CN111012865A - 补肾益脑制剂在制备***的药物中的应用 - Google Patents
补肾益脑制剂在制备***的药物中的应用 Download PDFInfo
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- CN111012865A CN111012865A CN201911396122.6A CN201911396122A CN111012865A CN 111012865 A CN111012865 A CN 111012865A CN 201911396122 A CN201911396122 A CN 201911396122A CN 111012865 A CN111012865 A CN 111012865A
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Abstract
本发明公开了补肾益脑制剂在制备***的药物中的应用,所述补肾益脑制剂包含以下重量份的组分:红参35‑85份、鹿茸6‑18份、炒酸枣仁35‑85份、熟地黄85‑125份、茯苓35‑85份、玄参30‑60份、蜜远志35‑85份、麦冬35‑85份、五味子30‑60份、当归35‑85份、川芎30‑60份、牛膝30‑60份、炒山药35‑85份、盐补骨脂30‑60份、枸杞子30‑60份、朱砂10‑20份;补肾益脑制剂采用不同药性的中药材,进行了科学配伍,应用范围广泛,滋肾益气,补血生津,且能增强机体免疫力,对正常的细胞和各脏器无损害,疗效可靠,可以抑制肿瘤的生长,同时还可以明显的增强人体体质,提高其自身抗病修复能力。
Description
技术领域
本发明涉及中成药的新用途技术领域,具体涉及补肾益脑制剂在制备***的药物中的应用。
背景技术
肿瘤已成为21世纪威胁人类生存的头号杀手,中国为世界癌症高发国家之一,并且每年呈快速增长趋势,因此肿瘤的防治已成为世界范围内广泛重视的课题,世界各国每年投入了大量人力、物力进行研究,但迄今为止,对其病因、病理仍不十分清楚,治疗方法尚无重大突破;临床***的方法多种多样,包括手术治疗、放疗、化疗和中西医结合疗法等。
手术切除肿瘤虽然是最广泛、有效的手段之一,但对患者的创伤较大,且不能切除微小的亚临床病灶,还有瘤细胞脱落种植的可能;对于恶性肿瘤来说,一旦发现则一般处于中晚期,手术治疗并不是最佳方法,因为对于中晚期肿瘤尽管切除了病灶,但同时手术对人体的巨大创伤也加速了癌细胞的转移,手术后一般要配合放疗或化疗,这种放、化疗对正常人体细胞有极大的杀伤作用,术后的放、化疗能杀灭残留癌细胞,产生一定的治疗控制作用,但是对人体正常组织的伤害是也是明显的,也存在特异性较差、部分肿瘤细胞具有耐药现象等不足之处,真正靠放、化疗治愈肿瘤也是难以实现的,并且手术、放疗与化疗治疗后的病人5年以上生存率还是很不理想的;化学药物治疗恶性肿瘤自从1946年氮芥的应用以来基本形成一个完整的理论体系,但是由于大多数化学药物选择性差,用药后对正常组织和脏器的生理功能有一定的破坏作用,往往致化疗疗程不能完成等一系列毒副反应,主要表现为:骨髓抑制、消化道反应、免疫功能低下等;虽然现代医学各种防治化疗毒副反应的方法疗效肯定,如输血、利血升、造血生长因子、枢复宁等,但目前的这些方法也存在许多问题,如输血存在血源不足,血中致病因素越来越多限制它的使用;造血生长因子能促进白血病细胞繁殖,抑制细胞毒性化疗药物诱发急性白血病细胞凋亡,且不能解决化疗的骨髓外损害,故而对造血生长因子应用存在争议;同时,这些药物主要从单一角度起作用,整体调节效果不佳,且价格昂贵,临床使用受限。
