Method for freeze-drying reducing glutathione for injection

Abstract

The invention provides a method for freeze-drying reducing glutathione for injection. In the method, after a pre-freezing process, a primary freeze-drying subliming process is performed, wherein the primary freeze-drying subliming process comprises: vacuumizing, raising temperature, raising the temperature of a partition board to -2 to 0 DEG C, keeping temperature for 10 to 20 hours, reducing the temperature of the partition board to -10 to -12 DEG C, keeping the temperature for 10 to 30 hours, and raising the temperature of the partition board to 0 DEG C within 5 to 15 hours. When the primary subliming process is adopted, the freeze-drying period is reduced obviously, and the production cost is reduced.

Description

technical field [0001] The invention relates to a preparation method of reduced glutathione for injection, in particular to a freeze-drying method of reduced glutathione for injection. Background technique [0002] Glutathione is a natural active peptide with important physiological functions, which is composed of glutamic acid, cysteine ​​and glycine. Glutathione exists in two forms in the body, namely reduced glutathione (referred to as GSH) and oxidized glutathione (referred to as GSSG), which exist in large quantities in the body and play a major role The most important is reduced glutathione [Jia Zhen, Wang Dan, You Song. Research progress of glutathione. Journal of Shenyang Pharmaceutical University. March 2009, Volume 26, Issue 3]. [0003] Reduced glutathione is unstable in water and sensitive to heat due to the presence of active sulfhydryl groups, so it is generally made into freeze-dried powder for injection by aseptic method for clinical use. At present, the pr...

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Problems solved by technology

[0004] (1) High direct production cost: the main reason is that the reduced glutathione solution itself has a high viscosity, it is difficult to sublimate the water in the freeze-drying and sublimation process of the product, it is difficult to control the freeze-drying process, the freeze-drying cycle is long, and the larger the specification, the more expensive the product will be. The greater the concentration of the aqueous solution, the more difficult it is to freeze-dry, so you can only choose a larger size injection bottle with a large bottom area and a large mouth diameter, such as using a 10ml injection bottle to freeze-dry 0.3g, 0.6g reduced glutathione to reduce the degree of difficulty, but doing so will reduce production capacity and increase production costs

[0005] (2) Batch-to-batch inhomogeneity of product quality: Due to the complexity of the freeze-drying process, some manufacturers mainly focus on the actual product temperature during the freeze-drying process Control the temperature, because the temperature of the product is directly affected by the position of the probe placed in the bottle manually by the personnel, the area of ​​the water sublimation channel occupied by the temperature sensor at the mouth of the bottle, and the position of the temperature sensor on the plate layer, etc., so in practice There are large variables in the production operation, and it is difficult to achieve stable and controllable product quality in batches, resulting in uneven product quality between batches

[0006] (3) Unable to provide large-scale products: Since reduced glutathione for injection is used in large doses within a safe range for most patient groups, small-scale products The product can only be used in multiple branches in clinical practice, which not only increases the risk of contamination but also consumes higher material costs. The current freeze-drying process can provide a product with a maximum size of 1.2g, which cannot well meet clinical needs