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Meglumine adenosine cyclphosphate microspheres and production method thereof

A technology for meglumine cyclophosphate and adenosine cyclophosphate is applied in the field of meglumine cyclophosphate lyophilized preparations and preparations thereof, and can solve the problems of increasing curative effect, lyophilized powder collapsing without looseness, deterioration of medicinal liquid, etc. problem, to achieve the effect of improving the therapeutic effect, no hemolytic reaction, and low production cost

Inactive Publication Date: 2011-02-02
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Cyclic adenosine monophosphate is slightly soluble in water, and adding meglumine can increase its solubility. However, in the ccyclic adenosine monophosphate meglumine solution, as the storage time prolongs, cyclic adenosine monophosphate will gradually precipitate, causing the liquid to Deterioration and turbidity will affect the curative effect of the drug and affect the safety of the drug. During the storage of the meglumine cyclophosphate solution in the solution state, it is easy to change when exposed to light, which will degrade the drug, cause clinical allergic reactions, increase the curative effect, and Meglumine cyclophosphate solution is susceptible to oxidation and polymerization due to environmental factors, resulting in changes in the structure of the drug
CN1459288A provides a large infusion solution of meglumine cyclic adenosine monophosphate, which is prepared from meglumine cyclic adenosine monophosphate, glucose, citric acid and distilled water. The disadvantages are poor stability in placement and storage, and inconvenient transportation
CN1579413A provides a kind of cyclic adenosine monophosphate meglumine, which directly makes cyclic adenosine monophosphate, meglumine and excipients into common freeze-dried preparations. hydration
[0004] The present inventor has found through long-term creative research that the freeze-dried preparation of meglumine adenosine monophosphate microspheres made of certain excipients not only greatly improves the storage stability of meglumine cyclic adenosine monophosphate, but also helps to improve its Drug concentration, increasing drug efficacy and drug safety, is a new preparation method, and no similar reports have been seen in China

Method used

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  • Meglumine adenosine cyclphosphate microspheres and production method thereof
  • Meglumine adenosine cyclphosphate microspheres and production method thereof
  • Meglumine adenosine cyclphosphate microspheres and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Preparation of lyophilized adenosine monophosphate meglumine microspheres

[0029] Cyclic adenosine monophosphate 30g

[0030] Meglumine 17.8g

[0031] Polycaprolactone 95.6g

[0032] Polyvinyl alcohol 31.8g

[0033] Polysorbate 80 45g

[0034] Sodium chloride 18g

[0035] Mannitol 180g

[0036] Ethanol 500ml

[0037] Distilled water 2000ml

[0038] Preparation Process

[0039] (1) Take by weighing 31.8g polyvinyl alcohol and dissolve it with 500ml distilled water first, then add 45g polysorbate 80 and 18g sodium chloride, stir and dissolve completely, obtain an aqueous solution isotonic with blood plasma, which is the water phase;

[0040] (2) Take by weighing 30g cyclic adenosine monophosphate, 17.8g meglumine and 95.6g polycaprolactone and dissolve in 500ml ethanol, stir;

[0041] (3) Slowly add the oil phase to the water phase, and keep stirring, the solution temperature is maintained at 55°C, and the oil phase rapidly diffuses into the water phas...

Embodiment 2

[0044] Example 2 Preparation of lyophilized adenosine monophosphate meglumine microspheres

[0045] Cyclic adenosine monophosphate 60g

[0046] Meglumine 35.6g

[0047] Polycaprolactone 95.6g

[0048] Polyvinyl alcohol 9.56g

[0049] Span 80 9.56g

[0050] Sodium chloride 27g

[0051] Lactose 285g

[0052] Chloroform 700ml

[0053] Distilled water 3000ml

[0054] The preparation process was the same as in Example 1, and a white loose block was obtained.

Embodiment 3

[0055] Example 3 Preparation of lyophilized adenosine monophosphate meglumine microspheres

[0056] Cyclic adenosine monophosphate 90g

[0057] Meglumine 53.4g

[0058] Polycaprolactone 215.1g

[0059] Polyvinyl alcohol 43g

[0060] Poloxamer 188 107.5g

[0061] Sodium chloride 36g

[0062] Glycine 430g

[0063] Acetone 1000ml

[0064] Distilled water 4000ml

[0065] The preparation process was the same as in Example 1, and a white loose block was obtained.

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Abstract

The invention relates to a meglumine adenosine cyclphosphate microsphere lyophilized preparation. The preparation is characterized in that the preparation is mainly prepared from adenosine cyclophosphate, meglumine, polycaprolactone, polyvinyl alcohol, a surfactant, an osmosis regulator and a lyophilized supporting agent.

Description

technical field [0001] The invention relates to a novel pharmaceutical preparation, in particular to a lyophilized preparation of meglumine cyclic adenosine monophosphate microspheres and a preparation method thereof. Background technique [0002] Cyclic adenosine monophosphate is slightly soluble in water, and adding meglumine can increase its solubility. However, in the ccyclic adenosine monophosphate meglumine solution, as the storage time prolongs, cyclic adenosine monophosphate will gradually precipitate, causing the liquid to Deterioration and turbidity will affect the curative effect of the drug and affect the safety of the drug. During the storage of the meglumine cyclophosphate solution in the solution state, it is easy to change when exposed to light, which will degrade the drug, cause clinical allergic reactions, increase the curative effect, and Meglumine cyclophosphate solution is easily oxidized and polymerized by environmental factors to change the structure o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/19A61K31/7076A61K47/42A61P9/00A61K47/18A61K47/34A61K47/26A61K47/10A61K47/02
Inventor 陶灵刚
Owner HAINAN YONGTIAN PHARMA INST