肿节风颗粒特定条件下最优制粒区间研究
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篇名: 肿节风颗粒特定条件下最优制粒区间研究
TITLE:
摘要: 目的:初步探索获得中药制剂最优制粒区间的可行性。方法:以肿节风颗粒成型工艺为模型,采用析因设计进行试验,以颗粒得率、颗粒成型率加权后的综合评分值为考察指标,采用Origin 8.0软件分别绘制不同含水量混合粉(浸膏粉-可溶性淀粉)综合评分值与润湿剂浓度、液固比关系效果图,并用Origin 8.0软件中的Screen Reader功能进行坐标提取,综合得到肿节风颗粒在特定条件下的最优制粒区间;在该制粒区间下,选择不同批次浸膏粉进行实验室规模及处方放大试验进行验证。结果 :当浸膏粉-可溶性淀粉配比为1 ∶ 2时,肿节风颗粒存在一个最适制粒区间,即当物料含水量在[2.0%,6.0%]、润湿剂浓度在 [50%,80%]及液固比在[15.3 mL/g,18.6 mL/g]范围内时,所制肿节风颗粒均符合要求;验证试验的综合评分值均大于85%,证实所制颗粒合格。结论:本研究建立的考察中药浸膏在特定条件下的最优制粒区间的方法,对解决中药制粒工业生产批间差异大、重现性差等问题,具有一定的参考作用。
ABSTRACT: OBJECTIVE: To preliminarily explore the feasibility of achieving the optimal granulation interval of TCM preparations. METHODS: Using molding technology of Zhongjiefeng granule as model, factorial design was adopted for test, using comprehensive score which was weighted with grain yield and particle formation rate as investigation index, Origin 8.0 software was used to draw relationship effect diagram about comprehensive score of mixture with different moisture contents (extract powder - soluble starch) and wetting agent concentration, solid-liquid ratio; coordinate extraction was conducted by Screen Reader in Origin 8.0 software, and the optimal granulation interval of Zhongjiefeng granule under specific conditions was obtained. In the granulation interval, different batches of extract powder were selected for laboratory scale and prescription amplification test, and verification test was conducted. RESULTS: When extract powder-soluble starch was equal to 1 ∶ 2, there was an optimal granulation interval for Zhongjiefeng granule, which meant when material moisture content ranged in [2.0%, 6.0%], wetting agent concentration ranged in [50%, 80%], and liquid-solid ratio ranged in [15.3 mL/g, 18.6 mL/g], the prepared Zhongjiefeng granule met the requirements. Comprehensive score of verification test were higher than 85%, which proved the prepared granule was qualified. CONCLUSIONS: The established method for exploring optimal granulation interval for TCM extract under specific conditions has certain reference function to solve the problems in industrial production of TCM granulation, such as large difference between batches and poor reproducibility.
期刊: 2017年第28卷第10期
作者: 钟绍金,韩珊颖,吉训恋,朱刚直
AUTHORS: ZHONG Shaojin,HAN Shanying,JI Xunlian,ZHU Gangzhi
关键字: 肿节风颗粒;制粒区间;析因设计;含水量;润湿剂浓度;液固比
KEYWORDS: Zhongjiefeng granule; Granulation interval; Factorial design; Moisture content; Wetting agent concentration; Li- quid-solid ratio
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