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Andrographolide powder preparation for injection and preparation method thereof

A technology for Yanhuning and injection, which is applied in the field of pharmaceutical preparations, can solve problems such as general medicinal effects of powder injections, increased adverse reactions of excipients, and influence on the quality of preparations, so as to avoid adverse reactions, and the freeze-drying method is scientific and reasonable, and improves the quality of preparations. The effect of resolubility

Active Publication Date: 2014-01-08
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the actual application process, it was found that although the stability of the freeze-dried preparation obtained by the above technical scheme has been improved to a certain extent, due to the excessive amount of excipients in the prescription, the medicinal effect of the powder injection is general and the storage time is long. After the stability will still be significantly reduced
In addition, the addition of excipients increases the probability of adverse reactions, and the type and amount of excipients will also affect the quality of the preparation (there have been cases of significant side effects in actual clinical practice), thus limiting its application.

Method used

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  • Andrographolide powder preparation for injection and preparation method thereof
  • Andrographolide powder preparation for injection and preparation method thereof
  • Andrographolide powder preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Prescription: Prepare 1000 bottles from the following ingredients: Yanhuning 80g, add water for injection to 8L;

[0055] Preparation:

[0056] (1) Weigh Yanhuning according to the prescription amount, add 75% of the prescription amount of water for injection, stir until fully dissolved, measure the pH value, and adjust the pH value to 6 with a pH regulator;

[0057] (2) Control the temperature of the solution at 10°C, add 0.1% activated carbon for needles, and stir at a speed of 64r / min for 15min;

[0058] (3) Use a 1.2 μm mixed cellulose ester microporous membrane to remove carbon, wash the activated carbon layer with the remaining 25% cold water for injection, combine the filtrate, and pass through a 0.22 μm mixed cellulose ester microporous membrane to remove carbon. bacteria;

[0059] (4) Check the content, clarity and pH value of the intermediate solution, and repackage;

[0060] (5.1) Lower the temperature of the freezer to -8°C, place the product in the box f...

Embodiment 2

[0065] Prescription: Prepare 1000 bottles from the following ingredients: Yanhuning 60g, add water for injection to 8L;

[0066] Preparation:

[0067] (1) Weigh Yanhuning according to the prescription amount, add 70% of the prescription amount of water for injection, stir well until fully dissolved, measure the pH value, and adjust the pH value to 6 with a pH regulator;

[0068] (2) Control the temperature of the solution at 5°C, add 0.05% activated carbon for needles, and stir at a speed of 60r / min for 10min;

[0069] (3) Use a 1.2 μm mixed cellulose ester microporous membrane to remove carbon, wash the activated carbon layer with the remaining 30% cold water for injection, combine the filtrate, and pass through a 0.22 μm mixed cellulose ester microporous membrane to remove carbon. bacteria;

[0070] (4) Check the content, clarity and pH value of the intermediate solution, and repackage;

[0071] (5.1) Lower the temperature of the freezer to -10°C, place the product in the...

Embodiment 3

[0076] Prescription: Prepare 1000 bottles from the following raw materials: Yanhuning 100g, add water for injection to 8L;

[0077] Preparation:

[0078] (1) Weigh Yanhuning according to the prescription amount, add 80% of the prescription amount of water for injection, stir until fully dissolved, measure the pH value, and adjust the pH value to 7 with a pH regulator;

[0079] (2) Control the temperature of the solution at 15°C, add 0.15% activated carbon for needles, and stir at a speed of 65r / min for 20min;

[0080] (3) Use a 1.2 μm mixed cellulose ester microporous membrane to remove carbon, wash the activated carbon layer with the remaining 20% ​​cold water for injection, combine the filtrate, and pass through a 0.22 μm mixed cellulose ester microporous membrane to remove carbon. bacteria;

[0081] (4) Check the content, clarity and pH value of the intermediate solution, and repackage;

[0082] (5.1) Lower the temperature of the freezer to -5°C, place the product in the...

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Abstract

The invention relates to an andrographolide freeze-dried powder preparation for injection. The preparation is just prepared from the following components in parts by weight: 30-50 parts of andrographolide and 4000 parts of water for injection. No auxiliary material is added into the freeze-dried powder preparation; and because the prescription only contains andrographolide, the material preparation step can be omitted, the production process is simplified, and unpredictable side effects brought by various auxiliary materials can be avoided. Because the sources of the original auxiliary materials are insufficient, the possibility of increase of related substances brought by the original auxiliary materials can be reduced, so that the hidden danger brought to administration safety of patients due to the increase of related substances and curative effect problems brought to the patients due to reduction of contents of active ingredients are avoided.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried powder preparation with Yanhuning as an active ingredient and a preparation method thereof. Background technique [0002] Yanhuning injection has good clinical curative effect, but due to the purity of raw materials, excipients, technology and other reasons, the injection will contain a large amount of impurities (related substances), which greatly affects the safety of the preparation, and at the same time will bring harm to patients. There are many allergic reactions, which affect the curative effect, and severe cases will cause anaphylactic shock, threatening the life of the patient. [0003] In order to seek a more stable Yanhuning preparation, the prior art discloses various preferred solutions, such as: [0004] Chinese application CN1824321 discloses a Yanhuning freeze-dried powder injection and its preparation method. The weight ratio of Yanhunin...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/365A61J3/02
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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