Louvain Drug Research Institute, Clinical Pharmacy, Université Catholique de Louvain (UCLouvain), Belgium.
Laboratoire de Chimie Analytique et Analyse des Médicaments, Université d'Abomey Calavi, Bénin.
Am J Trop Med Hyg. 2022 Jun 6;107(1):24-31. doi: 10.4269/ajtmh.21-0844. Print 2022 Jul 13.
Substandard and falsified medicines are an enormous threat to global health. Poor quality antibiotic preparations contribute to the development of antimicrobial resistance. In surgery, where the occurrence of healthcare-associated infections is high, healthcare teams need to rely on the quality of antibiotic prophylaxis to prevent infections. We assessed the quality of antibiotics used for surgical infection prophylaxis in Benin. Thirty-three samples were collected from six hospitals located in various departments in Benin. The antibiotics (powders for injection: amoxicillin + clavulanic acid, ampicillin, ceftriaxone; solutions for injection: ciprofloxacin, gentamicin, metronidazole) were assessed using visual inspection, pharmacotechnical tests (including uniformity of mass, pH measure, sterility test, and active pharmaceutical ingredient identification), and assay tests (including a simple analytical method thin layer chromatography) and complex analytical techniques (ultraviolet-visible spectrophotometry, high-performance liquid chromatography-diode-array detection, conductometry). Because the material needed for the methods recommended by the pharmacopeias to assess the dosage of gentamicin was not available, we developed and validated a conductometry method. Results showed that 97% (n = 32) of the samples passed visual inspection; 100% (n = 33) of the samples passed the pharmacotechnical tests, identification of active ingredients, and sterility test; 88% (n = 29) passed the test for percentage of active pharmaceutical ingredients. Overall, 15% of the samples did not pass the quality test (3% on visual inspection and 12% for excess active ingredients). Although most of the samples passed the quality tests, it appears important to perform routine quality control for intravenous medicines.
劣药和假药是全球健康的巨大威胁。质量差的抗生素制剂会助长抗菌药物耐药性的发展。在手术中，医院获得性感染的发生率很高，医疗团队需要依靠抗生素预防用药的质量来预防感染。我们评估了贝宁用于外科感染预防的抗生素质量。从贝宁六个医院的不同科室中采集了 33 个样本。通过外观检查、药剂学测试（包括质量均匀度、pH 值测量、无菌试验和活性药物成分鉴定）和含量测定测试（包括简单的分析方法薄层色谱法）以及复杂的分析技术（紫外可见分光光度法、高效液相色谱-二极管阵列检测、电导率法）评估了这些抗生素（注射用粉末：阿莫西林+克拉维酸、氨苄西林、头孢曲松；注射用溶液：环丙沙星、庆大霉素、甲硝唑）。由于没有评估庆大霉素剂量所需的药典推荐方法的材料，我们开发并验证了一种电导率法。结果表明，97%（n=32）的样本通过了外观检查；100%（n=33）的样本通过了药剂学测试、活性成分鉴定和无菌试验；88%（n=29）的样本通过了活性药物成分含量测试。总的来说，15%的样本未通过质量测试（外观检查 3%，活性成分过量 12%）。尽管大多数样本通过了质量测试，但似乎有必要对静脉内用药进行常规质量控制。
