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Freeze-dried B type natriuretic peptide preparation and preparation method thereof

A technology for natriuretic peptides and preparations, applied in the field of biopharmaceuticals, can solve the problems of inability to form crystal nuclei, difficult to guarantee product safety, and inability to guarantee the freeze-drying effect of B-type natriuretic peptides.

Active Publication Date: 2015-08-12
SHANGHAI JINGZE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In fact, during the freeze-drying preparation process of this product, the pre-freezing temperature and primary sublimation temperature are also one of the main factors affecting the product effect. The freeze-drying effect of sodium peptide will cause problems that the eutectic point temperature cannot be reached and crystal nuclei cannot be formed, which will ultimately affect product quality
[0003] In addition, the B-type natriuretic peptide product prepared by the existing technology is not a human physiological isotonic product, so the safety of the product is difficult to guarantee

Method used

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  • Freeze-dried B type natriuretic peptide preparation and preparation method thereof
  • Freeze-dried B type natriuretic peptide preparation and preparation method thereof
  • Freeze-dried B type natriuretic peptide preparation and preparation method thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0073] Preparation method of freeze-dried B-type natriuretic peptide preparation

[0074] The invention provides a method for preparing a freeze-dried B-type natriuretic peptide preparation, the method comprising the steps of:

[0075] (a) providing an isotonic solution containing B-type natriuretic peptide;

[0076] (b) The temperature of the isotonic solution containing B-type natriuretic peptide is reduced to the pre-freezing temperature interval T 0 , and keep it for a period of time P0, thereby forming a pre-frozen frozen mixture, wherein, the T 0 -70°C to -40°C, preferably -50°C to -45°C, P0 is 0.5 to 48 hours;

[0077] (c) raising the temperature of the pre-frozen frozen mixture to the first sublimation temperature interval Ts 1 , and maintain for a period of time P1 for the first sublimation, where Ts 1 -45°C to -20°C, preferably -45°C to -40°C;

[0078] (d) heating the frozen mixture obtained in step (c) to the second sublimation temperature interval Ts 2 , and ...

Embodiment 1

[0142] Example 1 Preparation of lyophilized B-type natriuretic peptide preparation

[0143] (1) Preparation of solution

[0144] ① Add a certain amount of disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride to the B-type natriuretic peptide in the original solution after separation and purification.

[0145] ②Use a 0.22um filter to filter and sterilize the stock solution of B-type natriuretic peptide.

[0146] ③Under a sterile environment, add a certain amount of mannitol (the final prepared solution contains 8mg / ml), add a small amount of water for injection to dissolve, and shake well.

[0147] (2) Dissolving filling

[0148] ① Add an appropriate amount of water for injection to dissolve, and constant volume, stir well, and then filter the sample with a 0.22um filter. Use a filling machine to subpackage into 1ml sample solution each.

[0149] (3) Freeze-dried preparation

[0150] ①Clean and sterilize the freeze-drying tray in the freeze-drying ...

Embodiment 2-24

[0152] Example 2-24 Preparation of lyophilized B-type natriuretic peptide preparation

[0153] The preparation of freeze-dried B-type natriuretic peptide preparation was carried out according to the method similar to that of Example 1, wherein different experimental conditions are shown in Table 1.

[0154] Table 1 Comparison of different experimental conditions in each embodiment of the present invention

[0155]

[0156]

[0157] Table 2 Comparison table of physical and chemical properties of B-type natriuretic peptide preparations prepared in each example

[0158]

[0159]

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Abstract

The invention discloses a freeze-dried B type natriuretic peptide preparation and a preparation method thereof. The preparation method saves energy and is easy to realize; and a phosphate buffer system used by the preparation product prepared in the invention is closer to neutral conditions than citrate / acetate buffer systems in the prior art, and the preparation product is a human body physiologic isotonic product, so irritation to human body is reduced, thereby the product is safe and has advantage in popularization.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a freeze-dried B-type natriuretic peptide preparation and a preparation method thereof. Background technique [0002] Freeze-dried B-type natriuretic peptide products have been on the market for many years, and the current patent on the method of preparing the product mainly focuses on the screening of prescriptions, as described in patent CN 102552177A. In fact, during the freeze-drying preparation process of this product, the pre-freezing temperature and primary sublimation temperature are also one of the main factors affecting the product effect. If the pre-freezing temperature and primary sublimation temperature are too high, it will not be possible to guarantee the benefit The freeze-drying effect of sodium peptide will cause problems that the eutectic point temperature cannot be reached and crystal nuclei cannot be formed, which will ultimately affect product quality. [...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/22
Inventor 邱永峰杨君王珙孙海胜付爱玲张庆义张兆利
Owner SHANGHAI JINGZE PHARMA CO LTD