CN117244016A - 一种防治癌因性疲乏的中药组合物及制备方法 - Google Patents
一种防治癌因性疲乏的中药组合物及制备方法 Download PDFInfo
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Abstract
本发明提供了一种防治癌因性疲乏的中药组合物及制备方法,所述中药组合物的活性成分由以下原料制备而成:黄芪15~20%,党参15~20%,茯苓7~12%,白术7~12%,淫羊藿6~10%,枸杞子7~12%,酒女贞子7~12%,陈皮3~6%,麦冬7~12%,五味子3~6%,炒酸枣仁7~12%,炙甘草6~10%。所述中药组合物联合化疗能有效降低患者化疗期间的Piper疲乏评分,并明显改善气血两虚证患者的中医证候积分。同时,所述中药组合物安全性良好,适合在临床推广使用。
Description
技术领域
本发明属于中医药技术领域,具体涉及一种防治癌因性疲乏的中药组合物及制备方法。
背景技术
癌因性疲乏是恶性肿瘤患者最常见和最痛苦的症状之一。高达60~90%的肿瘤患者会出现癌因性疲乏。癌因性疲乏,即肿瘤相关疲乏,是一种令人痛苦的、持久的、主观的劳累感,影响到身体、情感、认知功能,与癌症本身及其治疗有关,且疲乏程度不与活动情况成比例。它显著影响患者生活质量,使患者对抗肿瘤治疗的耐受性下降。临床上,引起癌因性疲乏的因素较为复杂,主要有以下四类。①肿瘤疾病本身:肿瘤无氧酵解的代谢产物、肿瘤生长导致营养缺乏等,均可引起疲乏;②抗肿瘤治疗:化疗、放疗、免疫治疗等抗肿瘤治疗可引起患者食欲不振、骨髓抑制等不良反应,均可导致疲乏;③肿瘤并发症,如疼痛、贫血、抑郁、焦虑、失眠、营养不良、电解质紊乱、恶病质、感染等均可引起疲乏。④不良情绪,当患者处于悲观、失望、抑郁、愤怒和恐惧等不良因素的影响时也会出现疲乏的症状。临床上,癌因性疲乏缺乏明确有效的治疗药物,可通过营养干预、心理干预、中医药治疗等方法进行改善。
针对癌因性疲乏,目前并没有明确有效的西医治疗药物。目前癌因性疲乏的治疗,临床常参考美国国立综合癌症网络癌因性疲乏治疗指南。指南强调对疲乏进行全程管理,强调多学科、患者和医护间的积极配合,认为全程都应积极对疲乏进行及时确认、评估、检测、记录和治疗。疲乏处理的一般策略是对患者及家属的宣教和辅导,建议其学会自我疲乏检测、适当节约体能、适当活动、分散注意力、做有意义的互动,可接受认知行为疗法、正念减压训练或者光疗、电疗等。另建议适当体力活动(据疾病状态决定活动强度)、心理社会干预、营养辅导、睡眠控制。药物上,有直接的病因,则行相应的对因治疗,如癌痛、贫血、消化道反应等。排除其他病因后,可考虑使用中枢兴奋剂哌醋甲酯,但目前临床研究证据均有限,尚不能充分验证其疗效。终末期患者可考虑使用皮质类固醇,但长期使用会带来明显的副作用。以上两种药物均治标不治本,且不适合长期使用。
发明内容
基于此,本发明的目的在于提供一种防治癌因性疲乏的中药组合物,其能有效改善癌因性疲乏,且无明显副作用。
为达到上述目的,本发明采用如下技术方案。
一种防治癌因性疲乏的中药组合物,所述中药组合物的活性成分由以下质量百分含量的原料制备而成:黄芪15~20%,党参15~20%,茯苓7~12%,白术7~12%,淫羊藿6~10%,枸杞子7~12%,酒女贞子7~12%,陈皮3~6%,麦冬7~12%,五味子3~6%,炒酸枣仁7~12%,炙甘草6~10%。
在一些实施例中,所述中药组合物的活性成分由以下质量百分含量的原料制备而成:黄芪12~20%,党参12~20%,茯苓8~12%,白术6~10%,淫羊藿6~10%,枸杞子6~10%,酒女贞子6~10%,陈皮1~5%,麦冬6~10%,五味子3~5%,炒酸枣仁6~10%,炙甘草4~8%。
