摘要
目的考察重组人角质细胞生长因子(rh-KGF)冻干粉针剂中β-巯基乙醇的残留量,确定其临床应用安全性。方法采用气相色谱法,考察β-巯基乙醇对照品的检测限、标准曲线、加样回收率及稳定性,并对不同批号的rh-KGF冻干针剂中β-巯基乙醇残留量进行考察。结果β-巯基乙醇的检测限为0.235μg/ml,在0～52.08μg/ml浓度范围内,β-巯基乙醇与其浓度有良好线性关系(r=0.9999)。加样回收率及稳定性均符合要求;且不同批号的rh-KGF冻干粉针剂中β-巯基乙醇基本无残留。结论 rh-KGF冻干粉针剂安全,无β-巯基乙醇残留,可应用于临床。
Objective To investigate the residue ofβ-mercaptoethanol in freeze-dried powder injection of recombinant human keratinocyte growth factor（rh-KGF）,to determine its security of clinical application.Methods Ivestigated the detectability,standard curve,recovery and stability of the reference substance of β-mercaptoethanol by gas chromatography（GC）,and the residue of β-mercaptoethanol in different batches of rh-KGF freeze-dried powder injection was investigated.Results The detectability was 0.235μg/ml,the assay was linear in the range of 0 ～ 52.08μg/ml（r = 0.9999）,the recovery and stability met the requirements,and no residue of β-mercaptoethanol was detected in this study.Conclusion The rh-KGF freeze-dried powder injection is safe,and can be used in clinical treatment.
出处
《临床合理用药杂志》
2013年第1期12-13,共2页
Chinese Journal of Clinical Rational Drug Use
