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Nicotinylmethylamide freeze-dried powder preparation for injection and preparation method thereof

A technology for oxymethonamide and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of not seeing the market of oxymethonamide injection formulation, single choleretic formulation, etc.

Active Publication Date: 2013-03-27
JIANGSU SKYRUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Oxymethoniatin is a choleretic drug. At present, the domestic choleretic drug form is single, and it is mainly taken orally. When encountering critically ill patients, patients and doctors have no choice
[0006] Based on the above reasons and clinical needs, it is necessary to develop a choleretic drug that can solve clinical problems for critically ill patients. After years of clinical practice, oxymethyleneamide has been verified for its safety and efficacy. The pharmaceutical regulatory authorities, so far, have not seen the listing of the injection form of oxymethyleneamide

Method used

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  • Nicotinylmethylamide freeze-dried powder preparation for injection and preparation method thereof
  • Nicotinylmethylamide freeze-dried powder preparation for injection and preparation method thereof
  • Nicotinylmethylamide freeze-dried powder preparation for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0037] prescription

[0038] Oxymethonamide 250g

[0039] Mannitol 25g

[0040] Add water for injection to 5L

[0041] Preparation Process

[0042] The freeze-dried preparation of oxymethyleneamine was prepared under the aseptic condition of grade 100 purification.

[0043] (1) Weigh 250 g of oxymethyleneamine into the mixing tank, add 4000 ml of water for injection into the mixing tank, and stir to completely dissolve the main ingredient;

[0044] (2) Weigh 25 g of mannitol into the above-mentioned mixing tank, stir to dissolve completely, add water for injection to 5000 ml, measure the pH value of the solution to 6.31, within the range of 6-8, do not need to adjust, stir evenly;

[0045] (3) Add 0.1% activated carbon for needles of the total volume of the above solution, stir for 30 minutes, filter the solution under reduced pressure with a titanium rod to remove carbon, and then fine filter with a 0.22 μm microporous membrane to obtain a oxymethyleneamide solution;

[...

Embodiment 2

[0053] prescription

[0054] Oxymethonamide 250g

[0055] Dextran 50g

[0056] Add water for injection to 5L

[0057] Preparation Process

[0058] The freeze-dried preparation of oxymethyleneamide was prepared under the aseptic condition of 100-grade purification.

[0059] (1) Weigh 250 g of oxymethyleneamine into the mixing tank, add 4000 ml of water for injection into the mixing tank, stir to make the main ingredient completely dissolve;

[0060] (2) Weigh 50 g of dextran into the above-mentioned mixing tank, stir to dissolve completely, add water for injection to 5000 ml, measure the pH value of the solution to 6.29, within the range of 6-8, do not need to adjust, stir evenly;

[0061] (3) Add 0.2% activated carbon for needles of the total volume of the above solution, stir for 30 minutes, filter the solution under reduced pressure with a titanium rod to remove carbon, and then fine filter with a 0.22 μm microporous membrane to obtain a oxymethyleneamine solution;

[0...

Embodiment 3

[0066] prescription

[0067] Oxymethonamide 300g

[0068] Add water for injection to 5L

[0069] Preparation Process

[0070] The freeze-dried preparation of oxymethyleneamide was prepared under the aseptic condition of 100-grade purification.

[0071] (1) Weigh 300 g of oxymethyleneamine into the mixing tank, add 4500 ml of water for injection into the mixing tank, and stir to completely dissolve the main ingredient;

[0072] (2) Add water for injection to 5000ml, measure the pH value of the solution to 7.42, within the range of 6-8, no need to adjust, stir evenly;

[0073] (3) Add 0.2% activated carbon for needles of the total volume of the above solution, stir for 30 minutes, filter the solution under reduced pressure with a titanium rod to remove carbon, and then fine filter with a 0.22 μm microporous membrane to obtain a oxymethyleneamine solution;

[0074] (4), get the oxymethyleneamine solution to measure the pH value, measure the content with the HPLC method, after...

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Abstract

The invention provides a nicotinylmethylamide freeze-dried powder preparation for injection and a preparation method thereof. The freeze-dried powder preparation is frozen and dried at low temperature, so the growth of microorganisms and the action of enzyme cannot happen, thereby better maintaining the stability of raw materials. The freeze-dried powder preparation has more convenient storage and transportation, thereby facilitating industrialized production at large scale and convenient clinical use. The freeze-dried powder preparation can be used for intravenous injection or be used for intravenous drip after being added into infusion solutions, can effect soon in the body of a patient, reduce first pass effect of oral medicines in the liver and enhances the bioavailability of medicines in body. The freeze-dried powder preparation can contain active ingredient, such as nicotinylmethylamide, and pharmaceutical excipients and is prepared from the following raw material and pharmaceutical excipients by weight percent: 50-100 nicotinylmethylamide which has content range of 100-1000 mg in the preparation, and 0-50 pharmaceutical excipients.

Description

technical field [0001] The invention relates to a freeze-dried powder preparation of oxymethyleneamine for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Hydroxymethylnicotinamide Hydroxymethylnicotinamide [Nicotinylmethylamide, Oxymethylnicotinamid,] (oxymethylnicotinamide, choleretic)], this product was originally produced in Hungary, Europe, and is the first choice drug recognized in Europe for the treatment of cholecystitis and cholangitis. It also has a good liver protection effect and can also be used as an adjuvant treatment for viral hepatitis. Pharmacokinetic studies have shown that: it can promote the secretion of bile, prevent fatty degeneration of the liver, protect from chemical damage, increase the concentration of salts and bile acids in bile, and its metabolites contain a certain concentration of formaldehyde hydrate ( Formaldehyde hydrate is a hydrogen donor, it plays an intermediate t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/455A61P1/16
Inventor 燕立波王丽黄迎春陶义华
Owner JIANGSU SKYRUN PHARMA CO LTD
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