Doxofylline composition injection and preparation method thereof

A technology of doxofylline and its composition, which is applied in the field of doxofylline composition injection and its preparation, and can solve problems affecting the quality of medicines and the safety of clinical medication

Inactive Publication Date: 2012-07-18
UNKNOWN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The emergence of this phenomenon has greatly affected the quality of drugs and the safety of clinical medication.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0051] Recipe 1,

[0052] The above prescription drugs are configured into 10000 milliliters of injection solutions, which are sterilized, filtered and filled into 10000 doxofylline composition injections of 10 milliliters each.

[0053] Formulation 2,

[0054] The above prescription drugs are configured into 10000 milliliters of injection solutions, which are sterilized, filtered and filled into 10000 doxofylline composition injections of 10 milliliters each.

[0055] Formulation 3,

[0056] The above prescription medicines are configured into 10,000 milliliters of injection solutions, which are sterilized, filtered, and filled into 5,000 doxofylline composition injections of 20 milliliters each.

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PUM

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Abstract

The invention relates to a doxofylline composition injection and a preparation method thereof, in particular to a small-dose doxofylline composition injection and a preparation process thereof. According to the preparation method, citric acid and an acidic buffer solution of sodium citrate are compatible with doxofylline, the mass ratio scheme of the optimal composition of three substances under different contents (0.1g/10ml, 0.2g/10ml and 0.3g/20ml) of the doxofylline is optimized, screened and established, and the preparation process for optimizing the scheme is formulated correspondingly. Therefore, the technical problem of low physical and chemical stability of the small-dose doxofylline composition injection in the processes of transportation and storage is solved, and the quality of medicines is improved.

Description

1. Technical field: [0001] The invention relates to a composition capable of effectively improving the physical and chemical stability of a doxofylline small-capacity injection preparation during daily storage, transportation and warehouse maintenance, and a preparation process thereof. 2. Technical background: [0002] Doxofylline preparations have been widely used in the treatment of asthma and respiratory diseases since they were introduced into China in the 1990s. However, since the doxofylline preparation is a weakly alkaline preparation, there are certain defects in the physical and chemical stability of the preparation. Especially under the condition of small-volume injection (the commercially available product is 0.1g / 10ml; 0.2g / 10ml; 0.3g / 20ml three specifications, of which 0.1g / 10ml is the most commonly used), during the storage and transportation process, Along with the change of external environment (temperature, humidity, illumination), the phenomenon that the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/522A61P11/00
Inventor 韩喆
Owner UNKNOWN
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