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目的研制复方增效氯硝柳胺悬浮剂,并分析其性能。方法将氯硝柳胺和氯辛硫磷与润湿剂、分散助悬剂和黏度调节剂等助剂混合,经球磨机研磨,制成复方增效氯硝柳胺悬浮剂。并对该制剂的黏度、粒径等进行分析,根据测定的氯硝柳胺和氯辛硫磷最大吸收峰波长,用高效液相法测定制剂中氯硝柳胺和氯辛硫磷的含量,并进行水溶液悬浮稳定性测定。结果复方增效氯硝柳胺悬浮剂是一种灰白色流动性黏稠液体,进入水体极易分散,可与水以任意比例混合。pH8.65,黏度137 mpa·s,药物颗粒粒径0.138-19.953μm,其中95.6%粒径<10 μm,82.24%粒径<5μm。氯硝柳胺的紫外吸收有3个峰值,分别为210、234 nm和332 nm,氯辛硫磷的吸收峰为269 nm。高效液相法测得复方增效剂氯硝柳胺含量为20.64%(W/W),氯辛硫磷含量为5.26%(W/W)。复方水溶液悬浮性2 h内中段氯硝柳胺含量均>100%,4 h仍为89.14%。结论新研制的复方增效氯硝柳胺悬浮剂是一种性能稳定,符合质量标准的制剂。
Objective To develop compound synergistic niclosamide suspensions and analyze its properties. Methods Niclosamide and chloroxthion were mixed with wetting agent, dispersible suspending agent and viscosity modifier and other adjuvants. The mixture was ground by ball mill to make compound synergistic niclosamide suspending agent. The viscosity and particle size of the preparation were analyzed. According to the maximum absorption wavelength of niclosamide and chloroxthion, the contents of niclosamide and chloroxthion in the preparation were determined by HPLC. And aqueous suspension stability test. Results Compound synergistic niclosamide suspending agent is a gray-white liquid viscous liquid, into the water easily dispersed, with water in any ratio of mixing. pH8.65, viscosity of 137 mPa · s and drug particle size of 0.138-19.953 μm, of which 95.6% was less than 10 μm and 82.24% was less than 5 μm. The niclosamide UV absorption has three peaks, respectively 210,234 nm and 332 nm, chlorine phoxim absorption peak of 269 nm. The content of niclosamide in compound synergist was 20.64% (W / W) and the content of chloroxthion was 5.26% (W / W) by HPLC. The content of niclosamide in the middle suspension of compound aqueous solution was> 100% within 2 h and 89.14% after 4 h. Conclusion The newly developed compound synergistic niclosamide suspension is a stable performance, in line with the quality standards of the preparation.