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目的:建立乳癖消片(胶囊)中是否非法掺入甾体激素类药(醋酸泼尼松、醋酸可的松、醋酸氢化可的松、醋酸地塞米松)的检测方法。方法:采用HPLC检测方法:C18柱(4.6 mm×200 mm,5μm),乙腈-水(24∶76)为流动相,检测波长254 nm,用二极管阵列检测联用技术进行定性鉴定。并摸拟在未检出4种甾体激素类药的样品中添加适量对照品作为阳性参比对照。结果:在同一条件下,测定了3个厂家的96批样品及阳性参比对照,结果阳性参比对照检出醋酸泼尼松、醋酸氢化可的松、醋酸可的松、醋酸地塞米松;96批样品均未检出。结论:所建方法专属性强、灵敏度高、操作方便,可作为监测掺有多种甾体激素类中成药的有效方法。
Objective: To establish whether Rupixiao Tablet (capsule) is illegally incorporated steroid hormones (prednisone acetate, cortisone acetate, hydrocortisone acetate, dexamethasone acetate) detection method. Methods: HPLC method was used: C18 column (4.6 mm × 200 mm, 5 μm) and acetonitrile-water (24:76) as mobile phase. The detection wavelength was 254 nm and was identified by diode array detection. And we did not detect the four kinds of steroid hormones in the sample to add the appropriate amount of reference substance as a positive reference control. Results: Under the same conditions, 96 batches of samples from 3 factories and positive control were measured. The results of positive reference control were prednisone acetate, hydrocortisone acetate, cortisone acetate and dexamethasone acetate. 96 batches of samples were not detected. Conclusion: The proposed method is specific, sensitive and easy to operate. It can be used as an effective method for monitoring proprietary Chinese medicines mixed with various steroid hormones.