论文部分内容阅读
目的:采用气相色谱法拆分醒脑静注射液中龙脑对映体,并通过对映体的分离测定含量。方法:采用CYCLOSIL-B(30m×0.25 mm×0.25μm)手性毛细管色谱柱、FID检测器,以内标法测定醒脑静注射液中左旋龙脑和右旋龙脑的含量。结果:龙脑对映体在CYCLOSIL-B手性毛细管色谱柱上具有较好的分离效果,其分离度为2.04。左旋龙脑和右旋龙脑线性范围分别为0.048～0.960和0.050～1.008 mg·mL-1(r≥0.9991);冰片投料为天然冰片的样品中右旋龙脑平均回收率(n=6)为98.4%,RSD为1.8%;冰片投料为艾片的样品中左旋龙脑的平均回收率(n=6)为99.1%,RSD为1.9%。结论:所建立的方法简单、准确、可靠,能用于醒脑静注射液的质量控制。
OBJECTIVE: To separate and analyze the enantiomer of borneol in Xingnaojing injection by gas chromatography, and to determine the content of enantiomers by enantiomeric separation. Methods: The CYCLOSIL-B (30m × 0.25 mm × 0.25μm) chiral capillary column and FID detector were used to determine the content of levarnor diltiazem and dextrorotronate in Xingnaojing injection by internal standard method. Results: The enantiomers of borneol had a good separation effect on CYCLOSIL-B chiral capillary column with a resolution of 2.04. The linear ranges of Levobetaine and dextromethron were 0.048-0.960 and 0.050-1.008 mg · mL-1, respectively (r≥0.9991). The average recoveries of dexamethasone in samples with borneol as natural borneol (n = 6) Was 98.4%, and the RSD was 1.8%. The average recovery (n = 6) of levobuterol in the samples with borneol as tablets was 99.1% and the RSD was 1.9%. Conclusion: The established method is simple, accurate and reliable and can be used for the quality control of Xingnaojing injection.