CN104258281A - 清咽无糖颗粒及其制备方法 - Google Patents
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Abstract
本发明公开了一种清咽无糖颗粒及其制备方法,所述清咽无糖颗粒包括:蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗、元参、石斛、麦冬、甘草、天花粉、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶、稀释剂和矫味剂;其制备方法为先制备含蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬的中药清膏,再制备含元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉的中药提取物,然后将所得清膏、中药提取物、稀释剂、矫味剂混合,制粒、干燥,即得。本发明的颗粒剂不仅有显著的清咽利喉疗效,而且不含庶糖,扩大了适用人群,制作工艺简单、质量可控,服用、携带方便。
Description
技术领域
本发明属于中药技术领域,具体涉及一种清咽无糖颗粒及其制备方法。
背景技术
咽喉炎是耳鼻喉科最常见的一种疾病,是咽部粘膜、粘膜下及淋巴组织的弥漫性炎症。现代医学已证实:细菌、病毒及一些物化因素(如吸烟、喝酒等)刺激会使咽部发生炎症,造成咽粘膜层充血,粘膜下部结缔组织及淋巴组织增生,黏液腺肥大,分泌亢进,从而引起咽部不适感,如干燥、发痒、灼热、微痛、异物感及声音嘶哑等。咽喉炎病因临床有内、外之分,外因多为感受风寒之邪,郁久化热或风热之邪;内因多为素体阴虚,又嗜食辛辣煎炒,痰热蕴结,上灼咽喉或日久耗伤肺肾之阴,导致虚火上炎,灼伤津液成痰,痰热循经上扰咽喉,清道失利所致。在现代医学中,一般将咽喉炎分急性咽炎和慢性咽炎两种。急性咽炎常为上呼吸道感染的一部分,多由细菌、病毒感染引起,其症状可表现为急性单纯性咽炎和急性化脓性咽炎,一般使用激光、微波或雾化吸入等非药物治疗方法、或使用化药治疗即可治愈。慢性咽炎则由急性咽炎反复发作、或受有害气体刺激引起,一般可分为慢性单纯性咽炎、慢性肥厚性咽炎和慢性萎缩性咽炎三种,对于慢性咽炎患者来说,非药物治疗或化药治疗虽能有助于改善症状,但难以去除造成病症的病灶,在症状缓解后容易复发。
治疗此类疾病的药物数不胜数,西药治疗多以抗生素类、解热镇痛类和抗病毒类药为主,虽然西药见效快,但容易产生耐药性,而且过多使用还会引起人体其他病症,使用中药治疗此类疾病则可以避免上述西药的缺点,但目前治疗此类疾病的中成药疗效参差不齐,许多药物都不能达到见效快的优点。
在中医理论中,咽为胃之关,喉为肺之门,外感之邪入肺易伤喉,饮食不当入胃易损于咽,咽喉为邪毒好浸久留之地。中医认为咽喉疾患与脏腑功能失调有关,风热犯肺、脾失健运、胃气虚弱等均可引发,防止可用清热解毒、理气化痰为法,在治疗上,中医中药显示出相当大得优势,也许还有很大潜力可挖。申请号为201210594811.X、名称为《清咽颗粒及其制备方法》的专利文献公开了一种清咽颗粒及其制备方法,其清咽的活性成分为:青黛、诃子、薄荷脑、冰片、人工牛黄,辅料为蔗糖、淀粉或糊精。该颗粒剂蔗糖作为矫味剂,蔗糖易吸湿,颗粒不稳定,加入量大,含糖量高,使得糖尿病、肥胖病和老年患者用药有局限性。申请号为201310715737.7、名称为《一种润喉清咽含片及其制备方法》的专利文献公开一种润喉清咽含片及其制备方法,该含片由青果、淡竹叶、菊花、甘草等药味经提取精制而成,该含片具有适应症较多,治疗范围广,疗效不明确,针对性不强等缺点。
发明内容
本发明的目的是克服现有技术的不足而提供一种清咽无糖颗粒及其制备方法,该颗粒剂不仅有显著的清咽利喉疗效,而且不含庶糖,扩大了适用人群,制作工艺简单、质量可控,服用、携带方便。
