CN1063646C - 小儿感冒颗粒(无糖型)及制备方法 - Google Patents
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Abstract
本发明涉及治疗小儿感冒、流感的小儿感冒颗粒(无糖型)生产制备方法。
本发明是以广藿香、连翘、板蓝根、白薇等药物制成的纯中药制剂。该药主治小儿感冒、流感,及伴见的发烧、咳嗽、头痛、鼻塞、流涕、打喷嚏、咽喉肿痛等病症。其生产方法是把上述中草药按处方配制,采用先进的制药工艺精制而成。本品经卫生部临床药理基地成都中医药大学附属医院和成都市儿童医院临床验证表明;小儿感冒颗粒治疗小儿感冒,总显效率为79.6%,总有效率为98.1%,无明显副作用,是目前治疗小儿感冒(上呼吸道感染)的有效中药制剂。
Description
本发明涉及治疗小儿感冒、流感的小儿感冒颗粒(无糖型)及其生产制备方法。
目前治疗小儿感冒的药物多为非甾体抗炎药、抗组胺药以及抗生素类药品,这些药品副作用较常见,有的还有严重的不良反应。如扑热息痛,虽有较好解热、镇痛作用,但常常会引起不良反应,如胃肠不适、过敏性皮炎。抗组胺药如扑尔敏等常引起嗜睡。抗生素类药品治感冒疗效不确,且易导致耐药菌株产生及菌群失调、过敏反应等。中成药治疔感冒疗效确切已被公认,但一些中成药如抗病毒冲剂等,因含糖量大,每次服用剂量大(为12g以上)、溶解性较差,故小儿服用不方便。
本发明的目的是提供一种安全性好,疗效确切,服用量少,治疗小儿感冒的药物制剂的制备方法。
本发明是根据中医理论,选取多种道地药材、合理组方、采用现代先进制药技术精制而成的无糖颗粒。本品为国内独家研制,独家生产的儿童感冒用的纯中药制剂(见查新报告附件1)。药物组成为广藿香、菊花、连翘、大青叶、地骨皮、白薇、薄荷、地黄、板蓝根。方中广藿香疏风解表,芳香化浊,板蓝根清热解毒,二药相须为用,祛除本方主症病因,作为主药。臣以菊花、薄荷疏风、清热解表、针对外感风邪,给外邪以出路用连翘、大青叶、板蓝根清热解毒之效,配伍甘寒之品石膏及清热凉血作用的地骨皮、白微、地黄,针对发热等症,截断疾病的传变,全方选药精良,组方合理,共凑清热解表之功。现代药理研究证实,本品有抗菌、抗病毒、解热、镇咳、抗炎作用,对感冒、流感具有良好的治疗作用,适用于小儿感冒、流感,症见:发烧、咳嗽、头痛、鼻塞、流涕、打喷嚏、咽喉肿痛等病症。经卫生部临床药理基地成都中医药大学附属医院和成都市儿童医院临床验证表明:小儿感冒颗粒是治疗小儿感冒的有效中药制剂,总显效率为79.6%,总有效率为98.1%,无明显副作用,是目前治疗小儿感冒(上呼吸道感染)的有效中药制剂。
我们对市场上用于治疗小儿感冒的药品进行了调查,并结合临床医生的实践经验,选定了将本复方制备成颗粒剂,具体的制备方法为
1.【处方】广藿香75g 菊花75g 连翘75g 大青叶125g 板蓝根75g
地黄75g 地骨皮75g 白薇75g 薄荷50g 石膏125g
2.【制法】以上十味,地黄、白薇、地骨皮、石膏(100g)加水煎煮二次,第一次3小时,第二次1小时,合并煎液,滤过;菊花、大青叶热浸二次,第一次2小时,第二次1小时,合并浸出液,滤过:广藿香、薄荷、连翘提取挥发油,其水溶液滤过,滤液与以上二液合并,浓缩至相对密度为1.10~1.20(50℃)的清膏,将石膏25g,板蓝根粉碎成细粉。取清膏1份、乳糖及细粉1份,混匀,置一步制粒机内制成颗粒,喷入挥发油,混匀,检验,分装成每袋6克或3克,即得。工艺流程见图1。
制粒机制粒时应注意:
1.制粒时应先由低至高逐渐升温,避免升温速度过快,使物料表面硬结成块。
2.喷雾完毕后,进行干燥,干燥时间一般在20~40分钟,干燥时可调整排气风门控制物料颗粒在流化床内高度沸腾,以利颗粒完整,制得的颗粒使用分级式振荡筛,过筛。
本发明的特点为:本品退热快而温和(不会产生反跳现象)。既可消除感冒症状,又能提高机体免疫能力。临床应用未见不良反应。本品为无糖型颗粒,降低了辅料的使用量,小儿服用量减少。乳糖作辅料,溶解性较好。一步制粒机喷雾制粒,药效损失小。
本发明的质量控制是依据《中国药典》九五版一部颗粒剂检测项下和本品的药物特性而制订并获卫生部药典委的批准执行(附件2)。
以下述实例详细说明本发明:
1.批号961012,照上述处方量的10倍投料,制法与上述制法相同,得颗粒10.2kg,送四川省药品检验所检验,结果:符合规定。
2.批号961013,照上述处方量的10倍投料,制法与上述制法相同,得颗粒10.0kg,送四川省药品检验所检验,结果:符合规定。
3.批号961014,照上述处方量的10倍投料,制法与上述制法相同,得颗粒10.1kg,送四川省药品检验所检验,结果:符合规定。
