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华法林钠颗粒的制备及质量控制
引用本文:刘茂柏,郑斌,曾晓芳,周翔. 华法林钠颗粒的制备及质量控制[J]. 中国药房, 2006, 17(17): 1306-1308
作者姓名:刘茂柏  郑斌  曾晓芳  周翔
作者单位:1. 福建医科大学附属协和医院,福州市,350001
2. 福建医科大学附属第一医院,福州市,350005
摘    要:
目的:制备华法林钠颗粒并建立其质量控制方法。方法:采用等量递加配研法制成颗粒,以颗粒的溶解时间和溶化性为指标对处方中各辅料的用量进行正交试验筛选;采用紫外分光光度法测定主药华法林钠含量。结果:筛选出较佳处方,所制颗粒大小均匀;华法林钠检测浓度在5·92~17·86μg/ml范围线性关系良好(r=0·9998,n=7),平均回收率为101·26%~101·84%(n=5),RSD<1·0%;颗粒溶解后水溶液放置10d稳定性较好。结论:本制剂制备方法简便、可行,含量测定方法准确、可靠、灵敏,可用于其质量控制;颗粒溶解后可进一步准确地分剂量。

关 键 词:华法林钠  颗粒  处方筛选  制备  质量控制
文章编号:1001-0408(2006)17-1306-03
收稿时间:2006-02-07
修稿时间:2006-04-27

Preparation and Quality Control of Warfarin Sodium Granules
LIU Maobai, ZHENG Bin, ZENG Xiaofang,ZHOU Xiang. Preparation and Quality Control of Warfarin Sodium Granules[J]. China Pharmacy, 2006, 17(17): 1306-1308
Authors:LIU Maobai   ZHENG Bin   ZENG Xiaofang  ZHOU Xiang
Affiliation:1.The Affiliated Union Hospital of Fujian Medical University, Fuzhou, 350001, China;2.The First Affiliated Hospital of Fujian Medical University,Fuzhou,350005, China
Abstract:
OBJECTIVE:To prepare warfarin sodium granules(WSG)and to establish it’s quality control methods .METHO_DS:To prepare WSG with part.aeq.geometric method,to optimize the amounts of all sorts of agents in the formulation in terms of dissolution time and abilityof WSG by orthogonal experiment.To determin the content of WS by UV. RESULTS:The formulation was designed and optimized,the WSG’s size were evenly.The concentration of WS was linear within the range of 5.92~17.86μg/ml with r=0.9 998(n=7),the average recovery rate was 101.26%~101.84%(n=5)with the RSD lower than 1.0%.The solution dissolved by granules is stable within 10 days.CONCLUSIONS:The preparation method is simple and feasible,the content determination methods is accurate,realible and sensitive,suitable for the quality control of WSG.The dissolved solution can be divided in accurate doses.
Keywords:Warfarin sodium   Granules   Optimize of formulation    Preparation   Quality control
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