CN106798785A - 一种治疗哮喘的药剂配方、制备方法及其鉴别方法 - Google Patents

一种治疗哮喘的药剂配方、制备方法及其鉴别方法 Download PDF

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CN106798785A
CN106798785A CN201710156929.7A CN201710156929A CN106798785A CN 106798785 A CN106798785 A CN 106798785A CN 201710156929 A CN201710156929 A CN 201710156929A CN 106798785 A CN106798785 A CN 106798785A
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李洋
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Abstract

本发明涉及药物配方领域。其目的是为了提供一种成本低廉、无毒副作用的治疗哮喘的药剂配方。本发明以重量百分比计算,每份药剂配方中紫苑50g、莱菔子45g、五味子45g、麻黄30g、前胡45g、党参100g、黄芪280g、附子30g、紫苏子45g、枸杞子45g、钩藤45g、远志50g、苦参80g、黄芩50g。本发明成本低廉,无毒副作用,针对外源性支气管哮喘和内源性支气管哮喘具有良好的疗效。

Description

一种治疗哮喘的药剂配方、制备方法及其鉴别方法
技术领域
本发明涉及一种中成药制剂,特别是涉及一种治疗哮喘的药剂配方、制备方法及其鉴别方法。
背景技术
在现阶段的医疗领域中,支气管哮喘主要包括三种类型:
第一种为过敏因素导致的哮喘(外源性哮喘):有过敏性体质的患者在吸入过敏性抗原微粒或者发生感染时,均可引起发病。致敏原主要是吸入花粉、屋尘、螨、动物毛屑、工业粉尘或者真菌孢子;进食鱼、蟹、虾或者接触工业染料等,亦可导致过敏。免疫学的研究表明吸入的过敏抗原,可产生多量的特异性抗体IgE(免疫球蛋白E),附着在支气管粘膜的肥大细胞及血液嗜碱粒细胞上。若患者再次接触同一抗原,抗原即与附着在肥大细胞表面的IgE结合,发生过敏反应,释放出多种生物活性物质(如组织胺、5-羟色胺、慢反应素和/或缓激肽等),使支气管粘膜充血、水肿,平滑肌痉挛与腺体分泌增加,细支气管管腔狭窄,肺通气不畅而发困难,导致哮喘发作。
第二种为感染因素导致的哮喘(内源性哮喘):由病毒或者细菌,尤其是病毒性呼吸道感染,逐渐形成和激发哮喘极为常见。致敏原来自体内,为细菌或者病毒的代谢产物,故与鼻、咽、扁桃体、肺或者其他感染病灶未及时清除有密切关系。但目前由感染而激发或者形成哮喘的机理尚不十分清楚。本病除接触过敏原、呼吸道感染等诱发因素外,每常与气候骤变以及精神因素有关。精神因素的性质和作用途径是复杂的,可能是大脑皮质作用于丘脑,使丘脑功能改变而导致迷走神经的过渡兴奋,分泌乙酰胆碱,从而增加了支气管平滑肌的张力。
第三种为遗传因素导致的哮喘:哮喘患者常有家族性和遗传性。
发明内容
本发明要解决的技术问题是提供一种成本低廉、效果显著的治疗哮喘的药剂配方、制备方法及其鉴别方法。
本发明一种治疗哮喘的药剂配方,包括紫苑4.8%~5.8%、莱菔子4.3%~5.3%、五味子4.3%~5.3%、麻黄2.7%~3.7%、前胡4.3%~5.3%、党参10.1%~11.1%、黄芪29.3%~30.3%、附子2.7%~3.7%、紫苏子4.3%~5.3%、枸杞子4.3%~5.3%、钩藤4.3%~5.3%、远志5%~5.6%、苦参8%~9%、黄芩5%~5.6%。
本发明一种治疗哮喘的药剂配方,其中所述紫苑5.3%、莱菔子4.8%、五味子4.8%、麻黄3.2%、前胡4.8%、党参10.6%、黄芪29.8%、附子3.2%、紫苏子4.8%、枸杞子4.8%、钩藤4.8%、远志5.3%、苦参8.5%、黄芩5.3%。
本发明一种治疗哮喘的药剂的制备方法,其中,所述取20%的黄芪粉碎成细粉状备用,将剩余的黄芪与另外十三味中药加水煎煮三次,每次2小时,合并煎液,过滤后滤液浓缩至相对密度至1.25~1.30,加乙醇使含醇量达到65~70%,静置,取上清液回收乙醇至相对密度1.20~1.22,加入备用的黄芪,混匀制成颗粒,干燥后均匀压制成片剂。
本发明一种治疗哮喘的药剂的制备方法,其中所述静置时间为8小时。
