茜草双酯片溶出度测定的方法学验证  

Methodological validation of solubility of Rubidatum Tablets

作　　者：彭刚 杨伟权[2] 曾芳[2] 康志英 

机构地区：[1]广东大翔药业有限公司,广东广州510385 [2]中山大学附属第一医院黄埔院区,广东广州510700 [3]广州市香雪制药股份有限公司,广东广州510530

出　　处：《中国医药导报》2008年第13期27-29,共3页China Medical Herald

摘　　要：目的:对自制茜草双酯片的溶出度检查进行方法学验证,同时与市售产品进行对比研究。方法:根据《中国药典》2005年版二部附录ⅩC第二法对其溶出度进行检查。采用紫外分光光度法,在264nm波长处测定茜草双酯的吸收度,建立溶出度测定方法,同时进行了方法学验证。结果:采用该方法测定茜草双酯片,以浓度对吸收度进行线性回归,得回归方程为A=0.0899C-0.002,相关系数为0.9953。茜草双酯在1.67～8.05μg/ml范围内浓度与其吸收度呈良好的线性关系。重复性试验的RSD为0.51%;平均回收率为99.97%,RSD为1.04%。结论:经与市售产品比较,我们自制的产品质量与市售产品一致,且溶出度测定方法能有效控制该产品的质量。Objective： To methodologically validate the detection of solubility of self-made Rubidatum Tablets and to make comparision with similar products commercially available. Methods：The detection was carried out following the procedure described in the second method in appendix X C, second part of 2005 edition of Chinese Pharmacopoeia. The solubility of Rubidatum Tablets was detected with ultraviolet spectrophotometry at 264 nm.According to the results ,we established a procedure and validated it methodologically. Results： we performed a linear regression analysis by using the concentration （C） and UV absorption（A） as independent and dependent variables respectively, the regression equation was calculated as A =0.089 9C-0.002, r=0.995 3. Within the concentration range of 1.67-8.05 μg/ml, excellent linear relevance was witnessed between concentration and absorption. RSD of repeatability test was 0.51%;the average recovery was 99.97% with RSD of 1.04%. Conclusion：Comparing with the products commercially available, our product are proved to be of the same quality, while the validation of the detection method is effective.

关 键 词：茜草双酯片 溶出度测定 方法学研究 

分 类 号：R917[医药卫生—药物分析学]