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大容量注射液中的微粒除不容性微粒外,还有随溶液温度升高而从不溶性微粒变为可溶性微粒,其同样影响制剂成品微粒的检测结果。通过多年的工作实践和实验观察,发现注射用NaCl原料中的Ca2+、Ba2+、Mg2+、Fe2+、Fe3+等溶解度较小的一些盐类及CaCl2本身均能够造成制剂成品微粒超标。1微线超标现象在多年配制0.9%氯化钠注射液、乳酸钠林格注射液过
Large particles in addition to the injection of particles can not contain particles, but also with the solution temperature increases from insoluble particles into soluble particles, which also affect the finished product particles of the test results. After years of working practice and experimental observation, it is found that some salts, such as Ca2 +, Ba2 +, Mg2 +, Fe2 +, Fe3 +, etc., which are less soluble and CaCl2 themselves, can cause the finished product particles to exceed the standard. 1 micro-line exceeded the standard in many years formulated 0.9% sodium chloride injection, sodium lactate Ringer injection too