本发明一种治疗哮喘的药剂的鉴别方法,其中,包括如下步骤,
步骤S1:取药剂10片,去除薄膜衣后研细,加入甲醇30ml,超声处理30min后进行过滤,滤液蒸干后将剩余残渣加入甲醇2ml使其溶解,作为供试品溶液;
步骤S2:取黄芩苷作为对照品,加甲醇制成每1ml含0.5mg的溶液,作为对照品溶液;
步骤S3:照薄层色谱法试验,吸取步骤S1和步骤S2中制得的两种溶液各1μl,分别点于同一聚酰胺薄膜上,采用醋酸作为展开剂进行展开,取出并晾干,喷以2%三氯化铁乙醇溶液;
步骤S4:供试品在色谱中,与对照品色谱相应的位置上显示相同颜色的斑点。
7、本发明一种治疗哮喘的药剂的鉴别方法,其中,包括如下步骤,
步骤C1:取药剂20片,去除薄膜衣后研细,加入饱和的正丁醇20ml,超声处理15min后进行过滤,滤液用氨试液洗涤3次,每次20ml,去除洗涤液,正丁醇液蒸干后将剩余残渣加入甲醇1ml使其溶解,作为供试品溶液;
步骤C2:取黄芪苷作为对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液;
步骤C3:照薄层色谱法试验,吸取步骤S1和步骤S2中制得的两种溶液各2~4μl,分别点于同一硅胶薄膜板上,采用氯仿-甲醇-水10℃以下放置的下层溶液作为展开剂进行展开,取出并晾干,喷以10%硫酸乙醇溶液,在105℃加热至斑点显色清晰;
步骤C4:供试品在色谱中,与对照品色谱相应的位置上显示相同颜色的斑点。
本发明一种治疗哮喘的药剂的鉴别方法,其中所述氯仿-甲醇-水的质量比为13:7:2。
本发明一种治疗哮喘的药剂配方、制备方法及其鉴别方法与现有技术不同之处在于:本发明成本低廉、无毒副作用,能够有效的治疗外源性支气管哮喘以及内源性支气管哮喘,尤其对哮喘患者在哮喘病缓解期有良好疗效。
具体实施方式
本发明一种治疗哮喘的药剂配方,包括紫苑、莱菔子、五味子、麻黄、前胡、党参、黄芪、附子、紫苏子、枸杞子、钩藤、远志、苦参和黄芩。以重量百分比计算,每份药剂配方中紫苑50g、莱菔子45g、五味子45g、麻黄30g、前胡45g、党参100g、黄芪280g、附子30g、紫苏子45g、枸杞子45g、钩藤45g、远志50g、苦参80g、黄芩50g。以上十四味中药,取黄芪180g,粉碎成细粉状(80目)备用。将剩余100g黄芪与另外十三味中药加水煎煮三次,每次2小时,合并煎液,过滤后滤液浓缩至相对密度至1.25~1.30(80℃),加乙醇使含醇量达到65~70%,静置8小时,取上清液回收乙醇至相对密度1.20~1.22(60~70℃),加入备用的180g黄芪,混匀制成颗粒,干燥后均匀压制成1000片,包薄膜衣即制得治疗哮喘的片剂,每片药剂的重量为0.25g。
服用方法为:成人缓解期一次1片,一日2次;儿童1~3岁,一次1/4~1/3片,一日2次;儿童4~6岁,一次1/3~1/2片,一日2次;儿童7~9岁,一次1/2~3/4片,一日2次;儿童10~13岁,一次3/4~1片,一日2次;14岁以上同成人量。
本发明中紫苑祛痰止咳,抑制细菌生长,同时具有一定的抗癌作用;莱菔子入脾、胃、肺经,能消食除胀,功效显著,可用于治疗饮食停滞、脘腹胀痛、大便秘结、积滞泻痢、痰壅喘咳等;五味子通常用于神经系统疾病和心血管疾病的治疗,因五味子能增强中枢神经系统的兴奋与抑制过程,并使之趋向平衡,从而提高机体活动机能,减轻和解除疲劳,提高生活质量和工作效率,五味子有兴奋呼吸作用,改善肺功能,并有明显的止咳祛痰作用,五味子还能调节胃液分泌,有保护肝脏的作用;麻黄发汗解表和利水消肿力强,多用于风寒表实证,胸闷喘咳,风湿痹痛,麻黄性温偏润,辛散发汗作用缓和,增强了润肺止咳的功效,多用于表症已解,气喘咳嗽,作用缓和,适用于老人、幼儿及虚人风寒感冒患者;前胡具有入肺、生津功效,用于气虚阴亏、内热、咳喘痰血、虚热烦倦、消渴、口燥咽干,主要用益肺阴,清虚火,生津止渴,具有强壮、抗疲劳的作用清虚热、健胃生津、补气益血、抗缺氧、增强机体抗病能力及促进蛋白质合成等功效;党参具有强壮身体,可以提高人的身体精力,适用过度劳累,抗溃疡,调神剂对溃疡性结肠炎,慢性萎缩性胃炎,慢性腹泻,胃窦炎等都具有一些效果,而且正气足,治虚脱,不伤寒,除此之外党参还具有益智、镇静作用、抗疲劳及抗氧化、升血糖等功效和作用,党参多糖能够提高抗体滴度,增强免疫力。