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Freeze-drying method of pseudo-ginseng total saponin freeze-dried injection powder with filling amount more than 500 mg

A technology of notoginseng total saponins and drying method, which is applied in the field of freeze-drying of notoginseng total saponins freeze-dried powder injection, can solve the problems of no freezing method and conditions, long turnaround time, large production energy consumption, etc., and achieve remarkable results Economic and social benefits, efficiency improvement, and energy saving effects

Active Publication Date: 2014-05-21
GUANGXI WUZHOU PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patent application 96101652.3 relates to a drug in a special dosage form for the treatment of cardiovascular and cerebrovascular diseases. The freeze-dried finished product has a loading capacity of 100 mg. The application content does not give specific freezing methods and conditions
[0009] The safety of injections has exposed many problems in recent years. The use of excipients other than drugs in injections will cause patients to have to accept more unnecessary substances into the blood at the same time during treatment, laying the groundwork for adverse reactions. Hidden danger; while in the preparation method, the production is energy-intensive and the turnaround time is long

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Example 1: 500 mg loading capacity of Panax notoginseng freeze-dried powder injection

[0064] Method: Dissolve Panax notoginseng saponins with water for injection, so that the concentration of Panax notoginseng saponins in the solution is 10.0% (g / ml), and then subpackage according to 500mg filling volume, fill each bottle with 5ml, and put it in a freeze dryer:

[0065] 1) Pre-freezing and heat balance: start the compressor, set the temperature in the freeze dryer to -10°C within 0.75 hours, and maintain it for 0.5 hours;

[0066] 2) Freezing and system balance: After the end of heat release, set the temperature in the freeze dryer to drop below -30°C within 0.75 hours, and drop the temperature inside the freeze dryer to -30°C within 0.75 hours. Below 45°C; control the internal pressure of the freeze dryer to below 10Pa and maintain it for 1.5h;

[0067] 3) In the early stage of sublimation: set the temperature inside the freeze dryer to -4°C, and keep the vacuum bel...

Embodiment 2

[0072] Example 2: 600 mg loading capacity of Panax notoginseng freeze-dried powder injection

[0073] Method: Dissolve Panax notoginseng saponins with water for injection, so that the concentration of Panax notoginseng saponins in the solution is 12.0% (g / ml), divide into 600mg fillings, fill each bottle with 5ml, and place in a freeze dryer.

[0074] 1) Pre-freezing and heat balance: start the compressor, set it within 0.25 hours to drop the temperature inside the freeze dryer to -10°C, and maintain it for 1 hour;

[0075] 2) Freezing and system balance: After the end of heat release, set the temperature in the freeze dryer to drop below -30°C within 0.25 hours, and after the temperature reaches -30°C, drop the temperature inside the freeze dryer to -45°C within 0.5 hours Below ℃; control the freeze dryer to below 10Pa and maintain it for 1h;

[0076] 3) In the early stage of sublimation: set the temperature inside the freeze dryer to -4°C, and keep the vacuum below 10Pa, an...

Embodiment 3

[0081] Example 3: 700 mg loading capacity of Panax notoginseng freeze-dried powder injection

[0082] Method: Dissolve Panax notoginseng saponins with water for injection, so that the concentration of Panax notoginseng saponins in the solution is 14.0% (g / ml), divide into 700 mg, fill each bottle with 5 ml, and place in a freeze dryer.

[0083] 1) Pre-freezing and heat balance: start the compressor, set the temperature in the freeze dryer to -10°C within 0.5h, and maintain it for 0.75h;

[0084] 2) Freezing and system balance: After the end of heat release, set the temperature in the freeze dryer to drop below -30°C within 0.3 hours, and after the temperature reaches -30°C, drop the temperature inside the freeze dryer to -45°C within 1 hour below; control the pressure in the freeze dryer to below 10Pa and maintain it for 1.3h;

[0085] 3) In the early stage of sublimation: set the temperature inside the freeze dryer to -4°C, and keep the vacuum below 10Pa, and keep it warm fo...

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Abstract

The invention relates to a freeze-drying method of pseudo-ginseng total saponin freeze-dried injection powder with a filling amount more than 500 mg. In the method, freeze-dried is carried out mainly through specific refrigerating parameters. The freeze-drying method provided by the invention has good drying effect and significantly shortened freeze-drying time, which is 20-50% of common freeze-drying time.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-drying method for the freeze-dried powder injection of Panax notoginseng saponins with a loading capacity of more than 500 mg. Background technique [0002] There is no public literature report on the detailed research on the freeze-drying of Panax notoginseng lyophilized powder with a loading capacity of 500mg and above. According to the conventional freeze-drying method, the freeze-drying time of Panax notoginseng saponins with a loading capacity of 500mg is more than 50 hours , the shortest also needs about 40 hours. The following are the preparation process documents of some traditional Chinese medicines and Western medicine freeze-dried powder injections related to freeze-drying technology. [0003] Chinese patent application 96101652.3 relates to a drug in a special dosage form for the treatment of cardiovascular and cerebrovascular diseases. The freeze-...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K36/258A61J3/02
Inventor 许淑清黄宇声贤英越冯超陈勇杨子盛王如一张栩颜
Owner GUANGXI WUZHOU PHARMA GRP
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