CN116617295A - 一种小儿解表口服液制剂改变为浸膏剂的制备方法 - Google Patents
一种小儿解表口服液制剂改变为浸膏剂的制备方法 Download PDFInfo
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Abstract
本发明所属中药研究开发技术领域。本发明涉及一种小儿解表口服液制剂改变为浸膏剂的制备方法。方剂组成为金银花、连翘、紫苏叶、荆芥穗、牛蒡子(炒)、蒲公英、黄芩、防风、葛根、人工牛黄；将金银花、连翘、紫苏叶、荆芥穗粉末放入到微波萃取罐中，进行微波萃取，获得萃取液，过滤，得滤液；将牛蒡子(炒)、蒲公英、黄芩、防风、葛根粉末放入到多功能提取罐中，加水、加热、提取，获得提取液，过滤，得滤液；将滤液合并、过滤、静置、离心、冷藏储存、灭菌，将灭菌后的滤液中加入人工牛黄、加入环拉酸钠、山梨酸钾，加热至沸、冷却降温、过滤、浓缩，得浸膏；将浸膏灌装入浸膏瓶中，包装即可。本发明产品具有清热解毒，宣肺解表之功效。
Description
技术领域
本发明所属中药研究开发技术领域。本发明涉及一种小儿解表口服液制剂改变为浸膏剂的制备方法。本发明产品具有清热解毒，宣肺解表之功效。
背景技术
我国每年有75％的人至少患一次感冒，每年有近10亿人至少需用一次感冒药物，相比较成年人，儿童身体抵抗力更低，感冒的几率更大，儿童感冒发病率占儿科疾病首位，每年发病次数约5-7次。但由于儿童处于不断生长发育的动态变化过程中，脏器发育及其功能、心理发育尚不成熟，目前儿童用药领域存在市场规模较小，儿童专用药品少，适宜低龄儿童剂型、规格不足，口感差、儿童不易使用等问题。
小儿解表口服液主要用于治疗儿童流行性感冒、急性扁桃腺炎、咽炎、肺炎、疱疹、流行性腮腺炎等病毒性感染疾病的儿科中成药，成功解决了儿童常见感冒用药问题。小儿解表口服液以清代名医吴鞠通《温病条辨》中被称为“温病第一方”的辛凉平剂“银翘散”为基础方经加减后组成，与类似方剂相比，小儿解表口服液无大热大寒药材，药性温和，保护患儿的脏腑，安全性更高。同时其组方配伍严谨，既可以快速的解除感冒的所有症状，又可以根据病因深度治疗，达到真正的标本兼治，适应不同年龄层儿童用药；小儿解表口服液浓缩药品有效成分，增加药效，且口感甜、微苦，使儿童更易于饮用。
1、根据儿童特点研发，疗效确切。《幼科释谜·感冒》当其感冒，浅在肌肤，表之则散，发之则祛，病斯痊矣。若不早治，由外内徂，侵经及络，脏腑壅沮，变成大病，难以骤驱，而至于危，而至于殂。患儿感冒初期，应宣肺解表，为其治疗的关键本品具有清热解毒、宣肺解表的功效，适用于小儿外感风热感冒。具有宣肺解表、清热解毒、豁痰定惊之作用，同时具有抗菌抗病毒，解热和增强小儿免疫力的作用，故也适用于手足口病患儿。
2、适应症明确，临床循证有效。小儿解表口服液被明确标注为可用于治疗因外感风热引起的感冒发热、头痛咳嗽、鼻塞流涕、咽喉痛痒等症状，其适应症明确无误。300例多中心临床试验结果表明，小儿解表口服液在临床痊愈时间、完全退热时间等主要治疗指标上与其他抗病毒药物(如磷酸奥司他韦颗粒)无差异，且在包括头身疼痛/不适、咽痛、咳嗽、鼻塞、喷嚏、流涕、汗出、便秘、小便黄症等单项症状消失率方面明显优于后者。小儿解表口服液不仅真正实现了小儿感冒病症的快速治疗，而且中成药成分不会对小儿身体造成危害，无毒副作用。
3、剂型优势，疗效更稳定。相比于颗粒剂、片剂、胶囊剂，小儿解表口服液采用口服液，具有使用方便、快速吸收的特点，更加适合儿童使用。
口服液优点：与汤剂相比较，口服液具有以下优点：
(1)属于液体制剂，绝大部分为溶液型，吸收快，奏效迅速。
(2)采用单剂量包装，携带和服用方便，易保存，安全有效。
(3)制备工艺控制严格，口服液质量和疗效稳定。
(4)服用量小，易为患者，特别是儿童、婴幼儿所接受。
4、精准的儿童用法用量。针对不同年龄段儿童生长发育特点，采用精细的用法用量标准。在安全性与有效性上更理想。此药品安全剂量范围较大，每只小鼠灌胃小儿解表口服液0.8ml(1.95g生药/ml)，相当于临床用药量200倍，观察7天，小鼠活动正常，无一例死亡。该药品上市后临床试验研究，308例患者安全性检测血液学指标，尿、便常规及心、肝、肾功能等亦未见异常变化，说明此药品安全性较好(上海复旦大学附属儿科医院感染科)。
小儿解表口服液由金银花、连翘、紫苏叶、荆芥穗、牛蒡子(炒)、蒲公英、黄芩、防风、葛根、人工牛黄等10味中药组成，具有宣肺解表，清热解毒之效。用于外感风热引起的感冒恶寒发热，头痛咳嗽，鼻塞流涕，咽喉痛痒。药性温和，适合小儿娇嫩脏腑。
