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目的:通过前列安栓水提粉HPLC指纹图谱系统,研究水提粉不同工序的成分损失及不同容量设备、不同工艺参数对质量波动的影响。方法:采用HPLC法,以Agilent HC-C18(250 mm×4.6 mm,5μm)为色谱柱;甲醇-0.25%冰醋酸溶液(p H 3.0)为流动相,25℃梯度洗脱;流速为1.0 m L/min;检测波长为280 nm。对两种提取温度的产品进行对比;对水提、醇沉、干燥工序的成分进行检测分析,研究工序损失率;对两种容量的提取设备进行对比。结果:建立有26个共有特征峰的对照图谱对A、B工艺样品进行分析,相似度均大于0.95;对A、B工艺不同工序进行含量分析,考察工序损失率,干燥工序>醇沉工序,A工艺优于B工艺,3M3罐优于2M3罐。结论:以HPLC指纹图谱法对中成药生产过程的中间产品进行分析和定量研究,对优化工艺参数和提高工艺质量控制水平具有重要意义。
OBJECTIVE: To study the influence of different composition and equipment parameters and process parameters on quality fluctuation by using HPLC method of Qianlieanshui powder HPLC fingerprinting system. Methods: The mobile phase was eluted with a mobile phase of methanol-0.25% glacial acetic acid (p H 3.0) using a mobile phase of Agilent HC-C18 (250 mm × 4.6 mm, 5 μm) L / min; detection wavelength is 280 nm. The two products were compared in temperature; the water extraction, alcohol precipitation, drying process components were detected and analyzed to study the process loss rate; two capacity extraction equipment were compared. Results: A control map of 26 common characteristic peaks was established to analyze the A and B process samples, and the similarities were all greater than 0.95. The content of A and B processes were analyzed. The process loss rate, drying process, alcohol precipitation process, A process is better than B process, 3M3 tank is better than 2M3 tank. Conclusion: The analysis and quantitative study of the intermediates in the production of proprietary Chinese medicines by HPLC fingerprinting are of great significance to optimize the process parameters and improve the quality control of the process.