CN105749071A - 一种缓解乳腺肿瘤放疗后反应的药物及其制备方法 - Google Patents
一种缓解乳腺肿瘤放疗后反应的药物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种缓解乳腺肿瘤放疗后反应的药物,由以下原料制成,火麻仁,地肤子,党参,荆芥,苍术,黄芩,玉竹,大青叶,栀子,黄柏,土茯苓,五倍子,金银花,杜仲,川芎。本发明药剂基于中医中药治疗放疗副反应原理,是在研究了大量文献、药理工作和临床试验的基础上制成的。本药剂所选材料均为传统中药材,无任何毒副作用;而且药材药源易得,药材成本低廉,不会给患者带来经济负担。本药剂完全按照中医药原则及恶性肿瘤患者的身心特点,对放疗引起的副反应有很好的治疗效果。
Description
技术领域
本发明涉及一种中药组合物及其制备方法,具体涉及一种缓解乳腺肿瘤放疗后反应的药物及其制备方法。
背景技术
放射治疗是恶性肿瘤最常用的治疗方法之一,临床上大部分肿瘤患者都要接受放射治疗。放疗就是放射治疗,指利用射线对细胞的杀伤作用来杀死体内恶变的细胞,从而达到治疗恶性肿瘤的目的。放射治疗是一种针对肿瘤的物理疗法,现已成为治疗恶性肿瘤的一个重要手段,对于许多癌症可以产生较好效果。放疗可以迅速作用于局部或全身,近期治疗效果较好,但是放疗副作用也很大,它们在杀伤肿瘤细胞的同时,也杀伤正常组织的细胞,而这些细胞与组织是人体重要的免疫防御系统,破坏了人体的免疫系统,癌细胞就可能迅速发展,导致病情加重,甚至缩短患者的生命。因此无论在心理上还是身体上,又给患者造成了不同程度的伤害。
放疗后病人可出现一系列局部和全身的不良反应,表现为虚弱、乏力、头晕、头痛、厌食,个别有恶心、呕吐等,特别是腹部照射和大面积照射时,反应较重。目前西医一般对症治疗,或服用一些止痛及抗生素类药物予以治疗,并无特效药物,而且副作用大,具有一定的药物依赖性。
中医认为放射线属火毒之邪,放射线在杀伤肿瘤细胞的同时,亦作为“热毒”损伤人体气阴。中医药作为恶性肿瘤常用的治疗方法之一,将其配合放射治疗,不仅可以减轻机体的毒副反应,还可以增强放疗的疗效,提高患者的耐受力和生活质量,从而增强患者的免疫功能,减少肿瘤复发和转移的机会,以延长患者的寿命。
发明内容
本发明要解决的技术问题是提供一种减轻乳腺癌放疗副反应的中药及其制备方法。
为解决上述技术问题,本发明的缓解乳腺肿瘤放疗后反应的药物,由以下原料制成,火麻仁,地肤子,党参,荆芥,苍术,黄芩,玉竹,大青叶,栀子,黄柏,土茯苓,五倍子,金银花,杜仲,川芎。
优选的,各原料的重量份是,火麻仁10-15份,地肤子8-12份,党参8-12份,荆芥4-8份,苍术5-10份,黄芩2-6份,玉竹2-5份,大青叶2-5份,栀子2-6份,黄柏5-8份,土茯苓5-8份,五倍子1-3份,金银花2-4份,杜仲1-3份,川芎1-3份。
优选的,各原料的重量份是,火麻仁12份,地肤子10份,党参10份,荆芥6份,苍术8份,黄芩4份,玉竹4份,大青叶4份,栀子4份,黄柏6份,土茯苓6份,五倍子2份,金银花3份,杜仲2份,川芎2份。
本发明还涉及一种制造上述缓解乳腺肿瘤放疗后反应的药物的方法,包括下列步骤,
a.按重量份称取火麻仁,地肤子,党参,荆芥,粉碎成粉末,加入水煎煮,水沸后文火煮3小时,静置沉淀10-12小时,过滤,滤渣备用,浓缩滤液得到清膏,将所得清膏在40℃-55℃的温度下,减压微波干燥,得到干浸膏块A;;
b.按重量份称苍术,黄芩,玉竹,大青叶,栀子,黄柏,土茯苓,五倍子,金银花,粉碎成粉末,加入10倍原料重量的浓度为70%的乙醇,浸泡3小时,利用超声装置超声提取,超声频率为10-15kHz,温度为35-40℃,超声时间为50-60分钟,过滤,浓缩滤液得到清膏,将所得清膏在45℃-55℃的温度下,减压微波干燥,得到干浸膏块B;
c.按重量份称杜仲,川芎,切成1cm大小的小块,置锅内用文火炒至表皮焦黄后,取出,冷却至室温,超细研磨,过300目筛,得粉末C
d.将干浸膏块A、B粉碎,加入粉末C,混合均匀,即得治疗湿疹的外用药物。
