CN104415111A - 一种苦黄注射液及其制备方法 - Google Patents

一种苦黄注射液及其制备方法 Download PDF

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CN104415111A
CN104415111A CN201310377165.6A CN201310377165A CN104415111A CN 104415111 A CN104415111 A CN 104415111A CN 201310377165 A CN201310377165 A CN 201310377165A CN 104415111 A CN104415111 A CN 104415111A
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张�浩
金红娣
陈程
梁慧容
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CHENGDU LISITE PHARMACEUTICAL Co Ltd
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Abstract

本发明公开了一种苦黄注射液及其制备方法，取茵陈、柴胡、苦参、大黄、大青叶、HS-15和注射用水组成。苦黄注射液制备方法：取茵陈、柴胡水蒸气蒸馏提取挥发油，收集挥发油备用；将蒸馏所得水溶液与蒸馏后药渣一起，与苦参、大青叶加水煎煮，浓缩水煎液,浓缩后中加入乙醇，回收浸膏药液备用；取大黄加水煎煮，水煎煮液浓缩,加入乙醇回收浸膏药液备用；将备用液与挥发油合并，加入HS-15混匀，调PH值，过滤，至澄明度合格后灌封，即得。全过程在无菌条件下进行，采用非最终灭菌工艺。与市售苦黄注射液相比较，本发明采用了新的制备方法，制成的产品符合药典标准，其突出的优势是极大地提高了苦黄注射液的临床用药安全性。

Description

一种苦黄注射液及其制备方法
技术领域
本发明涉及医药制剂工艺领域，特别涉及一种苦黄注射液及其制备方法。
技术背景
苦黄注射液具有清热利湿，疏肝退黄。之功效。用于主治湿热黄疸，也用于黄疸型病毒性肝炎。苦黄注射液药理研究证实其有促进胆汁分泌，保护肝损伤以及免疫调节作用，是临床常用药物之一，不良反应偶见注射局部有一过性潮红，个别患者出现轻度消化道症状，经查阅，临床上有过药物热、变态反应性喉水肿等过敏反应。经调查，现行市售苦黄注射剂其增溶剂为聚三梨酯80(吐温-80)，相关药理研究发现：2%吐温-80给豚鼠1m l/只静脉注射后出现生身体歪斜，嗜睡等明显症状，5%吐温-80豚鼠均出现耳朵发紫、步态不稳、身体歪斜，侧卧、嗜睡等非常明显的症状；Beagle犬静脉缓注吐温-80，剂量降低至0.02％吐温-80，以4ml/体积给予时,动物仍然会出现很显的过敏反应症状（孙立，刘晓萌等，J Toxicol August 2007 Vo1.21 No.4）,其它文献资料也确切证明吐温-80是导致临床用药时发生不良反应（过敏反应）的主要原因之一，为了进一步提高苦黄注射液临床用药的安全性，本发明选择了比吐温-80安全性更高的药用辅料。
发明内容
本发明目的在于提供一种全新处方和制备工艺的苦黄注射液、使苦黄注射液不仅质量稳定而且还具有比市售更高的临床用药安全性。为了达上上述目的，本发明采用如下技术方案：取茵陈50g、柴胡55g、苦参15g、大黄20g、大青叶40g、10.0-30.0g HS-15和注射用水组成。
苦黄注射液具体制备方法，取茵陈50g、柴胡55g采用水蒸气蒸馏法提取挥发油，收集挥发油备用；将蒸馏所得的水溶液与蒸馏后的药渣一起，加入苦参15g、大青叶40g合并加水煎煮2次，浓缩水煎液使密度达到1.12然后往浓缩液中加入乙醇，使乙醇浓度为70%（30℃），回收浸膏得到浓度为0.8g生药/ml药液备用；取大黄20g加水煎煮，水煎煮液浓缩后加入乙醇回收浸膏使其浓度为0.25 g生药/ml药液备用；将备用液浓缩后与挥发油合并，加入10.0-30.0g HS-15混合均匀，加注射用水1000ml，调PH值5.0-6.0，过滤，至澄明度合格后灌封，即得。
本发明中的制备方法全过程在无菌条件下进行，采用非最终灭菌工艺。
安全性实验证明：本发明在安全性方面（过敏反应）明显优于市售苦黄注射液。
具体实施方式
实施例1  苦黄注射液，由茵陈50g、柴胡55g、苦参15g、大黄20g、大青叶40g、10.0g HS-15和注射用水组成。
实施例1  取茵陈50g、柴胡55g加入蒸馏水，采用水蒸气蒸馏法提取挥发油，收集挥发油备用；将蒸馏所得的水溶液与蒸馏后的药渣一起，加入苦参15g、大青叶40g合并，加水煎煮2次，每次2小时，浓缩水煎液使密度达到1.12，然后往浓缩液中加入乙醇，使乙醇浓度为70%（30℃），置于4℃冷藏48小时，过滤，回收乙醇浸膏，加水混匀，冷藏过滤，得到浓度为0.8g生药/ml药液备用；取大黄20g加水煎煮2次，每次2小时，水煎煮液浓缩后加入乙醇，使其乙醇浓度在25-40℃浓度达到70%，置于4℃冷藏48小时，过滤，回收浸膏，加水混匀，冷藏过滤，使其浓度为0.25 g生药/ml药液备用；将备用液浓缩后与挥发油合并，加入10.0g HS-15混合均匀，加注射用水1000ml，调PH值5.8，过滤，至澄明度合格后灌封，即得。
实施例2  苦黄注射液，由茵陈50g、柴胡55g、苦参15g、大黄20g、大青叶40g、20.0g HS-15和注射用水组成。
实施例2  取茵陈50g、柴胡55g加入蒸馏水，采用水蒸气蒸馏法提取挥发油，收集挥发油备用；将蒸馏所得的水溶液与蒸馏后的药渣一起，加入苦参15g、大青叶40g合并，加水煎煮2次，每次2小时，浓缩水煎液使密度达到1.12，然后往浓缩液中加入乙醇，使乙醇浓度为70%（30℃），置于4℃冷藏48小时，过滤，回收乙醇浸膏，加水混匀，冷藏过滤，得到浓度为0.8g生药/ml药液备用；取大黄20g加水煎煮2次，每次2小时，水煎煮液浓缩后加入乙醇，使其乙醇浓度在25-40℃浓度达到70%，置于4℃冷藏48小时，过滤，回收浸膏，加水混匀，冷藏过滤，使其浓度为0.25 g生药/ml药液备用；将备用液浓缩后与挥发油合并，加入20.0g HS-15混合均匀，加注射用水1000ml，调PH值5.5，过滤，至澄明度合格后灌封，即得。
实施例3  苦黄注射液，由茵陈50g、柴胡55g、苦参15g、大黄20g、大青叶40g、30.0g HS-15和注射用水组成。
实施例3  取茵陈50g、柴胡55g加入蒸馏水，采用水蒸气蒸馏法提取挥发油，收集挥发油备用；将蒸馏所得的水溶液与蒸馏后的药渣一起，加入苦参15g、大青叶40g合并，加水煎煮2次，每次2小时，浓缩水煎液使密度达到1.12，然后往浓缩液中加入乙醇，使乙醇浓度为70%（30℃），置于4℃冷藏48小时，过滤，回收乙醇浸膏，加水混匀，冷藏过滤，得到浓度为0.8g生药/ml药液备用；取大黄20g加水煎煮2次，每次2小时，水煎煮液浓缩后加入乙醇，使其乙醇浓度在25-40℃浓度达到70%，置于4℃冷藏48小时，过滤，回收浸膏，加水混匀，冷藏过滤，使其浓度为0.25 g生药/ml药液备用；将备用液浓缩后与挥发油合并，加入30.0g HS-15混合均匀，加注射用水1000ml，调PH值6.0，过滤，至澄明度合格后灌封，即得。

