CN104435837A - 一种治疗自汗、盗汗的药物组合物 - Google Patents

一种治疗自汗、盗汗的药物组合物 Download PDF

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CN104435837A
CN104435837A CN201410718371.3A CN201410718371A CN104435837A CN 104435837 A CN104435837 A CN 104435837A CN 201410718371 A CN201410718371 A CN 201410718371A CN 104435837 A CN104435837 A CN 104435837A
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刘庆香
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Jinan Children's Hospital
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邹士东
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Abstract

本发明属于医药技术领域,涉及一种治疗自汗、盗汗的药物组合物。所述药物组合物包括如下组分:黄芪,浮小麦,熟地黄,糯稻根,五味子,麦冬,野料豆,黄连,桑叶,川芎,制首乌。该药物组合物具有益气养阴、生津止渴、敛阴止汗之功效,在治疗自汗、盗汗特别是气阴两虚引起的自汗、盗汗疗效确切,安全可靠,副作用小,是一种可以推广用于治疗自汗、盗汗的有效药物,临床意义显著。

Description

一种治疗自汗、盗汗的药物组合物
技术领域
[0001] 本发明属于医药技术领域,具体涉及一种治疗自汗、盗汗的药物组合物。
背景技术
[0002] 小儿多汗症是指儿童在安静状态下,以全身或局部出汗过多为主的一种不正常出 汗的儿科常见病。根据表现不同分为自汗和盗汗,临床亦见自汗和盗汗兼有。
[0003] 古代中医大多将小儿汗症分为:肺卫不固、营卫失调、气阴两虚、湿热迫蒸四种情 况,现代医家大多认为小儿汗症病因不外乎虚实两端,虚者,指机体虚弱,失于闭藏,津液外 泄所致,包括卫气不固、营卫不和及脏腑阴阳气血亏虚;实者,指实邪淤阻,内热煎迫所致, 包括邪郁肌表,营卫失调,食滞内阻,郁而化热,邪热内盛,里热熏蒸以及淤血内阻,气血失 调等。
[0004] 结合现代中医药发展理论,从提高药物疗效、降低副作用的角度出发,经过对中药 成分进行筛选提取和/或配伍制得的制剂,其毒副作用小,安全性高,具有化学合成药不能 比拟的优势。
发明内容
[0005] 本发明提供了一种治疗自汗、盗汗的药物组合物,该药物组合物疗效好,毒副作用 小,它由以下原料制得:黄芪,浮小麦,熟地黄,糯稻根,五味子,麦冬,野料豆,黄连,桑叶,川 考,制首乌。
[0006] 本发明所述药物组合物中,所述黄芪,性甘,味温。归肺、脾经。补气固表,利尿托 毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气 虚水肿,痈疽难溃,久溃不敛,血虚瘘黄,内热消渴。
[0007] 浮小麦,性甘,味凉。止虚汗,养心安神。用于体虚多汗,脏躁症。
[0008] 熟地黄,甘,微温。归肝、肾经。滋阴补血,益精填髓。用于肝肾阴虚,腰膝酸软,骨 蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早 白。
[0009] 糯稻根,甘,平。养阴,止汗,健胃。用于自汗,盗汗,肝炎。
[0010] 五味子,酸,温。入肺、肾经。敛肺,滋肾,生津,收汗,涩精。治肺虚喘咳,口干作渴, 自汗,盗汗,劳伤羸瘦,梦遗滑精,久泻久痢。
[0011] 麦冬,甘,微苦,微寒。归心、肺、胃经。养阴生津,润肺清心。用于肺燥干咳。虚痨 咳嗽,津伤口渴,心烦失眠,内热消渴,肠燥便秘;咽白喉。
[0012] 野料豆,别名零乌豆、马料豆(《本草汇言》),细黑豆、稽豆、料豆(《本经逢原》), 马豆(《本草经解》),甘,凉。补益肝肾,祛风解毒。治阴亏目昏,肾虚腰痛,盗汗,筋骨疼痛, 产后风痉,小儿疳疾。
[0013] 黄连,苦,寒。入心、肝、胃、大肠经。泻火,燥湿,解毒,杀虫。治时行热毒,伤寒,热 盛心烦,痞满呕逆,菌痢,热泻腹痛,肺结按,吐、衄、下血,消渴,疳积,蛔虫病,百日咳,咽喉 肿痛,火眼,口疮,痈疽疮毒,湿瘆,汤火烫伤。
[0014] 桑叶,甘、苦,寒。归肺、肝经。疏散风热,清肺润燥,清肝明目。用于风热感冒,肺 热燥咳,头晕头痛,目赤昏花。
