色差计法在注射剂溶液颜色检查法中的应用

Application of colorimeter method for solution color inspection in injections

目的:为应用色差计法检查中药注射剂的颜色以对其安全性控制提供理论和实验依据。方法:用色差计分别测定黄绿色、黄色、橙黄色、橙红色、棕红色标准比色液的色品[(L、a、b)、(L、C、H)]和色差[ΔE(L、a、b)、ΔE(L、C、H)],并以色差计检测清开灵注射液的溶液颜色,并考察其与异常毒性检查法和含量测定结果之间的相关性。结果:用标准比色液的色品、色差(ΔE)及红绿度(a)或黄兰度(b)作为判别标准,则可以检测出供试品比色液的色调和色号,清开灵注射液溶液颜色的差异与异常毒性检查中动物反应呈现正相关,并提示与其含量测定结果具有某种关联性。结论:直接用色差计法可以准确地检查注射剂的溶液颜色,提示灵敏的溶液颜色测定对于中药注射剂安全性控制具有实际意义。

Objective： To provide theoretical and experimental evidence for applying chromatism meter to analyze standard colorimetric solution chromaticity,hue and color and to evaluate the safety of the solution. Methods：（ L,a,b）,（ L,C,H） and ΔE（ L,a,b）,ΔE（ L,C,H） for standard colorimetric solution of yellowish green,yellow,orange yellow,orange red,brownish red were determined by chromatism meter method and the correlation between the solution color and abnormal toxicity was studied. Results： The test colorimetric solution hue and color number can be determined using ΔE and a or b of standard colorimetric solution as a criterion. The solution color is correlated with the animal reaction in abnormal toxicity test. Conclusion： Chromatism meter method can accurately test the color of solution,and thus is useful in controlling the clinic safety of traditional Chinese medicine injection.