清咽利肺散医院制剂的关键工艺研究

Studies on key technology of hospital preparations of Qingyan Lifei Prescription

目的摸索中药医院制剂"清咽利肺散"处方水提液的纳滤浓缩工艺及干燥方法。方法采用HPLC测定黄芩苷经过纳滤浓缩后的保留率,以黄芩苷的保留率和膜通量为指标,通过单因素试验分析纳滤操作压力、吸附特征等因素对水提液浓缩工艺的影响。比较纳滤浓缩前后提取液HPLC图谱的一致性,并进一步比较两者的喷雾干燥效果。结果黄芩苷的保留率未受压力、浓缩倍数的影响,纳滤浓缩前后药液的HPLC图谱基本一致;提取液经过纳滤浓缩再喷雾干燥所得粉末更稳定。结论纳滤适用于浓缩清咽利肺处方的水煎提取液,纳滤浓缩液经过喷雾干燥后制成的散剂更稳定。

Objective To explore the nanofiltration enrichment process and drying method of extract solution for hospital preparation of Qingyan Lifei prescription. Methods Taking Baicalin as detection object, HPLC was employed to determine the nanofiltration retention rate of Baicalin of the extract solution. The effects of nanofiltration operating pressure and adsorption characteristics on concentration process were investigated by single factor tests with the retention rate of baicalin and membrane flux as the indexes. The consistency of the HPLC spectra of the extracts before and after nanofiltration was compared, and the spray drying results of the both were compared. Results The retention rate of Baicalin is not affected by pressure and cycles of concentration. The HPLC spectra of the solution after concentration is consistent with that before, and the powder of spray drying is more stable after nanofiltration process. Conclusion Nanofiltration concentration is suitable for concentrating the extract solution of Qingyan Lifei prescription, and the powder of spray drying is more stable by nanofiltration process.