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近年来，国家支持仪器自主创新，规模以上的国产仪器企业有2 000余家。然而，行业仍面临高端国产仪器占有率低、技术转移低效的困境。中国仪器仪表学会科学仪器设备验证评价中心（生命科学站）通过提供应用验证评价，有效提升国产仪器性能指标。文章详述了高效液相色谱仪在食品应用领域的验证评价工作，该工作不仅促进了高效液相色谱仪性能指标的提升，还促进了更多的用户关注国产仪器。
Abstract：[Significance] National support for the independent innovation of domestic instruments highlights their strategic role in technological self-reliance. However, this industry faces dual challenges: a low high-end market share(for instance, >80% of the high-end analytical instruments in Chinese labs are imported) and inefficient technology transfer, a structural contradiction particularly critical in cutting-edge fields such as biomedicine and semiconductors, where imported instruments occupy >90% of the market and core patent barriers trap domestic enterprises in the low-value chain. This gap stems from technical bottlenecks(e.g., precision components) and a lack of trust in the market, as users do not have access to authentic data to ensure reliability, while enterprises undergo a stagnation crisis due to inadequate application feedback. This issue can be addressed by establishing verification and evaluation centers that provide real-world performance data to enterprises. For instance, since 2018, the China Instrument and Control Society Center has evaluated >200 domestic instruments, helping firms identify design flaws through practical scenarios, including 37 models from 12 leading liquid chromatograph(LC) enterprises that generated >5 000 performance datasets. This procedure breaks the low-recognition cycle, accelerates technological iteration, and aligns with national goals to contribute to the development of the industry. [Progress] LC evaluation functions via a four-dimensional framework:(1) Basic performance: Key indicators such as separation efficiency have notably improved. For instance, the peak symmetry factor of leading domestic liquid chromatographs has declined from 1.5 to 1.2 within 5 years, gradually approaching the international standards of 1.0～1.1; this decrease indicates a remarkable improvement in the chromatographic peak shape and separation accuracy, both of which are core factors in ensuring the reliability of analytical results.(2) Domestic ultra-high-performance liquid chromatographs have achieved 92% of the resolution of imported models in food analysis; this substantial increase validates the rapid technological advancement concerning the separation of structurally similar compounds in food, such as pesticide residue isomers and food additive homologs. This feature of liquid chromatographs is a core requirement for food safety testing. Notably, certain domestic models even outperform imported products by 15%～20% with regard to the signal-to-noise ratio parameter for aflatoxin detection in food. This property enables the precise quantification of ppb-level toxins in grains, nuts, and other foodstuffs. [Conclusions and Prospects] The verification and evaluation systems for domestic instruments have narrowed gaps and shifted perception, the preference for academic labs for domestic LCs has increased from 18% to 35% since 2020. Provincial quality inspection bids have witnessed a rise in domestic LC win rates from 12%(2019) to 28%(2024). Nevertheless, this field still faces challenges. The high-end components(e.g., microdetectors) rely on imports, and the evaluation standards for emerging technology such as LC-MS are incomplete, especially for areas like single-cell analysis. Future priorities in this industry include the following:(1) Targeted standardization: Development of industry-specific protocols, such as life models for antibody drug columns or baseline stability criteria for surface water trace organic materials.(2) Digital integration: Leveraging AI for predicting performance trends, aiming for a fault warning accuracy of >90% and a consumable life prediction error of <5% via big data platforms.(3) Global alignment: Collaboration with ISO to incorporate 3～5 domestic evaluation standards into international systems by 2025, thereby breaking the technical barriers for exports. As China's 14th Five-Year Plan emphasizes self-reliance, verification of domestic instruments will remain a critical requirement. Thus, with sustained innovation, domestic LCs could capture 50% of mid-to-high-end markets by 2030, demonstrating a leap from the “following” mode to the “leading” mode in strategic fields such as clinical mass spectrometry, offering a “Chinese solution” to the global instrument industry.
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基本信息:
DOI：10.16791/j.cnki.sjg.2025.08.005
中图分类号:TH70
引用信息:
[1]张丽娜,杨娟,吴爱华等.科学仪器验证评价探索与实践[J].实验技术与管理,2025,42(08):29-35.DOI:10.16791/j.cnki.sjg.2025.08.005.
基金信息:
国家科技基础条件平台专项课题(2023WT121)