CN104258046A - 一种配合tp方案治疗中晚期非小细胞肺癌的中药组合物及其制备工艺 - Google Patents
一种配合tp方案治疗中晚期非小细胞肺癌的中药组合物及其制备工艺 Download PDFInfo
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Abstract
本发明的组合物涉及一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物及其制备工艺本发明属于中药领域。制备方法为:取凤尾蕉叶、黄芪用60-80%乙醇提取并浓缩成膏-A。醇提后的凤尾蕉叶和黄芪,与麦冬和南沙参一起水提取两次,浓缩成膏-B。川芎、当归尾粉碎成粗粉,用50-90%的乙醇渗漉,并将渗漉液浓缩成膏-C。半枝莲、地龙、赤勺、桃仁、红花、蜈蚣加水煮两次,滤液浓缩成相对密度为1.08-1.18(80℃)的浸膏,加乙醇使含醇量为50-80%,搅匀,静置48小时,取上清液,回收乙醇得膏-D,合并膏-A、B、C、D,加炼蜜与山梨酸钾,搅匀即得。该中药组合物配合使用能提高TP方案治疗中晚期非小细胞肺癌的效果、减轻化疗毒副反应,提高5年生存率。
Description
技术领域
本发明的组合物涉及一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物及其制备工艺。
背景技术
目前,对中晚期非小细胞肺癌的治疗仍属于姑息治疗,处在研究阶段,尚无标准化治疗。近年来应用PTX(紫衫醇)治疗肺癌,特别是晚期非小细胞肺癌,显示出其较好的临床应用价值。美国M·D·Anderson肿瘤医院报道,PTX(200 mg/m2)单药治疗25例初治晚期非小细胞肺癌有效率为24%,参考文献:Erringer Ds.Overview of paclitaxel(Taxol)in advanced lung cancer[J].Semin Oncol,1993,20(4):4649。肺癌诊疗规范(2011年版)对于不能手术切除的NSCLC的药物治疗推荐TP方案(紫杉醇/多西紫杉醇+铂类)化疗。Breathnach等报告TP方案治疗中晚期非小细胞肺癌有效率为43%,中位生存期8.5个月,1年生存率37%,参考文献:Breathnach OS,Georgiadis MS,Schuler BS,et al.Phase trial of paclitaxel by 96howr continuous infusion in combination with cisplatin for patients with advanced nonsmall cell lung cancer[J].Clin Cancer Res,2000,6(7):26702676。郭进华等报道TP方案治疗晚期晚期非小细胞肺癌有效率为42.8%。参考文献:TP 和 GP 方案治疗晚期非小细胞肺癌的临床对照研究《山西大同大学学报:自然科学版》2013年 第6期。对于TP方案的实施,仍有待提高疗效与减轻化疗中的毒副反应。本发明的目的在于提供一种配合TP方案治疗中晚期非小细胞肺癌的一种中药组合物,联合使用本药能减轻TP方案的毒副反应,提高TP方案化疗的临床效果,提高5年生存率。
发明内容
本发明的目的在于提供一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物及其制备工艺。
本发明的目的是通过如下途径实现的:一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物,该中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏46.0-99.7%,辅料炼蜜0-68%,防腐剂山梨酸钾0-0.3%。
