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Preparation method of pharmaceutical preparation and injection of exenatide acetate

A technology for exenatide and preparations, applied in the field of exenatide injection and its preparation, can solve problems such as adverse reactions and achieve the effect of stable quality

Inactive Publication Date: 2010-02-10
JIANGSU WANBANG BIOPHARMLS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commonly used drugs may cause adverse reactions in the body. Therefore, it is necessary to develop a more ideal therapeutic approach to control blood sugar for patients with type 2 diabetes

Method used

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  • Preparation method of pharmaceutical preparation and injection of exenatide acetate
  • Preparation method of pharmaceutical preparation and injection of exenatide acetate
  • Preparation method of pharmaceutical preparation and injection of exenatide acetate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Exenatide injection, including the following components:

[0033]

[0034]

[0035] The preparation method of exenatide injection, according to the following steps:

[0036] Step 1: Dissolve the auxiliary materials chlorobutanol (preservative), mannitol (isotonic agent), glacial acetic acid and sodium acetate trihydrate (buffering agent) in sequence with water for injection according to the prescription amount and move them into the batching tank, and stir Dissolved, the amount of water for injection should be more than 75% of the total volume of the liquid medicine;

[0037] Step 2: After the excipients are completely dissolved, dissolve exenatide with water for injection and move it into the batching tank, and stir evenly;

[0038] Step 3: Add water for injection to the total volume, mix well, and measure the pH value of the liquid to be around 4.5;

[0039] Step 4: Filter and sterilize the drug solution with a 0.22 μm filter membrane to make exenatide injecti...

Embodiment 2

[0041] Exenatide injection, including the following components:

[0042]

[0043] The preparation method of exenatide injection, according to the following steps:

[0044] Step 1: Dissolve the excipients chlorobutanol (preservative), mannitol (isotonic agent), glacial acetic acid and sodium acetate trihydrate (buffer) in sequence with water for injection according to the prescription amount and move them into the batching tank for injection. The amount of water used should be more than 75% of the total volume of the liquid medicine;

[0045] Step 2: After the excipients are completely dissolved, take an appropriate amount of exenatide solution and water for injection, dissolve the exenatide and move it into the batching tank, and stir evenly;

[0046] Step 3: Add water for injection to the total volume, mix well, and measure the pH value of the liquid to be around 4.5;

[0047] Step 4: Filter and sterilize the drug solution with a 0.22 μm filter membrane to make exenatide...

Embodiment 3

[0049] Exenatide injection, including the following components:

[0050]

[0051] Exenatide injection is prepared according to the following steps:

[0052] Step 1: Dissolve the excipients chlorobutanol (preservative), mannitol (isotonic agent), glacial acetic acid and sodium acetate trihydrate (buffer) in sequence with water for injection according to the prescription amount and move them into the batching tank for injection. The amount of water used should be more than 75% of the total volume of the liquid medicine;

[0053] Step 2: After the excipients are completely dissolved, take an appropriate amount of exenatide solution and water for injection, dissolve the exenatide and move it into the batching tank, and stir evenly;

[0054] Step 3: Add water for injection to the total volume, mix well, and measure the pH value of the liquid to be around 4.5;

[0055] Step 4: Filter and sterilize the drug solution with a 0.22 μm filter membrane to make exenatide injection, and...

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Abstract

The invention relates to a preparation method of pharmaceutical preparation and injection of exenatide acetate. The exenatide acetate pharmaceutical preparation is a stable liquid formulation appliedto a plurality of dosing manners. Per 100ml of the pharmaceutical preparation contains at least the exenatide acetate of 0.005-0.4g, preservative of 0.1-0.75g, appropriate amount of buffer and isotonic agent, wherein the preservative is chosen from one or two of chlorobutanol and phenethyl alcohol, with pH value of the pharmaceutical preparation being 3.0-7.0. The preparation method has the following steps: dissolving auxiliary materials of the preservative, the isotonic agent and the buffer according to prescription amount by using water for injection, and immigrating the dissolving solutioninto batching pot; taking the auxiliary solution or the water for injection to dissolve the exenatide acetate; and replenishing the water for injection to total volume and uniformly stirring; filtering the pharmaceutical preparation for degerming by using filter membrane of 0.22mu m to produce the exenatide acetate injection. The invention has the advantages that the preservative of chlorobutanolhas the dual effects of bacteriostasis and local pain relieving; and the exenatide acetate completes the stability examination of high temperature, hard light, long-term experiment and speed-up experiment, thus having stable quality and fitting for long-term storage.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to an exenatide injection and a preparation method thereof. Background technique [0002] Diabetes mellitus is a metabolic disorder characterized by chronic hyperglycemia caused by a variety of etiologies. Hyperglycemia is mainly caused by defects in insulin secretion or action. At present, the treatment goal of type 2 diabetes is to make blood sugar reach or close to the normal level, based on diet therapy and physical exercise, and give drug treatment according to different conditions. Commonly used drugs may cause adverse reactions in the body. Therefore, it is necessary to develop a more ideal therapeutic approach to control blood sugar for patients with type 2 diabetes. [0003] Exenatide (also known as Exenatide or Exenatide) is a synthetic exendin-4, which is an analogue of human glucagon-like peptide-1 (GLP-1). The sequence partially overlaps with the amino acid sequence ...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K9/08A61K47/10A61K47/34A61K47/26A61K47/12A61P3/10
Inventor 乔德水孙秀丽高雪芹陈慧徐良芹
Owner JIANGSU WANBANG BIOPHARMLS
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