[0015] 川考,辛,温。归肝、胆、心包经。活血行气,祛风止痛。用于月经不调,经闭痛经, 癥瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
[0016] 制首乌,苦、甘、湿,温。归肝、心、肾经。补肝肾,益精血,乌须发,强筋骨。用于血 虚萎黄,眩晕耳鸣,须发早白,腰膝酸软,肢体麻木,崩漏带下,久疟体虚;高血脂。
[0017] 本发明药物组合物在中药组分选择上以益气养阴、生津止渴、敛阴止汗为主要标 准,方中,黄苗、浮小麦益气固表止汗;熟地黄、懦稻根养阴止汗;五味子、麦冬生津止渴;野 料豆、黄连、桑叶清热养阴,川芎、制首乌活血益气。诸药合用有益气养阴、生津止渴、敛阴止 汗之效,对小儿先天享斌不足或后天气阴两虚症均起到了根本治疗。
[0018] 为了更好的解决技术问题,本发明对上述诸味中药的重量份数进行了优选,优选 的条件是中药配伍使用后药物对自汗、盗汗治疗效果的增强。优选的是,本发明药物组合物 由以下重量份的原料制得:黄芪10-30份,浮小麦10-30份,熟地黄10-20份,糯稻根10-20 份,五味子8-16份,麦冬8-16份,野料豆8-16份,黄连6-10份,桑叶6-10份,川;5-8份, 制首乌5-8份。
[0019] 作为本发明的最优选实施例,本发明药物组合物由以下重量份的原料制得:黄芪 20份,浮小麦20份,熟地黄15份,糯稻根15份,五味子12份,麦冬12份,野料豆12份,黄 连8份,桑叶8份,川芎7份,制首乌6份。
[0020] 本发明还提供了一种上述所述药物组合物的制备方法,其主要包含下述步骤:按 处方量称取黄芪、浮小麦、熟地黄、糯稻根、五味子、麦冬、野料豆、黄连、桑叶、川芎、制首乌, 加药材总重量3倍量的冷水浸泡30min后,先用武火煎煮20min,再用文火煎煮20min,纱布 过滤除渣取汁;将过滤后的药渣加水1. 5倍量,武火煎煮lOmin,再用文火煎煮15min,纱布 过滤除渣取汁,合并两次滤液,即可。
[0021] 本领域技术人员可以在制得的本发明药物活性成份基础上直接入药服用或加入 药剂学上可接受的辅料按常规工艺制备成所需制剂。如可以制成常用的片剂(分散片、泡 腾片、口腔崩解片、含片、咀嚼片、泡腾片)、胶囊剂(硬胶囊、软胶囊剂)、颗粒剂、丸剂(滴 丸剂)、散剂等固体制剂形式的口服药物,也可以制成糖衆、口服液、水剂、合剂、汤剂等液体 制剂形式的口服药物。因此,该药物组合物中除有效成分外,还可以含有药学上可以接受的 辅料。例如崩解剂、润滑剂等,按照常规制剂方法制备得到临床上常用中药药物剂型。优 选地,本领域技术人员可以在此基础上加入辅料用常规制剂工艺制得成丸剂、口服液、颗粒 剂、胶囊、散剂等常用的口服制剂。本发明所制备的散剂,每袋含生药量6. 00g,1次0. 5-1 袋,一日2次,饭后半小时口服。
[0022] 本发明药物组合物为天然纯中药制剂,服用后副作用显著降低,且本发明药物组 合物作用全面,全方标本兼顾,祛邪而不伤正,充分发挥了益气养阴、生津止渴、敛阴止汗的 药效,有利于治愈自汗、盗汗病情。临床观察结果表明,本发明药物组合物对气阴两虚型自 汗、盗汗患者疗效显著,2个疗程后可明显改善出汗等临床症状,疗效好,且治疗组的治愈率 及治疗总有效率均明显高于对照组,P〈〇. 05,具有统计学意义,治疗过程中,两组均未出现 严重的不良反应,无明显毒副作用,安全可靠。同时本发明药物组合物制备工艺简单易操 作,制备成常用剂型可显著提高自汗、盗汗患者的用药依从性及生活质量,是一种可以广泛 推广用于治疗自汗、盗汗的有效药物。
具体实施方式
[0023] 以下通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发 明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替 换,对于本领域的技术人员来说是显而易见的,且包含在本发明的范围之内。
[0024] 实施例1
[0025] 按以下重量份称取本发明各原料:黄芪20份,浮小麦20份,熟地黄15份,糯稻根 15份,五味子12份,麦冬12份,野料豆12份,黄连8份,桑叶8份,川芎7份,制首乌6份。
[0026] 制备工艺:按处方量称取黄芪、浮小麦、熟地黄、糯稻根、五味子、麦冬、野料豆、黄 连、桑叶、川芎、制首乌,加药材总重量3倍量的冷水浸泡30min后,先用武火煎煮20min,再 用文火煎煮20min,纱布过滤除渣取汁;将过滤后的药渣加水1. 5倍量,武火煎煮lOmin,再 用文火煎煮15min,纱布过滤除渣取汁,合并两次滤液,即可。本领域技术人员可以在制得的 本发明药物活性成份基础上直接入药服用或加入药剂学上可接受的辅料按常规工艺制备 成丸剂、口服液、颗粒剂、胶囊、散剂等常用的口服制剂。本发明所制备的散剂,每袋含生药 量6. 00g,l次0. 5-1袋,一日2次,饭后半小时口服。
