Cyclic adenosine meglumine freeze-dried powder for injection and preparation method thereof

A technology of meglumine cyclic adenosine monophosphate and freeze-dried powder injection, which is applied in the direction of freeze-dried delivery, medical preparations containing active ingredients, powder delivery, etc., which can solve the problem that the drug safety of stabilizers is not fully guaranteed and affects product dissolution It has the effects of good resolubility, suitable for industrial production, and improved drug safety and stability.

Active Publication Date: 2018-03-27
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] During the long-term storage of the existing meglumine cyclic adenosine monophosphate injections on the market, the meglumine cyclic adenosine monophosphate has a strong hygroscopicity, and after absorbing moisture, it melts and degrades, resulting in a decrease in the content of the preparation, an increase in related substances, and a deepening of the color. The stability is related to its own pH. This strain is a salt of cyclic adenosine monophosphate and meglumine, and its stability is better when the pH is between 5.8 and 6.0. Low or high pH may affect the solubility of the product and induce Moisture, in the prior art, citric acid is added as a stabilizer in the injection, but the drug safety of the stabilizer is not fully guaranteed. At the same time, due to the need for high temperature sterilization, the stability of the product is not good, and the related substances increase after sterilization Obviously, and during storage, the drug is prone to hydrolysis

Method used

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  • Cyclic adenosine meglumine freeze-dried powder for injection and preparation method thereof
  • Cyclic adenosine meglumine freeze-dried powder for injection and preparation method thereof
  • Cyclic adenosine meglumine freeze-dried powder for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The formula of the freeze-dried powder for injection of adenosine meglumine cyclophosphate consists of:

[0031]

[0032] Its preparation method:

[0033] 1. Add the prescribed amount of water for injection into the batching tank, and cool down to below 25°C.

[0034] 2. Weigh the prescribed amount of meglumine, add it into the batching tank, and stir until dissolved.

[0035] 3. Weigh the prescribed amount of cyclic adenosine monophosphate, add it into the batching tank, stir until dissolved, and control the pH at 5.65.

[0036] 4. Filling after sterilization and filtration.

[0037] 5. Put the drug into the freeze dryer for pre-freezing at -35°C, maintain for 3h, raise the medium to -5°C, maintain for 9h, raise the medium to 10°C, maintain for 1h, raise the medium to 30°C, and maintain for 4h.

[0038] 6. Capping.

[0039] 7. Packing, full inspection, storage.

Embodiment 2

[0041]

[0042] Its preparation method:

[0043] 1. Add the prescribed amount of water for injection into the batching tank, and cool down to below 25°C.

[0044] 2. Weigh the prescribed amount of meglumine, add it into the batching tank, and stir until dissolved.

[0045] 3. Weigh the prescribed amount of cyclic adenosine monophosphate, add it into the batching tank, stir until dissolved, and control the pH at 5.75.

[0046] 4. Filling after sterilization and filtration.

[0047] 5. Put the drug into the freeze dryer for pre-freezing at -35°C, maintain for 3.5h, raise the medium to -5°C, maintain for 10h, raise the medium to 10°C, maintain for 1.5h, raise the medium to 30°C, and maintain for 4.5h.

[0048] 6. Capping.

[0049] 7. Packing, full inspection, storage.

Embodiment 3

[0051]

[0052] Its preparation method:

[0053] 1. Add the prescribed amount of water for injection into the batching tank, and cool down to below 25°C.

[0054] 2. Weigh the prescribed amount of meglumine, add it into the batching tank, and stir until dissolved.

[0055] 3. Weigh the prescribed amount of cyclic adenosine monophosphate, add it into the batching tank, stir until dissolved, and control the pH at 5.90.

[0056] 4. Filling after sterilization and filtration.

[0057] 5. Put the drug into the freeze dryer for pre-freezing at -35°C, maintain for 3.8h, raise the medium to -5°C, maintain for 11h, raise the medium to 10°C, maintain for 1.8h, raise the medium to 30°C, and maintain for 4.8h.

[0058] 6. Capping.

[0059] 7. Packing, full inspection, storage.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lyophilized adenosine monophosphate meglumine powder for injection and a preparation method thereof. It is made of cyclic adenosine monophosphate and meglumine, and the mass ratio of cyclic adenosine monophosphate and meglumine is 1:0.55‑0.65. The invention does not need to add glycine, mannitol, sodium chloride, sodium citrate, citric acid, disodium hydrogen phosphate, etc., and improves the safety and stability of medication. The present invention also provides a preparation method thereof, first using cyclic adenosine monophosphate and meglumine in a molar ratio of 1:1 to form a salt, and then using meglumine to adjust the pH to 5.8-7.0, which improves the stability of the main drug. According to the test, the content of the product is stable within 6 months, the change of related substances is small, and the storage period of the preparation is prolonged. The preparation method has simple process and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lyophilized adenosine monophosphate meglumine powder for injection and a preparation method thereof. Background technique [0002] Cyclic adenosine meglumine is a drug used for heart failure, myocarditis, sick sinus syndrome, coronary heart disease and cardiomyopathy, and can be used as an adjuvant therapy for arrhythmia. After years of clinical use, the curative effect is definite, and its main mechanism of action is: meglumine cyclic adenosine monophosphate is a non-digital cardiotonic agent, which has positive inotropic effect, can enhance myocardial contractility, improve myocardial pumping function, and has the effect of dilating blood vessels. Can reduce myocardial oxygen consumption; improve myocardial cell metabolism, protect ischemic and hypoxic myocardium; can improve sinoatrial node P cell function. [0003] During the long-term stora...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61P9/04A61P9/10A61P9/06A61P9/00A61K31/133
Inventor 苗得足张光明艾全陈付杰张国明王元英黄芳生
Owner REYOUNG PHARMA
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