| 摘要: |
| 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。 |
| 关键词: 芹菜 胶囊 黄酮类 苯酞类 质量控制 |
| DOI：10.3724/SP.J.1008.2012.001347 |
| 投稿时间：2012-07-27修订日期：2012-11-07 |
| 基金项目:上海市中药现代化基金(09DZ1974000),上海市重点学科建设项目(B906). |
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| Preparation and quality control of Apium graveolens L. capsules |
| CHEN Yan1△,ZHAO Ping2△,CHEN Wen-hui3,SHENG Gang3,CHEN Hai-sheng3* |
(1. Department of Pharmaceutics, School of Pharmacy, Second Military Medical University, Shanghai 200433, China
2. Department of Pharmacy, Tongren Hospital, Capital Medical University, Beijing 100730, China
3. Department of Natural Medicinal Chemistry, School of Pharmacy, Second Military Medical University, Shanghai 200433,China
△Co-first authors.
*Corresponding author.) |
| Abstract: |
| ObjectiveTo study the preparation technique of Apium graveolens L.capsules and to assess the quality of the prepared capsules. Methods and ResultsUsing moldability and fluidity of the granules as indices, we optimized the formulation of Apium 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. ConclusionThe 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. |
| Key words: Apium graveolens L. capsules flavones phthalides quality control |