清咽无糖颗粒,以重量份计包括:蒲公英3~8份,牛蒡子2~7份,大青叶1~6份,马勃2~9份,郁金1~7份,桔梗3~9份,元参2~8份,石斛1~9份,麦冬3~10份,甘草2~8份,天花粉3~10份,连翘1~9份,丹参2~7份,射干3~8份,玄参4~9份,乳香2~7份,没药3~12份,薄荷叶2~9份,荆芥4~9份,前胡3~8份,桑叶2~10份,稀释剂2~10份,矫味剂1~5份。
蒲公英:具有清热解毒、消痈散结的功效。主治:乳痈;肺痈;肠痈;痄腮;疔毒疮肿;目赤肿痛;感冒发热;咳嗽;咽喉肿痛;胃火;肠炎;痢疾;肝炎;胆吓炎;尿路感染;蛇虫咬伤。
牛蒡子:具有疏散风热、宣肺透疹、利咽散结、解毒消肿的功效。主治:风热咳嗽;咽喉肿痛;斑疹不透;风疹瘙痒;疮疡肿毒。
大青叶:具有清热解毒、凉血消斑的功效;主治:热病高热烦渴;神昏;斑疹;吐血;衄血;黄疸;泻痢;丹毒;喉痹;口疮;痄腮。
马勃:具有清肺利咽、解毒止血的功效。主治:咽喉肿痛,咳嗽失音,吐血衄血,诸疮不敛。
郁金:具有活血止能、行气解郁、清心凉血、疏肝利胆的功效。主治:胸腹胁肋诸痛;妇女痛经;经闭;癥瘕结块;热病神昏;癫狂;惊痫;吐血;衄备;血淋;砂淋;黄疸。
桔梗:具有宣肺、祛痰、利咽、排脓的功效。主治:咳嗽痰多;咽喉肿痛;肺痈吐脓;胞满胁痛;痢疾腹痛;小便癃闭。
石斛:具有生津益胃、滋阴清热、润肺益肾、明目强腰的功效。主治:热病伤津;口干烦渴;胃阴不足;胃痛干呕;肺燥干咳;虚热不退;阴伤目暗;腰膝软弱。
麦冬:具有养阴生津的功效。主治:阴虚肺燥;咳嗽痰粘;胃阴不足;口燥咽干;肠燥便秘。
甘草:具有清热解毒、止咳化痰、利尿消肿的功效。主治:肺热咳嗽;咽喉肿痛;肾炎水肿;尿路感染。
天花粉:具有清热生津、润肺化痰、消肿排浓的功效。主治:热病口渴;消渴多饮;肺热燥咳;疮疡肿毒。
连翘:具有清热解毒、消肿散结、风热感冒的功效。主治:风热感冒;温病;热淋尿闭;痈疽;肿毒;瘰疬;瘿瘤;喉痹。
丹参:具有清热化痰、益肾、调经、止血的功效。主治:肺热咳嗽痰多气喘;吐血;肾虚腰酸;小便频数;带下;月经过多。
射干:具有清热解毒、祛痰利咽、消瘀散结的功效。主治:咽喉肿痛;咳壅咳喘;瘰疬结核;疟母癓瘕;痈肿疮毒。
玄参:具有清热凉血、滋阴降火、解毒散结的功效。主治:温热病热和营血;身热;烦渴;舌绛;发斑;骨蒸劳嗽;虚烦不寤;津伤便秘;目涩昏花;咽喉喉肿痛;瘰疬痰核;痈疽疮毒。
荆芥:具有发表清热、解毒利湿、散瘀消肿的功效。主治:感冒发热;头痛;肺痈;肝炎;水肿;淋痛。
前胡:具有疏散风热、降气化痰的功效。主治:外感风热;肺热痰郁;咳喘痰多;痰黄稠粘;哎逆食少;胸膈满闷。
桑叶:具有疏散风热、清肺、明目的功效。主治:风热感冒;风温初起,发热头痛,汗出恶风,咳嗽胸痛;或肺燥干咳无痰;咽干口渴;风热及肝阳上扰;目赤肿痛。
作为上述发明的进一步改进,所述清咽无糖颗粒以重量份计包括:蒲公英5份,牛蒡子6份,大青叶2份,马勃3份,郁金6份,桔梗5份,元参7份,石斛8份,麦冬8份,甘草6份,天花粉5份,连翘5份,丹参5份,射干6份,玄参5份,乳香4份,没药10份,薄荷叶6份,荆芥7份,前胡6份,桑叶5份,稀释剂6份,矫味剂2份。
作为上述发明的进一步改进,所述稀释剂为淀粉、糊精、麦芽糖或乳糖。
作为上述发明的进一步改进,所述矫味剂选自甘露醇、木糖醇、甜菊素、麦芽糖醇、或阿斯巴甜。
上述清咽无糖颗粒的制备方法,包括以下步骤:
步骤1,取蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬,加入6倍重量份的纯净水煎煮二次,合并煎液,滤过,滤液浓缩得浓缩液,加入乙醇使含醇量为60~70%,搅匀,静置12小时,滤过,将滤液浓缩得清膏;
步骤2,将元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉碎成粗粉,用乙醇浸渍,渗漉速度为3~5mL/min,收集渗漉液,回收乙醇得浓缩液,用乙醚萃取,合并萃取液减压回收得提取物;