Claims (4)

1.一种苦黄注射液，由茵陈、柴胡、苦参、大黄、大青叶、五味中药活性提取物 、增溶剂、及注射用水组成。
2.如权利要求1所述的苦黄注射液，其特征在于增溶剂采用HS-15（15-羟基硬脂酸聚乙二醇酯）。
3.如权利要求1-2所述的苦黄注射液，其特征在于茵陈50g、柴胡55g、苦参15g、大黄20g、大青叶，10.0-30.0g HS-15,和注射用水组成，过滤至澄明度合格后灌封，全过程在无菌条件下进行，采用非最终灭菌工艺。
4.如权利要求1-3所述的苦黄注射液，其特征在于采用如下制备工艺：
a.取茵陈50g、柴胡55g加入蒸馏水，采用水蒸气蒸馏法提取挥发油，收集挥发油备用；
b.将蒸馏所得的水溶液与蒸馏后的药渣一起，加入苦参15g、大青叶40g合并，加水煎煮2次，每次2小时，浓缩水煎液使密度达到1.12，然后往浓缩液中加入乙醇，使乙醇浓度为70%（30℃），置于4℃冷藏48小时，过滤，回收乙醇浸膏，加水混匀，冷藏过滤，得到浓度为0.8g生药/ml药液备用；
c.取大黄20g加水煎煮2次，每次2小时，水煎煮液浓缩后加入乙醇，使其乙醇浓度在25-40℃浓度达到70%，置于4℃冷藏48小时，过滤，回收浸膏，加水混匀，冷藏过滤，使其浓度为0.25 g生药/ml药液备用；
d.将备用液浓缩后与挥发油合并，加入10.0-30.0g HS-15混合均匀，加注射用水1000ml，调PH值5.0-6.0，过滤，至澄明度合格后灌封，即得，本品全过程在无菌条件下进行，采用非最终灭菌工艺。
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CN111228368A (zh) * 2020-02-28 2020-06-05 雷允上药业集团有限公司 中药组合物在制备用于防治新型冠状病毒合并肝损伤药物中的应用

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CN110960601A (zh) * 2019-12-20 2020-04-07 雷允上药业集团有限公司 一种具有治疗脂肪代谢异常疾病的中药组合物及其应用
CN111228368A (zh) * 2020-02-28 2020-06-05 雷允上药业集团有限公司 中药组合物在制备用于防治新型冠状病毒合并肝损伤药物中的应用
CN111228368B (zh) * 2020-02-28 2022-04-12 雷允上药业集团有限公司 中药组合物在制备用于防治新型冠状病毒合并肝损伤药物中的应用

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