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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 is applied in freeze-dried transportation, medical preparations containing active ingredients, antiviral agents, etc., and can solve the problem of long production cycle and strong corrosion , low yield and other problems, to achieve the effect of good drug formation, stability assurance and good formability

Inactive Publication Date: 2013-02-06
KAIFENG MINGREN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, because the aqueous injection has the characteristics of quick effect and easy preparation, it is widely used. For example, the application number is CN200410021225.1, which discloses a vidarabine monophosphate and its preparation method. However, compared with Water injection and freeze-dried powder injection not only have good curative effect, but also have more advantages in transportation, storage, etc., and although there are some researches on the freeze-drying process and formula of adenosine vidarabine monophosphate in the prior art, the existing The formula and preparation method of freeze-dried powder injection in the technology generally have problems such as long production cycle, low output, complicated operation process, and high technical content requirements; and, in the existing preparation technology of vidarabine monophosphate freeze-dried powder injection, all adopt Excipients or strong bases such as sodium hydroxide, which are more corrosive during operation
The use of various excipients and strong bases in the existing preparation technology has adverse effects on the quality of the drug, thereby increasing the toxic and side effects of the drug

Method used

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

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Effect test

Embodiment 1

[0024] The preparation method of the adenosine monophosphate lyophilized powder injection for injection of the present invention comprises the formula of the adenosine monophosphate drug solution, the preparation of the drug solution of the vidarabine monophosphate drug solution, the canning of the drug solution, and the half-tamponing , freeze-drying, plugging, re-pressing and out of the box, wherein the specific process of freeze-drying is:

[0025] Place the canned and semi-plugged product in a freeze dryer, and pre-freeze it for 2 hours at -35 to -38°C; when the condenser cools down to -50 to -52°C, evacuate to a vacuum When the temperature reaches 10-13Pa, set the temperature program; the current partition temperature rises to 0°C in 3 hours, maintain the partition temperature, and keep it for 2 hours after the product ice crystal disappears; set the program temperature rise, the current partition temperature is 2.5 The temperature was raised from 0°C to 36°C within 1 hou...

Embodiment 2

[0027] The preparation method of the adenosine monophosphate lyophilized powder injection for injection of the present invention comprises the formula of the adenosine monophosphate drug solution, the preparation of the drug solution of the vidarabine monophosphate drug solution, the canning of the drug solution, and the half-tamponing , freeze-drying, plugging, re-pressing and out of the box, wherein the specific process of freeze-drying is:

[0028] Place the canned and semi-plugged product in a freeze dryer, and pre-freeze it at -38 to -40°C for 2 hours; when the condenser cools down to -52 to -55°C, evacuate to a vacuum When the temperature reaches 10-13Pa, set the temperature program; the current partition temperature rises to 0°C in 3 hours, maintain the partition temperature, and keep it for 2 hours after the product ice crystal disappears; set the program temperature rise, the current partition temperature is 2.5 The temperature was raised from 0°C to 36°C within 1 hou...

Embodiment 3

[0030] The preparation method of the adenosine monophosphate lyophilized powder injection for injection of the present invention comprises the formula of the adenosine monophosphate drug solution, the preparation of the drug solution of the vidarabine monophosphate drug solution, the canning of the drug solution, and the half-tamponing , freeze-drying, plugging, re-pressing and out of the box, wherein the specific process of freeze-drying is:

[0031] Place the canned and semi-plugged product in a freeze dryer, and pre-freeze it at -35 to -40°C for 2 hours; when the condenser is cooled to -55 to -63°C, evacuate to a vacuum When the temperature reaches 10-13Pa, set the temperature program; the current partition temperature rises to 0°C in 3 hours, maintain the partition temperature, and keep it for 2 hours after the product ice crystal disappears; set the program temperature rise, the current partition temperature is 2.5 The temperature was raised from 0°C to 36°C within 1 hour...

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Abstract

The invention discloses a preparation method of a vidarabine monophosphate freeze-dried powder injection for injection. The preparation method comprises the steps as follows: taking vidarabine monophosphate, sodium bicarbonate and injection water as raw materials; preparing the raw materials into a vidarabine monophosphate drug solution; canning the drug solution and pressing by half; freezing and drying; pressing; re-pressing; and unpacking to obtain the vidarabine monophosphate freeze-dried powder injection. An excipient or a similar sodium hydroxide strong base solution is not adopted in the adopted vidarabine monophosphate drug solution, so that the influence of the excipient or the similar sodium hydroxide strong base solution on the quality of the vidarabine monophosphate freeze-dried powder injection in the prior art is avoided, the influence of the excipient or the similar sodium hydroxide strong base solution on the vidarabine monophosphate freeze-dried powder injection is effectively reduced, and the quality of drugs is better guaranteed. The vidarabine monophosphate freeze-dried powder injection is better in re-solubility, good in formability and appearance, full and glossy.

Description

technical field [0001] The invention relates to a preparation method of medicine, in particular to a preparation method of adenosine vidarabine monophosphate freeze-dried powder for injection. Background technique [0002] Adenosine monophosphate is a monophosphate compound of adenosine vidarabine, which is a synthetic purine nucleoside compound. 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), whose antiviral activity is mainly caused by adenosine adenosine triphosphate (Ara-ATP), which competes with deoxyadenosine triphosphate (dATP) to bind to the virus 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 can also inhibit the activity of vi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7076A61P31/20
Inventor 王新房王斐张宝国毛影刘向前张广强张立峰杨晓霞
Owner KAIFENG MINGREN PHARMA
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