目的从化学成分质量分数变化的角度,考察不同干燥方式和条件对板蓝根水提物质量的影响,为建立制剂工艺有无质的改变的早期快速检测方法体系提供依据。方法板蓝根水提液分别采用冷冻干燥、减压干燥、常压干燥、喷雾干燥4种不同方式进行干燥,测定并比较各干燥样品中的苯甲酸、水杨酸、腺苷和多糖的质量分数。结果不同干燥方式样品中苯甲酸、水杨酸、腺苷和多糖的质量分数存在较大差异,以冷冻干燥样品各项成分质量分数最高,喷雾干燥次之,90℃常压干燥样品最低。在实验范围内,板蓝根水提物在冷冻干燥、喷雾干燥条件下比较稳定,60℃以上常压或减压干燥条件下不稳定。结论板蓝根制剂的干燥工艺从冷冻干燥、喷雾干燥转变成60℃以上减压干燥或常压干燥时,须注意其生产工艺是否存在质的改变。干燥方式和条件的改变对板蓝根水提物质量的影响不容忽视,指标性化学成分测定可作为不同干燥工艺对板蓝根水提物是否产生质的改变的早期快速评价方法。

From the viewpoint of chemical composition, the effect of different drying methods and conditions on thequality of water extracts from Isatidis Radix was investigated. Evidence was provided for the establishment of early and rapid detection system of the quality change of traditional Chinese medicine preparation. Methods Water extracts from Isatidis Radix were dried by freeze drying, vacuum drying, drying under normal pressure, and spray drying, respectively. The contents of salicylic acid, benzoic acid, adenosine, and polysaccharose in samples by different drying methods were determined and compared with each other. Results The contents of salicylic acid, benzoic acid, adenosine, and polysaccharose in samples by different drying methods were obviously different. Those in samples prepared by freeze drying were the highest, those by spray drying were the second highest, and those by drying under normal pressure at 90 ℃ were the lowest. Water extracts from Isatidis Radix prepared by freeze drying and spray drying were stable, while those prepared by vacuum drying and drying under normal pressure at the temperature over 60 ℃ were not stable. It was indicated that quality change might happen when the drying method transferred from freeze drying/spray drying to vacuum drying or drying under normal pressure at the temperature over 60 ℃. Conclusion The effect of different drying methods and conditions on the quality of water extracts from Isatidis Radix should not be ignored. Determination of the index chemical composition can be an early and rapid detection method to evaluate the quality change of traditional Chinese medicine preparation.

国家杰出青年科学基金项目(30625042);国家自然科学基金资助项目(30600824)