本发明还涉及一种用上述药物做成的片剂,所述片剂由15质量份所制成的药物加2质量份的淀粉、1质量份的羟丙基甲基纤维素和2质量份的羟甲基淀粉钠压片而成。
本发明药剂基于中医中药治疗放疗副反应原理,是在研究了大量文献、药理工作和临床试验的基础上制成的。本药剂所选材料均为传统中药材,无任何毒副作用;而且药材药源易得,药材成本低廉,不会给患者带来经济负担。本药剂完全按照中医药原则及恶性肿瘤患者的身心特点,对放疗引起的副反应有很好的治疗效果。
具体实施方式
实施例1
制备本发明的缓解肿瘤放疗后反应的药物,包括下列步骤:
a.按重量份称取火麻仁10份,地肤子8份,党参8份,荆芥4份,粉碎成粉末,加入水煎煮,水沸后文火煮3小时,静置沉淀10-12小时,过滤,滤渣备用,浓缩滤液得到清膏,将所得清膏在40℃-55℃的温度下,减压微波干燥,得到干浸膏块A;;
b.按重量份称苍术,苍术5份,黄芩6份,玉竹5份,大青叶5份,栀子6份,黄柏8份,土茯苓8份,五倍子3份,金银花4份,粉碎成粉末,加入10倍原料重量的浓度为70%的乙醇,浸泡3小时,利用超声装置超声提取,超声频率为10-15kHz,温度为35-40℃,超声时间为50-60分钟,过滤,浓缩滤液得到清膏,将所得清膏在45℃-55℃的温度下,减压微波干燥,得到干浸膏块B;
c.按重量份称杜仲3份,川芎3份,切成1cm大小的小块,置锅内用文火炒至表皮焦黄后,取出,冷却至室温,超细研磨,过300目筛,得粉末C
d.将干浸膏块A、B粉碎,加入粉末C,混合均匀,即得治疗湿疹的外用药物。
由15质量份所制成的药物加2质量份的淀粉、1质量份的羟丙基甲基纤维素和2质量份的羟甲基淀粉钠压片制成片剂。
实施例2
制备本发明的缓解肿瘤放疗后反应的药物,包括下列步骤:
a.按重量份称取火麻仁15份,地肤子12份,党参12份,荆芥8份,粉碎成粉末,加入水煎煮,水沸后文火煮3小时,静置沉淀10-12小时,过滤,滤渣备用,浓缩滤液得到清膏,将所得清膏在40℃-55℃的温度下,减压微波干燥,得到干浸膏块A;;
b.按重量份称苍术10份,黄芩2份,玉竹2份,大青叶2份,栀子2份,黄柏5份,土茯苓5份,五倍子1份,金银花2份,粉碎成粉末,加入10倍原料重量的浓度为70%的乙醇,浸泡3小时,利用超声装置超声提取,超声频率为10-15kHz,温度为35-40℃,超声时间为50-60分钟,过滤,浓缩滤液得到清膏,将所得清膏在45℃-55℃的温度下,减压微波干燥,得到干浸膏块B;
c.按重量份称杜仲1份,川芎1份,切成1cm大小的小块,置锅内用文火炒至表皮焦黄后,取出,冷却至室温,超细研磨,过300目筛,得粉末C
d.将干浸膏块A、B粉碎,加入粉末C,混合均匀,即得治疗湿疹的外用药物。
由15质量份所制成的药物加2质量份的淀粉、1质量份的羟丙基甲基纤维素和2质量份的羟甲基淀粉钠压片制成片剂。
实施例3
制备本发明的缓解肿瘤放疗后反应的药物,包括下列步骤:
a.按重量份称取火麻仁12份,地肤子10份,党参10份,荆芥6份,粉碎成粉末,加入水煎煮,水沸后文火煮3小时,静置沉淀10-12小时,过滤,滤渣备用,浓缩滤液得到清膏,将所得清膏在40℃-55℃的温度下,减压微波干燥,得到干浸膏块A;;
b.按重量份称苍术8份,黄芩4份,玉竹4份,大青叶4份,栀子4份,黄柏6份,土茯苓6份,五倍子2份,金银花3份,粉碎成粉末,加入10倍原料重量的浓度为70%的乙醇,浸泡3小时,利用超声装置超声提取,超声频率为10-15kHz,温度为35-40℃,超声时间为50-60分钟,过滤,浓缩滤液得到清膏,将所得清膏在45℃-55℃的温度下,减压微波干燥,得到干浸膏块B;
c.按重量份称杜仲2份,川芎2份,切成1cm大小的小块,置锅内用文火炒至表皮焦黄后,取出,冷却至室温,超细研磨,过300目筛,得粉末C
d.将干浸膏块A、B粉碎,加入粉末C,混合均匀,即得治疗湿疹的外用药物。
由15质量份所制成的药物加2质量份的淀粉、1质量份的羟丙基甲基纤维素和2质量份的羟甲基淀粉钠压片制成片剂。
本发明经临床试用,取得了满意的效果,有关临床资料如下:
临床资料:
共观察211例,年龄35~63岁,平均52.1岁。上述患者随机分为4组,包括治疗组1,治疗组2,治疗组3,对照组,组间病例年龄、病程等方面经统计学处理差异无显著性,具有可比性。
治疗方法:
治疗组1:口服实施例1中的方法制备的药片,每日3次,每次2片,一周为一个疗程,连续治疗两个疗程,治疗期间停用其他药物。
治疗组2:口服实施例2中的方法制备的药片,每日3次,每次2片,一周为一个疗程,连续治疗两个疗程,治疗期间停用其他药物。
治疗组3:口服实施例3中的方法制备的药片,每日3次,每次2片,一周为一个疗程,连续治疗两个疗程,治疗期间停用其他药物。
对照组:服用安慰剂。
疗效判定:
治愈:放疗后反应症状基本消失,身体状况明显增强。
显效:放疗后反应症状明显缓解,身体状况有所好转。
有效:放疗后反应症状有一定程度缓解。
无效:症状同施治前无明显差异。
治疗效果比较:
病例数 | 痊愈 | 显效 | 有效 | 无效 | 治愈率 | 总有效率 | |
治疗组1 | 52 | 17 | 17 | 8 | 10 | 32.7% | 80.8% |
治疗组2 | 53 | 20 | 14 | 10 | 9 | 37.7% | 83.0% |
治疗组3 | 53 | 22 | 13 | 11 | 7 | 41.5% | 86.8% |
对照组 | 53 | 10 | 8 | 9 | 26 | 18.9% | 50.9% |
结果表明,采用本发明药物进行治疗,治愈率明显高于对照组。
典型病例:李某某,女,49岁,该患者因肿瘤接受放疗后,出现口干咽燥、食欲不振、身体乏力、心慌气短、体重减轻、等症状。服用一个疗程,患者感到有所好转,不适症状改善;服用两个疗程,患者感到有所好转,不适症状改善或消失,精神、体力增强;服用三个疗程,患者感到有所好转,食欲明显增强,不适症状改善或消失,精神、体力增强,部分患者自感无不适症状。
Claims (5)
1.一种缓解乳腺肿瘤放疗后反应的药物,其特征在于:由以下原料制成,火麻仁,地肤子,党参,荆芥,苍术,黄芩,玉竹,大青叶,栀子,黄柏,土茯苓,五倍子,金银花,杜仲,川芎。
2.按照权利要求1所述的缓解乳腺肿瘤放疗后反应的药物,其特征在于:各原料的重量份是,火麻仁10-15份,地肤子8-12份,党参8-12份,荆芥4-8份,苍术5-10份,黄芩2-6份,玉竹2-5份,大青叶2-5份,栀子2-6份,黄柏5-8份,土茯苓5-8份,五倍子1-3份,金银花2-4份,杜仲1-3份,川芎1-3份。
3.按照权利要求2所述的用于缓解乳腺肿瘤放疗后反应的药物,其特征在于:各原料的重量份是,火麻仁12份,地肤子10份,党参10份,荆芥6份,苍术8份,黄芩4份,玉竹4份,大青叶4份,栀子4份,黄柏6份,土茯苓6份,五倍子2份,金银花3份,杜仲2份,川芎2份。
4.一种制造权利要求1-3中所述的缓解乳腺肿瘤放疗后反应的药物的方法,其特征在于:包括下列步骤,
a.按重量份称取火麻仁,地肤子,党参,荆芥,粉碎成粉末,加入水煎煮,水沸后文火煮3小时,静置沉淀10-12小时,过滤,滤渣备用,浓缩滤液得到清膏,将所得清膏在40℃-55℃的温度下,减压微波干燥,得到干浸膏块A;;
b.按重量份称苍术,黄芩,玉竹,大青叶,栀子,黄柏,土茯苓,五倍子,金银花,粉碎成粉末,加入10倍原料重量的浓度为70%的乙醇,浸泡3小时,利用超声装置超声提取,超声频率为10-15kHz,温度为35-40℃,超声时间为50-60分钟,过滤,浓缩滤液得到清膏,将所得清膏在45℃-55℃的温度下,减压微波干燥,得到干浸膏块B;
c.按重量份称杜仲,川芎,切成1cm大小的小块,置锅内用文火炒至表皮焦黄后,取出,冷却至室温,超细研磨,过300目筛,得粉末C
d.将干浸膏块A、B粉碎,加入粉末C,混合均匀,即得治疗湿疹的外用药物。
5.一种用权利要求4中所述的药物做成的片剂,其特征在于:所述片剂由15质量份所制成的药物加2质量份的淀粉、1质量份的羟丙基甲基纤维素和2质量份的羟甲基淀粉钠压片而成。
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