在日常生活中,党参用于改善脾肺虚弱、气短心悸、虚喘咳嗽、内热消渴等症状;黄芪用于补气固表,利尿托毒,排脓,敛疮生肌,气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿黄芪圆片,痈疽难溃,久溃不敛,血虚痿黄,内热消渴,黄芪具有增强免疫力功能,能够增强机体耐缺氧及应激能力,促进机体代谢,调节血糖抗菌及抑制病毒作用;附子用于阴盛克阳,大汗亡阳,吐泻厥逆,肢冷脉微,心腹冷痛,冷痢,脚气水肿,风寒湿痹,宫冷,虚寒吐泻,阴寒水肿,阳虚外感,阴疽疮疡以及沉寒痼冷等症状;紫苏子归肺经,降气消痰,平喘,润肠,用于痰壅气逆,咳嗽气喘,肠燥便秘,解表散寒,行气和胃,咳嗽气喘等症;枸杞子具有滋补肝肾,益精明目的功效,用于虚劳精亏、腰膝酸痛、眩晕耳鸣、内热消渴、血虚萎黄、目昏不明,抗脂肪肝的作用,可调节机体免疫功能、能有效抑制肿瘤生长和细胞突变、具有延缓衰老、抗脂肪肝、调节血脂和血糖、促进造血功能等方面的作用;钩藤具有清热、平肝、息风、定惊等功能,主治头晕、高血压及小儿惊风等病症;远志主治咳逆伤中,能补不足,除邪气,利九窍,使耳目聪明,不忘,强志倍力的功效,能治健忘,安魂魄,使人不迷,坚壮阳道。苦参清热燥湿,用于皮肤瘙痒等症;黄芩具有清热燥湿,泻火解毒,止血,安胎,降血压的功效,主要用于湿温、暑温胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安等症状。十四味中草药巧妙组方,科学配伍,药物相互协调作用,起到治疗哮喘的神奇效果。
本发明一种治疗哮喘的药剂鉴别方法,包括两种不同的鉴别方法,
第一种鉴别方法,包括以下步骤:
步骤S1:取药剂10片,去除薄膜衣后研细,加入甲醇30ml,超声处理30min后进行过滤,滤液蒸干后将剩余残渣加入甲醇2ml使其溶解,作为供试品溶液;
步骤S2:取黄芩苷作为对照品,加甲醇制成每1ml含0.5mg的溶液,作为对照品溶液;
步骤S3:照薄层色谱法(中国药典2005年版一部附录VI B)试验,吸取步骤S1和步骤S2中制得的两种溶液各1μl,分别点于同一聚酰胺薄膜上,采用醋酸作为展开剂进行展开,取出并晾干,喷以2%三氯化铁乙醇溶液;
步骤S4:供试品在色谱中,与对照品色谱相应的位置上显示相同颜色的斑点,则鉴别的药剂为本发明的治疗哮喘的药剂。
第二种鉴别方法,包括以下步骤:
步骤C1:取药剂20片,去除薄膜衣后研细,加入饱和的正丁醇20ml,超声处理15min后进行过滤,滤液用氨试液洗涤3次,每次20ml,去除洗涤液,正丁醇液蒸干后将剩余残渣加入甲醇1ml使其溶解,作为供试品溶液;
步骤C2:取黄芪苷作为对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液;
步骤C3:照薄层色谱法(中国药典2005年版一部附录VI B)试验,吸取步骤S1和步骤S2中制得的两种溶液各2~4μl,分别点于同一硅胶薄膜板上,采用氯仿-甲醇-水(13:7:2)10℃以下放置的下层溶液作为展开剂进行展开,取出并晾干,喷以10%硫酸乙醇溶液,在105℃加热至斑点显色清晰;
步骤C4:供试品在色谱中,与对照品色谱相应的位置上显示相同颜色的斑点,则鉴别的药剂为本发明的治疗哮喘的药剂。
下面结合具体的临床试验对本发明作进一步详细的描述:
1、病例选择:共选择100例,平均年龄16~45岁,其中男性62例、女性38例,外源性支气管哮喘60例,内源性支气管哮喘40例。
2、诊断标准:呼吸急促,喉中有哮呜声,喘憋气逆,胸膈满闷如塞,咳不甚,痰稀薄色白而有泡沫,面色晦滞带青,口不渴或者渴喜热饮,初起多兼恶寒发热,无汗头痛等表症,舌苔白滑,脉弦紧或浮紧。
3、治疗方法:成人缓解期一次1片,一日2次;儿童1~3岁,一次1/4~1/3片,一日2次;儿童4~6岁,一次1/3~1/2片,一日2次;儿童7~9岁,一次1/2~3/4片,一日2次;儿童10~13岁,一次3/4~1片,一日2次;14岁以上同成人量。
4、疗效评价标准:
临床治愈:不需任何药物,保持无症状在1年以上者。
显效:偶用支气管舒张药物而缓解喘息者。
有效:喘息症状有所减轻,但时常需药物治疗者。
无效:症状依然如故。
治疗效果:显效42例、有效50例、无效8例,总有效率为92%。
以上所述的实施例仅仅是对本发明的优选实施方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案作出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。

