阴,故发不寐。常会影响患者的日间功能。目前CRI常以镇静催眠类药物对症治疗,缺乏统一的诊疗指南。
现有技术:田建辉辨治肺癌伴发失眠的临床经验(2017)中介绍了田建辉主任医师辨治肺癌伴发失眠的临床经验。认为肺癌伴发失眠主要是由精神心理因素、放化疗不良反应及癌痛等影响而引发;临证需重视情志治疗,并根据核心病机,以调肝为核心,从虚证、实证、错杂证3个方面入手,辨病与辨证相结合论治。并且针对不同证型的患者给出了经典方剂:如:胆郁痰热为主者,常选用制半夏、陈皮、竹茹、枳壳、胆南星、秫米等。对于肝阳化火为主者,常选用龙胆草、生白芍、栀子、黄芩等。对于肝郁气滞为主者,常用柴胡、薄荷、枳壳、夏枯草、薄荷等轻宣之品。对于瘀血为主者,常选用当归、赤芍、川芎、丹参等,以理肝经血瘀、畅通气机。临床也可见肝胃不和者,可选用半夏、枳壳、制大黄、芦荟等通腑泻肝,胃气和则寐自安。但作者最后发现这些方剂疗效仍有待改进。
中国专利申请:CN201110312561.1公开了一种治疗失眠的中药组合物及其制剂的制备方法。中药组合物原料成分为黄芩10-20份、栀子10-20份、夜交藤25-35份、炒枣仁15-25份、合欢皮15-25份、远志10-20份、龙骨25-35份、牡蛎25-35份、黄连5-15份、茯苓10-20份、甘草5-15份、白芍15-25份、珍珠母25-35份和青皮5-15份。其中,龙骨、牡蛎粉碎,珍珠母研末;其余药物混合后粉碎,加75%乙醇回流提取2-3次,合并滤液,将龙骨粉、牡蛎粉,珍珠母粉加入滤液后浓缩至稠浸膏剂;烘干得粉剂。但是我们看到该专利中药味数目较多,且疗效仍有待改进。
本专利发明人针对现有技术的缺陷,总结之前多年的临床工作经验,创新性的提出了一种药味数目少、且疗效好的中药组方,关于本发明一种治疗肿瘤相关性失眠的中药组合物及其应用目前还未见报道。
发明内容
本发明的目的是针对现有技术的不足,提供一种治疗肿瘤相关性失眠的中药组合物及其应用。
为实现上述目的,本发明采取的技术方案是:
第一方面,本发明提供了一种治疗肿瘤相关性失眠的中药组合物,所述中药组合物由以下重量份的原料药组成:黄芪9~30份、酸枣仁9~30份、郁金6~12份、重楼3~9份。
优选地,所述中药组合物由以下重量份的原料药组成:黄芪20~30份、酸枣仁20~30份、郁金6~9份、重楼5~9份。
优选地,所述中药组合物由以下重量份的原料药组成:黄芪30份、酸枣仁30份、郁金9份、重楼9份。
优选地,所述中药组合物还包括药学上可接受的载体。
优选地,所述中药组合物的剂型为内服剂型。
优选地,所述剂型包括汤剂、丸剂、胶囊剂、片剂、颗粒剂和散剂。
第二方面,本发明提供了如上所述的中药组合物在制备治疗肿瘤相关性失眠的药物中的应用。
优选地,所述肿瘤包括卵巢癌肿瘤和肺癌肿瘤。
第三方面,本发明提供了如上所述的中药组合物的制备方法,包含按照重量份配比称取各原料药的步骤。
术语
如本文所用,术语“药学上可接受的”的成分是适用于人和/或动物而无过度不良副反应(如毒性、刺激和变态反应)的,即有合理的效益/风险比的物质。
如本文所用,术语“药学上可接受的载体”指用于治疗剂给药的载体,包括各种赋形剂和稀释剂等。该术语指这样一些药剂载体:它们本身并不是必要的活性成分,且施用后没有过分的毒性。合适的载体是本领域普通技术人员所熟知的。
如本文所用,“重量份”可以是任何一个固定的以毫克、克数或千克数表示重量(如1mg、1g、2g、5g或1kg等)。例如,一个由1重量份组分a和9重量份组分b构成的组合物,可以是1克组分a+9克组分b,也可以是10克组分a+90克组分b等构成的组合物。在所述组合物中,某一组分的百分比含量=(该组分的重量份数/所有组分的重量份数之和)×100%。因此,由1重量份组分a和9重量份组分b构成的组合物中,组分a的含量为10%,组分b为90%。
方解
治疗原则:调神、扶正、抗癌、祛邪4味药物为核心,安寐调神,扶正治癌。
