CN118217370A - 一种复方紫杉醇广谱抗癌中药制剂及其制备方法 - Google Patents
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Abstract
本发明提供了一种复方紫杉醇广谱抗癌中药制剂及其制备方法,属于中药技术领域,本发明提供复方紫杉醇广谱抗癌中药制剂,由以下质量分数的组分制备而成:纯度99%紫杉醇粉剂0.5~2.0份、半枝莲18~30份、仙鹤草18~30份、黄芩18~30份、郁金14~25份、白术14~25份、绞股蓝14~25份、佛手14~25份、黄芪10~18份、鸡血藤10~18份、白芍10~18份、伸筋草10~18份、五味子6~12份、地龙6~12份、甘草6~12份。本发明所述的复方紫杉醇广谱抗癌中药制剂的组方使用不仅能够显著抑制肺癌患者身上肿瘤细胞的增长,还能显著减轻紫杉醇造成的骨髓抑制和免疫功能损伤。
Description
技术领域
本发明涉及中药技术领域,特别涉及一种复方紫杉醇广谱抗癌中药制剂及其制备方法。
背景技术
癌症是严重威胁人类生存健康的重大疾病之一,其发病率呈上升趋势,其死亡率很高。癌症的治疗,传统的方法包括手术、放射治疗和化学药物治疗,目前化学治疗是晚期癌症的主要治疗手段之一。但目前临床上广泛使用的化疗药物疗效有限,毒性作用较大,多次后还会发生耐药。紫杉醇是从天然植物红豆杉属树皮中提取的单体双萜类化合物,是一种复杂的次生代谢产物,也是目前所了解的唯一一种可以促进微管聚合和稳定已聚合微管的药物。通过临床研究,紫杉醇主要适用于卵巢癌和乳腺癌,对肺癌、大肠癌、黑色素瘤、头颈部癌、淋巴瘤、脑瘤也都有一定疗效。但单纯的紫杉醇具有多种毒副反应:1.过敏反应:用药数分钟后出现麻疹、呼吸窘迫、支气管痉挛、低血压。2.神经***反应:手足麻木、感觉过敏、肌痉挛、关节痛。3.消化***反应:恶心、呕吐、腹泻、口腔炎、胃炎。4.心血管***反应:心动过速、室性心律不齐、或心动过缓、房室传导阻滞。5.脱发。6.骨髓抑制反应:用药后有白细胞减少,血小板减少及贫血发生。毒副反应限制了紫杉醇的临床应用。
因此市面上亟须一种既可以显著减轻紫杉醇副作用,又能显著增强抗癌效果的中药制剂。
发明内容
本发明目的在于提供一种复方紫杉醇广谱抗癌中药制剂及其制备方法。
为了实现上述目的,本发明提供以下技术方案:
本发明提供了一种复方紫杉醇广谱抗癌中药制剂,由以下质量分数的组分制备而成:
纯度为99%的紫杉醇粉剂0.5~2.0份、半枝莲18~30份、仙鹤草18~30份、黄芩18~30份、郁金14~25份、白术14~25份、绞股蓝14~25份、佛手14~25份、黄芪10~18份、鸡血藤10~18份、白芍10~18份、伸筋草10~18份、五味子6~12份、地龙6~12份、甘草6~12份。
优选的,所述中药制剂的剂型为胶囊剂、片剂、颗粒剂或丸剂。
本发明还提供了一种所述复方紫杉醇广谱抗癌中药制剂的制备方法,包括以下步骤:
1)将除紫杉醇外的各中药原料混合、粉碎后得混合物料;
2)将混合物料与水混合后依次煎煮、过滤后得滤液Ⅰ和药渣;
3)将药渣与水混合后依次煎煮、过滤后得滤液Ⅱ;
4)将滤液Ⅰ、滤液Ⅱ与紫杉醇粉剂合并后,将合并后的混合液依次减压浓缩、干燥后制得本发明所述的复方紫杉醇广谱抗癌中药制剂。
优选的,所述步骤1)中粉碎的粒径为80~120目。
优选的,所述步骤2)中混合物料与水的质量比为1:8~14。
优选的,所述步骤2)中的煎煮时间为80~120min,煎煮温度为65~75℃。
优选的,所述步骤3)中的药渣与水的质量比为1:4~6。
优选的,所述步骤3)中的煎煮时间为40~60min,煎煮温度为55~68℃。
优选的,所述混合液减压浓缩至24~28℃下相对密度1.2~1.3稠膏。
优选的,所述干燥方式为真空干燥。
本发明具有以下有益技术效果:
