Freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection

A technology of omeprazole sodium and drying method, which is applied in the direction of freeze-drying transportation and powder transportation, etc., which can solve the problems of unguaranteed product quality, unfavorable preservation, instability, etc., and achieve qualified quality, favorable preservation, and roundness Good results

Inactive Publication Date: 2015-08-19
GUIZHOU JINGFENG INJECTION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Omeprazole sodium for injection is a freeze-dried preparation. Omeprazole sodium has a sulfinyl group in its chemical structure and is unstable in aqueous solution. Therefore, it is made into a freeze-dried powder preparation, which requires strict control of water content. With ordinary production methods, product quality cannot be guaranteed, which is not conducive to preservation

Method used

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  • Freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection
  • Freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection
  • Freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection

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Embodiment Construction

[0013] The specific technical scheme and experimental steps are as follows:

[0014] 1. The first trial

[0015] 1.1 Test time: April 5 to April 7, 2012

[0016] 1.2 Product batch number: 20120401

[0017] 1.3 Name of product batch number: Omeprazole Sodium for Injection

[0018] 1.4 Product specification: 40mg

[0019] 1.5 Test steps:

[0020] 1.5.1 Put the prepared and filtered medicinal liquid through the filling half-pressed stopper, put the half-pressed product 9500 bottles into the freeze dryer, and close the freeze dryer door.

[0021] 1.5.2 Set the parameters of the freeze dryer:

[0022] 1.5.2.1 Pre-freezing parameter setting: it takes 1.0 hours for the product to cool down from normal temperature to -40°C, and it is kept at this temperature for 1.0 hours;

[0023] 1.5.2.2 Sublimation drying parameter setting: the temperature of the product from -40℃ to -20℃, the required time is 10.0 hours, and the temperature is kept for 5.0 hours;

[0024] 1.5.2.3 Analysis o...

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Abstract

The invention discloses a freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection. A prepared omeprazole sodium liquid medicine for injection is subjected to filling and then to quick-freezing in a vacuum freezing dryer. The specific quick-freezing steps include: cooling the liquid medicine from normal temperature to -40DEG C within 1.0-1.5h and conducting heat preservation for 1.0-2.0h; at the end of quick-freezing, letting the liquid medicine enter a sublimation drying stage, raising the temperature of the product from -40DEG C to -20DEG C in 15.0-20.0 hours and conducting heat preservation for 5.0-8.0h, when the ice crystal line disappears and the sublimation drying finishes, bringing the product into a desorption drying stage, raising the temperature of the product from -20DEG C to 30DEG C in 10.0-15.0h and conducting heat preservation for 4.0-5.0h, then decreasing the temperature to normal temperature in 1.0-2.0h, and taking the product out of the box, thus finishing the freeze drying process. The omeprazole sodium for injection obtained in the invention has the advantages of qualified quality, soft appearance, no collapse or shrinkage phenomenon, good roundness, and easy solubility, and is easy to preserve.

Description

Technical field: [0001] The invention relates to a freeze-drying method of omeprazole sodium for injection and omeprazole sodium for injection. Background technique: [0002] There are many methods of drying medicines, such as microwave drying, hot air drying, spray drying and vacuum drying, etc., but common drying methods are usually carried out at temperatures above 0°C or higher. The products obtained by drying generally have the phenomenon of shrinking in volume and hardening in texture. Most of those volatile components will be lost due to excessive temperature, and some heat-sensitive substances will be denatured, inactivated, and oxidized. Therefore, the dried product has a great difference in properties compared with that before drying. [0003] The vacuum freeze-drying method is basically carried out below 0 °C, that is, the drying is carried out in the state of freezing the product. Only when the residual moisture content of the product is reduced in the later sta...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/26
Inventor 叶湘武胡德军余渊周燕
Owner GUIZHOU JINGFENG INJECTION
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