中医学认为肿瘤发生原因不外乎外因和内因两种,外因是邪气、邪毒,阻碍气血运行,导致气滞血凝,痰湿凝聚;内因则是五脏六腑的蓄毒、气血运行失常和七情刺激;外邪之所以能侵入致病还是由于人体先有内虚,因为邪之所凑,其气必虚,中医药在***方面具有独特的优势,以中药为代表的天然类药物具有毒副作用小、作用靶点多样、耐受性好等特点,在***方面愈来愈受到重视。
发明内容
为了解决现有技术存在的不足,基于中医学对***疾病机理的认识及治疗原则,本发明的目的在于提供补肾益脑制剂在制备***的药物中的应用,补肾益脑制剂配比科学合理,疗效确切,临床使用安全,可多靶点发挥抗肿瘤作用,达到见效快、治愈率高、疗程短及无毒副作用的效果,标本兼治,能一定程度上解决患者的痛苦。
为了解决上述技术问题,本发明是通过以下技术方案进行实现的:
本发明所述中药组分可以被有相同或相似功效的中药代替,并且这些药材均可按照《全国中药炮制规范》进行炮制。
本发明提供了补肾益脑制剂在制备***的药物中的应用,所述补肾益脑制剂包含以下重量份的组分:红参35-85份、鹿茸6-18份、炒酸枣仁35-85份、熟地黄85-125份、茯苓35-85份、玄参30-60份、蜜远志35-85份、麦冬35-85份、五味子30-60份、当归35-85份、川芎30-60份、牛膝30-60份、炒山药35-85份、盐补骨脂30-60份、枸杞子30-60份、朱砂10-20份。
作为本发明所述的补肾益脑制剂在制备***的药物中的应用的优选实施例,所述补肾益脑制剂包含以下重量份的组分:红参50份、鹿茸8份、炒酸枣仁48份、熟地黄103份、茯苓48份、玄参37份、蜜远志48份、麦冬48份、五味子37份、当归48份、川芎37份、牛膝37份、炒山药48份、盐补骨脂37份、枸杞子39份、朱砂13份。
作为本发明所述的补肾益脑制剂在制备***的药物中的应用的优选实施例,所述补肾益脑制剂包含以下重量份的组分:红参40份、鹿茸8份、炒酸枣仁40份、熟地黄90份、茯苓40份、玄参36份、蜜远志40份、麦冬40份、五味子38份、当归40份、川芎36份、牛膝35份、炒山药40份、盐补骨脂35份、枸杞子35份、朱砂12份。
作为本发明所述的补肾益脑制剂在制备***的药物中的应用的优选实施例,所述补肾益脑制剂包含以下重量份的组分:红参75份、鹿茸16份、炒酸枣仁75份、熟地黄115份、茯苓75份、玄参55份、蜜远志75份、麦冬75份、五味子50份、当归70份、川芎50份、牛膝55份、炒山药75份、盐补骨脂55份、枸杞子50份、朱砂18份。
作为本发明所述的补肾益脑制剂在制备***的药物中的应用的优选实施例,所述药物为口服给药制剂。
作为本发明所述的补肾益脑制剂在制备***的药物中的应用的优选实施例,所述药物的剂型为片剂、颗粒剂、胶囊剂、软胶囊剂或滴丸剂。
作为本发明所述的补肾益脑制剂在制备***的药物中的应用的优选实施例,所述补肾益脑制剂采用如下方法制备而成:
S1、按照配方各组分的配比称取原料;
S2、五味子、盐补骨脂、川芎和当归提取挥发油,提取液滤过备用;药渣加60%乙醇加热回流提取 2-4小时,滤过,药渣再加80%乙醇加热回流提取2-4小时,滤过,合并两次提取液,回收乙醇,浓缩,备用;
S3、玄参、蜜远志、麦冬、炒酸枣仁、枸杞子、熟地黄和牛膝加水煎煮2-4次,每次1-3小时,合并煎煮液,滤过,备用;
S4、将步骤S2得到的提取液和步骤S3得到的煎煮液合并,浓缩至相对密度为1.20-1.35(60℃-90℃)的稠膏;将红参、鹿茸、茯苓、炒山药粉碎成细粉,朱砂水飞或粉碎成极细粉,拌入稠膏内,混匀,低温干燥,粉碎,加入药学上可接受的辅料制成口服给药制剂。
