Doxufylline for injection and its preparing method

A technology for doxofylline and injection, which is applied in the field of pharmaceutical preparations and western medicines, can solve the problems of increased chances of bacterial endotoxin and bacterial contamination, inconvenient compatibility and use of infusion preparations, and contamination of medicinal liquid by glass slag. Accurate and easy-to-control dosage, good formulation appearance, and reduced chance of contamination

Inactive Publication Date: 2005-10-05
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

[0004] (1) The storage of drugs in an environment with water is not conducive to drug stability
[0005] (2) The small needles are divided into ampoules, and it is easy to produce glass shards to contaminate the liquid medicine when sawing the ampoule
[0006] (3) Infusion preparations are inconvenient to be used in combination with other infusions according to clinical needs
[0007] (4) High transportation costs
[0008] (5) The production process of infusion preparations requires the addition of a large amount of water for injection, which increases the chance of bacterial endotoxin and bacterial contamination of the product, and the process of aseptic control increases the production cost

Method used

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  • Doxufylline for injection and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0019] Example 1: Formulation Screening - Excipients and their proportions:

[0020] prescription

[0021] preparation

[0022] Dissolve the prescribed amount of excipients in water for injection accounting for 50% of the total amount, add 3‰ needles, heat and boil with activated carbon for 30 minutes, decarbonize and filter, dissolve the prescribed amount of doxofylline in water for injection accounting for 30% of the total amount medium, stir to dissolve, add 3‰ activated carbon for needles, stir for 30 minutes, decarbonize and filter, mix the two filtrates, adjust the pH value to 5.5~6.5 with dilute hydrochloric acid, add water for injection to the total amount—gram weight of doxofylline 50-100 times the number of milliliters, the liquid medicine is filtered with a 0.45 μm microporous membrane, and the sample is taken for semi-finished product content and bacterial endotoxin inspection. 20ml antimicrobial vials, 5ml per bottle, pre-frozen at -35°C for 3 hours, th...

example 2

[0026] Example 2: Investigation of drying process

[0027] Freeze-drying is an optimized process based on the preparation of multiple small samples. It includes three different stages: pre-freezing, decompression freeze-drying, and drying. The three links are an organism, and any improper step will lead to problems in the quality of the finished product, and even the product is unqualified.

[0028] 1) According to the above prescription 9, the eutectic point of the components is -5°C. Therefore, during the decompression freeze-drying process, the temperature should be controlled below -5°C.

[0029] 2) Pre-freezing: Keep at -40°C for 3 hours. If the storage time is too short, the solidification will not be good, and the texture of the sample will be uneven.

[0030] 3) Freeze-drying under reduced pressure: the sample is raised from -35°C to -5°C, and then heated to 0°C, and kept for 19 hours. If the time is too short, the texture of the sample will be affected, making it so...

example 3

[0038] Example 3: Investigation of pH value

[0039] prescription:

[0040] Doxofylline 10.0g

[0041] Mannitol 30.0g

[0042] Water for injection 500ml

[0043] Makes 100

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Abstract

The present invention relates to a doxofylline for injection and its preparation method. It contains doxofylline and excipient, their mixing ratio is 1:1-1:10, the described excipient is mannitol, lactose, glucose and sucrose. Its preparation method adopts freeze-drying method, and said invention also provides the concrete steps of said method.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to the field of pharmaceutical preparations of western medicine. Background technique [0002] Theophylline drugs have a long history of being used to relieve asthma. Doxofylline is a new type of purine bronchodilator drug, which adds a dioxolane structure to the N-7 position of theophylline molecular structure, and its chemical name is 1,3 -Dimethyl-7(1,3-dioxolan-2-yl)methyl-3,7-dihydro-1H-purine-2,6-dione. The synthesis and metabolism of this product were successfully developed and researched by Italian ABC Company as early as the early 1980s, and have been widely used clinically for the treatment of wheezing symptoms caused by bronchial asthma and chronic obstructive pulmonary disease. Doxofylline is a new generation of xanthine derivatives. Compared with the traditional drugs theophylline and aminophylline, its anti-asthma effect is strong...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/522A61P11/00
Inventor 梅开忠南英柱
Owner 天津市铭泰医药科技有限公司
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