CN103417827A - 一种治疗慢性支气管炎的口服中药及其制备方法 - Google Patents
一种治疗慢性支气管炎的口服中药及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性支气管炎的口服中药及其制备方法,该中药制剂由原料药君迁子、太白茶、南沙参、女贞子、竹黄、石韦、麦冬、炒葶苈子、补骨脂、梅花、椒目制成,该中药制备工艺科学,操作简单,生产周期短,安全无污染,实验证明,本发明制剂具有显著的抑制炎症肿胀作用,且使用其治疗慢性支气管炎后咳嗽消失,未见复发。
Description
技术领域
本发明涉及一种治疗慢性支气管炎的口服中药的制备方法,属于生物制药技术领域。
背景技术
慢性支气管炎(chronic bronchitis)的特点是病程长、治疗难、痛苦多、反复发作,他是由于感染或非感染因素引起气管、支气管粘膜及其周围组织的慢性非特异性炎症。其病理特点是支气管腺体增生、粘液分泌增多。主要临床表现为咳嗽,咳痰。气喘及反复呼吸道感染,可并发严重的并发症。(1)咳嗽 长期、反复而逐渐加重的咳嗽是本病的突出表现。(2)咳痰 一般痰呈白色粘液泡沫状。在感染或受寒后症状迅速加剧、痰量增多,粘度增加,或呈黄色脓性痰或伴有喘息。(3)气喘 当合并呼吸道感染时,由于细支气管粘膜充血水肿,痰液阻塞及支气管管腔狭窄,可以产生气喘(喘息)症状。(4)反复感染 发生反复的呼吸道感染,病人气喘加重,痰量明显增多且呈脓性,伴有全省乏力,胃寒、发热等。(5)并发症 病程迁延可并发阻塞性肺气肿、肺源性心脏病,严重影响劳动和健康。
慢性支气管炎的病因尚未完全清楚,一般将病因分为外因和内因两个方面。外因包括:(1)吸烟 香烟中含焦油、尼古丁等化学物质,可损伤气道上皮细胞,使纤毛运动减退和巨噬细胞吞噬功能降低,导致气道净化功能下降。(2)感染 感染是慢性支气管炎发生发展的重要因素,主要有病毒、细菌、支原体等感染。(3)理化 如烟雾、粉尘、有害气体对气道黏膜上皮均有刺激和细胞毒作用。(4)气候 寒冷常为慢性支气管炎发作的重要原因。(5)过敏 喘息型慢性支气管炎患者多有过敏史,痰液中嗜酸性粒细胞数量和组胺含量和血中IgE具有增多的趋向。
内因包括:(1)自身免疫功能低下 年老体衰、慢性感染灶、营养缺乏、遗传因素等导致呼吸道局部防御降低。(2)植物神经功能失调 导致支气管平滑肌收缩、毛细血管通透性增加等。综合上述病因,当机体抵抗力减弱时,病人支气管存在不同程度易感性,在一种或多种外因刺激下,长期反复作用,逐渐发展为慢性支气管炎。
西医治疗慢性支气管炎以对症治疗为主,急性发作期和慢性迁延期治疗有:(1)控制感染给予青霉素类、头孢类、大环内酯类或者喹诺酮类抗生素。(2)祛痰止咳 使用盐酸氨溴索、氯化铵、棕色合剂等。(3)解痉平喘 选用氨茶碱、β2受体激动剂等药物治疗。(4)气化疗法 溴化异丙托品等雾化吸入。
缓解期的治疗包括:(1)增强体质 可使用核酪、转移因子等,以减少感冒及反复发作。(2)注射疫苗 采用气管炎菌苗、核酪注射液、卡介苗素注射液或必思添治疗。(3)其他 戒烟、避免烟雾、加强体育锻炼。
由于病因复杂,慢性支气管炎的发生发展与呼吸道感染、理化因素、过敏因素、气候因素、植物神经功能失调、呼吸道防御功能及免疫功能低下等诸多因素有关,加之长期应用抗生素,造成体内菌群失调,免疫功能更为低下,易导致慢性支气管炎患者的病情反复发作,并可能发生复杂性并发症。因而单用西药治疗本病,复发率高且副作用多。
