CN108686034A - 一种拮抗肿瘤化疗后骨髓抑制的中药组合物及制备方法 - Google Patents
一种拮抗肿瘤化疗后骨髓抑制的中药组合物及制备方法 Download PDFInfo
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Abstract
一种拮抗肿瘤化疗后骨髓抑制的中药组合物及制备方法,该中药组合物由下述原料组成,将一定量黄芪、桂枝、炒白芍、炙甘草、大枣、当归、熟地、川芎、制首乌、鸡血藤、枸杞、红花、大蓟、小蓟、生地榆、鹿角胶、紫河车、侧柏叶混合,得到混合料,加8‑12倍水,在常温下浸泡2小时以上,然后在100℃下煎煮1‑3小时,反复煎煮2‑3次,过滤,合并,将滤液灭菌,冷却至室温后,包装。本发明为临床验方,疗效显著,可以有效拮抗肿瘤患者化疗后骨髓抑制,快速提升患者不同血项成分,同时防止发热、乏力、出血、周身酸楚等肿瘤伴发症状的发生,提高肿瘤患者的免疫功能,进而提高了肿瘤患者整体临床满意度。提高患者生活质量,值得临床推广应用。
Description
技术领域
本发明涉及抗肿瘤中成药制备技术领域,具体涉及一种拮抗肿瘤化疗后骨髓抑制的中药组合物及制备方法。
背景技术
近些年来,肿瘤的发病率呈持续性上升趋势,当下化疗在恶性肿瘤综合治疗中的作用举足轻重。但因为正常细胞和恶性肿瘤细胞之间没有根本性代谢差异,所以大多数抗肿瘤药物在杀灭肿瘤细胞的同时也损伤正常细胞,其中对增殖较快的骨髓造血干细胞的损伤最为显著,导致外周血以白细胞为主的全血细胞降低,从而导致患者免疫力低下,易出现感染,贫血,甚至出血等多种临床不良后果,严重阻碍了肿瘤患者的临床治疗。大量肿瘤病人在出现骨髓抑制后化疗无法继续进行,最终导致患者无法有效完成专科治疗致使病情失控。
防治骨髓抑制已成为研究热点,现代医学多着眼于造血过程的某一因素、某一环节,治疗过程中个体差异大,缺乏整体性,主要手段包括:造血细胞集落刺激因子、粒细胞集落刺激因子、促血小板生成素、重组人白介素-11等。但此类药物很容易加速耗竭造血干细胞,大量长期使用会导致真性红细胞增多和慢性粒细胞白血病等发病风险,并刺激某些肿瘤细胞增值和转移、抑制细胞免疫功能;成分输血,有严格适应症,副反应较多,如发热、血源性感染等风险;升血药物如利血生、鲨肝醇、咖啡酸片等,此类药对造血系统的促进作用较慢,难以收获满意疗效;其他还有小剂量激素疗法,如地塞米松,但疗效不可靠,副反应大,而且可能刺激肿瘤进展;脐血输注、胚胎干细胞移植等技术要求高,费用昂贵,限制其广泛应用。
中医中药在骨髓抑制的治疗中具有一定优势,并以疗效明显、副作用小,服用方便为特色逐渐被广大肿瘤患者所认可。本专利所用方剂综合经典方剂及现代药理成果进行创新,通过补气养血,调补中焦,生精益髓并联合清热凉血止血的治法,在骨髓抑制的治疗上取得了较好的临床效果,不但可改善肿瘤患者化疗后骨髓抑制状态,同时也降低了患者发热、乏力、周身酸楚等肿瘤伴发症状出现的概率,进而提高了肿瘤患者整体临床满意度。其组方特色如下:
1、该组方创造性地在补气养血,调补中焦,生精宜髓的基础上创造性地联合了清热凉血止血中药,在骨髓抑制治疗过程中能有效降低患者继发感染及出血的概率,有利于提高患者的整体疗效,降低临床治疗风险。
2、该组方注重调补中焦,顾护脾胃功能,补益气血不雍滞,易于补血成分有效吸收,进而促进血液组分的提高。
3、该组方注重精血同源的重要性,通过温阳生髓补血的作用使因骨髓抑制导致的血细胞成分下降情况得到明显临床改善。
发明内容
针对背景技术提到的的技术缺陷,本发明的目的是提供一种通过补气养血,调补中焦,清热止血方式拮抗肿瘤化疗后骨髓抑制的中药及其制备方法。
一种拮抗肿瘤化疗后骨髓抑制的中药组合物,它包括以下原料及重量份所组成:
