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A kind of insulin aspart injection and preparation method thereof

A technology for preparing insulin aspart and injection, which is applied in the field of biomedical preparations, can solve problems such as the difficulty in accurately controlling the ratio of crystalline protamine insulin and fast-acting protein insulin, and uneven crystal forms, so as to achieve uniform size, regular crystal forms, Quality stable and reliable effect

Active Publication Date: 2021-11-26
BEIJING HUIZHIHENG BIOTECHNOLOGY CO LTD +1
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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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  • A kind of insulin aspart injection and preparation method thereof
  • A kind of insulin aspart injection and preparation method thereof
  • A kind of insulin aspart injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: Insulin Aspart 50 Injection I and its preparation

[0045] Prepare insulin aspart 50 injection I according to the following method:

[0046] Step 1: Prepare Protamine Sulfate Insulin Crystal Liquid, the preparation method is as follows

[0047] 1.1 Prepare solution A: fully dissolve about 1.75 g of the insulin aspart with an appropriate amount of 0.1 mol / L dilute hydrochloric acid to prepare an insulin aspart solution; dissolve 6.4 g of glycerin, 600 mg of phenol, 688 mg of m-cresol, and chlorine Sodium chloride 468mg, disodium hydrogen phosphate dihydrate 500mg; Zinc chloride is added to the amount of zinc to be 9.8mg to obtain an adjuvant solution; the insulin aspart solution is mixed with the adjuvant solution, and the volume of ultrapure water is adjusted to 400ml, and 0.5 M sodium hydroxide solution adjusts the pH value to 7.10-7.44 to obtain solution A;

[0048] Wherein, the concentration of the dilute hydrochloric acid is 0.05-0.15mol / L, and the c...

Embodiment 2

[0055] Embodiment 2: insulin aspart 50 injection II and its preparation

[0056] Prepare insulin aspart 50 injection II according to the following method:

[0057] Step 1: Prepare Protamine Sulfate Insulin Crystal Liquid, the preparation method is as follows

[0058] 1.1 Prepare solution A: Fully dissolve about 1.75 g of the insulin aspart with an appropriate amount of 0.1mol / L dilute hydrochloric acid to prepare an insulin aspart solution; dissolve 8 g of glycerin, 750 mg of phenol, 860 mg of m-cresol, and Sodium 585 mg, disodium hydrogen phosphate dihydrate 1250 mg; the amount of zinc chloride added to zinc is 9.8 mg to obtain adjuvant solution; the insulin aspart solution is mixed with the adjuvant solution, and the volume of ultrapure water is adjusted to 400ml, and 0.5M Sodium hydroxide solution adjusted the pH value to 7.10-7.44 to obtain solution A;

[0059] Wherein, the concentration of the dilute hydrochloric acid is 0.05-0.15mol / L, and the concentration of the sodi...

Embodiment 3

[0066] Embodiment 3: insulin aspart 30 injection I and preparation thereof

[0067] Prepare insulin aspart 30 injection I as follows:

[0068] Step 1: Prepare Protamine Sulfate Insulin Crystal Liquid, the preparation method is as follows

[0069] 1.1 Prepare solution A: Dissolve about 2.45 g of the insulin aspart in an appropriate amount of 0.1 mol / L dilute hydrochloric acid to prepare an insulin aspart solution; dissolve 9.6 g of glycerin, 900 mg of phenol, 1032 mg of m-cresol, chlorinated Sodium 526.2 mg, disodium hydrogen phosphate dihydrate 750 mg; the amount of zinc chloride added to the zinc is 13.72 mg to obtain adjuvant solution; the insulin aspart solution is mixed with the adjuvant solution, and the volume of ultrapure water is adjusted to 600 ml, and 0.5 M sodium hydroxide solution adjusts the pH value to 7.2-7.44 to obtain solution A;

[0070] Wherein, the concentration of the dilute hydrochloric acid is 0.05-0.15mol / L, and the concentration of the sodium hydroxi...

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Abstract

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

Description

technical field [0001] The invention belongs to the field of biomedical preparations, and in particular relates to an insulin aspart injection and a preparation method thereof, in particular to an insulin aspart 50 or 30 injection and a preparation method thereof. Background technique [0002] Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia. The main feature is excessive drinking and eating but polyuria and weight loss caused by chronic hyperglycemia. The main cause of diabetes is the absolute or relative insufficiency of human insulin secretion, and / or the impairment of human body function, which leads to the impairment of insulin utilization. Diabetes leads to carbohydrate, protein and fat metabolism disorders in the human body, especially high blood sugar as the main sign, and further leads to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. [0003] Insulin is a protein h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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