| 引用本文: | 李志刚,倪广才,孙学伟,丁锐,余立.GC测定中药丹酚酸A中有机溶剂残留量[J].中国现代应用药学,2013,30(1):59-61. |
| LI Zhigang,NI Guangcai,SUN Xuewei,DING Rui,YU Li.Determination of the Residual Organic Solvents in Salvianolic Acid A by GC[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(1):59-61. |
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| 摘要: |
| 目的 建立测定中药丹酚酸A中有机溶剂乙醇和乙酸乙酯残留量的方法。方法 采用气相色谱法。色谱柱为HP-INNOWAX毛细管柱，检测器为氢火焰离子化检测器，柱温为程序升温，载气为氮气。进样口温度为200 ℃，检测器温度为250 ℃。结果 乙醇和乙酸乙酯检测浓度的线性范围分别为2.5~2 500 μg·mL-1(r=0.995 3)和0.5~2 500 μg·mL-1(r= 0.998 1)；平均回收率为100.97%和102.19%(RSD均<5.0%)；检测限为0.84 μg·mL-1和0.17 μg·mL-1；3批样品中2种有机溶剂残留量均符合中国药典要求。结论 本方法简单、准确、灵敏度高、重复性好，可用于该药物中有机溶剂残留量的测定。 |
| 关键词: 丹酚酸A 有机溶剂 残留量 气相色谱法 |
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| 基金项目:国家“重大新药创制”科技重大专项 |
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| Determination of the Residual Organic Solvents in Salvianolic Acid A by GC |
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LI Zhigang1, NI Guangcai1, SUN Xuewei1, DING Rui2, YU Li2
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1.Beijing Bencaotianyuan Institute of Pharmaceutical Research, Beijing 100039, China;2.Beijing Institute for Drug Control, Beijing 100035, China
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| Abstract: |
| OBJECTIVE To establish a method for the content determination of residual organic solvents in salvianolic acid A, include alcohol and ethyl acetate. METHODS Headspace gas chromatography was adopted. Residual organic solvents were separated on HP-INNOWAX capillary column using temperature programming and nitrogen gas as carrier gas. The inlet temperature was 200 ℃. FID was used as detector with a temperature of 250 ℃. RESULTS The linear ranges of alcoho1 and ethyl acetate were 2.5-2 500 μg·mL-1(r=0.995 3) and 0.5-2 500 μg·mL-1(r=0.998 1), respectively, the average recoveries were 100.97% and 102.19%, respectively. RSD was both less than 5.0%. The detection limits were 0.84 mg·mL-1 and 0.17 mg·mL-1, respectively. The residual levels of two kinds of organic solvents in three batches of samples were in line with the standard stated in Chinese Pharmacopeia. CONCLUSION The method is simple, accurate, sensitive and reproducible. It can be used for the determination of the residua1 organic solvents in salvianolic acid A. |
| Key words: salvianolic acid A organic solvents residual GC |
