本文選題：雙氫青蒿素哌喹片　切入點：雙氫青蒿素　出處：《中國藥房》2017年15期 　論文類型：期刊論文

【摘要】：目的:改進雙氫青蒿素哌喹片中雙氫青蒿素的溶出度測定方法。方法:采用槳法進行溶出試驗,以0.1 mol/L鹽酸溶液為溶出介質(zhì),溶出介質(zhì)體積為500 mL,轉(zhuǎn)速為75 r/min,取樣時間為45 min;樣品前處理中加入3.6%氫氧化鈉溶液的體積由原來的5mL改為20 mL,加入磷酸的體積由原來的0.2 mL改為0.7 mL。采用高效液相色譜法測定制劑中雙氫青蒿素的溶出度:色譜柱為YMC-Pack ODS-A,流動相為0.02 mol/L磷酸氫二鈉溶液(用磷酸調(diào)節(jié)p H為2.4)-乙腈(65∶35,V/V),流速為1.0 mL/min,檢測波長為237 nm,柱溫為30℃,進樣量為20μL。結(jié)果:雙氫青蒿素檢測質(zhì)量濃度線性范圍為7.802~117.03μg/mL(r=0.999 9);定量限為2.0 ng,檢測限為0.6 ng;精密度、重復(fù)性試驗的RSD1.0%;回收率為99.18%~100.46%(RSD=0.45%,n=9)。3批樣品中雙氫青蒿素的平均溶出度分別為94.9%、77.9%、89.6%。結(jié)論:改進后的方法提高了其靈敏度、溶出度以及檢測結(jié)果的準確性。
[Abstract]:Objective: to improve the dissolution of dihydroartemisinin in dihydroartemisinin piperaquine tablets. The volume of dissolved medium was 500mL, the rotational speed was 75rmin, the sampling time was 45min, the volume of 3.6% sodium hydroxide solution was changed from 5 mL to 20 mL, and the volume of phosphoric acid was changed from 0.2 mL to 0.7 mL. The dissolution of dihydroartemisinin in the preparation was determined by phase chromatography. The chromatographic column was YMC-Pack ODS-A, the mobile phase was 0.02 mol/L disodium hydrogen phosphate solution (adjusted by phosphoric acid to pH = 2.4- acetonitrile 65: 35V / V), the flow rate was 1.0 mL / min, the detection wavelength was 237nm, and the column temperature was 30 鈩，

本文編號：1575158