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Pantoprazole sodium freeze-drying preparation, preparation method thereof, and injection preparation prepared from pantoprazole sodium freeze-drying preparation

A technology for pantoprazole sodium and freeze-dried preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of long freeze-drying time and instability of pantoprazole sodium freeze-dried preparations, and achieve stable product quality, clarity and color stability , Improving the effect of molding and color

Inactive Publication Date: 2020-09-11
武汉九州钰民医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved in the present invention is in order to overcome the instability of prior art pantoprazole sodium freeze-dried preparation, the long defect of freeze-drying time, and a kind of pantoprazole sodium freeze-dried preparation and preparation method thereof are provided, by Injectable preparations made from it

Method used

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  • Pantoprazole sodium freeze-drying preparation, preparation method thereof, and injection preparation prepared from pantoprazole sodium freeze-drying preparation
  • Pantoprazole sodium freeze-drying preparation, preparation method thereof, and injection preparation prepared from pantoprazole sodium freeze-drying preparation
  • Pantoprazole sodium freeze-drying preparation, preparation method thereof, and injection preparation prepared from pantoprazole sodium freeze-drying preparation

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Embodiment 1

[0031] The preparation of embodiment 1 injection pantoprazole sodium freeze-dried preparation

[0032] In Example 1, batches 1, 2 and 3 are different batches of products prepared by the method in Example 1.

[0033] The prescription of this product is as follows Table 1:

[0034] Table 1 Product prescription

[0035] Raw materials unit dose Pantoprazole Sodium Sesquihydrate 45.1mg Edetate Disodium (for injection) 1mg sodium hydroxide 0.24mg Water for Injection Add to 2ml

[0036] Take the water for injection below 30°C, inject nitrogen gas, add water for injection according to the amount of 95% of the water for injection in the prescription amount, cool the water for injection below 30°C, fill with nitrogen gas, and weigh edetate disodium according to the prescription amount Put it into the liquid mixing tank, and circulate and stir for at least 5 minutes until it is completely dissolved; add a part of sodium hydroxide solution, and...

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Abstract

The invention discloses a pantoprazole sodium freeze-drying preparation, a preparation method thereof, and an injection preparation prepared from the pantoprazole sodium freeze-drying preparation. Thepreparation method comprises the steps of uniformly mixing pantoprazole sodium with auxiliary materials, and performing freeze-drying, wherein freeze-drying steps comprise pre-freezing, drying for the first time and parsing drying, drying for the first time comprises substeps of vacuumizing pre-freezing products, performing doping with nitrogen, raising temperature to minus 11-minus 13 DEG C, andmaintaining the temperature being minus 11-minus 13 DEG C for 9-11h, raising temperature to minus 4-minus 6 DEG C, maintaining the temperature being minus 4-minus 6 DEG C for 3-5h, quickly raising the temperature to minus 2-2DEG C and maintaining the temperature being minus 2-2DEG C for 1-2h, and parsing drying comprises steps of quickly raising the temperature to 9-11 DEG C, maintaining the temperature being 9-11 DEG C for 2-4h, raising the temperature to 28-30 DEG C, maintaining the temperature being 28-30 DEG C for 1-3h, performing ultimate vacuumizing, and continuing performing heat insulation. The pantoprazole sodium freeze-drying preparation provided by the invention has the advantages of being good in stability and low in impurity content, and the preparation method is short in freeze-drying time.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pantoprazole sodium freeze-dried preparation, a preparation method thereof, and an injection preparation prepared therefrom. Background technique [0002] Pantoprazole Sodium (Pantoprazole Sodium), chemical name: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)-methyl]-sulfinyl-1H - benzimidazole sodium salt. It is clinically used for duodenal ulcer, gastric ulcer, Zoller's syndrome, and moderate to severe reflux esophagitis, and its advantages are high cure rate and fast cure speed. 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 It is suitable for making freeze-dried powder injection. [0003] However, due to the extremely unstable...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/18A61K47/02A61K31/4439A61P1/04
CPCA61K9/0019A61K9/19A61K31/4439A61K47/02A61K47/183A61P1/04
Inventor 范昭泽姚萍刘松林陈龙张璐余艳平柳少群龚丹凤陈程顿伟许勇
Owner 武汉九州钰民医药科技有限公司
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