CN105535227A - 治疗中晚期胰腺癌的药物组合物 - Google Patents
治疗中晚期胰腺癌的药物组合物 Download PDFInfo
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Abstract
本发明公开了一种治疗中晚期胰腺癌的药物组合物及其制备方法,本发明药物组合物是以凤蝶色素II、弹刀子菜、密花草为原料药,配比而成,可按常规制剂工艺制成各种剂型,治疗中晚期胰腺癌疗效显著。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗中晚期胰腺癌的药物组合物及其制备方法。
背景技术
胰腺癌是一种恶性程度极高的消化***肿瘤,近年来国内外胰腺癌的发病率均呈明显增高趋势。胰腺癌起病隐匿,较少特异性症状和体征,仅<20%的胰腺癌患者有手术切除机会,术后复发率和转移率高,位居肿瘤死因第4位,是预后很差的恶性肿瘤之一。由于很多患者确诊时已达中晚期,因此积极探讨新的治疗方案以期控制肿瘤进展,特别是改善患者的生活质量具有重要价值。
胰腺癌是一种使人逐渐衰竭的疾病,改善症状尤具重要性。美国国立癌症中心(NCI)和FDA已经认同改善肿瘤相关症状本身也是当前癌症治疗的一个有价值的目标。由于肿瘤的临床症状与肿瘤负荷的大小直接相关,因此肿瘤负荷降低很小的部分即可使临床症状得到较大的改善。一些研究也表明化疗期间CA19-9水平的变化可作为监测胰腺癌疗效与判断其预后的重要指标。
凤蝶色素II(PapiliochromeII):CAS号68335-21-7,分子式C21H26N4O6,分子量430.46。
弹刀子菜:本品为玄参科通泉草属植物弹刀子菜Mazusstachydifolius(Turcz.)Maxim.的全草。开花结果时采收,晒干。【性味】味微辛;性凉。【功能主治】清热解毒;凉血散瘀。主便秘下血;疮疖肿毒;毒蛇咬伤;跌打损伤。【原形态】多年生草本,高10-50cm。粗壮,全株被白色长柔毛。根状茎短;茎直立,稀上升,圆柱形,不分枝或基部分枝,老时基部木质化。基生叶匙形,有短柄,常早枯;茎生叶对生,上部的常互生,无柄;叶片长椭圆形至倒卵状披针形;纸质,长2-7cm,以茎中部的量大,边缘具锯齿。总状花序顶生,长2-20cm,花稀疏;苞片三角形;花萼漏斗状,长0.5-1cm,比花梗长,萼齿略长于筒部,先端长锐尖;花冠紫以,长1.5-2cm;花冠筒与唇部近等长,上唇短,2裂,裂片狭长三角形,端部尖,下唇宽大,开展,3裂,中裂片较侧裂片小,近圆形,稍突出,有两条着生腺毛的皱褶直达喉部;雄蕊4枚,二强;子房上部被长硬毛。蒴果扁卵球形,长2-4mm。花期4-6月,果期7-9月。收载于中药大辞典。
密花草:本品为沟繁缕科田繁缕属植物田繁缕BergiaammannioidesRoxb.ExRoth的全草。全年可采;洗净;晒干。【性味】味甘;性凉。【功能主治】清热解毒。主***;痈疖;口腔炎。【原形态】一年生草本,高7-30cm。近直立或渐升,分枝多,淡红色,具平展的腺毛。叶对生,几无柄;插叶长约2mm,2深裂,裂片披针形,有撕裂状小齿;叶片狭椭圆形或倒披针形,长0.4-2cm,宽2-8mm,边缘有尖锐的小锯齿,下面有短毛。花小,多数簇生于叶腋;花梗长1-2mm;萼片5,狭卵形,长约1.2mm,先端渐尖;花瓣5,淡红色,狭卵形,约与萼片等长;雄蕊5;花柱5,短。蒴果近球形,长1.2-2mm,裂为5瓣。种子我数,极小。花期几近全年。收载于中药大辞典。
1个原料药化学结构:
凤蝶色素II(PapiliochromeII)。
发明内容
本发明的目的是克服背景技术的不足,提供一种有效治疗中晚期胰腺癌的药物组合物及其制备方法。
本发明是采用如下技术方案实现的:
制成该治疗中晚期胰腺癌的药物组合物的原料药的组成和重量份为:
凤蝶色素II460-490重量份弹刀子菜6680-6700重量份密花草5500-5700重量份。
优选的用于治疗中晚期胰腺癌的药物组合物,是由如下重量份的原料药组成:
凤蝶色素II480重量份弹刀子菜6690重量份密花草5600重量份。
一种治疗中晚期胰腺癌的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗中晚期胰腺癌的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗中晚期胰腺癌药物。
一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:凤蝶色素II460-490重量份弹刀子菜6680-6700重量份密花草5500-5700重量份;
制备方法:
(1)按原料药配比取凤蝶色素II、弹刀子菜、密花草,混匀,用重量百分比浓度29%乙醇作为溶剂,在37℃温浸提取,提取次数为18次,每次提取时间为22小时,每次溶剂用量为原料药总重量的15倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.22,滤过,药液通过HPD700大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度44.5%乙醇溶液洗脱HPD700大孔吸附树脂柱,收集重量百分比浓度44.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度57.5%乙醇作为溶剂,加热回流提取23次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的28倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.09,滤过,药液通过GDX-104大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度91.5%乙醇溶液洗脱GDX-104大孔吸附树脂柱,收集重量百分比浓度91.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
