扑尔敏片溶出度考察
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程红霞1，王 煜2
(1. 北京联合大学 生物化工学院，北京100023 ; 2.北京拜耳医药有限公司，北京100024 )
摘要:目的 比较5个厂家生产的扑尔敏片的溶出度，为进一步比较不同厂家制剂的体内生物利用等效性以及指导临床用药提供理论参考。方法 采用中国药典方法，以XC第三法进行体外溶出试验，以威布尔分布拟合溶出参数。结果 5个厂家生产的扑尔敏片符合中国药典要求，但不同厂家的溶出度存在差异，B厂最快。结论 不同厂家扑尔敏片溶出度存在差异。
关键词：药剂学；溶出度；生物利用等效性；体外溶出实验；威布尔分布；扑尔敏片
中图分类号：R94 文献标识码：A
Comparison of dissolution rates of chlorphenamine maleate tablets from different manufacturers
CHENG Hong-xia, WANG Yu²
(1. Bio-chemistry engineering college of Beijing Union University，Beijing 100023; 2. Beijing Bayer Healthcare Company Ltd., Beijing 100024, China)
Abstract: Objective To investigate the difference of the dissolution rates of chlorphenamine maleate tablets from 5 pharmaceutical companies in vitro. Method(s) The dissolution rate test was carried out in dissolution test system according to Chinese pharmacopoeia. The dissolution parameters were evaluated by the Weibubll’s equation. Result(s) The dissolution rates of chlorphenamine maleate tablets from 5 pharmaceutical companies all met with the Pharmacopoeia, but there was difference among different pharmaceutical companies. The tablets from B manufacturer was the fastest. Conclusion(s) There is difference of dissolution rates among different pharmaceutical manufacturers.
Key words: pharmaceutics; dissolution rate; BA; dissolution experiment in vitro; Weibubll’s equation; chlorphenamine maleate tablets
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