Recombinant human thyrotropin injection

A technology for thyrotropin and thyroxine, which is applied in the field of biomedicine, can solve the problems of difficulty in ensuring biological activity, difficulty in thyrotropin storage and increase the cost of medication for patients, and achieves the effect of high safety.

Pending Publication Date: 2021-03-09
SUZHOU SMARTNUCLIDE BIOPHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the oxidation rate of this recombinant human thyrotropin solution is very fast, so it can only be used and prepared immediately. It is difficult to guarantee its biological activity after preparation, and the storage difficulty of recombinant human thyrotropin increases the cost of medication for patients.

Method used

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  • Recombinant human thyrotropin injection
  • Recombinant human thyrotropin injection
  • Recombinant human thyrotropin injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0259] 1.1 Materials and Instruments

[0260] The reagent information and instrument information used in the examples of the present application are shown in Table 1 and Table 2 below, respectively.

[0261] Table 1 Reagent information

[0262] Reagent name factory Item No. Disodium hydrogen phosphate dodecahydrate Sigma 04273-1kg Sodium dihydrogen phosphate monohydrate Merck 106349 9025 Sodium chloride Merck 137017 5000 Mannitol Sigma M8429-500G Poloxamer 188 Merck 1.37065.1000 L-methionine Sigma M5308-100g Tween 20 Merck 817061 1000

[0263] Table 2 Instrument information

[0264] equipment name factory model Nucleic acid protein detector Thermo Nanodrop 2000 Desktop centrifuge Beckman Coulter Allegra TM X-12R-Centrifuge

-80℃ ultra-low temperature refrigerator Haier DW-87L 386 Drug stability test box Shanghai Yiheng Scientific Instrument Co., Ltd...

Embodiment 2

[0284] Experiment 2: Effects of different concentrations of sodium chloride and mannitol on the storage effect of liquid preparations

[0285] This example explores the effects of different concentrations of sodium chloride and mannitol on the storage effect of the thyrotropin liquid preparation. The prescription composition of each test group in Test 2 is shown in Table 4. The liquid formulation was subjected to a 60-day accelerated stability test at 25±2°C to simulate the impact of long-term storage conditions under extreme conditions on the sample.

[0286] The prescription composition of each test group of table 4 test two

[0287]

[0288] Note: The protein concentration indicates the protein concentration of recombinant human thyrotropin, and the PB buffer indicates phosphate buffer.

[0289] Detection results and analysis of the content of subunit oxidation products

[0290] Such as Figure 6 As shown, using the samples of 12 prescriptions in Experiment 2, the de...

Embodiment 3

[0294] Experiment 3: Effect of different methionine concentrations on the storage effect of liquid preparations

[0295] This example explores the effects of different methionine concentrations on the storage effect of thyrotropin liquid preparations. The prescription composition of each test group in Test 3 is shown in Table 5. The liquid formulation was subjected to a 60-day accelerated stability test at 25±2°C to simulate the impact of long-term storage conditions under extreme conditions on the sample.

[0296] The prescription composition of each test group of table 5 test three

[0297] prescription protein concentration PB buffer Mannitol Sodium chloride L-methionine pH 1 0.9mg / mL 20mM 30mg / mL 2mg / mL 0.1mg / mL 7.0 2 0.9mg / mL 20mM 30mg / mL 2mg / mL 0.2mg / mL 7.0 3 0.9mg / mL 20mM 30mg / mL 2mg / mL 1.5mg / mL 7.0

[0298] Note: The protein concentration indicates the protein concentration of recombinant human th...

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Abstract

The invention relates to a pharmaceutical preparation. The pharmaceutical preparation comprises thyrotropin and methionine, wherein the concentration of the methionine is about 0.005mg / mL or above. The invention further provides a kit containing the pharmaceutical preparation, a method for preparing the pharmaceutical preparation and application of the pharmaceutical preparation.

Description

technical field [0001] This application relates to the field of biomedicine, in particular to a recombinant human thyrotropin injection. Background technique [0002] At present, the incidence of differentiated thyroid carcinoma (DTC) is high, but the prognosis after surgical treatment is relatively optimistic. After differentiated thyroid cancer surgery, long-term thyroid stimulating hormone (TSH) suppression therapy can effectively reduce the risk of tumor recurrence and control the progression of the disease. [0003] In recent years, human thyrotropin has been replaced by synthetic recombinant human thyrotropin. However, since TSH is a glycoprotein molecule, its biological activity is easily affected by environmental factors, and its synthesis and storage conditions are very harsh. Therefore, the cost of using TSH treatment is extremely high. At present, commercial recombinant human thyrotropin products are provided in the form of powder, which needs to be formulated ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/06A61K9/08A61K47/18A61P35/00A61P5/14A61P25/00A61P43/00
CPCA61K9/08A61K9/0019A61K47/183A61P35/00A61P5/14A61K38/24A61K47/26A61K47/02
Inventor 须涛孙艳李芳芳薛井中顾奕
Owner SUZHOU SMARTNUCLIDE BIOPHARMACEUTICAL CO LTD
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