黄芪45-55份、桂枝10-20份、炒白芍25-35份、炙甘草5-15份、大枣5-15份、当归25-35份、熟地10-20份、川芎5-15份、制首乌15-25份、鸡血藤45-55份、枸杞10-20份、红花1-10份大蓟10-20份、小蓟10-20份、生地榆45-55份、鹿角胶5-15份、紫河车5-15份、侧柏叶25-35份。
作为本发明的进一步方案,所述中药组合为:
黄芪48-52份、桂枝13-17份、炒白芍28-32份、炙甘草8-12份、大枣8-12份、当归28-32份、熟地13-17份、川芎8-12份、制首乌18-22份、鸡血藤48-52份、枸杞13-17份、红花3-7份、大蓟13-17份、小蓟13-17份、生地榆48-52份、鹿角胶8-12份、紫河车8-12份、侧柏叶28-32份。
作为本发明的进一步方案,所述中药组合为:
黄芪50份、桂枝15份、炒白芍30份、炙甘草10份、大枣10份、当归30份、熟地15份、川芎10份、制首乌20份、鸡血藤50份、枸杞15份、红花5份、大蓟15份、小蓟15份、生地榆50份、鹿角胶10份、紫河车10份、侧柏叶30份。
一种治疗肿瘤化疗后骨髓抑制的中药的制备方法:将黄芪、桂枝、炒白芍、炙甘草、大枣、当归、熟地、川芎、制首乌、鸡血藤、枸杞、红花、大蓟、小蓟、生地榆、鹿角胶、紫河车、侧柏叶混合,得到混合料,加8-12倍水,在常温下浸泡2小时以上,然后在100℃下煎煮1-3小时,反复煎煮2-3次,过滤,合并,将滤液灭菌,冷却至室温,包装后即为成品。
药理学分析
骨髓抑制病机及组方制法制则分析:
80%患者在肿瘤放化疗过程中均会出现骨髓抑制,肿瘤患者在接受化学治疗过程中会影响骨髓干细胞的增殖,进而导致不同类型血细胞分化增殖受限,引发不同种类血细胞成分下降,致使患者体内红细胞、白细胞、血小板等血项成分降低,从而出现恶性贫血、出血、免疫机制下降等现象。其中,白细胞减少最为突出,会削弱人体免疫能力,临床常出现严重的感染和恶性合并症。根据放化疗后出现骨髓抑制的临床症状,如头晕、乏力、腰膝酸软或易外感发热及出血等,中医将本病归为“虚劳”、“血虚”、“血劳”、“血证”等范畴。大多学者将骨髓抑制的病理状态归结为“脾肾两虚、气血不足、瘀血搏结”。
方中以黄芪、炙甘草、大枣健脾补中,佐以紫河车、熟地、制首乌之品补肾填精,并配合当归、鹿角胶、白芍、鸡血藤之品补血,共奏调补中焦、补气养血之功效。首创配以清热解毒、散瘀解毒消痈、凉血止血的大蓟、小蓟、侧柏叶,可促进凝血因子生成、增加血小板数目,止血同时防止感染。生地榆可解毒敛疮,提升白细胞数目并防止感染。本方剂在健脾补中、补肾填精、益气养血治疗基础上,增加了凉血止血,解毒消痈的中药应用,从而对骨髓抑制的出血、继发感染起到了预防和治疗作用,对白系和红系血项成分的提高亦有明显的促进作用,对骨髓抑制患者不同血项成分均有明显的提升作用。
本发明的独创性:本发明首次在传统治疗基础上,应用凉血止血、解毒消痈类的大蓟、小蓟、侧柏叶,对骨髓抑制继发感染、出血证起到了预防和治疗作用,同时也有效促进了骨髓抑制患者不同类型血项的提升。
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。
具体实施方式
实施例1
一种拮抗肿瘤化疗后骨髓抑制的中药组合物,由以下重量份的原料组成:
黄芪45份、桂枝10份、炒白芍25份、炙甘草5份、大枣5份、当归25份、熟地10份、川芎5份、制首乌15份、鸡血藤45份、枸杞10份、红花1份大蓟10份、小蓟10份、生地榆45份、鹿角胶5份、紫河车5份、侧柏叶25份。
一种治疗肿瘤化疗后骨髓抑制的中药的制备方法:
将黄芪、桂枝、炒白芍、炙甘草、大枣、当归、熟地、川芎、制首乌、鸡血藤、枸杞、红花、大蓟、小蓟、生地榆、鹿角胶、紫河车、侧柏叶混合,得到混合料,加8-12倍水,在常温下浸泡2小时以上,然后在100℃下煎煮1-3小时,反复煎煮2-3次,过滤,合并,将滤液灭菌,冷却至室温后,包装即为成品。
