盐酸氨基葡萄糖原料及制剂的药学影响因素研究

Study on the Pharmaceutical Influencing Factors of Glucosamine Hydrochloride Raw Materials and the Preparations

目的考察盐酸氨基葡萄糖原料及不同剂型的影响因素,为处方工艺研究及质量控制提供依据。方法样品经过破坏试验和高温、高湿处理后,用反相高效液相色谱法测定有关物质。通过考察盐酸氨基葡萄糖的有关物质变化,作为影响因素的评价指标。结果盐酸氨基葡萄糖原料比较稳定。在高温高湿条件下,原料与硬脂酸镁和羧甲基淀粉钠辅料分别发生了相容性反应,产生杂质2,5-脱氧果糖嗪或果糖嗪。在高温及高湿条件下,盐酸氨基葡萄糖片剂A厂和颗粒剂D厂有关物质均增加明显,A厂总杂质分别为9.95%和9.22%(未破坏总杂质为5.20%),D厂总杂质分别为8.74%和7.92%(未破坏总杂质为2.82%)。结论盐酸氨基葡萄糖制剂中处方工艺的差异可能是影响有关物质出现较大差异的重要因素。

Objective To provide the information for the formulation process and quality control by studying the influencing factors of glucosamine hydrochloride raw materials and preparation experiment.M ethods The relative substances were detected by RP-HPLC after treated under the condition of destruction test,high temperature and high humidity.The changes of related substances of glucosamine hydrochloride were studied as the evaluation index of influencing factors.Results The glucosamine hydrochloride raw materials were relatively stable.Under the condition of high temperature and high humidity,the compatibility reaction occurred among the raw materials and sodium carboxymethyl starch and magnesium stearate respectively,producing impurities 2,5-deoxyfructose or fructose.Related substances in glucosamine hydrochloride of tablets of manufacturer A and granule of manufacturer D both increased significantly,the total impurity of manufacturer A was 9.95%and 9.22%respectively（those not destroyed were 5.20%）,and the total impurity of manufacturer D was 8.74%and 7.92%（those not destroyed were 2.82%）.Conclusion The differences of the formulation technology in glucosamine hydrochloride preparations may be the critical factors that influence the relative substances.