双氯芬酸钠凝胶的处方改进及其含量测定

Selecting the Formula of Prescription and Concentration Determination of Diclofenac Sodium Gels

[目的 ]改进双氯芬酸钠凝胶的处方 ;选择能精密而简便地测定双氯芬酸钠凝胶主药的含量方法。 [方法 ]采用正交设计优化处方 ,选择适当的高效液相色谱条件进行含量测定。 [结果 ]稳定的处方为 :双氯酚酸钠 15 0 g ,卡波姆 15 0 g,丙二醇 15 0 0 g ,聚乙二醇 3 0 0 0g ,EDTA二钠 3 75 g。共 10 0 0支。HPLC法的色谱条件 :色谱柱为十八烷基硅烷柱 (4 6mm× 15 0mm) ;流动相为水∶甲醇 (3 0∶70 ) ,流速 1.0ml/min ;检测波长 2 84nm ,纸速 3mm/min ,柱温为室温 2 5℃。该法平均回收率 99.5 % (RSD =0 .8% ,n =6)。 [结论 ]该处方稳定 ,检测方法简便。

To select a formula of diclofenac sodium (DCS) gels and to find out a precise,simple and convenient method for concentration determination of diclofenac sodium gels The formulation was optimized by using orthogonal design and the content of DCS was determined by HPLC methods The new formulation was :diclofenac sodium 150 g,carbomer 150g, propylene glycol 1 500 g, PEG 3 000 g and EDTA 2Na 3.75 g. The ananlysis was carried out on C18 column at the temperature of 25℃. The mobile phase is methanol water(70∶30) , the wavelength was set at 284 nm,and the flow rate was 1.0 ml/min,and the paper rate was at 3 mm/min. The recovery of diclofenac sodium by HPLC methods was 99.5%.(RSD=0.8%,\%n\%=6).[CONCLUSION]The new formulation was stable and diclofenac sodium in the gels was detemined by HPLC methods.