抗菌药的质量控制及用药安全

目的：提出并探讨我国当前抗菌药研究、生产及应用领域中存在的一些问题。方法：从抗茵药质量控制的要点和临床合理使用抗菌药两个方面．对我国当前抗菌药研究及应用中存在的一些具体问题进行举例说明。结果：在我国抗菌药的研究及生产中，需要根据质量源于设计的原理．科学制定质量标准，严格控制有关物质特别是过敏性杂质、毒性杂质的含量．加强对抗菌药理化性质以及稳定性的研究；在抗菌药的临床使用中．需要进一步加强对不良反应的监测及相关报告的研究，尽量不与中药注射剂混合使用。结论：安全高效的抗菌药物需要完善的质量标准．严密的质量控制以及合理的临床用药方式方能保证其临床安全有效。

The Quality Control and Medication Safety of Antibiotics

Objective： To point out and discuss some problems in the field of research and application of antibiotics. Methods： From critical points of quality control and the rational use of antibiotics in clinical application, the existing examples in current antibiotics application were illustrated and discussed. Results： In research and production of antibiotics, the development of scientific quality standards were needed. The detection of allergic impurities, toxic impurities was important. And the study of stability and physicochemical properties of antibiotics should be strengthened. In the clinical application, the monitoring and researching on adverse drug reaction reporting about the use of antibiotics were needed to be further strengthened. The combination of Chinese traditional medicine injections and antibiotics should be minimized. Conclusions： Perfect quality standards, strict quality control and reasonable way in clinical use would ensure the safety of antibiotics.