金刚藤分散片的制备工艺及质量标准研究

目的优化金刚藤分散片的制备工艺,并建立其质量标准。方法采取水提醇沉法制备金刚藤浸膏,以崩解时限为指标筛选处方,并采用直接压片法制备金刚藤分散片。以薯蓣皂苷元为指标,采用薄层色谱法对其进行鉴别,并采用高效液相色谱法测定其含量。结果金刚藤分散片在3 min内崩解成能通过二号筛的细微颗粒,且均匀分散;薄层色谱法能专属性地鉴别分散片中的薯蓣皂苷元;金刚藤分散片中薯蓣皂苷元的含量初步确定为60μg/片。结论本文制备工艺简单可行,制定的质量标准可靠准确。

Study on preparation and quality control of Jingangteng dispersible tablets

Objective The aim of this study is to optimize the preparation process of Jingangteng dispersible tablets and to establish its quality criterion.Methods Jingangteng was extracted in water and precipitated with ethanol.The formulation was studied according to its disintegration time,and Jingangteng dispersible tablets was made by powder compression.Diosgenin from Jingangteng dispersible tablets was identified with TLC,and determined with HPLC.Results Jingangteng dispersible tablets disintegrate into tiny granules sieved through No 2 screen within 3 minutes uniformly.Diosgenin from Jingangteng dispersible tablets can be identified with TLC,and determined with HPLC.The content of diosgenin per Jingangteng dispersible tablet is more than 60 mg.Conclusions The preparation of Jingangteng dispersible tablets is simple with its quality standard can be controlled stably.Jingangteng can be developed into dispersible tablets.