慢性支气管炎属于中医学“咳嗽”、“痰饮”、“咳喘”、 “肺胀”的范畴,其病机是本虚标实,本病的发生发展与外邪反复侵袭,肺脾肾三脏功能失调密切相关。肺气虚弱,卫外不固,外邪入侵,日久不愈。具体而言,初期大多数由于外邪犯肺,肺失肃降而引起咳嗽。而饮食不当、嗜食烟酒、辛辣肥甘之品,亦可使肺气上逆而作咳。外感咳嗽如迁徙失治,邪伤肺气,更易反复感邪,而致咳嗽屡作,转为内伤咳嗽。久咳伤肺,肺气亏虚,进而损及脾肾。脾虚不能运化水湿,则积液为痰,上渍于肺。因痰而咳,痰浊壅肺而喘。痰既是病理产物,又是致病因素。痰饮内聚,脾失健运,水湿留滞,上渍于肺,留滞肺络,阻塞气道。肺有停痰宿饮,易受外邪诱发,致使咳喘反复不愈。“肺为气之主,肾为气之根”,肺病日久必累及肾,肾气不能摄纳,以致肺气不能归根于肾,故气短而喘,动则尤甚。随着年龄的增长,病情日趋严重。所谓“肺不伤不咳,肾不伤不喘”、“五脏六腑,皆令人咳,非独肺也”。
中医对于慢性支气管炎的治疗,多用“扶正培本”的思想为指导,以肺脾肾虚损为本,痰阻气逆血瘀为标,标本兼治。治以健脾益气补肾、止咳化痰平喘,佐以袪瘀。在发作期,治疗以攻邪为主,泄逐邪、泻肺降气、祛痰止咳、宣肺平喘。在缓解期则以扶正为主,固元正气、补益脾肾来提高身体的抵抗力,防止病情反复发作。
选用具有补益脾肾、扶正补虚、疏风化痰、宣肺止咳等功效的中药材进行合理组方,配制成内服的中药制剂,通过胃肠道吸收后发挥全身作用。诸药合用,以宣肺涤痰、止咳平喘为主,佐以健脾益气、补肾养阴治其本,标本兼治,具有抗炎、化痰、止咳、平喘、提高免疫力的作用。从而治疗慢性支气管炎的咳嗽、多痰、气喘的症状,并减少呼吸道的反复感染。
发明内容
本发明的目的在于提供一种治疗慢性支气管炎的口服中药,该中药治疗患者咳嗽、多痰、气喘的症状,并减少呼吸道的反复感染。
该治疗慢性支气管炎的口服中药由以下质量百分比的原料药制成:
君迁子 15-50%
太白茶 10-40%
南沙参 5-20%
女贞子 5-20%
竹黄 5-20%
石韦 5-20%
麦冬 5-20%
炒葶苈子 2-10%
补骨脂 2-10%
梅花 1-5%
椒目 1-5%
所述治疗慢性支气管炎的口服中药,优选下列质量百分比的原料组合,疗效更佳:
君迁子 25%
太白茶 20%
南沙参 8%
女贞子 8%
竹黄 8%
石韦 8%
麦冬 8%
炒葶苈子 5%
补骨脂 5%
梅花 3%
椒目 2%
其中,君迁子为柿科植物君迁子Diospyros lotus Linn的果实,别名:黑枣、软枣、牛奶枣、野柿子、小柿、塔枝枝等。味甘、涩,性凉;功效:清热、止渴、去烦热、镇心、令人肤色润泽。归属清热止咳药。
太白茶为地茶科地茶属植物雪地茶Thamnolia vermicularis(Ach.)Asahina的地衣体。别名雪茶、地茶、蛔样地衣;味甘、微苦、微辛,性凉;功能:清热解渴、醒脑安神。用于虚劳骨蒸、肺炎咳嗽、癫痫狂躁、神经衰弱、高血压。
南沙参为桔梗科沙参属植物轮叶沙参Adenophora tetraphylla (Thunb. Fisch.)、杏叶沙参 A. stricta Miq.或其同属植物的干燥根。别名泡参、泡沙参;味甘、苦,性凉。归肺、胃经。功能:养阴清肺、益胃生津、补气化痰。主治阴虚发热、肺燥干咳、肺痿痨嗽、痰中带血、喉痹咽痛、津伤口渴。
