摘要
Abstract
Objective To establish a preparation method of Norcantharidin tablets,and to detect content of Norcan-tharidin Tablets by using HPLC method. Methods Norcantharidin tablets were prepared with norcantharidin as the main drug,microcrystalline cellulose (MCC) and lactose as the fillers,sodium carboxymethyl starch (CMS-Na) as the disintegrating agent,polyvinylpyrrolidone K30 (PVP-K30) as adhesive.Content of Norcantharidin tablets was detected with the method of HPLC;HPLC chromatographic conditions were: Spherigel ODS C18 chromatographic column;mobile phase:acetonitrile-pH 3.1 phosphoric acid aqueous solution (10:90) (V/V );the flow rate of 1.0 ml/min;column temperature 25℃;detection wavelength of 210 nm;sample quantity 20μl.The factors A (starch),B (MCC) and C (CMS-Na) were se-lected,U7 (73) uniform design was adopted,and preparation of Norcantharidin tablets was optimized through the dissolu-tion index. Results HPLC standard curve equation: Y=925.374X-1778.8 (r=0.9999);linear range: 20~800 μg/ml.The intra-day precision RSD were 1.880%,0.172%,0.945%;inter-day precision RSD were 1.420%,1.126% and 1.468%.Co-efficient of recovery in low,medium and high concentrations were separately (98.77 ±1.24)%, (100.08 ±1.14)%, (99.59 ± 0.58)% (n=5).Uniform design regression equation was K=-0.107-0.004A+0.017B-0.025C-0.0002B2+0.007C2 (F=245.312, P﹤0.05);the optimized prescription composition was 10% starch,40% MCC,43% lactose and 7% CMS-Na;dissolution rate constant K was validated of (0.332 ±0.019)/min. Conclusion Norcantharidin tablets prepared with the optimized prescription preparation are with beautiful shape,good liquidity,lubricity and compression formability;HPLC method can effectively control the quality of tablets.关键词
去甲斑蝥素片/高效液相色谱/溶出度/均匀设计Key words
Norcantharidin tablets/High performance liquid chromatography/Dissolution/Uniform design分类
医药卫生
