CN102885998B - 一种预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物 - Google Patents
一种预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物 Download PDFInfo
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Abstract
本发明公开了一种预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物，由如下重量份的中药材制备而成：薏仁28-35份、玉竹10-14份、蒲公英18-23份、陈皮15-20份、桃仁15-20份、山楂15-20份、女贞子13-18份、香菇18-22份、黑豆15-22份、黄芪8-12份、知母8-12份、党参8-12份。本发明的药物组合物在肿瘤放疗的同时预防白细胞降低，甚至提高中性粒细胞的数量，从而对放射治疗过程中产生的骨髓抑制起到预防或治疗作用，提高了肿瘤的放疗效果，延长癌症患者生存期，改善生存质量。
Description
技术领域
本发明涉及中药技术领域，具体涉及一种预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物。
背景技术
人体的造血系统由少量骨髓造血干细胞及不同发育时期不同系列的造血细胞组成，对各种物理化学及体内代谢产生的有害因素非常敏感，比如机体暴露于辐射，以及临床上接受放疗的患者极易受到损伤而出现不同程度的骨髓抑制，表现为外周血白细胞降低、骨髓增殖功能下降甚至发生再生障碍性贫血，对患者的生存质量造成严重的危害甚至危及生命。一旦患上癌症，病人可能需要放射治疗，放疗可引起不同程度的骨髓抑制，主要表现为白细胞减少，尤其是中性粒细胞减少最为显著。目前放疗仍然是肿瘤治疗中常用的手段，但治疗后引起的骨髓造血抑制等并发症成为了影响患者生存质量的重要原因。许多医务工作者都在致力于寻找一些有效但副反应少的药物，来对抗放疗带给患者的损害。
目前临床上对出现骨髓抑制多是采用给予各种生长因子，以增加造血细胞的增殖。如近年来刚刚上市的基因重组的造血生长因子如生白能（rhGM-GSF）、惠尔血（rhG-CSF）等，用来升高白细胞效果显著，但因价格昂贵，并非多数病人能够承受，并且rhGM-GSF、rhG-CSF不可以在放疗的同时使用，也不可以预防使用，只能在出现白细胞减少时给予使用，否则会有毒副作用产生。此外，造血生长因子的基因疗法如IL-6、IL-3等基因疗法尚处于动物试验阶段。
因此，寻找一种安全、有效、价廉的方法对抗放疗的副反应，升高放疗后白细胞，对于提高肿瘤的放疗效果，延长癌症患者生存期，改善生存质量都有非常重要的意义。
发明内容
鉴于现有防治骨髓抑制的药物在放疗应用中的不足，本发明的目的在于提供一种能与其它抗癌药物同时使用的治疗放疗引起的骨髓抑制的药物组合物。
本发明的目的是这样实现的：
本发明预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物，由如下重量份的中药材制备而成：薏仁28-35份、玉竹10-14份、蒲公英18-23份、陈皮15-20份、桃仁15-20份、山楂15-20份、女贞子13-18份、香菇18-22份、黑豆15-22份、黄芪8-12份、知母8-12份、党参8-12份。
本发明预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物，由如下优选重量份的中药材制备而成：薏仁32份、玉竹12份、蒲公英20份、陈皮18份、桃仁18份、山楂18份、女贞子15份、香菇20份、黑豆20份、黄芪10份、知母10份、党参10份。
本发明预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物优选为口服制剂。
本发明预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物优选为口服液或颗粒剂。
根据中医药史料记载，上述十二味中药具有如下药理活性：
薏仁：健脾渗湿，除痹止泻。主治水肿、脚气、小便不利、湿痹拘挛、脾虚泄泻。选用禾本科植物薏苡（Coix lachryma-jobi L)的干燥成熟种仁。
玉竹：滋阴润肺；养胃生津。主治燥咳；劳嗽；热病阴液耗伤之咽干口渴；内热消渴；阴虚外感；头昏眩晕；筋脉挛痛。选用百合科植物（Polygonatum odoratum (Mill.) Druce）玉竹的根茎。
蒲公英：具有清热解毒，消肿散结，利尿通淋的功效。用于疔疮肿毒，乳痈，瘰疠，目赤，咽痛，肺痈，肠痈，湿热黄疸，热淋涩痛。选用干燥蒲公英的全草。
