CAJ | 학술논문

目的：探讨冻干粉针剂产品不溶性微粒在检测过程中的影响因素。方法通过不同体积、不同溶剂复溶冻干粉针剂，利用搅拌与否和不同的进样方式，测定不溶性微粒的数据。结果与结论采用不同的复溶溶剂、复溶溶剂的体积、进样方式及搅拌等均会影响不溶性微粒的检验数据，操作过程中需要注意这些因素对检测数据的影响。
목적：탐토동간분침제산품불용성미립재검측과정중적영향인소。방법통과불동체적、불동용제복용동간분침제，이용교반여부화불동적진양방식，측정불용성미립적수거。결과여결론채용불동적복용용제、복용용제적체적、진양방식급교반등균회영향불용성미립적검험수거，조작과정중수요주의저사인소대검측수거적영향。
Objective To discuss the influencing factors of using light blockage inspection to measure insoluble parti-cles of freeze dried powder for injection. Methods Using different volume and different solvent to dissolve freeze dried powder for injection and using stirring or not and different injection mode to measure the quantity of insoluble particles. Re-sults and Conclusion different kinds of solvent,different volume of solvent,injection mode and stirring or not were all in-fluence the quantity of insoluble particles. So we should pay attention to the influencing factors to test results in operation process.