STABLE SECUKINUMAB INJECTION AND PREPARATION METHOD THEREFOR

Provided are a stable secukinumab injection and a preparation method therefor. The stable secukinumab injection is composed of the following ingredients: 50 mg/ml - 300 mg/ml of secukinumab, 5 mmol/L - 50 mmol/L of histidine and a histidine hydrochloride, 5 mmol/L - 50 mmol/L of methionine, 150 mmol...

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Bibliographische Detailangaben
Hauptverfasser:	WEI, Shanshan, ZHANG, Zhongyu, FAN, Xindan, CHANG, Xiaohui, WANG, Depeng, LENG, Chunsheng, ZHANG, Nan
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	CHEMISTRY HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE METALLURGY ORGANIC CHEMISTRY PEPTIDES PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung:	Provided are a stable secukinumab injection and a preparation method therefor. The stable secukinumab injection is composed of the following ingredients: 50 mg/ml - 300 mg/ml of secukinumab, 5 mmol/L - 50 mmol/L of histidine and a histidine hydrochloride, 5 mmol/L - 50 mmol/L of methionine, 150 mmol/L - 400 mmol/L of a low-sugar alcohol, and 0.01 % - 0.02% of polysorbate 80, wherein the balance is water for injection, and the pH is 5.0 - 7.0. Stability tests prove that the quality of the stable secukinumab injection is stable, wherein the stability thereof is superior to that of commercial varieties on the market, and same has various indicators that meet the relevant regulations of the Chinese Pharmacopoeia, and has good application prospects.