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目的:研究影响番荔枝内酯滴丸制剂工艺的各种因素,确立最佳制剂工艺。方法:以滴丸成型情况、硬度、溶散时限及丸重差异等为指标,对滴丸处方工艺及滴制条件等方面进行优选;采用紫外分光光度法对番荔枝内酯滴丸中的番荔枝总内酯进行含量测定。结果:最佳工艺条件为冷却剂二甲基硅油,PEG4000与PEG6000比4∶1,药物与基质比例1∶4,料液温度70℃,冷却剂温度5～15℃,滴距2 cm,滴头内径/外径2/2.5 mm;滴丸中番荔枝总内酯含量分别为2.53,2.54,2.66 mg/滴丸。结论:该工艺简单、可行、重现性好;紫外分光光度法简便、准确,可作为番荔枝内酯滴丸的质量控制方法。
Objective: To study the various factors affecting the technology of Annona Ligustici pills and establish the best preparation technology. Methods: The dripping pill formulation, hardness, dissolution time limit and the difference of pill weight were taken as indexes to optimize the prescription of drip pills and the dropping conditions. The ultraviolet spectrophotometry Litchi total lactone content determination. Results: The optimum conditions were as follows: dimethylsilicone oil, ratio of PEG4000 to PEG6000 4:1, drug to matrix ratio 1: 4, feed temperature 70 ℃, coolant temperature 5-15 ℃, drip distance 2 cm Head inner diameter / outer diameter 2 / 2.5 mm; dripping pills litchi total lactone content were 2.53,2.54,2.66 mg / drop pills. Conclusion: The method is simple, feasible and reproducible. UV spectrophotometry is simple and accurate and can be used as a quality control method of annona lilatone pills.