本发明所添加的紫杉醇可抑制癌细胞的有丝***,有效阻止癌细胞的增殖,广谱抗癌;半枝莲主治清热解毒,化瘀利尿。用于疔疮肿毒,咽喉肿痛,毒蛇咬伤,跌扑伤痛,水肿,黄疸等,《药镜拾遗赋》记载"半枝莲解蛇伤之仙草"。仙鹤草既收敛止血,兼补虚,又解毒止痢、截疟,还杀虫、止咳、抗癌。黄芩用于湿温、暑湿,胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。本发明采用以上四味共为君药,共奏解毒散结、防癌抗癌之功。
郁金用于胸胁刺痛,胸痹心痛,经闭痛经,***胀痛,热病神昏,癫痫发狂,血热吐衄,黄疸尿赤。白术的主要药效成分为多糖类、黄酮类、内酯类、挥发性成分、苷类等,具有抗炎镇痛、抗肿瘤、调节免疫、降糖、降脂、保肝等功效。绞股蓝用于益气健脾,化痰止咳,养心安神,药理研究表明:绞股蓝具有抗疲劳、抗缺氧、抗高温、抗低温,降低心、脑、肝细胞内脂褐素的含量,防止正常细胞癌化的作用。佛手用于肝郁气滞,胸胁胀痛;脾胃气滞,脘腹胀痛,呕逆少食;咳嗽痰多。本发明采用以上四味共为臣药,共奏健脾益气、疏肝解郁、止痛抗癌之功。
黄芪用于补气升阳、固表止汗、利水消肿、生津养血、行滞通痹、托毒排脓、敛疮生肌、提高抗氧化能力,清除体内自由基。鸡血藤用于活血补血,调经止痛,舒筋活络,减弱周围神经毒性。白芍用于养血调经,敛阴止汗,柔肝止痛,平抑肝阳。伸筋草用于祛风除湿、舒筋通络、活血消肿,治风寒湿痹、骨节酸痛、屈伸不利者最宜,治跌打肿痛者可选。本发明采用以上四味共为佐药共奏补血和胃、益气活血之功,气行则血行,可补癌症患者体虚。
五味子含木脂素类成分、挥发油,还含有多糖、氨基酸等成分,可用于收敛固涩,益气生津,补肾宁心。现代研究表明,地龙主要含蚯蚓解热碱、蚯蚓毒素、6-羟基嘌呤、黄嘌呤、腺嘌呤、鸟嘌呤、胆碱等;还含多种氨基酸、脂肪酸等,地龙有解热、镇静、抗惊厥、抗血栓、降血压、抗炎、镇痛、平喘、增强免疫等药理作用。生甘草在补中益气、清热解毒、祛痰止咳、缓急止痛的同时,还可调和药性,可用于治疗食少、脾胃虚弱、腹痛便溏、倦怠乏力、心悸气短、咳嗽痰多、脘腹、四肢挛急疼痛、痈肿疮毒、缓解药物毒性和烈性。本发明采用以上三味为使药,共奏补肾宁心、增强免疫力,调和药性、缓解全方药物毒性、烈性之功。
本发明所述复方紫杉醇广谱抗癌中药制剂根据中医药理论,充分体现了通过调节机体整体生理功能的平衡而发挥抗癌治癌的科学用药原则,以解毒散结、防癌抗癌为主,在健脾补气生血而扶正治本的同时有效药物毒性、烈性,提高用药安全。不仅能够显著抑制肺癌患者身上肿瘤细胞的增长,还能显著减轻紫杉醇造成的骨髓抑制和免疫功能损伤。
具体实施方式
为了更好地理解本发明,下面结合实施例进一步阐明本发明的内容,但本发明的内容不仅仅局限于下面的实施例。本发明所述紫杉醇为市***99%的医药级紫杉醇粉剂。
实施例1
本发明提供了一种复方紫杉醇广谱抗癌中药制剂,由以下质量分数的组分制备而成:
纯度为99%的紫杉醇粉剂0.5份、半枝莲18份、仙鹤草18份、黄芩18份、郁金14份、白术14份、绞股蓝14份、佛手14份、黄芪10份、鸡血藤10份、白芍10份、伸筋草10份、五味子6份、地龙6份、甘草6份。
所述复方紫杉醇广谱抗癌中药制剂的制备方法,包括以下步骤:
1)将除紫杉醇外的各中药原料混合、粉碎为80目后得混合物料;
2)将混合物料与水按1:8质量比混合后,65℃煎煮80min,煎煮完成后过滤,收集滤液Ⅰ和药渣;
3)将药渣与水按1:4质量比混合后,55℃煎煮40min,煎煮完成后过滤,收集滤液Ⅱ;
4)将滤液Ⅰ、滤液Ⅱ与紫杉醇粉剂合并,将合并后的混合液减压浓缩至24℃下相对密度1.2稠膏后,真空干燥至200目,制得本发明所述的复方紫杉醇广谱抗癌中药制剂。
实施例2
本发明提供了一种复方紫杉醇广谱抗癌中药制剂,由以下质量分数的组分制备而成:
