CN105688147A - 一种治疗肿瘤的中药组合物 - Google Patents

一种治疗肿瘤的中药组合物 Download PDF

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CN105688147A
CN105688147A CN201610122270.9A CN201610122270A CN105688147A CN 105688147 A CN105688147 A CN 105688147A CN 201610122270 A CN201610122270 A CN 201610122270A CN 105688147 A CN105688147 A CN 105688147A
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chinese medicine
composition
medicine composition
tumor
carcinoma
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吴风平
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    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
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Abstract

本发明公开一种治疗肿瘤的中药组合物。该组合物由乌骨藤、松针层孔菌、乌梢蛇、土鳖虫、蜈蚣、海马、全蝎、薏苡仁等49味原料药组成。本发明中药组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂或口服液。本发明药物组合物能够提高机体免疫力，抑制肿瘤细胞生长，改善症状，大大提高肿瘤患者的生存质量并延长其生存期，对治疗效果显著，无不良反应。

Description

一种治疗肿瘤的中药组合物
技术领域
本发明涉及一种药物组合物，特别是涉及一种治疗肿瘤的中药组合物。
背景技术
肿瘤是机体在各种致癌因素作用下，局部组织的某一个细胞在基因水平上失去对其生长的正常调控，导致其克隆性异常增生而形成的新生物，是威胁现代人健康的头号杀手。现有技术中治疗肿瘤的方法主要采用化疗和放疗，这两种治疗方法虽然有一定的疗效，但是，病人在治疗期间会感觉很痛苦，因此，患者对于这两种治疗方法具有恐惧心理，不利于疾病的治疗。
目前，在多数发达国家及我国大城市，肿瘤患者就诊时，多数为中晚期患者，往往失去了最佳的治疗机会。如何提高患者的生存质量，延长生存期是目前肿瘤治疗的重要课题。在我国，中医在治疗肿瘤方面占有重要地位；经过几十年的临床和实验研究证明：中医药能减轻肿瘤患者的症状及化疗副作用，在延长患者生存期方面起了重要的作用。
本发明要解决的技术问题：提供一种治疗肿瘤的中药，尤其是治疗肝癌、肺癌、直肠结肠癌、胃癌、食道癌、乳腺癌和宫颈癌。该中药能够提高机体免疫力，抑制肿瘤细胞生长，改善症状，大大提高肿瘤患者的生存质量并延长其生存期，效果明显，而无不良反应。
发明内容
本发明目的在于提供一种治疗肿瘤的中药组合物。
本发明是通过如下技术方案实现的：
本发明中药组合物的原料药组成为：
本发明中药组合物的原料药组成优选为：
本发明中药组合物的原料药组成优选为：
本发明中药组合物的原料药组成优选为：
本发明中药组合物中所述木鳖子为去壳后的木鳖子；所述山楂为焦山楂，所述谷芽为炒至焦黄的焦谷芽；所述海浮石、青礞石、瓦楞子、海蛤壳均为煅制。
本发明中药组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂或口服液。
本发明药物组合物能够提高机体免疫力，抑制肿瘤细胞生长，改善症状，大大提高肿瘤患者的生存质量并延长其生存期，对治疗效果显著，无不良反应。
下面实验例用于进一步说明本发明，但不限于本发明。
实验例一：临床试验
临床试验
1、临床资料
共统计肝癌、肺癌、直肠结肠癌、胃癌、食道癌、乳腺癌和宫颈癌各50例，共计350例患者，年龄为30-65岁。所有病例均经现代医学病理学或细胞学检查、CT及X片证实。患者均为III期或IV期癌症患者。
2、治疗情况：服用本发明口服液(按照实施例1方法制备，每日3次，每次1支，10ml/支)，服用2个月。)