Claims (7)

1.一种治疗哮喘的药剂配方,其特征在于:包括紫苑4.8%~5.8%、莱菔子4.3%~5.3%、五味子4.3%~5.3%、麻黄2.7%~3.7%、前胡4.3%~5.3%、党参10.1%~11.1%、黄芪29.3%~30.3%、附子2.7%~3.7%、紫苏子4.3%~5.3%、枸杞子4.3%~5.3%、钩藤4.3%~5.3%、远志5%~5.6%、苦参8%~9%、黄芩5%~5.6%。
2.根据权利要求1所述的一种治疗哮喘的药剂配方,其特征在于:所述紫苑5.3%、莱菔子4.8%、五味子4.8%、麻黄3.2%、前胡4.8%、党参10.6%、黄芪29.8%、附子3.2%、紫苏子4.8%、枸杞子4.8%、钩藤4.8%、远志5.3%、苦参8.5%、黄芩5.3%。
3.权利要求1中一种治疗哮喘的药剂的制备方法,其特征在于:取20%的黄芪粉碎成细粉状备用,将剩余的黄芪与另外十三味中药加水煎煮三次,每次2小时,合并煎液,过滤后滤液浓缩至相对密度至1.25~1.30,加乙醇使含醇量达到65~70%,静置,取上清液回收乙醇至相对密度1.20~1.22,加入备用的黄芪,混匀制成颗粒,干燥后均匀压制成片剂。
4.根据权利要求3所述的一种治疗哮喘的药剂的制备方法,其特征在于:所述静置时间为8小时。
5.权利要求1中一种治疗哮喘的药剂的鉴别方法,其特征在于:包括如下步骤,
步骤S1:取药剂10片,去除薄膜衣后研细,加入甲醇30ml,超声处理30min后进行过滤,滤液蒸干后将剩余残渣加入甲醇2ml使其溶解,作为供试品溶液;
步骤S2:取黄芩苷作为对照品,加甲醇制成每1ml含0.5mg的溶液,作为对照品溶液;
步骤S3:照薄层色谱法试验,吸取步骤S1和步骤S2中制得的两种溶液各1μl,分别点于同一聚酰胺薄膜上,采用醋酸作为展开剂进行展开,取出并晾干,喷以2%三氯化铁乙醇溶液;
步骤S4:供试品在色谱中,与对照品色谱相应的位置上显示相同颜色的斑点。
6.权利要求1中一种治疗哮喘的药剂的鉴别方法,其特征在于:包括如下步骤,
步骤C1:取药剂20片,去除薄膜衣后研细,加入饱和的正丁醇20ml,超声处理15min后进行过滤,滤液用氨试液洗涤3次,每次20ml,去除洗涤液,正丁醇液蒸干后将剩余残渣加入甲醇1ml使其溶解,作为供试品溶液;
步骤C2:取黄芪苷作为对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液;
步骤C3:照薄层色谱法试验,吸取步骤S1和步骤S2中制得的两种溶液各2~4μl,分别点于同一硅胶薄膜板上,采用氯仿-甲醇-水10℃以下放置的下层溶液作为展开剂进行展开,取出并晾干,喷以10%硫酸乙醇溶液,在105℃加热至斑点显色清晰;
步骤C4:供试品在色谱中,与对照品色谱相应的位置上显示相同颜色的斑点。
7.根据权利要求6所述的一种治疗哮喘的药剂的鉴别方法,其特征在于:所述氯仿-甲醇-水的质量比为13:7:2。
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