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Saxagliptin pharmaceutical composition and preparation method thereof

A composition and drug technology, applied in the field of saxagliptin pharmaceutical composition and its preparation, can solve the problems of uncontrollable end point, complex production technology, poor stability, etc., and achieve the advantages of drug dissolution, simple process and high stability Effect

Inactive Publication Date: 2015-11-25
陈跃坚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] The purpose of the present invention is to overcome the defects of the prior art such as complicated production technology of saxagliptin, uncontrollable end point, poor stability, excipients and administration methods, etc., and provide a simple production process, controllable process, stable Better prescription and preparation technology, and provide a kind of saxagliptin pharmaceutical composition and preparation method thereof that need not be watered when taking, need not chew, disintegration speed in the oral cavity and its preparation method, and this method preparation is easy to control, and is suitable for industrialized production

Method used

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  • Saxagliptin pharmaceutical composition and preparation method thereof
  • Saxagliptin pharmaceutical composition and preparation method thereof
  • Saxagliptin pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Prescription quantity: 1000 tablets

[0064]

[0065] Dissolve the prescribed amount of gelatin in 80%-90% of the prescribed amount of water, and heat until completely dissolved; dissolve the prescribed amount of mannitol in the above solution, add the prescribed amount of saxagliptin, and stir; adjust the pH with hydrochloric acid value to 1-3, constant volume; according to the specifications of the saxagliptin pharmaceutical composition, after determining the loading amount, the medicinal solution is transferred to the mold according to the loading amount, and put into a freeze-drying box, and the medicinal solution is frozen and Vacuum drying, the process is freezing at -15°C--40°C for 2-4h, slowly heating up to 5-15°C at a speed of (0.5-1°C) / min and drying for 2-8h, pressing (0.5-1°C) Continue to slowly heat up to 20-35°C for 5-24 hours at a speed of 1 / min, and control the vacuum degree of the whole process at 0.05 Pa to 20 Pa; control the moisture content to no ...

Embodiment 2

[0067] Prescription quantity: 1000 tablets

[0068]

[0069] Dissolve the prescribed amount of gelatin in 80%-90% of the prescribed amount of water, and heat until completely dissolved; dissolve the prescribed amount of mannitol in the above solution, add the prescribed amount of saxagliptin, and stir; adjust the pH with hydrochloric acid value to 1-3, constant volume; according to the specifications of the saxagliptin pharmaceutical composition, after determining the loading amount, the medicinal solution is transferred to the mold according to the loading amount, and put into a freeze-drying box, and the medicinal solution is frozen and Vacuum drying, the process is freezing at -15°C--40°C for 2-4h, slowly heating up to 5-15°C at a speed of (0.5-1°C) / min and drying for 2-8h, pressing (0.5-1°C) Continue to slowly heat up to 20-35°C for 5-24 hours at a speed of 1 / min, and control the vacuum degree of the whole process at 0.05 Pa to 20 Pa; control the moisture content to no ...

Embodiment 3

[0071] Prescription quantity: 1000 tablets

[0072]

[0073]Dissolve the prescribed amount of gelatin in 80%-90% of the prescribed amount of water, and heat until completely dissolved; dissolve the prescribed amount of mannitol in the above solution, add the prescribed amount of saxagliptin, and stir; adjust the pH with hydrochloric acid Value to 1-3, constant volume: according to the specifications of the saxagliptin pharmaceutical composition, after determining the loading amount, the medicinal solution is transferred to the mold according to the loading amount, and put into a freeze-drying box, and the medicinal solution is frozen and Vacuum drying, the process is freezing at -15°C--40°C for 2-4h, slowly heating up to 5-15°C at a speed of (0.5-1°C) / min and drying for 2-8h, pressing (0.5-1°C) Continue to slowly heat up to 20-35°C for 5-24 hours at a speed of 1 / min, and control the vacuum degree of the whole process at 0.05 Pa to 20 Pa; control the moisture content to no m...

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Abstract

The invention relates to saxagliptin pharmaceutical composition and a preparation method thereof. The saxagliptin pharmaceutical composition is freeze-dried orally-disintegrating preparation which comprises saxagliptin, filler, water-soluble or water-dispersable binder, pH adjusting agent, corrigent and / or flavoring agent and preservatives. The freeze-dried orally-disintegrating preparation refers to fast-disintegrating oral tablets or fast-disintegrating oral films obtained through freeze drying. The invention further provides the preparation method of the saxagliptin pharmaceutical composition. The saxagliptin pharmaceutical composition has the advantages that the saxagliptin pharmaceutical composition is simple in component, high in auxiliary material safety and simple and controllable in preparation process, a user can take the saxagliptin pharmaceutical composition without water and chewing, the total disintegrating time of the saxagliptin pharmaceutical composition in the oral cavity is less than 2 seconds, the saxagliptin pharmaceutical composition is fast in release and absorption, high in bioavailability, good in stability and low in toxic and side effects, and beneficial and unexpected technical effects are achieved.

Description

technical field [0001] The invention relates to a saxagliptin pharmaceutical composition and a preparation method thereof. Background technique [0002] Diabetes is a chronic disease that cannot be cured. Controlling the stability of blood sugar can better delay the development of the disease. The clinical treatment method is through drug control and diet control. Therefore, diabetes treatment drugs must be used for a long time to effectively control diabetes. The mechanism of action of DPP-4 inhibitors is completely different from other hypoglycemic drugs currently on the market. Its mechanism of action in the human body is multifaceted: in terms of pancreatic islets, it can stimulate β cells to secrete insulin while inhibiting the secretion of glucagon, and this mechanism of action is dependent on glucose concentration, so it can maximize Minimize the prevention of hypoglycemia; in addition, it can also suppress the appetite center, which can control blood sugar well with...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/403A61K9/20A61K47/26A61P3/10
Inventor 陈跃坚
Owner 陈跃坚
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