CN105396022A - 缓解肿瘤病人放疗反应的药剂片剂的制备方法 - Google Patents
缓解肿瘤病人放疗反应的药剂片剂的制备方法 Download PDFInfo
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Abstract
本发明公开了一种缓解肿瘤病人放疗反应的药剂片剂的制备方法,取下述重量配比的主要原料制备而成:党参3-12份,白术(麸炒)6-15份,白芍2-6份,丹参6-12份,白及5-12份,大黄3-6份,丁香5-11份,青黛3-6份,香附(醋)4-8份,甘草3-9份,广木香6-12份,乌梅4-8份,山柰3-8份,姜半夏4-12份。本发明所选材料均为传统中药材,无任何毒副作用;且药源易得,药材成本低廉,不会给患者造成负担。
Description
分案申请,原申请号2014101448706,申请日2014.04.12,名称缓解肿瘤病人放疗反应的药剂及制备方法。
技术领域
本发明涉及中医中药领域,尤其是涉及一种缓解肿瘤病人放疗反应的药剂及制备方法。
背景技术
恶性肿瘤是当今威胁人类生命和健康的最严重疾病之一,其死亡率在我国一直居前三位。恶性肿瘤早期不易发现,放疗是中晚期肿瘤及转移性肿瘤常用的治疗方法之一。放疗,即放射性治疗,是癌症三大治疗手段之一。是用各种不同能量的射线照射肿瘤,以抑制和杀灭癌细胞的一种治疗方法。放疗可单独使用,也可与手术、化疗等配合,作为综合治疗的一部分,以提高癌症的治愈率。在手术前先作一段放疗使肿瘤体积缩小些,便可使原来不能手术的患者争取到手术的机会。对晚期癌症则可通过姑息性放疗达到缓解压迫、止痛等效果。放疗对缓解恶性肿瘤患者的疼痛起到一定的效果,但是放疗不能从根本上治疗恶性肿瘤,而且放疗还会对患者产生一些副作用,易导致骨髓抑制,重者可出现感染、出血等并发症,导致死亡。
放疗的副反应主要表现为:
1、疲劳:恶性肿瘤患者在放疗期间,因为时间较长,所以患者就需要大量消耗人体的一些能量。疾病带来的压力,每天往返治疗以及放射对正常细胞的影响都会导致疲劳。大多数恶性肿瘤患者在放疗进行几个星期后都会感到疲倦,而且随着放疗的持续进行会更感疲劳。
2、饮食:恶性肿瘤患者在进行放疗时,患者还会出现一些饮食及消化的问题。在患者治疗过程中,患者可能完全没有食欲。
3、全身反应:表现为一系列的功能紊乱与失调,如精神不振,食欲下降,身体衰弱,疲乏,恶心呕吐,出虚汗,嗜睡,食后胀满等。
4、局部反应:(1)皮肤:干性皮肤表现为皮肤瘙痒,色素沉着及脱皮,能产生永久浅褐色斑。湿性皮肤表现为照射部位湿疹、水泡,严重时可造成糜烂、破溃。(2)粘膜反应:轻度:表现为口腔粘膜红肿、红斑、充血,分泌物减少。口干,稍痛,进食略少。中度:口咽部明显充血水肿,斑点状白膜、溃疡形成,有明显疼痛,进食困难。重度:口腔粘膜极度充血、糜烂、出血,融合成白膜,溃疡加重,并有脓性分泌物,剧痛,不能进食,并偶有发热。
5、免疫功能下降:放疗可损害患者的免疫系统,导致免疫功能缺陷或下降。免疫功能指标如CH50、C3补体、T细胞亚群,NK细胞活性、白介素Ⅱ等,在放疗后均可不同程度地较放疗前有所下降。
放疗对恶性肿瘤有一定的治疗效果,但是由于放疗的毒副作用,尤其是对造血功能、机体免疫功能的抑制,使许多患者无法完成其疗程,从而严重影响了放疗的治疗效果。所以,研制能减少放疗毒副反应的有效药物,使恶性肿瘤患者能更好的接受放疗,具有十分重要的价值。
恶性肿瘤属于中医“积”、“虚劳”的范畴,存在着正虚邪实的表现。并且由于病程的绵延,会导致“久病及肾”的现象。在接受放疗之后,其正虚症候更加明显,因元气进一步受损可致:精神萎靡、全身乏力、五心烦热、少言懒语等。伤于胃则恶心纳呆,伤于肾则头晕耳鸣,齿落发脱,腰酸足软,伤于心则心悸气短。