本实例所提供的中药使用方法:
上述中药在化疗前三日开始服用,至整个化疗周期结束后两周停药,每次200ml,每日早中晚日三次口服,每2周为一疗程。
依据诊断:骨髓抑制程度根据WHO标准分为0——IV级
WBC | Hb | PLT | |||
0级 | ≥4.0×109/L | ≥110g/L | ≥100×109/L | ||
Ⅰ级 | (3.0—3.9)×109/L | 95—100g/L | (75—99)×109/L | ||
Ⅱ级 | (2.0—2.9)×109/L | 80—94g/L | (50—74)×109/L | ||
Ⅲ级 | (1.0—1.9)×109/L | 65—79g/L | (25—49)×109/L | ||
IV级 | (0—1.0)×109/L | <65g/L | <25×109/L |
疗效评价:但凡符合骨髓抑制I—IV级标准患者皆可考虑服此方剂进行治疗。治疗周期为14天,治疗后以外周血计数及骨髓抑制症状、体征改善程度作为疗效评价的主要指标,并参照2012年版《中药新药治疗恶性肿瘤临床研究技术指导原则》之“中药新药治疗骨髓抑制的临床研究指导原则”进行制定。
显效:脱离接触致病因素后,连续2次血细胞计数正常范围或III级及III级以上骨髓抑制血细胞计数较未治疗者提高200%,并持续2周以上;骨髓抑制症状、体征明显改善者。
有效:脱离接触致病因素后,连续2次血细胞计数。I级、II级恢复正常,或III级、IV级骨髓抑制改善程度较未治疗者提高100%;骨髓抑制症状、体征有所改善者。
无效:血细胞计数无明显改善,骨髓抑制症状、体征无明显好转。
本发明具有理论及临床依据。本发明系临床辨证施治过程中研发成果,是临床卓有疗效的经验方,对化疗后的骨髓抑制现象有明显治疗效果。临床中共收集126例不同程度化疗后骨髓抑制患者,年龄分布在45-70岁之间,患者中男性61例,女性65例,其中I级33例,II级42例,III级28例,IV级23例。经过中药复方治疗后疗效数据如下表所示:
总数(例) | 显效(例) | 有效(例) | 无效(例) | |
I级 | 33 | - | 33 | 0 |
II级 | 42 | - | 40 | 2 |
III级 | 28 | 9 | 16 | 3 |
IV级 | 23 | 7 | 11 | 5 |
(注:I级、II级骨髓抑制患者疗效按有效标准计算。)
经统计计算显示:126例骨髓抑制患者中经过该复方中药制剂治疗2周后,显效患者占患者总数12.70%,总有效率(显效+有效)高达92.06%。
显效病例:
患者戴某,66岁,男性患者,2016年初发现肺门占位,经支气管镜活检诊断为“小细胞肺癌”,予EP方案进行第一程化疗后出现III度骨髓抑制,查血细胞分析:WBC:1.8×109/L,PLT:39×109/L,患者合并严重咯血,经该中药组合物按实施例1制备后服用一周复查血细胞分析,WBC:6.9×109/L,PLT:380×109/L,患者咯血症状得以控制。此后患者继续服用该中药组合物制剂,并继续进行余下5程化疗治疗,历次复查血细胞分析均未再发生骨髓抑制,患者亦无骨髓抑制相关临床表现。化疗结束后评价疗效:CR。影像学回报:肺门未见明显占位性改变。
实施例2
黄芪55份、桂枝20份、炒白芍35份、炙甘草15份、大枣15份、当归35份、熟地20份、川芎15份、制首乌25份、鸡血藤55份、枸杞20份、红花10份、大蓟20份、小蓟20份、生地榆55份、鹿角胶15份、紫河车15份、侧柏叶35份。
制备方法同实施例1。
实施例3
黄芪48份、桂枝13份、炒白芍28份、炙甘草8份、大枣8份、当归28份、熟地13份、川芎8份、制首乌18份、鸡血藤48份、枸杞13份、红花3份、大蓟13份、小蓟13份、生地榆48份、鹿角胶8份、紫河车8份、侧柏叶28份。
