Purification method of SSMT-22

Through two-step HPLC purification and HPLC conversion methods, the problems of complex operation, high cost and low purity in SSMT-22 purification were solved, and efficient and low-cost high-purity purification was achieved, meeting the needs of industrial production.

CN119192294APending Publication Date: 2024-12-27BEIJING SAISHENG PHARMA
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Patent Information

Application Number
CN202411351565.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-09-26
Publication Date
2024-12-27

AI Technical Summary

Technical Problem

The existing SSMT-22 purification methods have problems such as complex operation, high cost, many purification times and low purity, and are difficult to meet the needs of industrial production.

Method used

Using a two-step HPLC purification method, firstly, gradient elution is performed using reverse phase filler and trifluoroacetic acid aqueous solution to obtain components with a purity of more than 90%, and then further gradient elution is performed using TEAP solution to achieve a purity of more than 99.2%, and through HPLC converted to salt and lyophilized to obtain high purity SSMT-22.

Benefits of technology

It realizes efficient and low-cost SSMT-22 purification, reduces the number of purifications, improves the purity and yield of the product, and meets the needs of large-scale industrial production.

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Abstract

The invention relates to the technical field of purification of polypeptide drugs, in particular to a purification method of SSMT-22. Comprising the following steps: carrying out gradient elution on an SSMT-22 crude peptide solution by taking a mobile phase A as a trifluoroacetic acid aqueous solution and a mobile phase B as acetonitrile, collecting components with the purity of more than 90%, and concentrating; a mobile phase A is a TEAP solution, a mobile phase B is acetonitrile, gradient elution is further carried out, and components with the purity larger than 99.2% and the single impurity smaller than 0.2% are collected; performing HPLC (high performance liquid chromatography) salt conversion: further performing isocratic elution; all elution components are collected, concentrated and freeze-dried, and purified SSMT-22 is prepared. The method is convenient to operate, large in one-step purification sample loading amount and high in yield, the purification times can be reduced, the loss is reduced, and the cost is saved; the product with the purity of 99% or above and the maximum single impurity of 0.2% or below can be collected through two-step purification.
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