Freeze-drying process of thymalfasin for injection

A thymosin and injection technology, which is applied in the freeze-drying process of thymosin for injection, can solve the problems of increasing the impurity content of the finished product and the long time, and achieve the effects of easy use and good resolubility.

Inactive Publication Date: 2017-04-26
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

[0015] The purpose of the present invention is to provide a new freeze-drying process of the thymus method for injection, which solves the problem that the entire freeze-drying

Method used

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  • Freeze-drying process of thymalfasin for injection

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Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: A new freeze-drying process of thymus for injection

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

[0042] (1) Pre-freezing: transfer the new thymus method product to the freezer of the freeze dryer, and the new thymus method product conducts the cold through the plate in the freeze dryer, adjusts the temperature of the inner plate layer of the freeze dryer, and puts the plate layer The temperature of the new product of the upper thymus method is reduced to -45°C, and it is kept warm for 0.5 hours; pressure in the cavity;

[0043](2) One-time sublimation drying, adopting seven-stage stepped heating: a. Directly heat the refrigerant in the slab to -10°C at a heating rate of 1.5°C / min and keep it 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 vac...

Embodiment 2

[0053] Embodiment 2: A kind of new freeze-drying process of thymus method for injection

[0054] Described freeze-drying process comprises the following steps successively:

[0055] (1) Pre-freezing: transfer the new thymus method product to the freezer of the freeze dryer, and the new thymus method product conducts the cold through the plate in the freeze dryer, adjusts the temperature of the inner plate layer of the freeze dryer, and puts the plate layer The temperature of the new product of the upper thymus method is reduced to -42°C, and it is kept warm for 0.5 hours; after the heat preservation is completed, the temperature of the cold trap of the lyophilizer is dropped to -58°C, and it is kept warm for 0.5 hours, then vacuuming is started, and the freezer is lowered pressure in the cavity;

[0056] (2) One-time sublimation drying, adopting seven-stage stepped heating: a. Directly heat the refrigerant in the slab to -11°C, with a heating rate of 1.5°C / min, and keep warm ...

Embodiment 3

[0066] Embodiment 3: A kind of new freeze-drying process of thymus method for injection

[0067] Described freeze-drying process comprises the following steps successively:

[0068] (1) Pre-freezing: transfer the new thymus method product to the freezer of the freeze dryer, and the new thymus method product conducts the cold through the plate in the freeze dryer, adjusts the temperature of the inner plate layer of the freeze dryer, and puts the plate layer The temperature of the new product of the upper thymus method is reduced to -40°C, and it is incubated for 1 hour; after the end of the incubation, the temperature of the cold trap of the lyophilizer is reduced to -50°C, it is incubated for 0.5 hours and vacuumized, and the freezer is lowered. pressure in the cavity;

[0069] (2) One-time sublimation drying, adopting seven-stage stepped heating: a. Directly heat the refrigerant in the slab to -9°C, the heating rate is 1.0°C / min, and keep warm for 1.5 hours; when the freezer...

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Abstract

The invention discloses a freeze-drying process of thymalfasin for injection. The freeze-drying process is characterized by including the first step of pre-freezing, the second step of primary sublimation drying and the third step of secondary sublimation drying. In the second step of primary sublimation drying, seven-stage step temperature rise is adopted, wherein a, a coolant is heated to -10 DEG C+/-1 DEG C, and heat preservation is conducted for 1-1.5 h; when the vacuum degree reaches 15 Pa+/-3 Pa, automatic pulsed gas infiltration is conducted, and when the vacuum degree reaches 25 Pa+/-5 Pa, gas infiltration is stopped; b, the coolant is heated to -5 DEG C+/-1 DEG C, heat preservation is conducted for 1-1.5 h, and gas infiltration is conducted till the vacuum degree reaches 25 Pa+/-5 Pa; c, the coolant is heated to 0 DEG C+/-1 DEG C, heat preservation is conducted, and gas infiltration is conducted till the vacuum degree reaches 25 Pa+/-5 Pa; d, the coolant is heated to 5 DEG C+/-1 DEG C, heat preservation is conducted, and gas infiltration is conducted till the vacuum degree reaches 25 Pa+/-5 Pa; e, the coolant is heated to 10 DEG C+/-1 DEG C, heat preservation is conducted, and gas infiltration is conducted till the vacuum degree reaches 25 Pa+/-5 Pa; f, the coolant is heated to 15 DEG C+/-1 DEG C, heat preservation is conducted, and gas infiltration is conducted till the vacuum degree reaches 25 Pa+/-5 Pa; g, the coolant is heated to 25 DEG C+/-1 DEG C, heat preservation is conducted, and gas infiltration is conducted till the vacuum degree reaches 33 Pa+/-3 Pa. By means of the freeze-drying process, it can be ensured that the moisture content and impurity limit of the finished product meet the requirements of National Drug Standards, and the time of the whole freeze-drying process can be shortened.

Description

technical field [0001] The invention belongs to the field of medicine production, and in particular relates to a new freeze-drying process of thymus for injection. Background technique [0002] Thymus fasin for injection is a drug developed by SciClone Pharmaceuticals International to treat hepatitis B and improve immunity. [0003] The common specification on the market is 1.6mg, which is obtained through aseptic freeze-drying. [0004] In the prior art, the new production method of the thymus method for injection includes the following steps in sequence: [0005] (1) Ingredients: Weigh the prescription amount of thymofasin and the excipient mannitol, add an appropriate amount of water for injection, stir to dissolve completely, and adjust the pH value to 6.8-7.2 with sodium phosphate buffered saline solution. [0006] (2) Sterilizing filtration: the above solution is pre-filtered through a 0.45µm filter, and then sterilized by two 0.22µm sterile filters; [0007] (3) As...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61K9/19A61P1/16A61P31/20A61P37/04
CPCA61K9/0019A61K9/19A61K38/22
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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