Quality control method for insulin inhalation powder

A quality control method and technology for inhaling powder aerosols, which can be used in aerosol delivery, medical preparations containing active ingredients, and measuring devices, etc., and can solve problems such as the inability to effectively control the quality of insulin inhalation powder aerosols.

Inactive Publication Date: 2011-06-08
CHINA NAT ACAD NANOTECH & ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The second part of the 2005 edition of the "Chinese Pharmacopoeia" describes the general principles of powder and aerosol preparations, and stipulates the relevant quality standards for recombinant human insulin, recombinant human insulin injection, and protamine recombinant human insulin injection, and does not systematically regulate insulin inhalation. Therefore, the existing quality control methods for insulin raw materials and their injections cannot effectively control the quality of insulin inhalation powders

Method used

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  • Quality control method for insulin inhalation powder
  • Quality control method for insulin inhalation powder
  • Quality control method for insulin inhalation powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Embodiment 1: a kind of quality control method of insulin inhalation powder mist is:

[0083] traits:

[0084] The product content is white or off-white powder or granule.

[0085] Identification:

[0086] High-performance liquid chromatography: In the chromatogram recorded under the potency determination item, the retention time of the main peak of the test product should be consistent with the retention time of the peak of the recombinant human insulin reference product. Blank excipients do not interfere with the determination.

[0087] an examination:

[0088] Related protein inspection: take an appropriate amount of this product, and use 0.01mol / L hydrochloric acid solution to make a solution containing 3mg per 1ml, as the test solution. According to the method under titer determination, use 0.2mol / L sulfate buffer (pH2.3)-acetonitrile (81:19) as mobile phase A, acetonitrile-water (50:50) as mobile phase B, carry out gradient elute.

[0089]

[0090] Adjust...

Embodiment 2

[0100] Embodiment 2: a kind of quality control method of insulin inhalation powder mist is:

[0101] traits:

[0102] The product content is white or off-white powder or granule.

[0103] Identification:

[0104] High-performance liquid chromatography: In the chromatogram recorded under the potency determination item, the retention time of the main peak of the test product should be consistent with the retention time of the peak of the recombinant human insulin reference product. Blank excipients do not interfere with the determination.

[0105] an examination:

[0106] Related protein inspection: take an appropriate amount of this product, and use 0.01mol / L hydrochloric acid solution to make a solution containing 4mg per 1ml, as the test solution. According to the method under titer determination, use 0.2mol / L sulfate buffer (pH2.3)-acetonitrile (81:19) as mobile phase A, acetonitrile-water (50:50) as mobile phase B, carry out gradient elute.

[0107]

[0108] Adjust...

Embodiment 3

[0118] Embodiment 3: a kind of quality control method of insulin inhalation powder mist is:

[0119] traits:

[0120] The product content is white or off-white powder or granule.

[0121] Identification:

[0122] High-performance liquid chromatography: In the chromatogram recorded under the potency determination item, the retention time of the main peak of the test product should be consistent with the retention time of the peak of the recombinant human insulin reference product. Blank excipients do not interfere with the determination.

[0123] an examination:

[0124] Relevant protein inspection: Take an appropriate amount of this product, and use 0.01mol / L hydrochloric acid solution to make a solution containing 3.5mg per 1ml, as the test solution. According to the method under titer determination, use 0.2mol / L sulfate buffer (pH2.3)-acetonitrile (81:19) as mobile phase A, acetonitrile-water (50:50) as mobile phase B, carry out gradient elute.

[0125]

[0126] Adj...

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Abstract

The invention provides a quality control method for insulin inhalation powder and the method comprises steps of: (1) determining the property of insulin inhalation powder contents; (2) discriminating with High Performance Liquid Chromatography (HPLC): in the chromatogram recorded according to a potency determination item, the retention time of the main peak of a tested object should be is consistent with the retention time of the main peak of a recombinant human insulin conference object and blank accessories do not interfere determination; (3) inspecting associated protein, content uniformity, the total inhalation times of each bottle, the main drug contents of each bottle, evacuation rates and the distribution of powder granules and determining that products are in accord with rules; (4) performing potency determinations on the products and determining the qualities of the products. According to the invention, a research on a quality control method for insulin inhalation powder is conducted, and effectively guarantees the security and curative effects of medicaments; the quality control method is advantageous with respect to a potency determination method with high precision, good reappearance and high stability; and moreover the inspection and discrimination methods can ensure the curative effects of the medicaments and realize the purpose of effectively controlling the qualities of the medicaments.

Description

(1) Technical field: [0001] The invention belongs to the technical field of quality control of medicines, and relates to a quality control method of insulin inhalation powder for treating diabetes. (two) background technology: [0002] Diabetes has become a common and frequently-occurring disease all over the world, and is listed as the third major disease affecting human health after cardiovascular disease and its tumors. Diabetes is mainly divided into type I diabetes and type II diabetes. Type I diabetes accounts for about 10%. Due to the lack of insulin in the patient's body, insulin therapy is required from the onset of the disease and used for life. Type II diabetes accounts for about 90%. Due to the relative lack of insulin produced in the patient's body, oral drugs are generally required to stimulate the secretion of insulin in the body. However, many patients must be treated with insulin in the same way as type I diabetes patients when they develop to an advanced s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K38/28A61P3/10G01N30/36G01N30/02
Inventor 周冉胡纯翼
Owner CHINA NAT ACAD NANOTECH & ENG
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