Metaduocine freeze-dried powder injection preparation and its preparation method

A technology of metadoxine and freeze-dried powder injection, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulations, etc., can solve the problems of clinical drug safety and effectiveness, large differences between batches, poor stability, etc., and achieve Conducive to storage and transportation, ensuring the safety of medication and the effect of reasonable preparations

Inactive Publication Date: 2004-02-25
杭州容立医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Aqueous injection is a liquid preparation. Due to poor stability during storage, it is easy to cause large differences between batches and many impurities. However, clinical practice shows that there is a positive relationship between toxic and side effects and the content of impurities, which has caused certain problems to the safety and effectiveness of clinical medication. influences

Method used

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  • Metaduocine freeze-dried powder injection preparation and its preparation method
  • Metaduocine freeze-dried powder injection preparation and its preparation method
  • Metaduocine freeze-dried powder injection preparation and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Metadoxine freeze-dried powder preparation preparation 1.1 Recipe: Metadoxine 300g mannitol 300g sodium metabisulfite 2g edetate sodium 1g water for injection was added to 3000ml to make 1000 vials in total. 1.2 Take the following steps to prepare:

[0049] a. According to the above preparation prescription, take 300g of metadoxine raw materials, 300g of mannitol, 2g of sodium metabisulfite and 0.3g of sodium edetate and dissolve them in 2400ml of water for injection;

[0050] b. Add activated carbon with 1% volume of the dissolved medicinal solution, decolorize, and filter to remove carbon;

[0051] c. Dilute to the preparation amount with the above-mentioned water for injection, and measure the concentration of the medicinal solution;

[0052] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the cap, and pack.

[0053] Sterilization measures: liquid medicine is sterilized by ...

Embodiment 2

[0061]Example 2 Preparation of metadoxine freeze-dried powder injection 2.1 Recipe: metadoxine 280g lactose 180g sodium bisulfite 12g edetate disodium 0.8g, water for injection was added to 2500ml to make 1000 tubes in total. 2.2 Take the following steps to prepare:

[0062] a. According to the above preparation prescription, take 280g of metadoxine raw materials, 180g of lactose, 12g of sodium bisulfite and 0.8g of disodium edetate, and dissolve them with 2000ml of water for injection;

[0063] b. Add 0.8% active carbon of the volume of the dissolved medicinal solution for decolorization, and filter to remove carbon;

[0064] c. Dilute to the preparation amount with the above-mentioned water for injection, and measure the concentration of the medicinal solution;

[0065] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the cap, and pack.

[0066] In this example, a general-purpose fr...

Embodiment 3

[0073] Example 3 Preparation of metadoxine freeze-dried powder injection 3.1 Recipe: Metadoxine 320g sorbitol 450g ascorbic acid 18g edetate calcium 2.1g water for injection was added to 4000ml to make 1000 vials. 3.2 Take the following steps to prepare:

[0074] a. According to the above preparation prescription, get 320g of metadoxine raw materials and 450g of sorbitol, 18g of ascorbic acid, 2.1g of calcium edetate, and dissolve them with 3200ml of water for injection;

[0075] b. add 1.5% activated carbon of water for injection for decolorization, and filter to remove carbon;

[0076] c. Dilute to the preparation amount with the above-mentioned water for injection, and measure the concentration of the medicinal solution;

[0077] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the cap, and pack.

[0078] In this example, a general-purpose freeze dryer was used for freeze-drying. ...

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Abstract

The present invention relates to a medicine for curing alcoholism-metadoxine freeze-dried powder injection and its preparation process. The proper quantity of anti-oxidant and chelator can be added in its medicine preparation formula composition so as to raise the stability of said medicinal component. The pharmacodynamic tests show that it has remittence action for rat liver injury due to carbontetrachloride. Said injection is stable, and is favorable for storage and transportation.

Description

1. Technical field [0001] The invention relates to a preparation technology of metadoxine freeze-dried powder preparation for treating alcoholism, in particular to a metadoxine freeze-dried powder preparation for injection and a preparation method thereof. 2. Background technology [0002] Alcohol drinking is more common in our country and has a long history. With the improvement of people's quality of life, the damage caused by drinking to the human body, such as liver acute and chronic alcoholism, has attracted more and more attention from all aspects. At present, besides naloxone and diazepam, which act on the central nervous system, there are few drugs used to accelerate alcohol metabolism and improve liver function in the treatment of alcoholism, and the effect is not satisfactory. [0003] Metadoxine (Pyridoxine L-2-pyrrolidone-5-carboxylate) is a compound composed of pyridoxine and pyrrolidone carboxylic acid, which is a metabolic balance It can accelerate the remova...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/16A61P25/32
Inventor 陆峰
Owner 杭州容立医药科技有限公司
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