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Dry powder inhalant of interferon Alpha

A dry powder inhaler and interferon α technology, which is applied in antiviral agents, respiratory diseases, medical preparations with non-active ingredients, etc., can solve the problems of inaccurate control of dosage, dosage discount, and low inhaled dosage

Active Publication Date: 2014-04-16
BEIJING TRI PRIME GENE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although interferon α prepared into injection, aerosol inhalation or spray has a clear curative effect for the treatment of viral pneumonia, the characteristics of systemic metabolism greatly reduce the actual dosage of injection dosage forms; aerosol inhalation and spray formulations have the disadvantages that the effective inhalation dose is low and the dosage cannot be precisely controlled

Method used

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  • Dry powder inhalant of interferon Alpha
  • Dry powder inhalant of interferon Alpha
  • Dry powder inhalant of interferon Alpha

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1: the preparation of the dry powder inhalation particle of interferon alpha

[0040] 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.

[0041] Table 1 Preparation of the solution formulation for spray drying of the dry powder inhaler granules of interferon α

[0042]

[0043] Table 2 The spray drying conditions of the dry powder inhaler of interferon α

[0044]

Embodiment 2

[0045] Embodiment 2: the quality evaluation of the dry powder inhaler particle of interferon alpha

[0046] 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 interferon α dry powder inhalation particle sample of the formula 1-3 obtained according to the method of Example 1 is not mixed with the large particle size carrier, and is directly divided into 20 mg per capsule as the interference of the formula 1'-3' The dry powder inhalation of interferon α is used for the research of embodiment 5; The dry powder inhalation particle sample of the interferon α of formula 4-6 mixes with commercially available large-size lactose carrier granule with the mass ratio of 1:3, and with each capsule The amount of 20 mg was subpackaged and used in the study of Example 5 as a dry powder inhaler of interferon-alpha with formula 4'-6'.

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Abstract

The invention belongs to the field of protein medicine preparation and relates to the application of dry powder inhalant in preparing the medicine for curing viral pneumonia. The dry powder inhalant of the interferon Alpha contains a therapeutically effective amount of interferon Alpha and a good amount of dry powder inhalant pharmaceutic adjuvant, and the dry powder inhalant pharmaceutic adjuvant comprises one or several of active protecting agent, dispersitive additive, PH stability conditioning agent, thinner and / or larger grained carriers according to functional partitioning. The dry powder inhalant of the interferon Alpha has a better drug effect in animal drug effect tests by compared with conventional interferon Alpha medicament form injection, atomizing inhalation agent and spraying agent for curing viral pneumonia.

Description

technical field [0001] The present invention generally relates to the application of the pharmaceutical composition of interferon α in the preparation of medicines for treating viral pneumonia, and in particular relates to the application of the inhalation dosage form of interferon α in the preparation of medicines for treating viral pneumonia. 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, i...

Claims

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Application Information

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Patent Type & Authority Patents(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