所述主料清膏由下述中药饮片加工提取浓缩而成,所用中药饮片按重量百分比由下述组分组成:凤尾蕉叶 10-49%、黄芪20-48%、麦冬6-15%、南沙参 5-12%、半枝莲4-9%、地龙 3-8%、川芎1-7%、归尾1-5%、赤芍 2-4%、桃仁 0-4%、红花0-3%、蜈蚣1-2%。
所述主料清膏由下述中药饮片加工提取浓缩而成,所用中药饮片重量百分比,其组分为凤尾蕉叶38%、黄芪22%、麦冬8%、南沙参 6.9%、半枝莲6.5%、地龙 5%、川芎4%、归尾3.8%、赤芍 3.8%、桃仁 0%、红花0%、蜈蚣2%。
所述主料清膏由下述中药饮片加工提取浓缩而成,所用中药饮片重量百分比,其组分为凤尾蕉叶11%、黄芪45%、麦冬7.6%、南沙参 7.6%、半枝莲5.6%、地龙 4.5%、川芎4.5%、归尾3.8%、赤芍 3.8%、桃仁 2.3%、红花2.3%、蜈蚣2%。
所述中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏99.7%,辅料炼蜜0%,防腐剂山梨酸钾0.3%。
所述中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏67.7%,辅料炼蜜32%,防腐剂山梨酸钾0.3%。
所述中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏50%,辅料炼蜜49.7%,防腐剂山梨酸钾0.3%。
一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物制备工艺步骤。
主料清膏制备:按[0005]、[0006]、[0007]所述的主料清膏制备所需组分比例分别称取中药饮片,凤尾蕉叶和黄芪切成5mm厚小片,加六倍量60-80%乙醇,回流提取1小时,滤过提取液,滤液减压回收乙醇使成膏-A,醇提后的凤尾蕉叶和黄芪,与麦冬和南沙参一起煎煮两次,每次1小时,煎液滤过,滤液浓缩成相对密度1.21-1.25(80℃)的膏-B,川芎、当归尾粉碎成粗粉,混均,用50-90%的乙醇浸渍48小时后缓缓渗漉,收集生药量四倍的渗漉液,减压回收乙醇得膏-C,半枝莲、地龙、赤勺、桃仁、红花、蜈蚣加水煮两次,每次1小时,滤过,合并滤液并浓缩滤液至相对密度为1.08-1.18(80℃)的浸膏,加乙醇使含醇量为50-80%,搅匀,静置48小时,取上清液,回收乙醇得膏-D,将上述膏-A、B、C、D合并,必要时加水调节,煮沸得相对密度1.16-1.22(80℃)的清膏即为主料清膏。
中药组合物配制:按[0004]、[0008]、[0009]、[0010]所述主料清膏加辅料炼蜜比例,按需称取主料清膏与辅料炼蜜,必要时可加少量水调节,煮沸,搅匀,保温30分钟,计算保温物料总重量,之后使物料降温至50-60℃,按比例取防腐剂山梨酸钾,加少许水溶解后搅入物料中,搅拌均匀后分装,密封保存。
本发明为一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物,能明显提高TP方案治疗中晚期非小细胞肺癌的临床疗效,减轻TP方案中的毒副反应,提高5年生存率,本发明的中药组合物为口服制剂,可制成液体、半固体、固体口服制剂,同时该中药组方也可制成注射剂,用以配合TP方案治疗中晚期非小细胞肺癌。
具体实施
本发明为一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物,各组分功效说明:
凤尾蕉叶:理气活血、通络解积。
黄芪:健脾益气、升举清阳、生津利肺。
麦冬:养阴生津、清心润肺。
南沙参:养阴清肺、益气化痰。
半枝莲:清热解毒、化瘀利尿。
地龙:清肺平喘、通经活络。
川芎:活血行气、祛风止痛。
当归尾:补血活血、调经止痛。
赤勺:清热凉血、散瘀止痛。