3、治疗结果
主要观察指标包括观察癌症患者的主要症状变化情况、生存质量、生存期情况，并通过治疗前后胸片及CT检查结果观察病灶情况。
4、主要症状变化：服用本发明口服液(按照实施例1方法制备)后的癌症患者，精神状况明显好转，咳嗽、胸痛、胸闷、气短、痰血也有明显好转或消失，无癌细胞转移情况。
5、体重变化：患者纳食改观大，均有不同程度的体重增加。
6、生存治疗评定变化：根据Karnofsky活动状况分级标准，与治疗前的状况对照，治疗后增加10分为增加，减少10分为下降，变化不超过10分为稳定。结果，增加者280例，下降者1例，稳定者69例。
7、近期疗效评定：按照1978年12月常州会议《抗肿瘤药物疗效通用标准》，对350例患者的前后情况作了对照，表明：经治疗二月后复查CT、X片，患者的病灶均有不同状况不等的改善，生存质量有大大的提高，疼通也明显减轻，癌细胞无转移。
8、病案举例：赵××，男57岁，退休教师，2005年11月经CT、X片、B超诊断为周围型肺癌，2006年1月服用本发明口服液(按照实施例1方法制备)。患者就诊时面色萎黄，咳嗽气喘，精神差，消瘦，饮食不佳，舌淡红，脉沉滑细。治疗：服用本发明口服液，每日3次，每次1支，10ml/支，服用1个月后，精神改观，身体有力，食量增加。继续服用1个月天后，咳嗽气喘明显缓解，精神明显好转，疼痛基本消失。
二、药效学试验
(一)一般情况
本发明药物(按照实施例1方法制备)具有益气养阴，化癥散结的功能，用于癌症气阴不足，痰瘀互结症的辅助治疗的药物。根据该药的功能主治特点，根据医院制剂的要求，采用祛邪扶正为主要试验，验证该药的功能和主治。根据确定的试验方案中的模型特点，选用两种阳性对照药物，一是祛邪作用显著的环磷酰胺，另一个是与该药功能主治近似的中药复方天仙胶囊。
剂量的确定：根据临床人用剂量推算得出。按实验动物与人体表面积比等效剂量推算比表折算而得。成人每天用量为1支/次，3次/日，10ml/支，因此，成人每天所用剂量为30ml。按表计算得出小鼠等效剂量以1和2倍及4倍量定为低、中、高剂量组：3ml/kg、6ml/kg、12ml/kg。临床给药途径为口服，因此小鼠给药也为口服灌胃给药，连续给药10天。
材料
1、受试药物：
本发明药物(按照实施例1方法制备)，用羧甲基纤维素钠配成混悬液(0.5％CMC-Na)，用时配制成所需浓度，4℃冰箱保存。
2、阳性对照药：
环磷酰胺：中美合资山西泰盛制药有限公司，批号：000906，用时以蒸馏水配成所需浓度，现用现配，实验选30mg/kg，腹腔注射，隔日给药，共5次。
3、动物：
ICR小鼠：二级，18～22g，雌雄均可(但每批选用同性别)，购自北京维通利华实验动物技术有限公司，许可证号：SCXK1100-0008。
C57BL/6小鼠：二级，18-22，雌雄均可(但每批选用同性别)，购自中国医科院动物所，许可证号：SCXK110-0006。
4、瘤株：
小鼠Lewis肺癌：由中国医科院药物所肿瘤室提供。
小鼠直肠结肠癌：由中国医科院药物所肿瘤室提供。
小鼠肝癌：由中国医科院药物所肿瘤室提供。
小鼠胃癌：由中国医科院药物所肿瘤室提供。
小鼠食道癌：由中国医科院药物所肿瘤室提供。
小鼠乳腺癌：由中国医科院药物所肿瘤室提供。
小鼠宫颈癌：由中国医科院药物所肿瘤室提供。
5、试剂：
印度墨汁：北京四中化工厂，批号：820501。用时用生理盐水稀释10倍。
6、仪器：
紫外分光光度计：日本岛津UV-1601PC
离心机：LXJ-II型，编号6260，上海医用分析仪器厂
精密电子分析天平：EB-280M-22型，日本KYOTO公司
酶标仪：DG-3022A型华东电子仪器厂
方法与结果
(二)、动物模型的建立
1、小鼠肝癌肿瘤模型
小鼠腹腔内传代7天肝癌瘤株，无菌取出后，用生理盐水洗涤2次，计数并调细胞到1×107个/ml，并接种到小鼠腹腔内，每只鼠接种上述细胞悬液为0.2ml。
2、小鼠肺癌模型
选腋下接种Lewis肺癌7天左右生长良好无破溃的小鼠，脱臼处死，固定，用酒精，碘酒消毒皮肤，无菌条件下剥离肿瘤，并将肿瘤外脂肪和组织剔除，秤重，按1∶4比例加入生理盐水，用研磨器研磨成细胞悬液，计数并调细胞到1×107个/ml，并接种到小鼠右腋皮下，每只鼠接种上述细胞悬液为0.2ml。
3、小鼠胃癌模型
(2)小鼠腹腔内传代7天胃癌瘤株，无菌取出后，用生理盐水洗涤2次，计数并调细胞到1×107个/ml，并接种到小鼠胃内，每只鼠接种上述细胞悬液为0.2ml。
