艾纳香提取物颗粒剂质量的评价
Quality evaluation of Blumea balsamifera(L.)DC extractive granules
何佳丽 1龙利 1齐维金 1王鲁2
作者信息
- 1. 贵州大学 药学院,贵州 贵阳 550025;西南特色药用生物资源开发利用教育部工程研究中心,贵州贵阳 550025
- 2. 西南特色药用生物资源开发利用教育部工程研究中心,贵州贵阳 550025
- 折叠
摘要
为了评价艾纳香提取物颗粒剂的质量,按《中国药典》2020年版要求的方法对自制艾纳香提取物颗粒剂的性状、粒度、水分、溶化性进行检测.采用紫外分光光度法(UV)对其总黄酮含量进行检测,采用气相色谱法(GC)对其挥发性成分进行检测,并进行颗粒剂稳定性试验及包装条件下的加速试验.结果显示,颗粒剂粒度均匀,呈棕黄色,粒度、溶化性均符合药典规定,水分未符合药典规定;总黄酮、L-龙脑、β-石竹烯、L-樟脑、芳樟醇含量分别为29.31 mg/g、20.52 mg/g、10.41 mg/g、10.02 mg/g、2.18 mg/g;挥发成分在高温下明显下降,而高湿、强光条件下外观性状及有效成分的含量均无明显变化;包装条件下常温的加速试验结果显示颗粒外观性状以及有效成分的含量均无明显变化.结果表明,室温下颗粒剂有包装情况下稳定性好,为颗粒剂质量标准的建立提供了数据.
Abstract
To evaluate the quality of Blumea balsamifera(L.)DC extractive granules.The proper-ties,particle size,moisture and solubility of the self-made Blumea balsamifera(L.)DC extract gran-ules were tested according to the methods required by the 2020 edition of the Chinese Pharmacopoeia.The total flavonoid content of the granules was detected by ultraviolet spectrophotometer(UV),and the volatile constituents were detected by gas chromatography(GC),and carried out the granule stability test and the accelerated test under the packaging conditions.The results showed that the granularity was uniform and brownish-yellow.The particle size and solubility were in accordance with the provi-sions of the Pharmacopoeia,but the moisture did not comply with the provisions of the Pharmacopoeia.The contents of total flavonoids,L-borneol,β-caryophyllene,L-camphor and Linalool were 29.31 mg/g,20.52 mg/g,10.41 mg/g,10.02 mg/g and 2.18 mg/g.The volatile constituents were significantly reduced at high temperature,and there is no significant change in the content of the active ingredients in the appearance of high humidity and bright light.The accelerated test results at room temperature under packaging conditions show that there is no obvious change in the appearance characteristics of the par-ticles and the content of the active ingredients.In summary,the granules has good room temperature stability under packaging,which provides data for the establishment of further quality standards for granules.
关键词
艾纳香提取物/颗粒剂/质量Key words
Blumea balsamifera(L.)DC extractive/granule/quality引用本文复制引用
基金项目
国家自然科学基金(32160849)
国家自然科学基金(32273051)
出版年
2024
国家科技期刊平台
NSTL
万方数据