中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
21期
47-48,49
,共3页
奋乃静片%溶出度%紫外分光光度法
奮迺靜片%溶齣度%紫外分光光度法
강내정편%용출도%자외분광광도법
Perphenazine Tablets%dissolution%UV spectrophotometric method
目的:根据2010年版《中国药典》药典科研课题任务书的要求,为了更好地控制和评价各厂家产品质量,对奋乃静片的溶出度测定方法进行了研究,建立奋乃静片剂的溶出度测定方法。方法以0.1 mol/L盐酸900 mL为溶出介质,溶出45 min(薄膜衣片30 min),采用紫外分光光度法在254 nm波长处进行测定。结果奋乃静质量浓度线性范围是0.2~7.0μg/mL,回归方程为 A=0.0819 C+0025, r=1( n=9);平均加样回收率为100.7%,RSD=1.34%( n=9)。结论该方法快速准确,可作为奋乃静片的质量控制方法。
目的:根據2010年版《中國藥典》藥典科研課題任務書的要求,為瞭更好地控製和評價各廠傢產品質量,對奮迺靜片的溶齣度測定方法進行瞭研究,建立奮迺靜片劑的溶齣度測定方法。方法以0.1 mol/L鹽痠900 mL為溶齣介質,溶齣45 min(薄膜衣片30 min),採用紫外分光光度法在254 nm波長處進行測定。結果奮迺靜質量濃度線性範圍是0.2~7.0μg/mL,迴歸方程為 A=0.0819 C+0025, r=1( n=9);平均加樣迴收率為100.7%,RSD=1.34%( n=9)。結論該方法快速準確,可作為奮迺靜片的質量控製方法。
목적:근거2010년판《중국약전》약전과연과제임무서적요구,위료경호지공제화평개각엄가산품질량,대강내정편적용출도측정방법진행료연구,건립강내정편제적용출도측정방법。방법이0.1 mol/L염산900 mL위용출개질,용출45 min(박막의편30 min),채용자외분광광도법재254 nm파장처진행측정。결과강내정질량농도선성범위시0.2~7.0μg/mL,회귀방정위 A=0.0819 C+0025, r=1( n=9);평균가양회수솔위100.7%,RSD=1.34%( n=9)。결론해방법쾌속준학,가작위강내정편적질량공제방법。
Objective To study the dissolution test method for better controlling and evaluating the products from various factories and to establish the dissolution test method of Perphenazine Tablets according to the requirement of the pharmacopoeia research project as-signment in the Chinese Pharmacopoeia ( 2010 edition ) . Methods The dissolving medium was 0. 1 mol/L hydrochloric acid 900 mL and the dissolution time was 45 min ( film coated tablets 30 min ) . Then theUV spectrophotometric method was adopted to conduct the detec-tion at the wavelength of 254 nm. Results The linear range of perphenazine was 0. 2-7. 0μg/mL, A=0. 081 9 C+0025, r=1 ( n=9 );the average recovery rate was 100. 7%,RSD=1. 34%( n=9 ) . Conclusion This method is rapid and accurate and can be used as the quality control method of Perphenazine Tblets.