酸枣仁为君药,入心、肝、胆经,养心益肝、宁心安神,《名医别录》中酸枣仁“主心烦不得眠……补中,益肝气,坚筋骨,助阴气”。黄芪、重楼为臣药,黄芪主入脾、肺经,能健脾扶正,补中益气,以助扶正安神。《医学衷中参西录》中言黄芪“能补气,兼能升气”,现代药理研究发现黄芪具有促进机体代谢、抗疲劳的作用。重楼主入肝经,解毒消癥定惊,以助镇惊安神、解毒抗癌。《神农本草经》中言及重楼可“主惊痫,摇头弄舌,热气在腹中,癫疾”。郁金为佐,主入肝、胆、心经,主活血行气、解郁清心,《本草纲目》中郁金“治血气心腹痛,产后败血冲心欲死,失心癫狂”。佐以郁金之辛散,与大量酸枣仁相伍,辛散与酸收并用,补血与行血结合,具有养血调肝,安神助眠之用。
酸枣仁汤中单味药抗抑郁主要成分为酸枣仁生物碱、酸枣仁皂苷等,主要与抑制促炎因子释放、调节神经递质水平、影响脑源性神经营养因子及其受体表达等相关。重楼皂苷是抗癌常用中药七叶一枝花的主要活性成分,现有的研究结果表明,其主要通过抑制肿瘤细胞增殖、诱导肿瘤细胞凋亡、抗血管生成、诱导肿瘤细胞分化、抑制肿瘤细胞转移、逆转肿瘤细胞的多药耐药性等方面发挥抗肿瘤作用。郁金中含有多种化学成分,活性成分以萜类和姜黄素类为主,具有抗肿瘤、保护神经、抗炎镇痛、保肝、细胞毒等作用,现代研究表明,包括姜黄素、莪术醇、莪术二醇在内的郁金有效成分,在保肝、抗肿瘤、抗氧化、降血脂、免疫抑制等方面作用显著,实验发现其重要作用靶点有AKT1、IL6、EGFR、STAT3等,主要作用通路为神经活性配体受体相互作用、癌症通路等。
本发明优点在于:
发明人总结多年工作经验,在先前方剂的基础上优选各原料药及其之间的重量份,全方以调神、扶正、抗癌、祛邪4味药物为核心,安寐调神,扶正治癌为治疗原则,符合“君臣佐使”配伍原则,其中酸枣仁为君药,黄芪、重楼为臣药,郁金为佐,全方协同共奏调神、扶正、抗癌、祛邪之效。而且本发明通过实验证实,该组方在药味数目少的前提下,疗效高、无毒副作用。
虽然现有技术中也有一些方剂是以调神、或扶正、或祛邪等为治疗原则,但是发明人发现这些方剂其疗效仍然有待改进,这表明药味的选择对疗效有显著性影响,而且即使有些药味功效相同,但是由于药味之间会存在相互作用,所以导致对最后的综合疗效产生显著性影响,而发明人也正是考虑到这一点,选择了协同作用的中药组方,最后得到的组方实验结果表明疗效高、无副作用,实用性强,应用前景广,并且本发明的中药组方无需考虑患者证型,适用范围广。
发明人发现酸枣仁汤作为治疗失眠的千古名方,疗效确切,但对于肿瘤患者伴发失眠症状,治疗失眠的同时还要兼顾肿瘤防治。调神治癌方以酸枣仁为君药养心益肝、宁心安神,黄芪、重楼为臣药,黄芪能健脾扶正,补中益气,提高机体免疫力扶正抗癌,重楼具有解毒消癥定惊功效,能够增强酸枣仁安神功效的同时,还能抗肿瘤。前期课题组有关重楼主要成分重楼皂苷抗肿瘤做了系列基础研究,疗效确切。调神治癌方酸枣仁佐以郁金解郁安神,同时现代药理证实郁金中有效成分姜黄素具有抗肿瘤作用,进一步增强全方抗肿瘤功效。
附图说明
附图1调神治癌方与肿瘤-失眠的交集靶点图。
附图2是“调神治癌方-肿瘤-失眠”核心靶点的生物过程富集分析图。
附图3是“调神治癌方-肿瘤-失眠”核心靶点的分子功能分析图。
附图4是“调神治癌方-肿瘤-失眠”核心靶点的KEGG通路分析图。
具体实施方式
下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1
黄芪9份、酸枣仁9份、郁金6份、重楼3份。
实施例2
黄芪30份、酸枣仁30份、郁金12份、重楼9份。
实施例3
黄芪9份、酸枣仁30份、郁金6份、重楼9份。
实施例4
黄芪30份、酸枣仁9份、郁金12份、重楼3份。、
实施例5
黄芪20份、酸枣仁20份、郁金6份、重楼5份。
实施例6
黄芪30份、酸枣仁30份、郁金9份、重楼9份。
实施例7
黄芪20份、酸枣仁30份、郁金6份、重楼9份。
实施例8
黄芪30份、酸枣仁20份、郁金9份、重楼5份。
实施例9
汤剂的制备方法:
按照实施例1-8任一所述重量份称取各原料药,加水煎煮,过滤,即可。
实施例10
颗粒剂的制备方法:
按照实施例1-8任一所述重量份称取各原料药,加水煎煮,过滤,共煎煮2次,合并2次滤液,浓缩得浸膏,将浸膏干燥粉碎至颗粒,即可。
