克淋通软胶囊质量标准的研究

Quality standard study of kelingtong soft capsules

目的制定克淋通软胶囊质量标准,以方便有效地控制其内在质量。方法用TLC法鉴别四季红、黄柏;用HPLC法测定盐酸小檗碱的含量。结果TLC方法专属性强;盐酸小檗碱在4.02～128.6 mg·L^-1范围内呈良好的线性关系r=0.999 9,平均回收率为98.21%,RSD=1.07%。结论本质量标准能有效地控制克淋通软胶囊的产品质量。

Aim To establish a quality standard for kelingtong soft capsules so as to control its quality efficiently and effectively. Methods Chinese medical plants Sijihong and Huangbai were identified by TLC. Contents of berberine hydrochloride were determined by HPLC. Results The method of TLC was reliable, accurate and specific. Hyperoside showed good linear relationship in the range of 4.02 ～ 128.6 mg·L^-1（ r = 0. 999 9）, with a mean recovery rate of 98.21% （ RSD = 1.07 % ）. Conclusion The quality of kelingtong soft capsules could be controlled by the standard.