九分喷雾剂质量控制方法研究

目的 :研究九分喷雾剂的质量控制方法。方法 :用薄层扫描法 (TLCs法 )测定含量 ,于硅胶GF254 薄层板上 ,以氯仿 -甲醇 -氨水 (4mol/L) (2∶6∶1)展开 ,双波长扫描 ,士的宁、马钱子碱波长为λs=254nm ,λr=325nm ;盐酸麻黄碱波长为λs=500nm ,λr=440nm。结果 :九分喷雾剂主要成分士的宁、马钱子碱、盐酸麻黄碱的日内回收率分别为 (99 048±2 388) %、 (99 532±0 958) %、(99 504±0 555) % ;日间回收率分别为 (98 796±1 058) %、(99 580±0 476) %、(99 420±0 838) % ;各成分含量分别为 (1 474±0 047) %、(1 372±0 052) %、(1 506±0 064) % (n=4)。结论 :TLCs法稳定可靠 ,可作为本制剂的含量测定方法。

Study on the Quality Method Control of Jiufen Spray

OBJECTIVE:To establish the quality method control of Jiufen spray,a percutaneous administration preparatio_n.METHODS:To determine the contents with TLCs method.The thin-layer plate was made of silica gel GF254. The spread out agent was chloroform-methanol-ammonia solution(4mol/L)(2∶6∶1). Dual wavelength scanning:strychnine and brucine:λs=254nm,λr=325nm;ephedrine:λs=500nm,λr=440nm.RESULTS:The within-day recoveries of strychnine,brucine and ephedrine were 99.048±2.388,99.532±0.958 and 99.504±0.555;the between-day recoveries were 98.796±1.058,99.58±0.476 and 99.42±0.838;the contents were(1.474±0.047)%,(1.372±0.052)%and(1.506±0.064)%(n=4) respectively.CONCLUSION:This method is stable and reliable and can be used for determination of the contents of this preparation.