在一些优选的实施例中,所述中药组合物的活性成分由以下质量百分含量的原料制备而成:黄芪15~17%,党参15~17%,茯苓8~10%,白术7~9%,淫羊藿6~8%,枸杞子7~9%,酒女贞子7~9%,陈皮2~4%,麦冬7~9%,五味子3~4%,炒酸枣仁8~10%,炙甘草6~8%。
本发明还提供了如上所述中药组合物的制备方法,包括以下步骤:按比例称取黄芪、党参、茯苓、白术、淫羊藿、枸杞子、酒女贞子、陈皮、麦冬、五味子、炒酸枣仁和炙甘草,用提取溶剂进行提取,收集提取液,浓缩。
在一些实施例中,所述提取溶剂为水;和/或,所述提取为煎煮提取。
本发明还提供了一种防治癌因性疲乏的药物,所述药物包含如上所述中药组合物或如上所述方法制备获得的中药组合物。
在一些实施例中,所述药物还包括药物学上可接受的辅料。
在一些实施例中,所述药物的剂型为口服液、散剂、颗粒剂、片剂、胶囊剂、丸剂。
本发明还提供了如上所述的药物的制备方法,所述药物为颗粒剂或胶囊剂,包括以下步骤:将所述中药组合物浓缩成浸膏,加入辅料,制粒。
本发明还提供了如上所述的药物的制备方法,所述药物为片剂,包括以下步骤:将所述中药组合物浓缩成浸膏,加入辅料,制粒,压片。
本发明通过优化获得了一种能有效改善癌因性疲乏的中药组合物,其包含合适用量的黄芪、党参、茯苓、白术、淫羊藿、枸杞子、酒女贞子、陈皮、麦冬、五味子、炒酸枣仁和炙甘草,其以益气培元、补肾固本为主效,方中党参补中益气、健脾益肺,白术健脾燥湿,茯苓健脾渗湿,黄芪补气固表,共为君药,共奏益气健脾祛湿之功;淫羊藿温补肾阳,枸杞子、酒女贞子补益肝肾,三药共为臣药,以达补肾固本之效;麦冬养阴生津,陈皮理气健脾、燥湿化痰,炙甘草健脾和胃,益气复脉,并有调和诸药之功,三者共为佐药,使全方阴阳并补而不滋腻;五味子益气生津、补肾宁心,归肺、心、肾经,炒酸枣仁养心安神、敛汗醒脾、补肝、生津,二者为使药,有引诸药归经之功。与单纯使用化疗相比,所述中药组合物联合化疗能有效降低患者化疗期间的Piper疲乏评分,并明显改善气血两虚证患者的中医证候积分。同时,所述中药组合物安全性良好,适合在临床推广使用。
具体实施方式
本发明下列实施例中未注明具体条件的实验方法,通常按照常规条件,或按照制造厂商所建议的条件。实施例中所用到的各种常用化学试剂,均为市售产品。
除非另有定义,本发明所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本发明的说明书中所使用的术语只是为了描述具体的实施例的目的,不用于限制本发明。
本发明的术语“包括”和“具有”以及它们任何变形,意图在于覆盖不排他的包含。例如包含了一系列步骤的过程、方法、装置、产品或设备没有限定于已列出的步骤或模块,而是可选地还包括没有列出的步骤,或可选地还包括对于这些过程、方法、产品或设备固有的其它步骤。
在本发明中提及的“和/或”,描述关联对象的关联关系,表示可以存在三种关系,例如,A和/或B,可以表示:单独存在A,同时存在A和B,单独存在B这三种情况。
本实施例提供一种能有效改善癌因性疲乏的中药组合物(本发明称其为益元固本方),其包含合适用量的黄芪、党参、茯苓、白术、淫羊藿、枸杞子、酒女贞子、陈皮、麦冬、五味子、炒酸枣仁和炙甘草。其中有5种药材为多来源,例如可选品种如下表1:
表1
下面结合具体实施例进行说明。
实施例1
