中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
1期
11-13,17
,共4页
盐酸苯环壬酯控释片%高效液相色谱%释放度,质量控制
鹽痠苯環壬酯控釋片%高效液相色譜%釋放度,質量控製
염산분배임지공석편%고효액상색보%석방도,질량공제
Phencynonate hydrochloride extended-release tablets%HPLC%Dissolution%Quality control
目的：：建立盐酸苯环壬酯控释片释放度的测定条件和释放量测定方法。方法：采用HPLC法测定盐酸苯环壬酯控释片的释放度,色谱条件：Diamonsil C18(250 mm ×4.6 mm,5μm)为色谱柱,乙腈-水-磷酸-三乙胺(270∶400∶1.3∶2)为流动相,检测波长为220 nm,流速为1.0 ml·min-1,柱温为30℃,进样量为20μl；考察释放装置、释放介质和转速对盐酸苯环壬酯控释片释放度的影响。结果：建立的释放量测定方法在0.3~5.0μg·ml-1线性关系良好,r=0.9998,释放度的平均回收率为100.6%,RSD为1.16%(n=15)；在以900 ml pH 3.0磷酸盐缓冲溶液为释放介质、转速为50 r·min-1、加沉降篮的释放条件下,本品的体外释药行为符合零级模型,释药方程为：Q=6.1412t-9.3287,r=0.996。结论：建立的释放度测定条件和释放量测定方法简便、准确、可靠,可用于盐酸苯环壬酯控释片释放度的质量控制。
目的：：建立鹽痠苯環壬酯控釋片釋放度的測定條件和釋放量測定方法。方法：採用HPLC法測定鹽痠苯環壬酯控釋片的釋放度,色譜條件：Diamonsil C18(250 mm ×4.6 mm,5μm)為色譜柱,乙腈-水-燐痠-三乙胺(270∶400∶1.3∶2)為流動相,檢測波長為220 nm,流速為1.0 ml·min-1,柱溫為30℃,進樣量為20μl；攷察釋放裝置、釋放介質和轉速對鹽痠苯環壬酯控釋片釋放度的影響。結果：建立的釋放量測定方法在0.3~5.0μg·ml-1線性關繫良好,r=0.9998,釋放度的平均迴收率為100.6%,RSD為1.16%(n=15)；在以900 ml pH 3.0燐痠鹽緩遲溶液為釋放介質、轉速為50 r·min-1、加沉降籃的釋放條件下,本品的體外釋藥行為符閤零級模型,釋藥方程為：Q=6.1412t-9.3287,r=0.996。結論：建立的釋放度測定條件和釋放量測定方法簡便、準確、可靠,可用于鹽痠苯環壬酯控釋片釋放度的質量控製。
목적：：건립염산분배임지공석편석방도적측정조건화석방량측정방법。방법：채용HPLC법측정염산분배임지공석편적석방도,색보조건：Diamonsil C18(250 mm ×4.6 mm,5μm)위색보주,을정-수-린산-삼을알(270∶400∶1.3∶2)위류동상,검측파장위220 nm,류속위1.0 ml·min-1,주온위30℃,진양량위20μl；고찰석방장치、석방개질화전속대염산분배임지공석편석방도적영향。결과：건립적석방량측정방법재0.3~5.0μg·ml-1선성관계량호,r=0.9998,석방도적평균회수솔위100.6%,RSD위1.16%(n=15)；재이900 ml pH 3.0린산염완충용액위석방개질、전속위50 r·min-1、가침강람적석방조건하,본품적체외석약행위부합령급모형,석약방정위：Q=6.1412t-9.3287,r=0.996。결론：건립적석방도측정조건화석방량측정방법간편、준학、가고,가용우염산분배임지공석편석방도적질량공제。
Objective:To establish the drug release determination conditions and method for phencynonate hydrochloride extended release tablets. Methods:The drug release of the tablets was determined by HPLC using a Diamonsil C18 (250 mm × 4. 6 mm, 5 μm) column with the mobile phase of acetonitrile-water-phosphoric acid-triethylamine (270∶400∶1. 3∶2), the detection wavelength was 220 nm, the flow rate was 1. 0 ml·min-1 , the column temperature was 30 ℃ and the injection volume was 20 μl. The effects of different release apparatus, release media and rotation speeds on the release of phencynonate hydrochloride extended-release tablets were studied as well. Results:The established drug release determination method had a good linear relationship within the range of 0. 3-5. 0 μg· ml-1(r=0. 999 8), and the average recovery was 100. 6%(RSD=1. 16%, n=15). Under the conditions of 900ml pH 3. 0 phos-phate buffer solution as the release medium, rotation speed of 50 r·min-1 and the settlement basket as the apparatus, the release be-havior of the product was complied with a zero-level model in vitro, and the release equation was as follows:Q=6. 141 2t-9. 328 7(r=0. 996). Conclusion:The method is simple, accurate and reliable, and suitable for the quality control of phencynonate hydrochlo-ride extended-release tablets.
