Dry powder inhalant of interferon alpha

A dry powder inhaler and interferon-α technology, which is applied in antiviral agents, respiratory diseases, medical preparations of non-active ingredients, etc., can solve problems that do not involve the optimization of the subtype and content of the main drug interferon-α

Active Publication Date: 2012-10-10
BEIJING TRI PRIME GENE PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The dry powder inhaler of interferon α reported in the above prior art mainly studies the preparation of the optimized formula composition based on the type and content of the pharmaceutically acceptable excipients of the dry powder inhaler, but basically does not involve the optimization of the subtype and content of the main drug interferon α. Therefore, it is possible to obtain a dry powder inhaler of interferon α with better performance by optimizing the subtype and content of the main drug interferon α, so as to be better used in the treatment of viral diseases such as viral pneumonia

Method used

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  • Dry powder inhalant of interferon alpha
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  • Dry powder inhalant of interferon alpha

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: the preparation of the dry powder inhalation particle of interferon alpha

[0038] Prepare each solution for spray drying according to the formula in Table 1 below, and spray dry the solution with a Buchi B-290 spray dryer according to the corresponding spray drying conditions in Table 2 (continue to maintain the inlet temperature and flow rate of the spray drying gas after the spraying of all liquids is completed) 15 minutes) to prepare dry powder inhalation particles of interferon α.

[0039] Table 1 Preparation of the solution formulation for spray drying of the dry powder inhaler granules of interferon α

[0040]

[0041]

[0042] Table 2 The spray drying conditions of the dry powder inhaler of interferon α

[0043]

Embodiment 2

[0044] Embodiment 2: the quality evaluation of the dry powder inhaler particle of interferon alpha

[0045] According to the provisions of the "Chinese Pharmacopoeia 2010 Edition (Part Three)" appendix "Interferon Biological Activity Assay Method", the activity of interferon α in the solution after the dissolution of the prepared interferon α dry powder inhalation particles of each formula (IU / ml); According to the provisions of the second method Lowry method of "Protein Content Determination Method" in the appendix of "Chinese Pharmacopoeia 2010 Edition (Part Three)", the interferon α in the solution of the prepared interferon α dry powder inhalation particles of each formula was determined after dissolution The concentration (mg / ml) was divided by the two to obtain the specific activity (IU / mg) of interferon α in the prepared interferon α dry powder inhalation particles of each formula. The specific activity of interferon α in each solution for spray drying was measured by ...

Embodiment 3

[0052] Embodiment 3: the dry powder inhaler of interferon alpha is prepared by the dry powder inhaler particle of interferon alpha

[0053] The dry powder inhalation particle sample of the interferon alpha of the formula 1-20 in each formula obtained by the method of Example 1 is not mixed with the large particle size carrier, and is directly packed with the amount of 20 mg per capsule as the interferon alpha. Dry powder inhalation is used for the research of embodiment 4-5; The dry powder inhalation particle sample of the interferon alpha of formula 21-40 mixes with commercially available large-size lactose carrier particle with the mass ratio of 1:3, with the dosage of 20mg per capsule. The amount was subpackaged and used as a dry powder inhaler of interferon α for the research of Examples 4-5.

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Abstract

The invention belongs to the field of preparations of protein drugs, and relates to a dry powder inhalant of interferon alpha. The dry powder inhalant contains consensus interferon of treatment effective dose and pharmaceutic adjuvant of the dry powder inhalant of proper dose; the interferon alpha consists of interferon alpha1b and the consensus interferon at a weight ratio of (4:6)-(6:4); and the pharmaceutic adjuvant of the dry powder inhalant comprises one or more of active protective agent, dispersive assistant, pH stability regulator, diluent and / or large-granularity carrier. In an optimized scheme, the dry powder inhalant of interferon alpha in single administration contains 1-200mu g of interferon alpha. The dry powder inhalant of interferon alpha provided by the invention has better stability and safety than the dry powder inhalant of interferon alpha of the prior art.

Description

technical field [0001] The present invention generally relates to an inhalation dosage form of interferon α, and particularly relates to a dry powder inhaler of interferon α. Background technique [0002] Interferon (interferon, IFN) is a kind of cytokine drug with broad-spectrum antiviral effect originally produced by the animal body. According to its production site and mechanism of action, it can be divided into α, β, γ, λ and other types , and each large type can be divided into several small subtypes. Different subtypes in the same large type have little difference in primary structure, and are very similar in secondary and higher-level structures. Among the several major types, the α-type is the most widely used one. Currently, this type of interferon in clinical use mainly includes interferon α2a, interferon α2b, interferon α1b, compound interferon, etc. [0003] In the prior art, there are many reports about the use of interferon alpha in the treatment of respirator...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K9/72A61K47/42A61K47/40A61K47/26A61K47/24A61K47/18A61P31/12A61P11/00
Inventor 周敏毅刘金毅程永庆
Owner BEIJING TRI PRIME GENE PHARMA CO LTD
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