本实施例体提供一种益元固本水溶剂,组分为:黄芪25g,党参25g,茯苓15g,白术12g,淫羊藿10g,枸杞子12g,酒女贞子12g,陈皮5g,麦冬12g,五味子6g,炒酸枣仁15g,炙甘草10g。
将所述重量百分比的原料药混合,清洗后进行破碎处理。分别用8倍、6倍水冷凝回流提取2次,每次提取时间为1小时。合并提取液后进行粗滤,进一步用澄清剂进行澄清后细滤机进行过滤。通过过滤的汁液按国家有关饮料标准加以调配。后续采用真空脱气机进行脱气处理,采用高压匀质机进行匀质处理,采用巴氏杀菌法杀菌后冷却。采用真空法对所得液体进行浓缩,在无菌条件下进行灌装并密封,即制得水溶剂。
实施例2
本实施例体提供一种益元固本颗粒,组分为:黄芪25g,党参25g,茯苓15g,白术12g,淫羊藿10g,枸杞子12g,酒女贞子12g,陈皮5g,麦冬12g,五味子6g,炒酸枣仁15g,炙甘草10g。
将所述重量百分比的原料药混合,分别用8倍、6倍水冷凝回流提取2次,每次提取时间为1小时。合并提取液后浓缩至密度为1.2的浸膏,加入0.7倍的β-环糊精辅料,于烘箱70℃烘至干。添加适量80%乙醇作粘合剂,搅拌均匀后过20目筛子,于50℃烘至干,湿法制粒,即制得颗粒剂。
实施例3
本实施例体提供一种益元固本片,组分为:黄芪25g,党参25g,茯苓15g,白术12g,淫羊藿10g,枸杞子12g,酒女贞子12g,陈皮5g,麦冬12g,五味子6g,炒酸枣仁15g,炙甘草10g。
将所述重量百分比的原料药混合,分别用8倍、6倍水冷凝回流提取2次,每次提取时间为1小时。合并提取液后浓缩至密度为1.2的浸膏,加入0.7倍的β-环糊精辅料,于烘箱70℃烘至干。添加适量淀粉作为辅料,混匀,干法制粒,压片,即制得片剂。
实施例4
本实施例体提供一种益元固本胶囊,组分为:黄芪25g,党参25g,茯苓15g,白术12g,淫羊藿10g,枸杞子12g,酒女贞子12g,陈皮5g,麦冬12g,五味子6g,炒酸枣仁15g,炙甘草10g。
将所述重量百分比的原料药混合,分别用8倍、6倍水冷凝回流提取2次,每次提取时间为1小时。合并提取液后浓缩至密度为1.2的浸膏,加入0.7倍的β-环糊精辅料,于烘箱70℃烘至干。再加入适量淀粉作为辅料,混匀,干法制粒,制成胶囊剂。
实施例5
本实施例以本发明实施例2中的益元固本颗粒为例研究本发明益元固本方对癌因性疲乏的治疗效果。
(一)研究对象
2019年8月到2022年8月期间来自广州中医药大学第一附属医院肿瘤中心住院部ⅢB-Ⅳ期非小细胞肺癌患者,治疗前评估患者的RPFS评分(评分范围0分~10分),将符合癌因性疲乏诊断的患者纳入本研究。
(二)纳入标准
受试者须符合以下所有标准,才有资格入组本试验:
①经病理或细胞学诊断明确的Ⅲb-IV期非小细胞肺癌患者;
②符合癌因性疲乏诊断标准;
③驱动基因野生型或未知;
④中医辨证符合“脾肾亏虚”证诊断标准;
⑤计划或正在进行化疗过程中,预期后续化疗至少2程;
⑥年龄18~75岁;
⑦ECOG评分0~2分;
⑧签署临床试验知情同意书;
⑨未使用抗抑郁药物等精神药品≥1个月;
⑩愿意接受调查,文化层次要求调查对象可以独立填写调查问卷;意识清楚,无认知障碍。
(三)排除标准
①驱动基因阳性,并使用靶向药物,或使用PD-1或PD-L1等免疫检测点抑制剂的患者;
②对益元固本颗粒过敏者(包括对方内组成成分具有过敏史者);
③合并严重急性感染,伤口迁延不愈者;
④贫血:HGB<9g/L,或PLT<50×109/L;
⑤甲状腺功能异常;
⑥同时参加其他临床试验者;
⑦怀孕或哺乳期妇女;
⑧严重肝肾功能异常者(血肌酐≥1.5倍ULN;ALT或AST≥1.5倍ULN;胆红素≥1.5倍ULN);
