CN114652782A - 一种小儿柴银口服液的制备工艺 - Google Patents
一种小儿柴银口服液的制备工艺 Download PDFInfo
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Abstract
柴银感冒颗粒由柴胡、金银花、拳参、射干、僵蚕、大青叶、板蓝根、陈皮、甘草九味药物组成。在此基础上本发明提供了一种小儿柴银口服液的制备方法，将柴银感冒颗粒剂型改为口服液，其更容易被人体吸收利用，起效更快；使用聚丙烯口服液瓶单剂量包装，便于携带和服用；不含防腐剂、香精等添加剂，提高儿童用药的安全性和患者的依从性；进一步研究了提取制备工艺，使得该制备方法更具有可行性。
Description
技术领域
本发明涉及一种具有清热解毒功效，用于风热感冒的中药组合物，特别涉及一种小儿柴银口服液的制备方法。
背景技术
柴银感冒颗粒由柴胡、金银花、拳参、射干、僵蚕、大青叶、板蓝根、陈皮、甘草九味药物组成，其功能主治维医为“平衡体液，调整气质，抗乃孜来”，中医为“清热解毒。用于风热感冒，症见发热，头痛，咽痛”，是进入自治区医保乙类目录的非处方药。
现有技术一：“张丽, 张文文. 柴银感冒颗粒（无糖型）辅料筛选研究[J]. 新疆中医药, 2006, 24（5):3.”对比了柴银感冒浸膏粉采用乳糖、甘露醇、糊精、淀粉、微品纤维素或者上述混合物作为辅料时制粒的效果，研究结果表明，乳糖与甘露醇（4∶1）的混合辅料制成的颗粒成型率好，吸湿性小，符合颗粒剂的质量要求，可以作为柴银感冒颗粒（无糖型）的辅料。
现有技术二：“张文文, 黎玉红. 综合评分法优化柴银感冒颗粒提取液的澄清工艺[J]. 西北药学杂志, 2010, 025（006):426-428.”选用ZTC1+1-Ⅱ型天然澄清剂，对柴银感冒颗粒提取液的澄清工艺进行筛选，通过综合评分法优化柴银感冒颗粒提取液的澄清工艺条件，达到了去除杂质，提高出膏率的目的。
以上对比文件均是对柴银感冒颗粒的部分工艺进行的研究，未完全披露柴银感冒颗粒或小儿柴银口服液的全部制备工艺，且颗粒剂相比口服液具有起效吸收慢，不易携带和服用，在高温潮湿环境下易吸潮结块，工艺复杂生产成本高的缺点。
发明内容
一、要解决的技术问题。
本发明目的在于提供一种小儿柴银口服液的制备方法，将柴银感冒颗粒剂型改为口服液，解决颗粒剂起效吸收慢，不携带和易服用，在高温潮湿环境下易吸潮结块的缺点，同时进一步研究了提取制备工艺，使其不含防腐剂、香精等添加剂，更适合儿童服用。
二、技术方案。
小儿柴银口服液的制备工艺如下：
步骤1：柴胡、陈皮提取：将柴胡和陈皮投入多功能提取罐中，注入纯化水，50℃温浸2h，煮沸，回流提取1-2小时，收得挥发油Ⅰ；下层水溶液滤过，得到水溶液Ⅱ和药渣Ⅲ。
步骤2：药材煎煮浓缩：将药渣Ⅲ、金银花、拳参、射干、大青叶、板蓝根、甘草投入多功能提取罐中，煎煮两次，每次2小时，分别滤过，所得滤液与水溶液Ⅱ合并，滤过，得到混合溶液；混合溶液真空抽置单效浓缩罐内，浓缩至相对密度为1.05的第一清膏；第一清膏冷却至室温，加入95%乙醇使药液含醇量为70%，用氢氧化钠溶液调节pH值至8，静置12小时，抽取上清液，沉淀离心，得到第二清膏；第二清膏吸入真空浓缩器内，浓缩至相对密度1.10～1.15，过滤得清膏Ⅳ。
步骤3：僵蚕提取浓缩：僵蚕用多功能超声波提取机，于50℃用70%乙醇提取30min，用真空浓缩器浓缩至相对密度为1.10～1.15，过滤得清膏Ⅴ。
步骤4：配液：将清膏Ⅳ、清膏Ⅴ、蜂蜜、蔗糖加入机械搅拌配液罐中搅匀，离心，煮沸并保温1小时以上，冷却至25℃以下，加入挥发油Ⅰ，纯化水，搅匀，灌装即得小儿柴银口服液。
