Panax notoginseng saponins freeze-dried powder injection and preparation method thereof

A technology of Panax notoginseng saponins and freeze-dried powder injection, which is applied in freeze-dried transportation, powder transportation, pharmaceutical formulations, etc. It can solve the problems of high production energy consumption, long turnaround time, and no freezing method and conditions given, and achieve Effects of energy saving, efficiency improvement, significant economic and social benefits

Active Publication Date: 2012-06-27
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, but does not give specific freezing methods and conditions
[0009] The safety of injections has exposed many problems in recent years. The use of excipients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Example 1: Freeze-dried powder injection of Panax notoginseng saponins in 150mg loading capacity

[0069] Method: Dissolve Panax notoginseng saponins with water for injection, so that the concentration of Panax notoginseng saponins in the solution is 15.0% (g / ml), then subpackage according to 150mg filling volume, fill each bottle with 1ml, and put it in a freeze dryer:

[0070] 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;

[0071] 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 0.5 hours. Below 45°C; control the internal pressure of the freeze dryer to below 10Pa and maintain it for 1.5h;

[0072] 3) In the early stage of sublimation: set the temperature inside the freeze dryer to -4°C, and keep the vacu...

Embodiment 2

[0077] Example 2: 100 mg loading capacity of Panax notoginseng freeze-dried powder injection

[0078] 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), divide into 100mg filling volume, fill 1ml in each bottle, and place in a freeze dryer.

[0079] 1) Pre-freezing and heat balance: Start the compressor, set it within 0.25h to drop the temperature inside the freeze dryer to -10°C, and maintain it for 0.25h;

[0080] 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 0.25 hours Below ℃; control the freeze dryer to below 10Pa and maintain it for 0.5h;

[0081] 3) In the early stage of sublimation: set the temperature inside the freeze dryer to -4°C, and keep the vacuum below 10Pa, a...

Embodiment 3

[0086] Example 3: 150 mg loading of total saponins of Panax notoginseng freeze-dried powder injection

[0087] Method: Dissolve Panax notoginseng saponins with water for injection, so that the concentration of Panax notoginseng saponins in the solution is 15.0% (g / ml), divide into 150 mg, fill each bottle with 1 ml, and place in a freeze dryer.

[0088] 1) Pre-freezing and heat balance: Start the compressor, set the temperature in the freeze dryer to drop to -10°C within 1 hour, and maintain it for 0.75 hours;

[0089] 2) Freezing and system balance: After the end of heat release, set the temperature in the freeze dryer to drop below -30°C within 1 hour, and after the temperature reaches -30°C, lower the temperature inside the freeze dryer to -45°C within 0.75 hours Below; control the pressure in the freeze dryer to below 10Pa and maintain it for 1h;

[0090] 3) In the early stage of sublimation: set the temperature inside the freeze dryer to -4°C, and keep the vacuum below 1...

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PUM

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Abstract

The invention relates to panax notoginseng saponins freeze-dried powder injection and a preparation method thereof. The freeze-dried powder injection is prepared by panax notoginseng saponins and water for injection. The panax notoginseng saponins freeze-dried powder injection is free of auxiliary materials or stent agents, good in re-dissolubility, low in water content and good in appearance forming.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried powder of Panax notoginseng saponins and a preparation method thereof. Background technique [0002] The freeze-drying time of Panax notoginseng saponins freeze-dried powder injection generally takes more than 30 hours, and the shortest one takes about 20 hours. There is no public literature report on the detailed study on the freeze-drying of Panax notoginseng saponins. The following are some preparation process literatures of Chinese medicine and western medicine freeze-dried powder injection related to freeze-drying technology. [0003] Chinese patent application 96101652.3 relates to a medicine in a special dosage form for treating cardiovascular and cerebrovascular diseases, but does not provide specific freezing methods and conditions. [0004] Chinese patent application 200610010988.5 states in its content that the filtered Panax notoginseng sapon...

Claims

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Application Information

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IPC IPC(8): A61K36/258A61K9/19A61J3/02
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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