纯度为99%的紫杉醇粉剂2.0份、半枝莲30份、仙鹤草30份、黄芩30份、郁金25份、白术25份、绞股蓝25份、佛手25份、黄芪18份、鸡血藤18份、白芍18份、伸筋草18份、五味子12份、地龙12份、甘草12份。
所述复方紫杉醇广谱抗癌中药制剂的制备方法,包括以下步骤:
1)将除紫杉醇外的各中药原料混合、粉碎为120目后得混合物料;
2)将混合物料与水按1:14质量比混合后,75℃煎煮120min,煎煮完成后过滤,收集滤液Ⅰ和药渣;
3)将药渣与水按1:6质量比混合后,68℃煎煮60min,煎煮完成后过滤,收集滤液Ⅱ;
4)将滤液Ⅰ、滤液Ⅱ与紫杉醇粉剂合并,将合并后的混合液减压浓缩至28℃下相对密度1.3稠膏后,真空干燥至400目,制得本发明所述的复方紫杉醇广谱抗癌中药制剂。
实施例3
本发明提供了一种复方紫杉醇广谱抗癌中药制剂,由以下质量分数的组分制备而成:
纯度为99%的紫杉醇粉剂1.2份、半枝莲24份、仙鹤草24份、黄芩24份、郁金18份、白术18份、绞股蓝18份、佛手18份、黄芪14份、鸡血藤14份、白芍14份、伸筋草14份、五味子8份、地龙8份、甘草8份。
所述复方紫杉醇广谱抗癌中药制剂的制备方法,包括以下步骤:
1)将除紫杉醇外的各中药原料混合、粉碎为100目后得混合物料;
2)将混合物料与水按1:12质量比混合后,70℃煎煮100min,煎煮完成后过滤,收集滤液Ⅰ和药渣;
3)将药渣与水按1:5质量比混合后,62℃煎煮50min,煎煮完成后过滤,收集滤液Ⅱ;
4)将滤液Ⅰ、滤液Ⅱ与紫杉醇粉剂合并,将合并后的混合液减压浓缩至25℃下相对密度1.25稠膏后,真空干燥至300目,制得本发明所述的复方紫杉醇广谱抗癌中药制剂。
对比例1
与实施例3完全相同,区别仅在于去除原料紫杉醇。
对比例2
与实施例3完全相同,区别仅在于将原料纯度为99%的紫杉醇粉剂用量替换为0.2份。
实验例1药理实验
1、实验分组:
选取50只体重18~22g,鼠龄6~8周的雄性健康C57BL/6小鼠,通过尾静脉注射Lewis肺癌细胞(取最佳生长状态的细胞,将细胞浓度调整至1×107/ml,0.2mL/只)进行造模。造模成功后,将小鼠进行以下分组:
模型组:生理盐水,剂量为30g/kg灌胃,每日1次;
实验组:本发明实施例3所述复方紫杉醇广谱抗癌中药制剂,剂量为30g/kg灌胃,每日1次;
对照组1:本发明对比例1所述复方紫杉醇广谱抗癌中药制剂,剂量为30g/kg灌胃,每日1次;
对照组2:本发明对比例2所述复方紫杉醇广谱抗癌中药制剂,剂量为30g/kg灌胃,每日1次;
现有技术组:常规剂量的紫杉醇化疗组,30mg/kg腹腔注射,5日/次;
实验期间小鼠正常饮食,设置饲养温度为24~26℃,湿度为45~65%;连续给药10天,最后一次给药后禁食不禁水,24h后称量小鼠体重并处死小鼠。
2、本发明所述复方紫杉醇广谱抗癌中药制剂对移植性肺癌的抑制实验
完整剥离步骤1所述处死小鼠的瘤块,称重并计算肿瘤抑制率,肿瘤抑制率=(模型组的肿瘤质量-治疗组的肿瘤质量)/模型组的肿瘤质量,结果如下表1所示。
表1
实验分组 | 瘤重(x±s) | 肿瘤抑制率(%) |
模型组 | 3.25±0.22 | / |
实验组 | 0.89±0.26a | 72.61 |
对照组1 | 1.86±0.12a | 42.77 |
对照组2 | 1.63±0.33a | 49.85 |
现有技术组 | 1.14±0.16a | 64.92 |
a:P<0.05;与模型组比较;
由表1可知,本发明所述复方紫杉醇广谱抗癌中药制剂的肿瘤抑制率明显高于现有技术组及对照组,本发明所述中药制剂对于肺癌的生长具有显著的抑制作用。
2、本发明所述复方紫杉醇广谱抗癌中药制剂对骨髓的抑制实验
完整取出步骤1所述处死小鼠一侧的股骨,将股骨头和胫骨端剪断后,用红细胞裂解液将股骨中的全部骨髓细胞冲出,反复冲洗,直到骨髓变白。将冲出骨髓细胞制成单细胞悬液,并加入8ml生理盐水终止裂解,经过1200rpm,离心6min后弃上清,再用1ml生理盐水重悬细胞后,取20μL细胞沉淀加入计数板中测定骨髓有核细胞数量,结果如下表2所示。
