肠胃适胶囊质量标准之研究

Study on Quality Standard of "Changweishi" Capsule

目的研究提高肠胃适胶囊的质量标准。方法采用同一薄层板及展开剂对组分中功劳木、黄连须、葛根进行薄层色谱鉴别，HPLC法测定盐酸小檗碱的含量。结果肠胃适胶囊中盐酸小檗碱含量为0．78—0．79mg／g，加样回收率为97．4％，RSD=1．9％（n=6）；精密度RSD=1．5％（n=5）；稳定性RSD=0．5％（8h内）；回归方程：y=3662296．7x＋5672．9，R=0．9999，线性范围是0．02—0．79μg。结论该方法结果准确，重现性好，可作为肠胃适胶囊的质量控制。

Objective To improve the quality control method for analyzing the ＂Changweishi＂ capsule. Methods The same thin layer plate was used to identify ＂Caulis Mahoniae＂, ＂Fibre Coptidix＂, and ＂Kudzuvine Root＂, by TLC, and the content of Berberine HCI was assayed by HPLC. Results The Berberine HCl in ＂Changweishi＂ Capsule was 0.78 - 0.79 mg/g; the recovery was 97.4%, and RSD = 1.9 % （ n = 6） ; the precision RSD = 1.5 % （ n = 5 ） ; stability RSD = 0.5 % （ within 8 h） ; the regression equation was y = 3662296. 7x ＋ 5672. 9, with R = 0. 9999, and linear range was 0.02 - 0.79 lang. Conclusion The method was accurate, and with good reproducibility. This method can be used for the quality control of ＂Changweishi＂ capsule.