不同培养基对硫酸庆大霉素注射液含量的影响

Effect of Different Culture Mediums on Content Assay of Gentamycin Sulfate Injection

目的研究不同培养基对硫酸庆大霉素注射液含量的影响。方法按照2005年版《中国药典(二部)》硫酸庆大霉素注射液含量测定项下的抗生素微生物检定法(管碟法),采用不同厂家或同一厂家不同批号的干粉抗生素检定培养基I号对硫酸庆大霉素注射液进行含量测定,将测定结果作比对分析。结果不同厂家或同一厂家不同批号的培养基检测结果有明显或较明显差异。结论建议对培养基的质量作进一步探讨,制订各种培养基的国家质量标准。

Objective To study the effect of different culture mediums on the content assay of Gentamycin sulfate Injection. Methods According to China Pharmacopoeia（Vol. Ⅱ, edition 2005）, the assay of Gentamycin Sulfate Injection was determined by cylinder-plate method,us- ing different culture mediums from different manufacturers or different batches of the same manufacturer. The determined results were compared. Results There was significant difference among the results obtained from different culture mediums. Conclusion The quality of culture mediums should be further studied and the national criteria also should be made.