步骤3,将步骤1所得清膏、步骤2所得提取物、稀释剂、矫味剂混合,制粒、干燥,即得。
作为上述发明的进一步改进,稀释剂的粒径为80~100目,矫味剂的粒径为60~80目。
作为上述发明的进一步改进,步骤1中第一次煎煮时间为1.5小时,第二次煎煮时间为1小时。
作为上述发明的进一步改进,步骤1中浓缩液85~95℃的相对密度为1.10。
作为上述发明的进一步改进,步骤1中清膏85~90℃的相对密度为1.32。
作为上述发明的进一步改进,步骤2中所得浓缩液85~90℃的相对密度为1.20~1.25。
本发明的颗粒剂不仅有显著的清咽利喉疗效,而且不含庶糖,扩大了适用人群,制作工艺简单、质量可控,服用、携带方便。
具体实施方式
实施例1
清咽无糖颗粒,以重量份计包括:蒲公英3份,牛蒡子2份,大青叶1份,马勃2份,郁金1份,桔梗3份,元参2份,石斛1份,麦冬3份,甘草2份,天花粉3份,连翘1份,丹参2份,射干3份,玄参4份,乳香2份,没药3份,薄荷叶2份,荆芥4份,前胡3份,桑叶2份,淀粉2份,甘露醇1份。
上述清咽无糖颗粒的制备方法,包括以下步骤:
步骤1,取蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬,加入6倍重量份的纯净水煎煮二次,第一次1.5小时,第二次1小时,合并煎液,滤过,滤液浓缩至相对密度为1.10(85~95℃),加入乙醇使含醇量为60~70%,搅匀,静置12小时,滤过,将滤液浓缩得相对密度为1.30(85~90℃)的清膏;
步骤2,将元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉碎成粗粉,用乙醇浸渍,渗漉速度为3~5mL/min,收集渗漉液,回收乙醇得相对密度为1.20浓缩液(85~90℃),用乙醚萃取,合并萃取液减压回收得提取物;
步骤3,将步骤1所得清膏、步骤2所得提取物、淀粉、甘露醇混合,制粒、干燥,即得。其中,淀粉的粒径为80目,甘露醇的粒径为60目。
实施例2
清咽无糖颗粒,以重量份计包括:蒲公英5份,牛蒡子4份,大青叶2份,马勃7份,郁金2份,桔梗4份,元参5份,石斛2份,麦冬8份,甘草6份,天花粉4份,连翘3份,丹参5份,射干5份,玄参7份,乳香4份,没药10份,薄荷叶8份,荆芥6份,前胡4份,桑叶3份,糊精5份,木糖醇3份。
上述清咽无糖颗粒的制备方法,包括以下步骤:
步骤1,取蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬,加入6倍重量份的纯净水煎煮二次,第一次1.5小时,第二次1小时,合并煎液,滤过,滤液浓缩至相对密度为1.10(85~95℃),加入乙醇使含醇量为60~70%,搅匀,静置12小时,滤过,将滤液浓缩得相对密度为1.30(85~90℃)的清膏;
步骤2,将元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉碎成粗粉,用乙醇浸渍,渗漉速度为3~5mL/min,收集渗漉液,回收乙醇得相对密度为1.20浓缩液(85~90℃),用乙醚萃取,合并萃取液减压回收得提取物;
步骤3,将步骤1所得清膏、步骤2所得提取物、糊精、木糖醇混合,制粒、干燥,即得。其中,糊精的粒径为100目,木糖醇的粒径为80目。
实施例3
清咽无糖颗粒,以重量份计包括:蒲公英6份,牛蒡子5份,大青叶3份,马勃5份,郁金3份,桔梗4份,元参6份,石斛8份,麦冬9份,甘草3份,天花粉8份,连翘8份,丹参5份,射干4份,玄参5份,乳香6份,没药4份,薄荷叶6份,荆芥8份,前胡6份,桑叶8份,乳糖9份,甜菊素4份。
上述清咽无糖颗粒的制备方法,包括以下步骤:
步骤1,取蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬,加入6倍重量份的纯净水煎煮二次,第一次1.5小时,第二次1小时,合并煎液,滤过,滤液浓缩至相对密度为1.10(85~95℃),加入乙醇使含醇量为60~70%,搅匀,静置12小时,滤过,将滤液浓缩得相对密度为1.30(85~90℃)的清膏;
步骤2,将元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉碎成粗粉,用乙醇浸渍,渗漉速度为3~5mL/min,收集渗漉液,回收乙醇得相对密度为1.25浓缩液(85~90℃),用乙醚萃取,合并萃取液减压回收得提取物;
步骤3,将步骤1所得清膏、步骤2所得提取物、乳糖、甜菊素混合,制粒、干燥,即得。其中,乳糖的粒径为80目,甜菊素的粒径为60目。
实施例4
清咽无糖颗粒以重量份计包括:蒲公英5份,牛蒡子6份,大青叶2份,马勃3份,郁金6份,桔梗5份,元参7份,石斛8份,麦冬8份,甘草6份,天花粉5份,连翘5份,丹参5份,射干6份,玄参5份,乳香4份,没药10份,薄荷叶6份,荆芥7份,前胡6份,桑叶5份,麦芽糖6份,阿斯巴甜2份。
上述清咽无糖颗粒的制备方法,包括以下步骤:
步骤1,取蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬,加入6倍重量份的纯净水煎煮二次,第一次1.5小时,第二次1小时,合并煎液,滤过,滤液浓缩至相对密度为1.10(85~95℃),加入乙醇使含醇量为60~70%,搅匀,静置12小时,滤过,将滤液浓缩得相对密度为1.30(85~90℃)的清膏;
步骤2,将元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉碎成粗粉,用乙醇浸渍,渗漉速度为3~5mL/min,收集渗漉液,回收乙醇得相对密度为1.20浓缩液(85~90℃),用乙醚萃取,合并萃取液减压回收得提取物;
步骤3,将步骤1所得清膏、步骤2所得提取物、麦芽糖、阿斯巴甜混合,制粒、干燥,即得。其中,麦芽糖的粒径为80目,阿斯巴甜的粒径为60目。
实施例5
清咽无糖颗粒,以重量份计包括:蒲公英8份,牛蒡子7份,大青叶6份,马勃9份,郁金7份,桔梗9份,元参8份,石斛9份,麦冬10份,甘草8份,天花粉10份,连翘9份,丹参7份,射干8份,玄参9份,乳香7份,没药12份,薄荷叶9份,荆芥9份,前胡8份,桑叶10份,糊精10份,麦芽糖醇5份。
上述清咽无糖颗粒的制备方法,包括以下步骤:
步骤1,取蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬,加入6倍重量份的纯净水煎煮二次,第一次1.5小时,第二次1小时,合并煎液,滤过,滤液浓缩至相对密度为1.10(85~95℃),加入乙醇使含醇量为60~70%,搅匀,静置12小时,滤过,将滤液浓缩得相对密度为1.30(85~90℃)的清膏;
步骤2,将元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉碎成粗粉,用乙醇浸渍,渗漉速度为3~5mL/min,收集渗漉液,回收乙醇得相对密度为1.20浓缩液(85~90℃),用乙醚萃取,合并萃取液减压回收得提取物;
步骤3,将步骤1所得清膏、步骤2所得提取物、糊精、麦芽糖醇混合,制粒、干燥,即得。其中,糊精的粒径为80目,麦芽糖醇的粒径为60目。
本发明所得颗粒剂临床疗效实验
1.病例选择标准
1.1诊断标准
症状:咽喉干燥、疼痛、声音嘶哑、甚或失音,或喉痒、干咳少痰,吞咽困难,咽喉部有异物感。
1.2纳入标准
(1)符合上述诊断标准者;
(2)年龄在18-65岁者。
1.3排除标准
1.3.1不符合上述中医诊断标准者。
1.3.2虽符合上述中医辩证标准,但同时具有如下情况之一者:
(1)年龄在18岁以下,或65岁以上者;
(2)孕产妇或哺乳期妇女;
(3)合并有心血管、肝、肾和造血系统等严重原发性疾病,精神病患者;
(4)凡不符合纳入标准,未按规定用药,无法判断疗效或资料不全等影响疗效和安全性判断者。
2.疗效判定
