复方板蓝根颗粒质量标准提升研究

Study on Improvement of Quality Standard of Compound Banlangen Granules

目的建立复方板蓝根颗粒的薄层色谱鉴别和含量测定方法,提升复方板蓝根颗粒的质量标准。方法采用薄层色谱法,以脯氨酸、亮氨酸、靛玉红作为指标成分进行定性鉴别;采用高效液相色谱法,以(R,S)-告依春和腺苷为指标成分进行定量测定,并对34批市售复方板蓝根颗粒样品进行质量分析评估。结果薄层色谱斑点清晰,分离度好;(R,S)-告依春和腺苷质量浓度分别在0.98～19.60μg/m L(r=1.000 0),3.144～62.880μg/mL(r=1.000 0)与峰面积线性关系良好;(R,S)-告依春和腺苷的平均回收率分别为99.52%和101.83%,RSD分别为3.69%和1.99%(n=9)。结论不同厂家的样品中(R,S)-告依春和腺苷含量差异较大,故提升质量标准对其质量控制很有必要。

Objective To establish a thin layer chromatography（ TLC） and content determination method for Compound Banlangen Granules,in order to improve the quality standard of Compound Banlangen Granules. Methods TLC method was adopted,the contents of proline, leucine and indirubin were taken as index components for qualitative identification. HPLC method was adopted,（ R, S）-goitrin and adenosine were taken as index components for quantitative determination, and 34 batches of commercially available Compound Banlangen Granules samples were taken for quality analysis and evaluation. Results The TLC spots were clear and the degree of separation was good.（ R, S）-goitrin and adenosine had good linear relationship in the range of 0.98-19.60 μg/mL（ r=1.000 0）,3.144-62.880 μg/mL（ r=1.0000）, the average recoveries of（ R, S）-goitrin and adenosine were 99.52% and 101.83%, respectively. RSDs were 3.69% and 1. 99%（n=9）. Conclusion There is a great difference in the contents of（ R, S）-goitrin and adenosine in different manufacturers. Therefore, it is necessary to improve the quality standard for the quality control of Compound Banlangen Granules.