红花:活血通络、散瘀止痛。
桃仁:活血祛瘀、润肠通便。
蜈蚣:息风镇痉、攻毒散结、通络止痛。
炼蜜:为炼制后的蜂蜜,蜂蜜:补中润燥、解毒止痛。
山梨酸钾:防腐剂。
本发明为一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物,其组方原理:凤尾蕉叶理气活血、通络解积;黄芪大补脾胃之元气,两者合用使气旺血行,积结得以消散,两者共为君药。麦冬养阴生津,清心润肺;南沙参清热养阴,润肺止咳,麦冬与沙参共为臣药,与两君药配伍,共奏气阴双补、活血解积之效。赤芍、川芎、桃仁、红花、当归尾均能活血散瘀,可助凤尾蕉叶解积消瘤;半枝莲助南沙参滋阴清热;地龙清肺定喘、通经活络;蜈蚣解毒散结,这八味均为佐药,综合全方,大量补气药与少量活血药相配,气旺则血行,活血而又不伤正,配伍滋阴清热散结药,阴血同源,补阴血而祛内热,散淤结又不伤气阴,诸药合用共奏滋阴补气活血散结之功。
实施例一:按重量百分比配方如下:凤尾蕉叶11%、黄芪45%、麦冬7.6%、南沙参 7.6%、半枝莲5.6%、地龙 4.5%、川芎4.5%、归尾3.8%、赤芍 3.8%、桃仁 2.3%、红花2.3%、蜈蚣2%。凤尾蕉叶和黄芪切成5mm厚小片,加六倍量65%乙醇,回流提取1小时,滤过提取液,滤液减压回收乙醇使成膏-A,醇提后的凤尾蕉叶和黄芪,与麦冬和南沙参一起煎煮两次,每次1小时,煎液滤过,滤液浓缩成相对密度1.22(80℃)的膏-B,川芎、当归尾粉碎成粗粉,混均,用70%的乙醇浸渍48小时后缓缓渗漉,收集生药量四倍的渗漉液,减压回收乙醇得膏-C,半枝莲、地龙、赤勺、桃仁、红花、蜈蚣加水煮两次,每次1小时,滤过,合并滤液并浓缩滤液至相对密度为1.12(80℃)的浸膏,加乙醇使含醇量为65%,搅匀,静置48小时,取上清液,回收乙醇得膏-D,将上述膏-A、B、C、D合并,用总膏重量8%的水洗涤桶中残膏,一并加入总膏中,煮沸浓缩,得相应密度1.20(80℃)的主料清膏,称重,计量。称取主料清膏67.7Kg,炼蜜32Kg,置夹层锅中,加热煮沸20分钟后,趁热倒入已称量的配制桶中,称量计量,得98.14Kg,另取煮沸后冷却至室温的纯化水1.56Kg,加山梨酸钾0.3Kg溶解,待配制桶中温度降至60℃时,加入溶解好的山梨酸钾溶液,搅拌均匀后罐装,即为本发明所述的一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物。临床服用方法:在第一次TP方案化疗前三天开始服用本发明的中药组合物,具体用法用量为:口服,一次60克,一日两次,即早晚各一次。连续服用3周后,停服本品1周,然后再服用3周,停用1周,如此反复,一般用药时间应不少于6个月。
临床应用
1临床资料
80例中晚期非小细胞肺癌患者全部为2007年3月~2009年3月的住院病人,均经细胞学或组织学确诊,采用CT进行TNM分期,根据国际抗癌联盟肺癌TNM分期第7版修订稿制定的标准均属于局部晚期肺癌(ⅢA期和ⅢB期),临床无咯血表现,Karnofsky评分>60分,80例患者随机分成两组,治疗组41人,其中男性26人,女性15人,年龄37岁~73岁,中位年龄55岁,组织病理类型腺癌21例, 鳞癌 14 例, 其它类型 6例,对照组39人,其中男性26人,女性13,年龄35岁~72岁,中位年龄53岁,组织病理类型腺癌 18例, 鳞癌15 例, 其它类型 6 例,两组年龄、性别、病理类型等经统计学处理,差异无显著性意义(P>0.05),具有可比性。
2治疗方法
2.1对照组
采用TP方案化疗6周期,化疗间隔时间为21天。化疗所用药物及用法用量为:紫杉醇注射液(生产厂家:扬州奥赛康药业有限公司,生产批号:051202)160 mg/m2加入生理盐水500ml中静滴 d1;注射用顺铂(生产厂家:锦州九泰药业有限责任公司,生产批号:050702)30 mg/m2加入生理盐水500ml中静滴 d1-3。
