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目的:制备齐墩果酸滴丸并建立其质量标准。方法:按常规方法制备滴丸,采用紫外分光光度法,以齐墩果酸为对照品,在210nm波长处测定齐墩果酸含量和齐墩果酸滴丸的溶出度。结果:制得的滴丸大小均匀、圆整光滑、硬度适中。齐墩果酸的检测浓度在4～120μg.mL-1范围内与吸光度呈良好线性关系(r=0.9998);平均加样回收率为99.56%,RSD=1.15%(n=6)。齐墩果酸滴丸30min时的溶出度为(76.2±1.94)%。结论:该制备方法简单,滴丸成形性好,质量可控,体外溶出度高。
OBJECTIVE: To prepare oleanolic acid drip pills and establish their quality standards. Methods: Dropping pills were prepared by the conventional method. The content of oleanolic acid and the dissolution rate of oleanolic acid dropping pills were determined by UV spectrophotometry with oleanolic acid as control. Results: The prepared pills were uniform in size, round and smooth, moderate hardness. The detection limit of oleanolic acid was linear with the absorbance in the range of 4 ~ 120μg.mL-1 (r = 0.9998). The average recoveries were 99.56% and RSD = 1.15% (n = 6). The dissolution of oleanolic acid dropping pills at 30 min was (76.2 ± 1.94)%. Conclusion: The preparation method is simple, dropping pills formability, quality control, high in vitro dissolution.