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Sterilization and preparation method of octreotide acetate injection

A technology of octreotide acetate and sterilization methods, which is applied in the field of sterilization and preparation of octreotide acetate liquid preparations, can solve problems such as instability and lack of high-temperature and damp-heat sterilization methods for octreotide acetate injections, and achieve the effect of improving drug safety

Active Publication Date: 2021-10-19
SICHUAN HUIYU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] It can be seen that the existing sterilization process related documents all stipulate that the sterilization method of injection preparations should be the first choice of moist heat sterilization, but for octreotide acetate injection, Due to its special instability, so far there is no suitable high temperature and humidity sterilization method for octreotide acetate injection

Method used

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  • Sterilization and preparation method of octreotide acetate injection
  • Sterilization and preparation method of octreotide acetate injection
  • Sterilization and preparation method of octreotide acetate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] prescription:

[0070] Table 1

[0071]

[0072] The preparation method of octreotide acetate injection comprises the steps:

[0073] Step 1: Prepare sodium bicarbonate solution, take 105g sodium bicarbonate, add cooled water for injection 1395g, use glass rod to stir until completely dissolved;

[0074] Step 2: Add 28L of cooled water for injection into the liquid preparation container, pass carbon dioxide into the water, filter it through a 0.22μm PTFE filter element to sterilize and filter, start stirring to make the dissolved oxygen in the water less than 0.3mg / L, and process in steps 3 to 7 To ensure the continuous introduction of carbon dioxide;

[0075] Step 3: Add 1800g mannitol and 136g lactic acid, stir until completely dissolved;

[0076] Step 4: Add 4.6g of octreotide acetate and stir until completely dissolved;

[0077] Step 5: adjust the pH of the solution obtained in step 4 to 4.2 with the sodium bicarbonate solution prepared in step 1;

[0078] S...

Embodiment 2

[0084] prescription:

[0085] Table 2

[0086]

[0087]

[0088] The preparation method of octreotide acetate injection comprises the steps:

[0089] Step 1: Prepare sodium bicarbonate solution, take 7g of sodium bicarbonate, add 93g of cooled water for injection, stir with a glass rod until completely dissolved;

[0090] Step 2: Add 80mL of cooled water for injection into the liquid mixing container, pass carbon dioxide into the water, filter it through a 0.22μm PTFE filter element for sterilization, start stirring, so that the dissolved oxygen in the water is less than 0.3mg / L, and process in steps 3 to 7 To ensure the continuous introduction of carbon dioxide;

[0091] Step 3: Add 45g of mannitol and 3.4g of lactic acid, stir until completely dissolved;

[0092] Step 4: Add 117.87mg of octreotide acetate and stir until completely dissolved;

[0093] Step 5: adjust the pH of the solution obtained in step 4 to 4.2 with the sodium bicarbonate solution prepared in ste...

Embodiment 3

[0100] prescription:

[0101] table 3

[0102]

[0103]

[0104] The preparation method of octreotide acetate injection comprises the steps:

[0105] Step 1: Prepare sodium bicarbonate solution, take 7g of sodium bicarbonate, add 93g of cooled water for injection, stir with a glass rod until completely dissolved;

[0106] Step 2: Add about 80mL of cooled water for injection into the liquid preparation container, pass carbon dioxide into the water, filter it through a 0.22μm PTFE filter element for sterilization, start stirring, so that the dissolved oxygen in the water is less than 0.3mg / L, and in steps 3 to 7 Ensure the continuous introduction of carbon dioxide during the process;

[0107] Step 3: Add 45g of mannitol and 3.4g of lactic acid, stir until completely dissolved;

[0108] Step 4: Add 117.87mg of octreotide acetate and stir until completely dissolved;

[0109] Step 5: adjust the pH of the solution obtained in step 4 to 4.2 with the sodium bicarbonate solut...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a sterilization and preparation method of an octreotide acetate liquid preparation. The sterilization and preparation method of the octreotide acetate liquid preparation provided by the invention comprises the following steps: preparing under the protection of inert gas, and then performing 0.22-micron filtration and 115-124 DEG C high-temperature sterilization to obtain the octreotide acetate liquid preparation. The stability of octreotide acetate is maintained through reasonable sterilization conditions, the highest sterility guarantee level is guaranteed, the medication safety is improved, and the product is lower in impurity content, better in stability and better in quality.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a method for sterilization and preparation of octreotide acetate liquid preparations. Background technique [0002] Octreotide Acetate (Octreotide Acetate) is a synthetic polypeptide composed of eight amino acids, its chemical name is: D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophanyl-L- Lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteineamide ring (2→7)-disulfide bond Acetate, its English chemical name is: LCysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl] -, cyclic(2→7)-disulfide; [R-(R*,R*)] acetate salt, CAS: 83150-76-9. Octreotide acetate has a variety of physiological activities, such as inhibiting growth hormone and thyrotropin; inhibiting the secretion of gastric acid, pancreatic enzymes, glucagon and insulin; reducing gastric motility and gallbla...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/07A61L2/04
CPCA61L2/0023A61L2202/21Y02A50/30
Inventor 付训忠张吉旺胡和平丁兆张桂林李瑞如唐棋
Owner SICHUAN HUIYU PHARMA
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