CAJ | 학술논문

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。
목적：가온용해감로순주사액중적결정병대기진행질량평개。방법수궤추취함감로순결정적감로순주사액3비，분별장기치우열수기적정부，대결정완전용해후취하。통과산도계측정3비공시품적pH치，현미계수법검사불용성미립，등검법검사가견이물，고효액상색보법（HPLC）측정감로순함량등검사방법대공시품용액진행질량평개。결과3비공시품적pH치분별5.70±0.21、5.50±0.28화5.50±0.16，부합감로순주사액적pH치표준（pH4.5～6.5）。불용성미립검사결과시공시품용액적불용성미립수부합질량표준。가견이물검사시3비공시품용액중미발현유이물，부기중3병대미량백점，가견이물검사부합질량표준。HPLC법측득3비공시품용액중감로순상대우표시량적백분함량분별위98.0%、97.9%화99.5%，감로순함량부합질량표준。결론가온시용해감로순결정적유효방법，결정용해후적감로순주사액부합해약품질량표준。
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.