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目的:改善复方链霉素滴鼻液的稳定性,建立其质量控制方法。方法:采用复合乳化剂改制成乳浊液。用氯仿去除鱼肝油后,利用链霉素的特征反应-麦芽酚反应生成麦芽酚,与Fe3+形成红色络合物,在550 nm处测定A值,求其含量。结果:成品在室温下贮存一年未见分层。链霉素的含量测定研究:空白试验A仅为0．001-0．003,3种不同浓度的回收率平均值(三次)分别为98．3％,98．0％,101．5％(RSD2．39％,0．50％,0．87％)。样品测定两批,每批测定3次,RSD分别为0．50％和 0．45％。结论:复方链霉素滴鼻液稳定,含量测定方法简便可靠。
Objective: To improve the stability of compound streptomycin nasal drops and establish its quality control method. Methods: The compound emulsifier into emulsion. After removing the cod liver oil with chloroform, maltol was formed by the reaction of maltol with the characteristic reaction of streptomycin and formed a red complex with Fe3 +. The content of A was determined at 550 nm. Results: The finished product was stored at room temperature for one year without stratification. The determination of streptomycin: blank test A was only 0.001-0.003, the average recoveries of three different concentrations (three times) were 98.3%, 98.0% and 101.5% respectively RSD 2.39%, 0.50%, 0.87%). The samples were tested in two batches, with three determinations per batch with RSDs of 0.50% and 0.45%, respectively. Conclusion: The compound streptomycin nasal drops is stable and the assay method is simple and reliable.