基于上述的技术方案,本发明取得的技术效果为:
(1)本发明提供的补肾益脑制剂在制备***的药物中的应用,根据中医药理论采用清热解毒、消肿散结、活血化瘀、健脾和胃的辨证论治理论,补肾益脑制剂采用不同药性的中药材,进行了科学配伍,具有滋肾益气,补血生津的作用,应用范围广泛,且能增强机体免疫力,对正常的细胞和各脏器无损害;实验结果表明,本发明提供的补肾益脑制剂具有很好的抑制肿瘤细胞生长和能促进肿瘤细胞凋亡的作用。
(2)本发明提供的补肾益脑制剂在制备***的药物中的应用,补肾益脑制剂可与手术、放疗、化疗同时使用,疗效可靠,既可以在短期内控制肿瘤的生长,消除肿瘤,同时还可以明显的增强人体体质,提高其自身抗病修复能力。
(3)本发明提供的补肾益脑制剂在制备***的药物中的应用,补肾益脑制剂可以方便和药学载体制备成多种剂型,临床上服用方便,能达到理想的治 疗效果,且安全,能有效减轻病患痛苦,提高病人生活质量;副作用小,治疗安全、方便,可减轻痛苦、延长生命,尤其对提高晚期癌症病人的生活质量效果显著;补肾益脑制剂的制备方法工艺简单、稳定、提取有效成分含量高,可操作性强,适合工业化大生产。
具体实施方式
为了便于理解本发明,下面将结合具体的实施例对本发明进行更全面的描述。本发明给出了的较佳实施方式。但是,本发明可以以许多不同的形式来实现,并不限于本文所描述的实施方式。相反地,提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的,不是旨在于限制本发明。
实施例1
本实施例公开了补肾益脑制剂在制备***的药物中的应用,所述补肾益脑制剂包含以下重量份的组分:红参35份、鹿茸6份、炒酸枣仁35份、熟地黄85份、茯苓35份、玄参30份、蜜远志35份、麦冬35份、五味子30份、当归35份、川芎30份、牛膝30份、炒山药35份、盐补骨脂30份、枸杞子30份、朱砂10份。
所述药物的剂型为片剂,所述补肾益脑片剂采用如下方法制备而成:
S1、按照配方各个组分的配比配制原料;
S2、五味子、盐补骨脂、川芎和当归提取挥发油,提取液滤过备用;药渣加60%乙醇加热回流提取 2小时,滤过,药渣再加80%乙醇加热回流提取2小时,滤过,合并两次提取液,回收乙醇,浓缩,备用;
S3、玄参、蜜远志、麦冬、炒酸枣仁、枸杞子、熟地黄和牛膝加水煎煮2次,每次1小时,合并煎煮液,滤过,备用;
S4、将步骤S2得到的提取液和步骤S3得到的煎煮液合并,浓缩至相对密度为1.20(60℃)的稠膏;将红参、鹿茸、茯苓、炒山药粉碎成细粉,朱砂水飞或粉碎成极细粉,拌入稠膏内,混匀,低温干燥,粉碎,过筛,制成颗粒,挥发油用β-环糊精包合后与颗粒混匀,加入硬脂酸镁,压制成片或分散片,然后包糖衣或薄膜衣。
实施例2
本实施例公开了补肾益脑制剂在制备***的药物中的应用,所述补肾益脑制剂包含以下重量份的组分:红参85份、鹿茸18份、炒酸枣仁85份、熟地黄125份、茯苓85份、玄参60份、蜜远志85份、麦冬85份、五味子60份、当归85份、川芎60份、牛膝60份、炒山药85份、盐补骨脂60份、枸杞子60份、朱砂20份。
所述药物的剂型为颗粒剂,所述补肾益脑颗粒剂采用如下方法制备而成:
S1、按照配方各个组分的配比配制原料;
S2、五味子、盐补骨脂、川芎和当归提取挥发油,提取液滤过备用;药渣加60%乙醇加热回流提取 4小时,滤过,药渣再加80%乙醇加热回流提取4小时,滤过,合并两次提取液,回收乙醇,浓缩,备用;
S3、玄参、蜜远志、麦冬、炒酸枣仁、枸杞子、熟地黄和牛膝加水煎煮4次,每次 3小时,合并煎煮液,滤过,备用;
