CN112891492A - 一种中药首乌益髓组合物及其胶囊和膏剂的制备方法 - Google Patents
一种中药首乌益髓组合物及其胶囊和膏剂的制备方法 Download PDFInfo
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- CN112891492A CN112891492A CN202110391070.4A CN202110391070A CN112891492A CN 112891492 A CN112891492 A CN 112891492A CN 202110391070 A CN202110391070 A CN 202110391070A CN 112891492 A CN112891492 A CN 112891492A
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Abstract
本发明提供了一种中药首乌益髓组合物及其胶囊和膏剂的制备方法。该原料包括首乌、熟地、山茱萸、桑葚、枸杞、当归、白芍、阿胶、紫河车、红芪、人参、天门冬、麦门冬、生地、砂仁、女贞子、仙鹤草、丹皮、大枣和炙甘草。制备方法包括研末、煎煮、取清液、浓缩清液、收膏。本发明的有益效果：更加方便患者使用，能够促进早期干细胞阶段血细胞恢复，提高骨髓抑制期血细胞水平，并通过促进T淋巴细胞的生成来增强机体自身的抗肿瘤免疫反应。而且能够增强化疗疗效。
Description
技术领域
本发明涉及中药组合物领域，具体来说，涉及急性髓系白血病骨髓抑制治疗领域，更具体来说，涉及一种中药首乌益髓组合物及其胶囊和膏剂的制备方法。
背景技术
化疗是急性髓系白血病(AML)的主要治疗手段，也是其他治疗的基础。但大剂量强化疗的副作用又必然导致骨髓抑制，引起长时间的粒细胞缺乏、细胞和体液免疫功能损伤，最终导致严重的感染和发热，危及患者生命。对于骨髓抑制的防治,以往临床常用鲨肝醇、利血生、维生素B4等,疗效甚差。生长因子如粒细胞集落刺激因子(G-CSF)已广泛用于临床,是目前化疗后骨髓抑制期白细胞降低的主要药物,该类药物的优势是起效快,但缺点是疗效不稳定,很多患者多次使用后无效，而且还可出现骨髓衰竭、白血病细胞骨转移、发热、骨痛等严重副反应,导致无法正常使用。国内采用中医及中西医结合治疗骨髓抑制，多采用补肾益髓方药为主，补肾方药能够缩短骨髓抑制期，促进免疫细胞生成及减轻化疗活化损伤来恢复机体自身的抗肿瘤免疫反应，并提高造血干细胞的正性调控因子生成促进骨髓造血恢复。本法的优点为服用方便，疗效稳定，无明显不良反应，根据10余年的观察统计，急性髓系白血病化疗过程中配合中医治疗能够明显提高骨髓恢复效果。
T细胞免疫应答是最具有重要意义的特异性抗肿瘤免疫反应。急性白血病患者免疫功能紊乱，表现为CD3+(T淋巴细胞总数)、CD4+(T辅助细胞或Th)及CD4+/CD8+(T抑制细胞或Ts)降低。CD4+细胞为免疫应答中的主要反应细胞,具有增强和扩大其他免疫细胞的功能,CD8+细胞可对靶细胞产生细胞介导的细胞毒作用,同时对CD4+细胞具有调节性免疫抑制作用,CD4+/CD8+的稳定比例维持着细胞免疫反应的平衡。白介素-3(IL-3)能促进多能干细胞增殖，为造血干细胞的正性调控因子，主要由活化的T细胞分泌而成，AML患者体内IL-3水平明显降低。白血病细胞在机体内扩增竞争性生长抑制正常造血细胞，因此白血病细胞分泌的调控因子具有量的优势。白血病细胞能自身分泌粒细胞-巨噬细胞集落刺激因子(GM-CSF)，所以AML患者体内GM-CSF水平升高。
