Freeze-drying Technology of Cardiopeptide for Injection

Abstract

The invention belongs to the field of pharmaceutical manufacture, and provides a lyophilization technology of myocardial peptide for injection. Filling volume and lyophilization technology parametersare adjusted and optimized during the preparation of a myocardial peptide solution, and the lyophilization of the myocardial peptide for injection is realized through methods of product pretreatment,lyophilization condition adjustment and the like. The technology is simple, mature and feasible in process, and low in waste rate; the prepared myocardial peptide for injection is good in appearance,fine in powder inside, extremely low in water content, and stable in quality; on the basis of ensuring the original activity of the myocardial peptide, moisture in the myocardial peptide is removed, so that the drying time is shortened, and the mass deviation within a batch is reduced.

Description

technical field [0001] The invention belongs to the field of medicine manufacturing, and relates to a purification and drying process of medicines, in particular to a freeze-drying process of cardiac peptide for injection. Background technique [0002] Indications for injection of cardiopeptide (Kidemetine) can be used as an adjuvant drug for perioperative myocardial protection in cardiac surgery. Based on the results of existing clinical studies, the use of cardioplegia peptide in the perioperative period of cardiac surgery can improve myocardial ultrastructure, but the overall benefit and improvement of cardiac function of cardiac surgery patients is not yet clear. [0003] Since cardiopeptide is a polypeptide, it is easily affected by temperature, acid and alkali in the production process, resulting in deformation to varying degrees, affecting its purity and activity. In the traditional freeze-drying process of cardiopeptide, the solution prepared by the original formula...

AI Technical Summary

Problems solved by technology

Based on the results of existing clinical studies, the use of cardiopeptide in the perioperative period of cardiac surgery can improve myocardial ultrastructure, but the overall benefit and improvement of cardiac function for patients undergoing surgery is still unclear.

[0003] Since cardiopeptide is a polypeptide, it is easily affected by temperature, acid and alkali in the production process, resulting in varying degrees of deformation, affecting its purity and activity

In the traditional freeze-drying process of cardiopeptide, the solution prepared by the original formula is used for freeze-drying. This drying process not only takes up to 78 hours, consumes energy, but also has serious deviations in the quality of the batch. Some freeze-dried products have poor appearance and waste products. high rate