正交试验法优选甲磺酸帕珠沙星滴丸的制备工艺

Optimization of processing technology of pazufloxacin mesilate drop pills by orthogonal design

目的确立甲磺酸帕珠沙星滴丸的最佳制备工艺。方法以丸重变异系数、溶散时限、滴丸成型率为评价指标，对基质及冷却剂的选择用平行试验法，对药物加入比例、药液温度、冷却液温度及滴速的选择用正交试验法，优选最佳滴制条件。结果以聚乙二醇4000为基质，甲基硅油-液状石蜡（3：1）为冷却剂，用玻璃注射器做滴管，12号针头，以20～25滴／min的滴速将（75±2）℃的药液滴入10～12℃的冷却液中（冷却柱高度固定）进行滴制，滴丸成型率最高。结论本实验筛选出的滴丸成型工艺条件制成的滴丸，符合药典规定。

OBJECTIVE To establish the best preparation technology of pazufloxacin mesilate drop pills. METHODS Parallel test was used to choose matrix and refrigerant with the different coefficients of drop pills weight, dissolved time and shaped ratio of drop pills as the evaluation index. Orthogonal test was used to choose the best dropping conditions by proportion of ingredients, temperature of drug solution, refrigerant temperature and dropping speed. RESULTS When PEG4000 acted as matrix, mixture of methyl-siliconil and liquid-paraffin （3：1） acted as refrigerant, burette was glass injector, drug solution （temperature： 75±2℃） was dropped into the refrigerant（ temperature： 0～12℃） by the rates of 20～25 drops per minute. Moulding probability of drop pills was the highest at the above conditions. CONCLUSION The technology conditions of the pazufloxacin mesilate drop pills accord with pharmacopoeia criterion.