女贞子为木犀科植物女贞Ligustrum lucidum Ait.的干燥成熟果实,味甘、苦,性凉。归肝、肾经。功效:补益肝肾、乌须明目;主治:头昏目眩、腰膝酸软、遗精、耳鸣、须发早白、骨蒸潮热。
竹黄为肉座菌科竹黄属真菌竹黄Shirain bambusicola Henn.的子座及孢子,多生于衰败或即将衰败的竹杆上,别名竹花、天竹花、淡竹花、竹茧、赤团子、竹赤团子、竹赤斑菌、竹参、竹三七、血三七等。气特异,味淡、辛,性平;归肺、肝经;功能:化痰止咳、活血祛风、利湿;主治咳嗽痰多、百日咳、带下、胃痛、风湿痹痛、小儿惊风;跌打损伤。
石韦为水龙骨科植物石韦Pyrrosia lingua (Thunb) Farw.、庐山石韦P. sheareri (Bak.) Ching或有柄石韦P. petiolosa (Christ) Ching等的干燥全草,又名石皮、石苇、金星草、石兰、生扯拢、石剑、虹霓剑革、金汤匙、肺心草、会全草、石耳朵、蛇舌风、小叶下虹等,味苦、甘,性寒,归肺、肾、膀胱经。功能:利水通淋、清肺化痰、凉血止血。主治淋证水肿、小便不利、痰热咳喘、咯血吐血、崩漏及外伤出血。
麦冬为百合科植物麦冬Ophiopogon japonicus (Thunb.)Ker-Gawl.的干燥块根。别名麦门冬、沿阶草。味甘、微苦,性微寒。归心、肺、胃经。功能: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。
炒葶苈子为十字花科植物独行菜Lepidium apetalum Willd.和播娘蒿Descurainia sophia (L.)Webb.ex Prantl.的干燥成熟种子经炒制后使用。味辛、苦,性寒。归肺经、心经、肝经、胃经、膀胱经。功效:泻肺降气、祛痰平喘、泄逐邪。用于痰涎壅肺之喘咳痰多、肺痈、慢性肺源性心脏病、心力衰竭之喘肿等。
补骨脂为豆科植物补骨脂Psoralea corylifolia L.的成熟果实。含香豆素类、黄酮类及单萜酚类等化学成分。性味:苦、辛,温。归肾、脾经。功效:补肾壮阳、固精缩尿、温脾止泻、纳气平喘。用于阳痿遗精,遗尿尿频,腰膝冷痛,肾虚作喘,五更泄泻。
梅花为蔷薇科植物梅Prunusmume (sieb.) Sieb.et Zucc.的干燥花蕾。味微酸、涩,性平。归肝、胃、肺经。功能:开郁和中、化痰,解毒。用于郁闷心烦、肝胃气痛、瘰疬疮毒、喘咳痰多。
椒目为芸香科花椒属植物花椒Zanthoxylum bungeanum Maxim.的干燥成熟种子。气香,味苦辛,性寒,归脾、肺、膀胱经。具有利水平喘的功效,用于痰饮喘逆、水肿胀满、哮喘。
本发明的另一个目的在于提供一种治疗慢性支气管炎的口服中药的制备方法,具体内容如下:
A、按下列质量百分比取料:
君迁子 15-50%
太白茶 10-40%
南沙参 5-20%
女贞子 5-20%
竹黄 5-20%
石韦 5-20%
麦冬 5-20%
炒葶苈子 2-10%
补骨脂 2-10%
梅花 1-5%
椒目 1-5%;
B、分别将上述药材直接碎成药粉,或者经各种溶剂的浸渍、渗滤、煎煮、回流、超声波处理、CO2临界(亚临界)萃取以提取药材中的有效成分,再加入适量的药用辅料,运用常规制剂方法,制备成煎膏剂、口服液、颗粒剂、片剂、胶囊剂、滴丸剂、糖浆剂等口服剂型,用以治疗慢性支气管炎。
本发明优选下列提取加工方法:
(1)按如下质量百分比称取原料药:君迁子15-50%、太白茶10-40%、南沙参5-20%、女贞子5-20%、竹黄5-20%、石韦5-20%、麦冬5-20%、炒葶苈子2-10%、补骨脂2-10%、梅花1-5%、椒目1-5%;
