摘要
目的评价国产注射用盐酸万古霉素的质量。方法按国家标准检验与探索性研究项结合,对抽验样品进行检验,对检验结果进行统计与分析。结果共抽取样品26批,按国家标准检验合格率为100%。探索性研究中对盐酸万古霉素的有关物质来源进行了研究,建议对有关物质中工艺杂质与降解杂质应分别进行控制;利用模拟预测技术建立万古霉素药动学模型,探讨万古霉素B含量与临床有效性的相互关系。根据现行盐酸万古霉素说明书中的剂量与用法,成年健康人群中万古霉素血药浓度无法在全部给药时间内满足《中国万古霉素治疗药物监测指南》推荐的最低治疗浓度要求。提高盐酸万古霉素中含量及万古霉素B的限度,可以有效的提高本品的临床有效性水平。建议现行标准提高万古霉素含量与万古霉素B的限度水平。结论目前国内注射用盐酸万古霉素总体质量较好,现行标准有待进一步提高。
Objective To evaluate the quality status of the domestic vancomycin hydrochloride for injection. Methods According to the general requirements of national drug assessment programs, the statutory testing methods combined with the exploratory researches were used to examine samples and evaluate the quality status of the vancomycin hydrochloride for injection, and the results were analyzed statistically. Results The statutory tests showed twenty-six batches of samples were all qualified. The exploratory research on the sources of major impurities, helped to distinguish process impurities and degradation impurities. The relationship between the content and the clinical effect by pharmacokinetics model of vancomycin which was built by the simulation technology were discussed. According to the dosage and the administration from the dispensatory of vancomycin hydrochloride for injection, the plasma comcentration of vancomycin in healthy human was unable to meet the requirements of the trough serum vancomycin concentrations from therapeutic drug monitoring of vancomycin： A guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. An improvement was needed to promote the clinical effect by raising the limit of the content and the content of vancomycin B. It is necessary to revise the limit of the content and vancomycin B. Conclusion At present, the quality of domestic vancomycin hydrochloride for injection meets the requirements of the current statutory standard. The current stutory standard should be further improved.
出处
《中国抗生素杂志》
CAS
CSCD
2018年第3期262-268,共7页
Chinese Journal of Antibiotics
关键词
注射用盐酸万古霉素
质量评价
有关物质
药动学模型
模拟与预测
Vancomycin hydrochloride for injection
Quality assessment
Related substance
Therapeutic drug monitoring
