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Preparation method of vidarabine monophosphate freeze-dried powder injection for injection

A technology of adenosine vidarabine monophosphate freeze-dried powder and adenosine monophosphate, which can be used in freeze-dried transportation, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of drug stability And the appearance, shape and loose shape need to be improved, so as to achieve the effect of good appearance, guarantee of uniformity and reduction of impurity content

Active Publication Date: 2021-07-27
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The Chinese invention patent with the notification number CN102379853B discloses a vidarabine monophosphate freeze-dried powder injection and its preparation method. Although it reduces the addition of auxiliary materials and potential safety hazards during the preparation process, its drug stability and The appearance shape and looseness still need to be improved

Method used

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  • Preparation method of vidarabine monophosphate freeze-dried powder injection for injection
  • Preparation method of vidarabine monophosphate freeze-dried powder injection for injection
  • Preparation method of vidarabine monophosphate freeze-dried powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1 Stability experiment of vidarabine monophosphate at different pH values

[0033] Take 13 parts of 9.5 mL of freshly boiled and cooled distilled water, numbered 1 to 13 respectively, and use hydrochloric acid or sodium hydroxide to adjust the pH value to 4, 6, 7, 8, 9, 9.2, 9.3, 9.4, 10, 10.4, 10.5, 10.6, 11, add water to 10mL again;

[0034] Add 0.1g of vidarabine monophosphate to No. 1-13 water respectively, shake and mix well, let stand for 10min, and follow the "High Performance Liquid Chromatography Determination of the Content of Vidarabine Monophosphate" (Modern Hospital, 2007) April, Volume 7 Supplement, Pages 28-29) published detection method, using high performance liquid chromatography to measure the content of vidarabine monophosphate, the results show that when the pH value is 9.3-10.5, the content of vidarabine monophosphate is relatively stable If the pH value exceeds this range, it will affect the content of adenosine monophosphate. When the...

Embodiment 2

[0037] Example 2 A preparation method of adenosine vidarabine monophosphate freeze-dried powder for injection

[0038] 1) Refining of vidarabine monophosphate

[0039] Under the protection of nitrogen, take 2000mL distilled water, add 20wt% sodium hydroxide aqueous solution dropwise to adjust the pH value to 10.0, add 200g of vidarabine monophosphate crude product at room temperature and stir to dissolve, then add 5g of activated carbon, and stir at room temperature for 20min to decolorize , filtered, the resulting filtrate was adjusted to pH 7.0 with 10wt% dilute hydrochloric acid aqueous solution, cooled to -5°C, slowly added ethanol dropwise until a small amount of crystals precipitated, then stopped adding, kept at -5°C and stirred slowly for 6 hours, and the crystallization was completed Afterwards, it was filtered at low temperature, washed three times with 5 mL of ice water, and dried in vacuum at room temperature for 3 hours to obtain 185.4 g of vidarabine monophosphat...

Embodiment 3～7

[0059] Example 3-7 Preparation method of adenosine vidarabine monophosphate freeze-dried powder for injection

[0060] Examples 3 to 7 are respectively a preparation method of adenosine vidarabine monophosphate freeze-dried powder for injection, and their steps are basically the same as those in Example 2, except that the amount of raw materials and process parameters are different. See Table 3:

[0061] List of each process parameter in table 3 embodiment 3~7

[0062]

[0063]

[0064]

[0065] The contents of the other parts of Embodiments 3 to 7 are the same as those of Embodiment 2.

[0066] The adenosine vidarabine monophosphate freeze-dried powder for injection prepared in Examples 2-7 has good stability and clarity, high main drug content, less impurities, smooth surface, good appearance and excellent resolubility.

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Abstract

The invention provides a preparation method of vidarabine monophosphate freeze-dried powder injection for injection, which belongs to the technical field of medicine preparation, and comprises the following steps: taking water for injection, adjusting the pH value to 8.0-8.5, adding vidarabine monophosphate for dissolving, decoloring, degerming, filtering, sub-packaging, pre-freezing the obtained feed liquid, sublimating and drying for four times, desorbing and drying for three times, and obtaining the vidarabine monophosphate freeze-dried powder injection for injection. By adjusting the pH value, the hydrolysis reaction of vidarabine monophosphate is reduced, and the impurity content of the finished product is reduced; through setting of technological parameters in the sublimation drying process and the desorption drying process, solute migration in liquid medicine is prevented, fullness and looseness of the finished product are guaranteed, and the surface of the finished product is smoother. The preparation method provided by the invention can effectively improve the drug stability, appearance shape and looseness of the finished product.

Description

technical field [0001] The invention relates to the preparation of freeze-dried powder injection, in particular to a preparation method of adenosine vidarabine monophosphate freeze-dried powder injection. Background technique [0002] Adenosine monophosphate for injection is a deoxyribonucleic acid (DNA) virus drug, which is a synthetic adenosine antiviral drug. Adenosine monophosphate binds to the deoxyribonucleic acid polymerase of the virus, reducing its activity and inhibiting DNA synthesis. After adenosine monophosphate enters the cell, it undergoes phosphorylation to generate adenosine adenosine diphosphate (Ara-ADP) and adenosine adenosine triphosphate (Ara-ATP). The antiviral activity is mainly caused by adenosine triphosphate (Ara-ATP), which competes with deoxyadenosine triphosphate (dATP) to bind to viral DNAP, thereby inhibiting the activity of enzymes and the synthesis of viral DNA , while inhibiting the activity of viral nucleotide reductase to inhibit the sy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/02A61K47/12A61P31/20F26B5/06
CPCA61K9/19A61K9/0019A61K31/7076A61K47/02A61K47/12A61P31/20F26B5/06
Inventor 王寿春王进宇潘淑华
Owner HAINAN JINRUI PHARMA
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