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Preparation method of small-volume doxofylline freeze-dried powder injection as well as product and device thereof

A technology of doxofylline and freeze-dried powder injection, which is applied in freeze-dried delivery, powder delivery, and devices for making medicines into special physical or taking forms, etc., can solve the problem of increasing energy consumption, increasing packaging and transportation costs, etc. problems, to achieve the effect of reducing packaging volume, reducing energy consumption, and reducing costs

Inactive Publication Date: 2011-01-26
天津市铭泰医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It not only increases the cost of packaging and transportation, but also needs to remove a large amount of water during the freeze-drying process, which increases energy consumption

Method used

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  • Preparation method of small-volume doxofylline freeze-dried powder injection as well as product and device thereof
  • Preparation method of small-volume doxofylline freeze-dried powder injection as well as product and device thereof
  • Preparation method of small-volume doxofylline freeze-dried powder injection as well as product and device thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0016] The preparation method of small-volume doxofylline freeze-dried powder injection, take 2kg of doxofylline and 2kg of mannitol, add 80°C water for injection to make a concentrated solution of 0.045g / ml, stir well to dissolve, add 0.3% Fully stir the needle with activated carbon, heat and boil for 30 minutes, filter with a 0.8um titanium rod (P≥0.6MPa), adjust the pH value to 5.5-6.5, take samples to determine the content and bacterial endotoxin, and add the qualified filtrate to the remaining preparation amount Dilute 80°C water for injection to make a dilute solution of 0.038g / ml, keep the temperature at not lower than 80°C, stir thoroughly for 20 minutes, filter through a 0.45μm microporous membrane (P≥0.23MPa), and then use 0.22 um microporous membrane for terminal filtration (P≥0.39MPa), and finally sent to the insulation storage tank through the pipeline, the temperature is kept at not lower than 80 ℃, 7.895ml is filled into a 20ml ampoule, freeze-dried, pressed Jus...

example 2

[0019] The preparation method of small-volume doxofylline freeze-dried powder injection is to take 2kg of doxofylline and 6kg of lactose, add 99°C water for injection to make a concentrated solution of 0.050g / ml, fully stir to dissolve, and add 0.3% of Stir well with activated carbon for needles, heat and boil for 30 minutes, filter with a 0.8um titanium rod (P≥0.6MPa), adjust the pH value to 5.5-6.5, take samples to determine the content and bacterial endotoxin, and add the qualified filtrate to the remaining preparation amount 99 ℃ dilute with water for injection to make a dilute solution of 0.042g / ml, keep the temperature at not lower than 80℃, stir thoroughly for 20 minutes, filter through a 0.45μm microporous membrane (P≥0.23MPa), and then use 0.22um The microporous filter membrane is used for terminal filtration (P≥0.39MPa), and finally sent to an insulated storage tank through a pipeline, and the temperature is kept at not lower than 80°C. Fill 7.14ml into a 20ml ampoule...

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Abstract

The invention discloses a preparation method of a small volume doxofylline freeze-dried powder injection. The preparation method is characterized by comprising the following steps: weighing doxofylline and auxiliary materials of the prescription amount, and adding the injection water of 80 to 90 DEG C to prepare a concentrated solution, and fully stirring so as to dissolve the materials; adding active carbon, stirring uniformly the mixture, heating to boil, and filtering; adding the dilute solution which is prepared by the residual injection water of 80 to 90 DEG C into the filtrate, keeping the temperature no lower than 80 DEG C, fully stirring, carrying out micro-filtering, and continuing to keep the temperature not lower than 80 DEG C; and filling into a 20ml ampoule, freeze-drying, pressing and sealing to obtain the product. The method of the invention has the beneficial effect of effectively reducing the packaging size so as to lower the packaging cost and the transport cost, and greatly reducing the energy consumption of the freeze-drying and evaporating so as to reduce the cost further due to that the preparation amount filled into the ampoule is only 7 to 8 ml before the freeze-drying.

Description

technical field [0001] The invention belongs to the field of freeze-dried powder injection and its preparation method and equipment; in particular, the field of doxofylline freeze-dried powder injection and its preparation method and equipment. Background technique [0002] The current doxofylline powder injection needs to be filled in a 30ml ampoule for a single therapeutic dose (only 0.3 grams), which has the disadvantage of a large inner packaging container. The reason for this is not because it needs such a large volume of water for injection to dissolve when it is used, but because it needs such a large amount of solvent during its preparation to be able to dissolve doxofylline so that it can be lyophilized into this dose of doxofyl tea Alkaline powder needle. The original preparation process does not control the dissolution temperature. Usually, the water for injection used for initial dissolution is 40°C to 50°C, and the temperature gradually decreases during the dil...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61J3/02A61P11/06A61P11/08
Inventor 梅开忠
Owner 天津市铭泰医药科技有限公司
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