公开号为CN101549154A(申请号200910031557.0)的中国专利文献公开了一种抗辐射和减轻放疗副反应的营养液,这种营养液由生理盐水加胡萝卜素、壳聚糖、维生素C、维生素E等制成。申请公布号为CN102764371A(申请号201210283513.9)的中国专利文献公开了一种减轻放疗副反应的中药复方及其制备方法和应用,其由太子参10-30份,天冬10-30份,麦冬10-30份,五味子5-10份,生地10-15份,三七3-5份,女贞子10-30份,旱莲草10-30份,枸杞子10-30份,山萸肉10-30份,白花蛇舌草15-30份,茯苓10-15份,山药10-30份,楮实子6-12份组成。
总之,中医药在缓解肿瘤病人放疗副反应方面取得了一定的效果,但也存在一些问题:临床上对放疗副反应的治疗效果还不够理想,有待进一步提高。
发明内容
针对现有技术的不足,本发明的目的是提供一种制备简单、服用方便、便于携带、易久服的缓解肿瘤病人放疗反应的药剂及制备方法。该药剂疗效确切且无任何毒副作用。
本发明的技术方案是:
缓解肿瘤病人放疗反应的药剂,取下述重量配比的主要原料制备而成:党参3-12份,白术(麸炒)6-15份,白芍2-6份,丹参6-12份,白及5-12份,大黄3-6份,丁香5-11份,青黛3-6份,香附(醋)4-8份,甘草3-9份,广木香6-12份,乌梅4-8份,山柰3-8份,姜半夏4-12份。
缓解肿瘤病人放疗反应的药剂,优选的方案为,取下述重量配比的主要原料制备而成:党参6-8份,白术(麸炒)8-12份,白芍3-5份,丹参8-10份,白及7-10份,大黄3-5份,丁香7-9份,青黛4-6份,香附(醋)5-7份,甘草5-7份,广木香8-10份,乌梅5-7份,山柰4-7份,姜半夏7-9份。
缓解肿瘤病人放疗反应的药剂,更加优选的方案为,取下述重量配比的主要原料制备而成:党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份。
本发明还提供了将上述药剂制成药学上可接受的粉剂、水剂、膏剂、颗粒剂、片剂或胶囊。
所述粉剂的制备方法是:
(1)将大黄、青黛分别粉碎成细粉,过60-120目筛(优选的,过85-115目筛;更加优选的,过105目筛);
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏混合粉碎过85-135目筛(优选的,过100-120目筛;更加优选的,过110目筛);
(3)将步骤(1)和(2)所得混匀即可。
所述水剂的制备方法是:
(1)将大黄、青黛分别粉碎成细粉,过60-120目筛(优选的,过85-115目筛;更加优选的,过105目筛);
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏置于砂锅内,加水(用水量为原料药总重的2.5-4.5倍(优选的,3-4倍;更加优选的,3.5倍))煎煮2次,第一次1.2-2.4小时(优选的,1.5-2.0小时;更加优选的,1.8小时),第二次0.8-1.2小时(优选的0.9-1.1小时;更加优选的,1.0小时),滤液合并,放冷;
(3)将步骤(1)粉碎后的大黄和青黛加入步骤(2)所得药液,无菌封装。
所述膏剂的制备方法是:
(1)将大黄、青黛分别粉碎成细粉,过60-120目筛(优选的,过85-115目筛,更加优选的,过105目筛);
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏置于砂锅内,加水(用水量为原料药总重的2.5-4.5倍(优选的,3-4倍;更加优选的,3.5倍))煎煮2次,第一次1.2-2.4小时(优选的,1.5-2.0小时;更加优选的,1.8小时),第二次0.8-1.2小时(优选的0.9-1.1小时;更加优选的,1.0小时),滤液合并,滤过,浓缩得相对密度为1.36-1.38(48℃)的清膏;
