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目的制备珍珠菜总黄酮提取物渗透泵控释片。方法以芦丁和柚皮素-7-O-葡萄糖苷为指标,通过体外释放度试验对衣膜处方及孔变量进行单因素考察,并通过均匀设计对衣膜处方进行优化。结果衣膜增重、衣膜中PEG400及邻苯二甲酸二丁酯的用量是影响药物释放的主要因素,二者用量分别为醋酸纤维素的45%及8.5%,所制得的渗透泵控释片呈现良好的零级释药特征。结论该处方工艺简便可行,所制得渗透泵控释片释药行为稳定,重现性好。
Objective To prepare the total flavonoids extract of pearl dish osmotic pump controlled release tablets. Methods Rutin and naringenin-7-O-glucoside were used as indexes to investigate the prescription and pore volume of drug-coated film by single factor test in vitro and optimize the prescription of film by uniform design. Results The weight gain of the film and the dosage of PEG400 and dibutyl phthalate in the film were the main factors affecting the drug release. The dosage of the two was 45% and 8.5% of the cellulose acetate, respectively. The obtained osmotic pump control Release tablets showed good grade 0 release characteristics. Conclusion The prescription process is simple and feasible. The controlled release tablets of osmotic pump prepared by this method are stable and reproducible.