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目的:建立医院制剂糖宁通络胶囊的鉴别方法。方法:对科夭罗曲、车前草、山银花的薄层色谱鉴别,考察不同展开介质、不同点样量、不同厂家薄层板、不同温度、不同湿度对方法的影响。结果:科夭罗曲的鉴别方法是以木犀草苷对照品为对照,以乙酸乙酯-丙酮-甲酸-水=7∶3∶1∶1.2为展开剂的薄层色谱法;车前草的鉴别方法是以大车前苷对照品为对照,以乙酸乙酯-丙酮-甲酸-水=7∶3∶1∶1.2为展开剂的薄层色谱法;山银花的鉴别方法是以异绿原酸A对照品为对照,以乙酸乙酯-丙酮-甲酸-水=7∶3∶1∶1.2为展开剂的薄层色谱法。结论:建立了医院制剂糖宁通络胶囊的鉴别方法,该方法灵敏度高、重复性好、方便可行、阴性对照无干扰,将其用于糖宁通络胶囊的质量检测方法中,可有效控制药品质量,从而确保产品质量的稳定以及临床用药的安全、有效。
Objective: To establish the identification method of hospital preparations of sugar Ning Tong Luo capsule. Methods: TLC, HPLC, TLC and HPLC were used to investigate the effects of different media, different sample volumes, thin plates from different manufacturers, different temperatures and different humidities. Results: The method of identification of Cordova was based on the reference substance of luteolin, with the ethyl acetate - acetone - formic acid - water = 7: 3:1: 1.2 as developing solvent; The method of identification is that the standard of glycosides glycosides in cart is controlled by thin layer chromatography with ethyl acetate-acetone-formic acid-water = 7: 3: 1: 1.2 as developing solvent; The control of the original acid A was the control, and the thin layer chromatography was developed with ethyl acetate - acetone - formic acid - water = 7: 3: 1: 1.2. Conclusion: The identification method of the hospital preparation of sugar Ning Tongluo Capsules is established. The method has the advantages of high sensitivity, good repeatability, convenient and feasible, and no interference with the negative control. The method can be used for the quality control of the sugar-tonifying capsule. Drug quality, so as to ensure the stability of product quality and clinical drug safety and effectiveness.