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目的建立魟鱼软骨多糖眼用纳米乳的质量评价方法及纳米乳中多糖的含量测定方法。方法制备魟鱼软骨多糖纳米乳,观测纳米乳的载药量、外观形状、pH值、粒径等指标,采用硫酸-咔唑法测定纳米乳中多糖的含量,检测波长为529.0nm。结果纳米乳平均粒径为51nm,澄清度、稳定性良好,无眼刺激性。在8.024～40.120mg/L浓度,A=0.0129c+0.008,r=0.9999,方法平均回收率为100.2%,RSD为0.92%;纳米乳载药量为50.03g/L。结论魟鱼软骨多糖眼用纳米乳制剂质量稳定,符合《中国药典》(2005版)关于眼用制剂的标准;硫酸-咔唑法测定多糖含量简单、快速、准确,可用于控制纳米乳制剂质量。
OBJECTIVE: To establish a method for the quality evaluation of ocular cartilage polysaccharide ophthalmic nanoemulsion and to determine the content of polysaccharide in nanoemulsion. Methods The cartilage polysaccharide nanoemulsion was prepared and the drug loading, appearance, pH and particle size of the nanoemulsion were observed. The content of polysaccharide in nanoemulsion was determined by sulfuric acid - carbazole method. The detection wavelength was 529.0 nm. Results Nanoemulsion average particle size of 51nm, clarity, good stability, no eye irritation. The average recovery was 100.2% and the RSD was 0.92% at a concentration of 8.024-40.120 mg / L, A = 0.0129c + 0.008, r = 0.9999. The drug loading of nanoemulsion was 50.03g / L. Conclusion The quality of ophthalmic cartilage polysaccharide ophthalmic nanoemulsion preparations is in line with the standards of Chinese Pharmacopoeia (2005 edition) for ophthalmic preparations. The determination of polysaccharide content by sulfuric acid-carbazole method is simple, rapid and accurate and can be used to control the quality of nanoemulsion preparations .