CN104398920B - 一种巩固宫颈癌放疗效果的药物及其制备方法 - Google Patents

一种巩固宫颈癌放疗效果的药物及其制备方法 Download PDF

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CN104398920B
CN104398920B CN201410703234.2A CN201410703234A CN104398920B CN 104398920 B CN104398920 B CN 104398920B CN 201410703234 A CN201410703234 A CN 201410703234A CN 104398920 B CN104398920 B CN 104398920B
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高春娟
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Abstract

一种巩固宫颈癌放、化疗效果的药物及其制备方法，由太子参、枸杞子、仙鹤草、佛手、薏苡仁、蒸黄精、焦山楂、炒稻芽、地锦草、黄芪、酒山茱萸肉、半枝莲、梅花、茯苓、炙鸡内金、焦六神曲、炒麦芽、酒女贞子配伍组成，具有清热解毒、化瘀散结，消肿止痛，补气养血，活血止血，滋补肝肾、养伤退肿、败毒抗癌，抑制艾氏腹水癌，抑制S180的功效。本发明采用标本兼治的方法，扶正祛邪，缓解疼痛，增强人体免疫力，抑制癌症细胞的生长，副作用小，并进一步杀死癌细胞，达到治愈宫颈癌、巩固宫颈癌放、化疗效果的目的，效果显著。

