INDUSTRIALIZATION PREPARATION METHOD FOR PACLITAXEL SUBMICRON EMULSION INJECTION

An industrialization preparation method for a paclitaxel submicron emulsion injection. The method comprises the following steps carried out in a submicron emulsion injection preparation system: S1, formulating an aqueous phase in an aqueous phase tank; S2, formulating an oil phase in an oil phase ta...

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Hauptverfasser: JIN, Yiqun, LIU, Zhihua, SUN, Dejun, SUO, Shiyue, GAO, Huiyu, LIU, Meng, WANG, Yanan, QIN, Caiyun, WANG, Huibin, WANG, Lu, LIU, Yang, SHEN, Qiqi, YANG, Hongzhen, WANG, Yujie
Format: Patent
Sprache:chi ; eng ; fre
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Zusammenfassung:An industrialization preparation method for a paclitaxel submicron emulsion injection. The method comprises the following steps carried out in a submicron emulsion injection preparation system: S1, formulating an aqueous phase in an aqueous phase tank; S2, formulating an oil phase in an oil phase tank; and S3, starting the submicron emulsion injection preparation system, and executing emulsification, homogenization and feed liquid transfer operations to obtain a final emulsion; and S4, canning the final emulsion, and sterilizing same to obtain a paclitaxel submicron emulsion injection. The industrialization preparation method can achieve large-scale submicron emulsion production and automatic cleaning and online sterilization of the whole system, and can achieve whole-process accurate temperature control, nitrogen charging and oxygen removal, closed bacteria isolation and whole-process automatic operation. The defects of closed operation and whole-process nitrogen charging being not capable of being carried o