脑复康软胶囊质量标准研究

Study on the Quality Standard of Naofukang Soft Capsule

目的建立脑复康软胶囊的定性鉴别方法和葛根素的含量测定方法。方法采用薄层色谱法对脑复康软胶囊进行薄层色谱（TLC）鉴别。采用高效液相色谱（HPLC）法测定软胶囊中葛根素含量,色谱柱为Agilent C18柱（250 mm×4.6 mm,5μm）,流动相为甲醇-水-磷酸（47∶53∶0.2）,检测波长为250 nm,流速为1.0 m L/min,柱温为室温,进样量为10μL,理论板数按葛根素计算应不低于2 500。结果 TLC法重复性良好。葛根素进样质量浓度在84.4~422.0μg/m L范围与峰面积呈良好线性关系,平均回收率为98.36%,RSD为0.64%（n=6）。结论该方法简便、准确、可靠,可作为该制剂的质量控制方法。

Objective To establish a method for identification of Naofukang Soft Capsule and determination of Purerain in Naofukang Soft Capsule. Methods Radix Puerarin in Naofukang Soft Capsule was qualitatively identified by thin layer chromatographic method. A HPLC method was also developed for the determination of Puerarin in Naofukang Soft Capsule. The chromatographic column was Agilent C18 Colume（ 250 mm × 4. 6 mm,5 μm）, the mobile phase was methanol- water- phosphoric acid（ 47 ∶ 53 ∶ 0. 2）; the detection wavelength was 250 nm,the flow rate was 1. 0 m L / min; the column temperature was room temperature,the injection volume was 10 μL. Number of theoretical plates calculated puerarin should not be less than 2 500. Results Reproductively was good by TLC. Puerarin in the range of84. 4- 422. 0 μg / m L showed a good linear relationship with the peak area,and the average recovery was 98. 36%, RSD was 0. 64%（ n = 6）. Conclusion The method is simple,accurate,reliable,and can be used as quality control method for this preparation.