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A kind of freeze-drying process of lornoxicam for injection

A technology for lornoxicam and injection, which is applied in the freeze-drying process of lornoxicam for injection, can solve the problems of long time and increase the impurity content of the finished product, and achieves time saving, energy saving, and speeding up the sublimation rate. Effect

Active Publication Date: 2020-01-24
苏州天马医药集团天吉生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The purpose of the present invention is to provide a freeze-drying process of lornoxicam for injection, which solves the problem that the entire freeze-drying process takes a long time in the existing freeze-drying process of lornoxicam for injection and may increase the impurities of the finished product content problem

Method used

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  • A kind of freeze-drying process of lornoxicam for injection

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Experimental program
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Effect test

Embodiment 1

[0040] Embodiment 1: A kind of lyophilization process of lornoxicam for injection

[0041] Described freeze-drying process comprises the following steps successively:

[0042](1) Pre-freezing: transfer the lornoxicam product to the freezer of the lyophilizer, and the lornoxicam product conducts the cold through the plate in the lyophilizer, and adjusts the temperature of the inner plate of the lyophilizer. The temperature of the lornoxicam product on the plate layer drops to -35°C, and it is incubated for 0.75 hours; internal pressure;

[0043] (2) One-time sublimation drying, adopting six-stage stepped heating: a. Directly heat the refrigerant in the slab to -5°C, with a heating rate of 1.5°C / min, and keep warm for 1 hour; when the freezer cavity When the vacuum degree in the body reaches 15 Pa, the pulsating air infiltration is automatically carried out in the cavity of the freezer, and the infiltration is stopped when the vacuum degree in the cavity of the freezer reaches...

Embodiment 2

[0052] Embodiment 2: A kind of lyophilization process of lornoxicam for injection

[0053] Described freeze-drying process comprises the following steps successively:

[0054] (1) Pre-freezing: transfer the lornoxicam product to the freezer of the lyophilizer, and the lornoxicam product conducts the cold through the plate in the lyophilizer, and adjusts the temperature of the inner plate of the lyophilizer. The temperature of the lornoxicam product on the plate layer drops to -32 ℃, and it is incubated for 0.5 hours; internal pressure;

[0055] (2) One-time sublimation drying, adopting six-stage stepped heating: a. Directly heat the refrigerant in the slab to -4°C, the heating rate is 1.5°C / min, and keep warm for 1.5 hours; when the freezer cavity When the vacuum degree in the body reaches 18Pa, the pulsating air infiltration is automatically performed, and the air infiltration is stopped when the vacuum degree in the cavity of the freezer reaches 28Pa;

[0056] b. Heat the...

Embodiment 3

[0064] Embodiment 3: A kind of lyophilization process of lornoxicam for injection

[0065] Described freeze-drying process comprises the following steps successively:

[0066] (1) Pre-freezing: transfer the lornoxicam product to the freezer of the lyophilizer, and the lornoxicam product conducts the cold through the plate in the lyophilizer, and adjusts the temperature of the inner plate of the lyophilizer. The temperature of the lornoxicam product on the plate layer drops to -40°C, and it is incubated for 1 hour; internal pressure;

[0067] (2) Primary sublimation drying, adopting six-stage stepped heating: a. Directly heat the refrigerant in the slab to -6°C, with a heating rate of 1.0°C / min, and keep warm for 1.5 hours; when the freezer cavity When the vacuum degree in the body reaches 12Pa, the pulsating gas infiltration is automatically performed, and the gas infiltration is stopped when the vacuum degree in the cavity of the freezer reaches 22Pa;

[0068] b. Heat the ...

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Abstract

The invention discloses a freeze-drying technology for injection lornoxicam. The freeze-drying technology is characterized by sequentially comprising the following steps: (1) conducting pre-freezing; (2) conducting sublimation drying in a mode of six-sectional stepped temperature raising as follows: a, heating up a coolant to a minus (6-4) DEG C, preserving heat for 0.5-1.5h, conducting automatic pulsation to promote air permeation when a vacuum degree is 12-18Pa and stopping the air permeation when the vacuum degree is 22-28Pa; b, heating up the coolant to a temperature ranging from minus 1 DEG C to 1 DEG C, preserving heat for 1-1.5h and conducting pulsation to promote air permeation to 22-28Pa; c, heating up the coolant to 4-6 DEG C, preserving heat for 2-2.5h and conducting pulsation to promote air permeation to 22-28Pa; d, heating up the coolant to 9-11 DEG C, preserving heat for 2-2.5h and conducting pulsation to promote air permeation to 22-28Pa; e, heating up the coolant to 14-16 DEG C, preserving heat for 2-2.5h and conducting pulsation to promote air permeation to 22-28Pa; and f, heating up the coolant to 24-26 DEG C, preserving heat for 1-1.5h and conducting pulsation to promote air permeation to 30-36Pa; and (3) conducting secondary sublimation drying. With the application of the freeze-drying technology provided by the invention, moisture content and impurity limit of the product (the injection lornoxicam) can conform to requirements prescribed within, and meanwhile, the time of an entire freeze-drying process can be also shortened.

Description

technical field [0001] The invention belongs to the field of medicine production, in particular to a freeze-drying process of lornoxicam for injection. Background technique [0002] Lornoxicam for injection is a non-steroidal anti-inflammatory analgesic drug with strong analgesic and anti-inflammatory effects. It is clinically used for various acute mild to moderate pain and joint pain and inflammation caused by rheumatic diseases. Its main components are lornoxicam and excipients, the common specification in the market is 8mg, and it is obtained through aseptic freeze-drying production. [0003] In the prior art, the production method of lornoxicam for injection comprises the following steps successively: [0004] (1) Ingredients: weigh the prescribed amount of lornoxicam and mannitol, add water for injection, stir to dissolve completely, and adjust the pH value to 8.0--9.5 with sodium hydroxide; [0005] (2) Sterilizing filtration: the above solution is pre-filtered thr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/542A61P29/00
CPCA61K9/0019A61K9/19A61K31/542
Inventor 欧阳健王良友顾世平沈云峰刘远征
Owner 苏州天马医药集团天吉生物制药有限公司
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