表2骨髓有核细胞数量(BMN)
a:P<0.05;与模型组比较;
b:P<0.05;与现有技术组对照比较;
结果如表2所示,单纯腹腔注射紫杉醇,小鼠的骨髓有核细胞数量显著降低,而与之相较,实验组的骨髓有核细胞数量明显高于单纯腹腔注射紫杉醇,由此可知,本发明所述复方紫杉醇广谱抗癌中药制剂能够明显减轻紫杉醇化疗引起的骨髓抑制。
3、本发明所述复方紫杉醇广谱抗癌中药制剂对免疫功能的影响实验
完整剥离步骤1所述处死小鼠的脾、胸腺,并根据公式计算各实验分组小鼠的脾指数和胸腺指数;脾指数=小鼠脾重量/小鼠体重;胸腺指数=小鼠胸腺重量/小鼠体重,结果如表3所示。
表3小鼠体重、胸腺/脾指数结果(x±s)
实验分组 | 体重(g) | 脾指数(mg/g) | 胸腺指数(mg/g) |
模型组 | 26.12±1.25 | 10.59±0.43 | 0.52±0.38 |
实验组 | 22.87±2.12 | 11.08±0.33 | 0.46±0.22b |
对照组1 | 23.68±3.97 | 12.24±0.56 | 0.51±0.16b |
对照组2 | 23.06±3.22 | 11.93±0.28 | 0.48±0.32b |
现有技术组 | 19.64±1.58 | 9.45±0.27 | 0.26±0.12a |
a:P<0.05;与模型组比较;
b:P<0.05;与现有技术组对照比较;
结果如表3可知,与单纯腹腔注射紫杉醇相较,实验组的胸腺指数与脾指数具有明显增加,由此可知,本发明所述复方紫杉醇广谱抗癌中药制剂可减轻紫杉醇化疗诱发的脾、胸腺萎缩,进而对抗紫杉醇引起的免疫功能的抑制作用。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种复方紫杉醇广谱抗癌中药制剂,其特征在于,由以下质量分数的组分制备而成:
紫杉醇0.5~2.0份、半枝莲18~30份、仙鹤草18~30份、黄芩18~30份、郁金14~25份、白术14~25份、绞股蓝14~25份、佛手14~25份、黄芪10~18份、鸡血藤10~18份、白芍10~18份、伸筋草10~18份、五味子6~12份、地龙6~12份、甘草6~12份。
2.根据权利要求1所述的复方紫杉醇广谱抗癌中药制剂,其特征在于,所述中药制剂的剂型为胶囊剂、片剂、颗粒剂或丸剂。
3.一种权利要求1或2所述复方紫杉醇广谱抗癌中药制剂的制备方法,其特征在于,包括以下步骤:
1)将除紫杉醇外的各中药原料混合、粉碎后得混合物料;
2)将混合物料与水混合后依次煎煮、过滤后得滤液Ⅰ和药渣;
3)将药渣与水混合后依次煎煮、过滤后得滤液Ⅱ;
4)将滤液Ⅰ、滤液Ⅱ与紫杉醇合并后,将合并后的混合液依次减压浓缩、干燥后制得本发明所述的复方紫杉醇广谱抗癌中药制剂。
4.根据权利要求3所述的制备方法,其特征在于,所述步骤1)中粉碎的粒径为80~120目。
5.根据权利要求3所述的制备方法,其特征在于,所述步骤2)中混合物料与水的质量比为1:8~14。
6.根据权利要求3所述的制备方法,其特征在于,所述步骤2)中的煎煮时间为80~120min,煎煮温度为65~75℃。
7.根据权利要求3所述的制备方法,其特征在于,所述步骤3)中的药渣与水的质量比为1:4~6。
8.根据权利要求3所述的制备方法,其特征在于,所述步骤3)中的煎煮时间为40~60min,煎煮温度为55~68℃。
9.根据权利要求3所述的制备方法,其特征在于,所述步骤4)中混合液减压浓缩至24~28℃下相对密度1.2~1.3稠膏。
10.根据权利要求3所述的制备方法,其特征在于,所述步骤4)中干燥方式为真空干燥。
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