柴胡口服液的工艺研究

Study on Bupleurum Oral Liquid

目的探讨完善柴胡口服液中的柴胡提取工艺及其参数的方法。方法以药典质量标准为指标,通过调整浸渍方法、浓缩温度和时间、冷藏条件和p H值、辅料用量等方法,解决原工艺产品鉴别和澄清度不合格的质量问题。结果通过增加药材冷浸12 h提高了挥发油的提取率;通过控制浓缩温度和时间尽可能减少了柴胡皂苷d的分解;通过正交试验筛检,将得到的提取液置于1℃、p H值为7.0条件下冷藏48 h,将杂质有效除去。通过增大丙二醇用量增加了产品的溶解稳定性。结论按改进后的工艺条件生产,三批成品质量合格,初步稳定性试验结果表明该工艺稳定、可行。

Objective To explore the methods that could improve the Bupleurum oral liquid technology and process parameters.Methods To take the Pharmacopoeia quality standards as the index,by adjusting the impregnation method,the concentration temperature and time,the condition of cold storage and p H value,the amount of excipients to solve quality problem about product identification of the original process and unqualification of clarification.Results By increasing medicinal cold impregnation 12 h to improve the extraction rate of volatile oil;By controlling the concentration temperature and time to minimize the decomposition of saikosaponin as possible; Through orthogonal test sieve to get extracting solution at 1 ℃,p H 7.0 under refrigeration conditions 48 h,under which the impurities can be effectively removed.By increasing the amounts of propylene glycol to improve the dissolution stability of product.Conclusion To produce according to the improved technolog conditions.The quality of three batch product is qualified.The results of the preliminary stability experiment is demonstrate that the technology is stable and feasible.