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Polyethylene glycol uricase freeze drying powder and preparation method thereof

A technology of uric acid oxidase and pegylation, applied in biochemical equipment and methods, oxidoreductase, freeze-drying and transportation, etc., can solve the problems of non-shaking, non-freezing, unsuitable for long-distance transportation, etc.

Active Publication Date: 2018-08-10
修正生物医药(杭州)研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the shortcomings of this liquid preparation, which cannot be shaken or frozen, it is not suitable for long-distance transportation

Method used

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  • Polyethylene glycol uricase freeze drying powder and preparation method thereof
  • Polyethylene glycol uricase freeze drying powder and preparation method thereof
  • Polyethylene glycol uricase freeze drying powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] According to the isoelectric point of pegylated urate oxidase, the appropriate formulation pH is selected.

[0056] The isoelectric point of pegylated urate oxidase was detected by capillary isoelectric focusing (cIEF). figure 1 ,pass figure 1 According to the analysis, the isoelectric point of pegylated urate oxidase is between 4.0-6.0, and the pH value of the preparation is designed according to the result, and the pH value range is designed between 6.0-10.

[0057] Experiments were carried out by designing the following 8 buffer systems with different pH values, adding 2.5mg / ml pegylated urate oxidase to each formulation, and detecting the change of activity after accelerating at 30°C for 1 hour.

[0058] Table 2. Retention activity of pegylated urate oxidase after accelerated experiment under different pH conditions

[0059]

[0060]

[0061] Through accelerated experiments on 9 prescriptions at 30°C, the activity of pegylated urate oxidase after the acceler...

Embodiment 2

[0063] Through the screening of different preparation prescriptions, the preparation prescription ingredients suitable for pegylated urate oxidase are selected.

[0064] Lyophilized formulations generally contain bulking ingredients to increase the amount of solid material as well as protectants, antifreezes and other stabilizers to protect the active ingredient from destruction during and after lyophilization.

[0065] Among the lyoprotectants, we prefer carbohydrates as protectants, because carbohydrates function as cryoprotectants during freezing and can also function as dehydration protectants during drying and dehydration. Sugars are divided into reducing sugars and non-reducing sugars. During the freeze-drying process, both reducing sugars and non-reducing sugars can have a good protective effect, but the presence of reduced sugars during freeze-drying storage The lyophilized product undergoes Maillard reaction, which eventually causes the lyophilized product to deterior...

Embodiment 3

[0097] Select the appropriate buffer concentration range for the preparation formulation.

[0098] Design 8 different buffer solution formulas for experiments, add 2.5mg / ml pegylated urate oxidase to each formula, detect the aggregation precipitation and activity decrease percentage of pegylated urate oxidase after repeated freezing and thawing, the results are shown in the table 11.

[0099] Table 11. Repeated freeze-thaw experiments of pegylated urate oxidase with different buffer concentrations

[0100] Numbering

[0101] Through the comparison of different buffer concentrations, it can be seen that due to the inherent characteristics of pegylated urate oxidase products, too low buffer concentration cannot provide effective protection for frozen samples, and too high It will affect the sample activity, so the optional buffer range of the pegylated urate oxidase preparation is 20-100mM phosphate buffer, preferably 30-60mM phosphate buffer.

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Abstract

The invention relates to a stable preparation of polyethylene glycol uricase conjugate, in particular to polyethylene glycol uricase freeze drying powder and a preparation method thereof. The polyethylene glycol uricase freeze drying powder is prepared from solid ingredients of polyethylene glycol uric acid oxidase, a protection agent and a freeze drying shaping agent, wherein the protection agentuses saccharose, the freeze drying shaping agent uses arginine; through being metered in parts by mass, the polyethylene glycol uric acid oxidase accounts for 0.5 to 5.0 parts; the saccharose accounts for 15 to 35 parts; the arginine accounts for 5.0 to 25 parts. The freeze drying powder improves the stability of the polyethylene glycol uricase freeze drying powder; in addition, the shaping performance is good. The invention also provides the preparation method of the freeze drying powder.

Description

technical field [0001] The invention relates to a stable preparation of pegylated urate oxidase conjugate, in particular to a pegylated urate oxidase freeze-dried powder and a preparation method thereof. Background technique [0002] Urate oxidase (Urate oxidase, UOX) is a key enzyme in purine metabolism in organisms. It catalyzes the oxidation of uric acid to form allantoic acid. It consists of four identical subunits. Each subunit contains 301 amino acids and has a molecular weight of about 34kD. Clinically, urate oxidase can be used not only as a diagnostic reagent for the detection of uric acid concentration in blood, but also as a biotherapeutic drug for the treatment of patients with hyperuricemia. The limited source of natural urate oxidase greatly limits its research and application. At present, a large number of urate oxidases used are produced by genetic engineering methods, that is, recombinant urate oxidases. For the human body, the recombinant urate oxidase is...

Claims

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Application Information

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IPC IPC(8): A61K38/44A61K9/19A61K47/26A61K47/18A61K47/60A61P19/06
CPCA61K9/0019A61K9/19A61K38/44A61K47/183A61K47/26C12Y107/03003
Inventor 张加慧刘翔钟达戎隆富董坤龙
Owner 修正生物医药(杭州)研究院有限公司
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