Claims (2)
1、一种治疗小儿感冒流感的感冒颗粒,其特征由下列中药组分组成:
广藿香75g 菊花75g
连翘75g 大青叶125g
板蓝根75g 地黄75g
地骨皮75g 白薇75g
薄荷50g 石膏125g
2、一种治疗小儿感冒,流感的感冒颗粒的制取方法,其特征在于:照上述组成取地黄75g、白薇75g、地骨皮75g、石膏100g加水煎煮二次,第一次3小时,第二次1小时,合并煎液,滤过;菊花75g、大青叶125g热浸二次,第一次2小时,第二次1小时,合并浸出液,滤过:广藿香75g、薄荷50g、连翘75g提取挥发油,其水溶液滤过,滤液与以上二液合并,在50℃下浓缩至相对密度为1.10-1.20的清膏;将石膏25g、板蓝根75g粉碎成细粉;取清膏1份、乳糖及细粉1份,混匀,置一步制粒机内制成颗粒,喷入挥发油,混匀,检验,分装成每袋6克或3克,即得。
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Cited By (1)
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CN102119978A (zh) * | 2007-03-27 | 2011-07-13 | 北京亚东生物制药有限公司 | 具有解表、清热解毒的组合物及其制备、检测方法 |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
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GB2401042B (en) * | 2003-04-28 | 2006-02-22 | Pharmaceutical Ind Tech & Dev | Antitussive agent and method for making the same |
CN100344320C (zh) * | 2006-04-18 | 2007-10-24 | 邯郸制药有限公司 | 一种治疗小儿感冒的药物组合物及其制备工艺 |
CN101274034B (zh) * | 2007-03-27 | 2011-03-30 | 北京亚东生物制药有限公司 | 一种具有疏风解表、清热解毒作用的中药组合物 |
CN101744946B (zh) * | 2010-01-15 | 2012-10-24 | 北京同仁堂科技发展股份有限公司 | 一种中药组合物及其制剂的检测方法 |
CN102614352A (zh) * | 2011-02-01 | 2012-08-01 | 王平平 | 一种治疗小儿感冒的中药组合物及制法和检测方法 |
CN102133301A (zh) * | 2011-03-24 | 2011-07-27 | 江苏苏南药业实业有限公司 | 一种小儿感冒颗粒的制备方法 |
CN104383512A (zh) * | 2014-12-08 | 2015-03-04 | 樊金刚 | 制备用于小儿退烧的药物制剂的方法 |
CN104474514A (zh) * | 2014-12-08 | 2015-04-01 | 樊金刚 | 一种用于小儿发烧的中成药物 |
CN105663056A (zh) * | 2016-03-01 | 2016-06-15 | 南京正亮医药科技有限公司 | 一种小儿感冒颗粒的制备方法及应用 |
-
1997
- 1997-05-29 CN CN97107520A patent/CN1063646C/zh not_active Expired - Lifetime
Non-Patent Citations (1)
Title |
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《中医杂志》33(8) 1992.1.1 刘征利等,香石清解袋泡剂治疗病毒性上感高热239例 * |
Cited By (2)
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CN102119978A (zh) * | 2007-03-27 | 2011-07-13 | 北京亚东生物制药有限公司 | 具有解表、清热解毒的组合物及其制备、检测方法 |
CN102119978B (zh) * | 2007-03-27 | 2012-10-31 | 北京亚东生物制药有限公司 | 具有解表、清热解毒的组合物及其制备、检测方法 |
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