(2)将太白茶、南沙参、麦冬混合,在混合物中添加4-12倍混合物质量的水进行煎煮,煎煮1-6小时,过滤;滤渣加最初混合物质量4-12倍水煎煮1-6小时,过滤;滤渣再加最初混合物质量4-12倍水煎煮1-6小时,过滤;合并滤液,将滤液浓缩成流浸膏,备用;
(3)在君迁子、女贞子、竹黄、石韦、炒葶苈子和补骨脂的混合物中加入混合物质量3-10倍的质量百分比浓度为30-90%的乙醇溶液,于60-85℃热回流1-4小时,过滤;滤渣再用最初混合物质量3-10倍量的质量百分比浓度为30-90%的乙醇溶液于60-85℃热回流提取1-4小时,过滤;合并滤液,滤液减压回收乙醇,得流浸膏备用;
(4)将梅花和椒目的混合物中加入混合物质量4-12倍的水,浸泡5-120分钟,通入水蒸气蒸馏5-120分钟,使挥发油蒸馏出来,收集蒸馏液,冷却后备用;
(5)将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液混合,添加常规辅料制备药物,即得到治疗慢性支气管炎的口服中药。
为调整药物浓度或者工艺需要,制剂过程中可能会用蒸馏水或者不同浓度的乙醇溶液稀释、溶解提取物,并且有可能需要过滤。
本发明中将步骤(1)、(2)所得流浸膏混合,加糖(蜜)熬炼,冷却后掺入步骤(3)所得蒸馏液,搅匀制成煎膏剂;或者
将步骤(1)和(2)所得流浸膏混合,加入适量常规辅料后,以湿法制粒,将步骤(3)所得蒸馏液均匀喷洒到颗粒上得到含药颗粒,再用常规方法进一步制备成治疗慢性支气管炎的口服中药的颗粒剂、片剂或者胶囊剂;或者
将步骤(1)和(2)所得流浸膏运用喷雾干燥、真空干燥、流化床干燥等方法制得干膏,粉碎,混合均匀,加入适量常规辅料后,以干法制粒,将步骤(3)所得蒸馏液均匀喷洒到颗粒上得到含药颗粒,再用常规方法进一步制备成治疗慢性支气管炎的口服中药的颗粒剂、片剂或者胶囊剂;或者
将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液混合,加入到已加热的常规滴丸基质中,不停搅拌使全部熔融,趁热滴入冷却液中,冷凝制得治疗慢性支气管炎的口服中药的滴丸剂;或者
将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液混合,加蒸馏水或者乙醇溶液粗略调节药物浓度,静置,过滤,另加饴糖、常用防腐剂后,继续加蒸馏水或者乙醇溶液精确调节药物浓度,制备成口服液;或者
将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液混合,加入适量甘油助溶,再加入单糖浆溶解,制成治疗慢性支气管炎的口服中药的糖浆剂。
本发明提供的治疗慢性支气管炎的口服中药,选用具有补益脾肾、扶正补虚、疏风化痰、宣肺止咳等功效的中药材进行合理组方,可根据需要制备成口服液、煎膏剂、颗粒剂、片剂、胶囊剂、滴丸剂、糖浆剂等口服剂型,制备工艺科学,操作简单,有效成分保留多,无需特殊设备,生产周期短,安全无污染。所制口服药物,通过胃肠道吸收后发挥全身作用,诸药协同,以宣肺涤痰、止咳平喘为主,佐以健脾益气、补肾养阴治其本,具有抗炎、化痰、止咳、平喘、提高免疫力的作用,慢性支气管炎的咳嗽、多痰、气喘的症状得以治疗,并能减少呼吸道的反复感染。
具体实施方式
下面通过实施例对本发明作进一步详细说明,但本发明保护范围不局限于所述内容。
