应用光阻颗粒计数仪检测抗生素注射剂中微粒的初步探讨

ANALYSIS OF PARTICULATE CONTAMINATION IN ANTIBIOTIC INJECTION VIALS USING A LIGHT BLOCKAGE PARTICLE ANALYZER

应用光阻颗粒计数仪(HIAC/ROYCO)初步考察国内部份注射用抗生素制剂及国外样品104批,并对质量标准,颗粒大小及数量,控制范围作初步探讨。

Particulate contamination in antibiotic injection vials including 21 pharmaceutical preparation of 100 samples from different sources, using a light blockage particle analyzer(HIAC/ROYCO)has been determined. Lower levels of particu-late contamination were found in antibiotic solution for injection, such as gentamicin sulfate for injection and kanamycin sulfate for injection, as compared with antibiotic powders for injection. The numbers of particles in penicillin potassium packed in different strength were revealed that the higher numbers of particles were relative to higner strength and vice versa. Results showed that the level of particulate contamination also fell well within the limits set by the USP XXII Edition for Small Volume Parenterals.