【摘要】 目的：评价虎杖解毒颗粒(无糖型)的质量，建立质量标准。方法：参照《中华人民共和国药典》(2020年版)对虎杖解毒颗粒(无糖型)的质量进行考察；用薄层色谱法建立制剂中虎杖、板蓝根和川射干的定性鉴别方法；用高效液相色谱法建立虎杖苷、大黄素的含量测定方法，测定了3批样品中虎杖苷、大黄素的含量，并考察颗粒稳定性。结果：虎杖解毒颗粒(无糖型)的粒度、水分、溶化性和装量差异均符合规定；薄层鉴别结果显示，虎杖、川射干和板蓝根色谱斑点显色清晰，阴性样品无干扰；高效液相色谱法测定结果显示，虎杖苷、大黄素分别在0.017 7～0.176 6μg、0.014 6～0.145 6μg范围内线性关系良好(r=0.999 8、0.999 9),精密度、稳定性和重复性试验的RSD均≤2%(n=6),平均加样回收率分别为98.79%(RSD=1.97%,n=9)、101.53%(RSD=1.63%,n=9)。暂定本品每袋含虎杖以虎杖苷计，不得少于8 mg/g;每袋含虎杖以大黄素计，不得少于5 mg/g。颗粒稳定性考察期间质量稳定。结论：本研究所建立的质量标准，可用于虎杖解毒颗粒(无糖型)的质量控制。更多还原

【Abstract】 OBJECTIVE: To evaluate the quality of Huzhang antidote granules(sugar-free) and establish the quality standard. METHODS: The quality of Huzhang antidote granules(sugar-free) was investigated with reference to Chinese Pharmacopoeia(2020). Qualitative identification method of polygonum cuspidatum, radix isatidis and Chuanshegan in preparations was established by thin-layer chromatography(TLC), and content determination method of polydatin and emodin was established by high performance liquid chromatography. The contents of polydatin and emodin in three batches of samples were determined, and the stability of the particles was investigated. RESULTS: The particle size, water content, solubility and loading difference of Huzhang antidote granules(sugar-free) were in line with the regulations. Results of TLC identification showed that the chromatographic spots of polygonum cuspidatum, Chuanshegan and radix isatidis were clear, and the negative samples had no interference. Results of high performance liquid chromatography showed that polydatin and emodin had good linear relationship in the range from 0.017 7 μg to 0.176 6 μg and from 0.014 6 μg to 0.145 6 μg respectively(r=0.999 8, 0.999 9). RSD of the precision, stability and repeatability tests were all ≤2%(n=6), and the average recovery rates were 98.79%(RSD=1.97%, n=9) and 101.53%(RSD=1.63%, n=9). Tentatively, each bag containing polygonum cuspidatum shall not be less than 8 mg/g in polydatin. Each bag containing polygonum cuspidatum shall not be less than 5 mg/g in emodin. The particle quality was stable during the inspection. CONCLUSIONS: The quality standard established by this study can be used for quality control of Huzhang antidote granules(sugar-free).更多还原