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Cyclic adenosine monophosphate freeze-dried powder injection pharmaceutical composition and quality control method and preparation method
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A technology of cyclic adenosine monophosphate freeze-dried powder and cyclic adenosine monophosphate, which is applied in drug combination, drug delivery, freeze-dried delivery, etc.
Active Publication Date: 2020-01-17
CHENGDU TIANTAISHAN PHARMA
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[0024] However, existing cyclic adenosine monophosphate preparations such as its freeze-dried powder still have technical problems to be overcome
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[0156] Prescription: 10mg cyclic adenosine phosphorus, 15mg mannitol, 1.5mg sodiumchloride, appropriate amount of acid-base regulator, and appropriate amount of water for injection to 1ml.
[0157] Preparation method:
[0158] (1) Add cyclic adenosine phosphate and sodium chloride to 60% water for injection at room temperature, stir to dissolve, adjust the pH value of the drug solution to 3.5-4.0 with an acid-base regulator, according to the volume of the drug solution 0.1w / v % Add activated carbon for needles, stir and adsorb for 20 minutes, filter and decarbonize, and set aside;
[0159] (2) Add mannitol to 20% of the prepared amount of water for injection at room temperature, stir to dissolve, add the activated carbon for needles according to the volume of the drug solution at 0.05w / v%, stir and absorb for 20 minutes, filter and decarbonize, and set aside;
[0163] Prescription: 9mg cyclic adenosine phosphorus, 10mg mannitol, 2mg sodium chloride, proper amount of acid-base regulator, proper amount of water for injection to 1ml.
[0164] Preparation method:
[0165] (1) Add cyclic adenosine phosphate and sodium chloride to 60% water for injection at room temperature, stir to dissolve, adjust the pH value of the drug solution to 3.5-4.0 with an acid-base regulator, according to the volume of the drug solution 0.05w / v % Add activated carbon for needles, stir and absorb for 20 minutes, filter and decarbonize, and set aside;
[0166] (2) Add mannitol to 20% of the prepared water for injection at room temperature, stir to dissolve, add needle activated carbon according to the volume of the drug solution at 0.15w / v%, stir and absorb for 20 minutes, filter and decarbonize, and set aside;
[0167] (3) Mix the drug solution obtained in step (1) and st...
preparation example 3
[0169] Preparation Example 3. Preparation of injection containing cyclic adenosine monophosphate
[0170] Prescription: 11mg cyclic adenosine phosphorus, 25mg mannitol, 1mg sodium chloride, proper amount of acid-base regulator, proper amount of water for injection to 1ml.
[0171] Preparation method:
[0172] (1) Add cyclic adenosine phosphate and sodium chloride to 60% water for injection at room temperature, stir to dissolve, adjust the pH value of the drug solution to 3.5-4.0 with an acid-base regulator, according to the volume of the drug solution 0.15w / v % Add activated carbon for needles, stir and absorb for 20 minutes, filter and decarbonize, and set aside;
[0173] (2) Add mannitol to 20% of the prepared amount of water for injection at room temperature, stir to dissolve, add the activated carbon for needles according to the volume of the drug solution at 0.05w / v%, stir and absorb for 20 minutes, filter and decarbonize, and set aside;
[0174] (3) Mix the drug solution obtaine...
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Abstract
The invention discloses an adenosine cyclophosphate freeze-dried powder injection pharmaceutical composition for injection, a quality control method of the adenosine cyclophosphate freeze-dried powder injection pharmaceutical composition for the injection and a preparation method of the adenosine cyclophosphate freeze-dried powder injection pharmaceutical composition for the injection. Specifically, the adenosine cyclophosphate freeze-dried powder injection pharmaceutical composition for the injection provided by an embodiment of the invention is prepared from adenosine cyclophosphate, mannitol and an acidifying or alkalizing agent. The preparation method comprises the following steps that in the composition in parts by weight, if 10 parts of adenosine cyclophosphate are taken as a reference, 10 to 50 parts of mannitol are needed; the acidifying or alkalizing agent is selected from sodiumhydroxide, potassiumhydroxide, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium phosphate, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid or a combination thereof; the usage amount of the acidifying or alkalizing agent meets the condition that when the pharmaceutical composition is dissolved in water and is diluted into a solution of which each 1ml of the solution contains 10mg of adenosine cyclophosphate, the pH value of the solution is 5.5 to 7.0. The adenosine cyclophosphate freeze-dried powder injection pharmaceutical composition for the injection and other aspects of the pharmaceutical composition provided by the invention have excellent properties shown in the description.
Description
Technical field [0001] The invention belongs to the technical field of medical preparations, and relates to a medicine that can be used for heart failure, myocarditis, sick sinus syndrome, coronary heart disease and cardiomyopathy, and can also be used for the auxiliary treatment of arrhythmia, in particular to a cyclophosphate gland for injection Glycoside freeze-dried powder injection pharmaceutical composition, and its quality control method and their preparation method. The injection-use cyclic adenosine freeze-dried powder injection pharmaceutical composition has good pharmaceutical properties. Background technique [0002] The lyophilized powder injection pharmaceutical composition of adenosine cyclophosphate for injection is an effective medicine that can be used for heart failure, myocarditis, sick sinus syndrome, coronary heart disease and cardiomyopathy, and can also be used for auxiliary treatment of arrhythmia . It is believed that the meglumine cyclic adenosine inje...
Claims
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Application Information
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