蜘蛛香胶囊的质量标准研究

Quality Research of Valeriana jatamansi Jones Capsule

关键词:  蜘蛛香胶囊  质量研究  橙皮苷  薄层色谱  高效液相色谱

Key words:  Valeriana jatamansi Jones capsule  quality research  hesperidin  TLC  HPLC

摘要:

对蜘蛛香胶囊进行质量研究，为其质量标准制定提供依据。采用显微鉴别和薄层色谱（TLC）法对蜘蛛香胶囊进行定性鉴别，按照《中国兽药典》进行蜘蛛香胶囊的水分、装量差异、崩解时限和微生物限度检查，采用高效液相色谱（HPLC）法测定蜘蛛香胶囊中橙皮苷含量。薄层鉴别斑点清晰，专属性强。蜘蛛香胶囊的各检查项均符合国家相关质量要求。含量测定方法简便、可靠、灵敏、重复性好，橙皮苷在0.16~6.4 μg范围内与峰面积呈良好线性关系（r=0.9999），平均回收率为97.6 %，RSD为1.3%，6批次蜘蛛香胶囊中的橙皮苷平均含量为2.08 mg/粒。研究结果表明蜘蛛香胶囊质量可靠，质控方法可行。

Abstract:

Study on quality standard of Valeriana jatamansi Jones capsule was carried out to provide the basis for its quality control. Valeriana jatamansi Jones capsule was identificated by microscopic observation and thin-layer chromatography (TLC) method. The moisture content, weight difference, disintegration time limited and microbial limit of Valeriana jatamansi Jones capsule were inspected according to Chinese Veterinary Pharmacopoeia. High performance liquid chromatography（HPLC）method was used to determine the content of hesperidin. Hesperidin could be identified by TLC and the spots were clear and strongly specific. All examination parameters of Valeriana jatamansi Jones capsule were in line with national quality requiments. The determination method was simple, sensitive and accurate with good repeatability. The linear range of hesperidin was 0.16-64 μg (r=0.9999), the average recovery rate was 97.6% and RSD was 1.3%. The average content of hesperidin in each Valeriana jatamansi Jones capsule was 2.08 mg from 6 batches. The results showed that the quality of Valeriana jatamansi Jones capsule was controllable and the quality control method was feasible.