犬用盐酸特比萘芬片剂矫味处方及含量测定研究

Taste-modifying and Determined the Content of Hydrochloride Terbinafine Tablets

为了对犬用盐酸特比萘芬片剂进行矫味处方筛选并对盐酸特比萘芬进行含量测定,试验以片剂成型性为指标优选出含5%纯天然鸡粉、3%鸡粉香精及5%味精的片剂矫味处方,并分别按照处方对所制片剂进行重量差异、崩解时限考察,再以比格犬对各处方片剂偏好筛选出最优矫味剂为纯天然鸡粉,采用HPLC法测定该矫味处方盐酸特比萘芬含量。盐酸特比萘芬回归曲线方程为y=2.652×10~7x-2.418×10~4（r=0.9998）,在0.0201~0.4026 mg/mL范围线性关系良好,平均回收率为97.97%,RSD=0.94（n=6）。对三批片剂进行含量测定,含量在99.17%~101.24%之间,含量均匀度A＋1.8S〈15。因此所筛选的矫味剂处方工艺可行,含量测定方法简便、符合生产要求,纯天然鸡粉作为矫味剂既可以迎合犬类的偏爱又不影响片剂的质量检查。

To study veterinary hydrochloride terbinafine tablets flavoring process for dogs and determined the content of hydrochloride terbinafine.We chose three prescriptions with flavor agent by tablet moldability as an index included 5% natural chicken powder,3% chicken essence and 5% monosodium glutamate of description dosages.Then we observed the weight variation and disintegration time in comformity with the rules.Finally,5% natrual chicken power is the best prescription by the compliance of beagle dogs.We determined the content of tablets by HPLC.Hydrochloride terbinafine concentration in the range of 0.0201 to 0.4026 mg/mL has a linear relationship（y = 2.652 × 10~7x- 2.418 ×10~4,r = 0.9998）,average recovery（n =6）97.97% （RSD = 0.94）.We prepared three batches of samples to test in some aspects.The content of hydrochloride terbinafine is between 99.17% and 101.24% ,the content uniformity is A ＋ 1.8S 15.Therefore the process of flavor test was proved to be feasible and stable.The method is simple and accurate for qualification,and can be used for the quality control.Natural chicken powder could improve the taste of dogs while hardly interfering the quality test.