(1)临床痊愈 用药3天以内症状减轻,1周以内临床症状、体征消失或基本消失。
(2)显效 用药1周以内症状减轻,2周以内临床症状、体征消失或基本消失。
(3)有效 用药1周以内症状减轻,2周以内临床症状减轻,大部分体征消失。
(4)无效 用药后症状稍有减轻或无减轻、体征无明显改善。
3.给药方法
取实施例1所得颗粒剂,
颗粒剂疗效结果
总数 | 临床痊愈 | 显效 | 有效 | 无效 | |
例数 | 500 | 329 | 106 | 62 | 3 |
所占百分数 | 65.8 | 21.2 | 12.4 | 0.6 |
本发明的颗粒剂不仅有显著的清咽利喉疗效,而且不含庶糖,扩大了适用人群,制作工艺简单、质量可控,服用、携带方便。
Claims (10)
1.清咽无糖颗粒,其特征在于:以重量份计包括:蒲公英3~8份,牛蒡子2~7份,大青叶1~6份,马勃2~9份,郁金1~7份,桔梗3~9份,元参2~8份,石斛1~9份,麦冬3~10份,甘草2~8份,天花粉3~10份,连翘1~9份,丹参2~7份,射干3~8份,玄参4~9份,乳香2~7份,没药3~12份,薄荷叶2~9份,荆芥4~9份,前胡3~8份,桑叶2~10份,稀释剂2~10份,矫味剂1~5份。
2.根据权利要求1所述的清咽无糖颗粒,其特征在于:以重量份计包括:蒲公英5份,牛蒡子6份,大青叶2份,马勃3份,郁金6份,桔梗5份,元参7份,石斛8份,麦冬8份,甘草6份,天花粉5份,连翘5份,丹参5份,射干6份,玄参5份,乳香4份,没药10份,薄荷叶6份,荆芥7份,前胡6份,桑叶5份,稀释剂6份,矫味剂2份。
3.根据权利要求1或2所述的清咽无糖颗粒,其特征在于:所述稀释剂为淀粉、糊精、麦芽糖或乳糖。
4.根据权利要求1或2所述的清咽无糖颗粒,其特征在于:所述矫味剂选自甘露醇、木糖醇、甜菊素、麦芽糖醇或阿斯巴甜。
5.权利要求1所述的清咽无糖颗粒的制备方法,其特征在于:包括以下步骤:
步骤1,取蒲公英、牛蒡子、大青叶、马勃、郁金、桔梗和麦冬,加入6倍重量份的纯净水煎煮二次,合并煎液,滤过,滤液浓缩得浓缩液,加入乙醇使含醇量为60~70%,搅匀,静置12小时,滤过,将滤液浓缩得清膏;
步骤2,将元参、石斛、甘草、连翘、丹参、射干、玄参、乳香、没药、薄荷叶、荆芥、前胡、桑叶粉与天花粉碎成粗粉,用乙醇浸渍,渗漉速度为3~5mL/min,收集渗漉液,回收乙醇得浓缩液,用乙醚萃取,合并萃取液减压回收得提取物;
步骤3,将步骤1所得清膏、步骤2所得提取物、稀释剂、矫味剂混合,制粒、干燥,即得。
6.根据权利要求5所述的清咽无糖颗粒的制备方法,其特征在于:所述稀释剂的粒径为80~100目,矫味剂的粒径为60~80目。
7.根据权利要求5所述的清咽无糖颗粒的制备方法,其特征在于:步骤1中第一次煎煮时间为1.5小时,第二次煎煮时间为1小时。
8.根据权利要求5所述的清咽无糖颗粒的制备方法,其特征在于:步骤1中浓缩液85~95℃的相对密度为1.10。
9.根据权利要求5所述的清咽无糖颗粒的制备方法,其特征在于:步骤1中清膏85~90℃的相对密度为1.32。
10.根据权利要求5所述的清咽无糖颗粒的制备方法,其特征在于:步骤2中所得浓缩液85~90℃的相对密度为1.20~1.25。
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CN105232957A (zh) * | 2015-11-13 | 2016-01-13 | 宋士兰 | 一种治疗实热证咽喉肿痛的中药汤剂 |
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CN110025601A (zh) * | 2019-05-13 | 2019-07-19 | 中国农业科学院农产品加工研究所 | 石斛酚在制备保护神经细胞药物中的应用 |
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