S-pantoprazole sodium freeze-drying medicament composition and preparation method thereof

A technology of levo-pantoprazole sodium and its composition, which is applied in the field of levo-pantoprazole sodium freeze-dried pharmaceutical composition and its preparation, and can solve problems such as product quality impact, increased clinical risk, and stability of freeze-dried preparations , to achieve the effect of improving reproducibility and improving stability

Active Publication Date: 2012-09-26
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Chinese patent CN101810588A discloses the method of using pantoprazole sodium, mannitol, disodium edetate, sodium sulfite, and sodium citrate to prepare powder injection by freeze-drying, using more auxiliary materials, which increases the clinical risk
[0011] There are generally some corresponding deficiencies in the prior art. In addition, the prior art believes that moisture will affect the stability of the freeze-dried preparation. Therefore, various methods are adopted to reduce the moisture content in the product, so as to improve the stability of the product.
Formed a technical bias that moisture would have a negative impact on the quality of the product

Method used

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  • S-pantoprazole sodium freeze-drying medicament composition and preparation method thereof
  • S-pantoprazole sodium freeze-drying medicament composition and preparation method thereof
  • S-pantoprazole sodium freeze-drying medicament composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] 1. Prescription:

[0041]

[0042] 2. Preparation process:

[0043]Take water for injection prepared with a total volume of 80%, control the water temperature below 30°C, turn on the agitator, add 1g of disodium ethylenediaminetetraacetate and stir to dissolve, then add 40g of mannitol into the batching tank, stir to dissolve completely, add 1mol / L sodium hydroxide solution to adjust the pH value of the liquid to between 10.0 and 11.0, then add 21.15g of levopantoprazole sodium, stir to dissolve, add water for injection to the full amount, after completely dissolving, add 1g of activated carbon and stir for 15min Decarburization, sampling for pH value and content determination of the intermediate medicinal solution. After the intermediate is qualified, it is filtered, filled and stoppered, and the freeze-drying process is ended when the water content of the finished product is 10-12%, so as to obtain the final freeze-dried preparation.

Embodiment 2

[0045] 1. Prescription:

[0046]

[0047]

[0048] 2. Preparation process:

[0049] Take water for injection prepared with a total volume of 80%, control the water temperature below 30°C, turn on the agitator, add 1.5g of disodium calcium edetate and 20g of mannitol into the batching tank, stir to dissolve completely, add 1mol / L Sodium hydroxide solution adjusts the pH value of the medicinal solution to between 10.0 and 11.0, then add 21.15 g of levopantoprazole sodium, stir to dissolve, add water for injection to the full amount, and after complete dissolution, take a sample for the pH of the intermediate medicinal solution value and content determination. After the intermediate is qualified, it is filtered, filled, and stoppered, and the freeze-drying process is ended when the water content of the finished product is about 15%, to obtain the final freeze-dried preparation.

Embodiment 3

[0051] 1. Prescription:

[0052]

[0053] 2. Preparation process:

[0054] Take water for injection prepared with a total volume of 80%, control the water temperature below 30°C, turn on the agitator, add 0.5g disodium edetate and 70g dextran-40 into the batching tank, stir to dissolve completely, add 1mol / L Sodium carbonate solution adjusts the pH value of the medicinal solution to between 10.0 and 11.0, then add 21.15 g of levo-pantoprazole sodium, stir to dissolve, add water for injection to the full amount, after completely dissolving, add 1 g of activated carbon and stir for 15 minutes to decarburize. Sampling was carried out to determine the pH value and content of the intermediate medicinal solution. After passing the test of the intermediate, it is filtered, filled, and stoppered, and the freeze-drying process is ended when the water content of the finished product is 18-20%, so as to obtain the final freeze-dried preparation.

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Abstract

The invention discloses an s-pantoprazole sodium freeze-drying medicament composition and a preparation method thereof. The preparation method comprises the following steps of: preparing an un-freeze-dried solution from s-pantoprazole sodium, an excipient, a stabilizer and an acid-base regulator; and freeze-drying to obtain a freeze-dried composition with the water content of 10-20%. The freeze-drying medicament composition, prepared by the method disclosed by the invention, has greatly improved stability during storage and transport processes and is conductive to clinical use.

Description

technical field [0001] The invention relates to a levo-pantoprazole sodium freeze-dried pharmaceutical composition and a preparation method thereof, in particular to a levo-pantoprazole sodium freeze-dried pharmaceutical composition containing a predetermined amount of water and a preparation method thereof. Background technique [0002] Pantoprazole sodium is a proton pump inhibitor widely used clinically for the treatment of gastric ulcer. Levopantoprazole sodium is an optical isomer of pantoprazole sodium, compared with pantoprazole sodium, has stronger drug effect and higher curative effect, but its stability is poor, in preparation and The degradation is obvious during storage, which brings hidden dangers to the safety of clinical medication. However, the existing preparation technology cannot fundamentally solve this problem. [0003] Many composition formulations and preparation methods of freeze-dried formulations of pantoprazole sodium or levopantoprazole sodium h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 赵俊陈祥峰盛琼波金雪锋
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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