基于混料设计的婷柳提取液喷雾干燥工艺及其物理指纹图谱研究

Study on Spray Drying Process and Physical Fingerprint of Tingliu Extract Based on Mixture Design

目的改善婷柳提取液喷雾干燥效果,并建立其物理指纹图谱。方法以婷柳喷干粉得率、吸湿率、流动性为指标对所加入辅料进行筛选,同时采用混料设计的方法,对所筛选辅料配比进行优化;在此基础上,建立由含水量、吸湿率、休止角、卡尔指数等9个指标构成的婷柳喷干粉物理指纹图谱,采用皮尔逊相关系数法,对10批婷柳喷干粉物理指纹图谱进行相似度评价。结果最终优选辅料为轻质氧化镁、麦芽糊精、羟丙基-β-环糊精,通过建立喷干粉得率、吸湿率、休止角与筛选辅料配比的回归方程,优选辅料配比为干膏∶轻质氧化镁∶麦芽糊精∶羟丙基-β-环糊精=0.55∶0.3∶0.1∶0.05;此优选辅料配比下,喷干粉得率为64.42%,吸湿率为13.27%,休止角为36.81°。10批婷柳喷干粉样品物理指纹图谱相似度均大于0.99。结论优选的辅料配比能够较好的提高婷柳喷雾干燥得粉率,改善喷干粉性质,建立基于物理指纹图谱的婷柳喷干粉的质量控制方法,为婷柳制剂过程质量控制提供参考。

OBJECTIVE To improve the spray drying effect of Tingliu extract and establish its physical fingerprint.METHODS The added auxiliary materials were screened by the yield,moisture absorption rate and fluidity of Tingliu spray dry powder,and the ratio of the selected auxiliary materials was optimized by the method of mixing design.On this basis,the physical fingerprint of Tingliu spray dry powder composed of nine indicators,including water content,moisture absorption,angle of repose,and Karl index,was established,and the similarity evaluation of the physical fingerprint of 10 batches of Tingliu spray dry powder was evaluated by using the Pearson correlation coefficient method.RESULTS The final preferred excipients were light magnesium oxide,maltodextrin,hydroxypropyl-β-cyclodextrin,and by establishing the regression equation of spray dry powder yield,moisture absorption,angle of repose and screening excipient ratio,the preferred excipient ratio was dry paste∶light magnesium oxide∶maltodextrin∶hydroxypropyl-β-cyclodextrin 0.55∶0.3∶0.1∶0.05;under this preferred excipient ratio,the spray-dried powder yield was 64.42%,the moisture absorption rate was 13.27%,and the angle of repose was 36.81°.The similarity of the physical fingerprints of 10 batches of Tingliu spray dry powder samples was greater than 0.99.CONCLUSION In this study,the preferred ratio of excipients can better improve the powder yield of Tingliu spray drying,improve the properties of spray dry powder,and establish a quality control method for Tingliu spray dry powder based on physical fingerprint,which provides a reference for the quality control of Tingliu preparation process.