(3)将步骤(1)粉碎后的大黄和青黛加入步骤(2)所得清膏,无菌封装。
所述颗粒剂的制备方法是:
(1)将大黄、青黛分别粉碎成细粉,过60-120目筛(优选的,过85-115目筛;更加优选的,过105目筛);
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏置于砂锅内,加水(用水量为原料药总重的2.5-4.5倍(优选的,3-4倍;更加优选的,3.5倍))煎煮2次,第一次1.2-2.4小时(优选的,1.5-2.0小时;更加优选的,1.8小时),第二次0.8-1.2小时(优选的0.9-1.1小时;更加优选的,1.0小时),滤液合并,滤过,浓缩得相对密度为1.36-1.38(48℃)的清膏;
(3)取清膏0.8-1.2份(优选的,0.9-1.1份;更加优选的,1.0份),蔗糖1.5-3.5份(优选的,2-3份;更加优选的2.5份),糊精0.8-1.2份(优选的,0.9-1.1份;更加优选的,1.0份),混合后加步骤(1)所得大黄和青黛细粉,混匀,制成颗粒,干燥,即得颗粒剂。
所述片剂的制备方法是:将权利要求5所得药剂粉剂按照0.3-0.5g/片(优选的,0.35-0.45g/片;更加优选的,0.4g/片)计量,按照片剂的加工制备方法压制成圆形或其他形状的片状剂型。
所述胶囊的制备方法是:将权利要求5所得药剂粉剂按照0.2-0.6g/粒(优选的,0.3-0.5g/粒;更加优选的,0.4g/粒)计量,按照胶囊的加工制备方法加工成胶囊状剂型。
本发明所用主要中药原料的药理如下:
党参:性味:性甘,平。归经:归脾、肺经。功效:健脾补肾,益气生津。主治:脾胃虚弱,食少便溏,四肢乏力,肺虚喘咳,气短自汗,气血两亏诸症。
白术(麸炒):性味:味苦、甘,温。归经:归脾、胃经。功效:健脾益气,燥湿利水,止汗,安胎。主治:脾气虚弱之乏力,食少腹胀,泄泻便秘,水饮内停之小便不利,水肿,痰饮眩晕,寒湿痹,身痛,气虚自汗,胎动不安。
白芍:性味:味苦,酸,微寒。归经:归肝、脾经。功效:养血合营,缓急止痛,敛阴平肝。主治:血虚寒热,脘腹疼痛,胁痛,肢体痉挛疼痛,痛经,月经不调,崩漏,自汗,盗汗,下痢泄泻,头痛眩晕。
丹参:性味:味苦,微寒。归经:归心、心包、肝经。功效:活血祛瘀,调经止痛,除烦安神,凉血消痈。主治:妇女月经不调,痛经,经闭,产后淤滞腹痛,心腹疼痛,癥瘕积聚,热痹肿痛,跌打损伤,热入营血,烦躁不安,心烦失眠,痈疮肿毒。
白及:性味:味苦、甘、涩,微寒。归经:归肺、肾经。功效:收敛止血,消肿生肌。主治:咯血,吐血,衄血,便血,外伤出血,痈疮肿毒,烫灼伤,手足皲裂,肛裂。
大黄:性味:味苦,寒。归经:胃、大肠、肝、脾经。功效:攻积滞,清湿热,泻火,凉血,祛瘀,解毒。主治:实积便秘,热结胸痞;湿热泻痢,黄疸,淋病,水肿腹满,小便不利;目赤,咽喉肿痛,口舌生疮,胃热呕吐,吐血,咯血,衄血,便血,尿血;蓄血,经闭,产后淤滞腹痛,癥瘕积聚,跌打损伤,热毒痈疡,丹毒,烫伤。
丁香:为桃金娘科丁子香属植物丁香的花蕾。性味:性辛,温。归经:归脾、胃、肾经。功效:温中,降逆,暖肾。主治:胃寒呃逆,呕吐,反胃,泻痢,脘腹冷痛,痃癖,疝气,奔豚气,癣症。
青黛:性味:味咸,寒。归经:归肝、肺、胃经。功效:清热,凉血,解毒。主治:温毒斑疹,吐血,衄血,咯血,小儿惊痫,肝火犯肺咳嗽,咽喉肿痛,丹毒,痄腮,疮肿,蛇虫咬伤。
