扶正抑癌苗方颗粒的质量控制研究

Study on Quality Control of Fuzheng Yiai Miaofang Granules

目的 建立扶正抑癌苗方颗粒的质量控制研究方法,为其质量控制标准制定提供参考价值。方法 定性采用薄层色谱法,建立法半夏、薏苡仁、吉祥草、冬凌草、仙鹤草5味中药饮片的薄层色谱鉴别方法;定量采用高效液相色谱法测定扶正抑癌苗方颗粒中鸟苷。结果 法半夏、薏苡仁、吉祥草、冬凌草、仙鹤草5味中药饮片的薄层色谱斑点清晰、重现性好、专属性好、阴性无干扰,能够有效鉴别5味中药饮片。鸟苷在0.20~1.12μg范围内呈现良好的线性关系,回归方程为Y=7E+06X-7 409.7,相关系数r=0.999 2;试验的精密度、重现性、稳定性相对标准偏差(RSD)均<2%,且平均加样回收率为100.93%,RSD为1.60%,加样回收良好。结论 建立的定性和定量研究方法专属性强、重现性好、方法简便准确,可作为扶正抑癌苗方颗粒的质量控制方法。

Objective To establish a research method for the quality control of Fuzheng Yiai Miaofang granules, and to provide reference value for its quality control standard. Methods TLC was used for qualitative identification of Pinellia ternata, Coix seed,Auspicious herb, Rubescens rubescens and Spirodendri. Quantitative determination of guanosine in Fuzheng Yiai Miaofang granules by HPLC. Results The TLC spots of Pinellia ternata, Coix seed, Auspicious herb, Rubescens rubescens and Spiroperus herba were clear, reproducible, specific and negative without interference, which could effectively identify the five herbs. Guanosine showed a good linear relationship in the range of 0.20~1.12 g, the regression equation was Y = 7E+06X-7 409.7, r=0.999 2. RSD of precision, reproducibility and stability were all less than 2%, and the average recovery was 100.93% and RSD was 1.60%,indicating good recovery. Conclusion The qualitative and quantitative methods established have strong specificity, good reproducibility, simple and accurate method, which can be used as the quality control method of Fuzheng Yiai Miaofang granules.