复方壳聚糖胶囊的研制及临床疗效观察

目的：研制复方壳聚糖胶囊，观察临床疗效。方法：以壳聚糖、氧氟沙得、赤石脂为原料制备复方壳聚糖胶囊，并通过鉴别、检查、含量测定等试验，建立其质量标准，并对205例病人进行临床疗效观察。结果：本品制备工艺可行，质量标准方法简便、可靠，氧氟沙星的平均回收率为99.95%（RSD＝0.33%）。本品临床疗效确切，不良反应少。结论：本品处方组成合理，制备方法可行，质量标准能够控制该制剂的质量。

Study and clinical observation of compound chitosan capsules

OBJECTIVE To study compound chitosan capsules, establish its quality standard, and observe the clinical effects.METHODS Compound chitosan capsules was prepared with chitosan, ofloxacin and halloysitum rubrum as materals. Its quality standard was established by these tests of identification, tests and assay, and clinical effects was observed on 205 gastrointestinal cases.RESULTS The prepared procedure of compound chitosan capsules was practicable, quality standard was simple and reliable. The average recovery was 99.95% with RSD= 0.33% of ofloxacin. The therapeutic effects were valid with few adverse reactions.CONCLUSIONS The results demonstrated that the recipe component was reasonable, and the prepared procedure of compound chitosan capsules was practicable, its quality standard be able to control the quality of this product.