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目的:制备复方雷公藤胶囊并建立其质量控制方法。方法:以雷公藤、赤芍、佛手等为主要成分制备复方雷公藤胶囊,采用薄层色谱法对处方中主要药材赤芍、佛手分别进行定性鉴别;采用高效液相色谱法测定有效成分雷公藤内酯醇、芍药苷的含量。结果:薄层色谱斑点清晰、集中;雷公藤内酯醇的检测浓度线性范围为0.048～2.88μg(r=0.9998,n=6),平均回收率为96.01%(RSD为1.89%,n=6)。芍药苷的检测浓度线性范围为0.14～4.20μg(r=0.9995,n=6),平均回收率为96.34%(RSD为1.93%,n=6)。结论:该制剂处方合理,制备工艺简便,质量控制方法简单、准确。
Objective: To prepare Compound Triptolide Capsules and establish its quality control method. Methods: Tripterygium wilfordii, Radix Paeoniae Rubra and bergamot were used as the main constituents to prepare Compound Tripterygium wilfordii. TLC was used to identify the main herbs of Paeonia lactiflora and Bergamot respectively. The content of Tripterygium wilfordii was determined by high performance liquid chromatography Ester alcohol, paeoniflorin content. Results: TLC spots were clear and concentrated. The linear range of the detection of triptolide was 0.048-2.88μg (r = 0.9998, n = 6) with an average recovery of 96.01% (RSD 1.89%, n = 6) . The linear range of detection of paeoniflorin was 0.14 ~ 4.20μg (r = 0.9995, n = 6). The average recovery was 96.34% (RSD 1.93%, n = 6). Conclusion: The preparation prescription is reasonable, the preparation process is simple, the quality control method is simple and accurate.