Concept Foundation, Geneva, Switzerland.
Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Int J Gynaecol Obstet. 2022 Jun;158 Suppl 1(Suppl 1):46-55. doi: 10.1002/ijgo.14197.
To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.
Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.
Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.
While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.
检查参与改善产后出血（PPH）诊断和管理实施研究项目的机构中使用的催产素和氨甲环酸（用于预防和治疗 PPH 的两种推荐产品）的质量。
2020 年 9 月至 2021 年 8 月，在肯尼亚、尼日利亚、南非和坦桑尼亚的研究设施中收集并冷藏用于分析的催产素和氨甲环酸产品。根据国际（催产素）和英国药典（氨甲环酸）标准对样品进行分析。
在 17 种独特的催产素产品中，进行了 33 项单独测量。只有 6 种独特的产品含量充足，且没有超过推荐限量的相关物质。在 14 个氨甲环酸样本中，有 10 个显示出足够的含量。肯尼亚的一个产品和尼日利亚的两个来自不同制造商的产品的相关物质含量很高，被归类为不合格产品。
虽然我们无法调查不良制造或储存或两者兼而有之的起源，但大量催产素不合格样本令人深感担忧。大多数氨甲环酸样本含量充足，但多个产品中存在杂质令人担忧，需要进一步研究。
