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乳果糖口服溶液系中国药典2000年版收载品种。在进行同类品种的质量标准研究中,发现该药典中采用的含量测定及有关物质检测方法,即十八烷基硅烷键合硅胶柱和乙腈-水系统,无论在理论上还是在实际分离方法上都不适宜乳果糖及其有关物质(乳糖、果糖、半乳糖)的分离和测定。经向国家药典委员查询,证实该质量标准确有问题。望有关单位及人员对此问题予以关注,以免造成不必要的人力、物力的浪费。下面将美国、
Lactulose oral solution of the Chinese Pharmacopoeia 2000 edition contained varieties. In the study of the quality standards of the same species, it was found that the content of the pharmacopoeial and related substances detection methods, namely octadecylsilane bonded silica column and acetonitrile - water system, both in theory and in the actual separation method Are not suitable for the separation and determination of lactulose and its related substances (lactose, fructose, galactose). Queried by the State Pharmacopoeia Commission, confirmed that the quality standard is indeed a problem. Hope that the relevant units and personnel to pay attention to this issue, so as to avoid unnecessary waste of human and material resources. The following will be the United States,