Powder aerosol capable of resisting to idiopathic pulmonary fibrosis and preparation method thereof

A technology of pulmonary fibrosis and powder spray, which is applied in the field of anti-idiopathic pulmonary fibrosis powder spray and its preparation, and can solve the problems of poor drug efficacy and poor lung deposition

Pending Publication Date: 2021-08-31
ZHUHAI RESPROLY PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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  • Powder aerosol capable of resisting to idiopathic pulmonary fibrosis and preparation method thereof
  • Powder aerosol capable of resisting to idiopathic pulmonary fibrosis and preparation method thereof
  • Powder aerosol capable of resisting to idiopathic pulmonary fibrosis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Prepare micropowder.

[0048] 1. Put pirfenidone, distearoylphosphatidylcholine and lecithin at room temperature for 20 minutes, weigh pirfenidone, distearoylphosphatidylcholine, lecithin and chloride Calcium, water and ethyl acetate, spare;

[0049] Table 1 Micropowder formula table

[0050]

[0051] 2. According to the formula in Table 1, put pirfenidone, distearoylphosphatidylcholine, and lecithin into the ethyl acetate solution, stir to dissolve it; dissolve calcium chloride in water, and set aside;

[0052] 3. Pour the ethyl acetate solution obtained in step 2 into a stirring tank with an ultrasonic function, add water dissolved in calcium chloride into it, stir for 30 minutes, and set the ultrasonic oscillation frequency to 20-130KHz. , set the frequency of ultrasonic oscillation to 80KHz, and after 30 minutes of ultrasonication, the drug-containing emulsion is obtained;

[0053] 4. Use a peristaltic pump to pump the drug-containing emulsion obtained in step...

Embodiment 2

[0060] Determination of various data indicators of micropowder.

[0061] The micropowder that obtains in embodiment 1 is carried out each data index measurement, adopts graduated measuring cylinder method to measure bulk density, adopts fillet cone method to measure angle of repose, adopts specific surface and pore size distribution meter to measure, and the results are as follows:

[0062] Table 2 The specific surface area of ​​different proportioning micropowders

[0063] group Bulk density g / ml Angle of repose° Specific surface area m 2 / g

recipe one 0.082 62 12.7028 recipe two 0.087 56 11.6099 Recipe three 0.089 50 13.928 Recipe 3-2 0.12 48 6.2532 Recipe four 0.092 53 12.3025 Recipe five 0.085 58 7.9524

[0064] Table 3 Geometric diameters of micropowders with different ratios Laser particle size analyzer was used to detect the geometric diameters of micropowders, the results are as follows:

[0065] ...

Embodiment 3

[0069] conditioning test.

[0070] The micropowder obtained by spray drying is mainly amorphous, which needs to be transformed into a stable crystalline state under the combination of temperature and relative humidity. The micropowder obtained in step 6 of Example 1 is placed in an environment of 25±5° C. and 65±15% RH, and the stability time is ≥240 minutes.

[0071]In this example, the micropowder was placed in an environment of 25°C and 75% RH, and was stabilized for 360 minutes, and the moisture content and crystal form before and after conditioning were compared. The micropowder obtained in the step is placed simultaneously in an environment of 30°C and 85% RH, and is stable for 360 minutes. This sample is marked as formula 3-3, and the results are compared, as shown in the following table:

[0072] Each formula conditioning result of table 4

[0073] group Moisture content before conditioning% Moisture content after conditioning% pre-conditioning crystal...

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Abstract

The invention relates to a powder aerosol capable of resisting to idiopathic pulmonary fibrosis and a preparation method thereof, and belongs to the field of medicinal preparations. The powder aerosol includes, by weight in parts, 80-95 parts of active pharmaceutical ingredients, 2.5-20 parts of an endogenous pulmonary surfactant, and 0-10 parts of calcium salt. The particle volume geometric diameter of the powder aerosol is 0.5-6 [mu]m. The powder aerosol has a less and narrow geometric diameter distribution, so that the powder aerosol can directly reach the lesion. A lung deposition rate FPF value is greater than 50%. An FPF value (3.4) is greater than 30%, which refers to a deep lung deposition pattern. The powder aerosol can be delivered to the depth of the lung to achieve a clinical effect of anti-pulmonary fibrosis; the dosage of active ingredients of drugs can be reduced; and therefore, adverse reactions caused by the increasing of the dosage of the active ingredients can be reduced to a greater extent.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an anti-idiopathic pulmonary fibrosis powder spray and a preparation method. Background technique [0002] Idiopathic pulmonary fibrosis (IPF) is a specific type of chronic progressive fibrotic interstitial pneumonia confined to the lungs, predilectionally occurring in older men, with histological and / or radiographic appearance of the usual pattern Interstitial pneumonia (UIP). The etiology of idiopathic pulmonary fibrosis is unknown, and the pathogenesis has not been fully elucidated, but the evidence of existing studies shows that it is related to immune inflammatory injury. Immunological abnormalities are more prominent, while bronchoalveolar lavage fluid mainly shows inflammatory reactions, and the abnormalities of local lung tissues are different. At present, it is believed that alveolar epithelial cell injury and abnormal repair are the main mechanisms leading t...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/14A61K47/24A61K47/02A61K9/48A61K31/4418A61K33/14A61P11/00
CPCA61K9/145A61K9/143A61K9/0075A61K47/24A61K47/02A61K9/4858A61K9/485A61K31/4418A61K33/14A61P11/00A61K2300/00
Inventor 陈永奇胡芳黄敏瑜刘家杰
Owner ZHUHAI RESPROLY PHARM TECH CO LTD
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