盐酸川丁特罗片的制备和质量控制

Preparation and quality control of trantinterol hydrochloride tablets

目的:制备盐酸川丁特罗片。方法:用淀粉、乳糖为稀释剂,PVPk30水溶液为粘合剂制备盐酸川丁特罗片,并参照《中华人民共和国药典》2005年版附录对制备的片剂进行质量控制。结果:制备的片剂符合制剂要求,用HPLC法测定含量,在5～15μg·mL^(-1)范围内线性关系良好,平均回收率为100.41%,RSD为0.64%。结论:制备工艺简单易行,质量标准能够有效控制药品质量。

Objective：To investigate the preparation of trantinterol hydrochloride tablets and to establish its quality control method. Methods：The tablets were prepared with starch and lactose as diluents, PVP k30 as binders, and the quality control was studied, based on China Pharmacopoeia 2005. Results：The prepared tablets met the pharmaceutical requirements, and a good linear relationship was obtained in the range of 5 -15μg·mL^-1, the average recovery of sample was 100.41% , and RSD was 0.64% （n = 9）. Conclusions： Both of easy manipulation and reliable quality control method were achieved.