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目的 :制备降钙素口服肠溶微粒。 方法 :以二酮哌嗪为载体材料 ,采用单凝聚法 ( self-assembly)制备降钙素肠溶微粒 ,对微粒的性状、体外溶出、在大鼠体内降血钙作用及生物利用度进行观察。 结果 :微粒粒径为 1～ 3μm,粒度分布较为均匀 ,含药量为 0 .42 % ,包封率为 91.1% ,药物在人工胃液中 2 h基本无释放 ,在人工肠液中完全释放为 6 h,大鼠口服该微粒后3h就有明显的降血钙作用 ,持续时间达 12 h以上。 结论 :降钙素肠溶微粒具有缓释作用 ,口服后能达到理想的降血钙目的
Objective: To prepare calcitonin oral enteric particles. Methods: Diclopiperazine was used as a carrier material to prepare calcitonin enteric-coated granules by single-assembly method. The properties of granules, in vitro dissolution, the effect of lowering blood calcium and the bioavailability in rats were observed . Results: The particle size was 1 ~ 3μm, the particle size distribution was uniform, the drug content was 0.42% and the entrapment efficiency was 91.1%. The drug was almost not released in the artificial gastric juice for 2 h and was completely released in the artificial intestinal juice h, 3h after oral administration of the particles there is a significant hypocalcemic effect, lasting more than 12h. CONCLUSION: Calcitonin enteric-coated granules have a slow-release effect and can achieve the desired goal of lowering blood calcium after oral administration