CN107714893A - 一种治疗肝癌的药物组合物及其制备方法 - Google Patents
一种治疗肝癌的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗肝癌的药物组合物及其制备方法，该药物组合物由中药成分和西药成分复配而成，以重量份数计，所述中药成分包括如下原料药：七叶一枝花24‑36份、八角莲20‑30份、穿山甲20‑30份、紫草18‑24份、泽漆18‑24份、黄芪15‑20份；所述西药成分包括如下原料药：氟尿嘧啶2.5‑4.5份、多柔比星2.5‑3.5份。本发明的治疗肝癌的药物组合物，采取中西药相结合的办法，精选多种中草药和西药联合，相互协同增强抗肝癌效果，降低纯西药毒副作用，本发明的药物组合物具有消炎解痛、活血化瘀、软化坚化结等降低肝癌转移复发率，效果好，见效快。
Description
技术领域
本发明属于医药技术领域，具体涉及一种治疗肝癌的药物组合物及其制备方法。
背景技术
据报道，原发性肝癌(简称肝癌)是世界范围内第六位的最常见恶性肿瘤，每年新增病例约70余万，其中肝细胞癌约占80％。调查显示肝癌是中国最常见的恶性肿瘤，我国每年新发肝癌病例约占全球发病总数的55％，肝癌已成为我国第二大肿瘤致死原因。目前人类对癌症一般采用药物治疗、手术治疗和放疗的办法，其中药物治疗包括化学药物治疗(化疗)和中药治疗，但存在的不足是，化学药物比较昂贵，大部分患者难以承受药费，中药治疗效果较慢，不能快速遏制癌细胞的扩散。而手术后的放化疗在杀死癌细胞的同时也杀死了正常细胞，并伴有脱发、白细胞减少、恶性呕吐、厌食等副作用。
发明内容
鉴于药物治疗存在的不足，本发明的目的是提供一种既能快速有效地杀死肝癌细胞，又能增强机体的抵抗能力，毒副作用小、价格低廉的中西联合抗癌药物制剂及其制备方法。
本发明采用的技术方案如下：
一种治疗肝癌的药物组合物，由中药成分和西药成分复配而成，以重量份数计，所述中药成分包括如下原料药：七叶一枝花24-36份、八角莲20-30份、穿山甲20-30份、紫草18-24份、泽漆18-24份、黄芪15-20份；所述西药成分包括如下原料药：氟尿嘧啶2.5-4.5份、多柔比星2.5-3.5份。
进一步的，以重量份数计，所述中药成分包括如下原料药：七叶一枝花30份、八角莲25份、穿山甲25份、紫草21份、泽漆21份、黄芪17份；所述西药成分包括如下原料药：氟尿嘧啶3.5份、多柔比星3份。
一种如上所述的治疗肝癌的药物组合物的制备方法，采用醇提法和水提法单独或混合提取得到中药成分的提取物，中药成分的提取物再与西药成分、药学上可接受的辅料加工制成药学上可接受的剂型。
一种治疗肝癌的药物组合物的制备方法，具体步骤如下：
S1：按上述重量配比称取各原料药物；
S2：将七叶一枝花、八角莲、穿山甲、紫草、泽漆、黄芪混合后加入8倍量的乙醇(质量浓度为50～95％)，浸渍24～48小时，滤过，滤液回收乙醇后备用；药渣中加入5倍药渣重量的水煎煮2次，每次1小时，合并煎液，滤过，滤液与上述备用滤液合并，在50～70℃下浓缩至相对密度为1.15～1.20的清膏，真空干燥成干膏后粉碎成干膏粉备用；
S3：将氟尿嘧啶、多柔比星研磨成细粉；
S4：将步骤S3所得的细粉与步骤S2所得的干膏粉混合均匀，加入药学上可接受的辅料，按照药学常规制药方法制备成药物组合物。
进一步的，所述辅料包括填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。
