CN105641615A - 配用黄芪姜黄辅助肿瘤放射治疗的中药组合物及其制备方法和应用 - Google Patents
配用黄芪姜黄辅助肿瘤放射治疗的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了配用黄芪姜黄辅助肿瘤放射治疗的中药组合物及其制备方法和应用，按重量份数计算配方包括：黄芪8‐16份，姜黄2‐6份，乌梅1‐3份，大黄0.5‐1.5份。本发明的中药组合物既可增强肿瘤细胞对放疗射线的敏感性，从而增强放射疗法的疗效，又可以滋补患者的身体，并减少放疗导致的各种副作用和不良反应。而且，本发明中的所用中药材都为药食同源药材，故而其毒副作用更小，且原料简单易得，服用方便，对患者的身体和经济压力都大大减少。
Description
技术领域
本发明涉及一种辅助肿瘤放射治疗的中药组方，具体涉及一种配用了黄芪姜黄辅助增强鼻咽癌肿瘤放射治疗敏感性的中药组方及其制剂。
背景技术
恶性肿瘤是严重威胁人类健康的疾病，由于肿瘤细胞的生物学特征，以及对不同射线的敏感性、耐受性的差异等因素往往导致放射治疗不尽人意。虽然通过提高局部放射剂量进一步控制肿瘤细胞的生存率，但会引起更严重的放射反应，特别是急性放射反应，如皮肤反应，黏膜反应，腮腺反应及更严重的全身反应。例如，鼻咽癌放疗后患者易出现口干，唾液分泌减少，颈部纤维化，颈部肌肉萎缩，颈部变细，颈部皮肤菲薄，张口困难。
中药抗肿瘤具有多靶点，多效性，毒副作用少等特点。研究中药结合西药以及肿瘤放射治疗联用具有广阔前景。
发明内容
本发明提供一种配用黄芪姜黄辅助肿瘤放射治疗的中药组合物，既可以增强放射治疗的疗效，又能减轻放射治疗带来的副作用和不良反应，可与西药以及肿瘤放射治疗配合联用。
本发明的另一个目的是提供上述中药组合物的制备方法。
本发明还有一个目的是提供上述中药组合物在制备辅助肿瘤放射治疗的药物上的应用。
本发明的目的是这样实现的：一种配用黄芪姜黄辅助肿瘤放射治疗的中药组合物，其特征在于：按重量份数计算配方包括：黄芪8‐16份，姜黄2‐6份，乌梅1‐3份，大黄0.5‐1.5份。
按重量份数计算配方包括：黄芪12份，姜黄4份，乌梅2份，大黄1份。
上述配用黄芪姜黄辅助肿瘤放射治疗的中药组合物制剂的制备方法，其特征在于包括以下步骤：(1)按重量份数计算取黄芪，姜黄，乌梅，大黄粉碎成粗粉；(2)姜黄用水或40‐95％乙醇回流提取2‐4次，每次加水或醇为药材量的5‐15倍，每次回流提取1‐3小时；(3)黄芪，乌梅，大黄用水煎煮提取2‐4次，每次加水的量为药材的5‐15倍量，煮沸提取1‐3小时，合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏；(4)将浸膏与允许加入的医药用辅料混合，通过常规方法制成相应的剂型。
由上述制备方法制得的制剂。
所述制剂的剂型为汤剂、丸剂、散剂、膏剂、丹剂、酒剂、糖浆剂、浸膏剂、锭剂、露剂、胶剂、茶剂、钉剂、棒剂、栓剂、曲剂、糊剂、糕剂、洗搽剂、油剂、线剂、条剂、熨剂、炙剂、烟剂、药香、片剂、冲剂、袋泡剂、口服液剂、胶囊剂、滴丸剂、合剂、酊剂、气雾剂、灌肠剂、膜剂、眼用制剂、鼻用制剂、海绵剂或针剂。
上述中药组合物在制备辅助肿瘤放射治疗的药物上的应用。
本发明的中药组合物既可增强肿瘤细胞对放疗射线的敏感性，从而增强放射疗法的疗效，又可以滋补患者的身体，并减少放疗导致的各种副作用和不良反应。而且，本发明中的所用中药材都为药食同源药材，故而其毒副作用更小，且原料简单易得，服用方便，对患者的身体和经济压力都大大减少。
附图说明
图1是本发明抗肿瘤(鼻咽癌CNE‐2)作用MTT实验数据图；
图2是本发明抗肿瘤(卵巢癌细胞SKOV)作用MTT实验数据图；
