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尼群地平(Nitrendipine)为第二代二氢吡啶类钙拮抗剂,见光易分解,形成无药理活性的1,4脱氢吡啶衍生物(称之为尼群地平杂质A)。《英国药典》中规定尼群地平中杂质A的量不得超过0.1%,其他单个杂质的量不得超过0.8%,杂质总量不得过1.2%。《中国药典》也收载了尼群地平,其有关物质检查方法差别较大,本文就05版药典和10版药典中测量方法的差异进行比较和讨论。
Nitrendipine, the second-generation dihydropyridine calcium antagonist, is readily degraded by light and forms the pharmacologically inactive 1,4-dehydropyridine derivative (known as nitrendipine impurity A). The British Pharmacopoeia stipulates that the amount of impurity A in nitrendipine should not exceed 0.1%, the amount of other individual impurities should not exceed 0.8% and the total amount of impurities should not exceed 1.2%. “Chinese Pharmacopoeia” also contains nitrendipine, its related substances more different methods of inspection, this article on the 05 version of Pharmacopoeia and 10 version of Pharmacopoeia differences in measurement methods were compared and discussed.