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目的:建立一种去甲斑螫素片的制备方法,采用HPLC法检测去甲斑螫素片的含量。方法以去甲斑螫素为主药,以淀粉、微晶纤维素(MCC)、乳糖为填充剂,以羧甲基淀粉钠(CMS-Na)为崩解剂,以聚乙烯吡咯烷酮-K30(PVP-K30)为轴合剂,以硬脂酸镁为润滑剂,制备去甲斑螫素片。采用高效液相色谱法(HPLC)检测去甲斑螫素片的含量;HPLC色谱条件为Spherigel ODS-C18色谱柱;流动相:乙腈-pH 3.1磷酸水溶液(10:90)(V/V );流速:1.0 ml/min;柱温:25℃;检测波长:210 nm;进样量:20μl。选定A(淀粉)、B(MCC)、C(CMS-Na)为考察因素,采用U7(73)均匀设计,通过溶出度指标优化去甲斑螫素片的制备工艺。结果HPLC标准曲线方程:Y=925.374X-1778.8(r=0.9999);线性范围:20~800μg/ml。日内精密度R SD:1.880%、0.172%、0.945%;日间精密度R SD:1.420%、1.126%、1.468%。低、中、高浓度的回收率分别为(98.77±1.24)%、(100.08±1.14)%、(99.59±0.58)%(n=5)。均匀设计回归方程为:K=-0.107-0.004A+0.017B-0.025C-0.0002B2+0.007C2(F=245.312,P﹤0.05);确定优化处方组成为:淀粉10%、MCC 40%、乳糖43%、CMS-Na 7%;验证得溶出速率常数K为(0.332±0.019)/min。结论按优选处方制备的去甲斑螫素片外形美观,流动性、润滑性、压缩成形性均良好;采用HPLC法可有效控制片剂质量。“,”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.