| 引用本文: | 胡向青,李胜,郝福,郭勇,张艳侠,侯金才.注射用米铂制剂配方与冻干工艺研究[J].中国现代应用药学,2018,35(8):1135-1140. |
| HU Xiangqing,LI Sheng,HAO Fu,GUO Yong,ZHANG Yanxia,HOU Jincai.Study on Formulation and Freeze-drying Process of Miriplatin for Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(8):1135-1140. |
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| 摘要: |
| 目的 研究注射用米铂的配方及冻干生产工艺。方法 通过冻干溶剂的选择、原料溶解度试验、处方筛选、预冻工艺研究等确定注射用米铂配方和冻干工艺参数的控制范围。结果 确定冻干溶剂采用叔丁醇和环己烷的混合溶剂，环己烷最佳比例范围为10%~30%，药物浓度最佳范围为5~25 mg·mL-1，确定冻干工艺采用阶段性预冻方式。结论 选定的配方和工艺可行，自研制剂与参比制剂质量等同，节约了工艺生产成本。 |
| 关键词: 米铂 冻干工艺 叔丁醇 环己烷 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.08.004 |
| 分类号:R943 |
| 基金项目:河北省科技计划项目（15272612D） |
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| Study on Formulation and Freeze-drying Process of Miriplatin for Injection |
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huxiangqing
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Shineway Pharmaceutical Group Co.Ltd
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| Abstract: |
| OBJECTIVE To study the formulation and manufacturing process of Miriplatin for Injection. METHODS The control range of manufacturing process and formulation were confirmed through choosing the kinds of freeze-drying solvent, solubility study of miriplatin, formulation selection and study on pre-freezing process. RESULTS The mixed solvents of tert-butyl alcohol and cyclohexane were selected to make freeze-drying formulation, the optimum ratio of cyclohexane was in the range of 10%-30%, the optimal drug concentration was in the range of 5-25 mg·mL-1, stage pre-freezing method was used as final freeze-drying process. CONCLUSION The formulation and manufacturing process is feasible. The self-made drug product is shown the same with and reference listed drug in pharmaceutical aspects. The production cost can be greatly saved compared with the original grinding process. |
| Key words: miriplatin freeze-drying process tert-butyl alcohol cyclohexane |