香附(醋):性味:味辛、甘、微苦,平。归经:归肝、三焦经。功效:理气解郁,调经,安胎。主治:胁肋胀痛,乳房胀痛,疝气疼痛,月经不调,脘腹痞满疼痛,嗳气吞酸,呕恶,经行腹痛,崩漏带下,胎动不安。
甘草:性味:味甘,平。归经:归脾、胃、心、肺经。功效:和中缓急,润肺,解毒,调和诸药。主治:炙用治脾胃积弱,倦怠食少,腹痛便溏,四肢挛急疼痛,心悸,脏躁,肺痿咳嗽;生用治咽喉肿痛,痈疮肿毒,小儿胎毒,及药物、食物中毒。
广木香:性味:味辛、苦,温。归经:归肺、肝、脾经。功效:行气止痛,温中和胃。主治:胸腹胀痛,呕吐,泄泻,痢疾里急后重。
乌梅:性味:味酸,平。归经:归肝、脾、肺、大肠经。功效:敛肺止咳,涩肠止泻,止血,生津,安蛔。主治:久咳不止,久泄久痢,尿血便血,崩漏,虚热烦渴,蛔厥腹痛,疮痈胬肉。
山柰:为姜科山柰属植物山柰的根茎。性味:性辛,温,归胃、脾经。功效:温中,辟秽,消食,止痛。主治:瘴疠,脘腹冷痛,霍乱吐泻,食积,牙痛,骨鲠喉,跌打肿痛。
姜半夏:性味:味辛、温。归经:归脾、胃、肺经。功效:降逆止呕。主治:呕吐反胃,胸脘痞闷,梅核气。
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
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
实施例1缓解肿瘤病人放疗反应的药剂,取下述重量配比的主要原料制备而成(每份取10g):党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份。
上述缓解肿瘤病人放疗反应的药剂粉剂的制备方法为:
(1)将大黄、青黛分别粉碎成细粉,过105目筛;
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏混合粉碎过110目筛;
(3)将步骤(1)和(2)所得混匀即可。
本发明粉剂的服用方法:将粉剂分3g/袋;采用每天2-3次,每次一袋,用温开水冲服,7天一个疗程。
典型病例一林XX,年龄:50岁,性别:男。食管中断癌长5cm,2009年3月以来进行5次放疗,患者自述放疗之后会出现疲乏,全身无力,精神不振,身体衰弱,而且食欲下降,食物吞咽困难,恶心呕吐等症状,服用过不少抗放疗副反应的中西药,均无明显效果。服用本实施例所得缓解肿瘤病人放疗反应的药剂粉剂,采用每天3次,每次一袋,用温开水冲服,7天一个疗程。服用10天,患者食欲有所增强,恶心呕吐现象改善;服用1个月,患者不适症状明显改善,体力有所增强;继续服用2个月,患者不适症状基本消失,体力、精神状态均有明显提高。
实施例2缓解肿瘤病人放疗反应的药剂,取下述重量配比的主要原料制备而成(每份取20g):党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份。
上述缓解肿瘤病人放疗反应的药剂膏剂的制备方法为:
(1)将大黄、青黛分别粉碎成细粉,过105目筛;
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏置于砂锅内,加水(用水量为原料药总重的3.5倍)煎煮2次,第一次1.8小时,第二次1.0小时,滤液合并,滤过,浓缩得相对密度为1.36-1.38(48℃)的清膏;
(3)将步骤(1)粉碎后的大黄和青黛加入步骤(2)所得清膏,无菌封装。
本发明膏剂服用方法:膏剂采用每天2次,每次5-10g,按照1:10比例冲水服用,7天一个疗程。
典型病例二李XX,年龄:65岁,性别:男。患者做胃切除手术,之后一直做放疗进行治疗,患者自述每次放疗之后会出现许多不适症状:精神不振,无食欲,全身乏力,皮肤异常干燥,嗜睡等。服用本实施例所得缓解肿瘤病人放疗反应的药剂膏剂,采用每日2次,每次10g,按照1:10的比例冲水服用,7天一个疗程。服用7天,患者食欲有所增强,不适症状有所改善;服用1个月,患者体力增强,精神状态明显好转;继续服用1个月,不适症状逐渐消失。