图3是本发明抗肿瘤(乳腺癌细胞MCF‐7)作用MTT实验数据图；
图4是本发明放射敏感性作用MTT实验数据图(鼻咽癌细胞放射抗拒株CNE‐2R)。
具体实施方式
本发明是一种配用黄芪姜黄辅助肿瘤放射治疗的中药组合物，其特征在于：按重量份数计算配方包括：黄芪8‐16份，姜黄2‐6份，乌梅1‐3份，大黄0.5‐1.5份。最优选的，按重量份数计算配方包括：黄芪12份，姜黄4份，乌梅2份，大黄1份。
一种配用黄芪姜黄辅助肿瘤放射治疗的中药组合物制剂的制备方法，其特征在于包括以下步骤：(1)按重量份数计算取黄芪8‐16份，姜黄2‐6份，乌梅1‐3份，大黄0.5‐1.5份粉碎成粗粉；(2)姜黄用水或40‐95％乙醇回流提取2‐4次，每次加水或醇为药材量的5‐15倍，每次回流提取1‐3小时；(3)黄芪，乌梅，大黄用水煎煮提取2‐4次，每次加水的量为药材的5‐15倍量，煮沸提取1‐3小时，合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏；(4)将浸膏与允许加入的医药用辅料混合，通过常规方法制成相应的剂型。
将上述浸膏与国家和行业标准及法规允许加入的辅料混合，通过适当方法制成药品的任何剂型，例如：汤剂、丸剂(蜜丸、水丸、糊丸、蜡丸、浓缩丸)、散剂、膏剂(膏滋、软膏、膏药)、丹剂、酒剂、糖浆剂、浸膏剂、锭剂、露剂、胶剂、茶剂、钉剂、棒剂、栓剂、曲剂、糊剂、糕剂、洗搽剂、油剂、线剂(药线)、条剂(药捻)、熨剂、炙剂、烟剂、药香等，片剂、冲剂、袋泡剂、口服液剂、胶囊剂、滴丸剂、合剂、酊剂、气雾剂、灌肠剂、膜剂(薄膜剂)、眼用制剂(洗眼剂、滴眼剂、眼用软膏)、鼻用制剂(滴鼻剂、喷鼻剂)、海绵剂(灭菌止血)、针剂等剂型。本发明优先选择口服剂型，如煎膏剂，片剂，胶囊剂，酒剂，茶剂，冲剂，袋泡剂，合剂等剂型。
中医理论认为：鼻咽癌放疗后患者所出现的症状，从中医角度分析，放疗后伤津耗气，阴份大虚，化生乏源，故见口干，唾液分泌稀少，同时气虚则生热，放疗射线焦灼，虚火实火同时存在。土气不足，土溉四旁之功能减退，肉气失养，故见颈部纤维化，颈部肌肉皮肤萎废。《素问·生气通天论》指出：“阳气者，精则养神，柔则养筋”，鼻咽癌放疗后出现的张口困难不仅与局部肌肉萎废相关，同时亦与阳气不足，不能濡养经脉筋骨相关。综上分析，鼻咽癌放疗后患者的病机集中在阴份大虚，土气不足，火热燥气浮越于外，虚火实火绞结。
黄芪：豆科(Fabaceae)黄芪属(Astraalus)植物蒙古黄芪、膜荚黄芪的干燥根。黄芪味甘性温，归肺、脾经。具有补气固表，利尿脱毒，排脓，敛疮生肌之功效。用于气虚乏力，食少便溏，中气下陷，久泄脱肛，便血崩漏，表虚自汗，气虚水肿，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。
姜黄：姜科植物姜黄(CurcumalongaL.)的干燥根茎。味辛、苦，性温。归脾、肝经。具有破血行气，通经止痛之功效。用于胸胁刺痛，闭经，癓瘕，风湿肩臂疼痛，跌扑肿痛。申请人对姜黄的主要有效成分姜黄素的研究发现，其对鼻咽癌具有明显抗肿瘤与增强肿瘤细胞对射线的敏感型双重效果。
乌梅：蔷薇科植物梅(PrunusmumeSieh.Sieb.etZucc.)的干燥近成熟果实。味酸、涩，性平。归肝、脾、肺、大肠经。具有敛肺，涩肠，生津，安蛔之功效。用于肺虚久咳，久痢滑肠，虚热消渴，蛔厥呕吐腹痛，胆道蛔虫症。
大黄：蓼科植物掌叶大黄(RheumpalmatumL.)、唐古特大黄(RheumtanguticumMaxim.ExBalf.)或药用大黄(RheumofficinaleBaill.)的干燥根及根茎。味苦，性寒。归脾、胃、大肠、肝、心包经。具有泄热通肠，凉血解毒，逐瘀通经之功效。用于实热便秘。湿热黄疸，血热吐衄。酒大黄善清上焦血分热毒。
