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目的:制备pH依赖、酶触和时间三重控制的苦参素结肠定位片释药系统,并考察其体外释放度。方法:从内到外分别以羟丙甲纤维素和聚乙二醇作为隔离层,以渗透型丙烯酸树脂Eudaragit RS 30D和Eudaragit RL 30D混合溶液作为时滞层,以渗透型丙烯酸树脂Eudaragit RS 30D,Eudaragit RL 30D和壳聚糖的混合溶液作为酶触层,以pH依赖型丙烯酸树脂Eudaragit L100-55的水分散体雅克宜作为外层肠溶层。考察了包衣片在体外模拟人体胃肠道环境中的释药情况。结果:制备的苦参素结肠定位片在pH 1.2模拟胃液中2 h不释药,在pH 6.8模拟小肠液中6 h释药量小于10%,在模拟结肠液中8 h部分释放或大部分释放。结论:所制备的苦参素结肠定位片具有良好的结肠定位效果。
OBJECTIVE: To prepare the drug delivery system of Oxymatrine colon-oriented tablets with pH-dependent, enzyme-triggered and time-controlled triplets, and investigate its in vitro release. METHODS: From the inside to the outside, hypromellose and polyethylene glycol (PEG) were used as the separation layer respectively. The mixed solution of Eudaragit RS 30D and Eudaragit RL 30D was used as the delamination layer. Eudaragit RS 30D, A mixed solution of Eudaragit RL 30D and chitosan was used as an enzyme contact layer and an aqueous solution of pH-dependent acrylic resin Eudaragit L100-55 Jacques was used as the outer enteric layer. The coated tablets were investigated in vitro to simulate the release of human gastrointestinal tract. Results: The kushenzine colon patch did not release for 2 h in simulated gastric fluid at pH 1.2, less than 10% in pH 6.8 simulated intestinal fluid for 6 h, or partially released in simulated colon juice for 8 h or mostly freed. Conclusion: The prepared oxymatrine colon positioning tablet has good colonic localization effect.