制备方法同实施例1。
实施例4
黄芪52份、桂枝17份、炒白芍32份、炙甘草12份、大枣12份、当归32份、熟地17份、川芎12份、制首乌22份、鸡血藤52份、枸杞17份、红花7份、大蓟17份、小蓟17份、生地榆52份、鹿角胶12份、紫河车12份、侧柏叶32份。
制备方法同实施例1。
实施例5
黄芪50份、桂枝15份、炒白芍30份、炙甘草10份、大枣10份、当归30份、熟地15份、川芎10份、制首乌20份、鸡血藤50份、枸杞15份、红花5份、大蓟15份、小蓟15份、生地榆50份、鹿角胶10份、紫河车10份、侧柏叶30份。
制备方法同实施例1。
Claims (6)
1.一种拮抗肿瘤化疗后骨髓抑制的中药组合物,它包括以下原料及重量份所组成:
黄芪45-55份、桂枝10-20份、炒白芍25-35份、炙甘草5-15份、大枣5-15份、当归25-35份、熟地10-20份、川芎5-15份、制首乌15-25份、鸡血藤45-55份、枸杞10-20份、红花1-10份大蓟10-20份、小蓟10-20份、生地榆45-55份、鹿角胶5-15份、紫河车5-15份、侧柏叶25-35份。
2.根据权利要求1所述的中药组合物,其特征在于:所述的原料及重量份为:黄芪48-52份、桂枝13-17份、炒白芍28-32份、炙甘草8-12份、大枣8-12份、当归28-32份、熟地13-17份、川芎8-12份、制首乌18-22份、鸡血藤48-52份、枸杞13-17份、红花3-7份、大蓟13-17份、小蓟13-17份、生地榆48-52份、鹿角胶8-12份、紫河车8-12份、侧柏叶28-32份。
3.根据权利要求1所述的中药组合物,其特征在于:所述的原料及重量份为:黄芪50份、桂枝15份、炒白芍30份、炙甘草10份、大枣10份、当归30份、熟地15份、川芎10份、制首乌20份、鸡血藤50份、枸杞15份、红花5份、大蓟15份、小蓟15份、生地榆50份、鹿角胶10份、紫河车10份、侧柏叶30份。
4.一种拮抗肿瘤化疗后骨髓抑制的中药组合物制备方法,其特征在于:先将黄芪、桂枝、炒白芍、炙甘草、大枣、当归、熟地、川芎、制首乌、鸡血藤、枸杞、红花、大蓟、小蓟、生地榆、鹿角胶、紫河车、侧柏叶按下述的重量份充分混合,得到混合料,加8-12倍水,在常温下浸泡2小时以上,然后在100℃下煎煮1-3小时,反复煎煮2-3次,过滤,合并,将滤液灭菌,冷却至室温,包装后即为成品;所述黄芪45-55份、桂枝10-20份、炒白芍25-35份、炙甘草5-15份、大枣5-15份、当归25-35份、熟地10-20份、川芎5-15份、制首乌15-25份、鸡血藤45-55份、枸杞10-20份、红花1-10份大蓟10-20份、小蓟10-20份、生地榆45-55份、鹿角胶5-15份、紫河车5-15份、侧柏叶25-35份。
5.根据权利要求4所述的中药组合物制备方法,其特征在于:所述黄芪48-52份、桂枝13-17份、炒白芍28-32份、炙甘草8-12份、大枣8-12份、当归28-32份、熟地13-17份、川芎8-12份、制首乌18-22份、鸡血藤48-52份、枸杞13-17份、红花3-7份、大蓟13-17份、小蓟13-17份、生地榆48-52份、鹿角胶8-12份、紫河车8-12份、侧柏叶28-32份。
6.根据权利要求4所述的中药组合物制备方法,其特征在于:所述黄芪50份、桂枝15份、炒白芍30份、炙甘草10份、大枣10份、当归30份、熟地15份、川芎10份、制首乌20份、鸡血藤50份、枸杞15份、红花5份、大蓟15份、小蓟15份、生地榆50份、鹿角胶10份、紫河车10份、侧柏叶30份。
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