在本发明中，黄芪补气托腐为君，姜黄活血化瘀为臣，大黄、乌梅泻热生津为佐使，药量搭配合理，临床上针对鼻咽癌放疗后辅助治疗，减毒增效，效果明显。
实施例1
黄芪，姜黄，乌梅，大黄药材的重量份数之比为12:4:2:1。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，每次加水的量为药材的5倍量，煮沸提取1小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例2
黄芪，姜黄，乌梅，大黄药材的重量份数之比为24:8:4:2。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，每次加水的量为药材的10倍量，煮沸提取2小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例3
黄芪，姜黄，乌梅，大黄药材的重量份数之比为36:12:6:3。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，每次加水的量为药材的15倍量，煮沸提取3小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例4
黄芪，姜黄，乌梅，大黄药材的重量份数之比为48:16:8:4。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，第1次加水的量为药材的15倍量，煮沸提取3小时，第2、3次加水的量为药材的10倍量，煮沸提取2h。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例5
黄芪，姜黄，乌梅，大黄药材的重量份数之比为60:20:10:5。黄芪，姜黄，乌梅，大黄均粉碎成粗粉。姜黄用75％乙醇回流提取3次，每次加醇量为药材的15倍量，每次提取3小时。黄芪，乌梅，大黄用水煎煮提取3次，每次加水的量为药材的15倍量，煮沸提取3小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例6
黄芪，姜黄，乌梅，大黄药材的重量份数之比为60:20:10:5。黄芪，姜黄，乌梅，大黄均粉碎成粗粉。姜黄用95％乙醇回流提取1次，加醇量为药材的15倍量，提取3小时。再用75％乙醇回流提取2次，每次加醇量为药材的10倍量，提取2小时。黄芪，乌梅，大黄用水煎煮提取3次，每次加水的量为药材的15倍量，煮沸提取3小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例7
黄芪，姜黄，乌梅，大黄药材的重量份数之比为10:3.5:2:1。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，每次加水的量为药材的5倍量，煮沸提取1小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例8
黄芪，姜黄，乌梅，大黄药材的重量份数之比为8:2:1:0.5。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，每次加水的量为药材的5倍量，煮沸提取1小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例9
黄芪，姜黄，乌梅，大黄药材的重量份数之比为16:6:3:1.5。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，每次加水的量为药材的5倍量，煮沸提取1小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
