不同生产厂家赤芍配方颗粒中单萜苷类化合物含量比较

目的比较不同厂家生产的赤芍配方颗粒中单萜苷类化合物(吡啶芍药苷、牡丹皮苷F、氧化白芍苷、氧化芍药苷、10-羟基芍药苷、白芍苷、芍药苷、oxypaeonidanin、4-甲氧基-氧化芍药苷、没食子酰基芍药苷、4-甲氧基芍药苷、白芍苷R_1、paeonidanin、苯甲酰氧化芍药苷、苯甲酰芍药苷)的含量差异,为制定统一的质量标准奠定基础。方法采用Zorbax SB-Aq C_(18)色谱柱(250 mm×4.6 mm,5μm);流动相为乙腈和磷酸二氢钾缓冲盐(pH 2.8)溶液,梯度洗脱,体积流量1.0 mL/min,柱温30℃,检测波长260 nm。结果芍药苷、白芍苷和氧化芍药苷是赤芍配方颗粒中含量最高的3种单萜苷类化合物,且不同厂家生产的赤芍配方颗粒中主要单萜苷类化合物的含量差异较大。样品CSPFKL-KRT中芍药苷和氧化芍药苷的含量最高,样品中质量分数分别为73.214mg/g和16.935mg/g,白芍苷的质量分数最低,为2.343mg/g。而样品CSPFKL-XLS中芍药苷和氧化芍药苷的质量分数最低,样品中分别为26.327 mg/g和4.165 mg/g,白芍苷的质量分数最高18.893 mg/g。结论不同厂家生产的赤芍配方颗粒中主要单萜苷类化合物的含量差异较大,可能会对临床应用产生影响。建立统一的质量标准对于赤芍配方颗粒的质量控制具有重要作用。

Comparative analysis of monoterpene glycosides in Paeoniae Rubra Radix Formula Granule from different manufacturers

Objective To establish an HPLC method for simultaneous determination of 15 monoterpene glycosides pyrindyl- paeoniflorin, mudanpioside F, oxyalbiflorin, oxypaeoniflorin, 10-hydroxypaeoniflorin, albiflorin, paeoniflorin, oxypaeonidanin, 4-O- methyl-oxypaeoniflorin, galloylpaeoniflorin, 4-O-methyl-paeoniflorin, albiflorin R₁, paeonidanin, benzoyloxypaeoniflorin, and benzoylpaeoniflorin in Paeoniae Rubra Radix Formula Granule, in order to compare the quality of Paeoniae Rubia Radix Formula Granule from different manufacturers and provide the basis for the establishment of a unified quality control method. Methods The separation was performed on an Agilent Zorbax SB-Aq C₁₈ column (250 mm×4.6 mm, 5 µm), using acetonitrile and potassium dihydrogen phosphate solution (pH 2.8) as the mobile phase at the flow rate of 1.0 mL/min for a gradient elution. The detection wavelength was set at 260 nm. Results Paeoniflorin, albiflorin, and oxypaeoniflorin were the three main monoterpene glycosides with the highest content in the Paeoniae Rubra Radix Formula Granule. There were extremely significant difference among the contents of 15 monoterpene glycosides in Paeoniae Rubra Radix Formula Granule produced by different manufacturers. The sample of CSPFKL-KRT was remarkable for the highest content of paeoniflorin and oxypaeoniflorin (73.214 mg and 16.935 mg per gram sample, respectively) and the lowest content of albiflorin among all samples (2.343 mg per gram sample), while sample CSPFKL-XLS was remarkable for the lowest content of paeoniflorin and oxypaeoniflorin (26.327 mg and 4.165 mg per gram sample, respectively) and the highest content of albiflorin among all samples (18.893 mg per gram sample). Conclusion There were extremely significant difference among the contents of main monoterpene glycosides in Paeoniae Rubra Radix Formula Granule produced by different manufacturers, which may affect the clinical use. The establishment of a unified quality standard plays an important role in the quality control of Paeoniae Rubia Radix Formula Granule.