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Glucoprotein incretion composition

A technology of glycoprotein hormones and compositions, which is applied in the fields of protein purification and biomedicine, can solve the problems of denaturation and inactivation, glycoprotein inactivation, and easy rupture, and achieve good stability

Active Publication Date: 2008-09-24
SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The form of this API is very important. Generally, solid form should be used as much as possible instead of liquid form, because liquid is not easy to store and transport, and for glycoprotein hormones, the solid form is mainly obtained through freeze-drying, but we know , high-purity glycoprotein hormones are prone to denaturation and inactivation during the freeze-drying process, so liquid methods have to be used in the prior art to preserve high-purity glycoprotein hormone raw materials, but the liquid form must be stored at -20 ℃, otherwise it is easy to inactivate; the liquid form is more likely to cause glycoprotein inactivation due to the freezing-dissolving process, or even repeated freezing-dissolving process; the liquid form will also encounter packaging containers close to the brittle point at low temperatures risk of breakage, etc.

Method used

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  • Glucoprotein incretion composition
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Compositions containing FSH

[0050] In this example, high-purity FSH (purchased from Shanghai Tianwei Biopharmaceutical Co., Ltd.) was used as the raw material of the FSH pharmaceutical composition, wherein the biological potency of FSH was 9521 international units / mg.

[0051] Prepare 50mL of 0.01M sodium dihydrogen phosphate solution (adjust the pH to about 6.5 with NaOH), add 2g of lactose, stir to dissolve, and filter with a 0.22μm filter. Take 10 mL of the filtrate, add 10.0 mg of the above-mentioned high-purity FSH (purchased from Shanghai Tianwei Bio-Pharmaceutical Co., Ltd.), completely dissolve, put it into a freeze dryer, and freeze-dry according to the following procedure:

[0052] 1. Pre-freeze the shelves at -40°C for 3 hours;

[0053] 2. Cold trap to -45°C;

[0054] 3. Start the vacuum pump;

[0055] 4. Store the laminate at -10°C for 15 hours;

[0056] 5. Keep the laminate at +20°C for 5 hours;

[0057] 6. Out of the box, 392 mg of freeze-dried powd...

Embodiment 2

[0071] Compositions containing LH

[0072] In this example, high-purity LH (purchased from Shanghai Tianwei Biopharmaceutical Co., Ltd.) was used as the raw material of the LH pharmaceutical composition, wherein the biological potency of LH was 4307 international units / mg.

[0073] Prepare 50mL of 0.01M sodium dihydrogen phosphate solution (adjust the pH to about 6.5 with NaOH), add 2g of lactose, stir to dissolve, and filter with a 0.22μm filter. Take 10mL of the filtrate, add 25mg of the above-mentioned high-purity LH (purchased from Shanghai Tianwei Biopharmaceutical Co., Ltd.), completely dissolve, put it into a freeze dryer, and freeze-dry it according to the procedure in Example 1 to obtain 402mg freeze-dried dry powder.

[0074] This product measures the biological potency of LH and investigates its stability at 30°C, the results are as follows

[0075]

[0076] It can be seen that the LH composition obtained by using the present invention has almost no denaturatio...

Embodiment 3

[0078] Compositions containing mixtures of FSH, LH

[0079] Prepare 100 mL of 0.9% sodium chloride solution (adjust the pH to about 7.0 with NaOH or HCl), add 4 g of maltose, stir to dissolve, and filter with a 0.22 μm filter. Take 10 mL of the filtrate, add 10.0 mg of high-purity FSH (purchased from Shanghai Tianwei Bio-Pharmaceutical Co., Ltd., the biological potency is 9521 international units / mg), and then add 25.0 mg of high-purity LH (purchased from Shanghai Tianwei Bio-Pharmaceutical Co., Ltd. company, the biological potency is 4307 international units / mg), after completely dissolving, put into the freeze-drying machine, carry out freeze-drying according to the program of embodiment 1, obtain 405mg freeze-dried powder. The measured biological potency of FSH was 223IU / mg, and that of LH was 242IU / mg.

[0080] The stability results of this product at 30°C are as follows:

[0081] FSH unit potency

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Abstract

The invention discloses a solid compound containing disaccharide and glycoprotein hormones or the variant thereof, wherein, the content of the glycoprotein hormones or the variant is not lower than 10 microgrammes per milligramme of compound or not lower than 100 international units per milligramme of compound. The compound provided by the invention has fine stability.

Description

technical field [0001] The invention relates to the fields of protein purification and biomedicine. Specifically, the present invention relates to compositions of glycoprotein hormones and their stabilizers, which have good stability. Background technique [0002] Follicle-stimulating hormone (FSH) is a glycoprotein hormone produced by the pituitary gland, which consists of two subunits, the α chain and the β chain. The α subunit of FSH is exactly the same as the α subunit of luteinizing hormone (LH) and chorionic gonadotropin (CG), with 92 amino acids and a molecular weight of about 14500D, at positions 52 and 78 The asparagine on is an amino acid that undergoes N-glycosylation. The β subunit of FSH consists of 111 amino acids with a molecular weight of about 18,000 D, and the asparagine at the 7th and 24th positions are N-glycosylated amino acids. The β subunit of LH consists of 121 amino acids with a molecular weight of about 14800D; the β subunit of CG has 145 amino a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/24A61P15/08A61K31/7016
CPCA61K9/19A61K38/24A61P15/08A61K31/7016
Inventor 季晓铭高霄梁季斌严惠敏洪云海
Owner SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD