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Meglumine adenosine cyclophosphate composition injection and preparation method thereof

A technology for meglumine cyclophosphate and meglumine cyclophosphate is applied in the field of meglumine cyclophosphate meglumine cyclophosphate composition injection and its preparation field, which can solve the problems such as difficulty in effect and good precipitation, and achieve good clarity. , good stability, simple and easy preparation method

Inactive Publication Date: 2012-07-25
湖北安邦医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The applicant applied for the above-mentioned similar patent in January 2009. Although the technical solution of this invention improves the solubility, the effect is still not very good, and precipitation still occurs after a long storage time

Method used

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  • Meglumine adenosine cyclophosphate composition injection and preparation method thereof
  • Meglumine adenosine cyclophosphate composition injection and preparation method thereof
  • Meglumine adenosine cyclophosphate composition injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Recipe: 1000ml divided into 500 tubes 2ml::30mg

[0018]

[0019]

[0020] The co-solvent is a mixture of sodium benzoate, glycerin, sodium salicylate and sodium p-hydroxybenzoate in a ratio of parts by weight of 1:1:1:1.

[0021] Preparation method: Take the prescribed amount of citric acid, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 6.2 with sodium hydroxide to form a buffer solution, then add sodium chloride and stir to dissolve, add an appropriate amount of water for injection, and stir while Add cyclic adenosine monophosphate and meglumine, add water for injection to the full amount after completely dissolving, add 0.05% (w / v) activated carbon, stir at a temperature of 55°C for 20 minutes, filter, reflux, fill, melt seal, and High-temperature sterilization at 121°C for 8 minutes, light inspection after cooling, packaging and inspection, to obtain the meglumine cyclic adenosine monophosphate composition inject...

Embodiment 2

[0023] Recipe: 1000ml divided into 500 tubes 2ml: 60mg

[0024]

[0025] Preparation method: Take the prescribed amount of citric acid, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 6.3 with sodium hydroxide to form a buffer solution, then add sodium chloride and stir to dissolve, add an appropriate amount of water for injection, and stir while Add cyclic adenosine monophosphate and meglumine, add water for injection to the full amount after completely dissolving, add 0.05% (w / v) activated carbon, stir at a temperature of 55°C for 20 minutes, filter, reflux, fill, melt seal, and Sterilize at a high temperature of 115°C for 30 minutes, perform light inspection after cooling down, pack and inspect, and obtain the meglumine cyclophosphate injection.

Embodiment 3

[0027] Recipe: 1000ml divided into 200 tubes 5ml: 60mg

[0028]

[0029]

[0030] Preparation method: Take the prescribed amount of citric acid, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 6.4 with sodium hydroxide to form a buffer solution, then add sodium chloride and stir to dissolve, add an appropriate amount of water for injection, and stir while Add cyclic adenosine monophosphate and meglumine, add water for injection to the full amount after completely dissolving, add 0.1% (w / v) activated carbon and stir at a temperature of 65°C for 30 minutes, filter, reflux, fill, melt seal, and Sterilize at a high temperature of 121°C for 15 minutes, perform light inspection after cooling down, pack and inspect, and obtain the meglumine cyclophosphate injection.

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PUM

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Abstract

The invention relates to a preparation method of chemical medicine, in particular to meglumine adenosine cyclophosphate composition injection and a preparation method thereof. The meglumine adenosine cyclophosphate composition injection comprises the following ingredients in part by weight: 5 to 15 parts of adenosine cyclophosphate, 3 to 10 parts of meglumine, 2.0 to 2.2 parts of citric acid, 0.6 to 0.8 parts of sodium hydroxide, 2 to 4 parts of sodium chloride and 2 to 5 parts of water for injection. The preparation method comprises the following steps that the citric acid is mixed and dissolved in the water for injection, the pH value of the mixed solution is adjusted to 5.9 to 6.5 by the sodium hydroxide to form buffering solution, then the sodium chloride and latent solvent are added into the buffering solution to be stirred and dissolved, the water for injection is added, the adenosine cyclophosphate and meglumine are slowly added while the solution is stirred, active carbon is added and stirred in the solution after the adenosine cyclophosphate and the meglumine are completely dissolved, and the mixed solution is filtered and reflowed to prepare colorless clear and bright liquid. The clarity of the injection is good, the stability is good, and the injection is safe to use.

Description

technical field [0001] The invention relates to a method for preparing chemicals, in particular to an injection of meglumine cyclic adenosine monophosphate composition and its preparation. Background technique [0002] Since meglumine cyclic adenosine is slightly soluble in water, adding meglumine to meglumine cyclic adenosine can increase its solubility. However, in the solution of meglumine cyclic adenosine Phosphate meglumine will gradually precipitate out, causing the liquid to deteriorate and become turbid. If the change is small, it will be difficult to detect. If it is given to the patient, it will cause serious adverse reactions to the patient, thereby affecting the curative effect of the drug, and at the same time affecting the safety of the drug. If the change is small, it will be difficult to detect. If it is given to the patient, it will cause serious adverse reactions to the patient, thereby affecting the curative effect of the drug, and at the same time affect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7076A61K47/18A61P9/10A61P9/12
Inventor 柯少鸿
Owner 湖北安邦医药有限公司
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