4、小鼠食道癌模型
(2)小鼠腹腔内传代7天食道癌瘤株，无菌取出后，用生理盐水洗涤2次，计数并调细胞到1×107个/ml，并接种到小鼠食道内，每只鼠接种上述细胞悬液为0.2ml。
5、小鼠直肠结肠癌模型
(2)小鼠腹腔内传代7天直肠结肠癌瘤株，无菌取出后，用生理盐水洗涤2次，计数并调细胞到1×107个/ml，并接种到小鼠肠道内，每只鼠接种上述细胞悬液为0.2ml。
6、小鼠乳腺癌、宫颈癌模型
(2)小鼠腹腔内分别传代7天乳腺癌或宫颈癌瘤株，无菌取出后，用生理盐水洗涤2次，计数并调细胞到1×107个/ml，并接种到小鼠腹腔内，每只鼠接种上述细胞悬液为0.2ml。
7、小鼠宫颈癌模型
(2)小鼠腹腔内分别传代7天宫颈癌瘤株，无菌取出后，用生理盐水洗涤2次，计数并调细胞到1×107个/ml，并接种到小鼠腹腔内，每只鼠接种上述细胞悬液为0.2ml。
(三)、对小鼠肿瘤的抑制作用
取上述7组小鼠模型，分别为雄性C57BL/6小鼠各10只，分别右腋皮下接种上述肿瘤细胞0.2ml，24小时后随机分为5组，每组14只(7组小鼠模型各2只)，空白组灌胃给等容量0.5％CMC-Na；阳性对照环磷酰胺，腹腔注射30mg/kg，(给药时间为第1天、3天、5天、7天、9天)；本发明药物高、中、低剂量组灌胃给药，每日一次，连续10日。于停药后24小时脱臼处死，称取体重、瘤重、胸腺、脾脏重量(计算胸腺和脾脏指数)。
计算肿瘤生长抑制率＝(C-T)/C×100％
T：实验组平均体重C：对照组平均瘤重，以上实验重复2次(共3批)。
结果显示，本发明药物连续灌胃给药10天，重复三批抑瘤率高剂量分别是：38.38、52.82、43.45％；
中剂量组为33.33、40.51、32.46％；低剂量组为23.23、33.85、15.18％，并具有一定的量效关系。高、中剂量组对小鼠移植性肿瘤具有明显的抑制肿瘤生长的作用(P＜0.01)。
(四)、对小鼠生存期影响
取上述7组小鼠模型，分别为雄性C57BL/6小鼠各10只，每只小鼠腹腔注射0.2mlEAC瘤细胞，24小时后随机分为5组，每组14只(7组小鼠模型各2只)。空白对照组给等容量0.5％CMC-Na；阳性对照环磷酰胺腹腔注射30mg/kg；本发明药物高、中、低剂量组灌胃给药，每日一次，连续10日。第11天停药，以后每天观察记录小鼠死亡情况并记录，结果计算小鼠生命延长率。
生命延长率＝(T-C)/C×100％
T：实验组平均生存天数C：对照组平均生存天数以上实验重复2次(共3批)。
结果显示，本发明药物连续灌胃给药10天，重复三批，各剂量组均明显的延长小鼠EAC腹水型肿瘤的生存期，高剂量组分别为34.54、65.54、69.40％；中剂量组分别为46.47、64.22、103.62％；低剂量组分别为43.55、26.57、85.18％。结果显示，各剂量组明显延长EAC腹水型肿瘤小鼠生存期，各组平均生命延长率均大于50％。
(五)、对小鼠的镇痛作用
取上述7组小鼠模型，分别为雄性C57BL/6小鼠各10只，分为5组，每组14只(7组小鼠模型各2只)。对照组给等容量0.5％CMC-Na，阳性药吲哚美辛；本发明药物高、中、低剂量组。以上各组均灌胃给药，给药1小鼠后，各鼠均腹腔注射0.6％醋酸0.2ml/只。观察15分钟内各鼠出现的扭体反应次数。
结果显示：本发明药物具有明显的镇痛作用，并有明显的量效关系，高、中剂量组与对照组比较有显著性差异(P＜0.05-0.001)。
对醋酸扭体反应的镇痛作用(X±S)组别剂量(mg/kg)动物数(只)扭体出现动物数(只扭体次数空白组-101030.15±11.65吲哚美辛101030.82±0.58***高剂量80010913.82±8.68**中剂量400101016.89±7.89**低剂量200101025.86±10.58
注：与空白组比较**P＜0.01，***P＜0.001。
下述实施例均能实现上述实验例的效果。
具体实施方式
实施例1口服液
上述药物按照常规工艺加入常规辅料制成口服液，10ml/支，一日三次，一次1支。
实施例2丸剂
上述药物按照常规工艺加入常规辅料制成水丸，6g/袋，一日三次，一次1袋。
实施例3胶囊剂
上述药物按照常规工艺加入常规辅料制成胶囊剂。0.3g/粒，每日三次，每次二粒。
实施例4片剂
上述药物按照常规工艺加入常规辅料制成片剂。0.3g/片，每日三次，每次二片。
实施例5颗粒剂
上述药物按照常规工艺加入常规辅料制成颗粒剂，每袋6g，一日三次，一次1袋。

