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Pantoprazole sodium for injection and preparation method thereof

A technology for pantoprazole sodium and injection, which is applied in the field of medicine and can solve the problems of destructive changes in chemical structure, low stability of pantoprazole sodium, poor stability of pantoprazole sodium, etc.

Active Publication Date: 2021-05-18
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pantoprazole sodium has poor stability and is very sensitive to light, heat, oxygen, water, etc., especially in acidic conditions, its chemical structure can undergo destructive changes, discoloration and polymerization, so it is not suitable for making water for injection , suitable for making freeze-dried powder injection
In order to ensure the stability of pantoprazole sodium, the prior art usually adds a lot of auxiliary materials, but the addition of too many auxiliary materials will increase the safety risk of medication, so the products with national approval numbers currently on the market still use mannitol, edide, etc. Disodium diacetate is mainly used as adjuvant. Although the use of mannitol and edetate disodium these two common and safe adjuvants has ensured the safety of the drug, it has little significance for improving the stability of pantoprazole sodium.

Method used

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  • Pantoprazole sodium for injection and preparation method thereof
  • Pantoprazole sodium for injection and preparation method thereof
  • Pantoprazole sodium for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Preparation of Pantoprazole Sodium for Injection (Specification: 40mg)

[0048] prescription:

[0049] Pantoprazole sodium: 40g

[0050] Mannitol: 25g

[0051] Edetate disodium: 0.5g

[0052] Water for injection up to 1000ml

[0053] Process:

[0054] 1. According to the prescription, add pantoprazole sodium, mannitol, and edetate disodium into 600ml water for injection and stir to dissolve, add water for injection to 1000ml, and stir well.

[0055] 2. Add 0.10g / 100ml of activated carbon to the solution in step 1, stir for 20 minutes, filter and sterilize with a 0.22μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume (about 1ml) according to the specifications, and divide into half-stoppered Score the liquid.

[0056] 3. Freeze-drying:

[0057] ①Pre-freezing: put the aliquot in a freezer that has been cooled to -33°C in advance, and keep it for 2 hours;

[0058] ②Sublimation: Turn on the vacuum device, a...

Embodiment 2

[0060] Example 2 Preparation of Pantoprazole Sodium for Injection (Specification: 40mg)

[0061] prescription:

[0062] Pantoprazole sodium: 40g

[0063] Mannitol: 25g

[0064] Edetate disodium: 0.5g

[0065] Water for injection up to 1000ml

[0066] Process:

[0067] 1. According to the prescription, add pantoprazole sodium, mannitol, and edetate disodium into 600ml water for injection and stir to dissolve, add water for injection to 1000ml, and stir well.

[0068] 2. Add 0.10g / 100ml of activated carbon to the solution in step 1, stir for 20 minutes, filter and sterilize with a 0.22μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume (about 1ml) according to the specifications, and divide into half-stoppered Score the liquid.

[0069] 3. Freeze-drying:

[0070] ① Pre-freezing: put the aliquot in a freezer that has been cooled to -42°C in advance, and keep it for 3 hours;

[0071] ②Sublimation: Turn on the vacuum device, ad...

Embodiment 3

[0073] Example 3 Preparation of Pantoprazole Sodium for Injection (Specification: 40mg)

[0074] prescription:

[0075] Pantoprazole sodium: 40g

[0076] Mannitol: 25g

[0077] Edetate disodium: 0.5g

[0078] Water for injection up to 1000ml

[0079] Process:

[0080] 1. According to the prescription, add pantoprazole sodium, mannitol, and edetate disodium into 600ml water for injection and stir to dissolve, add water for injection to 1000ml, and stir well.

[0081] 2. Add 0.10g / 100ml of activated carbon to the solution in step 1, stir for 20 minutes, filter and sterilize with a 0.22μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume (about 1ml) according to the specifications, and divide into half-stoppered Score the liquid.

[0082] 3. Freeze-drying:

[0083] ① Pre-freezing: Place the aliquot in a freezer that has been cooled to -37°C in advance and keep it for 22.5 hours;

[0084] ②Sublimation: Turn on the vacuum devi...

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Abstract

The invention relates to a pantoprazole sodium for injection and a preparation method thereof. The pantoprazole sodium for injection is prepared by freeze-drying pantoprazole sodium, mannitol and disodium edetate. 60mg and 80mg. The pantoprazole sodium for injection prepared by the invention has good quality and high stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to pantoprazole sodium for injection and a preparation method thereof. Background technique [0002] Pantoprazole Sodium (PantoprazoleSodium), chemical name: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)]-sulfinyl-1H-benzimidazole sodium salt. Pantoprazole sodium is a new generation of proton pump inhibitors (PPI) after omeprazole and lansoprazole, and is the first-line treatment for peptic ulcer disease. After being marketed globally, it immediately became a specific drug for the treatment of acid-related digestive system disorders due to its strong and long-lasting acid-suppressing effect, high ulcer healing rate, few adverse reactions and few drug interactions. Pantoprazole sodium injection is mainly used for peptic ulcer bleeding, acute gastric mucosal injury caused by non-steroidal anti-inflammatory drugs, ulcer bleeding under stress, general anesthesia or major surgery, a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/18A61K47/04A61K31/4439A61P1/04
CPCA61K9/0019A61K9/19A61K31/4439A61K47/02A61K47/183A61K47/26
Inventor 胡成忠周艳
Owner 湖北美林药业有限公司
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