复合番泻苷磷酸盐颗粒剂的研制及其药效学评价

Preparation and Efficacy Evaluation of Compound Sennoside Phosphate Granules

研制了1种肠道清洁效果较好、不良反应少的复合番泻苷磷酸盐颗粒剂。以提取物中番泻苷A和B的含量为指标,采用正交试验筛选番泻叶的最佳提取工艺。结果表明,番泻叶在60℃用40%乙醇溶液中提取3次、每次20 min,提取效果较好。以所得番泻叶提取物、磷酸钠盐、聚乙二醇(PEG)4000为基础药物,制备颗粒剂,并以SD大鼠为模型进行初步药效学和安全性评价。结果显示,所得颗粒剂的肠道清洁效果优于磷酸钠盐或PEG 4000电解质散;此外,颗粒剂在1、5及10倍剂量时均未致大鼠死亡,因此认为其较为安全。

The compound sennoside phosphate granules which had high bowel cleaning effectiveness and low side effect were prepared. Orthogonal test was used for screening the optimal extraction process of senna leaf with contents of sennoside A and sennoside B as indexes. The results showed that the optimal extraction process was as follows： senna leaves were extracted with 40% ethanol at 60 ℃ for three times, 20 min per time. Then the title granules were prepared by wet granulation with the above extract, sodium phosphate and polyethylene glycol （PEG） 4000 as main active ingredients. The efficacy and safety were preliminary investigated with SD rats as models. The results showed that the bowel cleaning effectiveness of the granules was prior to that of sodium phosphate or PEG 4000 electrolyte powder. No rats died during the acute toxicity test in the groups of the granules in up to 10 times conventional dose, indicating the granules were rather safe.