注射用盐酸万古霉素冻干工艺对冻干物外观形态及晶型的影响  

Effect of Freeze-dried Process of Vancomycin Hydrochloride for Injection onAppearance and Crystal Form of Freeze-dried Cakes

作　　者：徐慧娟 杜加秋 钟梁 张晓燕 陶成浩 XU Huijuan;DU Jiaqiu;ZHONG Liang;ZHANG Xiaoyan;TAO Chenghao(Hanhui Pharmaceuticals Co.,Ltd.,Hangzhou 310016;Zhejiang Hisun Pharmaceutical Co.,Ltd.,Hangzhou 311404)

机构地区：[1]瀚晖制药有限公司,浙江杭州310016 [2]浙江海正药业股份有限公司,浙江杭州311404

出　　处：《中国医药工业杂志》2022年第8期1196-1200,共5页Chinese Journal of Pharmaceuticals

摘　　要：市售注射用盐酸万古霉素冻干品的饼块易分层,或产生结晶。本研究设置了不同退火温度(–5和–10℃)、不同降温速率(6和0.5℃/min)的对比试验,结果显示增加退火步骤和加快预冻的降温速率均能明显改善冻干产品饼块的外观形态。但在较高的退火温度下,冻干样品的最下层产生了部分晶体,其主要特征峰位置(9.76、17.36、18.80、20.49、21.18、24.76和25.28°)与甘露醇特征峰的位置相对应,这可能是由于在较高的退火温度下,处于下层位置的无定形态甘露醇发生了晶型的构建,形成了甘露醇晶体,因此不宜选用过高的退火温度。The freeze-dried cakes of commercially available vancomycin hydrochloride for injection are easy to stratify and crystallize.Different annealing temperatures(–5 and–10℃)groups and different prefreezing rates(6 and 0.5℃/min)groups were set and compared in this study.It was confirmed that both adding an annealing step and speeding the prefreezing rate could obviously improve the cake appearance of the freeze-dried products.However,at a higher annealing temperature,some crystalline substances were found in the bottom layer of the sample.And the positions of characteristic peaks(9.76,17.36,18.80,20.49,21.18,24.76 and 25.28°)for these crystals were corresponding to the positions of characteristic peaks of mannitol.The possible reason for this phenomenon was the transformation of amorphous mannitol in the bottom layer to crystalline state at a higher annealing temperature.Therefore,it was not advisable to choose a higher annealing temperature.

关 键 词：盐酸万古霉素 注射剂 冻干工艺 外观 晶体 

分 类 号：R944.9[医药卫生—药剂学]