[0027] 实施例2
[0028] 按以下重量份称取本发明各原料:黄芪30份,浮小麦10份,熟地黄20份,糯稻根 10份,五味子16份,麦冬8份,野料豆16份,黄连6份,桑叶10份,川芎5份,制首乌8份。
[0029] 实施例3
[0030] 按以下重量份称取本发明各原料:黄芪10份,浮小麦10份,熟地黄10份,糯稻根 10份,五味子8份,麦冬8份,野料豆8份,黄连6份,桑叶6份,川芎5份,制首乌5份。
[0031] 实施例4
[0032] 按以下重量份称取本发明各原料:黄芪30份,浮小麦30份,熟地黄20份,糯稻根 20份,五味子16份,麦冬16份,野料豆16份,黄连10份,桑叶10份,川芎8份,制首乌8 份。
[0033] 实施例5
[0034] 按以下重量份称取本发明各原料:黄芪10份,浮小麦30份,熟地黄10份,糯稻根 20份,五味子8份,麦冬16份,野料豆8份,黄连10份,桑叶6份,川芎8份,制首乌5份。
[0035] 实施例2-5的制备工艺同实施例1。
[0036] 实施例6本发明药物组合物对自汗、盗汗的临床观察
[0037] 1、病例资料:
[0038] 本次研宄对象所选的82例患者来自医院住院患者及门诊确诊为气阴两虚证自 汗、盗汗患者,选取的病例均符合中医气阴两虚证自汗、盗汗患者的表现。将82例患者按随 机数字表法分为治疗组和对照组,每组各41例。其中治疗组男性患儿23例,女性患儿18 例,年龄为1-6岁,平均病史为(5. 33±2. 25)个月;对照组男性患儿22例,女性患儿19例, 年龄为1-6岁,平均病史为(5. 43±2. 35)个月。比较两组患儿的一般临床资料无明显差异, P > 0. 05无统计学意义,可研宄分析。
[0039] 2、诊断依据:
[0040] 1)诊断标准:
[0041] 中华人民共和国中医药行业标准《中医病证诊断疗效标准》中自汗、盗汗的诊断标 准如下:
[0042] (1)不因外界环境影响,在头面、颈胸、或四肢全身出汗者;
[0043] (2)昼日汗出溱溱,动则益甚为自汗;睡眠中汗出津津,醒后汗止者为盗汗;
[0044] (3)必要时作X线胸部摄片,痰涂片找抗酸杆菌以及作抗"0"、血沉、粘蛋白、T3、T4 基础代谢等检查以排除肺痨、风湿痹、甲亢等。
[0045] 2)纳入标准:
[0046] (1)符合诊断标准者;
[0047] (2)符合气阴两虚证的中医辨证标准,即自汗、盗汗,畏寒,劳累后加重,神倦乏力, 咽干口渴。舌红,苔薄白,脉细数。
[0048] 3)排除标准:
[0049] (1)其他证型患者;
[0050] (2)器质性病变而引发的多汗症状;
[0051] (3)合并有严重的其他系统疾病;如心、肾、血液及代谢等系统的严重原发性疾 病;
[0052] (4)精神病患者及不合作者;
[0053] (5)拒绝参加本研宄。
[0054] 4)剔除和脱落标准:
[0055] (1)治疗期间出现对本药物过敏者;
[0056] (2)未按规定用药,无法判断疗效,或资料不全等影响疗效或安全性判断者。
[0057] 3、用法用量:
[0058] 治疗组取实施例1制备的散剂,每袋含生药量6. 00g,1次0. 5-1袋,一日2次,饭 后半小时口服。
[0059] 对照组给予龙牡壮骨颗粒剂,开水冲服,2岁以下每次5g,2〜7岁每次7g,7岁以 上IOg/次,3次/日。
[0060] 以上两组均以7天为1个疗程,2个疗程后评价疗效。
[0061] 4、疗效评定:
[0062] 1)治愈:汗止,其他症状消失,随访1个月无复发。
[0063] 2)好转:汗出明显减少,其他症状改善。
[0064] 3)未愈:出汗及其他症状均无变化。
[0065] 总有效率=(临床治愈例数+好转例数)/本组总例数X 100%。
[0066] 5、治疗效果:该临床观察病例82人中,无脱落病例,治疗结束后,未发现副作用。。 两组的治疗结果见表1。
[0067] 表1.两组治疗结果对比
[0068]
Figure CN104435837AD00071
[0069] 本发明药物组合物充分发挥了益气养阴、生津止渴、敛阴止汗的药效,本发明药物 组合物全方标本兼顾,有利于治愈自汗、盗汗病情。临床观察结果表明,本发明药物组合物 对气阴两虚型自汗、盗汗患者疗效显著,2个疗程后可明显改善出汗等临床症状,疗效好, 且治疗组的治愈率及治疗总有效率均明显高于对照组,P〈〇. 05,具有统计学意义,治疗过程 中,患儿易接受,无毒副作用。所以本发明药物组合物是一种可以广泛推广用于治疗自汗、 盗汗的有效药物,值得临床推广应用。