实施例3缓解肿瘤病人放疗反应的药剂,取下述重量配比的主要原料制备而成(每份取30g):党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份。
上述缓解肿瘤病人放疗反应的药剂颗粒剂的制备方法为:
(1)将大黄、青黛分别粉碎成细粉,过105目筛;
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏置于砂锅内,加水(用水量为原料药总重的3.5倍)煎煮2次,第一次1.8小时,第二次1.0小时,滤液合并,滤过,浓缩得相对密度为1.36-1.38(48℃)的清膏;
(3)取清膏1.0份,蔗糖2.5份,糊精1.0份,混合后加步骤(1)所得大黄和青黛细粉,混匀,制成颗粒,干燥,即得颗粒剂。
本发明颗粒剂服用方法:将颗粒剂分4g/袋,每天2-3次,每次一袋,用温开水冲服,7天一个疗程。
典型病例三陈XX,年龄:57岁,性别:女。连续咳嗽3个月,2010年2月被诊断为右下肺腺癌,通过放疗进行治疗,病灶有所缩小,但是放疗之后出现了食欲不振、恶心呕吐、精神疲乏、嗜睡、皮肤异常干燥等不适症状。服用本实施例所得缓解肿瘤病人放疗反应的药剂颗粒剂,采用每日3次,每次一袋,用温开水冲服,7天一个疗程。服用21天,患者恶心呕吐现象消失;服用1个月,患者食欲改善,嗜睡状况好转,精神、体力显著增强;继续服用2个月,患者自感无不适症状。
实施例4缓解肿瘤病人放疗反应的药剂,取下述重量配比的主要原料制备而成(每份取40g):党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份。
上述缓解肿瘤病人放疗反应的药剂片剂的制备方法为:
(1)将大黄、青黛分别粉碎成细粉,过105目筛;
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏混合粉碎过110目筛;
(3)将步骤(1)和(2)所得混匀得粉剂;
(4)将步骤(3)所得粉剂按照0.4g/片计量,按照片剂的加工制备方法压制成圆形或其他形状的片状剂型。
本发明片剂服用方法:片剂采用每天3次,每次4-6片,用温开水冲服,7天一个疗程。
典型病例四李XX,年龄:69岁,性别:男。患者2008年患恶性肿瘤,两年后复发肺内转移,接受放疗进行治疗,缓解疼痛,但放疗之后出现以下不适症状:咳喘难平,无食欲,精神不振,全身乏力,异常口渴,出虚汗等。服用本实施例所得缓解肿瘤病人放疗反应的药剂片剂,采用每日3次,每次6片,用温开水冲服,7天一个疗程。服用14天,患者咳喘现象改善,不适症状均有所缓解;服用2个月,不适症状逐渐消失,精神、体力增强;继续服用1个月,患者自述无不适症状。
实施例5缓解肿瘤病人放疗反应的药剂,取下述重量配比的主要原料制备而成(每份取50g):党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份。
上述缓解肿瘤病人放疗反应的药剂胶囊的制备方法为:
(1)将大黄、青黛分别粉碎成细粉,过105目筛;
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏混合粉碎过110目筛;
(3)将步骤(1)和(2)所得混匀得粉剂;
(4)将步骤(3)所得粉剂按照0.5g/片计量,按照胶囊的加工制备方法加工成胶囊状剂型。
本发明胶囊服用方法:胶囊采用每天3次,每次5-8粒,用温开水冲服,7天一个疗程。