【用法与用量】口服，一至二岁一次5ml，一日2次；三至五岁一次5ml，一日3次；六至十四岁一次10ml，一日2～3次。
【规格】每支装10ml
【贮藏】密封，置阴凉处。
【有效期】2年
小儿解表口服液中的主要有效成分为具有抗病毒功效的绿原酸。采用微波萃取法取代传统的高温煎煮法，避免了高温破坏绿原酸有效成份，最大程度保留了绿原酸的活性，充分发挥其抗病毒作用。将连翘、紫苏叶、荆芥穗采用微波萃取获得有效性成分。将牛蒡子(炒)、蒲公英、黄芩、防风、葛根水提取有效成分。
小儿解表浸膏剂既具有小儿解表口服液的优点外，还具有体积小，便于服用、便于运输等特点。
发明内容
1.一种小儿解表口服液制剂改变为浸膏剂的制备方法，其特征在于步骤如下：
(1)方剂组成为金银花、连翘、紫苏叶、荆芥穗、牛蒡子(炒)、蒲公英、黄芩、防风、葛根、人工牛黄；
(2)将(1)中的金银花、连翘、紫苏叶、荆芥穗洗净、晾干，粉碎成10-20目粉末；
(3)将(1)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根洗净、烘干，粉碎成20-40目粉末；
(4)将(2)中的金银花、连翘、紫苏叶、荆芥穗粉末放入到微波萃取罐中，进行微波萃取，溶剂为80-85％乙醇，料液比1∶10，功率550-600W，反应时间20-30min，获得金银花、连翘、紫苏叶、荆芥穗萃取液、过滤，得滤液；
(5)将(3)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根粉末放入到多功能提取罐中，加水为药材的8-10倍、加热3-4h，过滤，获得滤液和残渣；
(6)将(5)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根残渣放入到多功能提取罐中，加水为药材的6-8倍、加热2-3h，过滤，获得滤液和残渣；
(7)将(4)中的滤液、(5)中的滤液和(6)中的滤液合并，过滤，静置；
(8)将(7)中静置后的滤液上清液泵入至冷藏罐，在冷沉液处理室进行分离机离心；
(9)将(8)中离心后的滤液泵入另一冷藏罐中，进行冷藏储存；
(10)将(9)中冷藏罐内的滤液进行灭菌：
(11)将(10)中灭菌后的滤液经密闭管道打入配液间的配液罐中，进行灭菌；
(12)将(11)中灭菌后的含有滤液的配液罐中加入(1)中的人工牛黄、加入环拉酸钠、山梨酸钾，盖上罐盖，调节罐内压力，加热至沸，冷却降温、过滤、浓缩，得浸膏；
(13)将浸膏瓶在烘干间进行清洗、烘干、灭菌；
(14)将(12)中浸膏灌装入(13)中浸膏瓶中，包装即可。
具体实施方式
本发明所述的涉及一种小儿解表口服液制剂改变为浸膏剂的制备方法，包括以下实施例，下面的实施例可进一步说明本发明，但不以任何方式限制本发明。
实施例1：
1.一种小儿解表口服液制剂改变为浸膏剂的制备方法，其特征在于步骤如下：
(1)方剂组成为金银花、连翘、紫苏叶、荆芥穗、牛蒡子(炒)、蒲公英、黄芩、防风、葛根、人工牛黄；
(2)将(1)中的金银花、连翘、紫苏叶、荆芥穗洗净、晾干，粉碎成10目粉末；
(3)将(1)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根洗净、烘干，粉碎成20目粉末；
(4)将(2)中的金银花、连翘、紫苏叶、荆芥穗粉末放入到微波萃取罐中，进行微波萃取，溶剂为80％乙醇，料液比1∶10，功率550W，反应时间20min，获得金银花、连翘、紫苏叶、荆芥穗萃取液、过滤，得滤液；
(5)将(3)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根粉末放入到多功能提取罐中，加水为药材的8倍、加热3h，过滤，获得滤液和残渣；
(6)将(5)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根残渣放入到多功能提取罐中，加水为药材的6倍、加热2h，过滤，获得滤液和残渣；
(7)将(4)中的滤液、(5)中的滤液和(6)中的滤液合并，过滤，静置；
(8)将(7)中静置后的滤液上清液泵入至冷藏罐，在冷沉液处理室进行分离机离心；
(9)将(8)中离心后的滤液泵入另一冷藏罐中，进行冷藏储存；
(10)将(9)中冷藏罐内的滤液进行灭菌：
(11)将(10)中灭菌后的滤液经密闭管道打入配液间的配液罐中，进行灭菌；
(12)将(11)中灭菌后的含有滤液的配液罐中加入(1)中的人工牛黄、加入环拉酸钠、山梨酸钾，盖上罐盖，调节罐内压力，加热至沸，冷却降温、过滤、浓缩，得浸膏；
(13)将浸膏瓶在烘干间进行清洗、烘干、灭菌；
(14)将(12)中浸膏灌装入(13)中浸膏瓶中，包装即可。
