WANG Dongxue,JIN Chengshan,JIN Lili,et al.Peparations and its quality standard of the Ranae Oviductus and Fritillaria Ussuriensis soft capsules[J].Journal of Yanbian University,2016,42(01):91-94.
林蛙油平贝母软胶囊制剂及质量标准研究
- Title:
- Peparations and its quality standard of the Ranae Oviductus and Fritillaria Ussuriensis soft capsules
- Keywords:
- sedimentation ratio; rheological properties; redispersion; total alkaloids; 1-methyl hydantoin
- 分类号:
- R283.6
- 文献标志码:
- A
- 摘要:
- 采用单因素平行试验与正交设计试验,以基质吸附率和沉降体积比为考察指标,将林蛙油与平贝母制成保健食品软胶囊,优选软胶囊内容物制剂.优选后的内容物制剂为:原料细粉与大豆油比例为1:1.5,蜂蜡为1.5%,吐温-80为0.5%,内容物为假塑性流体.采用酸性染料比色法测定总生物碱的含量,高效液相(HPLC)测定1-甲基海因含量,并以总生物碱和1-甲基海因的含量建立主要药效学成份的质量标准.经测定3批样品中总生物碱的平均含量为17.61 g·g-1,1-甲基海因的平均含量为8.56 g·g-1.检测表明,本文所制软胶囊的质量符合规定.
- Abstract:
- By using single-factor parallel experimental and orthogonal test, with the base adsorption and sedimentation ratio as the evaluation indexes, a type of soft capsule which is health food made from Ranae Oviductus and Fritillaria Ussuriensis, the content preparation of soft capsule is optimized. The optimized contents consist of the raw material powder and soybean oil in ratio of 1:1.5, 1.5% beeswax and 0.5% Tween-80, furthermore, the content is pseudo-plastic fluid. The content of the total alkaloids is determined by acid dye colorimetric method and the 1-methyl hydantoin is determined by the high performance liquid chromatography(HPLC)method. Quality standards of main pharmacodynamic component based on the content of the total alkaloids and 1-methyl hydantoin is established. In three batches of samples, the average content of total alkaloids is 17.61 g·g-1, 1-methyl hydantoin is 8.56 g·g-1. The quality of prepared soft capsule accords with the regulations.
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备注/Memo
收稿日期: 2016-02-25 基金项目: 吉林省科技发展计划项目(20140204034YY; 20150311051YY) *通信作者: 郭建鹏(1971—),男,教授,研究方向为中药新剂型与新技术.