中兽药参黄颗粒的制备工艺优化研究

Optimization of preparation technology of Chinese veterinary medicine Shenhuang granules

关键词:  参黄颗粒  正交实验  综合评分  工艺优化

Key words:  Shenhuang granule  Orthogonal experiment  comprehensive evaluation  Process optimization

摘要:

为了优化中兽药参黄颗粒的制备工艺，获得最佳制备工艺参数，采用正交试验设计优化水提，浓缩，并采用湿法制粒，通过单因素试验和正交试验优选药物与辅料的比例、乙醇浓度和烘干温度参数，以颗粒的成型性、堆密度、休止角、溶化性以及吸湿性来评价颗粒的最佳成型工艺。最佳水提工艺为加9倍水，回流提取3次，每次提取时间1 h；药物与辅料比例为3∶5(药物浸膏粉∶可溶性淀粉∶糊精∶蔗糖为(3∶2∶2∶1)，乙醇浓度为80%，烘干温度为60 ℃，制备的颗粒剂综合评分最高。中兽药参黄颗粒的制备工艺优化研究为其临床试验的扩大生产提供了科学参考依据。

Abstract:

In order to optimize the preparation parameters of traditional Chinese veterinary medicine Shenhuang granules, orthogonal design was adopted in the experiment for extraction, concentration and drying of traditional Chinese medicine by water extraction process, and wet granulate was adopted. The ratio of drug to excipatory, ethanol concentration and drying temperature were optimized by single factor test and orthogonal test.The best forming process of particles was evaluated by the formability, bulk density, repose Angle, solubility and hygroscopicity of particles.The results showed that the optimal extraction process was to add 9 times of water, reflux extraction for 3 times, each extraction time was 1 h.The ratio of drug to exchants was 3∶5 (drug extract powder: soluble starch: dextrin: sucrose was 3∶2∶2∶1), ethanol concentration was 80%, drying temperature was 60 ℃, and the comprehensive score of prepared granules was the highest.The optimization of preparation technology of Chinese veterinary medicine Shenhuang granules provides a scientific reference for the expansion of clinical trial production.