典型病例五郑XX,年龄:55岁,性别:女。2009年5月因咳嗽痰血就诊,经医生诊断为恶性肿瘤,采用放疗方法进行治疗,放疗之后出现一系列不适反应:患者全身无力,精神萎靡,食欲不振,毫无胃口,皮肤干燥异常,口渴难耐等。服用本实施例所得缓解肿瘤病人放疗反应的药剂胶囊剂,采用每日3次,每次8粒,用温开水冲服,7天一个疗程。服用10天,食欲增强,精神好转;服用2个月,患者不适症状基本消失,体力增强;继续服用2个月,患者自感无不适症状。
实施例6缓解肿瘤病人放疗反应的药剂,取下述重量配比的主要原料制备而成(每份取60g):党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份。
上述缓解肿瘤病人放疗反应的药剂水剂的制备方法为:
(1)将大黄、青黛分别粉碎成细粉,过105目筛;
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏置于砂锅内,加水(用水量为原料药总重的3.5倍)煎煮2次,第一次1.8小时,第二次1.0小时,滤液合并,放冷;
(3)将步骤(1)粉碎后的大黄和青黛加入步骤(2)所得药液,无菌封装。
本发明水剂服用方法:水剂采用每天2次(温热),每次300ml-500ml,7天一个疗程。
试验例1实施例6所得缓解肿瘤病人放疗反应的药剂水剂的临床应用:2008年2月-2010年11月,在6所医院筛选150例患者,其中女性71例,男性79例。试验之前2周,对该人群进行连续观察,记录症状及变化,随机分为两组,实验组及对照组,实验组服用实施例6所得产品,对照组服用其它药品(圣液口服液、硒维康等常规药品)。使用方法为:每天服用两次(温热),每次300m1-500m1(视具体情况有所调整),7天一个疗程。疗效情况判定标准:治愈:服用本品一个疗程,不适症状消失,精力及体力明显增强;有效:服用本品一个疗程,不适症状减轻或部分消失,精力及体力增强;无效:服用本品一个疗程,不适症状无变化。结果如表1所示。
表1:服用实施例6所得产品治疗效果验证
治疗效果:治愈70例(70%),有效28例(28%),无效2例(2%),总有效率98%。效果明显优于对照组。
服用期间自感症状及其体力精神变化如表2所示。
表2:
由表2可知:服用15天,51%以上的患者感到有所好转,不适症状改善;服用30天,72%以上的患者感到有所好转,不适症状改善或消失,精神、体力增强;服用45天,96%以上的患者感到有所好转,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。实验组中服用45天以上,有效率可达96%,而对照组仅为75%。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形。本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议的得到的,均应认为是本专利所要保护的范围。
Claims (1)
1.缓解肿瘤病人放疗反应的药剂片剂的制备方法,其特征是,取下述重量配比的主要原料制备而成:党参7份,白术(麸炒)10份,白芍4份,丹参9份,白及8份,大黄4份,丁香8份,青黛5份,香附(醋)6份,甘草6份,广木香9份,乌梅6份,山柰5份,姜半夏8份;步骤为:
(1)将大黄、青黛分别粉碎成细粉,过105目筛;
(2)将党参、白术(麸炒)、白芍、丹参、白及、丁香、香附(醋)、甘草、广木香、乌梅、山柰和姜半夏混合粉碎过110目筛;
(3)将步骤(1)和(2)所得混匀得粉剂;
(4)将步骤(3)所得粉剂按照0.4g/片计量,按照片剂的加工制备方法压制成圆形或其他形状的片状剂型。
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