美国药典第19版(下称 USP19版)后及其第一补充版本均于75年前后颁布,在补充版本中有关注射液中异物颗粒等的规定值得引起注意。USP19版在一般试验和含量测定项下规定了一项调制液(Constituted solutions)的有关医疗实践的标准。指出这种制品应在临用前适当时间配制,而最重要的一点就是要求调制液不含肉眼可见的异物颗粒。 The United States Pharmacopeia, 19th edition (hereinafter referred to as USP19 version) and its first supplementary version promulgated in the 75 years ago, in the supplementary version of the injection of foreign particles in the rules worthy of attention. USP 19 sets forth a standard for medical practice of Constituted solutions under the general test and assay. Pointed out that such products should be prepared at the appropriate time before use, and the most important point is that the modulation fluid does not contain visible foreign particles.