Purification method of insulin detemir

Abstract

The invention discloses a purification method of insulin determir. The purification method comprises the following steps of: during purification, balancing a cation exchange column by an acidic buffer solution; adjusting the pH value of an insulin determir solution to be less than 5 by the acidic buffer solution or an identically systematic diluted acid, thus obtaining a sample solution; adding the sample solution on the cation exchange column, then washing the cation exchange column by a balanced buffer solution; and successively washing various adsorbed substances down from the column by a 0.5-1.0M acidic buffer solution with a pH value of 2-4 in a liner gradient elution way, and then collecting a main peak, thus obtaining a target product, namely the insulin determir. The purification method not only has the advantages of being convenient to operate, large loading quantity of samples, high recycling efficiency and the like, but also avoids the rigorous requirements that a large quantity of organic reagents and a high pressure chromatographic system are needed in a traditional purification method, so that the purification method is cost-saving, economical and environmentally-friendly, and suitable for industrial production.

Description

technical field [0001] The invention relates to a method for purifying insulin detemir, belonging to the fields of biochemistry and medicinal chemistry. Background technique [0002] Diabetes is a major disease that threatens human health worldwide. In China, with the change of people's lifestyle and the acceleration of the aging process, the prevalence of diabetes is rising rapidly. In 2010, the total number of diabetic patients in China has exceeded 90 million. Acute and chronic complications of diabetes, especially chronic complications that accumulate in multiple organs, cause disability and high mortality, seriously affect the physical and mental health of patients, and bring heavy burdens to individuals, families and society. [0003] All patients with type 1 diabetes must receive insulin therapy, and most patients with type 2 diabetes will eventually need to use insulin to control blood sugar as the disease progresses. Existing evidence shows that once diabetic pat...

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Problems solved by technology

Yili Lili Company (Chinese patent CN95196266.3) discloses a purification method using C4 reverse-phase high-efficiency chromatographic column; The purification method of reversed-phase chromatographic column; from the existing literature, it can be seen that the product can be obtained through the purification of reversed-phase high-performance liquid chromatography, but this purification method has high requirements for equipment, and a complete set of chromatography that can withstand high pressure is required System, and a large amount of organic reagents such as acetonitrile will be used in the preparation process, which is costly and not environmentally friendly; the adsorption of the sample on the reversed-phase preparative column is strong, resulting in low recovery rate, and it is easy to cause irreversible damage to the reversed-phase preparative column damage

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