| 复方立达霉粉的稳定性研究 |
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| 引用本文： | 肖国初,胡鲲,邱军强,杨移斌,杨先乐.复方立达霉粉的稳定性研究[J].广西农业科学,2014(4):676-681. |
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| 作者姓名： | 肖国初 胡鲲 邱军强 杨移斌 杨先乐 |
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| 作者单位： | 上海海洋大学国家水生动物病原库,上海201306 |
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| 基金项目： | 科技部“863”计划项目（2011AA10A216）;上海市科教兴农重点攻关项目（沪农科攻字[2011]第4-8号） |
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| 摘 要： | 目的]探讨复方立达霉粉的稳定性,为其配方改善和保存条件提供理论依据.方法]依据《中华人民共和国药典（二部）》的有关规定对复方立达霉粉进行高温、强光照、高湿等稳定性试验和破坏性试验,采用反相高效液相色谱法（RP-HPLC）定量分析复方立达霉粉有效成分.结果]复方立达霉粉在高温条件（60℃）下放置5和10d后,其有效成分含量分别下降1.88％和4.12％.样品在强光照条件（4500±500 1x）下放置5和10d后,其有效成分含量分别下降0.34％和1.27％.样品在相对湿度92.5％的条件下放置10d,其性状由微黄色粉末变为深黄色且结块,有效成分含量下降4.49％,吸湿增重率达6.60％;在相对湿度75.0％的条件下放置10d,复方立达霉粉样品性状无明显变化,各项指标均符合《中华人民共和国药典（二部）》的相关规定.结论]复方立达霉粉对热较敏感,对光不敏感,容易吸潮,有一定的引湿性,因此在实际生产中,复方立达霉粉应密闭储存于阴凉通风干燥处,远离热源、火源,贮运过程中要防止受潮受热.
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| 关 键 词： | 复方立达霉粉 高温 强光照 高湿 稳定性 反相高效液相色谱法（RP-HPLC） |
Stability of compound preparation of metalaxyl |
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| XIAO Guo-chu,HU Kun,QIU Jun-qiang,YANG Yi-bin,YANG Xian-le.Stability of compound preparation of metalaxyl[J].Guangxi Agricultural Sciences,2014(4):676-681. |
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| Authors: | XIAO Guo-chu HU Kun QIU Jun-qiang YANG Yi-bin YANG Xian-le |
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| Institution: | (National Pathogen Collection Centre for Aquatic Animals, Shanghai Ocean University, Shanghai 201306, China) |
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| Abstract: | Objective]The stability of compound preparation of metalaxyl was investigated so as to provide references for formula improvement and preservation conditions. Method ]Based on the relevant stipulations of China Pharmacopoeia （Part Ⅱ ）, high temperature, strong light and high humidity stability test and destructive test were conducted. The effective con- stituents of metalaxyl were determined and quantitatively analyzed by RP-HPLC. Result]The effective constituent content of the preparation decreased by 1.88% and 4.12% under 60 ℃ for 5 and 10 d, respectively. The effective constituent content of the preparation decreased by 0.34% and 1.27% under （4500±500） lx for 5 and 10 d, respectively. Under 92.5% RH for 10 d, yellowish powder turned dark and clustered with the effective constituent content down by 4.49% and moisture absorption up to 6.60%. Under 75.0% RH for 10 d, samples did not change much and their indicators accorded with relevant stipulations of China Pharmacopoeia （part two）. Conclusion]Compound preparation of metalaxyl was sensitive to heat and not sensitive to light. It was vulnerable to moisture. Therefore in practical production, compound preparation of metalaxyl should be preserved in an airtight cool ventilated dry place, away from heat and fire. During transportation, moisture and heat should be avoided. |
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| Keywords: | compound preparation of metalaxyl high temperature strong light high humidity stability RP-HPLC |
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