目的 開發(fā)纈沙坦仿制片，并對其進(jìn)行體外質(zhì)量一致性評價(jià)。方法 以纈沙坦原研制劑（80 mg）為對照藥品，單因素實(shí)驗(yàn)考察影響纈沙坦溶出度的處方因素及制備工藝參數(shù)，從而確定最佳處方和制備工藝，并測定自制片和原研藥在4種溶出介質(zhì)的溶出過程，采用相似因子（f₂）法對兩者的溶解曲線進(jìn)行相似性評價(jià)。結(jié)果 3批纈沙坦仿制藥在磷酸鹽緩沖液（pH6.8）中15 min內(nèi)溶出85%，在水、pH1.2鹽酸溶液、pH4.5醋酸鹽溶液中的f₂均大于50。結(jié)論 以溶出度為主要考察指標(biāo)，通過單因素實(shí)驗(yàn)開發(fā)的纈沙坦片仿制藥與原研藥體外溶出具有一致性，質(zhì)量符合要求。

Objective To develop a formulation of generic Valsartan Tablets and evaluate the quality consistency in vitro. Methods Diovan® HCT (80 mg) was used as the reference drug. In order to determine the best formulation and the best preparation processing, the single factor experiments were applied to determining the best formulation and the best preparation processing. And dissolution test was used as the evaluation index in the single factor experiments. Meanwhile the dissolubility of generic Valsartan Tablets and original preparation was investigated in four different media to evaluate the similarity of dissolution by calculating similar factor (f₂). Results The dissolution was above 85% of three batches of generic Valsartan Tablets in the phosphate buffer (pH 6.8). The similar factors were all more than 50 in the water, hydrochloric acid solution (pH 1.2), and acetate buffer solution (pH 4.5). Conclusion The f₂ similarity factor results indicate a similarity in the reference drug and generic Valsartan Tablets which were developed by single factor experiments, which means the quality of genetic Valsartan Tablets is qualified.