优选的一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:凤蝶色素II480重量份弹刀子菜6690重量份密花草5600重量份;
制备方法:
(1)按原料药配比取凤蝶色素II、弹刀子菜、密花草,混匀,用重量百分比浓度29%乙醇作为溶剂,在37℃温浸提取,提取次数为18次,每次提取时间为22小时,每次溶剂用量为原料药总重量的15倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.22,滤过,药液通过HPD700大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度44.5%乙醇溶液洗脱HPD700大孔吸附树脂柱,收集重量百分比浓度44.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度57.5%乙醇作为溶剂,加热回流提取23次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的28倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.09,滤过,药液通过GDX-104大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度91.5%乙醇溶液洗脱GDX-104大孔吸附树脂柱,收集重量百分比浓度91.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗中晚期胰腺癌药物。
药物组合物治疗中晚期胰腺癌疗效显著。
具体实施方式
实施例1:治疗中晚期胰腺癌的药物组合物及其制备方法
治疗中晚期胰腺癌的药物组合物的原料药的组成和重量份为:凤蝶色素II480g弹刀子菜6690g密花草5600g;
制备方法:
(1)按原料药配比取凤蝶色素II、弹刀子菜、密花草,混匀,用重量百分比浓度29%乙醇作为溶剂,在37℃温浸提取,提取次数为18次,每次提取时间为22小时,每次溶剂用量为原料药总重量的15倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.22,滤过,药液通过HPD700大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度44.5%乙醇溶液洗脱HPD700大孔吸附树脂柱,收集重量百分比浓度44.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度57.5%乙醇作为溶剂,加热回流提取23次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的28倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.09,滤过,药液通过GDX-104大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度91.5%乙醇溶液洗脱GDX-104大孔吸附树脂柱,收集重量百分比浓度91.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例2:治疗中晚期胰腺癌的药物组合物及其制备方法
治疗中晚期胰腺癌的药物组合物的原料药的组成和重量份为:凤蝶色素II460g弹刀子菜6700g密花草5500g;
制备方法:
(1)按原料药配比取凤蝶色素II、弹刀子菜、密花草,混匀,用重量百分比浓度29%乙醇作为溶剂,在37℃温浸提取,提取次数为18次,每次提取时间为22小时,每次溶剂用量为原料药总重量的15倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.22,滤过,药液通过HPD700大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度44.5%乙醇溶液洗脱HPD700大孔吸附树脂柱,收集重量百分比浓度44.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度57.5%乙醇作为溶剂,加热回流提取23次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的28倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.09,滤过,药液通过GDX-104大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度91.5%乙醇溶液洗脱GDX-104大孔吸附树脂柱,收集重量百分比浓度91.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例3:治疗中晚期胰腺癌的药物组合物及其制备方法
治疗中晚期胰腺癌的药物组合物的原料药的组成和重量份为:凤蝶色素II490g弹刀子菜6680g密花草5700g;
制备方法:
