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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 ways to improve Bupleurum extraction process and its parameters in Chaihu oral solution. Methods Based on the quality standards of the pharmacopoeia, the quality problems of identification and clarification of the original product were solved by adjusting the dipping method, concentration temperature and time, refrigerating conditions and p H value, and the amount of excipients. The results showed that the extraction rate of volatile oil was increased by adding cold soak for 12 h; the decomposition temperature of saikosaponin d was reduced by controlling the concentration temperature and time; the obtained extract was placed at 1 ℃ by orthogonal test, and p H value of 7.0 refrigerated 48 h, the impurities effectively removed. Increasing the amount of propylene glycol increases the solubility stability of the product. Conclusion According to the improved process conditions, the quality of the three batches of finished products is qualified. The preliminary stability test results show that the process is stable and feasible.