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Pharmaceutical composition and preparation method and use thereof

A composition and drug technology, applied in the field of pharmaceutical composition and its preparation, can solve problems such as side effects, increased pancreatitis, and inconvenience of injection forms

Inactive Publication Date: 2015-06-17
上海建华精细生物制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inconvenience of injectable dosage forms and the side effects of drug injection are the main drawbacks of this class of drugs (gastrointestinal reactions, increased risk of pancreatitis, thyroid cancer, etc.)
In addition, pharmaceutical giants such as Sanofi, Roche, and GlaxoSmithKline are also developing new GLP preparations with long half-lives, but these studies are all based on subcutaneous injections.

Method used

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  • Pharmaceutical composition and preparation method and use thereof
  • Pharmaceutical composition and preparation method and use thereof
  • Pharmaceutical composition and preparation method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Design of main drug components of GLP-1 prodrug composition

[0053] According to the GLP-1 precursor structure diagram ( figure 1 ) designed the GLP-1 full-length prodrug molecule G52 and the prodrug molecule G37 consisting of the 1-52 amino acids of GLP-1, and synthesized them by chemical methods. At the same time, GLP-1 (7-37) polypeptide was synthesized as a control.

[0054] GLP-1 precursor polypeptide 1: GLP-1 (1-52), referred to as G52;

[0055] GLP-1 precursor polypeptide 2: GLP-1 (1-37), referred to as G37;

[0056] GLP-1 polypeptide: GLP-1 (7-37), referred to as G31.

Embodiment 2

[0058] Preparation of G31 (GLP-1, 7-37) enteric-coated preparation

[0059] Packaging of the drug layer

[0060] Weigh 75 mg of G31 polypeptide, 19 grams of bovine serum albumin (BSA), 5 grams of 10% hypromellose (HPMC), add 45 grams of purified water and mix well, use microcrystalline cellulose pellets CP507 as the inner core, use Fluidized bed coating: the air outlet temperature is set to 32 degrees, the air volume is 15m3 / h, and the spray pressure is 0.7bar.

[0061] protective wrapping

[0062] Weigh 2 grams of magnesium stearate, add 8 grams of ethanol, disperse evenly, add 80 grams of HPMC and 40 grams of pure water, and coat with a fluidized bed: the air outlet temperature is set to 32 degrees, the air volume is 20m3 / h, and the spray pressure is 0.9 bar.

[0063] Enteric coating

[0064] Weigh 18 grams of magnesium silicate, add 90 grams of pure water and stir evenly, add 4 grams of TEC (triethyl citrate), homogenize for 3-5 minutes, slowly add 40 grams of L30D-55 (...

Embodiment 3

[0067] Preparation of G37 (GLP-1, 1-37) enteric-coated preparation

[0068] Packaging of the drug layer

[0069] Weigh 95 mg of G37 polypeptide, 19 grams of bovine serum albumin (BSA), 5 grams of 10% hypromellose (HPMC), add 45 grams of purified water and mix well, use microcrystalline cellulose pellets CP507 as the inner core, use Fluidized bed coating: the air outlet temperature is set to 32 degrees, the air volume is 15m3 / h, and the spray pressure is 0.7bar.

[0070] protective wrapping

[0071] Weigh 2 grams of magnesium stearate, add 8 grams of ethanol, disperse evenly, add 80 grams of HPMC and 40 grams of pure water, and coat with a fluidized bed: the air outlet temperature is set to 32 degrees, the air volume is 20m3 / h, and the spray pressure is 0.9 bar.

[0072] Enteric coating

[0073] Weigh 18 grams of magnesium silicate, add 90 grams of pure water and stir evenly, add 4 grams of TEC (triethyl citrate), homogenize for 3-5 minutes, slowly add 40 grams of L30D-55 (...

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Abstract

The invention discloses a pharmaceutical composition and preparation method and use thereof. The pharmaceutical composition includes a polypeptide and a pharmaceutical acceptable carrier, and the polypeptide has at least 80% homology with human glucagon-like peptide-1 (GLP-1) precursor.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations. More specifically, it relates to a pharmaceutical composition and its preparation method and application. Background technique [0002] The number of diabetic patients in China has exceeded 90 million, becoming the country with the largest population of diabetics in the world. The sales of diabetes treatment drugs rank fourth after tumor drugs, blood lipid regulating drugs and respiratory system drugs. Currently commonly used diabetes drugs include insulin (injectable biological products), metformin, α-glucosidase inhibitors, sulfonylureas (oral chemical drugs), etc. The way of injecting drug administration often brings a lot of inconvenience to patients, and oral administration of chemical drugs has the disadvantages of poor hypoglycemic effect and large side effects. [0003] In the 1960s, researchers found that oral glucose had a significantly higher effect on insulin secretion tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/26A61K9/00A61K9/20A61K9/48A61K9/16A61P3/10
Inventor 张倩周庆玮钱悦杜鹏冯宝山丁红珍甘人宝
Owner 上海建华精细生物制品有限公司
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