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Freeze dried monophosphate adenine arabinoside powder injection for injection and preparation method thereof

A technology for freeze-dried powder of adenosine monophosphate and adenosine monophosphate, which can be used in freeze-dried transportation, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can meet the requirements of technical content High, complex operation process, long production cycle and other problems, to achieve the effect of low technical requirements, simple operation process, short production cycle

Active Publication Date: 2012-03-28
GUANGDONG LONGFU MEDICINE CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, most of the dosage forms of vidarabine monophosphate in clinical use are injection dosage forms. Among them, water injections are widely used due to their quick effect and easy preparation. For example, Chinese patent CN200410021225.1 discloses a single Adenosine vidarabine phosphate and its preparation method, but compared with water injection, freeze-dried powder injection not only has good curative effect, but also has advantages in transportation, storage, etc., and although the prior art has some for monophosphate Research on the freeze-drying process and formula of sugar adenosine, but the formula and preparation method of frozen powder injection in the prior art generally have problems such as long production cycle, low output, complicated operation process, and high technical content requirements

Method used

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  • Freeze dried monophosphate adenine arabinoside powder injection for injection and preparation method thereof
  • Freeze dried monophosphate adenine arabinoside powder injection for injection and preparation method thereof
  • Freeze dried monophosphate adenine arabinoside powder injection for injection and preparation method thereof

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Embodiment

[0024] 1. Prescription:

[0025] prescription:

[0026]

[0027] 2. Preparation method:

[0028] (1) Weighing. Weigh the required components according to the prescription, add the weighed raw materials into the batching tank in a preparation room with a cleanliness level of 10,000, and dissolve each of the above components with water for injection.

[0029] (2) Pour in the buffer solution, start stirring, adjust the pH between 7.0 and 7.5 with 2.5M sodium hydroxide, then use water for injection to make up the volume, after stirring evenly, take samples to the testing center, measure the content and do endotoxin examine.

[0030] (3) In the 10,000-grade filter chamber, the prepared medicinal solution is transported to the installed microporous membrane filter with a pore size of 0.45 μm and 0.22 μm by a peristaltic pump for sterilization and filtration. The initial filter oil is immediately returned to the original liquid barrel, and after the clarity inspection is quali...

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Abstract

The invention relates to freeze dried monophosphate adenine arabinoside powder injection for injection and a preparation method thereof. The freeze dried powder injection is prepared by freeze-drying a monophosphate adenine arabinoside liquid, wherein, the monophosphate adenine arabinoside liquid comprises 100 g of monophosphate adenine arabinoside, 25 g of mannitol, 3 g of disodium hydrogen phosphate, 0.3 g of sodium dihydrogen phosphate, 1 g of ethylenediaminetetraacetic acid, and 2000 mL water for injection. The preparation method comprises the following three steps: prefreezing, sublimating, and heating drying. Compared with common water injection in the prior art, the freeze dried powder injection and its preparation method disclosed herein have remarkable advantages in storage and transportation.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a vidarabine monophosphate freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Vidarabine Monophosphate (Ara-AMP) is a monophosphate compound of vidarabine monophosphate, which is a purine nucleoside compound artificially synthesized. Adenosine monophosphate can inhibit the synthesis of viral DNA. Specifically, after adenosine monophosphate enters cells, it is phosphorylated to generate adenosine adenosine diphosphate (Ara-ADP) and adenosine adenosine triphosphate ( Ara-ATP), its antiviral activity is mainly caused by arabinosine adenosine triphosphate (Ara-ATP), which competes with deoxyadenosine triphosphate (dATP). To the viral DNAP, thereby inhibiting the activity of the enzyme and the synthesis of viral DNA. At the same time, it inhibits the activity of viral nucleotide reductase and the synthesis of viral DNA. It ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7076A61K47/26A61P31/12
Inventor 张隆鑫
Owner GUANGDONG LONGFU MEDICINE CO LTD
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