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目的:建立抑霉洗剂的质量控制方法。方法:以苦参碱、氧化苦参碱为对照,采用TLC法鉴别该制剂中的苦参,并采用HPLC法测定制剂中苦参碱的含量。结果:在TLC鉴别中能检出苦参,供试品与对照品、对照药材色谱在相应的位置上显相同的橙红色斑点,阴性对照无干扰。苦参碱在0.258 4～2.584 0μg线性关系良好,回归方程为Y=71.217 8 X-1 045.177 9(r=0.999 4),平均回收率为97.89%。结论:建立的制剂质量控制方法简便、可靠、准确,可作为该制剂的质量控制方法。
Objective: To establish a quality control method for mold inhibitor. Methods: Matrine and oxymatrine were used as control. TLC was used to identify Sophora flavescens. The content of matrine in the preparation was determined by HPLC. Results: Sophora flavescens can be detected in TLC identification, the test sample and the reference substance, the control drug chromatography in the corresponding position was the same orange-red spots, negative control without interference. The linear relationship of matrine at 0.258 4 ~ 2.584 0 μg was good. The regression equation was Y = 71.217 8 X-1 045.177 9 (r = 0.999 4). The average recovery was 97.89%. Conclusion: The established quality control method of preparation is simple, reliable and accurate and can be used as the quality control method of the preparation.