进一步的，单效浓缩罐，真空浓缩器的压力控制在0.1～0.2Mpa。
进一步的，步骤1中纯化水的量为柴胡、陈皮两者质量和的10倍。
进一步的，步骤2中的煎煮两次，第一次煎煮加入10倍药材质量的纯化水，第二次煎煮加入8倍药材质量的纯化水。
进一步的，单效浓缩罐，真空浓缩器的温度不高于75℃。
进一步的，步骤3中，70%乙醇的加入量为僵蚕质量的10倍。
进一步的，小儿柴银口服液使用聚丙烯口服液瓶包装。
三、有益效果。
本发明相对于现有技术的有益效果是：提供了一种小儿柴银口服液的制备方法，将柴银感冒颗粒剂型改为口服液，使其更容易被人体吸收利用，起效更快；使用聚丙烯口服液瓶单剂量包装，便于携带和服用；不含防腐剂、香精等添加剂，提高儿童用药的安全性和患者的依从性；进一步研究了提取制备工艺，细化了生产工艺参数，减少生产耗时，使得该制备方法更具有可行性。
附图说明
图1是本发明权利要求1中步骤1的工艺流程图。
图2是本发明权利要求1中步骤2的工艺流程图。
图3是本发明权利要求1中步骤3的工艺流程图。
图4是本发明权利要求1中步骤4的工艺流程图。
具体实施方式
以下实施例中的描述仅用于更好地理解本发明，并不限定本发明的保护范围。下述实施例中的工艺方法，如无特殊说明，均为常规方法。
小儿柴银口服液每批1L的制法：
原料：柴胡 185g、金银花 185g、拳参 185g、僵蚕 185g、射干 111g、大青叶 93g、板蓝根 93g、甘草 99g、陈皮 74g、蔗糖300g、蜂蜜100g。
步骤1：柴胡、陈皮提取：将柴胡185g和陈皮74g投入多功能提取罐中，注入纯化水，50℃温浸2h，纯化水的量为柴胡、陈皮两者质量和的10倍，煮沸，回流提取1小时，收得挥发油Ⅰ；下层水溶液滤过，得到水溶液Ⅱ和药渣Ⅲ。
步骤2：药材煎煮浓缩：将药渣Ⅲ、金银花185g、拳参185g、射干111g、大青叶93g、板蓝根93g、甘草99g投入多功能提取罐中，煎煮两次，第一次煎煮加入10倍药材质量的纯化水，第二次煎煮加入8倍药材质量的纯化水，每次2小时，分别滤过；所得滤液与水溶液Ⅱ合并，滤过，得到混合溶液；混合溶液真空抽置单效浓缩罐内，温度控制在70℃，压力控制在0.15Mpa，浓缩至相对密度为1.05的第一清膏；第一清膏冷却至室温，加入95%乙醇使药液含醇量为70%，用氢氧化钠溶液调节pH值至8，静置12小时，抽取上清液，沉淀离心，得到第二清膏；第二清膏吸入真空浓缩器内，压力控制在0.15Mpa，温度控制在70℃浓缩至相对密度1.12，过滤得清膏Ⅳ。
步骤3：僵蚕提取浓缩：僵蚕用多功能超声波提取机，温度控制为50℃，用70%乙醇提取30min，70%乙醇的加入量为僵蚕质量的10倍；真空浓缩器温度控制在70℃，压力控制在0.15Mpa，浓缩至相对密度为1.11，过滤得清膏Ⅴ。
步骤4：配液：将清膏Ⅳ、清膏Ⅴ、蜂蜜100g、蔗糖300g加入机械搅拌配液罐中搅匀，离心，煮沸并保温1小时以上，冷却至25℃以下，加入挥发油Ⅰ，纯化水，搅匀，灌装既得小儿柴银口服液。
Claims (7)
1.一种小儿柴银口服液的制备工艺，其特征在于：
步骤1：柴胡、陈皮提取：将所述柴胡和所述陈皮投入多功能提取罐中，注入纯化水，50℃温浸2h，煮沸，回流提取1-2小时，收得挥发油Ⅰ；下层水溶液滤过，得到水溶液Ⅱ和药渣Ⅲ；
步骤2：药材煎煮浓缩：将所述药渣Ⅲ、金银花、拳参、射干、大青叶、板蓝根、甘草投入多功能提取罐中，煎煮两次，每次2小时，分别滤过，所得滤液与所述水溶液Ⅱ合并，滤过，得到混合溶液；所述混合溶液真空抽置单效浓缩罐内，浓缩至相对密度为1.05的第一清膏；所述第一清膏冷却至室温，加入95%乙醇使药液含醇量为70%，用氢氧化钠溶液调节pH值至8，静置12小时，抽取上清液，沉淀离心，得到第二清膏；所述第二清膏吸入真空浓缩器内，浓缩至相对密度1.10～1.15，过滤得清膏Ⅳ；