2.2治疗组
除按上述对照组治疗外,另加入本发明的一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物,具体为第一次TP方案化疗前三天开始服用,一次60克,一日两次,即早晚各一次。连续服用3周后,停服本品1周,然后再服用3周,停用1周,如此反复,一般用药时间应不少于6个月。
2.3统计学方法
应用SPSS10.0软件对计数资料进行卡方检验。
3疗效评价标准、毒性评价标准及治疗结果
3.1近期疗效评价
按WHO抗肿瘤疗效评价标准评价疗效,分为完全缓解(CR),部分缓解(PR),稳定(NC)和病情进展(PD),CR+PR为有效。
3.2毒性评价
按WHO统一制定的标准评价,所有病例化疗过程中每周查血常规、肝肾功能、心电图,以最严重的一次不良反应为最后评价。
3.3治疗结果
3.3.1临床近期疗效
对照组 CR 2.56%(1/39),PR 38.46%(15/39),总有效率41.03%(16/39),治疗组 CR 4.88%(2/41),PR 51.22%(21/41),总有效率56.10%(23/41)。
表1:两组患者临床疗效比较
组别 | n | CR | PR | NG | PD | 总有效率 |
对照组 | 39 | 1 | 15 | 18 | 5 | 41.03% |
治疗组 | 41 | 2 | 21 | 15 | 3 | 56.10% |
注:经卡方检验,两组治疗后总有效率比较,差异有显著性意义(P<0.05)
3.3.2不良反应
治疗组Ⅲ-Ⅳ度血液系不良反应发生率为21.95%(9/41),神经毒性发生率为21.95%(9/41),对照组Ⅲ-Ⅳ度血液系不良反应发生率为28.21%(11/39),神经毒性发生率为43.59%(17/39),神经毒性差异有显著性(P<0.05),Ⅲ-Ⅳ度血液系不良反应无显著性差异(P>0.05)。
3.3.3临床远期效果
治疗组 1年生存率为60.98%(25/41),2年生存率为31.71%(13/41),3年生存率为21.95%(9/41),4年生存率为17.07%(7/41),5年生存率为12.20%(5/41);对照组 1年生存率为39.47%(15/38),2年生存率为20.51%(8/39),3年生存率为12.82%(5/39),4年生存率为7.69%(3/39),5年生存率为2.56%(1/39),5年生存率有显著性(P<0.05)
表2:两组患者1-5年生存情况比较
组别 | n | 生存1年以上患者数 | 生存2年以上患者数 | 生存3年以上患者数 | 生存4年以上患者数 | 生存5年以上患者数 |
对照组 | 39 | 15 | 8 | 5 | 3 | 1 |
治疗组 | 41 | 25 | 13 | 9 | 7 | 5 |
注:经卡方检验,两组治疗后5年生存率差异有显著性意义(P<0.05)
本发明通过临床实验观察(治疗组)相比单纯TP方案化疗(对照组)具有如下优点:
1、配合TP方案化疗治疗中晚期非小细胞肺癌有较好的疗效,临床实验观察治疗组有效率为56.10%,对照组为41.03%。
2、本发明药品为纯中药制剂,没有明显毒副作用,配合TP方案化疗可以减轻化疗药物神经毒性发生率,临床实验观察治疗组神经毒性发生率为21.95%,对照组神经毒性发生率为43.59%。
3、配合TP方案化疗治疗中晚期非小细胞肺癌能明显提高患者的5年生存率,临床实验观察治疗组5年生存率为12.20%,对照组5年生存率为2.56%。
本发明配合TP方案化疗治疗中晚期非小细胞肺癌取得了较好疗效,由此推测:本发明配合其他方案化疗治疗肺癌、脑胶质瘤、卵巢癌、乳腺癌、肾癌、肝癌等恶性肿瘤,也可能取得相应效果。
Claims (12)
