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目的优化黄芩苷磷脂复合物鼻用原位凝胶的制备工艺。方法采用中心复合设计-效应面优化法,以胶凝温度为评价指标,对黄芩苷磷脂复合物鼻用原位凝胶的制备工艺关键影响因素Poloxamer407(P407)、Poloxamer188(P188)、聚乙二醇6000(PEG 6000)进行研究,利用多元数学统计矩模型,对制备工艺参数和胶凝温度的相关性进行研究,建立工艺参数与胶凝温度的相关方程,确立最佳工艺参数。结果先将黄芩苷磷脂复合物1.0 g溶于0.1%三乙醇胺溶液中,再加入18 gP407、6 g P188、1 g PEG 6000、葡萄糖5 g、苯扎氯胺0.02 g,加去离子水至100 g,于冰浴(4℃)磁力搅拌下使其分散均匀,置4℃冰箱中保存24 h以上,直至聚合物完全溶解得到澄明溶液。结论采用中心复合设计-效应面法优化的黄芩苷磷脂复合物鼻用原位凝胶的制备工艺稳定可行。
Objective To optimize the preparation process of nasal in situ gel of baicalin phospholipid complex. Methods The central composite design - effect surface optimization method was used to evaluate the gelation temperature of Poloxamer407 (P407), Poloxamer188 (P188), Polyethylene II Alcohol 6000 (PEG 6000). Using the multivariate mathematical moment model, the correlation between preparation parameters and gelling temperature was studied. The correlation equation between the parameters and the gelling temperature was established and the optimum technological parameters were established. Results First baicalin phospholipid complex 1.0 g dissolved in 0.1% triethanolamine solution, then add 18 gP407, 6 g P188, 1 g PEG 6000, glucose 5 g, benzalkonium chloride 0.02 g, add deionized water to 100 g, in the ice bath (4 ℃) under magnetic stirring to disperse evenly, set at 4 ℃ refrigerator for more than 24 h, until the polymer is completely dissolved to give a clear solution. Conclusion The preparation method of nasal in situ gel with baicalin phospholipid complex optimized by central composite design-response surface method is stable and feasible.