元胡止痛系列制剂中金胺O的检测

目的: 建立元胡止痛系列制剂中金胺O的检测方法。 方法: 采用TLC与HPLC-UV-MS相结合的方法检测元胡止痛制剂及模拟工艺制备小试样品中金胺O,并检测比较5种剂型245批样品。 结果: 该品种工艺可将药材中染色金胺O引入成品。在245批样品中有3批片剂、2批胶囊剂呈阳性。 结论: TLC与HPLC-UV-MS的方法,两者相结合可快速、准确、灵敏地检测出元胡止痛制剂中金胺O。

Objective: To establish a method for detection of auramine O in Yuanhu Zhitong preparations. Methods: TLC and HPLC-UV-MS was adopted for detecting auramine O in 245 batches of 5 dosages forms of Yuanhu Zhitong preparations and the samples prepared with simulative production process. Results: The production process could deliver auramine O from raw material medicine to finished products.Three batches in tablet form and two batches in capsule form showed positive among the 245 batches of the product. Conclusion: The combination of TLC and HPLC-UV-MS can rapidly,accurately and sensitively detect auramine O in Yuanhu Zhitong preparations.

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