进一步的，所述剂型为片剂、颗粒剂、胶囊剂、滴丸剂、口服溶液剂、冲剂或缓释微丸。
进一步的，所述剂型为片剂。
本发明还具体提供了一种治疗肝癌的药物组合物片剂的制备方法，包括如下步骤：
S1：按上述重量配比称取各原料药物；
S2：将七叶一枝花、八角莲、穿山甲、紫草、泽漆、黄芪混合后加入8倍量的乙醇(质量浓度为50～95％)，浸渍24～48小时，滤过，滤液回收乙醇后备用；药渣中加入5倍药渣重量的水煎煮2次，每次1小时，合并煎液，滤过，滤液与上述备用滤液合并，在50～70℃下浓缩至相对密度为1.15～1.20的清膏，真空干燥成干膏后粉碎成干膏粉备用；
S3：将氟尿嘧啶、多柔比星研磨成细粉；
S4：将步骤S3所得的细粉与步骤S2所得的干膏粉混合均匀，加入适量微粉硅胶和硬脂酸镁，压片即可。
本发明的治疗肝癌的药物组合物，采取中西药相结合的办法，精选多种中草药和西药联合，相互协同增强抗肝癌效果，降低纯西药毒副作用，本发明的药物组合物具有消炎解痛、活血化瘀、软化坚化结等降低肝癌转移复发率，效果好，见效快。
具体实施方式
以下将结合实施例来详细说明本发明的实施方式，所举实施例只用于解释本发明，并非用于限定本发明的范围。
实施例1
一种治疗肝癌的药物组合物的制备方法，包括如下步骤：
S1：称取七叶一枝花24份、八角莲20份、穿山甲20份、紫草18份、泽漆18份、黄芪15份混合后加入8倍量的乙醇(质量浓度为50～95％)，浸渍24～48小时，滤过，滤液回收乙醇后备用；药渣中加入5倍药渣重量的水煎煮2次，每次1小时，合并煎液，滤过，滤液与上述备用滤液合并，在50～70℃下浓缩至相对密度为1.15～1.20的清膏，真空干燥成干膏后粉碎成干膏粉备用；
S2：称取氟尿嘧啶2.5份、多柔比星2.5份并研磨成细粉；
S3：将步骤S2所得的细粉与步骤S1所得的干膏粉混合均匀，加入适量微粉硅胶和硬脂酸镁，压片即可。
实施例2
一种治疗肝癌的药物组合物的制备方法，包括如下步骤：
S1：称取七叶一枝花30份、八角莲25份、穿山甲25份、紫草21份、泽漆21份、黄芪17份混合后加入8倍量的乙醇(质量浓度为50～95％)，浸渍24～48小时，滤过，滤液回收乙醇后备用；药渣中加入5倍药渣重量的水煎煮2次，每次1小时，合并煎液，滤过，滤液与上述备用滤液合并，在50～70℃下浓缩至相对密度为1.15～1.20的清膏，真空干燥成干膏后粉碎成干膏粉备用；
S2：称取氟尿嘧啶3.5份、多柔比星3份并研磨成细粉；
S3：将步骤S2所得的细粉与步骤S1所得的干膏粉混合均匀，加入适量微粉硅胶和硬脂酸镁，压片即可。
实施例3
一种治疗肝癌的药物组合物的制备方法，包括如下步骤：
S1：称取七叶一枝花36份、八角莲30份、穿山甲30份、紫草24份、泽漆24份、黄芪20份混合后加入8倍量的乙醇(质量浓度为50～95％)，浸渍24～48小时，滤过，滤液回收乙醇后备用；药渣中加入5倍药渣重量的水煎煮2次，每次1小时，合并煎液，滤过，滤液与上述备用滤液合并，在50～70℃下浓缩至相对密度为1.15～1.20的清膏，真空干燥成干膏后粉碎成干膏粉备用；
S2：称取氟尿嘧啶4.5份、多柔比星3.5份并研磨成细粉；
S3：将步骤S2所得的细粉与步骤S1所得的干膏粉混合均匀，加入适量微粉硅胶和硬脂酸镁，压片即可。
对比例1
一种治疗肝癌的中药组合物的制备方法，包括如下步骤：