实施例1
(1)按下列配方取料:君迁子500g、太白茶400g、南沙参160g、女贞子160g、竹黄160g、石韦 160g、麦冬160g、炒葶苈子100g、补骨脂100g、梅花60g、椒目40g;
(2)将太白茶、南沙参、麦冬混合,在混合物中加混合物质量10倍水煎煮3小时,过滤;滤渣加最初混合物质量8倍水煎煮2小时,过滤;滤渣再加最初混合物质量6倍水煎煮2小时,过滤,合并滤液;将滤液浓缩成流浸膏,备用;
(3)在君迁子、女贞子、竹黄、石韦、炒葶苈子和补骨髓的混合物中加入混合物质量6倍的50% 乙醇溶液,于80℃热回流2小时,过滤;滤渣再用最初混合物质量5倍量的50% 乙醇溶液于80℃热回流提取1.5小时,过滤,合并滤液;滤液减压回收乙醇,得流浸膏备用;
(4)将梅花和椒目的混合物中加入混合物质量6倍水浸泡30分钟,通入水蒸气蒸馏60分钟,使挥发油蒸馏出来,收集蒸馏液,冷却后备用;
(5)将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液混合,加蒸馏水调至900ml,静置,过滤,另加饴糖350g、苯甲酸钠3g,继续加蒸馏水调整至1000ml,制备成口服液(浓度:1ml=2g生药)。
(6)本治疗慢性支气管炎的口服中药的抗炎实验
1、实验材料
1.1 供试药物 受试药物:本发明实施例1所制备口服液(浓度:1ml=2g生药),阳性对照药:醋酸地塞米松片:浙江仙琚制药股份有限公司产品,批号: 071112;
1.2 实验动物 健康ICR小鼠,体重18-20g,云南省天然药物药理重点实验室提供;
2、实验方法
ICR小鼠60只,雄性,体重18-22g,随机分成3组:生理盐水(NS)组、给药组(10ml.kg-1.d-1)、地塞米松阳性对照组(4.5mg.kg-1.d-1),每组20只;分别用NS、实施例1所制备口服液、地塞米松溶液(用NS稀释成0.045mg/0.1ml) 每日给药两次,每次按0.1ml/20g剂量灌胃,连续给药10d,最后一次给药45min后用微量吸样器吸取100%对二甲苯,均匀涂于小鼠右耳双面(0.05ml/只),15min后脱颈处死。立即用直径8mm的打孔器沿左右耳廓相同部位打孔取下圆形耳片,电子天平分别称重,以两耳片重差值作为肿胀程度指标。实验数据以均数±标准差( ± s)表示, 采用SPSS11.5统计软件包进行t检验,各组间两两比较采用单因素方差分析。
3、实验结果及分析
表1:对二甲苯致小鼠耳肿胀实验结果(n=20,**P<0.05)
从表1中可看出,小鼠用本发明实施例1所制备口服液灌胃10天后,对二甲苯涂抹所致小鼠耳廓肿胀有明显抑制作用,通过实验证实,本发明具有显著的抑制炎症肿胀作用。
为证明实施例1治疗慢性支气管炎的效果,下面以2例典型病例加以说明:
李某,男,58岁,间断性咳嗽,咯痰10余年,每逢冷空气或烟雾刺激致病情加重。X光胸透显示两肺纹理增粗紊乱,出现条索状、斑点状阴影,诊断为慢性支气管炎,依本发明实施例1所制口服液给予患者服用,每日60ml,分2次服用;半个月后病情明显减轻,1个月后咳嗽消失,随访3个月未见复发。
朱某,女,66岁。反复发作咳嗽、咳痰、胸闷、气喘4年,每年发作至少3个月,受寒感冒时症状加剧。两肺底部可闻及干湿性啰音,血常规检查结果白细胞、中性粒细胞偏高,X线胸透提示肺纹理增粗。曾经西药抗感染、止咳、化痰等治疗,上述症状仍时有发作。依本发明实施例1所制口服液给予患者服用,每日60ml,分2次服用。1周后,患者咳嗽咳痰明显减少,无胸闷气喘。1个月后诸症基本消失,两肺未闻及干湿性啰音,随访3个月未见复发。