(1)按原料药配比取凤蝶色素II、弹刀子菜、密花草,混匀,用重量百分比浓度29%乙醇作为溶剂,在37℃温浸提取,提取次数为18次,每次提取时间为22小时,每次溶剂用量为原料药总重量的15倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.22,滤过,药液通过HPD700大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度44.5%乙醇溶液洗脱HPD700大孔吸附树脂柱,收集重量百分比浓度44.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度57.5%乙醇作为溶剂,加热回流提取23次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的28倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.09,滤过,药液通过GDX-104大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度91.5%乙醇溶液洗脱GDX-104大孔吸附树脂柱,收集重量百分比浓度91.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
实施例4:片剂的制备
取实施例1药物组合物260g,加入淀粉178g,混匀,制粒,干燥,加微晶纤维素115g,硬脂酸镁6.5g,混匀,压制成1200片,即得药物组合物片剂。
实施例5:胶囊的制备
取实施例2药物组合物288g,加入淀粉186g,混匀,制粒,干燥,整粒,加入适量硬脂酸镁,混匀,装胶囊1400粒,即得药物组合物胶囊。
实施例6:滴丸的制备
称取聚乙二醇6000239g水浴(80℃)加热煮熔,加入实施例3药物组合物11g,充分搅拌均匀,以液体石蜡为冷却剂,置玻璃管(4*80cm)中,冷却温度为2℃,滴口内外径为7.0/2.0(mm/mm),滴口距液面为3.5cm,滴速以每分55滴为最佳条件,用棉布吸干滴丸表面的冷凝剂,即得药物组合物滴丸。
实验例1:治疗中晚期胰腺癌的试验研究
1临床资料
1.1病例纳入标准
诊断符合《常见恶性肿瘤诊治规范》中的有关标准确诊为胰腺癌;年龄18-70岁;Karnofsky(卡氏)评分\60分;预期生存期>3个月以上;血常规、肾功能、肝功能和各项生化指标正常;近1个月以上未接受过其他抗肿瘤治疗;依从性好的、、期患者。
1.2病例排除标准
不符合纳入标准者;妊娠期或哺乳期妇女;严重的心、肝、肾、脑等器质性损害和骨髓造血功能障碍者;认知能力丧失或精神异常的精神病患者;过敏体质及多种药物过敏者。
1.3一般资料
26例纳入病例均为2009年5月-2011年6月我市医院住院患者。包括男13例,女13例;年龄最大66岁,最小30岁,中位年龄55.4岁;期5例,期15例,期6例。采用随机数字表法分为化疗组13例和药物组合物+化疗组13例。经过治疗前基线分析比较两组性别、年龄、卡氏评分和临床分期等均无显著性差异(P>0.05),具有可比性。
2方法
2.1治疗方法
化疗组:吉西他滨1000mg/m2第1天和第8天加生理盐水稀释静滴30min以上。此方案每21天为1个周期,连续化疗2个周期。
药物组合物+化疗组:化疗方案及疗程同化疗组,在化疗同时口服药物组合物(实施例1药物组合物批号20081120),每日3次,每次0.6g,直至2个化疗周期结束。
2.2观察方法
2个化疗周期后进行疗效评价。
2.2.1实体瘤客观疗效
采用WHO关于实体瘤治疗的疗效评定标准。完全缓解(CR):可见的病变完全消失,超过1个月;部分缓解(PR):肿块缩小(单个病变肿瘤面积指肿块两个最大垂直径的乘积,多个肿块指两个最大垂直径乘积之和)50%以上,时间不少1个月;稳定(NC):肿块缩小不及50%或增大未超过25%;进展(PD):一个或多个病变增大25%以上或出现新的病变。根据CR+PR+NC计算临床受益率。
2.2.2血清CA19-9变化
治疗后血清CA19-9水平降至正常为完全缓解(CR);下降>25%为部分缓解(PR);下降<25%且增高<25%为稳定(NC);增高>50%为进展(PD)。
2.2.3体力状况评定
根据卡氏评分(Karnofsky)进行生活质量评定。卡氏评分标准:治疗前后评分提高10分为提高;减少10分为降低;无增减者为稳定。根据提高和稳定计算受益率。
2.2.4临床症状改善评定
临床症状改善情况,无症状评0分,有症状评2分,症状显著4分,各单项评分的总和称为临床症状积分。
2.2.5毒副反应观察
治疗前后外周血白细胞、红细胞、血红蛋白、血小板及肝、肾功能变化情况,毒副反应评定根据《抗癌药物临床研究指导原则》中“抗癌药物急性及亚急性毒性标准”评定。
2.2.6统计方法
采用SPSS11.5统计软件,计数资料采用卡方检验,计量资料采用t检验,等级资料采用秩和检验。
3结果
3.1实体瘤客观疗效比较
两组治疗后实体瘤CR、PR、NC、PD客观疗效比较无统计学差异,P>0.05。临床受益率药物组合物+化疗组(100%)优于化疗组(76.92%),有显著性差异,P<0.05,见表1。
表1两组实体瘤客观疗效比较/例(%)
组别 | n | CR | PR | NC | PD | CR+PR+NC |
化疗组 | 13 | 0 | 4 | 6 | 3 | 10(76.92) |
药物组合物+化疗组 | 13 | 1 | 9 | 3 | 0 | 13(100)* |
注:与化疗组比较,*P<0.05。
3.2血清CA19-9变化比较
药物组合物+化疗组疗效优于化疗组,有显著性差异(P<0.05),见表2。
表2两组治疗后血清CA19-9变化比较/例(%)
注:经秩和检验,与化疗组比较,*P<0.05。
3.3体力状况评分
化疗组治疗后较治疗前提高1例,稳定6例;药物组合物+化疗组提高4例,稳定8例;两组受益率分别为53.85%、92.31%,差异均有显著意义,P<0.05,见表3。
表3两组卡氏评分比较/例(%)
组别 | n | 提高 | 稳定 | 降低 | 提高+稳定 |
化疗组 | 13 | 1(7.69) | 6(46.15) | 6(46.15) | 7(53.85) |
药物组合物+化疗组 | 13 | 4(30.77)* | 8(61.54)* | 1(7.69)* | 12(92.31)*# |