称取七叶一枝花36份、八角莲30份、穿山甲30份、紫草24份、泽漆24份、黄芪20份混合后加入8倍量的乙醇(质量浓度为50～95％)，浸渍24～48小时，滤过，滤液回收乙醇后备用；药渣中加入5倍药渣重量的水煎煮2次，每次1小时，合并煎液，滤过，滤液与上述备用滤液合并，在50～70℃下浓缩至相对密度为1.15～1.20的清膏，真空干燥成干膏后粉碎成干膏粉备用，在干膏粉中加入适量微粉硅胶和硬脂酸镁，压片即可。
对比例2
一种治疗肝癌的西药片剂的制备方法，包括如下步骤：
称取氟尿嘧啶4.5份、多柔比星3.5份并研磨成细粉，在细粉中加入适量微粉硅胶和硬脂酸镁，压片即可。
临床疗效实验
一、一般资料
选取150例患有肝癌的患者，分为5组，每组30人，5组患者的病情轻重比较无显著性差异(P>0.05)。
二、实验方法
第1-3组为实验组，第4、5组为对照组，第1组服用实施例1的药物组合物，第2组服用实施例2的药物组合物，第3组服用实施例3的药物组合物，第4组服用对比例1的中药组合物，第5组服用对比例2的西药片剂，连续服用30天，每日服3次，每次服用2片。
三、疗效判定标准
治愈：经过半年、一年以上治疗，经医院身体检查无异常，自觉身体感觉无异常；
好转：经过半年、一年以上的治疗，经医院身体检查，包块变小，正在缓慢恢复；
无效：经过半年、一年以上治疗，经医院身体检查，肿瘤逐渐长大，自觉身体感觉疼痛加剧；
有效率＝(治愈人数+好转人数)/各组总人数。
四、结果
表1
| 组别 | 治愈人数 | 好转人数 | 无效人数 | 有效率％ |
| 实施例1 | 22 | 3 | 5 | 83.3 |
| 实施例2 | 23 | 4 | 3 | 90 |
| 实施例3 | 25 | 4 | 1 | 96.7 |
| 对比例1 | 9 | 4 | 17 | 43.3 |
| 对比例2 | 10 | 5 | 15 | 50 |
五组疗效比较，实验组的治愈人数和有效率均高于对照组。经X2检验实施例1-3组中任一组与对比例1或对比例2相比均有显著性差异(P＜0.01)，说明本发明将中草药和西药复配后，产生的治疗肝癌功效高于纯中药配方或纯西药配方。
以上所述仅为本发明的较佳实施例，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)
1.一种治疗肝癌的药物组合物，其特征在于，由中药成分和西药成分复配而成，以重量份数计，所述中药成分包括如下原料药：七叶一枝花24-36份、八角莲20-30份、穿山甲20-30份、紫草18-24份、泽漆18-24份、黄芪15-20份；所述西药成分包括如下原料药：氟尿嘧啶2.5-4.5份、多柔比星2.5-3.5份。
2.根据权利要求1所述的治疗肝癌的药物组合物，其特征在于，以重量份数计，所述中药成分包括如下原料药：七叶一枝花30份、八角莲25份、穿山甲25份、紫草21份、泽漆21份、黄芪17份；所述西药成分包括如下原料药：氟尿嘧啶3.5份、多柔比星3份。
3.一种如权利要求1或2所述的治疗肝癌的药物组合物的制备方法，其特征在于，采用醇提法和水提法单独或混合提取得到中药成分的提取物，中药成分的提取物再与西药成分、药学上可接受的辅料加工制成药学上可接受的剂型。
4.根据权利要求3所述的制备方法，其特征在于，所述剂型为片剂、颗粒剂、胶囊剂、滴丸剂、口服溶液剂、冲剂或缓释微丸。
5.根据权利要求4所述的制备方法，其特征在于，所述剂型为片剂。
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