实施例2
(1)按下列配方取料君迁子400g、太白茶400g、南沙参200g、女贞子200g、竹黄200g、石韦 200g、麦冬110g、炒葶苈子110g、补骨脂80g、梅花50g、椒目50g;
(2)在太白茶、南沙参、麦冬混合,在混合物中加混合物质量8倍水煎煮4小时,过滤;滤渣加最初混合物质量6倍水煎煮3小时,过滤;滤渣再加最初混合物质量4倍水煎煮2小时,过滤,合并滤液;将滤液浓缩成流浸膏,备用;
(3)在君迁子、女贞子、竹黄、石韦、炒葶苈子和补骨髓的混合物中加入混合物质量10倍量的85% 乙醇溶液,于80℃热回流2小时,过滤;滤渣再用最初混合物质量8倍量的85% 乙醇溶液于80℃热回流提取1.5小时,过滤,合并滤液;滤液减压回收乙醇,得流浸膏备用;
(4)将梅花和椒目的混合物中加入混合物质量10倍水浸泡60分钟,通入水蒸气蒸馏30分钟,使挥发油蒸馏出来,收集蒸馏液,冷却后备用;
(5)将步骤(1)和(2)所得流浸膏加热到60℃,混合均匀,再加入氯化铵150g充分混合,迅速制成软材,制粒,将步骤(3)所得蒸馏液均匀喷洒到颗粒上得含药颗粒,低温干燥,整粒,加颗粒总重量1%的滑石粉,分装后得颗粒剂;或者在含药颗粒中加入颗粒总重量1%的滑石粉和0.5%的硬脂酸镁后压片制成片剂;还可以在含药颗粒中加入颗粒总重量1%的滑石粉,填充入胶囊制得胶囊剂。
为证明实施例2治疗慢性支气管炎的效果,下面以1例典型病例加以说明:
王某,女,53岁,胸闷胸痛、频繁咳嗽、气促微喘反复发作3年,先后口服、静脉滴注青霉素、左氧氟沙星等抗生素以对症治疗,但咳嗽延绵不愈,双肺闻及干湿罗音。依本发明实施例2所制片剂给予患者服用,每日6片(1片=20g生药),分2次服用。1周后,患者双肺干湿罗音减少,无胸闷气喘。继续服用1个月后康复,随访3个月未见复发。
实施例3
(1)按下列配方取料:君迁子550g、太白茶350g、南沙参120g、女贞子200g、竹黄200g、石韦 120g、麦冬150g、炒葶苈子90g、补骨脂90g、梅花80g、椒目50g;
(2)在太白茶、南沙参、麦冬混合,在混合物中加混合物质量7倍水煎煮2小时,过滤;滤渣再加最初混合物质量7倍水煎煮1小时,过滤,滤渣再加8倍水煎煮4小时,过滤,合并滤液;将滤液浓缩成流浸膏,备用;
(3)在君迁子、女贞子、竹黄、石韦、炒葶苈子和补骨髓的混合物中加入混合物质量5倍量的75% 乙醇溶液,于80℃热回流3小时,过滤;滤渣再用最初混合物质量5倍量的75% 乙醇溶液于80℃热回流提取3小时,过滤,合并滤液;滤液减压回收乙醇,得流浸膏备用;
(4)将梅花、椒目用5倍水浸泡45分钟,通入水蒸气蒸馏90分钟,使挥发油蒸馏出来,收集蒸馏液,冷却后备用;
(5)把PEG加热至90℃,再将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液加入到其中,在保温条件下不停搅拌使全部混匀,趁热滴入15℃的液状石蜡中,将成形的滴丸沥尽并擦除液状石蜡,置石灰缸里干燥,即制得治疗慢性支气管炎的口服中药的滴丸剂。
为证明实施例3治疗慢性支气管炎的效果,下面以1例典型病例加以说明:
丁某,男,69岁,以咳嗽、咯痰为主要症状,伴有喘息症状,多次出现哮鸣音,每年发病持续3个月以上,连续发作4年。依本发明实施例3所制滴丸剂给予患者服用,每日60颗(1颗滴丸=2g生药),分3次服用。1周后,患者咳嗽、咯痰、喘息明显减轻。继续服用1个月后咳嗽、咯痰、喘息及肺部哮鸣音消失,实验室检查明显好转,随访3个月未见复发。
实施例4
(1)按下列配方取料:君迁子300g、太白茶200g、南沙参100g、女贞子200g、竹黄100g、石韦100g、麦冬400g、炒葶苈子200g、补骨脂200g、梅花100g、椒目100g;
(2)在太白茶、南沙参、麦冬混合,在混合物中加混合物质量4倍水煎煮1小时,过滤;滤渣再加最初混合物质量4倍水煎煮5小时,过滤,滤渣再加5倍水煎煮3小时,过滤,合并滤液;将滤液浓缩成流浸膏,备用;
(3)在君迁子、女贞子、竹黄、石韦、炒葶苈子和补骨髓的混合物中加入混合物质量9倍量的30% 乙醇溶液,于85℃热回流1小时,过滤;滤渣再用最初混合物质量3倍量的90% 乙醇溶液于85℃热回流提取1小时,过滤,合并滤液;滤液减压回收乙醇,得流浸膏备用;
(4)将梅花、椒目用4倍水浸泡120分钟,通入水蒸气蒸馏10分钟,使挥发油蒸馏出来,收集蒸馏液,冷却后备用;
(5)将步骤(1)和步骤(2)所得流浸膏混合,加400g白沙糖熬炼,冷却后掺入步骤(3)所得蒸馏液,搅匀制成治疗慢性支气管炎的口服中药的煎膏剂。
为证明实施例4治疗慢性支气管炎的效果,下面以1例典型病例加以说明:
蒋某,男,60岁,已咳嗽.、咳痰7年,气息短促、颜面浮肿、长期咳嗽、痰不易咳出,双肺广泛闻及湿罗音和哮鸣音。依本发明实施例4所制煎膏剂给患者服用,每日30ml(1ml煎膏剂=4g生药),分2次服用。半个月后患者浮肿消失,胸闷气短症状明显好转,咳嗽咳痰有所减轻。服用2个月后,患者咳嗽、咳痰、气短、胸闷诸症消失。随访3个月未见复发。
实施例5
(1)按下列配方取料:君迁子1000g、太白茶380g、南沙参100g、女贞子100g、竹黄100g、石韦100g、麦冬100g、炒葶苈子40g、补骨脂40g、梅花20g、椒目20g;
(2)在太白茶、南沙参、麦冬混合,在混合物中加混合物质量12倍水煎煮6小时,过滤;滤渣再加最初混合物质量12倍水煎煮6小时,过滤,滤渣再加12倍水煎煮1小时,过滤,合并滤液;将滤液浓缩成流浸膏,备用;
(3)在君迁子、女贞子、竹黄、石韦、炒葶苈子和补骨髓的混合物中加入混合物质量3倍量的90% 乙醇溶液,于60℃热回流4小时,过滤;滤渣再用最初混合物质量10倍量的30% 乙醇溶液于60℃热回流提取4小时,过滤,合并滤液;滤液减压回收乙醇,得流浸膏备用;
(4)将梅花、椒目用12倍水浸泡5分钟,通入水蒸气蒸馏120分钟,使挥发油蒸馏出来,收集蒸馏液,冷却后备用;
(5)将步骤(1)、(2)所得流浸膏采用喷雾干燥的方法制得干膏,粉碎,混合均匀后,加入乳糖10g、微晶纤维素40g后,以干法制粒,将步骤(3)所得蒸馏液均匀喷洒到颗粒上得到含药颗粒,低温干燥,整粒,在含药颗粒中加入颗粒总重量1%的滑石粉和0.5%的硬脂酸镁后压片制成片剂。
王某,男,56岁,以咳嗽、咯痰为主要症状,伴有喘息症状,多次出现哮鸣音,胸闷胸痛、每年发病持续3个月以上,连续发作4年,先后口服、静脉滴注青霉素、左氧氟沙星等抗生素以对症治疗,但咳嗽延绵不愈,双肺闻及干湿罗音。依本发明实施例5所制片剂给予患者服用,每日6片(1片=20g生药),分2次服用。1周后,患者双肺干湿罗音减少,无胸闷气喘。继续服用1个月后康复,随访3个月未见复发。
