气相色谱法测定万福液中利多卡因和樟脑的含量(1)
 |
| 第1页 |
参见附件(1342KB，2页)。
[摘要] 目的：建立一种用气相色谱法测定万福液中樟脑、利多卡因二组分含量的方法。方法：气相色谱法，采用HP-5MS毛细管色谱柱；柱温90℃，保持1 min，然后以5℃/min升温至130℃，保持5 min，再以20℃/min升温至240℃，保持10 min；进样口温度为210℃；检测器温度(FID)为240℃；载气为氮气。结果：盐酸利多卡因线性范围为0.392 3～1.569 2 mg/ml，r=0.999 3；樟脑线性范围为0.232 8～1.862 4 mg/ml，r=0.999 5。平均加样回收率分别为盐酸利多卡因99.58%，RSD为0.38%(n=9)；樟脑99.51%，RSD为0.46%(n=9)。结论：该法简便快速，结果准确，可用于该制剂的质量控制。
[关键词] 气相色谱法；万福液；利多卡因；樟脑；含量测定
[中图分类号] R927.2 [文献标识码] A [文章编号] 1673-7210(2011)11(b)-053-03
Contents determination of lidocaine and camphor in Wanfu Liquid by the method of gas chromatography
XIN Huping, WANG Li, ZHANG Xiaohong, GAO Ming
Institute for Food and Drug Control in Wuwei City, Gansu Province, Wuwei 733000, China
[Abstract] Objective: To establish a method of gas chromatography to determine the contents of camphor and lidocaine in Wanfu Liquid. Methods: Gas chromatography with HP-5MS capillary column was uesd; temperature of column was 90℃, which was keeping for 1 min, then heated it up to 130℃ by rising 5℃/min, which was keeping in 5 minutes, then heated it up to 240℃ by rising 20℃/min, which was keeping in 10 minutes. The temperature of inlet was 210℃. The temperature of detector (FID) was 240℃. The carrier gas was Nitrogen. Results: The linear range of lidocaine hydrochloride was 0.392 3-1.569 2 mg/ml, r=0.999 3, the linear range of camphor was 0.232 8-1.862 4 mg/ml, r=0.999 5. The average rates of recovery of lidocaine were 99.58%, with RSD was 0.38% (n=9); camphor were 99.51%, with RSD was 0.46% (n=9). Conclusion: This method is simple, rapid, and also accurate. It can be used for the quality control for this preparation.
[Key words] Gas chromatography; Wanfu Liquid; Lidocaine; Camphor; Determination.
万福液是由氯霉素、樟脑、盐酸利多卡因、地塞米松磷酸钠加甘油、乙醇和水制成。万福液具有消炎、镇痛、止痒的作用，用于皮肤病和蚊虫叮咬的治疗。经过多年临床应用证明，万福液质量稳定，疗效可靠。为了更好地控制制剂质量，确保用药安全，笔者查阅了有关文献[1-6]，本文采用气相色谱法测定万福液中樟脑、盐酸利多卡因二组分的含量，取得了满意的效果，可以有效地控制该制剂的质量。
1 仪器与试药
Agilent6820气相色谱仪；电子天平(瑞士Precisa XR 205SM-DR)；樟脑对照品(中国药品生物制品检定所，批号：110747-200603，供含量测定用)；盐酸利多卡因对照品(中国药品生物制品检定所，批号：100341-200301，供含量测定用)；马来酸氯苯拉敏对照品(中国药品生物制品检定所，批号：100047-200606，供含量测定用)；萘(中国药品生物制品检定所 ......
您现在查看是摘要介绍页，详见PDF附件(1342KB，2页)。