Preparation method and packaging method of octreotide acetate injection

A technology of octreotide acetate and encapsulation method, which is applied in the field of pharmacy, can solve problems such as poor stability of octreotide acetate injection, and achieve the effect of improving stability

Inactive Publication Date: 2021-09-07
SPH NO 1 BIOCHEM & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The present invention is in order to overcome the problem of poor stability of octreotide acetate injection in the prior art, and provides a kind of preparation method of octreotide acetate injection and packagi

Method used

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  • Preparation method and packaging method of octreotide acetate injection
  • Preparation method and packaging method of octreotide acetate injection
  • Preparation method and packaging method of octreotide acetate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Table 1: Prescription

[0022] composition Dosage Octreotide Acetate 0.1g lactic acid 3.5g Mannitol 45g sodium bicarbonate Appropriate amount Add water for injection to 1L

[0023] Preparation Process:

[0024] Measure 850mL of water for injection (the water temperature is controlled at 5-25°C), add 3.5g of lactic acid, stir and dissolve evenly, add 45g of mannitol, stir and dissolve evenly, adjust the pH value of the above solution to 4.2 with 6% sodium bicarbonate solution, add acetic acid Octreotide 0.1g, stir until dissolved evenly, add water for injection to 1L. The medicinal solution is sterilized and filtered through a secondary 0.2μm filter element. The liquid medicine is filled in a 2mL medium borosilicate vial, filled with carbon dioxide, quickly corked and capped.

Embodiment 2

[0026] Table 2: Prescription

[0027] composition Dosage Octreotide Acetate 0.1g lactic acid 3.6g Mannitol 40g sodium bicarbonate Appropriate amount Add water for injection to 1L

[0028] Measure 850mL of water for injection (the water temperature is controlled at 5-25°C), add 3.6g of lactic acid, stir and dissolve evenly, add 40g of mannitol, stir and dissolve evenly, adjust the pH value of the above solution to 4.1 with 5% sodium bicarbonate solution, add acetic acid Octreotide 0.1g, stir until dissolved evenly, add water for injection to 1L. The medicinal solution is sterilized and filtered through a secondary 0.2μm filter element. The liquid medicine is filled in a 2mL medium borosilicate vial, filled with carbon dioxide, quickly corked and capped.

Embodiment 3

[0030] The preparation of octreotide acetate injection does not use the carbon dioxide protective gas process.

[0031] Table 3: Prescription

[0032] composition Dosage Octreotide Acetate 0.1g lactic acid 3.5g Mannitol 45g sodium bicarbonate Appropriate amount Add water for injection to 1L

[0033] Preparation Process:

[0034] Measure 850mL of water for injection (the water temperature is controlled at 5-25°C), add 3.5g of lactic acid, stir and dissolve evenly, add 45g of mannitol, stir and dissolve evenly, adjust the pH value of the above solution to 4.2 with 6% sodium bicarbonate solution, add acetic acid Octreotide 0.1g, stir until dissolved evenly, add water for injection to 1L. The medicinal solution is sterilized and filtered through a secondary 0.2μm filter element. The liquid medicine is filled in 2mL medium borosilicate vials, corked and capped.

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PUM

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Abstract

The invention discloses a preparation method and a packaging method of an octreotide acetate injection. The preparation method comprises the following steps: (1) mixing lactic acid with water for injection; (2) mixing mannitol with the mixture obtained in the step (1); (3) adjusting the pH value of the mixture obtained in the step (2), and then adding octreotide acetate; (4) filtering to obtain an octreotide acetate injection; and (5) adding the water for injection to the total amount. The stability of the octreotide acetate injection can be effectively improved, so that the octreotide acetate injection still has stable pH value and octreotide acetate total amount and low maximum single impurity and total impurity percentage after being stored for 5 days and 10 days. The packaging method comprises the step of filling carbon dioxide, the stability of the octreotide acetate injection under the conditions of high temperature and illumination can be improved, and after the octreotide acetate injection is stored for 5 days, 10 days and 30 days, the high octreotide acetate content and the low maximum single impurity and total impurity percentage can still be kept.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method for the stability of octreotide acetate injection and a packaging method thereof. Background technique [0002] Octreotide acetate is clinically used in the emergency treatment of esophageal-gastric variceal bleeding caused by liver cirrhosis, and it is used in combination with special treatment (such as endoscopic sclerotherapy). Relief of signs and symptoms associated with gastroenteropancreatic endocrine tumors. Such diseases have great adverse effects and require mutual medication, so the requirements for drug quality and stability are relatively high. [0003] Octreotide acetate is a polypeptide drug with poor stability, and its stability needs to be improved through optimization of prescription and process. The present invention aims to provide a preparation method of octreotide acetate injection and a packaging method thereof, thereby improving th...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/08A61K47/10A61K47/12A61P1/16A61P7/04
CPCA61K38/08A61K9/0019A61K9/08A61K47/12A61K47/10A61P7/04A61P1/16
Inventor 朱玲玲陈辰丁金国
Owner SPH NO 1 BIOCHEM & PHARMA CO LTD
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