【摘要】 目的:制备盐酸帕洛诺司琼注射液,并建立质量控制方法。方法:考察辅料用量、配伍液和灭菌参数等对制剂的影响,参照盐酸帕洛诺司琼注射液同类产品Aloxi的处方,确定制剂处方工艺。采用HPLC法,测定制剂中盐酸帕洛诺司琼的含量和有关物质,并考察制剂稳定性。结果:金属络合剂依地酸二钠、渗透压调节剂甘露醇和针用活性炭的用量分别为盐酸帕洛诺司琼注射液制剂体积的0.01%、4.15%和0.01%(质量浓度分别为0.1、41.5和0.1 g.L-1);制剂与0.9%氯化钠注射液和5%葡萄糖注射液配伍时含量不受影响;流通蒸汽灭菌条件为121℃下15 min。制备的盐酸帕洛诺司琼注射液含量和有关物质以及稳定性均符合质量控制要求。HPLC法所测盐酸帕洛诺司琼质量浓度的线性范围为1～200 mg.L-1(r2=0.999 7)。结论:该处方工艺合理、实用,质量控制方法可靠、易行。更多还原

【Abstract】 Objective:To prepare palonosetron hydrochloride injection and to establish the method of quality control.Methods:The effect of the content of excipients,compatible solution,and sterilization parameters on the preparation were investigated,and the formula and technique were determined with reference to the formula of Aloxi.HPLC method was established to determine the content and the related substances of the preparation,and its stability was also investigated.Results:The contents of metal comp-lexant edetate disodium,osmotic regulator mannitol and active carbon accounted for 0.01%,4.15% and 0.01% of the volume of the preparation.The compatible solution,such as 0.9% NaCl and 5% glucose injection,had no effect on content of the prearation.The preparation was sterilized for 15 min by using circulating steam under the condition of 121 ℃.The content,related substances and stability of palonosetron hydrochloride injection conformed to the requirements of quality control.The linear range of palonosetron hydrochloride measured by HPLC method was from 1 to 200 mg ·L-1(r2=0.999 7).Conclusion:The formula and technique are rational and practical,and the methods of quality control were reliable and easy to operate.更多还原