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目的建立对匹多莫德咀嚼片进行质量研究的测定方法,并进行质量研究。方法采用HPLC法,色谱柱为ODS-C18色谱柱(200mm×4.6mm,5μm),流动相为0.01mol·L-1磷酸二氢钠-甲醇-异丙醇(体积比为97:2:1),检测波长为210nm,柱温为30℃,流速为1.0mL·min-1。以片剂外观颜色、主药及有关物质含量评价制剂稳定性。结果辅料和水与主药分离度大于1.5,破坏试验中破坏产物与主药分离度不低于1.5。稳定性试验显示:经高湿92.5%及75.0%放置10d,有关物质增长较快。咀嚼片经40℃环境温度和强光照射处理,各项质量指标均未发生明显改变;高温60℃放置10d,样品颜色变黄。加速试验和长期试验,制剂各项质量指标均未发生明显改变。结论建立的质量研究方法专属性好,方法可靠,制剂质量可控;本品在高温高湿的环境中不稳定,储存时应注意;制剂稳定性好,可长期放置。
Objective To establish a method for the determination of pidotimod chewable tablets and study its quality. Methods The HPLC method was as follows: ODS-C18 column (200 mm × 4.6 mm, 5 μm) with a mobile phase of 0.01 mol·L -1 sodium dihydrogen phosphate-methanol-isopropanol (volume ratio of 97: 2: 1 ), The detection wavelength was 210nm, the column temperature was 30 ℃ and the flow rate was 1.0mL · min-1. The stability of the preparation was evaluated by the appearance color of the tablet, the main drug and the related substances. Results accessories and water and the main drug separation greater than 1.5, the destruction of the test product and the main drug drug separation of not less than 1.5. The stability test showed that the substances grew rapidly after 92.5% and 75.0% of high humidity were placed for 10 days. The chewable tablets were treated with ambient temperature of 40 ℃ and bright light irradiation without any significant change in the quality indicators. The samples were yellow at 60 ℃ for 10 days. Accelerated test and long-term test, the preparation of the quality indicators did not change significantly. Conclusion The established quality research method has good specificity, reliable method and controllable preparation quality. The product is not stable in high temperature and high humidity environment and should be noticed when stored. The preparation has good stability and can be placed for a long time.