板青颗粒质量标准提升研究

Improvement of the Quality Standard for Banqing Granules

为了提高和完善板青颗粒的质量标准。改进精氨酸的薄层鉴别,新增亮氨酸、脯氨酸、靛玉红的薄层鉴别,采用高效液相色谱法,以尿苷、鸟苷、(R,S)-告依春和腺苷作为指标性成分进行定性定量测定。建立的薄层方法,斑点清晰,分离度好,专属性强;供试品色谱图中在与混合对照品溶液中尿苷、鸟苷、(R,S)-告依春和腺苷保留时间相同的位置有吸收光谱图一致的色谱峰,4种对照品分别在1.08~32.42μg·mL^(-1)(r=1.0000)、1.01~30.33μg·mL^(-1)(r=1.0000)、0.39~9.43μg·mL^(-1)(r=0.9999)和1.05~31.56μg·mL^(-1)(r=1.0000)的浓度范围内与峰面积呈现良好的线性关系。尿苷、鸟苷、(R,S)-告依春和腺苷的平均加样回收率(n=9)分别为98.6%、100.5%、98.5%和99.8%。对20批样品数据综合分析,建议每1 g板青颗粒含尿苷、鸟苷和腺苷的总量不得少于0.46 mg,(R,S)-告依春不得少于0.075 mg。

To improve quality standard for Banqing Granules.Improve the TLC identification of arginine.Proline,leucine,and indirubin as index components were qualitative identified by TLC.Uridine,guanosine,(R,S)-goitrin and adenosine as index components were simultaneously determined by HPLC.TLC spots were clear and separated nicely.Retention time and peak spectral similarity were helped to identify the four kinds of target analytes.The linear ranges of uridine,guanosine,(R,S)-goitrin and adenosine were 1.08~32.42μg·mL^(-1)(r=1.0000),1.01~30.33μg·mL^(-1)(r=1.0000),0.39~9.43μg·mL^(-1)(r=0.9999),1.05~31.56μg·mL^(-1)(r=1.0000),respectively.The average recoveries(n=9)of the four compounds were 98.6%,100.5%,98.5%and 99.8%,respectively.From comprehensive data analysis,the suggestion was that the total contents of uridine,guanosine and adenosine were no less than 0.46 mg,(R,S)-goitrin content 0.075 mg in Banqing Granules(1 g).