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目的选取5批实验室自制的HBOCs制品溶液,考察其不溶性微粒的含量并比较不同检测方法检测结果的差异。方法按照《中国药典》(2010年版,三部)不溶性微粒规定的光阻法和显微计数法对HBOCs制品进行检测。结果实验选取的5批次HBOCs制品不溶性微粒检测结果均符合《中国药典》(2010年版)相关要求;光阻法检测结果明显高于显微计数法检测结果;HBOCs溶液不同梯度稀释后,显微计数法检测结果线性相关性分别为0.9095(>10μm粒径)和0.8255(>25μm粒径),而光阻法检测结果线性相关性分别为0.1967(>10μm粒径范围)和0.0283(>25μm粒径范围)。结论选取的HBOCs制品不溶性微粒含量质量总体情况较好;梯度稀释法显示,显微计数法检测HBOCs不溶性微粒结果具有较明显的线性相关性,而光阻法检测结果无明显线性关系,二者检测结果具有显著差异。
OBJECTIVE To select five batches of HBOCs solution prepared by laboratories to investigate the content of insoluble particulates and to compare the differences between different test methods. Methods HBOCs products were tested according to the method of photochromic and microscopic counting according to “Chinese Pharmacopoeia” (2010 edition and No. 3). Results The test results of 5 batches of insoluble HBOCs particles in the experiment were in accordance with the requirements of the Chinese Pharmacopoeia (2010 edition). The results of the photoplethysmography were significantly higher than those of the microscopical method. After different gradient dilutions of HBOCs solution, The linear correlation of counting results was 0.9095 (> 10μm particle size) and 0.8255 (> 25μm particle size), respectively, while the linear correlations were 0.1967 (> 10μm particle size range) and 0.0283 Diameter range). Conclusion The results show that the quality of insoluble particles in HBOCs is better than others. The gradient dilution method shows that there is a significant linear correlation between the results of micro-counting and HBOCs, but there is no obvious linear relationship between the two. The results have significant differences.