番荔枝内酯滴丸制剂工艺及其含量测定

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.

Preparation Technology and Determination of Annonaceous Acetogenin Dripping Pill

Objective:To determine optimum preparation technology of annonaceous acetogenin dripping pill(AADP) by researching various factors on it.Method:Shape of dripping pill,hardness,dissolution time and pill weight as parameters to select formulation technology and dripping conditions of pill.The content of annonaceous total acetogenin was determined by UV spectrophotometry.Result:Optimum technology was:methyl-silicon oil as refrigerant,proportion of PEG4000-PEG6000 was 4∶1,annonaceous acetogenin to matrix was 1∶4,processing temperature was at 70 ℃,and cooling temperature was 5-15 ℃,dripping distance was 2 cm and ID/OD of emitter was 2/2.5 mm;The content of annonaceous total acetogenin was 2.53,2.54,2.66 mg.Conclusion:This process was simple,feasible and reproducible;Ultraviolet spectrophotometry method was simple,accurate and could be used to control quality of this dripping pill.