Description

一种巩固宫颈癌放疗效果的药物及其制备方法
技术领域
本发明涉及一种由中草药为原料药的中药组合物及其制备方法，具体的说是涉及一种巩固宫颈癌放疗效果的药物及其制备方法。
背景技术
宫颈癌是最常见的妇科恶性肿瘤。原位癌高发年龄为30～35岁，浸润癌为45～55岁，近年来其发病有年轻化的趋势。根据癌灶累及范围出现不同的继发性症状，如尿频、尿急、便秘、下肢肿痛等；癌肿压迫或累及输尿管时，可引起输尿管梗阻、肾盂积水及尿毒症；晚期可有贫血、恶病质等全身衰竭症状。目前西医巩固宫颈癌放、化疗效果主要有以下三种治疗方案：
1.手术治疗
手术主要用于早期宫颈癌患者。常用术式有：全子宫切除术；次广泛全子宫切除术及盆腔淋巴结清扫术；广泛全子宫切除术及盆腔淋巴结清扫术；腹主动脉旁淋巴切除或取样。年轻患者卵巢正常可保留。对要求保留生育功能的年轻患者，属于特别早期的可行宫颈锥形切除术或根治性宫颈切除术。根据患者不同分期选用不同的术式。
2.放射治疗
适用于：①中晚期患者；②全身情况不适宜手术的早期患者；③宫颈大块病灶的术前放疗；④手术治疗后病理检查发现有高危因素的辅助治疗。
3.化疗
主要用于晚期或复发转移的患者，近年也采用手术联合术前新辅助化疗(静脉或动脉灌注化疗)来缩小肿瘤病灶及控制亚临床转移，也用于放疗增敏。常用化疗药物有顺铂、卡铂、紫杉醇、博来霉素、异环磷酰胺、氟尿嘧啶等。
不管是手术治疗，切除病灶，还是放射治疗、化疗，希望杀死或控制病灶，其治疗过程都使病人异常痛苦，而且对病人的身体也要产生严重的损害，病人的生存治疗极差。
目前，放、化疗公认为是治疗恶性肿瘤、癌症的最有效的方法，但是放、化疗同时也是一把双刃剑，在杀死肿瘤细胞的同时，还会对身体产生一系列的毒副作用，如出现骨髓抑制，外周血白细胞下降等，还会消弱恶性肿瘤患者身体的免疫功能。
发明内容
本发明从临床医疗用药需求及中医组方辩证原则出发，提出一种巩固宫颈癌放、化疗效果的药物及其制备方法。它是由以下重量配比的原料药制备而成的药剂：太子参12-18g、枸杞子12-18g、仙鹤草12-18g、佛手7-13g、薏苡仁27-33g、蒸黄精12-18g、焦山楂12-18g、炒稻芽12-18g、地锦草12-18g、黄芪12-18g、酒山茱萸肉7-13g、半枝莲12-18g、梅花3-9g、茯苓7-13g、炙鸡内金12-18g、焦六神曲12-18g、炒麦芽12-18g、酒女贞子7-13g。优选配比为：太子参15g、枸杞子15g、仙鹤草15g、佛手10g、薏苡仁30g、蒸黄精15g、焦山楂15g、炒稻芽15g、地锦草15g、黄芪15g、酒山茱萸肉10g、半枝莲15g、梅花6g、茯苓10g、炙鸡内金15g、焦六神曲15g、炒麦芽15g、酒女贞子10g。所述药剂为胶囊剂、片剂或丸剂。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
(1)取方中太子参、枸杞子、仙鹤草、佛手、薏苡仁、蒸黄精、焦山楂、炒稻芽、地锦草、黄芪、酒山茱萸肉、半枝莲、梅花、茯苓、炙鸡内金、焦六神曲、炒麦芽、酒女贞子粉碎筛析；
(2)将步骤(1)中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将滤液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
(3)制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤(2)中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤(2)中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
本发明原料药药理如下：
太子参：补益脾肺，益气生津，主脾胃虚弱；食欲不振；倦怠无力；气阴两伤；干咳痰少；自汗气短；以及温病后期气虚津伤；内热口渴；或神经衰弱，心悸失眠，头昏健；
枸杞子：滋补肝肾，益精明目；
仙鹤草：败毒抗癌，凉血止血，用于血热出血，养伤退肿，用于损伤肿痛，可用于癌瘤积毒、胃癌、食管癌、肝癌、宫体腺癌、乳腺癌、白血病、宫颈癌等病症；
佛手：有理气化痰、止呕消胀、舒肝健脾疗效，对老年人的气管炎、哮喘病有明显的缓解作用；对一般人的消化不良、胸腹胀闷，有更为显著的疗效；
薏苡仁：甘、淡，微寒。归脾、胃、肾、肺经。利水渗湿，健脾，舒筋，清热排脓。所含苡仁素有明显的抑制艾氏腹水癌的作用，对S180有抑制作用。适应症各种常见肿瘤。用量15－30g。禾本科植物薏苡仁的成熟种仁。[别名]苡仁、胶念珠、薏米。是一种扶正抗癌类中草药。
蒸黄精：益气养阴、补脾润肺益肾功效增强，用于肺之阴虚燥咳、脾胃虚弱乏力、肾虚精亏、头晕足软；
焦山楂：主治腹泻和消积开胃，以及活血散瘀、防暑、降压等功效；
炒稻芽：和中消食，健脾开胃。用于食积不消，腹胀口臭，脾胃虚弱，不饥食少；
地锦草：能够清热解毒；利湿退黄；活血止血。主痢疾、泄泻、黄疸；咳血；吐血；尿血；便血；崩漏；乳汁不下；跌打肿痛及热毒疮疡等；
黄芪：其有增强机体免疫功能、保肝、利尿、抗衰老、抗应激、降压和较广泛的抗菌作用；
酒山茱萸肉：补益肝肾，涩精固脱。用于眩晕耳鸣，腰膝酸痛，阳痿遗精，遗尿尿频，崩漏带下，大汗虚脱，内热消渴；
半枝莲：具有清热解毒、活血祛瘀、消肿止痛、抗癌等功能。性寒味酸，全草含多种维生素、微量元素及氨基酸等成分，有凉血解毒，散瘀止痛，消肿和清热利湿之功效；
梅花：有止咳、止泻、生津、止渴之效；
茯苓：味甘、淡、性平，入药具有利水渗湿、益脾和胃、宁心安神之功用，现代医学研究：茯苓能增强机体免疫功能，茯苓多糖有明显的抗肿瘤及保肝脏作用；
炙鸡内金：消食健胃助消化，涩精止遗。可以促进胃液分泌，提高胃酸度及消化力，使胃运动功能明显增强，胃排空加快；
焦六神曲：治饮食停滞，胸痞腹胀，呕吐泻痢，产后瘀血腹痛；
炒麦芽：主治食积不消，脘腹胀痛，脾虚食少；
酒女贞子：治阴虚内热，头晕，目花，耳鸣，腰膝酸软。