⑨入组前两周以内使用激素、纠正贫血等相关改善疲乏药物的患者;
⑩入组前两周以内使用“人参”、“黄芪”、“茯苓”、“淫羊藿”、“巴戟天”等具有健脾或补肾作用中药的患者。
(四)脱落标准
①试验期间发生某些合并症、并发症、特殊生理变化或严重不良事件,不宜继续参加试验;
②受试者拒绝继续参加试验,并向研究者明确要求退出本试验;
③受试者未明确提出退出试验,但因各种原因而失访。
(五)脱落病例的处理
①中途退出病例或失访病例:尽可能与受试者联系,询问理由,尽可能获取评价所需的资料;
②因不良事件或不良反应退出的病例:根据实际情况,采取相应治疗措施,保存资料以备分析。
(六)研究方法
①分组
以肺癌类型为分层因素,按分层随机方法将受试者按1:1比例分配到益元固本组和对照组。
②干预方案
益元固本组:益元固本颗粒+含铂双药方案化疗
对照组:含铂双药方案化疗
用药方法、剂量:
含铂双药方案化疗,鳞癌,DP方案(多西紫杉醇75mg/m2第1天,顺铂25mg/m2第1~3天或者卡铂AUC5~6,第1天);腺癌,AP方案(培美曲塞500mg/m2第1天,顺铂25mg/m2第1~3天或者卡铂AUC5~6,第1天),21天为1个周期,连用2个周期。
益元固本颗粒,连续21天,每次20g,每日2次,早晚餐后服用。第2个周期重复。2个周期共服药42天。
(七)观察项目及指标
①患者基线资料(入组前进行采集),包括人口学资料、肿瘤的诊断和治疗信息及既往/伴随疾病情况;
②疗效指标(第2周期化疗后第21±3天进行采集):主要结局指标为RPFS评分及疗效评价,次要结局指标为中医原发性肺癌症状积分;
③安全性指标(第2周期化疗第21±3天检测):血分析,电解质,肝肾功能、心电图等。
(八)数据处理与统计分析
所有数据采用SPSS22.0统计软件进行处理及统计学分析。所有计量资料以均数±标准差表示,两组间均值比较采用两个独立样本的t检验,干预前后自身对照均值比较,采用配对t检验,计数资料采用卡方检验。P<0.05为差异有统计学意义。
(九)研究结果
①试验完成情况
本研究共纳入广州中医药大学第一附属医院肿瘤中心住院的非小细胞肺癌患者105例,其中益元固本组45例,对照组46例。
②Piper疲乏量表评分
组间比较:在治疗前,益元固本组与对照组RPFS评分差异无统计学意义(4.50±1.52 VS 3.89±1.56,P>0.05),提示两组患者的疲乏评分具有均衡性;治疗后,治疗后益元固本组RPFS评分明显低于对照组且差异有显著统计学意义(3.80±1.34 VS 6.54±1.54,P<0.001),提示益元固本颗粒联合化疗较单用化疗能减轻患者疲乏。具体如表2所示:
表2两组治疗前后RPFS评分组间比较情况
注:***P<0.001
组内自身前后比较:对照组治疗后的RPFS评分较治疗前明显上升且差异具有统计学意义(3.89±1.56 VS 6.54±1.54,P<0.001),提示化疗能加重患者的疲乏程度。益元固本组治疗后RPFS评分较治疗前有降低,差异有统计学意义(4.50±1.52 VS 3.80±1.34,P<0.05),提示益元固本颗粒能改善患者的疲乏。具体如表3所示:
表3两组治疗前后Piper评分自身对照情况
注:*P<0.05,***P<0.001
③中医原发性肺癌症状积分
组间比较:在治疗前,益元固本组与对照组中医原发性肺癌症状积分差异无统计学意义(11.58±4.57 VS 12.67±4.08,P>0.05),提示两组患者的中医症状积分具有均衡性;治疗后,治疗后益元固本组中医症状积分明显低于对照组且差异有显著统计学意义(12.13±2.94 VS 16.30±4.67,P<0.001),提示益元固本颗粒联合化疗较单用化疗能改善患者中医症状。具体如表4所示:
表4两组治疗前后中医原发性肺癌症状积分比较情况
注:***P<0.001
组内自身前后比较:对照组治疗后的中医原发性肺癌症状积分较治疗前明显上升且差异具有统计学意义(16.30±4.67VS12.67±4.08,P<0.001),提示化疗能加重患者的中医症状。益元固本组治疗后中医症状积分于治疗前差别不大(12.13±2.94VS11.58±4.57,P>0.05),提示益元固本颗粒能稳定化疗期间的中医症状。具体如表5所示:
表5两组治疗前后中医原发性肺癌症状积分自身对照情况
注:***P<0.001
⑥安全性指标
所有患者用药前后均进行了心电图、血常规、肝肾功能、尿组合等常规检查,未发现有临床意义的异常改变。3例患者出现了轻度腹泻,停药后症状消失。
⑦结论
应用益元固本颗粒治疗肺癌化疗相关性疲乏有明确的疗效,尤其可以改善脾肾亏虚证患者的RPFS评分,稳定化疗期间的中医症状积分。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对以上实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (10)
1.一种防治癌因性疲乏的中药组合物,其特征在于,所述中药组合物的活性成分由以下质量百分含量的原料制备而成:黄芪15~20%,党参15~20%,茯苓7~12%,白术7~12%,淫羊藿6~10%,枸杞子7~12%,酒女贞子7~12%,陈皮3~6%,麦冬7~12%,五味子3~6%,炒酸枣仁7~12%,炙甘草6~10%。
2.如权利要求1所述的中药组合物,其特征在于,所述中药组合物的活性成分由以下质量百分含量的原料制备而成:黄芪12~20%,党参12~20%,茯苓8~12%,白术6~10%,淫羊藿6~10%,枸杞子6~10%,酒女贞子6~10%,陈皮1~5%,麦冬6~10%,五味子3~5%,炒酸枣仁6~10%,炙甘草4~8%。
3.如权利要求1所述的中药组合物,其特征在于,所述中药组合物的活性成分由以下质量百分含量的原料制备而成:黄芪15~17%,党参15~17%,茯苓8~10%,白术7~9%,淫羊藿6~8%,枸杞子7~9%,酒女贞子7~9%,陈皮2~4%,麦冬7~9%,五味子3~4%,炒酸枣仁8~10%,炙甘草6~8%。
4.如权利要求1~3任一项所述中药组合物的制备方法,其特征在于,包括以下步骤:按比例称取黄芪、党参、茯苓、白术、淫羊藿、枸杞子、酒女贞子、陈皮、麦冬、五味子、炒酸枣仁和炙甘草,用提取溶剂进行提取,收集提取液,浓缩。
5.如权利要求4所述的制备方法,其特征在于,所述提取溶剂为水;和/或,所述提取为煎煮提取。
6.一种防治癌因性疲乏的药物,其特征在于,所述药物包含如权利要求1~3任一项所述中药组合物或如权利要求4~5任一项所述方法制备获得的中药组合物。
7.如权利要求6所述的药物,其特征在于,所述药物还包括药物学上可接受的辅料。
8.如权利要求6所述的药物,其特征在于,所述药物的剂型为口服液、散剂、颗粒剂、片剂、胶囊剂、丸剂。
9.如权利要求6~8任一项所述的药物的制备方法,其特征在于,所述药物为颗粒剂或胶囊剂,包括以下步骤:将所述中药组合物浓缩成浸膏,加入辅料,制粒。
10.如权利要求6~8任一项所述的药物的制备方法,其特征在于,所述药物为片剂,包括以下步骤:将所述中药组合物浓缩成浸膏,加入辅料,制粒,压片。
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