实施例2：
1.一种小儿解表口服液制剂改变为浸膏剂的制备方法，其特征在于步骤如下：
(1)方剂组成为金银花、连翘、紫苏叶、荆芥穗、牛蒡子(炒)、蒲公英、黄芩、防风、葛根、人工牛黄；
(2)将(1)中的金银花、连翘、紫苏叶、荆芥穗洗净、晾干，粉碎成20目粉末；
(3)将(1)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根洗净、烘干，粉碎成40目粉末；
(4)将(2)中的金银花、连翘、紫苏叶、荆芥穗粉末放入到微波萃取罐中，进行微波萃取，溶剂为85％乙醇，料液比1∶10，功率600W，反应时间30min，获得金银花、连翘、紫苏叶、荆芥穗萃取液、过滤，得滤液；
(5)将(3)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根粉末放入到多功能提取罐中，加水为药材的10倍、加热4h，过滤，获得滤液和残渣；
(6)将(5)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根残渣放入到多功能提取罐中，加水为药材的8倍、加热3h，过滤，获得滤液和残渣；
(7)将(4)中的滤液、(5)中的滤液和(6)中的滤液合并，过滤，静置；
(8)将(7)中静置后的滤液上清液泵入至冷藏罐，在冷沉液处理室进行分离机离心；
(9)将(8)中离心后的滤液泵入另一冷藏罐中，进行冷藏储存；
(10)将(9)中冷藏罐内的滤液进行灭菌：
(11)将(10)中灭菌后的滤液经密闭管道打入配液间的配液罐中，进行灭菌；
(12)将(11)中灭菌后的含有滤液的配液罐中加入(1)中的人工牛黄、加入环拉酸钠、山梨酸钾，盖上罐盖，调节罐内压力，加热至沸，冷却降温、过滤、浓缩，得浸膏；
(13)将浸膏瓶在烘干间进行清洗、烘干、灭菌；
(14)将(12)中浸膏灌装入(13)中浸膏瓶中，包装即可。
Claims (1)
1.一种小儿解表口服液制剂改变为浸膏剂的制备方法，其特征在于步骤如下：
(1)方剂组成为金银花、连翘、紫苏叶、荆芥穗、牛蒡子(炒)、蒲公英、黄芩、防风、葛根、人工牛黄；
(2)将(1)中的金银花、连翘、紫苏叶、荆芥穗洗净、晾干，粉碎成10-20目粉末；
(3)将(1)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根洗净、烘干，粉碎成20-40目粉末；
(4)将(2)中的金银花、连翘、紫苏叶、荆芥穗粉末放入到微波萃取罐中，进行微波萃取，溶剂为80-85％乙醇，料液比1∶10，功率550-600W，反应时间20-30min，获得金银花、连翘、紫苏叶、荆芥穗萃取液、过滤，得滤液；
(5)将(3)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根粉末放入到多功能提取罐中，加水为药材的8-10倍、加热3-4h，过滤，获得滤液和残渣；
(6)将(5)中的牛蒡子(炒)、蒲公英、黄芩、防风、葛根残渣放入到多功能提取罐中，加水为药材的6-8倍、加热2-3h，过滤，获得滤液和残渣；
(7)将(4)中的滤液、(5)中的滤液和(6)中的滤液合并，过滤，静置；
(8)将(7)中静置后的滤液上清液泵入至冷藏罐，在冷沉液处理室进行分离机离心；
(9)将(8)中离心后的滤液泵入另一冷藏罐中，进行冷藏储存；
(10)将(9)中冷藏罐内的滤液进行灭菌：
(11)将(10)中灭菌后的滤液经密闭管道打入配液间的配液罐中，进行灭菌；
(12)将(11)中灭菌后的含有滤液的配液罐中加入(1)中的人工牛黄、加入环拉酸钠、山梨酸钾，盖上罐盖，调节罐内压力，加热至沸，冷却降温、过滤、浓缩，得浸膏；
(13)将浸膏瓶在烘干间进行清洗、烘干、灭菌；
(14)将(12)中浸膏灌装入(13)中浸膏瓶中，包装即可。
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| CN105816528A (zh) * | 2016-03-23 | 2016-08-03 | 四川好医生药业集团有限公司 | 改善了口感的小儿解表颗粒及其制备方法 |
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| CN105816528A (zh) * | 2016-03-23 | 2016-08-03 | 四川好医生药业集团有限公司 | 改善了口感的小儿解表颗粒及其制备方法 |
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