清热解毒口服液ZTC1+1Ⅲ型天然澄清剂精制工艺技术改进

Technical Improvement in Refining Process for ZTC1+1Ⅲ Natural Clarificant for Qingrejiedu Oral Liquid

为解决清热解毒口服液中药水提醇沉精制存在的回收乙醇能源用量大,静置生产周期长,生产效率低,费工费时及有效成分易在醇沉制备过程中损失等问题,对精制工艺进行技术改进。采用水提醇沉和ZTC1+1Ⅲ型天然澄清剂进行精制工艺对比试验。按ZTC1+1Ⅲ型天然澄清剂精制生产工艺制备,提取液、浸膏、药液配制后及产品灭菌后的澄清度、性状、鉴别、pH值、黄芩苷含量测定、微生物限度等各项检查均符合标准要求。ZTC1+1Ⅲ型天然澄清剂精制工艺相对于醇沉精制工艺,澄清度好,黄芩苷含量提高了30%,具有生产周期短、生产费用低、生产效率高、方便快捷的优势,为ZTC1+1Ⅲ型天然澄清剂在中药口服液及中药制剂精制生产当中的应用提供了参考依据。

To solve the problems in the process of alcohol precipitation for Qingrejiedu oral liquid,such as large amount of consumed energy in recovery of ethanol,long production cycle,low production efficiency,time and labor consuming,and easy loss of effective components,the technical improvement of the refining process was carried out.Water extraction and alcohol precipitation and ZTC1+1Ⅲ natural clarificant were used in refining process for comparative study.Prepared with the refined production process of ZTC1+1Ⅲ natural clarificant,all the indexes from the test were reached the requirements in the standard,including the clarity,character,identification,PH value,determination of baicalin content,and microbial limit.Compared with the alcohol precipitation refining process,the refining process with ZTC1+1Ⅲ natural clarifying agent has a better degree of clarification,and the baicalin content can be increased by 30%.It also has the advantages of short production cycle,low production cost,high production efficiency,convenient and fast operation.What presented herein can be the reference for the application of ZTC1+1Ⅲ natural clarifying agent in refining production of traditional Chinese medicine oral liquid and traditional Chinese medicine preparation.