犬用盐酸特比萘芬喷雾剂处方筛选及含量测定研究

Prescription-screening and Determined the Content of Hydrochloride Terbinafine Sprays for Dogs

关键词:  盐酸特比萘芬  喷雾剂  处方筛选  含量测定

Key words:  terbinafine hydrochloride  spray agent  prescription-screening  content determination

摘要:

对犬用盐酸特比萘芬喷雾剂进行处方筛选并对盐酸特比萘芬进行含量测定。以喷雾剂成型性为指标优选出2%月桂氮卓酮（水溶性），0.35g/L的苯甲酸钠，10 %Kolliphor? HS 15和适量高纯水制成水溶液。采用HPLC法测定该处方中有效成分盐酸特比萘芬的含量。含量测定中盐酸特比萘芬在0.0201~0.4026mg/ml的浓度范围内线性关系良好，回归方程为Y = 2.652×107X - 2.418×104（r=0.9998 n=6），平均回收率为104.14%，RSD为1.23%。通过采用高效液相色谱法测量有效成分盐酸特比萘芬的含量稳定，所筛选的处方工艺可行，制备方法简单方便。

Abstract:

The present experiment focused on dogs with hydrochloride terbinafine sprays which prescription was screening and we determined the content of hydrochloride terbinafine.Forming the spray as an index optimized the prescription with laurocapram（Water-soluble），sodium acetate anhydrous，sodium benzoate，10% Kolliphor? HS 15 and purity water that formulated as an aqueous solution.Then we determined the active ingredient content of terbinafine hydrochloride by HPLC.The screened formulation process was feasible. The content determination of hydrochloride terbinafine concentration in the range of 0.0201~0.4026mg/ml had a good linear relationship, the regression equation was Y=2.652×107X - 2.418×104（r=0.9998 n=6），the average recovery rate was 104.14%, RSD was 1.23%.Measuring the active ingredient content of hydrochloride terbinafine is stable by HPLC.The screened prescription is feasible in this study, the formulation process of preparation is simple.