1.本发明的目的在于提供一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物及其制备工艺。
2.本发明的目的是通过如下途径实现的:一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物,该中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏46.0-99.7%,辅料炼蜜0-68%,防腐剂山梨酸钾0-0.3%。
3.所述主料清膏由下述中药饮片加工提取浓缩而成,所用中药饮片按重量百分比由下述组分组成:凤尾蕉叶 10-49%、黄芪20-48%、麦冬6-15%、南沙参 5-12%、半枝莲4-9%、地龙 3-8%、川芎1-7%、归尾1-5%、赤芍 2-4%、桃仁 0-4%、红花0-3%、蜈蚣1-2%。
4.所述主料清膏由下述中药饮片加工提取浓缩而成,所用中药饮片重量百分比,其组分为凤尾蕉叶38%、黄芪22%、麦冬8%、南沙参 6.9%、半枝莲6.5%、地龙 5%、川芎4%、归尾3.8%、赤芍 3.8%、桃仁 0%、红花0%、蜈蚣2%。
5.所述主料清膏由下述中药饮片加工提取浓缩而成,所用中药饮片重量百分比,其组分为凤尾蕉叶11%、黄芪45%、麦冬7.6%、南沙参 7.6%、半枝莲5.6%、地龙 4.5%、川芎4.5%、归尾3.8%、赤芍 3.8%、桃仁 2.3%、红花2.3%、蜈蚣2%。
6.所述中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏99.7%,辅料炼蜜0%,防腐剂山梨酸钾0.3%。
7.所述中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏67.7%,辅料炼蜜32%,防腐剂山梨酸钾0.3%。
8.所述中药组合物由主料清膏、辅料炼蜜与防腐剂山梨酸钾构成,按质量百分比主料清膏50%,辅料炼蜜49.7%,防腐剂山梨酸钾0.3%。
9.一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物制备工艺步骤。
10.主料清膏制备:按3、4、5所述的主料清膏制备所需组分比例分别称取中药饮片,凤尾蕉叶和黄芪切成5mm厚小片,加六倍量60-80%乙醇,回流提取1小时,滤过提取液,滤液减压回收乙醇使成膏-A,醇提后的凤尾蕉叶和黄芪,与麦冬和南沙参一起煎煮两次,每次1小时,煎液滤过,滤液浓缩成相对密度1.21-1.25(80℃)的膏-B,川芎、当归尾粉碎成粗粉,混均,用50-90%的乙醇浸渍48小时后缓缓渗漉,收集生药量四倍的渗漉液,减压回收乙醇得膏-C,半枝莲、地龙、赤勺、桃仁、红花、蜈蚣加水煮两次,每次1小时,滤过,合并滤液并浓缩滤液至相对密度为1.08-1.18(80℃)的浸膏,加乙醇使含醇量为50-80%,搅匀,静置48小时,取上清液,回收乙醇得膏-D,将上述膏-A、B、C、D合并,必要时加水调节,煮沸得相对密度1.16-1.22(80℃)的清膏即为主料清膏。
11.中药组合物配制:按2、6、7、8所述主料清膏加辅料炼蜜比例,按需称取主料清膏与辅料炼蜜,必要时可加少量水调节,煮沸,搅匀,保温30分钟,计算保温物料总重量,之后使物料降温至50-60℃,按比例取防腐剂山梨酸钾,加少许水溶解后搅入物料中,搅拌均匀后分装,密封保存。
12.本发明为一种配合TP方案治疗中晚期非小细胞肺癌的中药组合物,能明显提高TP方案治疗中晚期非小细胞肺癌的临床疗效,减轻TP方案中的毒副反应,提高5年生存率,本发明的中药组合物为口服制剂,可制成液体、半固体、固体口服制剂,同时该中药组方也可制成注射剂,用以配合TP方案治疗中晚期非小细胞肺癌。
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