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Preparation method of insulin aspart 30 suspension

A technology for insulin aspart and suspension, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, liquid delivery, etc. It can solve the problems of long standing crystallization time, preparation impurities, and high energy consumption in the process and other problems, to achieve the effect of low process energy consumption, uniform and stable particle size, and simple process

Pending Publication Date: 2022-04-12
NANJING HANXIN PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the static crystallization time is long, the process energy consumption is large, and it will bring undesirable impurities to the preparation

Method used

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  • Preparation method of insulin aspart 30 suspension
  • Preparation method of insulin aspart 30 suspension
  • Preparation method of insulin aspart 30 suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] 1. Prescription:

[0071] Table 1 The prescription of insulin aspart 30 suspension

[0072] prescription ingredients prescription content insulin aspart 35g glycerin 160g phenol 15g m-cresol 17.2g Zinc chloride 0.196g Sodium chloride 8.8g Disodium hydrogen phosphate dihydrate 12.5g protamine sulfate 3.2g

[0073] 2. Solution preparation:

[0074] (1): Take by weighing 12.5g prescription quantity disodium hydrogen phosphate dihydrate, 8.8g prescription quantity sodium chloride, 80g glycerin, 7.5g phenol, 17.2g prescription quantity m-cresol, dissolve with 4L water for injection and stir until clarification, Adjust the pH to 9.8, filter and sterilize the medicinal solution through a 0.22 μm filter membrane to obtain solution A, which is added to the liquid mixing tank;

[0075] (2): Weigh 35g prescription insulin aspart, 3.2g prescription protamine sulfate, add hydrochloric acid solution to dissolve, then a...

Embodiment 2

[0079] 1. the prescription is consistent with the prescription of embodiment 1.

[0080] 2. Solution preparation:

[0081] (i): Weigh 12.5g prescription quantity of disodium hydrogen phosphate dihydrate, 8.8g prescription quantity sodium chloride, 40g glycerin, 6g phenol, dissolve with 2.5L water for injection and stir until clear, adjust pH to 9.8, and pass through 0.22μm filter membrane to filter and sterilize to obtain solution A, which is added to the liquid mixing tank;

[0082] (ii): Take by weighing 35g prescription insulin aspart, 3.2g prescription protamine sulfate, after adding hydrochloric acid solution to dissolve, then add 0.196g prescription zinc chloride, 40g glycerol, 6g phenol, then use 2.5L water for injection After dissolving, adjust the pH to 2.5, filter and sterilize the drug solution through a 0.22 μm filter membrane to obtain solution B, which is added to the liquid mixing tank;

[0083] (iii): Stir and mix solution A and solution B evenly, adjust the ...

Embodiment 3

[0087] 1. the prescription is consistent with the prescription of embodiment 1.

[0088] 2. Solution preparation:

[0089] (1): Take by weighing 12.5g prescription quantity disodium hydrogen phosphate dihydrate, 8.8g prescription quantity sodium chloride, 80g glycerin, 7.5g phenol, 17.2g prescription quantity m-cresol, dissolve with 4L water for injection and stir until clarification, Adjust the pH to 9.5, filter and sterilize the medicinal liquid through a 0.22 μm filter membrane to obtain solution A, which is added to the liquid mixing tank;

[0090] (2): Weigh 35g prescription insulin aspart, 3.2g prescription protamine sulfate, add hydrochloric acid solution to dissolve, then add 0.196g prescription zinc chloride, 80g glycerin, 7.5g phenol, dissolve with 4L water for injection Finally, adjust the pH to 2.2, filter and sterilize the medicinal solution through a 0.22 μm filter membrane to obtain solution B, which is added to the liquid mixing tank;

[0091] (3): Stir and m...

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Abstract

The invention discloses a preparation method of an insulin aspart 30 suspension, and belongs to the field of pharmaceutical preparations. According to the invention, the stirring paddle with small shearing force is used for stirring the mixture composed of the insulin aspart prescription at a low speed instead of the existing standing crystallization method, such as an anchor paddle, a propeller, a frame paddle and the like, the stirring speed is 40-80rpm, the stirring time is 12-18h, and finally the quick-acting and long-acting insulin aspart 30 suspension is prepared. The insulin aspart suspension prepared in the invention has the advantages of small storage impurity content, uniform and stable particle size, strong storage stability, simple preparation process, short preparation time and high repeatability, and is suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of insulin aspart 30 suspension. Background technique [0002] Diabetes mellitus (DM) is a common metabolic disease. According to the information released by the International Diabetes Federation (IDF) in 2014, the number of people with diabetes in the world has exceeded 387 million, and it is expected to exceed 592 million by 2035. Clinically, diabetes can be mainly divided into Type I diabetes mellitus (T1DM) and Type II diabetes mellitus (T2DM). Insulin is the only hormone that can lower blood sugar in the body. When the islet β cells in the body are damaged and the insulin in the body is insufficient to regulate blood sugar, exogenous insulin needs to be supplemented. Exogenous insulin mainly includes animal insulin, recombinant human insulin and insulin analogues. Due to the limited source of raw materials, animal insulin is pron...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K9/10A61K47/64A61P3/10
CPCA61K47/64A61P3/10A61K9/10A61K38/28
Inventor 王玮贡光杰陈松张昊宁
Owner NANJING HANXIN PHARMA TECH CO LTD
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