芹菜籽胶囊的制备与质量研究

Preparation and quality control of Apium graveolens L. capsules

目的研究芹菜籽胶囊的制备工艺,并对其质量进行评价。方法和结果以颗粒成型性和流动性为指标,采用单因素分别考察微晶纤维素、微粉硅胶和乳糖用量,确定最佳处方为:药物浸膏42%,微粉硅胶26%,微晶纤维素30%,交联聚乙烯吡咯烷酮2%。微粉硅胶对挥发油有很好的吸附性,对颗粒的黏性、成型性和流动性影响最大。对优选处方制备的3批制剂进行装量差异、水分测定、总黄酮和苯酞类成分含量的质量评价实验,结果表明芹菜籽胶囊的质量符合要求。结论本实验制备的芹菜籽胶囊颗粒成型性和流动性好,制备工艺简单,质量可控,适用于工业化生产。

Objective To study the preparation technique of Apium graveolens L. capsules and to assess the quality of the prepared capsules. Methods and Results Using moldability and fluidity of the granules as indices, we optimized the formulation of ADium graveolens L. capsules by mono-factor test, with the mono-factors including microcrystalline cellulose, aerosil and lactose. In the optimized formula, the contents of aerosil, microcrystalline cellulose and polyvinylpolypyrrolidone were 26%, 30% and 2%, respectively. The aerosil had a satisfactory adsorption for volatile oil, which is important to the viscosity, moldability and fluidity of the granules. Three batches of samples were made using the optimized formula, and the quality evaluation tests showed that mass variation, the moisture content and contents of flavonoids and phthalides all met the quality control criteria. Conclusion The granules of capsules prepared in this study have satisfactory moldability and fluidity. The preparation technique is simple and the quality can be controlled, making it suitable for industrial production.