S4、将步骤S2得到的提取液和步骤S3得到的煎煮液合并,浓缩至相对密度为1.35(90℃)的稠膏;将红参、鹿茸、茯苓、炒山药粉碎成细粉,朱砂水飞或粉碎成极细粉,混合均匀,与稠膏混合制粒,干燥,喷入挥发油,混匀,密闭2小时,分装,即得颗粒剂。
实施例3
本实施例公开了补肾益脑制剂在制备***的药物中的应用,其特征在于,所述补肾益脑制剂包含以下重量份的组分:红参50份、鹿茸8份、炒酸枣仁48份、熟地黄103份、茯苓48份、玄参37份、蜜远志48份、麦冬48份、五味子37份、当归48份、川芎37份、牛膝37份、炒山药48份、盐补骨脂37份、枸杞子39份、朱砂13份。
所述药物的剂型为胶囊剂,所述补肾益脑胶囊剂采用如下方法制备而成:
S1、按照配方各个组分的配比配制原料;
S2、五味子、盐补骨脂、川芎和当归提取挥发油,提取液滤过备用;药渣加60%乙醇加热回流提取 3小时,滤过,药渣再加80%乙醇加热回流提取3小时,滤过,合并两次提取液,回收乙醇,浓缩,备用;
S3、玄参、蜜远志、麦冬、炒酸枣仁、枸杞子、熟地黄和牛膝加水煎煮3次,每次 1.5小时,合并煎煮液,滤过,备用;
S4、将步骤S2得到的提取液和步骤S3得到的煎煮液合并,浓缩至相对密度为1.30(80℃)的稠膏;将红参、鹿茸、茯苓、炒山药粉碎成细粉,朱砂水飞或粉碎成极细粉,拌入稠膏内,混匀,低温干燥,粉碎,过筛,用乙醇制粒,干燥,喷入挥发油,混匀,密闭 2小时,装入胶囊,即得胶囊剂。
实施例4
本实施例公开了补肾益脑制剂在制备***的药物中的应用,所述补肾益脑制剂包含以下重量份的组分:红参40份、鹿茸8份、炒酸枣仁40份、熟地黄90份、茯苓40份、玄参36份、蜜远志40份、麦冬40份、五味子38份、当归40份、川芎36份、牛膝35份、炒山药40份、盐补骨脂35份、枸杞子35份、朱砂12份。
所述药物的剂型为软胶囊剂,所述补肾益脑软胶囊剂采用如下方法制备而成:
S1、按照配方各组分的配比称取原料;
S2、五味子、盐补骨脂、川芎和当归提取挥发油,提取液滤过备用;药渣加60%乙醇加热回流提取 3小时,滤过,药渣再加80%乙醇加热回流提取3小时,滤过,合并两次提取液,回收乙醇,浓缩,备用;
S3、玄参、蜜远志、麦冬、炒酸枣仁、枸杞子、熟地黄和牛膝加水煎煮3次,每次2小时,合并煎煮液,滤过,备用;
S4、将步骤S2得到的提取液和步骤S3得到的煎煮液合并,浓缩至相对密度为1.29(75℃)的稠膏;将红参、鹿茸、茯苓、炒山药粉碎成细粉,朱砂水飞或粉碎成极细粉,拌入稠膏内,混匀,低温干燥,粉碎,制成软胶囊内容物,囊材配比为明胶:甘油和水质量比1:0.25:0.85,压制法制成软胶囊剂。
实施例5
本实施例公开了补肾益脑制剂在制备***的药物中的应用,所述补肾益脑制剂包含以下重量份的组分:红参75份、鹿茸16份、炒酸枣仁75份、熟地黄115份、茯苓75份、玄参55份、蜜远志75份、麦冬75份、五味子50份、当归70份、川芎50份、牛膝55份、炒山药75份、盐补骨脂55份、枸杞子50份、朱砂18份。
所述药物的剂型为滴丸剂,所述补肾益脑滴丸剂采用如下方法制备而成:
S1、按照配方各组分的配比称取原料;
S2、五味子、盐补骨脂、川芎和当归提取挥发油,提取液滤过备用;药渣加60%乙醇加热回流提取3小时,滤过,药渣再加80%乙醇加热回流提取3小时,滤过,合并两次提取液,回收乙醇,浓缩,备用;
S3、玄参、蜜远志、麦冬、炒酸枣仁、枸杞子、熟地黄和牛膝加水煎煮3次,每次2.5小时,合并煎煮液,滤过,备用;
