在11个国家对米费普里斯顿和米索普罗斯托尔进行质量测试
Jason Bower1, Lester Chinery2, Alessandra Fleurent2
1Independent Consultant, London, UK.
概括
在低收入和中等收入国家 (LMIC) 中,医疗堕胎药物的质量问题仍然存在. 超过一半的被采样的mizoprostol和mifepristone产品未能通过质量测试,这表明需要改进制造工艺.
科学领域:
- 制药品质量控制 制药品质量控制
- 生殖健康药品 生殖健康药品
- 全球药品质量保证全球药品质量保证
背景情况:
- 之前的研究强调了对mizoprostol的质量问题.
- 米费普里斯顿的质量还没有得到广泛的研究.
- 在低收入和中等收入国家 (LMIC) 中,医疗堕胎药物至关重要.
研究的目的:
- 在LMIC中评估mizoprostol和mifepristone的质量.
- 确定这些基本药物的特定质量偏差.
- 为改善药品质量和患者安全提供数据.
主要方法:
- 经过培训的特工在选择的LMIC中收集药物样本 (单个和组合包).
- 样品由世卫组织预先合格的实验室进行分析.
- 测试包括识别,测定,相关物质,内容均性 (美苏),溶解 (米弗利斯顿).
主要成果:
- 在64个集成批量样品中,54.7%的样品未能达到质量规格.
- 合并包的不合规率为51.6%,misoprostol为57.1%,而mifepristone为23.7%.
- 发现了一种伪造的mizoprostol产品.
结论:
- 在LMIC中,医疗堕胎药物仍然存在重大质量问题.
- 虽然可以解决mizoprostol的包装问题,但制造质量需要改进.
- 这项研究提供了LMIC中米费普里斯的质量问题的证据.
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