注:经秩和检验,与化疗组比较,*P<0.05;经卡方检验,与化疗组比较,#P<0.05。
3.4临床症状改善评定
结果显示药物组合物+化疗组与化疗组比较临床症状改善主要表现在腹痛、食欲减退、神疲、失眠方面,经统计学检验差异均有显著性,P<0.05,见表4。
表4临床症状积分比较(x±s)
临床症状 | 化疗组/分 | 药物组合物+化疗组/分6 --> |
腹痛 | 2.37±0.35 | 1.76±0.16* |
食欲减退 | 2.45±0.78 | 1.79±0.96* |
神疲 | 2.56±1.04 | 1.69±0.81* |
失眠 | 2.46±1.22 | 1.58±0.92* |
注:经t检验,与化疗组比较,*P<0.05。
3.5毒副反应观察
两组治疗后外周血白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、血小板(PLT)及肝(ALT)、肾功能(Cr)均未出现级化疗毒性反应,两组WBC毒性反应具有显著意义,P<0.05,其他血液学毒性及肝、肾功能毒性比较无统计学差异,P>0.05。
结果表明,药物组合物具有延缓实体瘤增长,降低CA19-9,改善临床症状,提高患者生活质量,减轻化疗引起白细胞减少的毒副反应,对中晚期胰腺癌患者显示出良好的临床受益反应。
Claims (8)
1.一种治疗中晚期胰腺癌的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
凤蝶色素II460-490重量份弹刀子菜6680-6700重量份密花草5500-5700重量份。
2.根据权利要求1所述一种治疗中晚期胰腺癌的药物组合物,其特征在于制成该药物组合物的原料药的组成和重量份为:
凤蝶色素II480重量份弹刀子菜6690重量份密花草5600重量份。
3.根据权利要求1所述一种治疗中晚期胰腺癌的药物组合物,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
4.根据权利要求1所述一种治疗中晚期胰腺癌的药物组合物,其特征在于药物组合物与化学药或中药组成的治疗中晚期胰腺癌药物。
5.一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:凤蝶色素II460-490重量份弹刀子菜6680-6700重量份密花草5500-5700重量份;
制备方法:
(1)按原料药配比取凤蝶色素II、弹刀子菜、密花草,混匀,用重量百分比浓度29%乙醇作为溶剂,在37℃温浸提取,提取次数为18次,每次提取时间为22小时,每次溶剂用量为原料药总重量的15倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.22,滤过,药液通过HPD700大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度44.5%乙醇溶液洗脱HPD700大孔吸附树脂柱,收集重量百分比浓度44.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度57.5%乙醇作为溶剂,加热回流提取23次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的28倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.09,滤过,药液通过GDX-104大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度91.5%乙醇溶液洗脱GDX-104大孔吸附树脂柱,收集重量百分比浓度91.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
6.根据权利要求5所述一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于按如下步骤制备:
原料药的组成和重量份为:凤蝶色素II480重量份弹刀子菜6690重量份密花草5600重量份;
制备方法:
(1)按原料药配比取凤蝶色素II、弹刀子菜、密花草,混匀,用重量百分比浓度29%乙醇作为溶剂,在37℃温浸提取,提取次数为18次,每次提取时间为22小时,每次溶剂用量为原料药总重量的15倍,滤过,得药渣A和提取液A,提取液A回收乙醇,浓缩至相对密度1.22,滤过,药液通过HPD700大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度44.5%乙醇溶液洗脱HPD700大孔吸附树脂柱,收集重量百分比浓度44.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物A;
(2)取步骤(1)药渣A,用重量百分比浓度57.5%乙醇作为溶剂,加热回流提取23次,每次提取时间为0.6小时,每次溶剂用量为药渣A重量的28倍,滤过,得药渣B和提取液B,提取液B回收乙醇,浓缩至相对密度1.09,滤过,药液通过GDX-104大孔吸附树脂柱,先用水洗脱,再用重量百分比浓度91.5%乙醇溶液洗脱GDX-104大孔吸附树脂柱,收集重量百分比浓度91.5%乙醇洗脱液,回收乙醇,浓缩干燥,即得提取物B;
(3)将提取物A和提取物B混匀,即得药物组合物。
7.根据权利要求5所述一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于药物组合物可以采用制剂学的常规方法制备成片剂或胶囊剂或滴丸。
8.根据权利要求5所述一种治疗中晚期胰腺癌的药物组合物的制备方法,其特征在于药物组合物与化学药或中药组成治疗中晚期胰腺癌药物。
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