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感冒清热颗粒挥发油包合工艺的优化
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| 篇名： | 感冒清热颗粒挥发油包合工艺的优化 |
| TITLE： | Optimization of Inclusion Technology of Volatile Oil from Ganmao Qingre Granules |
| 摘要： | 目的：优化感冒清热颗粒挥发油包合工艺。方法：以“质量源于设计”理念为指导，以挥发油包合率、包合物收得率为关键质量属性，两者加权后的综合评分为响应值，包合温度、包合时间、β-环糊精（β-CD）与挥发油比例为关键工艺参数，采用Box-Burman响应曲面设计建立关键工艺参数与关键质量属性的设计空间，通过95％置信区间优化设计空间并进行验证；同时初步考察了包合物的稳定性。结果：所得最优设计空间即最优工艺参数范围为包合温度35～40℃，包合时间1.8～2.0h，β-CD与挥发油比例9.5∶1～10∶1（g/mL）。3次验证实验结果显示，挥发油包合率均大于62％，包合物收得率均大于75％，综合得分均大于80分。初步稳定性结果显示，挥发油包合率、包合物收得率以及综合评分均未发生明显变化，7d之内各项指标差异均在5％以内。结论：所得最优包合工艺可行，所得包合物稳定性良好。 |
| ABSTRACT： | OBJECTIVE：To optimize the inclusion technology of volatile oil from Ganmao qingre granules. METHODS ： Guided by the concept of “quality by design ”，taking volatile oil inclusion rate and inclusion complex yield as key quality attribute，comprehensive score of above two indexes after weighting as response value ，inclusion temperature ，inclusion time ，the ratio of β-CD to volatile oil as key technology parameters ，Box-Burman response surface design was adopted to establish the design space of key technology parameters and key quality attributes. The design space was optimized and verified by 95％ confidence interval. The stability of inclusion complex was investigated preliminarily. RESULTS ：The optimal design space ，i. e. the optimal technology parameters rang ，included inclusion temperature 35-40 ℃，inclusion time 1.8-2.0 h，the ratio of β-CD to volatile oil 9.5∶1- 10∶1（g/mL）. The results of 3 validation tests showed that the volatile oil inclusion rates were all over 62％，the yields of inclusion complex were all over 75％，and the comprehensive scores were all over 80 point. The results of preliminary stability showed that the inclusion rate of volatile oil ，the yield of inclusion complex and the comprehensive score did not change significantly. The difference in evaluation indicators within 7 days was within 5％. CONCLUSIONS ：The optimized inclusion technology is feasible ， and the obtained inclusion complex is stable. |
| 期刊： | 2021年第32卷第14期 |
| 作者： | 张东阁，王凤霞，杨宇杰，王春民，陈宝鑫，吴鑫宇 |
| AUTHORS： | ZHANG Dongge ，WANG Fengxia ，YANG Yujie，WANG Chunmin ，CHEN Baoxin ，WU Xinyu |
| 关键字： | 质量源于设计理念；感冒清热颗粒；挥发油；包合工艺；Box-Burman响应曲面法；设计空间；稳定性 |
| KEYWORDS： | Quality by design ；Ganmao qingre granules ；Volatile oil ；Inclusion technology ；Box-Burman response surface |
| 阅读数： | 311 次 |
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