黄芩配方颗粒的质量控制

Quality control of Huangqin Dispensing Granules

目的:以标准汤剂为基准,探讨黄芩配方颗粒的质量控制方法。方法:采用高效液相色谱(HPLC)法同时测定黄芩配方颗粒黄芩苷、汉黄芩苷、黄芩素和汉黄芩素4个化学成分的峰面积和指纹图谱,并计算这4个化学成分的含量和转移率等,与标准汤剂相关结果进行对比研究。结果:实验室制备的黄芩配方颗粒化学成分含量与标准汤剂差异无显著性,均在标准汤剂可接受范围内,即黄芩苷含量为5.32%~9.88%,汉黄芩苷含量为1.01%~1.87%,黄芩素含量为0.20%~0.38%,汉黄芩素含量为0.06%~0.12%,并且指纹图谱相似度均大于0.9。结论:本研究报告的基于标准汤剂的质量控制方法科学、易于操作,可为黄芩配方颗粒的应用研究和产业发展提供参考依据。

OBJECTIVE To investigate the quality control method of Huangqin Dispensing Granules based on the standard decoction. METHODS The peak areas and fingerprints of baicalin,wogonoside,baicalein and wogonin were determined by HPLC. The contents and transfer rates of these four compounds were calculated and compared with those of the standard decoction. RESULTS The component contents of laboratory prepared Huangqin Dispensing Granules were all in the acceptable ranges,showing no significant difference compared with the standard decoction. The detailed acceptable ranges were set based on the standard decoction as follows：baicalin（ 5. 32 %-9. 88 %）,wogonoside（ 1. 01 %-1. 87 %）,baicalein（ 0. 20 %-0. 38 %） and wogonin（ 0. 06 %-0. 12 %）. Meanwhile,the HPLC fingerprint similarity between Huangqin Dispensing Granules and the standard decoction was more than 0. 9. CONCLUSION This quality control study based on standard decoction is scientific and practical,which provides references for the quality control of Huangqin Dispensing Granules.