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

1 Cites 2 Cited by

AI-Extracted Technical Summary

Problems solved by technology

[0004] The current Astragalus injection preparation process cannot meet the requirements of the above-mentioned "Notice" ...

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.

Application Domain

Digestive systemPharmaceutical delivery mechanism +4

Technology Topic

Astragalus murinusFood and drug administration +4

Examples

Experimental program(4)

Example Embodiment

[0050] Example 1

[0051] An astragalus injection containing 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 includes the following steps:

[0057] (1) Extract astragalus extract, weigh the 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 of step (2) is pre-filtered through micropores, and then through micropore ultrafiltration, after the ultrafiltration is completed, rinse the residual liquid in the column with an appropriate amount of water for injection, and merge it with 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] (5) Add water for injection to the solution obtained in step (4) to the total amount, and stir evenly;

[0062] (6) Filter the solution obtained in step (5) with a 0.45μm pleated filter element into the control bottle before potting;

[0063] (7) Potting the filtrate obtained in step (6), pass N during potting 2;

[0064] (8) Sterilize the product obtained in step (7) within 4 hours after the completion of step (7), with a sterilization temperature of 115°C and a sterilization time of 30 minutes.

Example Embodiment

[0065] Example 2

[0066] An astragalus injection containing 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 includes the following steps:

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

[0074] (1) Extract astragalus extract, weigh the 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 of step (2) is pre-filtered through micropores, and then through micropore ultrafiltration, after the ultrafiltration is completed, rinse the residual liquid in the column with an appropriate amount of water for injection, and merge it with the previous filtrate;

[0077] (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;

[0078] (5) Add water for injection to the solution obtained in step (4) to the total amount, and stir evenly;

[0079] (6) Filter the solution obtained in step (5) through 0.45μm and 0.22μm pleated filter elements into the control bottle before potting;

[0080] (7) Potting the filtrate obtained in step (6), pass N during potting 2.

Example Embodiment

[0081] Example 3

[0082] An astragalus injection containing the following ingredients:

[0083] Each 10000ml injection contains,

[0084] Astragalus extract 9000ml

[0085] Polysorbate-80120g

[0086] Add water for injection to 10000ml.

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

PUM

Description & Claims & Application Information

We can also present the details of the Description, Claims and Application information to help users get a comprehensive understanding of the technical details of the patent, such as background art, summary of invention, brief description of drawings, description of embodiments, and other original content. On the other hand, users can also determine the specific scope of protection of the technology through the list of claims; as well as understand the changes in the life cycle of the technology with the presentation of the patent timeline. Login to view more.