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目的:深入了解产品质量,加强该产品有机溶剂检测与控制。方法:采用顶空气相色谱法,对12个厂家的18批头孢曲松钠原料和34个厂家的37批注射用头孢曲松钠进行了残留溶剂的检查。结果:12家企业的18批原料,甲醇的检出率达100%,77.8%的原料中检出丙酮,38.9%的原料检出乙酸乙酯,11.1%的原料检出乙醇和16.7%的原料检出异丙醇,所有原料中均未检出乙腈。34家企业的37批注射用头孢曲松钠,甲醇和丙酮的检出率均达97.3%,乙腈和乙酸乙酯的检出率达21.6%;乙醇检出率达18.9%,异丙醇的检出率较小,为8.15%。结论:在原料和制剂的溶剂检查中,本试验能有效增加头孢曲松钠中有机溶剂的控制。
Purpose: To understand product quality in depth and to enhance the detection and control of organic solvents in the product. Methods: Headspace gas chromatography was used to examine the residual solvents in 18 batches of ceftriaxone sodium in 12 batches and 37 batches of ceftriaxone sodium in 34 batches. Results: The detection rates of 18 batches of raw materials in 12 enterprises were 100% for methanol, 77.8% for acetone, 38.9% for ethyl acetate, 11.1% for ethanol and 16.7% for raw materials Isopropanol was detected and no acetonitrile was detected in all the raw materials. 37 batches of ceftriaxone sodium for injection, 97.3% of methanol and acetone were detected in 34 batches, the detection rate of acetonitrile and ethyl acetate was 21.6%, the detection rate of ethanol was 18.9%, the content of isopropanol The detection rate is small, 8.15%. Conclusion: This test can effectively increase the control of organic solvents in ceftriaxone sodium in the solvent tests of raw materials and preparations.