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Preparation method and application of insulin detemir crystal

A technology of insulin detemir and crystallization, which is applied in the field of preparation of insulin detemir crystals, can solve problems such as the unfavorable structure stability of insulin detemir, and achieve the effects of overcoming crystallization difficulties, small crystal sedimentation volume, and short freeze-drying time.

Inactive Publication Date: 2015-07-08
ZHUHAI UNITED LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Secondly, because insulin glargine is insoluble in neutral pH conditions, a large amount of organic acids are used as a dissolution buffer system in the crystallization, but this is not conducive to the stability of the structure of insulin detemir

Method used

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  • Preparation method and application of insulin detemir crystal
  • Preparation method and application of insulin detemir crystal
  • Preparation method and application of insulin detemir crystal

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Refer to Example 1 and Example 2 in the Chinese patent CN201110118026.2 titled "Method for preparing insulin glargine crystals" to prepare insulin detemir crystals. The ingredients and concentrations are as follows: Experimental group A is insulin detemir 3.5g / L, acetonitrile 20% (v / v), acetic acid 0.7M, phenol 0.4% (w / v), zinc chloride 120mg / L, sodium acetate 0.5M; experimental group B was insulin detemir 3g / L, ethanol 15% (v / v), acetic acid 0.5M, zinc chloride 90mg / L, phenol 0.2% (w / v), sodium chloride 0.3M. The preparation process is as follows: Weigh two parts of insulin detemir, A1: 0.175g, B1: 0.15g, add 20ml of water respectively to suspend for use; prepare saline solution a1: 10ml of acetonitrile, 2ml of acetic acid, 6% (w / v) 3.33ml of phenol aqueous solution, 3.4g of sodium acetate and 55μl of 0.5M zinc acetate solution, add water to dissolve and dilute to 25ml; prepare salt solution b1: 7.5ml of ethanol, 1.43ml of acetic acid, 1.68ml of 6% (w / v) phenol aqueou...

Embodiment 2

[0039] Prepare insulin detemir crystal liquid, each component concentration is: experimental group A is insulin detemir 2g / L, acetonitrile 7.5% (v / v), ammonium acetate 0.1M, sodium chloride 0.2M, phenol 0.2% (w / v) The molar ratio of zinc ions to insulin detemir was 2:1; for experimental group B, 0.1M trisodium citrate dihydrate was added on the basis of experimental group A.

[0040] The preparation process is as follows: Weigh 0.2g insulin detemir, add 50ml of acetonitrile aqueous solution with a concentration of 15% (v / v), adjust the pH value to 8.57 with 2M sodium hydroxide solution, dissolve completely, and set aside; prepare salt solution a2: acetic acid Ammonium 0.39g, sodium chloride 0.58g, 6% (w / v) phenol aqueous solution 1.68ml, add water to dissolve and set the volume to 25ml, 2M sodium hydroxide to adjust the pH value to 8.86; prepare salt solution b2: in solution a2 On top of that, 1.47 g of trisodium citrate dihydrate was added. Take two 4g / L insulin detemir sol...

Embodiment 3

[0042] Prepare insulin detemir crystal liquid, the concentration of each component is: insulin detemir 1g / L, acetonitrile concentration 5% (v / v), trisodium citrate 0.2M, trishydrochloride 0.4M, phenol 0.05% (w / v), the molar ratio of zinc ions to insulin detemir is 7:1.

[0043] The preparation process is as follows: Weigh 0.05 g of insulin detemir, add 25 ml of acetonitrile aqueous solution with a concentration of 10% (v / v), adjust the pH value to 8.64 with 2M sodium hydroxide solution, dissolve completely, and set aside; prepare salt solution: dihydrate 2.94 g of trisodium citrate, 3.15 g of trishydroxymethylaminomethane hydrochloride, and 420 μl of aqueous phenol solution with a concentration of 6% (w / v), were dissolved in water and adjusted to 25 ml, and the pH value was adjusted to 2M sodium hydroxide solution. 8.78, and added to 25ml of insulin detemir solution, mixed; finally added 118μl of 0.5M zinc acetate solution, 2M hydrochloric acid to adjust the pH value to 8.21; ...

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Abstract

The invention discloses a preparation method and application of an insulin detemir crystal. The preparation method comprises the following step: under the conditions of a 0.1-0.2M trisodium citrate system and a 5-10 vol% organic solvent, crystallizing insulin detemir from a crystalline liquid containing insulin detemir, zinc ions, phenols and certain salts under the pH value of 8.0-8.5. The insulin detemir obtained by the preparation method has uniform and stable definite form, has the advantages of low sedimentation volume, high tendency to separation from the supernatant, short freeze-drying time and high production efficiency, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a preparation method of human insulin analog crystals, in particular to a preparation method and application of insulin detemir crystals. Background technique [0002] With the development of my country's economy, people's quality of life has been greatly improved, and the number of diabetic patients has also increased sharply. According to the latest survey report, the number of diabetic patients in China continues to increase. By 2013, the adult diabetes prevalence rate was close to 12%, and the number of diabetic patients exceeded 100 million, ranking first in the world. Diabetes mellitus is a chronic systemic metabolic disorder characterized by hyperglycemia resulting from defective insulin secretion and / or reduced biological effects (insulin resistance). Chronic hyperglycemia will lead to long-term damage, insufficiency and failure of multiple tissues in the human body, especially the eyes, kidneys, nerves and cardiovascu...

Claims

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Application Information

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IPC IPC(8): C07K14/62
CPCC07K14/62
Inventor 黄亮肖拥军曹永恒曹春来陈航周翠
Owner ZHUHAI UNITED LAB
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