S4、将步骤S2得到的提取液和步骤S3得到的煎煮液合并,浓缩至相对密度为1.33(85℃)的稠膏;将红参、鹿茸、茯苓、炒山药粉碎成细粉,朱砂水飞或粉碎成极细粉,挥发油用β-环糊精包合,拌入稠膏内,混匀,低温干燥,粉碎,过筛,加入熔融的聚乙二醇6000中,搅拌均匀,保温55℃状态下倒入滴丸装置中,以65d/min的滴速滴入8℃的液体石蜡中,制成滴丸剂。
实施例6 药理实验研究
选用雄性SD大鼠50只,8-10周龄,体重170-210g,随机分为5组,分别为阳性对照组(替加弗 (FT-207),3.5ml/kg),阴性对照组(蒸馏水),高、中、低剂量组(本发明实施例3药物,给药剂量分别为18.5、9.5、5.5ml/kg);每天上、下午灌胃给药两次,共7天,末次给药后1.5h麻醉固定,手术暴露腹主动脉,小心剥离***,以10ml一次性注射器取血,迅速将血置于洁净玻璃离心管中,静置 3h;离心(4500rpm×1h),取血清;56℃水浴中静置30min灭活,针式滤器(0.24μm)滤过除菌,EP管无菌分装,1ml/管,封口,-20℃冷冻保存,得到含加药血清。
以下采用MTT法测定补肾益脑制剂对肿瘤细胞的抑制影响实验:
分别制备以下肿瘤细胞悬浮液100μl(含2×104个细胞):人胃癌细胞(MGC-803)、小鼠肝癌细胞(H22)、人肝癌细胞(SMMC-7451)、人肝癌细胞(MCF-7)、人肝癌细胞(HepG-2);加入96孔板中,置37℃5%CO2、饱和水汽细胞培养箱中培养24h;去除含加药血清20μl,培养48h;再加0.5%MTT液15μl,继续培养4h,取出,悬浮细胞2500rmp×30min离心,小心去除上清,加DMSO 200μl,置恒温振荡器中振摇10min,使甲臜颗粒溶解,于酶标仪上570nm波长处测光密度(OD)值,并按下式计算各组抑制率:
抑制率(%)=(对照组平均OD值一样品组平均OD值)÷对照组平均OD值×100(%)。
实验所有结果用均数±标准差表示。采用SPSS13.0统计软件,用单因素方差分析法(One-Way ANOVA)比较组间差异,组间两两显著性比较采用LSD法,以0.05或0.01作为显著性差异标志。
结果见表1-5。
与阴性对照组比较,*p<0.05,**p<0.01,下同;
由实验结果表1-5表明,补肾益脑胶囊高剂量组、中剂量组可以抑制SMMC-7451细胞的生长(p<0.01),补肾益脑胶囊高剂量组可以抑制MGC-803和HepG-2细胞的生长(p<0.01),补肾益脑胶囊高剂量组、中剂量组可以抑制H22和MCF-7细胞的生长(p<0.01,p<0.05)。因此,补肾益脑制剂对肿瘤细胞 MGC-803、H22、MCF-7、SMMC-7451、HepG-2均有一定程度的抑制作用,可以用于肿瘤的治疗。
实施例7 本发明补肾益脑制剂的临床应用效果
1、病例选择:
随机选择临床表现经病理或临床确诊的原发性肝癌患者,符合中医气滞血瘀证辨证标准,共40人,其中年龄最小的37岁,最大的75岁,平均年龄55岁。瘤体最大直径12cm,最小2cm,平均8.1cm;病程最短的1年,最长的5年,平均病程为肝癌中晚期,其中25人有治疗史,即曾施化疗,须化疗结束1个月以上而有实体瘤或手术未能切除者。
2、诊断标准:
主要表现为肝区疼痛、乏力、消瘦、腹块、肢体无力、消化不良、恶心腹胀,或有腹水、水肿、黄疽,CT检查可见肝部肿瘤。
3、治疗方法:
口服本发明实施例3制备得到的补肾益脑胶囊剂,每日3次,每次4粒,温开水服用,1个月为1个疗程,4疗程结束后复查。
4、治疗效果:
①治愈:症状及客观检查阳性征象消失,连续观察半年至一年无复发者;
②显效:瘤体明显缩小,其它症状明显消失,生命延长;