实施例11
片剂/胶囊剂的制备方法:
按照实施例1-8任一所述重量份称取各原料药,加水煎煮,共煎煮2次,将2次煎煮的煎煮液滤过,合并2次滤液,浓缩得浸膏,加入制药辅料,真空干燥,粉碎制粒,压制成片剂或填充装胶囊,即可.
实施例12
1实验方法
通过TCMSP(Traditional Chinese Medicine Systems Pharmacology Databaseand Analysis Platform)数据库、PubChem、SwissTargetPrediction等数据库获取重楼、酸枣仁、郁金、黄芪的主要化学成分及其靶点,根据ADME筛选中药活性组分;通过Gencards数据库获取肿瘤、失眠疾病的主要靶点,利用String平台进行蛋白质相互作用分析,构建PPI网络并挖掘网络中潜在的蛋白质功能模块。采用DAVID平台分析“药物-成分-靶点”及其参与的生物过程及通路,而后采用Cytoscape3.7.1软件构建“调神治癌方-卵巢癌-抑郁”靶点通路网络。
2实验结果
2.1.筛选出调神治癌方中的有效化学成分,具体见表1:
表1调神治癌方的主要有效化学成分表
2.2.调神治癌方治疗肿瘤相关性失眠的核心靶点
见图1,筛选出调神治癌方作用靶点266个,肿瘤作用靶点26112个,失眠靶点2915个,交集靶点25个,肿瘤Relevance score大于10,筛选出1100个靶点,失眠Relevancescore>1,筛选出292个,交集靶点10个,分别为GSK3B、TNF、CYP3A4、IL10、IL6、IL1B、NOS3、CHEK2、CLDN4、CRP。
2.3.调神治癌方治疗肿瘤相关性失眠的基因本体功能分析
通过R语言对“调神治癌方-肿瘤-失眠”的10个交集核心靶点进行基因本体(GeneOntology,GO)功能分析,按照校正P<0.05筛选,将富集得到的GO功能中排名前15的条目进行可视化分析,具体生物过程及分子功能图见图2及图3。
2.4.调神治癌方治疗肿瘤相关性失眠的KEGG通路富集分析
采用DAVID平台分析“调神治癌方-肿瘤-失眠”核心靶点涉及的KEGG通路,按照校正P<0.05筛选,将富集得到的KEGG通路中排名前15的条目进行可视化分析,具体见图4。
3结论
本发明的调神治癌方治疗肿瘤相关性失眠具有多靶点多通路的作用特点。
实施例13
1研究方法
采用前瞻性研究设计,对就诊于上海中医药大学附属市中医医院及龙华医院田建辉教授门诊及住院病人,根据纳排标准入组确诊为恶性肿瘤的患者。于入组时填写一般资料表、中医证候表,通过辨证分型对患者进行调神治癌方为基础方的随证加减治疗,28日/周期,共干预2个周期,分别于入组时、干预后,填写PSQI睡眠质量量表,通过自身前后对照探究调神治癌方辨证加减对肿瘤患者失眠及其他症状的治疗效果。本研究经由龙华临床医学院伦理委员会批准(伦理号:2018LCSY022),上海市中医医院伦理委员会批准(批件号2021SHL-KY-52-01)。
1.1.研究标准
1.1.1纳入标准
(1)参考2020版NCCN肿瘤学临床实践指南[1],病理确诊为恶性肿瘤的患者;
(2)年龄18周岁以上,小学及以上文化程度、能独立完成问卷填写;
(3)ECOG体能状态评分3分以上;
(4)患者知情同意,愿意填写相关量表及进行实验室检查,并能够配合长期随访。
(5)预计生存时间要大于随访时间。
1.1.2排除标准
(1)病理不明确及病理分期不明的患者;
(2)资料信息不全及量表问卷反馈不全者;
(3)既往有其它精神疾病病史;
(4)合并有严重心脑血管疾病、呼吸系统疾病,或存在严重基础疾病,合并严重感染性疾病;
(5)入组时正在接受其他临床实验;
(6)有自杀行为倾向。
1.1.3脱落标准
(1)治疗期间主动要求退出;
(2)治疗期间病情恶化,无法继续参与研究;
(3)治疗期间出现严重并发症;
(4)治疗期间未严格遵守治疗方案。
2.研究结果
2.1基线资料
