甘露醇注射液中结晶经加温溶解后的质量评价

Quality evaluation of mannitol injection after crystallization dissolved by heating

目的加温溶解甘露醇注射液中的结晶并对其进行质量评价。方法随机抽取含甘露醇结晶的甘露醇注射液3批,分别将其置于热水器的顶部,待结晶完全溶解后取下。通过酸度计测定3批供试品的pH值,显微计数法检查不溶性微粒,灯检法检查可见异物,高效液相色谱法(HPLC)测定甘露醇含量等检查方法对供试品溶液进行质量评价。结果 3批供试品的pH值分别5.70±0.21、5.50±0.28和5.50±0.16,符合甘露醇注射液的pH值标准(pH4.5～6.5)。不溶性微粒检查结果示供试品溶液的不溶性微粒数符合质量标准。可见异物检查示3批供试品溶液中未发现有异物,仅其中3瓶带微量白点,可见异物检查符合质量标准。HPLC法测得3批供试品溶液中甘露醇相对于标示量的百分含量分别为98.0%、97.9%和99.5%,甘露醇含量符合质量标准。结论加温是溶解甘露醇结晶的有效方法,结晶溶解后的甘露醇注射液符合该药品质量标准。

Objective To evaluate the quality of mannitol injection after the crystal ization was dissolved by heating. Methods Three batches of crystal ized mannitol injection were selected randomly. The samples of selected batches were heated on the top of the water heater to completely dissolve the crystal. pH value was measured by acidity meter, insoluble particles were check by microscopic counting method, visible foreign matters were check by lamp test, and content of mannitol was determina-tion by high performance liquid chromatography（HPLC）. Results The pH value of three batches was 5.70±0.21, 5.50±0.28 and 5.50±0.16, respectively, which met the pH standard of mannitol injection （4.5~6.5）. Insoluble particles met quality standards by examination. Visible foreign matter was not found in 3 batches of test samples, and there was only little white dots in 3 bottles. The amount of mannitol measured by HPLC was 98.0%was 97.9%and 99.5%of the labeled value in 3 batches test samples,respec-tively, which met the quality standards of mannitol injection. Conclusion Heating is the effective method to dissolve the mannitol crystal ization. The mannitol injection after crystal ization dissolved by heating can meet the drug quality standard.