现代医学在治疗AML化疗后骨髓抑制存在局限性，发明人结合传统中医学进行了系统研究，目前诸多中医补肾中药方效果并不明显，难以长期维持治疗，主要原因是多数研究者未能摒弃化疗思维，采用峻烈攻下药导致骨髓抑制期患者难以耐受，不注意分期论治。申请人认为治疗急性髓系白血病化疗所致骨髓抑制，当以补益正气为主，兼顾解毒驱邪。首先分清脏腑，重视肝脾肾的作用，因肾为先天之本，内寓元阴元阳，肝与肾同源且助血气生成，脾为后天之本，气血化生之源，药毒入侵，肝脾肾三脏亏虚则导致气血阴阳亏虚，脏腑功能紊乱。因此该病的发生与肝、脾、肾关系最为密切。
发明内容
本发明的目的是提供一种中药首乌益髓组合物。该中药首乌益髓组合物由包括如下重量份的原料制得：首乌50份、熟地30份、山茱萸25份、桑葚30份、枸杞30份、当归30份、白芍30份、阿胶15份、紫河车20份、红芪40份、人参20份、天门冬20份、麦门冬30份、生地30份、砂仁10份、女贞子20份、仙鹤草30份、丹皮20份、大枣25份、炙甘草20份。
本发明创新性地发现使用特定重量份的首乌、熟地、山茱萸、桑葚、枸杞、当归、白芍、阿胶、紫河车、红芪、人参、天门冬、麦门冬、生地、砂仁、女贞子、仙鹤草、丹皮、大枣和炙甘草制得的首乌益髓组合物较现有的益血生胶囊有更好的临床效果，特别在AML化疗后白细胞减低的患者中。
在本发明中，将中药首乌益髓组合物制成本领域中常用的制剂形式，如颗粒、丸剂、胶囊、膏剂、口服液、悬浮液，在本发明中，优选为胶囊、膏剂。
在本发明中，中药首乌益髓组合物中1重量份为1g计。
本发明的胶囊的制备方法：将上述中药成分研磨成药末状，备好淀粉胶囊皮，每个胶囊皮中灌注0.45g研磨好的药末。
本发明的膏剂的制备方法：
1)煎煮：称取若干所述中药首乌益髓组合物，将不含阿胶的中药首乌益髓组合物先泡制30分钟，然后加水煮沸，2小时后提取药液，重复上述过程2次，将三次煎煮的药液合并；加入的水的总量为不含阿胶的中药首乌益髓组合物重量的10倍；
2)取清液：将合并的药液过滤并静置1小时，取上清液；
3)浓缩清液：将清液放入蒸发锅中，先以大火煮沸，取出上层浮沫，待清液变浓时，改用文火保持微沸，不断搅拌浓缩，直至变成稠膏状，以沾取少许滴于滤纸上，无渗润水迹则停止，此时清膏制成；
4)收膏：将阿胶，并另取蜂蜜适量烊化后缓慢加入上述清膏中，并搅拌混匀，直至用棒挑起膏剂呈薄片状流下，取出，冷却后装入清洁干燥灭菌后的广口瓶内，密封备用。
本发明的另一目的在于提供上述中药首乌益髓组合物在急性髓系白血病化疗后骨髓抑制中的应用。急性早幼粒细胞白血病因诱导分化剂的出现，治疗上与其他类型急性髓系白血病有明显不同，因此将其排除在外。
在本发明中，中药首乌益髓组合物中首乌，苦涩而温，苦补肾，温补肝；人参甘温，可峻补元气；熟地滋补肝肾，填精益髓；当归润燥补血，又可宣通气分；麦冬甘寒，养阴润肺，清心除烦；天冬润肺清心，泻热除烦，滋阴生津；阿胶甘平，平补而润，既可滋阴补血，止血清热，又可填精固肾；桑椹、女贞子补肾乌须，强腰明目，安合五脏；枸杞子滋肾益肝，生精助阳，益阴除烦；山萸肉酸温，补肾温肝，固精秘气，安五脏，暖腰膝；白芍苦酸，微寒，补血泻肝，敛阴缓中；红芪大补脾肺之气；牡丹皮清热凉血，活血化瘀；生地，泻丙火、清燥金，入心肾血分；仙鹤草收敛止血，补虚消积；枣、草健脾和中；砂仁苦温，行气调中，和胃醒脾。全方肝脾肾三脏兼顾，临床效果显著。
