Dry powder inhalant of interferon alpha

A dry powder inhaler and interferon α technology, which is applied in antiviral agents, medical preparations containing active ingredients, peptide/protein components, etc., can solve the problems of increasing the complexity and cost of the preparation process, the stability of dry powder inhalers, and the use of performance impact etc.

A dry powder inhaler and interferon α technology, which is applied in antiviral agents, medical preparations containing active ingredients, peptide/protein components, etc., can solve the problems of increasing the complexity and cost of the preparation process, the stability of dry powder inhalers, and the use of performance impact etc.

CN102727467AActive Publication Date: 2012-10-17BEIJING TRI PRIME GENE PHARMA CO LTD
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  • Dry powder inhalant of interferon alpha
  • Dry powder inhalant of interferon alpha

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: the preparation of the dry powder inhalation of interferon alpha

[0031] Prepare each solution for spray drying according to the formula in Table 1 below, and then use Buchi B-290 spray dryer to spray dry according to the following conditions: spray drying air inlet temperature 120 ° C, spray drying air flow rate 500 L / h, spray liquid flow rate 5ml / min, spray liquid temperature 8°C, keep spray drying gas inlet temperature and flow rate for 20 minutes after all liquid spray is completed.

[0032] Table 1 Prepare the solution formula (1000ml) for spray drying of the dry powder inhaler of interferon α

[0033]

Embodiment 2

[0034] Embodiment 2: the quality evaluation of the dry powder inhaler particle of interferon alpha

[0035] 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

[0041] Embodiment 3: the in vitro deposition test of the dry powder inhalation of interferon alpha

[0042] A part of the dry powder inhalation sample of interferon alpha of each formula obtained by the method of Example 1 is subpackaged with the amount of 20 mg per capsule, respectively, to obtain non-loaded body capsule subpackage samples of formula 1-12; Mix evenly with commercially available large-size lactose carrier granules at a mass ratio of 1:2, and subpackage in an amount of 20 mg per capsule to obtain loading capsule subpackage samples of formulas 1-12. For formula 1-12, the unloaded capsule subpackage samples and the loaded capsule subpackage samples were respectively according to the "Chinese Pharmacopoeia 2010 Edition (Part Two)" appendix "Appendix X H inhalation gas (powder) aerosol effective part drug deposition method "Determination of in vitro deposition properties. The secondary deposits were weighed and completely dissolved respectively, and then the conce...

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Abstract

The invention relates to a dry powder inhalant of an interferon alpha, belonging to the field for agents of protein drug, wherein the inhalant comprises 1-100 parts of interferon alpha, 3,000-4,000 parts of leucine, 0-4,000 parts of threonine, 12,000-16,000 parts of mannitol, 400 to 10,000 parts of buffer salt system with the pH controlled within the range of 6.0 to 8.0 by weight; and the inhalant does not comprise large-granularity carriers. The dry powder inhalant of the interferon alpha without the large-granularity carriers can achieve basically the same lung deposition effect with the powder inhalant of the interferon alpha with the large-granularity carriers in the in-vitro simulated deposition test.

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] Dry powder inhalation of interferon α, that is, powder aerosol is a new dosage form of interferon α that ...

Claims

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Application Information

Patent Timeline
17 Oct 2012
Publication
CN102727467A
IPC
A61K9/72; A61K38/21; A61P31/12
Inventors
周敏毅; 刘金毅