Claims (10)

1.一种治疗肿瘤的中药组合物，其特征在于，该组合物的原料药组成为：
2.如权利要求1所述的中药组合物，其特征在于该组合物的原料药组成为：
3.如权利要求1所述的中药组合物，其特征在于该组合物的原料药组成为：
4.如权利要求1所述的中药组合物，其特征在于该组合物的原料药组成为：
5.如权利要求1-4之一所述的中药组合物，其特征在于所述木鳖子为去壳后的木鳖子；所述山楂为焦山楂，所述谷芽为炒至焦黄的焦谷芽；所述海浮石、青礞石、瓦楞子、海蛤壳均为煅制。
6.如权利要求1-4之一所述的中药组合物，其特征在于该组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂或口服液。
7.如权利要求5所述的中药组合物，其特征在于该组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂或口服液。
8.如权利要求1-4之一所述的中药组合物在制备治疗肿瘤的药物中的应用。
9.如权利要求5所述的中药组合物在制备治疗肿瘤的药物中的应用。
10.如权利要求8或9之一所述的中药组合物在制备治疗肿瘤的药物中的应用，其中所述肿瘤是指肝癌、肺癌、直肠结肠癌、胃癌、食道癌、乳腺癌或宫颈癌。
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CN106110182A (zh) * 2016-06-30 2016-11-16 杨亚清 一种治疗癌症的中药组合物
CN107019771A (zh) * 2017-03-16 2017-08-08 郑学峰 一种抗肿瘤的中药组合物

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