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Astragalus injecta and preparation technology therefore

A technology of Astragalus injection and injection, applied in blood diseases, extracellular fluid diseases, medical preparations containing active ingredients, etc.

Inactive Publication Date: 2016-06-22
SHANGHAI JINGFENG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The current Astragalus injection preparation process cannot meet the requirements of the above-mentioned "Notice" for the SAL of the product after sterilization. Therefore, the current preparation process and formula need to be improved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] An injection of astragalus, comprising the following ingredients:

[0052] Each 10000ml injection contains,

[0053] Astragalus extract 6000ml;

[0054] Polysorbate - 8080g;

[0055] Add water for injection to 10000ml.

[0056] The preparation process of the above-mentioned Astragalus injection comprises the following steps:

[0057] (1) Extract Radix Astragali Extract, take raw materials according to the formula:

[0058] (2) Filter the astragalus extract with a titanium rod, boil the filtrate for 5 minutes, and cool;

[0059] (3) After the solution in step (2) is pre-filtered through micropores, it is then subjected to micropore ultrafiltration, and after the ultrafiltration is completed, the residual liquid in the column is rinsed with an appropriate amount of water for injection, and merged into the previous filtrate;

[0060] (4) Add polysorbate-80 to the filtrate obtained in step (3) and stir evenly, and adjust the pH value to 7.8-8.0 with 20% NaOH;

[0061]...

Embodiment 2

[0066] An injection of astragalus, comprising the following ingredients:

[0067] Each 10000ml injection contains,

[0068] Each 10000ml injection contains,

[0069] Astragalus extract 7000ml;

[0070] Polysorbate - 8080g;

[0071] Add water for injection to 10000ml.

[0072] The preparation process of the above-mentioned Astragalus injection comprises the following steps:

[0073] The following test steps are all carried out according to the aseptic production process,

[0074] (1) Extract Radix Astragali Extract, take raw materials according to the formula:

[0075] (2) Filter the astragalus extract with a titanium rod, boil the filtrate for 5 minutes, and cool;

[0076] (3) After the solution in step (2) is pre-filtered through micropores, it is then subjected to micropore ultrafiltration, and after the ultrafiltration is completed, the residual liquid in the column is rinsed with an appropriate amount of water for injection, and merged into the previous filtrate;

[0...

Embodiment 3

[0082] An injection of astragalus, comprising the following ingredients:

[0083] Each 10000ml injection contains,

[0084] Astragalus Extract 9000ml

[0085] Polysorbate - 80 120g

[0086] Add water for injection to 10000ml.

[0087] The preparation process is the same as in Example 1.

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PUM

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Abstract

The invention discloses astragalus injecta.Every 10000 ml of astragalus injecta comprises 6000-9000 ml of astragalus extract, 80-120 g of polysorbate-80 and the balance injection water.The invention further discloses a preparation method of the astragalus injecta.The astragalus injecta has the advantage that the astragalus extract meets the regulations of Notice published by State Food and Drug Administration in 2008.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to astragalus injection and its preparation process. Background technique [0002] The Evaluation Center of the State Food and Drug Administration issued the State Food and Drug Administration [2008] No. 7 document "Notice on Issuing Basic Technical Requirements for Chemical Drug Injections and Multi-component Biochemical Drug Injections" (hereinafter referred to as the "Notice") in 2008. "), the article stipulates that small-volume injections should adopt a terminal sterilization process, and it is recommended that the overkill method be preferred (F 0 ≥12), if the product cannot tolerate overkill conditions, the survival probability method (8≤F 0 <12), but it should be ensured that the SAL (sterility assurance level) of the product after sterilization is not greater than 10 -6 . Use other F 0 Processes with terminal sterilization conditions whose value is less than 8 are not approve...

Claims

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Application Information

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IPC IPC(8): A61K36/481A61K9/08A61K47/34A61P1/16A61P7/00A61P7/04
CPCA61K36/481A61K9/08A61K47/26A61K2236/331A61K2236/39A61K2236/51A61K2236/53
Inventor 叶湘武张云付爱玲罗丽
Owner SHANGHAI JINGFENG PHARMA
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