Atomization inhalant prepared from interferon alpha and salbutamol sulfate

A technology of salbutamol sulfate and atomized inhalation, which is applied in the field of preparation of drugs for the treatment of viral pneumonia, and can solve the problems of mixed infection in children, insufficient system of viral pneumonia, statistical differences, etc.

Active Publication Date: 2012-05-02
BEIJING TRI PRIME GENE PHARMA CO LTD
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  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, since the above-mentioned children are prone to further bacterial infection after being infected with viral pneumonia, resulting in mixed infections and complications for the children, the clinical effect of using a single drug to treat infant viral pneumonia is not ideal, resulting in Combined drug or pharmaceutical composition of two or more active ingredients for the treatment of viral pneumonia
For example, the article "Observation on the Curative Effect of Interferon Combined with Ribavirin in the Treatment of 30 Cases of Children with Viral Pneumonia" published in March 2009, Volume 4, Issue 9, Page 144-145 of "China Practical Medicine" reported that interferon combined with ribavirin The curative effect of treating children with viral pneumonia shows that the effective rate of the combined drug group is 96.7%, while the effective rate of the control group using ribavirin alone is only 76.6%, and there is a statistically significant difference between the two
However, the research on the use of combined drugs or combination drugs for viral pneumonia is not systematic enough, and the types of research are still small, so the research results are not yet suitable for large-scale clinical application

Method used

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  • Atomization inhalant prepared from interferon alpha and salbutamol sulfate
  • Atomization inhalant prepared from interferon alpha and salbutamol sulfate
  • Atomization inhalant prepared from interferon alpha and salbutamol sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: the preparation of the atomized inhalation of interferon alpha and albuterol sulfate

[0029] The nebulized inhalation of interferon alpha and albuterol sulfate was prepared according to the method in Table 1 below. Among them, "Anfulong" (trade name) is the recombinant human interferon α2b injection with a specification of 50 μg / ml / bottle produced by Tianjin Hualida Bioengineering Co., Ltd.; "Interfern" (trade name) is Shenyang Sansheng Pharmaceutical Co., Ltd. Recombinant human interferon α2a injection with a specification of 50 μg / ml / bottle produced by the limited liability company; Interferon α1b injection, "salbutamol sulfate injection" is produced by Jiangsu Yongda Pharmaceutical Co., Ltd., the specification is 0.48mg / 2ml / bottle; "PBS" is 25mmol / L disodium hydrogen phosphate containing 0.15mol / L NaCl- Sodium dihydrogen phosphate buffer (pH7.0). Unless otherwise specified in the subsequent embodiments, the above trade names have the same meaning as ...

Embodiment 2

[0033] Example 2: Detection of the purity of albuterol sulfate after mixing interferon alpha and salbutamol sulfate

[0034] The aerosol inhalation of each interferon α and albuterol sulfate prepared by the method of Example 1 is carried out ultrafiltration with the Millipore ultrafiltration centrifuge tube with a molecular weight cut-off of 3000Da after placing the preset time, and the filtrate is treated with After diluting with deionized water to the same volume as before ultrafiltration and centrifugation, take 20 μl and put them on a DIKMAPlatisil C18 reversed-phase high-performance liquid chromatography column (5 μm filler particle size, column size 4.6×250mm), and perform chromatographic operation at a column temperature of 25°C. Phase 0.08mol / L sodium dihydrogen phosphate (phosphoric acid to adjust the pH value to 3.1±0.05)-methanol (85:15) elution, flow rate 1.0ml / min, detection wavelength 276nm. The measurement results are shown in Table 2 below.

[0035] Salbutamol...

Embodiment 3

[0038] Embodiment 3: detection of salbutamol sulfate content after mixing interferon alpha and salbutamol sulfate

[0039] The salbutamol sulfate reference substance (prepared by China Institute for the Control of Pharmaceutical and Biological Products, batch number 100328-200502) is dissolved and diluted with water respectively to a concentration of 0.06, 0.12, 0.24, 0.48, 0.72mg / ml and then presses the high performance liquid chromatography conditions of Example 2 Samples were loaded to determine the peak area of ​​the main peak. Use the peak area (y) to perform linear regression on the concentration (x) to obtain a working curve, the equation is y=6900000x+5158, and the regression coefficient is r=0.9999.

[0040] The aerosolized inhalation of each interferon α and albuterol sulfate prepared by the method of Example 1 is carried out ultrafiltration centrifugation according to the method of Example 2 respectively after placing the preset time, and the filtrate is deionized w...

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Abstract

The invention belongs to the field of composites of antiviral medications, which relates to an atomization inhalant prepared from interferon alpha and salbutamol sulfate. The atomization inhalant comprises the interferon alpha with a curative effective dose, the salbutamol sulfate and a pharmaceutically acceptable adjuvant with sufficient quantity. Preferentially, the single dose comprises 2.5-30mug of the interferon alpha, 0.048-0.192mug of the salbutamol sulfate and the pharmaceutically acceptable adjuvant with the sufficient quantity, and more preferentially, the single dose comprises 10-20mug of the interferon alpha, 0.096-0.144mug of the salbutamol sulfate and the pharmaceutically acceptable adjuvant with the sufficient quantity. Compared with treating viral pneumonia by singly usingthe interferon alpha or the salbutamol sulfate, the curative effect can be obviously improved on treating the viral pneumonia by using the atomization inhalant prepared from the interferon alpha and the salbutamol sulfate.

Description

technical field [0001] The invention relates to a composition of antiviral drugs and its application in the preparation of drugs for treating viral pneumonia. Background technique [0002] Viral pneumonia is a common disease in infants and young children, which seriously endangers the life and health of infants and young children. According to incomplete statistics, more than 90% of infants and young children have been infected with viral pneumonia before the age of 2, of which more than 80% of the cases are within 1 year old, the peak age of onset is 2-6 months, and severe cases can be seen in 1-6 months . The death rate of infants and young children caused by infection of viral pneumonia is 0.5%-2.0% in developed countries, up to 7% in developing countries, and it is the leading cause of infant death in my country. In addition, viral pneumonia is very contagious and reinfectious. It has been reported that family members can be infected successively, and the incidence of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K9/70A61P11/00A61P31/14A61P31/16A61P31/20A61P31/22A61K31/137
Inventor 周敏毅刘金毅徐晨宋文进李洁程永庆
Owner BEIJING TRI PRIME GENE PHARMA CO LTD
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