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IAPP (Islet Amyloid Polypeptide) analog injection with better stability

An analogue and stable technology, applied in the direction of drug combinations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of poor stability and unfavorable patient acceptance

Active Publication Date: 2011-08-10
无锡市恒益健康科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has poor stability and can only be stored at a refrigerator temperature of 2°C to 8°C; when it is injected intravenously or intramuscularly, it will cause pain at the injection site, which is not conducive to patient acceptance.

Method used

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  • IAPP (Islet Amyloid Polypeptide) analog injection with better stability
  • IAPP (Islet Amyloid Polypeptide) analog injection with better stability
  • IAPP (Islet Amyloid Polypeptide) analog injection with better stability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Pramlintide acetate (0.60 mg / ml as pramlintide), 2.25 mg / ml m-cresol, 43.00 mg / ml mannitol, 0.1% w / v sodium bisulfite, 2% w / v benzyl alcohol, with Acetic acid and sodium acetate regulate pH to be 4.0, and its preparation process is as follows:

[0023] Weigh pramlintide acetate (3g in terms of pramlintide), 11.25g m-cresol, 215.0g mannitol, 5.0g sodium bisulfite, 100.0g benzyl alcohol, dissolve completely with 80% water for injection of prescription quantity, and use acetic acid Adjust the pH to 4.0 with sodium acetate, and add water for injection to 5000ml. Before filtering, add 5g of activated carbon to the injection, absorb pyrogen for 30 minutes under stirring, decarbonize and filter. The filtrate was filtered through a 0.22 μm titanium rod filter, and then sterilized and filtered through a 0.22 μm microporous membrane, filled in a 7ml sterilized vial (5ml / bottle), and sealed with a cap. Make each vial equivalent to 3 mg pramlintide.

[0024] Prepare 1000 bottles...

Embodiment 2

[0056] Pramlintide acetate (0.60 mg / ml as pramlintide), 2.25 mg / ml m-cresol, 43.00 mg / ml mannitol, 0.1% w / v sodium metabisulfite, 0.4% w / v chlorobutanol, Regulate pH with acetic acid and 1 sodium acetate to be 4.0, and its preparation process is as follows:

[0057] Weigh pramlintide acetate (3g in pramlintide), 11.25g m-cresol, 215.0g mannitol, 5.0g sodium metabisulfite, 20.0g chlorobutanol, dissolve completely with prescription amount 80% water for injection, use Adjust the pH to 4.0 with acetic acid and sodium acetate, and add water for injection to 5000ml. Before filtering, add 5g of activated carbon to the injection, absorb pyrogen for 30 minutes under stirring, decarbonize and filter. The filtrate was filtered through a 0.22 μm titanium rod filter, and then sterilized and filtered through a 0.22 μm microporous membrane, filled in a 7ml sterilized vial (5ml / bottle), and sealed with a cap. Make each vial equivalent to 3 mg pramlintide.

[0058] Prepare 1000 bottles of p...

Embodiment 3

[0090] Pramlintide acetate (1.00 mg / ml as pramlintide), 2.25 mg / ml m-cresol, 5% w / v glucose, 0.1% w / v ascorbic acid, 2% w / v benzyl alcohol, with acetic acid and acetic acid Sodium regulates pH to be 4.0, and its preparation process is as follows:

[0091] Weigh pramlintide acetate (1.5g in terms of pramlintide), 3.38g m-cresol, 75.0g glucose, 1.5g ascorbic acid, 30.0g benzyl alcohol, dissolve completely with prescription amount 80% water for injection, and use acetic acid and sodium acetate Adjust the pH to 4.0, add water for injection to 1500ml. Before filtering, add 1.5g of activated carbon to the injection, absorb pyrogen for 30 minutes under stirring, decarbonize and filter. The filtrate was filtered through a 0.22 μm titanium rod filter, and then sterilized and filtered through a 0.22 μm microporous membrane, filled in a 3 ml sterilized vial (1.5 ml / bottle), and sealed with a cap. Make each vial equivalent to 1.5 mg pramlintide.

[0092] Prepare 1000 bottles of pramlin...

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PUM

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Abstract

The invention relates to an IAPP (Islet Amyloid Polypeptide) analog injection with better stability. The preparation consists of pramlintide acetate, antiseptic, isoosmotic adjustment agent. pH value adjusting agent, antioxidant, local painkiller and solvent, wherein the antioxidant is added to enhance the stability of the preparation and the local painkiller is added to mitigate the pain of patient without impacting basic remedy. The preparation process of the preparation mainly comprises weighing, dissolution, pyrogen adsorption by activated carbon, filtration, end filtration, subpackage and piston injection and capping. The preparation is used as a medicine for the auxiliary treatment of Type I and Type II diabetes in order to achieve the therapeutic effect of assisting in blood sugar reduction. The preparation is stable in quality, accurate in therapeutic effect and favorable for being accepted by patients.

Description

Technical field: [0001] The invention relates to the field of preparations, in particular to a more stable IAPP analogue injection. Background technique: [0002] Pramlintide (Pramlintide) is a synthetic analogue of amylin, and it is also the second drug approved for the treatment of type 1 diabetes after insulin so far. Clinical studies have found that when pramlintide is used in combination with insulin, it may lead to moderate weight loss in patients. [0003] Amylin is a polypeptide hormone composed of 37 amino acid residues, which is released by pancreatic β-cells after a meal and has various physiological functions, such as slowing down the absorption rate of food (including glucose) in the small intestine, inhibiting high Glucagon reduces the production of glycogen, reduces the patient's appetite, assists the body to regulate blood sugar levels, and so on. However, natural amylin is not stable in solution, is easily hydrolyzed, and has the characteristics of high vi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/22A61K47/12A61K47/26A61P3/10
Inventor 李新宇支钦姚志勇
Owner 无锡市恒益健康科技有限公司
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