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Meglumine adenosine cyclophosphate powder injection medicine composition for injection and preparation method thereof

A kind of adenosine cyclophosphate and the technology of the composition, which are applied in the field of pharmaceutical composition and preparation method of adenosine cyclophosphate meglumine powder for injection

Active Publication Date: 2015-06-17
山东北大高科华泰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] However, existing meglumine cyclophosphate preparations, especially its freeze-dried powder injection, still have technical problems to be overcome

Method used

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  • Meglumine adenosine cyclophosphate powder injection medicine composition for injection and preparation method thereof
  • Meglumine adenosine cyclophosphate powder injection medicine composition for injection and preparation method thereof
  • Meglumine adenosine cyclophosphate powder injection medicine composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0115] Preparation Example 1, Preparation of Powder Injection Containing Adenosine Cyclic Meglumine

[0116] formula:

[0117] cyclic adenosine monophosphate 10mg, meglumine 6mg, Mannitol 12 mg, maltose 1 mg, pH regulator to pH6.2, Water for Injection Appropriate amount, add to 0.8ml.

[0118] Preparation:

[0119] (1) Weigh the main drug and auxiliary materials (except the pH regulator) of the prescribed amount, place them in a stainless steel bucket, add about 80% of the prescribed amount of water for injection, stir to dissolve, and then add 0.1% (w / v) according to the volume of the solution ) of activated carbon, stirred for 30 minutes, decarbonized by filtration, and added water for injection to close to the full amount of the prescription.

[0120] (2) The filtrate is sampled, and the pH value is measured, and if necessary, adjust to a specified value with a pH regulator (that is, take an appropriate amount of the f...

preparation example 2： reference preparation example 1 approach ，，0mg、0.2mg、0.5mg、2mg、5mg、10mg、 or 20mg， to Ex121、Ex122、Ex123、Ex124、Ex125、Ex126、Ex127。 preparation example 3： reference preparation example 1 approach ，0.5mg，0mg、4mg、9mg、15mg、25mg、 or 50mg， to Ex131、Ex132、Ex133、Ex134、Ex135、Ex136。 preparation example 4： reference preparation example 1 approach ，5mg，0mg、4mg、9mg、15mg、25mg、 or 50mg， to Ex141、Ex142、Ex143、Ex144、Ex145、Ex146。 preparation example 5： reference preparation example 1 approach ，9mg，0mg、0.2mg、0.5mg、2mg、5mg、10mg、 or 20mg， to Ex151、Ex152、Ex153、Ex154、Ex155、Ex156、Ex157。 preparation example 6： reference preparation example 1 approach ，15mg，0mg、0.2mg、0.5mg、2mg、5mg、10mg、 or 20mg， to Ex161、Ex162、Ex163、Ex164、Ex165、Ex166、Ex167。 preparation example 7： reference preparation example 1 approach ，、、、 or ， to Ex171、Ex172、Ex173、Ex174； reference preparation example 1 approach ，、、、 or ， to Ex175、Ex176、Ex177、Ex178。 preparation example 8

[0124] Supplementary Preparation Example 1: Referring to the method of Preparation Example 1 above, the difference is that the amount of mannitol in it is adjusted to 0 mg, 4 mg, 9 mg, 15 mg, 25 mg, or 50 mg, respectively, and the obtained powder injection numbers are Ex111, Ex112, Ex113, Ex114, Ex115, Ex116 six powder needles. Supplementary Preparation Example 2: Referring to the method of Preparation Example 1 above, the difference is that the amount of maltose in it is adjusted to 0mg, 0.2mg, 0.5mg, 2mg, 5mg, 10mg, or 20mg, and the numbers of the obtained powder injections are respectively Ex121, Ex122, Ex123, Ex124, Ex125, Ex126, Ex127. Supplementary Preparation Example 3: Referring to the method of Preparation Example 1 above, the difference is that the amount of maltose is 0.5 mg, and the amount of mannitol is 0 mg, 4 mg, 9 mg, 15 mg, 25 mg, or 50 mg. The numbers of the obtained powder injections are Ex131, Ex132, Ex133, Ex134, Ex135, Ex136. Supplementary Preparation E...

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Abstract

The invention relates to a meglumine adenosine cyclophosphate powder injection medicine composition for injection and a preparation method thereof. Specifically, the invention relates to a medicine composition on one hand and the medicine composition comprises adenosine cyclophosphate, meglumine, mannitol and an optional acid-alkali regulator, wherein based on every 10 parts of adenosine cyclophosphate by weight, the medicine composition comprises the following materials in parts by weight: 5.5-6.5 parts of meglumine, 9-15 parts of mannitol and a proper use amount of the acid-alkali regulator; and the use amount of the acid-alkali regulator ensures that when the medicine composition is dissolved and diluted in water to prepare a solution every 1ml of which contains 10mg of adenosine cyclophosphate, the pH value of the solution is 5.5-7.0. The powder injection composition disclosed by the invention can be used for treating cardiac failure, myocarditis, sick sinus syndromes, coronary heart diseases and cardiomyopathy and can also be applied to adjuvant therapy of cardiac arrhythmia; and the meglumine adenosine cyclophosphate powder injection medicine composition for injection disclosed by the invention has good pharmaceutical properties.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a drug that can be used for heart failure, myocarditis, sick sinus syndrome, coronary heart disease and cardiomyopathy, and can also be used for adjuvant treatment of arrhythmia, in particular to a cyclophosphine for injection Meglumine glucosamine powder injection pharmaceutical composition, and their preparation method, the injection of meglumine cyclic adenosine meglumine powder injection pharmaceutical composition has good pharmaceutical properties. Background technique [0002] The meglumine cyclic adenosine monophosphate powder for injection involved in the present invention is an effective drug that can be used for heart failure, myocarditis, sick sinus syndrome, coronary heart disease and cardiomyopathy, and can also be used for adjuvant treatment of arrhythmia. It is believed that the meglumine cyclic adenosine monophosphate injection powder for injecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7076A61K9/19A61K47/26A61P9/04A61P9/00A61P9/10A61P9/06A61P9/12A61P13/12
Inventor 赵丽颖郭明娟林丽娟夏云李敏
Owner 山东北大高科华泰制药有限公司
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