Medicinal material capable of being used in injection as well as preparation method and application of medicinal material

Through specific process parameters and purely physical technical means, the problem of high impurity content in food-grade ε-polylysine was solved, and ε-polylysine that meets injection-grade standards was prepared, achieving a high recovery rate and good safety, meeting the requirements for use in injections.

CN120754048APending Publication Date: 2025-10-10CHENYANG SHENGKEWEIZHENG BIOLOGICAL CO LTD
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Patent Information

Application Number
CN202510735548.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-04
Publication Date
2025-10-10

AI Technical Summary

Technical Problem

It is difficult to prepare food-grade ε-polylysine that meets injection-grade standards using existing technologies, as there are problems with high bacterial endotoxin and impurity content.

Method used

Specific process parameters and purely physical technical means, including micropore filtration, anion exchange, ultrafiltration, etc., combined with specific pH adjustment and buffer treatment, are used to prepare ε-polylysine that meets injection-grade requirements.

Benefits of technology

A high recovery rate and good safety of ε-polylysine were achieved, and the bacterial endotoxin removal rate reached more than 99.38%, meeting the quality requirements of injection-grade pharmaceutical materials.

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Abstract

The invention discloses a medicinal material capable of being used in an injection as well as a preparation method and application of the medicinal material, and belongs to the technical field of medicines, and the main component of the medicinal material capable of being used in the injection comprises epsilon-polylysine. The invention provides a preparation process of a medicinal material capable of being used in an injection, and the medicinal material has a good recovery rate; experimental studies on bacterial endotoxin, safety and the like are carried out, the self-made medicinal material capable of being used in the injection has good safety, and the blank that the medicinal material capable of being used in the injection is prepared from food-grade epsilon-polylysine is filled.
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