注射用硫酸链霉素细菌内毒素检查限值的研究

摘要

OBJECTIVE: To increase the bacterial endotoxin limit of Streptomycin sulfate for injection in accordance with the clinical usage and dosage, "Guidance for Security Test of Chemical Injection", matching with international level. METHODS: The interference test and bacterial endotoxin test of 43 batches of Streptomycin sulfate for injection from 6 manufacturers were carried out in accordance with the bacterial endotoxin test approved by appendix Ⅱ of Chinese Pharmacopeia (2010 edition). RESULTS: Diluted to a concentration of 5 mg·mL-1, the samples showed no interference action on bacterial endotoxin test. The limit value of the bacterial endotoxin could be improved to "it contains less than 0.10 EU per mg of streptomycin". The results of the bacterial endotoxin test of the 43 batches of samples were all accorded with the standard of the established quality control. CONCLUSION: The endotoxin test of Streptomycin sulfate for injection could be increased from "it contains less than 0.25 EU per mg of streptomycin" stated in Chinese Pharmacopoeia (2010 edition) to "it contains less than 0.10 EU per mg of streptomycin", which reflects the requirements of drug combination in the clinic to guarantee the safety of drug use, and it consists with the bacterial endotoxin test stated in Japanese Standards of Antibiotics (2000 edition).%目的:提高注射用硫酸链霉素细菌内毒素检查限值,与临床实际用法用量及“化学药品注射剂安全性检查法应用指导原则”要求相符合,且与国际标准接轨.方法:按2010年版《中国药典》(二部)细菌内毒素检查法,用不同厂家鲎试剂对6个厂家生产的43批注射用硫酸链霉素进行干扰试验和细菌内毒素检查.结果:样品浓度稀释到5 mg·mL-1时对所用细菌内毒素检查法无干扰作用；细菌内毒素的限值提高为“每1 mg链霉素中小于0.10 EU”时,按此标准检查,43批样品细菌内毒素均符合规定.结论:建议注射用硫酸链霉素细菌内毒素检查限值由2010年版《中国药典》规定的“每1 mg链霉素中小于0.25 EU”提高至“每1 mg链霉素中小于0.10 EU”,体现了临床使用中联合用药的要求,可保证用药安全,且与2000年版《日本抗生物质医药品基准解说》对本品细菌内毒素检查限值要求一致.