三种板蓝根制剂质量标准的研究

Quality standard of Radix Isatidis Preparations

目的:从板蓝根3种剂型———糖浆剂、咀嚼片和颗粒剂出发建立板蓝根制剂质量控制方法。方法:建立TLC方法,以精氨酸、亮氨酸对照品和板蓝根对照药材为对照进行制剂样品的鉴别研究;建立HPLC法,同时测定制剂中腺苷和告依春的含量。结果:3种制剂的色谱中均可检出精氨酸、亮氨酸和板蓝根药材色谱中相应位置的斑点;腺苷和告依春的含量在被测样品中差异较大,说明产品的批次间稳定性有待提高。结论:上述检测方法操作简单,快捷,可用于板蓝根制剂的质量控制和标准提高。

AIM ： To improve the quality control standard based on 3 kinds of Radix Isatidis preparations-Radix Isatidis syrup, chewable tablet and granules. METHODS： A TLC method was established for iden tification of with Isatidis indigotica RS, Vleucine CRS and Arginine CRS as the references. A HPLC method was developed for the determination of adenosine and igoitrin in Radix Isatidis Preparations, with DIKMA Diamonsil Cls column （5 μm, 200 mm × 4.6 mm id）, a mixure of acetonitrile-water-triethylamine（ 10： 90： 0.2, using glacial acetic acid to adjust to pH 5.2）-water （85： 15） as the mobile phase. The detection wavelength was set at 245 nm. RESULTS： lsatidis indigotica, Vleucine and Arginine were detected in all the preparations. The contents of adenosine and igoitrin varied greatly in tested samples from different pharmaceutical enterprises. CONCLUSION： The above methods are simple, accurate, and suitable for the quality control of Radix Isatidis Preparations.