本发明中药组合物具有清热解毒、化瘀散结，消肿止痛，补气养血，活血止血，滋补肝肾、养伤退肿、败毒抗癌，抑制艾氏腹水癌，抑制S180的功效。本发明所述的药物承中医之精髓、严谨组方，诸药君臣佐使合用，补破结合、相得益彰，符合中医用药规律和辨证施治的原则。本发明采用标本兼治的方法，扶正祛邪，缓解疼痛，增强人体免疫力，抑制癌症细胞的生长，副作用小，并进一步杀死癌细胞，达到治愈宫颈癌、巩固宫颈癌放、化疗效果的目的，效果显著。
本发明经药效学试验结果如下：
增强免疫力：给小鼠灌本发明所述的药物，能提高正常小鼠对血中碳粒的清除速度和抗体形成细胞的数量，促进B细胞受抗原刺激后的分裂增殖，增加幼鼠胸腺指数，增加吞噬、杀伤细胞数量，增强小鼠单核一吞噬细胞和腹腔巨噬细胞吞噬能力的能力，提高小鼠腹腔巨噬细胞吞噬鸡红细胞的吞噬百分率和吞噬指数。
消肿止痛：将16只小白鼠在腹腔注射醋酸溶液，注射后小白鼠出现腹部内凹，躯干与四肢伸张，臀部高起等行为反应，此形为扭体反应。其中8只给予本发明药物后小白鼠扭体次数明显减少；另外8只给予阿司匹林药物，扭体次数也明显减少。此试验证明，本药物具有显著的镇痛作用。
急毒性试验：较大剂量和较长疗程服用对大鼠的生长无显著毒性，对大鼠的脑、心、肝、肾等切片形态学检查未见明显毒性损伤改变，试验显示，本药物毒性甚小。
镜下检查典型增生表现：连续服药30天后，对患者进行镜下检查底层细胞增生情况，底层细胞增生停止，细胞排列紊乱消失，细胞核减小，浓染、染色质分布不均等核异质改变明显减少。
典型病例：
病例1：孙女士，45岁，该患者阴道接触性流血，阴道排液，液体为白色或血性，有腥臭，经医院检查为宫颈癌早期，在西医化疗后，食欲不振，恶心呕吐，精神倦怠，腰膝酸软，身体免疫力下降。经服用本发明药物治疗6个疗程后，症状消失，恢复正常，宫颈癌化疗效果得到巩固控制。
病例2：邓女士，54岁，该患者阴道不规则出血3个多月，经医院病理切片诊断为宫颈癌，在西医化疗后，食欲不振，恶心呕吐，身体抵抗力明显下降，经服用本发明药物治疗6个疗程后，症状消失，恢复正常，宫颈癌化疗效果得到巩固控制。
具体实施方式
实施例1：一种巩固宫颈癌放、化疗效果的药物及其制备方法。它是由以下重量配比的原料药制备而成的药剂：太子参12-18g、枸杞子12-18g、仙鹤草12-18g、佛手7-13g、薏苡仁27-33g、蒸黄精12-18g、焦山楂12-18g、炒稻芽12-18g、地锦草12-18g、黄芪12-18g、酒山茱萸肉7-13g、半枝莲12-18g、梅花3-9g、茯苓7-13g、炙鸡内金12-18g、焦六神曲12-18g、炒麦芽12-18g、酒女贞子7-13g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量配比称取原料药、
太子参12-18g、枸杞子12-18g、仙鹤草12-18g、佛手7-13g、薏苡仁27-33g、蒸黄精12-18g、焦山楂12-18g、炒稻芽12-18g、地锦草12-18g、黄芪12-18g、酒山茱萸肉7-13g、半枝莲12-18g、梅花3-9g、茯苓7-13g、炙鸡内金12-18g、焦六神曲12-18g、炒麦芽12-18g、酒女贞子7-13g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下、
(1)取方中太子参、枸杞子、仙鹤草、佛手、薏苡仁、蒸黄精、焦山楂、炒稻芽、地锦草、黄芪、酒山茱萸肉、半枝莲、梅花、茯苓、炙鸡内金、焦六神曲、炒麦芽、酒女贞子粉碎筛析；
(2)将步骤(1)中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将滤液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
(3)制作胶囊、丸剂时、
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时、
将2-4份淀粉与步骤(2)中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤(2)中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
实施例2、一种巩固宫颈癌放、化疗效果的药物及其制备方法。它是由以下重量
份数配比的原料药制备而成的药剂、太子参15g、枸杞子15g、仙鹤草15g、佛手10g、薏苡仁30g、蒸黄精15g、焦山楂15g、炒稻芽15g、地锦草15g、黄芪15g、酒山茱萸肉10g、半枝莲15g、梅花6g、茯苓10g、炙鸡内金15g、焦六神曲15g、炒麦芽15g、酒女贞子10g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量配比称取原料药、
太子参15g、枸杞子15g、仙鹤草15g、佛手10g、薏苡仁30g、蒸黄精15g、焦山楂15g、炒稻芽15g、地锦草15g、黄芪15g、酒山茱萸肉10g、半枝莲15g、梅花6g、茯苓10g、炙鸡内金15g、焦六神曲15g、炒麦芽15g、酒女贞子10g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下、
(1)取方中太子参、枸杞子、仙鹤草、佛手、薏苡仁、蒸黄精、焦山楂、炒稻芽、地锦草、黄芪、酒山茱萸肉、半枝莲、梅花、茯苓、炙鸡内金、焦六神曲、炒麦芽、酒女贞子粉碎筛析；
(2)将步骤(1)中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将滤液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
(3)制作胶囊、丸剂时、
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时、
将2-4份淀粉与步骤(2)中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤(2)中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。

