New process of freeze-drying procedure of riboflavin sodium phosphate for injection

Abstract

The invention provides a new process of a freeze-drying procedure of riboflavin sodium phosphate for injection, and belongs to the technical field of biological medicine. The new process mainly solves the problems that in the freeze-drying process of riboflavin sodium phosphate for injection, penicillin bottles are seriously damaged, and the product rejection rate is high. The new process is low in cost, low in rejection rate and more stable in product quality. The process is mainly and technically characterized in that the temperature of products is decreased to -35 DEG C or lower, cold insulation is conducted for about 35 minutes, and it is ensured that the products are completely frozen; when the temperature of a condenser is decreased to -45 DEG C+ / -5 DEG C and the pressure is decreased to about 20 Pa through vacuumizing, the sublimation temperature of -10 DEG C is set, electric heating is started, and the temperature rising speed is controlled to be 0.5 DEG C per hour; when the temperature of the products reaches 40 DEG C, heat preservation is conducted for about 2.5 hours, the crystalline form of the products is plump, uniform and thin, and when the pressure in the box does not obviously increase any more, in the state that the pressure is 6 Mpa, all the products are pressed and plugged out of the box. The finished products produced through the process is more stable in quality, cost is obviously reduced, market prospects are good, and the new process is worthy of popularization.

Description

1. Technical field [0001] The invention relates to a new freeze-drying process of riboflavin sodium phosphate for injection, which belongs to the technical field of biomedicine. 2. Background technology [0002] Riboflavin Sodium Phosphate. Its chemical name is: riboflavin 5'-(dihydrogen phosphate) monosodium salt dihydrate. It is an integral part of the prosthetic group of yellow enzymes in the body. When it is lacking, it will affect the biological oxidation of the body and cause metabolic disorders. For the treatment of angular cheilitis, cheilitis, glossitis, conjunctivitis and scrotitis caused by riboflavin deficiency. [0003] Problems existing in the production process of this product in the same industry in China: [0004] 1. The freeze-drying process generally adopted in China is to lower the temperature of the product to below -35°C and keep it cold for 35 minutes. After vacuuming, set the sublimation temperature (-5°C) and start sublimation directly. [0005] ...

AI Technical Summary

Problems solved by technology

[0010] Purpose of the present invention: to solve the serious damage of vials and high product rejection rate in the freeze-drying process of riboflavin sodium phosphate for injection, and to provide a freeze-drying process with low cost, low rejection rate and more stable product quality, mainly for:

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