质量是临床实验室管理的核心。在国际标准化组织(International Organization for Standardization,ISO)15189:2012中对质量指标的建立、应用、评估和监测提出了明确要求。本文根据ISO 15189:2012的规定,对质量指标和质量目标的概念、...质量是临床实验室管理的核心。在国际标准化组织(International Organization for Standardization,ISO)15189:2012中对质量指标的建立、应用、评估和监测提出了明确要求。本文根据ISO 15189:2012的规定,对质量指标和质量目标的概念、定量检验项目分析质量指标的建立及应用进行诠释,以达到持续质量改进的目的。展开更多
In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one ...In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one antimalarial (quinine) and two antibiotics (amoxicillin and metronidazole) have been developed and validated according to the total error strategy using the accuracy profiles as a decision tool. The dosing range was 2 - 10 μg/mL (for quinine sulfate in tablet), 4 - 12 μg/mL (for quinine bichlorhydrate in oral drop-metronidazole benzaote in oral suspension) and 15 - 35 μg/mL (for amoxicillin trihydrate in capsule). The validated methods were then applied in determining the content of some analogous medicines sold in the Democratic Republic of Congo. Thus, the proposed UV-Visible spectrophotometric methods are simple and suitable to quantify quinine, amoxicillin and metronidazole in different pharmaceutical forms.展开更多
文摘质量是临床实验室管理的核心。在国际标准化组织(International Organization for Standardization,ISO)15189:2012中对质量指标的建立、应用、评估和监测提出了明确要求。本文根据ISO 15189:2012的规定,对质量指标和质量目标的概念、定量检验项目分析质量指标的建立及应用进行诠释,以达到持续质量改进的目的。
文摘In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one antimalarial (quinine) and two antibiotics (amoxicillin and metronidazole) have been developed and validated according to the total error strategy using the accuracy profiles as a decision tool. The dosing range was 2 - 10 μg/mL (for quinine sulfate in tablet), 4 - 12 μg/mL (for quinine bichlorhydrate in oral drop-metronidazole benzaote in oral suspension) and 15 - 35 μg/mL (for amoxicillin trihydrate in capsule). The validated methods were then applied in determining the content of some analogous medicines sold in the Democratic Republic of Congo. Thus, the proposed UV-Visible spectrophotometric methods are simple and suitable to quantify quinine, amoxicillin and metronidazole in different pharmaceutical forms.
