易激胶囊质量标准研究

Quality Standard for Yiji Capsule

目的建立易激胶囊(芍药、防风、陈皮、木香)的质量标准。方法采用薄层色谱法鉴别易激胶囊中防风、陈皮、木香;采用高效液相色谱法对制剂中有效成分芍药苷进行定量分析。结果3批样品TLC图谱中均可检出防风、陈皮、木香;芍药苷的含量限度规定为不得少于1.050 mg/粒。结论所建立的方法可行、能有效地控制易激胶囊的质量,能运用于大生产产品质量控制。

Objective To establish the quality standard for Yiji Capsules（ Radix Paeoniae Alba, Radix Saposhnikoviae, Perieapium Cirri Reticulatae, Radix Aucklandiae ）. Methods Radix Saposhnikoviae, Perieapium Cirri Reticulatae, Radix Aucklandiae in this prescription were identified by TLC. The content of paeoniflorin which is the effective element in the preparation was determined as the index by HPLC. Results Radix Saposhnikoviae, Perieapium Cirri Reticulatae, Radix Aucklandiae could be detected by TLC from three batches of samples. The content limit of paeoniflorin shouldn＇t be lower than 1. 050mg per granule. Conclusion The quality control is feasible and can be applied to control the products from mass production. It can be ensured the stability of the produet＇s quality.