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Medicine preparation formulation for treating type 2 diabetes and preparation method of medicine preparation formulation

A type 2 diabetes and drug dosage form technology, which is applied in the direction of drug combinations, pharmaceutical formulas, and medical preparations with non-active ingredients, etc., can solve problems such as insulin deficiency and discounted insulin effects, and achieve stable quality, uniform appearance, and advanced technology Effect

Active Publication Date: 2020-01-07
山西诺普生物医药科技有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The ability to produce insulin in patients is not completely lost, and some patients even produce too much insulin in their bodies, but the effect of insulin is greatly reduced, so the insulin in patients is a relatively deficient

Method used

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  • Medicine preparation formulation for treating type 2 diabetes and preparation method of medicine preparation formulation
  • Medicine preparation formulation for treating type 2 diabetes and preparation method of medicine preparation formulation
  • Medicine preparation formulation for treating type 2 diabetes and preparation method of medicine preparation formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1) Preparation of 100mg Sitagliptin Phosphate for Injection

[0036] Prescription composition (1000 prescriptions)

[0037]

[0038] 2) Preparation process:

[0039] (1) Take 80% of the prescribed amount of phosphate buffer solution with a pH value of 4.5 and cool it down to 25°C ± 5°C;

[0040] (2) add dexpanthenol, mannitol, Tween 80 of prescription quantity and make stirring and dissolving, then slowly and evenly add the sitagliptin phosphate of prescription quantity and make stirring fully dissolve;

[0041] (3) Adjust the pH value to 5.06, add 0.1% (w / v) activated carbon and stir evenly, keep the temperature at 25°C±5°C, and adsorb for 30 minutes;

[0042] (4) Decarburization, add phosphate buffer solution with a pH value of 4.5 to the prescribed amount, filter the filtrate through a two-stage 0.22 micron microporous membrane, and fill it into a brown vial that has been sterilized at >350°C for >5 minutes medium, vacuum freeze-dried after half-corking.

[00...

Embodiment 2

[0049] 1) Preparation of 80mg Sitagliptin Phosphate for Injection

[0050] Prescription composition (1000 prescriptions)

[0051]

[0052] 2) Preparation process:

[0053] (1) Take 80% of the prescribed amount of phosphate buffer solution with a pH value of 4.8 and cool it down to 25°C ± 5°C;

[0054] (2) add dexpanthenol, mannitol, Tween 80 of prescription quantity and make stirring and dissolving, then slowly and evenly add the sitagliptin phosphate of prescription quantity and make stirring fully dissolve;

[0055] (3) Adjust the pH value to 5.09, add 0.2% (w / v) activated carbon and stir evenly, keep the temperature at 25°C±5°C, and adsorb for 30 minutes;

[0056] (4) Decarburization, add phosphate buffer solution with a pH value of 4.8 to the prescribed amount, filter the filtrate through a two-stage 0.2-micron microporous membrane, and fill it into a brown vial that has been sterilized at >350°C for >5 minutes medium, vacuum freeze-dried after half-corking.

[0057...

Embodiment 3

[0063] 1) Preparation of 120mg Sitagliptin Phosphate for Injection

[0064] Prescription composition (1000 prescriptions)

[0065]

[0066] 2) Preparation process:

[0067] (1) Take 80% of the prescribed amount of phosphate buffer solution with a pH value of 5.0 and cool it down to 25°C ± 5°C;

[0068] (2) add dexpanthenol, mannitol, Tween 80 of prescription quantity and make stirring and dissolving, then slowly and evenly add the sitagliptin phosphate of prescription quantity and make stirring fully dissolve;

[0069] (3) Adjust the pH value to 5.12, add 0.15% (w / v) activated carbon and stir evenly, keep the temperature at 25°C±5°C, and adsorb for 30 minutes;

[0070] (4) Decarburization, add phosphate buffer solution with a pH value of 5.0 to the prescribed amount, filter the filtrate through a double-stage 0.21-micron microporous membrane, and fill it into a brown vial that has been sterilized at >350°C for >5 minutes medium, vacuum freeze-dried after half-corking.

...

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Abstract

The invention discloses a medicine preparation formulation for treating type 2 diabetes. The medicine preparation formulation consists of active components namely sitagliptin phosphate, pharmaceutically acceptable excipients, solubilizers, dexpanthenol, and a buffer solution of which the pH value is 4.0-5.5 according to the compounding proportion being (10-50):(10-100):(0.5-1):(40-100):(500-1000)(g:g:g:g:ml). The invention further discloses a preparation method of the medicine preparation formulation for treating type 2 diabetes, and the pH value is adjusted to be 4.5-5.5. The medicine preparation formulation for treating type 2 diabetes is prepared through the steps of adding activated carbon, performing uniform stirring, performing adsorption at the temperature of 30 DEG C or below for20-30 minutes, performing decarbonizing, filtering filtrate with a dual-stage millipore filter of 0.2-0.22 micron, performing filling in a brown penicillin bottle sterilized at 350 DEG C for 5 minutes, performing semi-pressing and plugging, and then performing vacuum freeze drying. The sitagliptin phosphate is good in injection type stability, not liable to decompose, convenient to use, good in tolerance, and stable when being stored for a long time.

Description

technical field [0001] The invention relates to a pharmaceutical dosage form for treating type 2 diabetes. [0002] The invention also relates to a preparation method of a pharmaceutical dosage form, in particular to a preparation method of a pharmaceutical dosage form for treating type 2 diabetes. Background technique [0003] Type 2 diabetes is adult-onset diabetes, mostly after the age of 35-40, accounting for more than 90% of diabetic patients. The ability to produce insulin in the patient's body is not completely lost. Some patients even produce too much insulin in their body, but the effect of insulin is greatly reduced, so the insulin in the patient's body is relatively deficient. [0004] Type 2 diabetes has stronger genetic and environmental factors and is significantly heterogeneous. At present, it is believed that the cause of the disease is the combination of insulin resistance (mainly manifested as hyperinsulinemia and decreased glucose utilization rate) and i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4985A61K47/18A61P3/10F26B5/06
CPCA61K9/19A61K31/4985A61K47/18A61P3/10F26B5/06
Inventor 王宇丰毛永强万山青
Owner 山西诺普生物医药科技有限责任公司
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