陈皮：具有理气健脾，调中，燥湿，化痰的作用。主治脾胃气滞之脘腹胀满或疼痛、消化不良。湿浊阻中之胸闷腹胀、纳呆便溏。痰湿壅肺之咳嗽气喘。选用为芸香科植物橘及其栽培变种的干燥成熟果皮。
桃仁：活血祛瘀，润肠通便，止咳平喘。用于经闭，痛经，癓瘕痞块，跌扑损伤，肠燥便秘。选用蔷薇科植物桃Prunus persica （L.） Batsch 或山桃 Prunus davidiana （Carr.）Franch.的干燥成熟种子。
山楂：开胃消食、化滞消积、活血散瘀、化痰行气。用于肉食滞积、症瘕积聚、腹胀痞满、瘀阻腹痛、痰饮、泄泻、肠风下血等。山楂能防治心血管疾病，具有扩张血管、强心、增加冠脉血流量、改善心脏活力、兴奋中枢神经系统、降低血压和胆固醇、软化血管及利尿和镇静作用；防治动脉硬化，防衰老、抗癌的作用。山楂酸还有强心作用，对老年性心脏病也有益处。
女贞子：补肝肾阴，乌须明目。用于肝肾阴虚，腰酸耳鸣，须发早白；眼目昏暗，视物昏暗；阴虚发热，胃病及痛风和和高尿酸血症。选用木犀科植物女贞Ligustrum lucidum Ait. 的干燥成熟果实。
香菇：具有补气养血、开胃助食、抗肿瘤等功用，适用于贫血、胃痛、佝偻病、食欲不振、肝硬化、肿瘤、高脂血症、小儿麻疹、功能性子宫出血、子宫颈癌及癌症术后放疗、化疗等。
黑豆：性味甘、平、无毒。有活血、利水、祛风、清热解毒、滋养健血、补虚乌发的功能。《本草纲目》说：“黑豆入肾功多，故能治水、消胀、下气、制风热而活血解毒。”
黄芪：有益气固表、敛汗固脱、托疮生肌、利水消肿之功效。用于治疗气虚乏力，中气下陷，久泻脱肛，便血崩漏，表虚自汗，痈疽难溃，久溃不敛，血虚萎黄，内热消渴，慢性肾炎，蛋白尿，糖尿病等。炙黄芪益气补中，生用固表托疮。
知母：清热泻火，生津润燥。主治：温热病、高热烦渴、咳嗽气喘、燥咳、便秘、骨蒸潮热、虚烦不眠、消渴淋浊。选用单子叶植物百合科 Liliaceae 知母 Anemarrhena asphodeloides Bge. 的干燥根茎。
党参：补中益气，健脾益肺的功效。用于脾肺虚弱，气短心悸，食少便溏，虚喘咳嗽，内热消渴等。选用桔梗科植物党参 Codonopsis pilosula （Franch.） Nannf.的干燥根。
将上述各中药材制备成本发明的中药制剂的制备方法，包括如下步骤：
（1）称取处方量的上述中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取罐中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮2h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.25的浓缩液；
（3）将浓缩液置4℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，搅拌均匀，置5℃低温冷藏24h，将冷藏液滤过，得口服液。或者，将浓缩液置4℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至浸膏，喷雾干燥，添加药用辅料制成颗粒剂。
本发明的中药组合物在防治放疗引起的骨髓抑制方面具有如下有益的效果：在肿瘤放疗的同时预防白细胞降低，甚至提高中性粒细胞的数量，从而对放射治疗过程中产生的骨髓抑制起到预防或治疗作用，提高肿瘤的放疗效果，延长癌症患者生存期，改善生存质量。通过实施例4表1的中药口服液对4Gy照射60Co肿瘤小鼠白细胞和血小板的影响数据可以看出，本发明的中药组合物具有预料不到的缓解放疗产生的骨髓抑制的效果。具体为，与模型组相比，中药高、低剂量组的白细胞总数和血小板总数均有增高，并有极显著性差异（P＜0.01）或显著性差异（P＜0.05）。
具体实施方式
以下是本发明的具体实施例，对本发明的技术方案做进一步作描述，但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代均包括在本发明的保护范围之内。
实施例1
生药处方：薏仁320克、玉竹120克、蒲公英200克、陈皮180克、桃仁180克、山楂180克、女贞子150克、香菇200克、黑豆200克、黄芪100克、知母100克、党参100克。
制备工艺：
（1）称取处方量的上述中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取罐中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮2h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.25的浓缩液；
（3）将浓缩液置4℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，搅拌均匀，置5℃低温冷藏24h，将冷藏液滤过，得口服液。
实施例2
