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Preparation method of a gemcitabine hydrochloride freeze-dried powder injection

A technology of gemcitabine hydrochloride and freeze-dried agent, which is applied in the field of pharmaceutical preparations, can solve the problems of long time-consuming, long-time-consuming, and long production cycle of gemcitabine hydrochloride freeze-dried agent, reduce crusting and peeling, increase freeze-drying efficiency, and improve The effect of freeze-drying efficiency

Active Publication Date: 2017-01-04
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the production process of gemcitabine hydrochloride injection, the raw materials need to be fed excessively due to process loss, and at the same time, due to the use of activated carbon adsorption, the product quality is difficult to pass or the loss of gemcitabine is too much
The gemcitabine hydrochloride freeze-dried agent obtained by the freeze-drying process of the existing freeze-drying technology takes a long time, which leads to the problems of too long production cycle and high cost
[0004] Gemcitabine hydrochloride (0.2g) for anti-tumor freeze-dried powder injection is currently about 63 hours in total freeze-drying cycle, which takes a long time and has low production efficiency

Method used

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  • Preparation method of a gemcitabine hydrochloride freeze-dried powder injection
  • Preparation method of a gemcitabine hydrochloride freeze-dried powder injection
  • Preparation method of a gemcitabine hydrochloride freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Recipe: See Table 1

[0031] Table 1: Process prescription of gemcitabine hydrochloride for injection

[0032]

[0033]

[0034] Add about 40kg of water for injection into the 50L preparation tank, add the prescribed amount of mannitol and sodium acetate into the 50L preparation tank, control the temperature of the liquid medicine at 45°C-55°C, set the stirring speed at 70%, and stir for 5 minutes to completely dissolve. After confirming that mannitol and sodium acetate are completely dissolved and that the temperature of the drug solution is within the range of 45°C to 55°C, add the prescribed amount of gemcitabine hydrochloride into a 50L preparation tank, maintain the stirring speed at 70%, and stir for 10 minutes to completely dissolve it. Use 1mol / L sodium hydroxide solution to adjust the pH value of the liquid to 2.9-3.1. After the pH value is adjusted to pass, confirm that the temperature of the liquid medicine is within the range of 45°C to 55°C.

[0035...

Embodiment 2

[0038] The gemcitabine hydrochloride (0.2g) solution prepared by the method of Example 1 is freeze-dried according to the following method:

[0039] a. Into the box: control the heat transfer oil inlet temperature to 20°C, and put the gemcitabine hydrochloride solution into the freeze-drying box;

[0040] b. Pre-freezing: reduce the temperature of the heat transfer oil inlet to -2°C at full speed and maintain it for 2 hours, then reduce the temperature of the heat transfer oil inlet to -45°C at full speed and maintain it for another 4 hours;

[0041] c. Condenser cooling and vacuuming: After the pre-freezing is completed, confirm that the temperature of the condenser has dropped below -45°C, and vacuum to the limit;

[0042] d. Primary drying: after the vacuum degree reaches 10Pa, it takes 240 minutes to raise the temperature of the heat transfer oil inlet from -45°C to 20°C, turn on the vacuum control, adjust the vacuum control range of the front box to 35±5Pa, observe the di...

Embodiment 3

[0046] The gemcitabine hydrochloride (1.0g) solution was freeze-dried according to the following method:

[0047] a. Into the box: control the heat transfer oil inlet temperature to 20°C, and put the gemcitabine hydrochloride solution into the freeze-drying box;

[0048] b. Pre-freezing: reduce the temperature of the heat transfer oil inlet to -2°C at full speed, and after maintaining at -2°C for 2 hours, lower the temperature of the heat transfer oil inlet to -45°C at full speed, and then maintain it at -45°C for 4 hours;

[0049] c. Condenser cooling and vacuuming: After the pre-freezing is completed, confirm that the temperature of the condenser has dropped below -45°C, and vacuum to the limit;

[0050]d. Primary drying: after the vacuum degree reaches 10Pa, it takes 240 minutes to raise the temperature of the heat transfer oil inlet from -45°C to 20°C, turn on the vacuum control, adjust the vacuum control range of the front box to 35±5Pa, observe the disappearance of the w...

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Abstract

The invention discloses preparation method of a gemcitabine hydrochloride freeze-dried powder injection, which comprises the following steps of: Controlling the inlet temperature of the conducting oil within 20oC+-5 oC and putting the gemcitabine hydrochloride solution into the freeze-drying box; Conductng pre-freeze; Reducing the conduction oil inlet temperature at a full speed to - 2oC and keeping the temperature for 2 hours. Reducing the conduction oil inlet temperature at a full speed to -45oC and keeping the temperature for 4 hours. After the pre-freeze is completed, confirming that the condenser temperature has reduced to be lower than 45oC. Then pumping ultimate vacuum. When the vacuum degree reaches 10Pa , reducing the conduction oil inlet temperature from -45 oC to 20 oC and opening the vacuum control. Adjusting the vacuum control range of the front box to 35+-5Pa and keeping the temperature for 4 hours till the water trace disappears. Heating up the plate at a full speed to 30oC and maintaining it for 4-6 hours. Then stopping the vacuum control. Keeping maintaining the temperature for 1 hour. Testing that the pressure rise range does not exceed 2Pa within 15 minutes. Taking the gemcitabine hydrochloride solution out of the box. This preparation method can reduce the cost of freeze-drying, improve production efficiency and increase the production capacity to the utmost.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a preparation method of gemcitabine hydrochloride freeze-dried powder injection, in particular to a preparation method of gemcitabine for injection which can improve production capacity. Background technique [0002] Cancer is a common multiple malignant disease that seriously endangers people's life and health. Due to the different locations of cancer, it is divided into different cancers: such as: gastric cancer, lung cancer, bone cancer, skin cancer, intestinal cancer, bladder cancer and so on. Gemcitabine hydrochloride (Gemcitabine hydrochloride) is a kind of difluoronucleoside antitumor drug that destroys cell replication synthesized by Eli Lilly Company of the United States in 1983. Its chemical name is: 2-deoxy-2,2-difluorodeoxycytidine hydrochloride (β -isomer), the mechanism of action is to prevent DNA synthesis. It was launched in South Africa, Sweden...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7068A61K47/26A61K47/12A61P35/00A61P35/04
CPCA61K9/0019A61K9/19A61K31/7068A61K47/12A61K47/26
Inventor 杨永丰王东春陈磊姚崇侯国旭
Owner NANJING CHIA TAI TIANQING PHARMA
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