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Novel insulin inhalation aerosol powder and preparation method thereof

A technology for inhaling powder aerosols and insulin, applied in the field of medicine, can solve problems such as affecting the normal function of the lungs, lung toxicity, etc., and achieve the effects of avoiding the influence of drug activity, rounding the microscopic shape, and avoiding the influence.

Inactive Publication Date: 2011-05-18
CHINA NAT ACAD NANOTECH & ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since a large number of irrelevant compounds enter the lungs, they may affect the normal function of the lungs, resulting in toxicity to the lungs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024]Embodiment 1: Adopt isopropanol as stripping solvent. Dissolve an appropriate amount of insulin in hydrochloric acid solution with a concentration of 10mM to prepare a drug solution with a concentration of 50mg / ml for future use. The selected preparation conditions are pressure 11MPa, temperature 37°C, carbon dioxide flow rate 25ml / min, isopropanol flow rate 1.5ml / min, liquid medicine flow rate 0.05ml / min, to obtain 0.5-7μm insulin micropowder; use fluidized bed supersonic airflow pulverization The machine crushes mannitol, lysine, and alanine into powders with a particle size of 30-200 μm; by weight percentage: 5% of insulin micropowder and 93% of crushed mannitol, 1.5% of lysine, and 0.5% of alanine % uniformly mixed, packed into a dry powder delivery device, and made into a new type of insulin inhalation powder. It can be prepared by high-speed grinding, grinding in ball mill or vibrating mill, or recrystallization in supercritical solvent.

Embodiment 2

[0025] Embodiment 2: Adopt isopropanol as stripping solvent. Dissolve an appropriate amount of insulin in hydrochloric acid solution with a concentration of 50mM to prepare a medicinal solution with a concentration of 80mg / ml for future use. The selected preparation conditions are pressure 11MPa, temperature 37°C, carbon dioxide flow rate 35ml / min, isopropanol flow rate 1.0ml / min, liquid medicine flow rate 0.05ml / min, to obtain 0.5-7μm insulin micropowder; Grind arginine and glycine into powders with a particle size of 30-200 μm; mix 20% of insulin micropowder with 70% of pulverized xylitol, 2% of arginine, and 8% of glycine, and put them into a dry powder drug delivery device. Made a new type of insulin inhalation powder.

Embodiment 3

[0026] Embodiment 3: adopt acetone as stripping solvent. Dissolve an appropriate amount of insulin in an acetic acid solution with a concentration of 10 mM to prepare a drug solution with a concentration of 50 mg / ml for future use. The selected preparation conditions are pressure 30MPa, temperature 55°C, carbon dioxide flow rate 30ml / min, acetone flow rate 1.5ml / min, liquid medicine flow rate 0.05ml / min, to obtain 0.5-7μm insulin micropowder; - β-cyclodextrin and sodium citrate are ground into a powder with a particle size of 30-200 μm; 10% of insulin micropowder and 85% of pulverized lactose, 4% of 2-hydroxypropyl-β-cyclodextrin, citron Mix evenly with 1% sodium nitrate, put it into a dry powder drug delivery device, and make a new type of insulin inhalation powder.

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Abstract

The invention discloses novel insulin inhalation aerosol powder, which is characterized by comprising the following components in percentage by weight: 3 to 20 percent of insulin micro powder and 50 to 96 percent of medicinal carrier material. A preparation method comprises the following steps of: (1) preparing the insulin micro powder by using supercritical fluid technology; and (2) preparing the novel insulin inhalation aerosol powder. The invention has the advantages that: the method for preparing the insulin particles by adopting the supercritical fluid technology has simple process conditions, is safe and non-toxic, and has short operation time; the obtained product has round and smooth micro shape, good powder flowability and high yield; and the novel inhalation aerosol powder is prepared by mixing the particles prepared by the supercritical fluid technology and carrier particles with big particle diameters, and the big carrier particles are deposited on the throat and do not enter the lung during inhalation, so the influence of a large amount of irrelevant compounds on the normal function of the lung is avoided, and the novel inhalation aerosol powder has high safety.

Description

(1) Technical field: [0001] The invention belongs to the technical field of medicine, and relates to a medicine preparation and a preparation process thereof, in particular to a novel insulin inhalation powder for treating diabetes and a preparation method thereof. (two) background technology: [0002] Insulin is one of the most studied drugs for pulmonary delivery and has been clinically used to treat diabetes for 60 years. Diabetes mellitus can be divided into insulin-dependent (IDDM) and non-dependent (NIDDM) according to its clinical manifestations. The survival of IDDM patients depends on exogenous insulin, and most of them need life-long injection of INS. Insulin injections (solutions and powder injections) are traditional clinical dosage forms, and the route of administration is generally skin or intramuscular injection, 3-4 times a day. It is undeniable that the hypoglycemic effect of insulin injections is reliable and rapid, but its hypoglycemic duration is too sho...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K38/28A61P3/10
Inventor 周冉郑洪浩
Owner CHINA NAT ACAD NANOTECH & ENG
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