微乳剂质量技术指标的确定及测定方法研究

Selection and Measurement of Microemulsion Quality Parameters

以笔者配制的几种微乳剂制剂为对象,对微乳剂的质量技术指标及测定方法进行研究。提出了微乳剂质量技术指标的建议值:透明温度区域范围为0℃～56℃,最佳为-5℃～60℃;冷贮稳定性(0±1)℃下贮存14d稳定;乳液稳定性的稀释倍数为100倍;经时稳定性2a,对于稳定的品种可以延长到3a或4a;热贮稳定性在(54±2)℃下贮存14d,有效成分分解率≤5%;pH值主要根据有效成分性质确定范围;水质一般为自来水,配制用水量在30%以上。希望为有关部门制定微乳剂剂型标准要求提供依据及供微乳剂制剂品种农药登记时参考。

Quality parameters andrespective determination methods suitable for microemulsions were studied with 10microemulsion types . Recommendations from this research are as follows: (1) Microemulsions should maintain trans-parency at temperatures from 0 to 56 oC, with best quality emulsions transparent from 5 to 60oC; (2) Microemulsionsshould remain stable for 14 days during low temperature (0±1oC) storage; (3) Emulsion stability dilution rate shouldbe 1:100; (4) Microemulsion should be stable for 2 years, with some pesticide types maintaining stability for 3 or 4years; (5) Testing for high temperature stability should be done at 54±2oC for 14 days and the amount of activeingredient decomposed should be <5%; (6) The pH range for microemulsions should primarily depend on the nature ofthe active ingredient; (7) Water content of microemulsions should be >30%, and the water source is usually tap water.The above recommendations could provide a foundation for establishing microemulsion standards and be useful as areference for pesticide registration.