林可霉素利多卡因凝胶的质量评价  

Quality assessment of lincomycin hydrochloride and lidocaine hydrochloride gel

作　　者：牟建平 滕宝霞 何小英 顾海燕 朱玲 贺晓文 Mu Jian-ping;Teng Bao-xia;He Xiao-ying;Gu Hai-yan;Zhu Ling;He Xiao-wen(Gansu Institute for Drug Control,Lanzhou 730060)

机构地区：[1]甘肃省药品检验研究院

出　　处：《中国抗生素杂志》2020年第1期49-52,共4页Chinese Journal of Antibiotics

摘　　要：目的评价林可霉素利多卡因凝胶的质量现状并分析存在问题。方法按照2018年评价性抽验计划总体要求,采用法定检验方法进行样品检验,并结合探索性研究进行统计分析,对林可霉素利多卡因凝胶的质量现状进行评价。结果共抽取样品214批次,按国家标准检验不合格率为0.5%。探索性研究显示个别生产企业盐酸利多卡因的含量较低,部分生产企业防腐剂使用过量,个别生产企业处方中未添加防腐剂。结论林可霉素利多卡因凝胶法定检验合格率较好,但仍存在一些问题,建议企业对处方的抑菌效力进行评价,加强工艺控制,建议进一步完善质量标准,加强监管。Objective To evaluate the quality status of the lincomycin hydrochloride and lidocaine hydrochloride gel and to analyze the existing problems.Methods According to the general requirements of national assessment programs in 2018,statutory testing methods combined with the exploratory research were used to evaluate the quality of lincomycin hydrochloride and lidocaine hydrochloride gel,and the results were analyzed statistically.Results According to the statutory standards for the examination of the 214 batches,the unqualified rate was 0.5%.Exploratory studies showed that the lidocaine hydrochloride content of the samples from some companies was obviously low.Some manufacturers used excessive preservatives,and a few producers did not add preservatives.Conclusion At present,the quality of most of the lincomycin hydrochloride and lidocaine hydrochloride gel injection can meet the current standards,but there were still some problems.Companies need to adjust their evaluation of the antibacterial efficacy of prescriptions,strengthen process control,further improve quality standards,and strengthen supervision.

关 键 词：林可霉素利多卡因凝胶 评价性抽验 质量评价 

分 类 号：R978.15[医药卫生—药品]