Composition for teriparatide injection, and preparation method and preparation thereof

A technology for teriparatide and injection, which is applied in the field of teriparatide injection composition and its preparation, can solve the problems of complex filling production line, high impurity content, toxic reaction, etc., and achieve simple and reasonable formula composition, production Simple process and good resolubility

Inactive Publication Date: 2013-09-18
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The property that benzoquinone is easily oxidized makes the existing teriparatide injection easy to produce impurities during the preparation process, making the injection product very unstable; moreover, the existing teriparatide injection contains more excipients , is relatively complicated, and it is also easy to cause teriparatide degradation, resulting in excessively high impurity content; moreover, the dos...

Method used

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  • Composition for teriparatide injection, and preparation method and preparation thereof
  • Composition for teriparatide injection, and preparation method and preparation thereof
  • Composition for teriparatide injection, and preparation method and preparation thereof

Examples

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Effect test

Embodiment 1

[0042] The preparation of embodiment 1 teriparatide injection composition

[0043] Weigh 20.0mg of teriparatide and 50g of mannitol in a sterile container, stir and dissolve the mixture with 800mL of water for injection, after stirring and dissolving, adjust the pH value to 3.5 with acetic acid, continue to dilute to 1000mL with water for injection, under sterile conditions It is obtained by filtering with a 0.22 μm microporous membrane and freeze-drying.

[0044] The freeze-drying process is as follows: ①In the pre-freezing stage, the sample reaches the set temperature of 0°C within 1 minute and maintains it for 2 hours, then the sample reaches the pre-freezing temperature of -45°C within half an hour and maintains it for 5 hours; ②Freezing and sublimation once In the drying stage, the sample reaches the set temperature of 0°C within 1 minute and maintains it for 15 hours; ③ in the freeze-sublimation secondary drying stage, the sample reaches the secondary drying temperature of...

Embodiment 2

[0045] The preparation of embodiment 2 teriparatide injection composition

[0046] Weigh 1mg of teriparatide and 1g of glucose into a sterile container, stir and dissolve the mixture with 800mL of water for injection, after stirring and dissolving, adjust the pH value to 4.5 with acetic acid, continue to dilute to 1000mL with water for injection, use under sterile conditions Filter through a 0.22 μm microporous membrane, freeze-dry, and obtain the obtained product.

[0047] The freeze-drying process is as follows: ① In the pre-freezing stage, the sample reaches the set temperature of -15°C within half an hour and maintains it for 2 hours, and then the sample reaches the pre-freezing temperature of -55°C within half an hour and maintains it for 2 hours; ② Freeze sublimation In the primary drying stage, the sample reaches the set temperature of -10°C within 1 minute and maintains it for 25 hours; ③ in the freeze-sublimation secondary drying stage, the sample reaches the secondar...

Embodiment 3

[0048] The preparation of embodiment 3 teriparatide injection composition

[0049] Weigh 10mg of teriparatide and 10g of sucrose in a sterile container, stir and dissolve the mixture with 800mL of water for injection, after stirring and dissolving, adjust the pH value to 3.8 with acetic acid, continue to dilute to 1000mL with water for injection, use under sterile conditions Filter through a 0.22 μm microporous membrane, freeze-dry, and obtain the obtained product.

[0050] The freeze-drying process is as follows: ① In the pre-freezing stage, the sample reaches the set temperature of -10°C within half an hour and maintains it for 2 hours, and then the sample reaches the pre-freezing temperature of -50°C within half an hour and maintains it for 3 hours; ② Freeze sublimation In the primary drying stage, the sample reaches the set temperature of -5°C within 1 minute and maintains it for 20 hours; ③ in the freeze-sublimation secondary drying stage, the sample reaches the secondary...

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Abstract

The invention relates to the technical field of medicaments, and particularly relates to a composition for teriparatide injection, and a preparation method and preparation thereof. The composition for teriparatide injection comprises teriparatide, a freezing and drying protecting agent and a pH regulator, wherein the mass ratio of the teriparatide to the freezing and drying protecting agent is 1:(10-100000). The composition for teriparatide injection is simple in formula; the freezing and drying protecting agent ensures that the teriparatide is not degraded in preparation and preservation processes; and the pH regulator is used for regulating the pH value in a preparation process and regulating the pH value after the composition for teriparatide injection is redissolved, so as to maintain the stability of the teriparatide. The used auxiliary materials are safe, and do not cause toxic reaction. Therefore, the composition for teriparatide injection provided by the invention is good in stability, simple and reasonable in formula, and good in redissolving performance, and can be prepared into powder-injection or injection and is needless to be prepared into a pen-type injector. Thus, the production technology is simple.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a teriparatide injection composition and a preparation method and preparation thereof. Background technique [0002] Osteoporosis is a group of diseases caused by an imbalance between bone resorption and bone formation in the human body. According to its main etiology, it is divided into two types: senile osteoporosis and postmenopausal osteoporosis. Osteoporosis is more common in postmenopausal women, and the loss of bone mass in general women is particularly serious within 5 to 10 years after menopause. According to statistics, the incidence rate of osteoporosis among elderly women aged 60 to 69 in my country is as high as 50% to 70%, and the incidence rate of elderly women over 70 years old is almost 100%. [0003] Teriparatide, English name Teriparatide, is a 1-34 amino acid fragment containing 84 amino acids of endogenous parathyroid hormone PTH with a biologically active...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K38/29A61K47/10A61K47/12A61K47/26A61K47/34A61K47/36A61K47/18A61K47/42A61P19/10
Inventor 徐春莲郑春莲马亚平袁建成
Owner HYBIO PHARMA
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