本发明的有益效果：本发明更加方便患者使用，临床中能够促进早期干细胞阶段血细胞恢复，提高骨髓抑制期血细胞水平，并通过促进T淋巴细胞的生成来增强机体自身的抗肿瘤免疫反应。而且能够增强化疗疗效。
具体实施方式
下面结合实施例，对本发明的具体实施方式进一步详细描述，所描述的实施例仅仅是本发明的一部分实施例，而不是全部的实施例。基于本发明的实施例，本领域普通技术人员所获得的所有其他实施例，都属于本发明的保护范围。
本实施例中所用技术手段为本领域技术人员所熟知的常规手段，所用原料均为市售商品。
本实施例提供了一种中药首乌益髓组合物，包括以下重量组份的药料：
首乌50份、熟地30份、山茱萸25份、桑葚30份、枸杞30份、当归30份、白芍30份、阿胶15份、紫河车20份、红芪40份、人参20份、天门冬20份、麦门冬30份、生地30份、砂仁10份、女贞子20份、仙鹤草30份、丹皮20份、大枣25份、炙甘草20份。
在一个具体的实施例中，选取如下重量组分的药料：
首乌50g、熟地30g、山茱萸25g、桑葚30g、枸杞30g、当归30g、白芍30g、阿胶15g、紫河车20g、红芪40g、人参20g、天门冬20g、麦门冬30g、生地30g、砂仁10g、女贞子20g、仙鹤草30g、丹皮20g、大枣25g、炙甘草20g。
一种中药首乌益髓组合物的胶囊的制备方法：将上述中药成分研磨成药末状，备好淀粉胶囊皮，每个胶囊皮中灌注0.45g研磨好的药末。
一种中药首乌益髓组合物的膏剂的制备方法：
1)煎煮：称取若干所述中药首乌益髓组合物，将不含阿胶的中药首乌益髓组合物先泡制30分钟，然后加水煮沸，2小时后提取药液，重复上述过程2次，将三次煎煮的药液合并；加入的水的总量为不含阿胶的中药首乌益髓组合物重量的10倍；
2)取清液：将合并的药液过滤并静置1小时，取上清液；
3)浓缩清液：将清液放入蒸发锅中，先以大火煮沸，取出上层浮沫，待清液变浓时，改用文火保持微沸，不断搅拌浓缩，直至变成稠膏状，以沾取少许滴于滤纸上，无渗润水迹则停止，此时清膏制成；
4)收膏：将阿胶，并另取蜂蜜适量烊化后缓慢加入上述清膏中，并搅拌混匀，直至用棒挑起膏剂呈薄片状流下，取出，冷却后装入清洁干燥灭菌后的广口瓶内，密封备用。
对中药首乌益髓组合物的疗效进行实验性研究，具体研究如下：
1.一般资料：选择我院AML(M3除外)患者60例，按入院先后随机分为空白组、对照组、治疗组各20例。
1.1纳入标准临床病例诊断符合AML诊断标准，化疗后达到完全缓解(CR)。骨髓原+幼粒小于等于5％，或原+幼单小于等于5％，红细胞和巨核细胞系统正常，化疗后临床上无白血病细胞浸润所致的症状和体征，生活正常或接近正常，血象完全恢复或基本恢复。
1.2治疗方法所有病例均给予DA、MA、IA等常规序贯化疗及支持治疗等常规药物。
空白组给予常规化疗；
对照组在常规化疗开始的基础上服用益血生胶囊(吉林敖东珠海药业有限公司，国药准字Z19983056)，每次4粒，每日3次口服，共4周；
治疗组在常规化疗的基础上服用中药首乌益髓胶囊，每次4粒，每日3次口服，共4周。
2.观察指标
2.1外周血象检测白细胞(WBC)、血红蛋白(Hb)、血小板(PLT)、中性粒细胞绝对值(NE#)于化疗前、化疗后1d及化疗后21d各检查1次。