Claims (7)

1. 一种治疗自汗、盗汗的药物组合物,其特征在于,它主要由以下原料制得:黄芪,浮 小麦,熟地黄,糯稻根,五味子,麦冬,野料豆,黄连,桑叶,川芎,制首乌。
2. 如权利要求1所述的药物组合物,其特征在于,它主要由以下重量份的原料制得:黄 芪10-30份,浮小麦10-30份,熟地黄10-20份,糯稻根10-20份,五味子8-16份,麦冬8-16 份,野料豆8-16份,黄连6-10份,桑叶6-10份,川芎5-8份,制首乌5-8份。
3. 如权利要求1所述的药物组合物,其特征在于,它主要由以下重量份的原料制得:黄 芪20份,浮小麦20份,熟地黄15份,糯稻根15份,五味子12份,麦冬12份,野料豆12份, 黄连8份,桑叶8份,川芎7份,制首乌6份。
4. 如权利要求1-3任一所述的药物组合物,其特征在于,它是口服制剂。
5. 如权利要求4所述的药物组合物,其特征在于,所述口服制剂是丸剂、颗粒剂、散剂、 水剂或胶囊剂。
6. -种制备如权利要求4所述的药物组合物的方法,其特征在于,它包括以下步骤:按 处方量称取黄芪、浮小麦、熟地黄、糯稻根、五味子、麦冬、野料豆、黄连、桑叶、川芎、制首乌, 加药材总重量3倍量的冷水浸泡30min后,先用武火煎煮20min,再用文火煎煮20min,纱布 过滤除渣取汁;将过滤后的药渣加水1. 5倍量,武火煎煮lOmin,再用文火煎煮15min,纱布 过滤除渣取汁,合并两次滤液,即可;本领域技术人员可以在制得的本发明药物活性成份基 础上直接入药服用或加入药剂学上可接受的辅料按常规工艺制备成所需制剂。
7. 如权利要求1-3任一所述的药物组合物在制备治疗气阴两虚症自汗、盗汗药物中的 用途。
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