右旋布洛芬分散片的研制与质量控制_谢斌.pdfVIP

# # 1 2* 谢斌, 邹尚荣 ( 1. , 430019; 2., 510060) : 制备右旋布洛芬分散片并建立其质量控制方法 以维晶纤维素 P 102为可 性辅料, 采用粉末直接 片, 确定处方组成实验确定了右旋布洛芬分散片的溶出度测定法, 并用高效液相色谱法测定其含量与有关物质,建立右旋 布洛芬分散片的质量控制方法 处方设计合理,制备工艺可行右旋布洛芬分散片的最佳溶出介质为 p 7. 20的磷酸 3 - 3 - 3 - 1 盐缓冲液回归方程 A= 1 728. 9@ 10 C- 971. 03, 线性范围为 4@ 10 ~ 100@ 10 g# L (r = 1. 000 0),含量测定的平均回 收率为 99. 69%, RSD为 0. 92% ( n= 9) 该品种制备工艺简单, 所得制剂质量可控 : 右旋布洛芬;分散片; 制备;粉末直接 片;质量控制 : R944. 4; R971. 1 : A : 1007-7693(2008) 08-0699-04 Study onPreparationandQuality Standard ofDexibuprofenDispersibleTablets 1 2* XIE B in, ZOU Shang-rong ( 1. H ubei C-Bons Pharmaceutical Co. Ltd. , Wuhan 430019, China; 2. Pharm acy D ep ar tm ent, Guang hou N o. 8P eop le. s H osp ital, Guang hou 510060, China ) ABSTRACT: OBJECTIVE To prepare dexibuprofen dispersible talbets and establish a method for their quality control. ETHODS The composition of recipe and powder rolling techniquewere designed on thebasis ofM icrocrystalline CelluloseP 102. The content of dexibuprofen in preparation was determ ined by PLC and its quality standard was established. RESULTS The designation of the recipe was reasonable, and manufacturing technique was feasible. The linear regression formulewas below: A = 3 -3 - 3 - 1 1728. 9@ 10 C- 971. 03. Calibration curvewas linear over the range of 4 @ 10 ~ 100 @ 10 g# L ( r = 1. 000 0); for potency assay themean recoverywas 99. 69% with RSD as 0. 92% ( n = 9). CONCLUSION The preparing technique of dexibuprofen dispersible tablets is smi ple. Quality of the products can be easily controlled. KEY WORDS:dex ibuprofen; dispersible tablet; preparation; powder rolling directly; quality control ( dexibuprofen), ( S)-2-( + )-( 4- , , ) ,,