摘要
目的考察氨基葡萄糖枸橼酸钙分散片的稳定性。方法采用高效液相色谱-蒸发光散射检测器(HPLC-ELSD)法测定氨基葡萄糖的含量,参照2005年版《中国药典(二部)》中葡萄糖酸钙测定方法测定枸橼酸钙含量,并按照药典规定进行稳定性考察。结果在不同条件下,氨基葡萄糖枸橼酸钙分散片的外观性状、含量、溶出度、有关物质均符合规定。结论氨基葡萄糖枸橼酸钙分散片质量可控,稳定性较好。
Objective To explore the stability of Glucosamine Calcium Citrate Dispersible Tablets. Methods Glucosamine hydrochloride was determined by HPLC- ELSD and calcium citrate was measured by the method for determining calcium gluconate according to volume Ⅱ of the Chinese Pharmacopoeia(edition 2005). Samples were taken under different conditions for stability test. Results Under the testing conditions, no obvious changes were observed. The appearance, content, dissolution and related substances of the dispersible tablets all conformed to the pharmacopoeia stipulation. Conclusion Glucosamine Calcium Citrate Dispersible Tablets could be controllable in quality and shows good stability.
出处
《中国药业》
CAS
2009年第20期18-20,共3页
China Pharmaceuticals
关键词
氨基葡萄糖枸橼酸钙分散片
含量测定
稳定性
Glucosamine Calcium Citrate Dispersible tablets
content determination
stability