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Adenine arabinoside monophosphate freeze-dried powder injection and preparation method thereof

A technology of adenosine vidarabine monophosphate freeze-dried powder and adenosine monophosphate, which can be used in freeze-dried transportation, medical preparations containing non-active ingredients, medical preparations containing active ingredients, etc., and can meet technical content requirements High, complex operation process, long production cycle and other problems, to achieve the effect of low technical requirements, simple operation process and short production cycle

Active Publication Date: 2010-02-10
GUANGDONG LONGFU MEDICINE CO LTD
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  • Claims
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Problems solved by technology

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

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  • Adenine arabinoside monophosphate freeze-dried powder injection and preparation method thereof

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Embodiment

[0028] 1. Prescription:

[0029] prescription:

[0030] Vidarabine monophosphate 100g

[0031] Mannitol 25g

[0032] Disodium hydrogen phosphate 3g

[0033] Sodium dihydrogen phosphate 0.3g

[0034] Disodium edetate 1g

[0035] Add water for injection to 2000mL

[0036]

[0037] Packed into 1000 bottles

[0038] 2. Preparation method:

[0039] (1) Weighing. Weigh the required components according to the prescription, add the weighed raw materials into the batching tank in the preparation room with a cleanliness level of 10,000, and dissolve each of the above components with water for injection

[0040] (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.

[0041] (3) In the 10,000-grade filter cham...

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Abstract

The invention relates to an adenine arabinoside monophosphate freeze-dried powder injection and a preparation method thereof. The freeze-dried powder injection is formed by freeze-drying an adenine arabinoside monophosphate drug solution. The adenine arabinoside monophosphate drug solution comprises 100g of adenine arabinoside monophosphate, 25g of mannitol, 3g of disodium hydrogen phosphate, 0.3gof monosodium orthophosphate, 1g of disodium ethylene diamine tetraacetate and 2,000ml of water for injection. The freeze-drying process in the preparation method comprises pre-freezing, sublimationand heating for drying. Compared with the common water injections in the prior art, the freeze-dried powder injection and the preparation method thereof have obvious advantages on 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): A61K9/19A61K31/7076A61K47/18A61P31/12
Inventor 张隆鑫
Owner GUANGDONG LONGFU MEDICINE CO LTD
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