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输液中微粒系指在输液生产或应用过程中经各种途径所污染的微小颗粒杂质。其直径主要在1μ以下至25μ之间。25μ以上的微小颗粒虽也能发现但数目较少。对静脉注射剂的澄明度各国药典大多规定有检查方法和标准。检查法多基于肉眼观查,因此只能看出较大的粒子(约在50μ以上),一些较小的微粒则不能检出,只有任其存在而随溶液输入血管。由于近年来对输液中微粒的临床危害有了进一步的认识,对微粒的排除和检查通过研究而提出了新的方法,从而自七十年代初期各国药典才重新规定对注射液微粒的仪器检查法和新的检查标准。
Infusion of particles refers to the infusion of production or application of various ways by the tiny particles of impurities. Its diameter is mainly between 1μ and 25μ. Although tiny particles of more than 25μ can be found but the number is small. Clarity on intravenous injection Pharmacopoeia in most countries are provided with inspection methods and standards. The test is based on the naked eye and therefore can only be seen in larger particles (above about 50μ). Some smaller particles can not be detected and only enter the blood vessels with solution as they exist. Due to the clinical harm to the particles in the infusion has been further recognized in recent years, new methods have been proposed for the exclusion and examination of the particles. Therefore, since the early 1970s, the pharmacopoeias of various countries have re-prescribed the instrument examination method of the injection particles And new inspection standards.