Claims (3)

1.一种巩固宫颈癌放疗效果的药物，其特征在于它是由以下重量配比的原料药制备而成的药剂：太子参12-18g、枸杞子12-18g、仙鹤草12-18g、佛手7-13g、薏苡仁27-33g、蒸黄精12-18g、焦山楂12-18g、炒稻芽12-18g、地锦草12-18g、黄芪12-18g、酒山茱萸肉7-13g、半枝莲12-18g、梅花3-9g、茯苓7-13g、炙鸡内金12-18g、焦六神曲12-18g、炒麦芽12-18g、酒女贞子7-13g。
2.根据权利要求1所述的巩固宫颈癌放疗效果的药物，其特征在于它是由以下重量配比的原料药制备而成的药剂：太子参15g、枸杞子15g、仙鹤草15g、佛手10g、薏苡仁30g、蒸黄精15g、焦山楂15g、炒稻芽15g、地锦草15g、黄芪15g、酒山茱萸肉10g、半枝莲15g、梅花6g、茯苓10g、炙鸡内金15g、焦六神曲15g、炒麦芽15g、酒女贞子10g。
3.根据权利要求1或2所述的巩固宫颈癌放疗效果的药物，其特征在于：所述药剂为胶囊剂、片剂或丸剂。
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Effective date of registration: 20231018

Address after: 150026 D10-08, Block A, Modern Commercial Logistics City, South China City, Daowai District, Harbin City, Heilongjiang Province

Patentee after: Jiangming (Heilongjiang) Pharmaceutical Co.,Ltd.

Address before: Room 401, Building 12, Xinran Garden, Yuecheng International Garden, No. 9 Huashen Avenue, Yuhuatai District, Nanjing City, Jiangsu Province, 210008

Patentee before: Gao Chunjuan

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