实施例10
黄芪，姜黄，乌梅，大黄药材的重量份数之比为14:5:2:1。黄芪，姜黄，乌梅，大黄均粉碎成粗粉，用水煎煮提取3次，每次加水的量为药材的5倍量，煮沸提取1小时。合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏。
抗肿瘤作用MTT实验：细胞传代24h后，取对数生长期细胞，种植96孔板。细胞浓度调为5×104，每孔100μl(细胞数为5.0×103个)，以实施例5所得浸膏进行定容稀释，每个给药浓度做6个复孔。放入37℃、体积分数5％CO2、饱和湿度的孵箱培养孵箱培养。每次测量4h前加5g/LMTT溶液11μl，放回37℃、体积分数5％CO2、饱和湿度的孵箱继续培养。4h后，小心吸去每孔上层液体，再加入100μl分析纯DMSO溶液，振摇10min。M550酶标仪在490nm和570nm双波长下测量每孔的吸光度。结果发现随着给药浓度的增加，对应细胞的存活率逐渐降低，其中鼻咽癌CNE‐2细胞存活率下降最明显，卵巢癌细胞SKOV和乳腺癌细胞MCF‐7细胞存活率下降较为明显。见图1、2、3。实验证明，本发明中药组合物可以应用于制备辅助肿瘤放射治疗的药物，例如鼻咽癌、卵巢癌、乳腺癌等。
增加放射敏感性作用MTT实验：细胞传代24h后，取对数生长期细胞，种植96孔板。细胞浓度调为5×104，每孔100μl(细胞数为5.0×103个)，以实施例5所得浸膏进行定容稀释，每个给药浓度做6个复孔。放入37℃、体积分数5％CO2、饱和湿度的孵箱培养孵箱培养。每次测量4h前加5g/LMTT溶液11μl，放回37℃、体积分数5％CO2、饱和湿度的孵箱继续培养。4h后，小心吸去每孔上层液体，再加入100μl分析纯DMSO溶液，振摇10min。M550酶标仪在490nm和570nm双波长下测量每孔的吸光度。结果表明鼻咽癌细胞放射抗拒株CNE‐2R在给高浓度药后照射10GyX射线后存活率较给药前照射10GyX射线后存活率明显降低。说明本发明可以有效增加鼻咽癌细胞放射抗拒株CNE‐2R的放射敏感性。见图4。
Claims (6)
1.一种配用黄芪姜黄辅助肿瘤放射治疗的中药组合物，其特征在于：按重量份数计算配方包括：黄芪8‐16份，姜黄2‐6份，乌梅1‐3份，大黄0.5‐1.5份。
2.根据权利要求1所述的配用黄芪姜黄辅助肿瘤放射治疗的中药组合物，其特征在于：按重量份数计算配方包括：黄芪12份，姜黄4份，乌梅2份，大黄1份。
3.权利要求1或2所述配用黄芪姜黄辅助肿瘤放射治疗的中药组合物的制备方法，其特征在于包括以下步骤：(1)按重量份数计算取黄芪，姜黄，乌梅，大黄粉碎成粗粉；(2)姜黄用水或40‐95％乙醇回流提取2‐4次，每次加水或醇为药材量的5‐15倍，每次回流提取1‐3小时；(3)黄芪，乌梅，大黄用水煎煮提取2‐4次，每次加水的量为药材的5‐15倍量，煮沸提取1‐3小时，合并提取液过滤蒸发浓缩到相对密度为1.10/80℃‐1.30/80℃，得药材水提取浸膏；(4)将浸膏与允许加入的医药用辅料混合，通过常规方法制成相应的剂型。
4.由权利要求3所述制备方法制得的制剂。
5.根据权利要求4所述制剂，其特征在于：所述制剂的剂型为汤剂、丸剂、散剂、膏剂、丹剂、酒剂、糖浆剂、浸膏剂、锭剂、露剂、胶剂、茶剂、钉剂、棒剂、栓剂、曲剂、糊剂、糕剂、洗搽剂、油剂、线剂、条剂、熨剂、炙剂、烟剂、药香、片剂、冲剂、袋泡剂、口服液剂、胶囊剂、滴丸剂、合剂、酊剂、气雾剂、灌肠剂、膜剂、眼用制剂、鼻用制剂、海绵剂或针剂。
6.权利要求1或2所述的中药组合物在制备辅助肿瘤放射治疗的药物上的应用。
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