③有效:症状有所改善,癌灶缩小一半以上,其他客观检查有明显好转;
④无效:症状及客观检查无改善,或仅有短期改善,而又迅速恶化者。
5、治疗结果统计:
通过上述试验证明,本发明提供的补肾益脑胶囊对肝癌的总有效率为87.5%,具有抑制肿瘤的生长和转移作用,治疗效果显著,能明显增强患者的体质,食欲明显增强,长期服用可抑制和预防细胞病变,增强人体免疫功能,且没有毒副作用,具有广阔的市场应用前景。
以上所述实施例仅表达了本发明的实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制,但凡采用等同替换或等效变换的形式所获得的技术方案,均应落在本发明的保护范围之内。
Claims (7)
1.补肾益脑制剂在制备***的药物中的应用,其特征在于,所述补肾益脑制剂包含以下重量份的组分:红参35-85份、鹿茸6-18份、炒酸枣仁35-85份、熟地黄85-125份、茯苓35-85份、玄参30-60份、蜜远志35-85份、麦冬35-85份、五味子30-60份、当归35-85份、川芎30-60份、牛膝30-60份、炒山药35-85份、盐补骨脂30-60份、枸杞子30-60份、朱砂10-20份。
2.根据权利要求1所述的补肾益脑制剂在制备***的药物中的应用,其特征在于,所述补肾益脑制剂包含以下重量份的组分:红参50份、鹿茸8份、炒酸枣仁48份、熟地黄103份、茯苓48份、玄参37份、蜜远志48份、麦冬48份、五味子37份、当归48份、川芎37份、牛膝37份、炒山药48份、盐补骨脂37份、枸杞子39份、朱砂13份。
3.根据权利要求1所述的补肾益脑制剂在制备***的药物中的应用,其特征在于,所述补肾益脑制剂包含以下重量份的组分:红参40份、鹿茸8份、炒酸枣仁40份、熟地黄90份、茯苓40份、玄参36份、蜜远志40份、麦冬40份、五味子38份、当归40份、川芎36份、牛膝35份、炒山药40份、盐补骨脂35份、枸杞子35份、朱砂12份。
4.根据权利要求1所述的补肾益脑制剂在制备***的药物中的应用,其特征在于,所述补肾益脑制剂包含以下重量份的组分:红参75份、鹿茸16份、炒酸枣仁75份、熟地黄115份、茯苓75份、玄参55份、蜜远志75份、麦冬75份、五味子50份、当归70份、川芎50份、牛膝55份、炒山药75份、盐补骨脂55份、枸杞子50份、朱砂18份。
5.根据权利要求1所述的补肾益脑制剂在制备***的药物中的应用,其特征在于,所述药物为口服给药制剂。
6.根据权利要求1所述的补肾益脑制剂在制备***的药物中的应用,其特征在于,所述药物的剂型为片剂、颗粒剂、胶囊剂、软胶囊剂或滴丸剂。
7.根据权利要求1所述的补肾益脑制剂在制备***的药物中的应用,其特征在于,所述补肾益脑制剂采用如下方法制备而成:
S1、按照配方各组分的配比称取原料;
S2、五味子、盐补骨脂、川芎和当归提取挥发油,提取液滤过备用;药渣加60%乙醇加热回流提取 2-4小时,滤过,药渣再加80%乙醇加热回流提取2-4小时,滤过,合并两次提取液,回收乙醇,浓缩,备用;
S3、玄参、蜜远志、麦冬、炒酸枣仁、枸杞子、熟地黄和牛膝加水煎煮2-4次,每次1-3小时,合并煎煮液,滤过,备用;
S4、将步骤S2得到的提取液和步骤S3得到的煎煮液合并,浓缩至相对密度为1.20-1.35(60℃-90℃)的稠膏;将红参、鹿茸、茯苓、炒山药粉碎成细粉,朱砂水飞或粉碎成极细粉,拌入稠膏内,混匀,低温干燥,粉碎,加入药学上可接受的辅料制成口服给药制剂。
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