所有病例来自于2019年6月至2021年10月期间就诊于门诊的肿瘤合并失眠患者。共入组100例,实验中因不能随访原因脱落5例,共入组有效病例95例。其中女性70例,男性25例;年龄最小36岁,最大78岁。病理分期从IA期到IV期,其中I期40例(42.11%),II期10例(10.53%),III期34例(35.79%),IV期15例(15.79%)。病理类型主要是肺癌53例(55.79%)、卵巢癌42例(44.21%)。
2.2治疗前后PSQI评分比较
PSQI量表为自评量表[2],由19个单独的项目产生7个成分分数及PSQI总分,7个成分有主观睡眠质量、入睡时间、实际睡眠时间、睡眠效率、睡眠障碍、催眠药物、日间功能障碍,每个成分计分范围在0~3分,汇总为PSQI总分,临床常以PSQI总分是否小于11分划分睡眠质量的好坏,分数越高代表睡眠质量越差,具体分级为:0~5分为睡眠很好,6~10分为睡眠还行,11~15分为睡眠一般,16~21分为睡眠很差。
表2治疗前后PSQI评分组内比较
注:与治疗前比较,ΔP<0.05,ΔΔP<0.01
治疗组患者治疗前后匹兹堡睡眠质量等级比较组内变化比较见表3,患者治疗后睡眠质量等级变化为,睡眠质量很好的患者占比由0%升至8.42%,睡眠质量还行的占比由21.05%升至37.89%,睡眠质量一般的占比由44.21%升至47.37%,睡眠质量很差的占比由34.74%降至6.32%,秩和检验结果则显示治疗组治疗后睡眠质量程度平均水平较前显著升高(P<0.01)。
表3治疗前后PSQI睡眠质量程度组内比较
注:与治疗前比较,ΔP<0.05,ΔΔP<0.01.
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明原理的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
参考文献:
[1]ARMSTRONG D K,ALVAREZ R D,BAKKUM-GAMEZ J N,et al.Ovarian Cancer,Version 2.2020,NCCN Clinical Practice Guidelines in Oncology[J].J Natl ComprCanc Netw,2021,19(2):191-226.
[2]BUYSSE D J,REYNOLDS C F,3RD,MONK T H,et al.The Pittsburgh SleepQuality Index:a new instrument for psychiatric practice and research[J].Psychiatry research,1989,28(2):193-213.
Claims (8)
1.一种治疗肿瘤相关性失眠的中药组合物,其特征在于,所述中药组合物由以下重量份的原料药组成:黄芪9~30份、酸枣仁9~30份、郁金6~12份、重楼3~9份。
2.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物由以下重量份的原料药组成:黄芪20~30份、酸枣仁20~30份、郁金6~9份、重楼5~9份。
3.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物由以下重量份的原料药组成:黄芪30份、酸枣仁30份、郁金9份、重楼9份。
4.根据权利要求1-3任一所述的中药组合物,其特征在于,所述中药组合物还包含药学上可接受的载体。
5.根据权利要求1-3任一所述的中药组合物,其特征在于,所述中药组合物的剂型选自汤剂、丸剂、胶囊剂、片剂、颗粒剂和散剂。
6.权利要求1-3任一所述的中药组合物在制备治疗肿瘤相关性失眠的药物中的应用。
7.根据权利要求6所述的应用,其特征在于,所述肿瘤包括卵巢癌肿瘤和肺癌肿瘤。
8.根据权利要求1-3任一所述的中药组合物,其特征在于,所述中药组合物的制备方法为:
(1)称取各原料药;
(2)加水煎煮各原料药,过滤得滤液,放凉备用。
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