目的对制取的具pH依赖型和酶触依赖型的微丸进行模拟体内环境试验,以判断制备复方湿生扁蕾结肠靶向微丸的可行性。方法结合反相高效液相色谱(RP-HPLC)法,以湿生扁蕾中所含木犀草素为评价指标,结合2015版《中华人民共和国药典》中释放度测定法,评价微丸在模拟胃液、小肠液、结肠液中的释药行为。结果复方湿生扁蕾微丸中木犀草素在模拟胃液和小肠液中2 h后均未见释放;在模拟结肠液中1 h后释放度为85.3%,2 h后达95.3%。结论制备的复方湿生扁蕾结肠靶向微丸释放度满足《中华人民共和国药典》要求,工艺可靠,重现好,能达到预期释药效果。 OBJECTIVE To simulate the in vivo environmental test of the prepared pH-dependent and enzyme-contact-dependent pellets to determine the feasibility of preparing compound hygienic levator pellet targeting pellets. Methods Combined with RP-HPLC method, luteolin in wet flat bud was taken as evaluation index, combined with 2015 release “People’s Republic of China Pharmacopoeia” in the determination of release, evaluation pellets in the simulation Gastric juice, intestinal fluid, colonic fluid release behavior. Results The luteolin in compound hygienic sequins was not released after 2 h in simulated gastric juice and small intestine fluid. The release was 85.3% after 1 h in simulated colon liquid and 95.3% after 2 h. Conclusion The preparation of compound wet raw flattened granule targeted release pellets meet the requirements of the “People’s Republic of China Pharmacopoeia”, the process is reliable, reproducible, and can achieve the expected release effect.