不同工艺生产的硬脂酸镁质量对比及其生产工艺评价
目的对目前生产硬脂酸镁产品的2种不同生产工艺进行对比分析,根据对质量的影响评价生产工艺的优劣。方法通过多种调研方式了解硬脂酸镁生产工艺并进行分类和检测,将实验结果按2种不同生产工艺进行统计分析并进行评价。结果合成工艺的硬脂酸相对含量略高于精制工艺,而2种生产工艺硬脂酸与棕榈酸相对含量的总和则相当。2种生产工艺无机杂质和含量测定结果比较,差异均无统计学意义（P〉0.05）。整体而言,2种生产工艺质量控制水平基本相当。结论精制工艺需选择质量稳定的原料供应商;合成工艺中影响硬脂酸镁质量的主要因素为合成反应化学试剂的质量,相比于精制工艺具有较高的自主控制能力。...
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| Published in | 现代医药卫生 Vol. 33; no. 13; pp. 1942 - 1944 |
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| Main Author | |
| Format | Journal Article |
| Language | Chinese |
| Published |
湖南中医药大学第二附属医院药剂科,湖南长沙,410005
2017
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1009-5519 |
| DOI | 10.3969/j.issn.1009-5519.2017.13.008 |
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| Summary: | 目的对目前生产硬脂酸镁产品的2种不同生产工艺进行对比分析,根据对质量的影响评价生产工艺的优劣。方法通过多种调研方式了解硬脂酸镁生产工艺并进行分类和检测,将实验结果按2种不同生产工艺进行统计分析并进行评价。结果合成工艺的硬脂酸相对含量略高于精制工艺,而2种生产工艺硬脂酸与棕榈酸相对含量的总和则相当。2种生产工艺无机杂质和含量测定结果比较,差异均无统计学意义（P〉0.05）。整体而言,2种生产工艺质量控制水平基本相当。结论精制工艺需选择质量稳定的原料供应商;合成工艺中影响硬脂酸镁质量的主要因素为合成反应化学试剂的质量,相比于精制工艺具有较高的自主控制能力。 |
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| Bibliography: | Magnesium ; Stearic acids ; Quality control; Technology,pharmaceutical; Evaluation studies Objective To conduct the contrastive analysis of two different production processes for producing magnesium stearate at present, and to evaluate the advantages and disadvantages of production processes according to their influence on quality. Methods The production processes of magnesium stearate were understood through various investigation and research ways, then performed the classification and detection. The experimental results were statistically analyzed and evaluated according to two different production processes. Results The stearate acid relative content in the synthetic process was slightly higher than that in the refining process, while the sum totals of stearate acid and palmitic acid relative contents were roughly equal in these two production processes. The detection results of inorganic impurities and content had no statistical difference between the two pro- duction processes （P〉0.05）. Overall, the quali |
| ISSN: | 1009-5519 |
| DOI: | 10.3969/j.issn.1009-5519.2017.13.008 |