步骤3：僵蚕提取浓缩：所述僵蚕投入多功能超声波提取机中，温度设置为50度，加入70%乙醇提取30min，用真空浓缩器浓缩至相对密度为1.10～1.15，过滤得清膏Ⅴ；
步骤4：配液：将所述清膏Ⅳ、所述清膏Ⅴ、蜂蜜、蔗糖加入机械搅拌配液罐中搅匀，离心，煮沸并保温1小时以上，冷却至25℃以下，加入所述挥发油Ⅰ，纯化水，搅匀，灌装即得小儿柴银口服液。
2.如权利要求1所述的一种小儿柴银口服液的制备工艺，其特征在于：所述单效浓缩罐，真空浓缩器的压力控制在0.1～0.2Mpa。
3.如权利要求1所述的一种小儿柴银口服液的制备工艺，其特征在于：所述步骤1中纯化水的量为柴胡、陈皮两者质量和的10倍。
4.如权利要求1所述的一种小儿柴银口服液的制备工艺，其特征在于：所述步骤2中的所述煎煮两次，第一次煎煮加入10倍药材质量的纯化水，第二次煎煮加入8倍药材质量的纯化水。
5.如权利要求1所述的一种小儿柴银口服液的制备工艺，其特征在于：所述单效浓缩罐，所述真空浓缩器的温度不高于75℃。
6.如权利要求1所述的一种小儿柴银口服液的制备工艺，其特征在于：所述步骤3中，70%乙醇的加入量为僵蚕质量的10倍。
7.如权利要求1所述的一种小儿柴银口服液的制备工艺，其特征在于：所述小儿柴银口服液使用聚丙烯口服液瓶包装。
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| CN1861177A (zh) * | 2006-04-18 | 2006-11-15 | 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 |
| CN111228357A (zh) * | 2018-11-28 | 2020-06-05 | 鲁南制药集团股份有限公司 | 一种柴银微丸制剂及其制备方法 |
| CN112444579A (zh) * | 2020-12-15 | 2021-03-05 | 鲁南厚普制药有限公司 | 柴银口服液uplc指纹图谱的建立方法 |
| WO2021189743A1 (zh) * | 2020-03-25 | 2021-09-30 | 鲁南制药集团股份有限公司 | 柴银制剂在制备抗冠状病毒药物中的应用及其制备方法 |
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| CN1861177A (zh) * | 2006-04-18 | 2006-11-15 | 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 |
| CN111228357A (zh) * | 2018-11-28 | 2020-06-05 | 鲁南制药集团股份有限公司 | 一种柴银微丸制剂及其制备方法 |
| WO2021189743A1 (zh) * | 2020-03-25 | 2021-09-30 | 鲁南制药集团股份有限公司 | 柴银制剂在制备抗冠状病毒药物中的应用及其制备方法 |
| CN112444579A (zh) * | 2020-12-15 | 2021-03-05 | 鲁南厚普制药有限公司 | 柴银口服液uplc指纹图谱的建立方法 |
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