生药处方：薏仁280克、玉竹140克、蒲公英180克、陈皮150克、桃仁200克、山楂198克、女贞子130克、香菇220克、黑豆220克、黄芪80克、知母120克、党参80克。
制备工艺：
（1）称取处方量的上述中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取罐中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮2h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.25的浓缩液；
（3）将浓缩液置4℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，搅拌均匀，置5℃低温冷藏24h，将冷藏液滤过，得口服液。
实施例3
生药处方：薏仁350克、玉竹100克、蒲公英225克、陈皮200克、桃仁150克、山楂150克、女贞子180克、香菇200克、黑豆150克、黄芪120克、知母80克、党参120克。
制备工艺：
（1）称取处方量的上述中药材，洗净去杂，晾干，粉碎成颗粒；
（2）再将上述颗粒状药材加水漫过药面2cm，浸泡1-1.2h，捞出药材置多功能提取罐中加水煎煮二次，第一次加总药材8倍量的水，煎煮2h，取煎液，滤过，第二次加总药材8倍量的水，煎煮2h，取两次煎液合并，滤过，浓缩至90℃时相对密度为1.25的浓缩液；
（3）将浓缩液置4℃低温冷藏24h，将冷藏液加0.3%的助滤剂硅藻土，滤过，滤液再浓缩至每毫升含3g生药量，搅拌均匀，置5℃低温冷藏24h，将冷藏液滤过，得口服液。
实施例4中药口服液对60Co放射小鼠的血细胞数的影响
昆明小鼠，雌雄各半，7周龄，18～22g，试验温度（20±1）℃，湿度40％～70％，自由饮水，正常饲喂。除正常组外，对小鼠进行4Gy照射60Co放射，采用一次性照射。于第3、7、10 d分别眶静脉取血检测全血细胞数。
将照射后的小鼠随机分为以下模型对照组、中药低剂量组、中药高剂量组，每组16只，雌雄各半。各组分别按如下方式处理或给药。
正常对照组：灌胃等体积的纯化水；
模型对照组：灌胃等体积的纯化水；
中药低剂量组：10mL/kg/d实施例1制备的中药口服液；
中药高剂量组：20mL /kg/d实施例1制备的中药口服液。
各组每天给药一次，共给药2周。试验过程中，每天观察动物饮食、存活情况及行为活动，每日测量体重，试验结束后麻醉解剖，腹主静脉取血，测血常规，考察白细胞总数及血小板总数。
表1 中药口服液对4Gy照射60Co肿瘤小鼠白细胞和血小板的影响
与模型对照组比较，* P＜0.05，** P＜0.01。
白细胞包括中性粒细胞、嗜酸性粒细胞和嗜碱性粒细胞，白细胞是由骨髓造血而来，在临床上，肿瘤病人在接受药物放疗后，常常会出现骨髓抑制，从而使外周血白细胞数量降低，中性粒细胞数量降低。人体外周血中性粒细胞约占白细胞总数的50-70%，其增高和减低直接影响白细胞总数的变化，即中性粒细胞增高，白细胞随之增高；中性粒细胞减低，白细胞总数也随之减低。两者在数量上的相关性也表现在意义上的一致性，即中性粒细胞增减的意义与白细胞总数增减的意义基本上是一致的。
通过表1的中药口服液对4Gy照射60Co肿瘤小鼠白细胞和血小板的影响数据可以看出，本发明的中药组合物具有预料不到的缓解放疗产生的骨髓抑制的效果。具体为，与模型组相比，中药高、低剂量组的白细胞总数和血小板总数均有增高，并有极显著性差异（P＜0.01）或显著性差异（P＜0.05）。
Claims (4)
1.一种预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物，其特征在于由如下重量份的中药材制备而成：薏仁28-35份、玉竹10-14份、蒲公英18-23份、陈皮15-20份、桃仁15-20份、山楂15-20份、女贞子13-18份、香菇18-22份、黑豆15-22份、黄芪8-12份、知母8-12份、党参8-12份。
2.如权利要求1所述预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物，其特征在于由如下重量份的中药材制备而成：薏仁32份、玉竹12份、蒲公英20份、陈皮18份、桃仁18份、山楂18份、女贞子15份、香菇20份、黑豆20份、黄芪10份、知母10份、党参10份。
3.如权利要求1或2所述预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物，其特征在于：所述药物组合物为口服制剂。
4.如权利要求3所述预防或治疗肿瘤放疗引起的骨髓抑制的药物组合物，其特征在于：所述药物组合物为口服液或颗粒剂。
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