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目的:研究生物黏附制剂愈溃膜中有效成分丹皮酚、靛玉红、龙脑的体外释放机制。方法:采用高效液相色谱(HPLC)测定愈溃膜中丹皮酚、靛玉红的体外释放度,气象色谱(GC)测定龙脑的体外释放度,并将累积释放数据分别用零级方程、一级方程、Higuchi方程、Retiger-Peppas(R-P)方程拟合,分析三者的体外释药模式;采用相似因子法(f2)评价三者能否达到均衡释放。结果:丹皮酚的体外释放曲线接近R-P方程,靛玉红和龙脑的体外释放曲线接近一级方程;愈溃膜中丹皮酚与靛玉红、龙脑与丹皮酚、龙脑与靛玉红的相似因子均大于50%。结论:愈溃膜中有效成分丹皮酚、靛玉红和龙脑能够达到均衡释放。
OBJECTIVE: To study the in vitro release mechanism of paeonol, indirubin and borneol, the active ingredient in the ulceration of bioadhesive preparations. Methods: The in vitro release of paeonol and indirubin in the healing membrane was determined by high performance liquid chromatography (HPLC). The in vitro release of borneol was determined by gas chromatography (GC). The cumulative release data were calculated by using the zero-order equation , First order equation, Higuchi equation and Retiger-Peppas (RP) equation were used to analyze the in vitro release patterns of the three drugs. The similarity factor method (f2) was used to evaluate whether the three drugs reached equilibrium release. RESULTS: The in vitro release curve of paeonol was close to the RP equation. The in vitro release curves of indirubin and borneol were close to the first order equation. The more paeonol and indirubin, the binuclear and paeonol, Similar factors of indirubin were greater than 50%. CONCLUSION: Paeonol, indirubin and borneol, the active ingredients in the ulcerative membrane, can achieve a balanced release.