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Alpha-interferon dry powder inhalant for pigs and method for producing same

A dry powder inhaler and interferon technology, applied in the field of pharmaceutical preparations, can solve the problems of high risk of needle infection, poor patient adaptability, easy inactivation, etc., and achieve better absorption effect, large dosage, and extended shelf life. Effect

Inactive Publication Date: 2009-08-26
TIANJIN RINGPU BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since protein and polypeptide drugs are easily inactivated, most of them are administered by injection. For example, interferon α-2b treats hepatitis and is injected 3-5 times a week, so it has the following disadvantages that are difficult to overcome: poor adaptability of patients , the risk of needle infection is high, and the cost is high; in addition, human serum albumin (HSA) is usually used as a protective agent in the aqueous solution of interferon, so there is inevitably a potential risk of contamination and disease transmission; patients are often accompanied by fever after injection , chills, muscle pain and other side effects are also related to injection administration, so the clinical application of interferon is greatly limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: Preparation of porcine alpha-interferon dry powder inhalation

[0032] Take porcine α-interferon as an example:

[0033] Prepare 5L of porcine alpha-interferon solution (A) to be dried according to the following components:

[0034] Porcine alpha-interferon 2.12×10 7 IU / mL

[0035] NaCl 8mg / mL

[0036] Tween-80 0.05mL / mL

[0037] Mannitol 70.3mg / mL

[0038] Disodium hydrogen phosphate 4.0mg / mL

[0039] Prepare 5L of porcine alpha-interferon solution (B) to be dried according to the following components:

[0040] Porcine alpha-interferon 2.12×10 7 IU / mL

[0041] NaCl 4mg / mL

[0042] Tween-80 0.02mL / mL

[0043] Mannitol 50mg / mL

[0044] Disodium hydrogen phosphate 2mg / M1

[0045] Prepare 5L of porcine alpha-interferon solution (C) to be dried according to the following components:

[0046] Porcine alpha-interferon 2.12×10 7 IU / mL

[0047] NaCl 15mg / mL

[0048] Tween-80 0.20mL / mL

[0049] Mannitol 120mg / mL

[0050] Disodium hydrogen phosphat...

Embodiment 2

[0053] Embodiment 2: the activity level test of porcine alpha-interferon dry powder inhalation

[0054] The biological activity of porcine α-interferon stock solution and its dry powder inhalation finished product was determined according to the same dilution, and half of the cells were used to inhibit pathological changes, and the VSV-MDBK system was used for determination. (method with reference to "Pharmacopoeia of the People's Republic of China 2005 Edition)

[0055] The experimental data are as follows:

[0056] sample

[0057] Dry powder inhaler finished product C

[0058] From the experimental results, it can be seen that the biological activity of porcine α-interferon in the dry powder inhaler prepared by adding a protective agent to rotary evaporation and vacuum freeze-drying is basically no loss.

Embodiment 3

[0059] Embodiment 3: the preservation test of porcine alpha-interferon dry powder inhalation

[0060] The porcine α-interferon stock solution and its finished dry powder inhalation were stored in a refrigerator at 4°C, and the biological activity was tested regularly, using the method of half of the cells to inhibit the pathological changes, and the VSV-MDBK system was used for determination. (method with reference to "The Pharmacopoeia of the People's Republic of China" 2005 edition)

[0061] The experimental data are as follows:

[0062] sample

[0063] From the above experimental data, it can be seen that the finished product of porcine α-interferon dry powder inhalation is stored at 4°C for 2 years, and its biological activity is slightly reduced, which does not affect clinical use, while the porcine α-interferon stock solution is stored at 4°C for 2 years. It can be seen that the shelf life of the porcine α-interferon dry powder inhalation of the present invent...

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Abstract

The invention discloses a formulation of an alpha-interferon dry powder inhalant and a method for producing the same. The method comprises the following steps: adding a protective agent mainly comprising tween-80 into an alpha-interferon first; preparing the mixture into the dry powder inhalant mainly comprising the alpha-interferon through rotary evaporation and vacuum freezing and drying; and filling the dry powder inhalant into a rotary inhaler to prepare a finished product. The method prolongs the storage time of the interferon, and the interferon is convenient to use and advantageous for absorbing, thus the clinical using effect of the alpha-interferon is brought into play better.

Description

technical field [0001] The invention relates to a new dosage form dry powder inhaler of alpha-interferon and a preparation method thereof, in particular to a new dosage form dry powder inhaler of alpha-interferon for pigs and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Interferon (interferon, IFN) is a type of glycoprotein secreted by cells under the stimulation of specific antigens and has biological activities such as anti-virus, anti-tumor and immune regulation functions. Moreover, a type of interferon can inhibit the proliferation of various viruses, and it is a broad-spectrum antiviral drug in medicine, which can be divided into three types: α, β, and γ. Among them, α-interferon is mainly produced by monocytes, and it is also the most studied and applied type of interferon. [0003] The main biological activities of IFN-α are: (1) inhibit virus replication, mainly by inducing cells to synthesize var...

Claims

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Application Information

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IPC IPC(8): A61K38/21A61K9/72A61K47/16A61K47/24A61K47/34A61K47/40A61P11/02A61P11/06A61P31/12A61P31/16A61K47/26
Inventor 李旭东王丽娟苏建东
Owner TIANJIN RINGPU BIO TECH
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