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Doxofylline injection and preparation method thereof

A technology of doxofylline and injection, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. And other issues

Pending Publication Date: 2020-10-30
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, judging from the problems in actual production, the problem of broken bottles is a serious "disease" during the freeze-drying process
From the perspective of the freeze-drying process, during the freeze-drying process, because the bottle is heated evenly, the phenomenon of bottle breakage is easy to occur
To solve the problem of fragmentation and bottoming, it is generally reflected in the freeze-drying process curve to reduce the temperature line interval between the shelf temperature curve and the sample temperature curve, but it is also easy to lead to deterioration of appearance and redissolving performance. The researches all start with the ingredients of the preparation to improve the performance of the preparation, but the problem of broken bottles is still unsolved

Method used

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  • Doxofylline injection and preparation method thereof
  • Doxofylline injection and preparation method thereof
  • Doxofylline injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0079] The prescription composition of embodiment 1-3 is as shown in table 1:

[0080] Table 1.

[0081] number of copies Example 1 Example 2 Example 3 Doxofylline 1 0.8 1.2 Mannitol 3 2.5 3.5 Water for Injection 50 40 60

[0082] Embodiment 1-3 is prepared according to the following preparation process:

[0083] The specification of the injection bottle used is 10mL, and each preparation of the obtained product contains a volume of liquid medicine of 5±0.5mL,

[0084] (1) Preparation of liquid medicine: Select “Prescription of Doxofylline for Injection” in the batching system for preparation, and the parameters are set as:

[0085]

[0086] After the program starts, add 350kg of water for injection into tank T1 of the batching system, and the water temperature drops to between 20 and 30°C. Add mannitol under stirring and stir for 10 minutes; add doxofylline under stirring and stir for 30 minutes. The solution is clarified, add ...

Embodiment 4-5

[0113] The prescription of embodiment 4-5 is identical with embodiment 1, and preparation process is all the same with embodiment 1 except lyophilization; The lyophilization process of embodiment 4-5 is as shown in table 2:

[0114] Table 2.

[0115]

[0116]

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Abstract

The invention discloses a doxofylline injection and a preparation method thereof, and relates to the field of pharmaceutical preparations. The doxofylline injection is prepared from the following components in parts by weight: 0.8 to 1.2 parts of doxofylline, 2.5 to 3.5 parts of mannitol and 40 to 60 parts of water for injection, and the doxofylline injection is produced by adopting an injection bottle with the specification of 10mL. The doxofylline injection has the advantages that by improving the process, especially the freeze-drying process, the bottle breaking number is reduced, the lossis reduced, meanwhile, the uniformity, the redissolving property, the stability and other properties of the doxofylline injection are also improved by improving the freeze-drying process, and other auxiliary agents do not need to be added. In addition, a glass tube injection bottle with the specification of 10mL is adopted for production, so that the income is greatly increased.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a doxofylline injection and a preparation method thereof. Background technique [0002] With the deteriorating air quality and the seasonal frequency of respiratory diseases, doxofylline for injection as a bronchodilator has an increasing clinical demand. Doxofylline is a xanthine derivative with the chemical name 1,3-dimethyl-7-(1,3-dioxol-2-yl)methyl-3,7-dihydro -1H-purine-2,6-dione, white needle crystal or crystalline powder; odorless, slightly bitter taste. Soluble in chloroform, slightly soluble in water, ethanol or acetone, almost insoluble in ether. The melting point is 142-145°C. Its chemical structure is: [0003] [0004] Compared with the traditional medicines theophylline and aminophylline, doxofylline has high curative effect and low toxicity, and its therapeutic effect is 10-15 times that of aminophylline. Central nervous system, gastrointestinal t...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K31/522A61P11/08
CPCA61K9/0019A61K9/19A61K47/26A61K31/522A61P11/08
Inventor 夏丰度丁晶冯富贵褚炜
Owner 武汉人福药业有限责任公司
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