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Insulin aspart injection and preparation method thereof

A technology for preparing insulin aspart and injection, which is applied in the field of biopharmaceutical preparations and can solve the problems of difficulty in accurately controlling the ratio of crystalline protamine insulin and fast-acting protein insulin, and uneven crystal forms.

Active Publication Date: 2021-09-14
BEIJING HUIZHIHENG BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Patent CN101035557B discloses a preparation method of insulin aspart 50 / 30 injection, but in this method, directly mix alkaline solution and acidic solution to prepare crystallization, it is difficult to accurately control the crystallized protamine insulin and protamine in the injection liquid Rapid-acting protein insulin ratio, and in the preparation prepared by this method, there is a problem of inhomogeneity in the crystal form

Method used

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  • Insulin aspart injection and preparation method thereof
  • Insulin aspart injection and preparation method thereof
  • Insulin aspart injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1: Insulin aspart 50 injection and preparation I

[0045] Insulin aspart was prepared as follows 50 Injection I:

[0046] Step 1: preparing a crystalline insulin protamine sulfate solution prepared as follows

[0047] 1.1 preparation Solution A: 0.1mol L with an appropriate amount of dilute hydrochloric acid to fully dissolve / about the insulin aspart 1.75g, insulin aspart formulated as a solution; dissolving an appropriate amount of ultrapure water glycerol 6.4g, phenol 600mg, 688 mg m-cresol, chloro 468 mg sodium, 500 mg of disodium hydrogen phosphate dihydrate; amount of zinc chloride is added to 9.8 mg, to obtain excipient solution; mixing the solution with the excipient solution insulin aspart, ultrapure water volume to 400ml, and washed with 0.5 M sodium hydroxide solution to adjust the pH to 7.10-7.44 to obtain a solution A;

[0048] Wherein said dilute hydrochloric acid concentration 0.05-0.15mol / L, the concentration of the sodium hydroxide solution is 0....

Embodiment 2

[0055] Example 2: Insulin aspart 50 injection and preparation II

[0056] Insulin aspart was prepared as follows 50 Injection II:

[0057] Step 1: preparing a crystalline insulin protamine sulfate solution prepared as follows

[0058] 1.1 preparation Solution A: 0.1mol L with an appropriate amount of dilute hydrochloric acid to fully dissolve / about the insulin aspart 1.75g, was formulated as insulin aspart; glycerol was dissolved with an appropriate amount of ultrapure water 8g, 750 mg of phenol, m-cresol 860mg, chloride sodium 585 mg, 1250 mg disodium hydrogen phosphate dihydrate; zinc chloride is added to an amount of 9.8 mg, to obtain excipient solution; mixing the solution with the excipient solution insulin aspart, ultrapure water volume to 400ml, and washed with 0.5M sodium hydroxide solution to adjust the pH to 7.10-7.44 to obtain a solution A;

[0059] Wherein said dilute hydrochloric acid concentration 0.05-0.15mol / L, the concentration of the sodium hydroxide solution...

Embodiment 3

[0066] Example 3: Insulin aspart 30 injection and preparation I

[0067] Insulin aspart was prepared as follows 30 Injection I:

[0068] Step 1: preparing a crystalline insulin protamine sulfate solution prepared as follows

[0069] 1.1 preparation Solution A: amount sufficient 0.1mol / L dilute hydrochloric acid to dissolve the insulin aspart about 2.45g, insulin aspart formulated as a solution; dissolving an appropriate amount of ultrapure water glycerol 9.6g, 900 mg of phenol, m-cresol 1032mg, chloride sodium 526.2mg, 750 mg of disodium hydrogen phosphate dihydrate; zinc chloride is added to an amount of 13.72mg, to obtain excipient solution; mixing the solution with the excipient solution insulin aspart, ultrapure water volume to 600ml, and washed with 0.5 M sodium hydroxide solution to adjust the pH value to 7.2-7.44, to obtain a solution A;

[0070] Wherein said dilute hydrochloric acid concentration 0.05-0.15mol / L, the concentration of the sodium hydroxide solution is 0.3...

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Abstract

The invention provides a protamine sulfate insulin aspart crystal and a process method for preparing an insulin aspart premix preparation by using the protamine sulfate insulin aspart crystal, and particularly relates to a preparation method of an insulin aspart 50 injection and an insulin aspart 30 injection. The preparation obtained by the process method of the invention is regular in shape and uniform in size for the insulin crystal form, as well as has good stability. Most importantly, the process method provided by the invention is simple and stable, and very convenient for industrial application.

Description

Technical field [0001] The present invention belongs to the field of biomedicine preparations, and more particularly to a metallic insulin injection and a preparation method thereof, especially the door winter insulin 50 or 30 injection and a preparation method thereof. Background technique [0002] Diabetes is a group of metabolic diseases characterized by hyperglycemia, mainly characterized by multiple drinks caused by chronic hyperglycemia, but multi to lose weight. The main cause of diabetes is that human insulin secretion is absolutely insufficient or relatively insufficient, and / or damage to insulin uses disorder caused by insulin. Diabetes causes the human body to malfunction, especially high blood sugar, and further leads to a variety of tissue, especially chronic damage, dysfunction, and dysfunction of oculum, nerve. [0003] Insulin is a protein hormone secreted by islet beta cells in the pancreas or exogenous substance such as glucose, lactose, ribose, arginine, gluc...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K47/42A61K47/10A61K47/02A61K38/28A61P3/10
CPCA61K9/10A61K9/0019A61K47/42A61K47/10A61K47/02A61K38/28A61P3/10
Inventor 曹海燕林兆生顾志强安丰伟詹巾卓黄蓉
Owner BEIJING HUIZHIHENG BIOTECHNOLOGY CO LTD
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