Stable aflibercept preparation and preparation method thereof

The invention provides an aflibercept preparation, and the aflibercept preparation has a pH value of 5.8-6.4, and consists of the following components: (a) aflibercept with the concentration of 10mg/ml-70mg/ml; (b) a phosphate buffer agent with the concentration of 10-300mmol/L; (c) sodium chloride...

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Bibliographische Detailangaben
Hauptverfasser: WANG DEPENG, WEI SHANSHAN, LENG CHUNSHENG, CHANG XIAOHUI, ZHANG ZHONGYU
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention provides an aflibercept preparation, and the aflibercept preparation has a pH value of 5.8-6.4, and consists of the following components: (a) aflibercept with the concentration of 10mg/ml-70mg/ml; (b) a phosphate buffer agent with the concentration of 10-300mmol/L; (c) sodium chloride with the concentration of 0-200mmol/L; and (d) the balance water. The invention further provides a preparation method of the aflibercept preparation. The aflibercept preparation disclosed by the invention does not contain a surfactant; Compared with the prior art, the preparation disclosed by the invention has high safety, and meanwhile, the stability is also improved. 本发明提供一种阿柏西普制剂,pH=5.8-6.4,由以下成分组成:(a)浓度为10mg/ml-70mg/ml的阿柏西普;(b)浓度为10-300mmol/L的磷酸盐缓冲剂;(c)浓度为0-200mmol/L的氯化钠;(d)余量的水。本发明还提供该阿柏西普制剂的制备方法。本发明所述阿柏西普制剂不含表面活性剂;相较现有技术,本发明的制剂安全性好,同时稳定性也得到了提高。