复方珍珠粉泡腾颗粒处方筛选及溶出度考察

目的:筛选复方珍珠粉泡腾颗粒处方并考察其在不同介质中的体外溶出度。方法:以乙二胺四乙酸消耗量为指标,兼顾发泡高度和pH值,用均匀设计法筛选处方中无水柠檬酸、碳酸氢钠、乳糖的量;考察并比较复方珍珠粉泡腾颗粒、自制碳酸钙片、自制珍珠粉片中碳酸钙在蒸馏水和盐酸中的溶出度。结果:处方中无水柠檬酸、碳酸氢钠、乳糖的量分别为10.0、2.5、5.0g;3种制剂间的溶出度有明显差异。结论:制备的复方珍珠粉泡腾颗粒释药速度快、药物溶出完全,溶液呈酸性,适合特定人群使用。

Formulation Optimization and Dissolution of Compound Pearl Powder Effervescent Granule

OBJECTIVE： To optimize the formulation of Compound pearl powder effervescent granule and study its release behavior in vitro. METHODS： The contents of anhydrous citric acid, sodium bicarbonate, and lactose in the formulation were optimized by uniform design method with the consumption of ethylenediamine tetraacetic acid（EDTA） as index meanwhile giving consideration to the foaming height and pH of the solution. The dissolution of calcium carbonate in Compound pearl powder effervescent granule, self- made calcium carbonate tablets and self- made pearl power in distilled water and hydrochloric acid were investigated. RESULTS： The optimized formulation of the Compound pearl powder effervescent granule was stated as follows： 10.0 g anhydrous citric acid, 2.5 g sodium bicarbonate, and 5.0 g lactose. There were significant differences across the 3 different preparations in dissolution rates. CONCLUSION： The prepared Compound pearl powder effervescent granule is characterized by fast and complete drug release. Its solution is acid and indicated for specific population.