Adenosine cyclophosphate pharmaceutical composition and preparation method thereof

A cycloadenosine phosphate and cycloadenosine-containing technology are applied in the field of cycloadenosine phosphate pharmaceutical compositions and their preparation, and can solve problems such as poor stability of preparations

Inactive Publication Date: 2012-06-13
九瑞健康股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, cyclic adenosine monophosphate injection and freeze-dried powder injection have been disclosed. Since cyclic adenosine monophosphate is slightly soluble in water, it is easy to precipitate in water, so the stability of the preparation is relatively poor, and there is still room for improvement in the stability of the above preparations.

Method used

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  • Adenosine cyclophosphate pharmaceutical composition and preparation method thereof
  • Adenosine cyclophosphate pharmaceutical composition and preparation method thereof
  • Adenosine cyclophosphate pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Example 1 Injection

[0055] Cyclic adenosine monophosphate 20g,

[0056] Sodium hydroxide 2.3g,

[0057] PEG400 0.5g,

[0058] Appropriate amount of pH regulator,

[0059] Add water for injection to 2000ml;

[0060] Prepared into 1000 sticks.

[0061] The preparation method comprises the following steps:

[0062]1) Weigh the raw and auxiliary materials of the prescription amount;

[0063] 2) Sodium hydroxide is added with 70% water for injection, stirred to dissolve, then added cyclic adenosine monophosphate, stirred to dissolve completely;

[0064] 3) Add water for injection to the full amount, stir to mix evenly;

[0065] 4) Measure the pH value of the medicinal solution and adjust the pH value to 5.0-7.0;

[0066] 5) Add activated carbon with a dosing volume of 0.1%, heat and stir for 15 minutes, filter and decarbonize;

[0067] 6) 0.45 micron filter membrane fine filtration, check the clarity;

[0068] 7) Inspection of semi-finished products;

[0069] 8)...

Embodiment 2

[0073] Example 2 Injection

[0074] Cyclic adenosine monophosphate 40g,

[0075] Sodium hydroxide 4.6g,

[0076] PEG400 1g,

[0077] Appropriate amount of pH regulator,

[0078] Add water for injection to 5000ml;

[0079] Prepared into 1000 sticks.

[0080] The preparation method refers to the method of Example 1.

Embodiment 3

[0081] Embodiment 3 freeze-dried powder injection

[0082] Cyclic adenosine monophosphate 20g,

[0083] Sodium hydroxide 2.2g,

[0084] PEG400 0.5g,

[0085] Mannitol 80g,

[0086] Appropriate amount of pH regulator,

[0087] Add water for injection to 1000ml;

[0088] Prepared into 1000 vials.

[0089] The preparation method comprises the following steps:

[0090] 1) Weigh the raw and auxiliary materials of the prescription amount;

[0091] 2) Cyclic adenosine monophosphate is added with 80% sterile water for injection, then sodium hydroxide is added, stirred to dissolve, and then mannitol in the prescribed amount is added, stirred to dissolve;

[0092] 3) Add sterile water for injection to the full amount, stir to mix evenly;

[0093] 4) Measure the pH value of the solution and adjust the pH value to 5.0-7.0;

[0094] 5) Add activated carbon for needles with a dosing volume of 0.05%, heat and stir for 15 minutes, filter and decarbonize;

[0095] 6) 0.22 micron micr...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a stable adenosine cyclophosphate pharmaceutical composition which is characterized by being used for preparing an injection, wherein the solubilization ingredient is the combination of sodium hydroxide and PEG400 (polyethylene glycol 400). The injection prepared by the invention has the advantage of prominently improved stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, and specifically relates to a cyclic adenosine monophosphate pharmaceutical composition and a preparation method thereof. The composition is a cyclic adenosine monophosphate injection preparation, including injection liquid and freeze-dried powder injection. Background technique [0002] Cyclic adenosine monophosphate (cAMP) is a new type of non-cardiac glycoside cardiovascular drug. It can increase myocardial contractility by activating protein kinases in myocardial cells and slow channels on cell membranes, increasing calcium ions in the cytoplasm of myocardial cells, and at the same time It has the functions of dilating coronary arteries, improving microcirculation, expanding vascular smooth muscle, and reducing the before and after load of the heart. While expanding the peripheral blood vessels, the heart rate does not increase, or even slightly slows down, which reduces the myocardial oxyg...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/675A61K47/34A61P9/00
Inventor 王保明
Owner 九瑞健康股份有限公司
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