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目的:通过对比不同生产厂家复方谷氨酰胺颗粒制剂质量标准,以及与颗粒剂质量相关的检验项目的实验对比,找出各制剂处方工艺的差别和质量差异。方法:应用中国药典二部方法,取供试品10g,加热水200ml,搅拌5分钟,可溶颗粒应全部溶化或轻微浑浊,但不得有异物;有关物质采用高效液相色谱法,流动相乙腈-0.05mol/L磷酸二氢钾缓冲液(70:30);检测波长为215nm。结果:按颗粒剂制剂通则试验,及有关物质试验。均有一定差异。讨论:各公司产品质量标准各有利弊,建议尽快出台统一的质量标准,规范制剂质量。
OBJECTIVE: To find out the differences and quality differences between the prescriptions of various preparations by comparing the quality standards of the compound glutamine granules of different manufacturers, as well as the experimental comparison of the test items related to the granules quality. Methods: The Chinese Pharmacopoeia two methods, take the test product 10g, heated water 200ml, stirring for 5 minutes, the soluble particles should be all dissolved or slightly cloudy, but no foreign body; related substances using high performance liquid chromatography, the mobile phase acetonitrile -0.05mol / L potassium dihydrogen phosphate buffer (70:30); detection wavelength of 215nm. Results: According to the granule preparation general test, and the related material test. There are some differences. Discussion: The company product quality standards have their own advantages and disadvantages, it is recommended as soon as possible the introduction of a unified quality standards, regulate the quality of preparations.