曲尼司特滴鼻液制备和其质量控制.PDF

曲尼司特滴鼻液的制备及其质量控制 1＊ 1 1 1 2 金伟华 ，刘永胜 ，谭永红 ，陈 华 ，邱 维 （1.成都军区总医院药剂科，成都 610083；2.泸州医学院药学系， 四川泸州 646000） 中图分类号 R944.9 文献标志码 A 文章编号 1001-0408（2013）13-1205-03 DOI 10.6039/j.issn. 1001-0408.2013.13.18 摘 要 目的：制备曲尼司特滴鼻液，并对其进行质量控制。方法：以水为溶媒、葡甲胺为助溶剂进行制备；采用高效液相色谱法 测定其中曲尼司特的含量；并进行制剂的稳定性试验。结果：所制备的曲尼司特滴鼻液的物理、化学性质稳定。曲尼司特检测质 量浓度在5～40mg/L 范围内与峰面积积分值线性关系良好（r ＝0.9999，n ＝5），平均回收率为98.53％，RSD ＝1.69％（n ＝6）。本 品在6个月内稳定性较好，有效期可暂定为6个月。结论：该制剂配方合理，制备工艺简单，稳定性良好，质量控制方法简便、准确。 关键词 曲尼司特；滴鼻液；制备；质量控制；高效液相色谱法；稳定性 Preparation and Quality Control of Tranilast Nasal Drops 1 1 1 1 2 JIN Wei-hua ，LIU Yong-sheng ，TAN Yong-hong ，CHEN Hua ，QIU Wei （1.Dept. of Pharmacy ，General Hospital of Chengdu Military Region ，Chengdu 610083，China ；2.Dept. of Pharmacy ，Luzhou Medicine College ，Sich- uan Luzhou 646000，China ） ABSTRACT OBJECTIVE ：To prepare Tranilast nasal drops ，and to control the quality. METHODS ：Water was used as menstru- um ，and meglumine was used as cosolvent to prepare Tranilast nasal drops ；the contents of tranilast were determined by HPLC ； and the stability of Tranilast nasal drops was investigated. RESULTS ：The physico-chemical property of Tranilast nasal drops was stable. The linear ranges of tranilast were 5-40 mg/L （r ＝0.999 9，n ＝5）with an average recovery of 98.53％ （RSD ＝1.69％，n ＝ 6）. The nasal drops were stable within 6months ，and period of validity should be 6months tentatively. CONCLUSIONS ：The prep- aration is rational in formula ，simple in preparation ，good in stability ，simple and accurate in quality control. KEY WORDS Tranilast ；Nasal drops ；Preparation ；Quality control ；HPLC ；Stability 曲尼司特（Tranilast ，肉桂氨茴酸），系抗变态反应药物，可 2 处方与制备 稳定肥大细胞和嗜碱细胞膜，阻止细胞裂解脱颗粒，从而抑制 2.1 处方 组胺、5-羟色胺等过敏介质释放，临床上主要用于过敏性哮喘、