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目的:对市售11个厂家的曲克芦丁制剂进行质量评价。方法:就含量、溶出度和组分进行分析比较。结果:制剂A为散剂,制剂B,C,D,E,F,G,H,I,J,K为糖衣片剂,以HPLC测定含量,有6种制剂含羟乙基芦丁在标示量的90%以上,制剂A,B,D,H,J,K中主成分三羟乙基芦丁含量在50%以上,其中A制剂达88.28%。如用UV法测则不能区分各组分含量。薄层检查证明各制剂均与标示名称相符,只是二羟乙基物、三羟乙基物、四羟乙基物斑点色泽不等,说明含量有差异,有的制剂尚有部分未羟乙基化物。溶出度检查发现,符合中国药典要求的有A,B,E,F,I,J和K等7种。结论:制剂A,B,H,J,K结果较为满意
OBJECTIVE: To evaluate the quality of troxerutin in 11 commercial manufacturers. Methods: The content, dissolution and composition were analyzed and compared. Results: Formulation A was a powder, and formulations B, C, D, E, F, G, H, I, J and K were sugar-coated tablets. The contents of the preparations were determined by HPLC. , The content of Triethanolamine in the preparations A, B, D, H, J, K was over 50%, and the preparation A reached 88.28%. As with the UV method can not distinguish between the content of each component. Thin-layer examination to prove that the formulations are consistent with the name of the label, but dihydroxyethyl, trihydroxyethyl, tetrahydroxyethyl spots of varying color, indicating that there are differences in content, and some formulations are still some non-hydroxyethyl Chemicals. Dissolution inspection found that in line with the Chinese Pharmacopoeia requirements are A, B, E, F, I, J and K and other 7 species. Conclusion: The results of preparation A, B, H, J, K are satisfactory