大黄分散片的制备与质量控制

Preparation and quality control of dispersible tablets of Chinese Rhubarb

【目的】研究大黄分散片的制备及质量控制方法。【方法】采用薄层色谱法对大黄进行定性鉴别;采用高效液相色谱法测定大黄中大黄素的含量,Shim-pack VP-ODS色谱柱,流动相:甲醇:0.1%高氯酸(85:15);检测波长:254 nm,流速:1.0 ml/min;采用桨法,以PH4.5的乙酸铵冰醋酸溶液为溶出介质进行大黄分散片体外溶出度考察。【结果】薄层色谱鉴别专属性强,阴性对照无干扰;HPLC结果显示,大黄素在0.04～0.4μg/mL范围内线性关系良好,加样回收率为98.25%,RSD=1.16%(n=5),3批样品溶出度在30 min时均在80%以上。【结论】该制剂制备工艺可行,含量测定方法简便可靠。

[Objective] To study preparation technology of dispersible tablets of Chinese Rhubarb and establish its quality control methods. [Methods] Emodin in prescription were identified by TLC, the content of emodin was determined by HPLC. A RP-HPLC method was established using Shim-pack VP-ODS column, with methanol-perchloric acid（85：15） as the mobile phase, flow rate was 1.0 ml/min, detecting wavelength at 254 nm; According to paddle method, using glacial acetic acid solution of ammonium acetate （PH=4.5）. [ Results ] TLC identification exhibited good specificity without the interference from the negative samples, For emodin, the linear range was 0.04~0.4 μg/mLand the average recovery was 98.25%（RSD=1.16%,n=5）.The dissolution rate of 3 bathches of samples was more than 80% at 30min. [ Conclusion ] Preparation method is practical, content determination method is simple and relible.