中国中药杂志

2008, (20) 2343-2346

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半边旗5F注射液的质量标准研究
Studies on quality standard of PsL 5F injections

吕应年;G G Chen;龚先玲;吴科锋;梁念慈;
LV Ying-nian1,G G Chen2,GONG Xian-ling1,WU Ke-feng1,LIANG Nian-ci1(1.Guangdong Key Lab for Research and Development of Natural Drugs,Guangdong Medical College,Zhanjiang 524023,China;2.Department of Surgery,Prince of Wales Hospital,Chinese Universty of Hongkong,Shatin,Hongkong)

摘要(Abstract):

目的:建立半边旗注射液的质量标准。方法:采用薄层色谱法对半边旗注射液进行鉴别;采用高效液相色谱法测定主要成分11α-羟基-15-氧-16-烯-对映贝壳杉烷-19-酸(5F)的含量,色谱柱为Hypersil C18(4.6 mm×250 mm,5μm),流动相为甲醇-水-冰醋酸(55∶45∶0.045),检测波长254 nm,流速1.0 mL.min-1,柱温35℃;采用pH计法、离子火焰法和沉淀法分别测定注射液pH,K+、鞣质、蛋白质、草酸盐以及重金属含量。结果:薄层鉴别斑点清晰,重现性好。高效液相色谱法测定5F在30~240 mg.L-1线性关系良好(r=0.999 8),平均加样回收率为99.8%。连续3批注射液pH 7.80~8.20,K+浓度小于10 mmol.L-1,注射液的鞣质、蛋白质、草酸盐以及重金属含量都符合药典规定。结论:本实验建立的分析方法灵敏可靠,可作为半边旗注射液的质量控制方法。
Objective: To establish the quality standard of PsL injections containing mainly 5F(ent-11α-hydroxy-15-oxo-kaur-16-en-19-oic-acid).Method: The identification of PsL was performed by thin-layer chromatography,and the content was determined by HPLC.The column was Hypersil C18(4.6 mm×250 mm,5 μm),the mobile phase was the mixture of methane-water-acitic acid(55∶45∶0.045) with a flow rate of 1.0 mL·min-1,the detective wavelength was 254 nm,and the column temperature was maintained at 35 ℃.The pH value and K+ content of the three batchs injection were determined with pH meter and flame photometric meter,and the contents of tannin,protein,oxalic acid salt and heavy metals were detected by deferent methods.Result: The TLC method was suitable for the identification of PsL5F.The linearity for 5F was obtained over the range of 30-240 μg·mL-1(r=0.999 8),the average recovery of 5F was 99.8%.The injections were of pH value range from 7.80 to 8.20,K+ contents less than 10 mmol·L-1,and the contents of tannin,protein,oxalic acid salt and heavy metals were qualified with the Chinese pharmacopoeia,respectively.Conclusion: It's sensitive and reliable that can be used as quality control methods of PsL5F injections,

关键词(KeyWords): 半边旗;11α-羟基-15-氧-16-烯-对映贝壳杉烷-19-酸;注射液;质量控制
Pteris semipinnata;5F;injections;quality control

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(3987099);; 粤港合作项目(GHP022/06)

作者(Author): 吕应年;G G Chen;龚先玲;吴科锋;梁念慈;
LV Ying-nian1,G G Chen2,GONG Xian-ling1,WU Ke-feng1,LIANG Nian-ci1(1.Guangdong Key Lab for Research and Development of Natural Drugs,Guangdong Medical College,Zhanjiang 524023,China;2.Department of Surgery,Prince of Wales Hospital,Chinese Universty of Hongkong,Shatin,Hongkong)

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