2.2T淋巴细胞(Tc)亚群水平检测，CD3+、CD4+、CD8+于化疗前，化疗后1d各检查1次，均采集患者外周静脉血2mL，采用流式细胞术(FCM)直接免疫法检测。
2.3细胞因子检测，IL-3、GM-CSF于化疗前、化疗后21d各检测1次。
采集外周静脉血4mL，2800r/min离心6min，分离血清，－80℃保存。采用酶联免疫(ELISA)法检测。
3.统计学处理检测结果采用SPSS 22.0统计软件进行统计学处理，数据进行正态性及方差齐性检验，在此基础上进行t检验或t＇检验。以P<0.05为差异有统计学意义，以P<0.01为差异有极显著意义。
实验结果：
表1 3组患者治疗后血常规变化
可以看出，中药首乌益髓胶囊在促进白细胞恢复上具有明显疗效，优于对照组、空白组。促进红细胞恢复上同样具有很好疗效。
注:组内对比，*P<0.05，**P<0.01；与空白组组间对比，▲P<0.05
表2 2组患者治疗后T淋巴细胞亚群变化
可以看出，中药首乌益髓胶囊能提高CD3、CD4免疫细胞数量，改善患者免疫功能。
表3 3组患者治疗后IL-3、GM-CSF表达水平
可以看出，中药首乌益髓胶囊能够提高IL-3的生成，促进骨髓造血恢复。AML患者体内GM-CSF水平的高低能够在一定程度上反映化疗效果，可以看到，中药首乌益髓胶囊能够提高化疗疗效。
结论：本发明更加方便患者服用，中药首乌益髓组合物能够刺激骨髓造血恢复，特别是在白细胞、红细胞恢复水平上，并且能通过促进T淋巴细胞的生成增强机体免疫功能，而且能够提高化疗疗效。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (5)
1.一种中药首乌益髓组合物，其特征在于，由包括如下重量份的原料组成：
首乌50份、熟地30份、山茱萸25份、桑葚30份、枸杞30份、当归30份、白芍30份、阿胶15份、紫河车20份、红芪40份、人参20份、天门冬20份、麦门冬30份、生地30份、砂仁10份、女贞子20份、仙鹤草30份、丹皮20份、大枣25份、炙甘草20份。
2.一种如权利要求1所述的中药首乌益髓组合物的胶囊的制备方法，其特征在于，制备方法为：将上述中药成分研磨成药末状，备好淀粉胶囊皮，每个胶囊皮中灌注0.45g研磨好的药末。
3.一种如权利要求1所述的中药首乌益髓组合物的膏剂的制备方法，其特征在于，包括以下步骤：
1)煎煮：称取若干所述中药首乌益髓组合物，将不含阿胶的中药首乌益髓组合物先泡制30分钟，然后加水煮沸，2小时后提取药液，重复上述过程2次，将三次煎煮的药液合并；加入的水的总量为不含阿胶的中药首乌益髓组合物重量的10倍；
2)取清液：将合并的药液过滤并静置1小时，取上清液；
3)浓缩清液：将清液放入蒸发锅中，先以大火煮沸，取出上层浮沫，待清液变浓时，改用文火保持微沸，不断搅拌浓缩，直至变成稠膏状，以沾取少许滴于滤纸上，无渗润水迹则停止，此时清膏制成；
4)收膏：将阿胶，并另取蜂蜜适量烊化后缓慢加入上述清膏中，并搅拌混匀，直至用棒挑起膏剂呈薄片状流下，取出，冷却后装入清洁干燥灭菌后的广口瓶内，密封备用。
4.权利要求1至3中任一项所述的中药首乌益髓组合物在制备治疗急性髓系白血病化疗骨髓抑制的药物中的应用。
5.根据权利要求4所述的应用，其特征在于，所述急性髓系白血病不包括急性早幼粒细胞白血病。
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