拉曼无损测试对沙星类液体制剂光稳定性的影响考察

目的： 在药品快速筛查打假中，拉曼光谱可以快速无损的对液体制剂进行检测，本论文通过考察拉曼无损测试对液体制剂的稳定性的影响，来确定拉曼光谱快检方法不影响药品本身的安全性。 方法： 选择对光极不稳定的沙星类液体制剂，按照液体制剂拉曼无损检测方法进行测量，分别在测量前、测量后（300、600 s）取样，用HPLC法对其中的有关物质进行检查，同时与紫外破坏实验的产生杂质的HPLC结果对比，考察有关物质差异性。 结果： 所有样品拉曼测试前后均无新的杂质峰产生。氧氟沙星滴耳液拉曼测试300 s和600 s后与测试前 t检验结果分别为保留时间0.9865、0.1863，峰面积0.1350、0.3386，均大于0.05，即无显著差异；盐酸洛美沙星注射液拉曼测试300 s和600 s后与测试前 t检验结果分别为保留时间0.2440、0.3183，峰面积0.8360、0.2322，均大于0.05，即无显著差异。 结论： 785 nm激光拉曼无损测试对沙星类液体制剂无光不稳定性反应，因此测试方法对液体制剂进入再流通的安全性没有影响。

Objective: Raman spectra could determine the liquid preparation non-invasively in fast drug screening.This article studied the influence of non-invasive Raman measurements on the stability of liquid preparation to confirm the safety of the Raman method to the samples themselves. Method: Gatifloxacin liquid preparation were chosen because of their extremely unstable features to the light.By sampling both before and after Raman measurements with the testing times of 300 s and 600 s,the related substances were tested using the HPLC method,and additionally compared with the impurity peaks from UV destructive testing to find whether there were differences. Results: No new impurity peaks generated after the non-invasive Raman measurement of all samples.The results of the t-test of ofloxacin ear drops before Raman measurements and after 300 s and 600 s measurements were all larger than the confidence level of 0.05 with the value of 0.9865,0.1863 for retention times and 0.1350,0.3386 for peak areas respectively,which showed no significant difference between each other.And the results of the t-test of lomefloxacin hydrochloride and sodium chloride preparation before Raman measurements and after 300 s and 600 s measurements were all larger than the confidence level of 0.05 with the value of 0.2440,0.3183 for retention times and 0.8360,0.2322 for peak areas respectively,which also showed no significant difference between each other. Conclusion: The non-invasive Raman measurement with 785 nm laser had no light-unstable influence on gatifloxacin liquid preparation,therefore the non-invasively fast Raman screening on liquid preparation is safe to the drugs.

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