Claims (7)
1.一种治疗慢性支气管炎的口服中药,其特征在于其由以下质量百分比的原料药制成:
君迁子 15-50%
太白茶 10-40%
南沙参 5-20%
女贞子 5-20%
竹黄 5-20%
石韦 5-20%
麦冬 5-20%
炒葶苈子 2-10%
补骨脂 2-10%
梅花 1-5%
椒目 1-5%。
2.权利要求1所述治疗慢性支气管炎的口服中药的制备方法,其特征在于按如下步骤进行:(1)按如下质量百分比称取原料药:君迁子15-50%、太白茶10-40%、南沙参5-20%、女贞子5-20%、竹黄5-20%、石韦5-20%、麦冬5-20%、炒葶苈子2-10%、补骨脂2-10%、梅花1-5%、椒目1-5%;
(2)将太白茶、南沙参、麦冬混合,在混合物中添加4-12倍混合物质量的水进行煎煮,煎煮1-6小时,过滤;滤渣加最初混合物质量4-12倍水煎煮1-6小时,过滤;滤渣再加最初混合物质量4-12倍水煎煮1-6小时,过滤;合并滤液,将滤液浓缩成流浸膏,备用;
(3)在君迁子、女贞子、竹黄、石韦、炒葶苈子和补骨脂的混合物中加入混合物质量3-10倍的质量百分比浓度为30-90%的乙醇溶液,于60-85℃热回流1-4小时,过滤;滤渣再用最初混合物质量3-10倍量的质量百分比浓度为30-90%的乙醇溶液于60-85℃热回流提取1-4小时,过滤;合并滤液,滤液减压回收乙醇,得流浸膏备用;
(4)将梅花和椒目的混合物中加入混合物质量4-12倍的水,浸泡5-120分钟,通入水蒸气蒸馏5-120分钟,使挥发油蒸馏出来,收集蒸馏液,冷却后备用;
(5)将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液混合,添加常规辅料制备药物,即得到治疗慢性支气管炎的口服中药。
3.根据权利要求2所述治疗慢性支气管炎的口服中药的制备方法,其特征在于:将步骤(1)和步骤(2)所得流浸膏混合,加糖或蜜熬炼,冷却后掺入步骤(3)所得蒸馏液,搅匀制成治疗慢性支气管炎的口服中药的煎膏剂。
4.根据权利要求2所述治疗慢性支气管炎的口服中药的制备方法,其特征在于:将步骤(1)和(2)所得流浸膏混合,加入辅料后,以湿法制粒,将步骤(3)所得蒸馏液均匀喷洒到颗粒上得到含药颗粒,再用常规方法进一步制成治疗慢性支气管炎的口服中药的成粒剂、片剂或者胶囊剂。
5.根据权利要求2所述治疗慢性支气管炎的口服中药的制备方法,其特征在于:将步骤(1)、(2)所得流浸膏采用喷雾干燥、真空干燥或流化床干燥的方法制得干膏,粉碎,混合均匀后,加入辅料后,以干法制粒,将步骤(3)所得蒸馏液均匀喷洒到颗粒上得到含药颗粒,再用常规方法进一步制成治疗慢性支气管炎的口服中药的颗粒剂、片剂或者胶囊剂。
6.根据权利要求2所述治疗慢性支气管炎的口服中药的制备方法,其特征在于:将步骤(1)、(2)所得流浸膏、步骤(3)所得蒸馏液混合,加入到已加热的滴丸基质中,不停搅拌使全部熔融,趁热滴入冷却液中,冷凝制得治疗慢性支气管炎的口服中药的滴丸剂。
7.根据权利要求2所述治疗慢性支气管炎的口服中药的制备方法,其特征在于:将步骤(1)和(2)所得流浸膏、步骤(3)所得蒸馏液混合,加蒸馏水或者乙醇溶液调节药物浓度,静置,过滤,另加饴糖、常用防腐剂后,继续加蒸馏水或者乙醇溶液精确调节药物浓度,制备成口服液。
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