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Insulin powder spray for lung inhalation and preparation method thereof

A technology of insulin and lung inhalation, applied in the field of pharmaceutical preparations, can solve problems such as the lack of conditions for developing mature dosage forms

Inactive Publication Date: 2009-07-08
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Ji Ying et al. studied the in vitro physical properties of artificial lung surfactant as a pulmonary delivery carrier, mainly focusing on the surface tension and particle size of the suspension, and did not yet have the conditions to develop mature dosage forms (artificial lung surfactant as an insulin lung drug delivery system). Research on Partial Drug Delivery Carriers, "Chinese Journal of Pharmaceutical Sciences", Volume 41, Issue 10, May 2006, p766-768)

Method used

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  • Insulin powder spray for lung inhalation and preparation method thereof
  • Insulin powder spray for lung inhalation and preparation method thereof
  • Insulin powder spray for lung inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] Take 3 g of recombinant human insulin and add an appropriate amount of hydrochloric acid with pH 2.0 to completely dissolve the recombinant human insulin to obtain solution 1. Add 72.0 g of mannitol and 18.0 g of leucine to about 2000 ml of water to dissolve to obtain solution 2; mix solution 1 and solution 2 evenly, add water to 3000 ml, and filter with a 0.2 μm microporous membrane to obtain solution 3. Weigh 18 g of artificial lung surfactant (among them: 14.4 g of egg yolk lecithin, 1.8 g of cetyl alcohol, and 1.8 g of tyloxapol) and dissolve it in absolute ethanol to obtain a lipid solution. Place the solution in a ground-mouthed round-bottom flask, and evaporate the organic solvent with a rotary evaporator at 100 rpm and reduced pressure on a constant temperature water bath at 50°C, so that film-forming materials such as phospholipids form a uniform lipid film at the bottom of the flask. . Use solution 3 to rotate and wash the membrane in a rotary evaporator to o...

Embodiment 2

[0106] Take 0.5 g of bovine insulin, add appropriate amount of hydrochloric acid with pH 2.0 to dissolve all the bovine insulin, and obtain solution 1. Add 15g of mannitol and 4g of leucine into about 400ml of water to dissolve to obtain solution 2; mix solution 1 and solution 2 evenly, add water to 800ml, and filter through a 0.2μm microporous membrane to obtain solution 3. Weigh 3.2 g of artificial lung surfactant (among them: 2.5 g of soybean lecithin, 0.4 g of cholesterol, and 0.3 g of tyloxapol) and dissolve it in absolute ethanol to obtain a lipid solution. Place the solution in a ground-mouthed round-bottom flask, and evaporate the organic solvent with a rotary evaporator at 100 rpm and reduced pressure on a constant temperature water bath at 50°C, so that film-forming materials such as phospholipids form a uniform lipid film at the bottom of the flask. . Use solution 3 to rotate and wash the membrane in a rotary evaporator to obtain a milky white crude lipid suspensio...

Embodiment 3

[0108]Take 0.5 g of recombinant human insulin and add an appropriate amount of NaOH solution with pH 8.0 to completely dissolve the recombinant human insulin to obtain solution 1. Add 12g of mannitol and 1.5g of threonine into about 200ml of water to dissolve to obtain solution 2; mix solution 1 and solution 2 evenly, add water to 800ml, and filter with a 0.2μm microporous membrane to obtain solution 3. Weigh 3.0 g of bovine lung surfactant extract (Beijing Shuanghe Modern Medical Technology Co., Ltd., National Pharmaceutical Approval H20052106), and suspend it with solution 3 to obtain a milky white thick lipid suspension. The suspension was subjected to high-pressure homogenization using a high-pressure homogenizer at a pressure of 900 bar to obtain a recombinant human insulin lipid suspension. The suspension was spray-dried under the following conditions: inlet temperature 110°C, outlet temperature 70°C, air flow rate 100%, nozzle air flow rate 800ml / min. The white powder ...

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Abstract

The invention relates to the field of pharmaceutical preparation, in particular to insulin powder inhalation absorbed in lung through mouth. The invention is characterized in that the insulin powder inhalation consists of insulin, mannite, amino acid and lung surface active substances. The insulin powder inhalation has the advantages of high bioavailability, good safety, and better solubility, bulk density, angle of repose and atomizing property, and is not easy to absorb moisture.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an insulin powder aerosol absorbed in the lungs after oral inhalation and a preparation method thereof. Background technique [0002] Insulin is a 54-peptide compound produced by the pancreas and is involved in glucose metabolism. In a pathological state, insulin secretion is insufficient and blood sugar concentration rises, leading to diabetes. [0003] Diabetes is becoming one of the diseases that seriously endanger human health after cancer. Long-term hyperglycemia not only makes the patient lose weight and fatigue, but also induces other complications, such as cataract, stroke, myocardial infarction, and kidney disease. It is estimated that by 2025 the world will reach 300 million people, and China will have 38 million diabetic patients. Diabetes is divided into type 1 (insulin-dependent) and type 2 (non-insulin-dependent). Insulin is an important first-line dru...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K9/14A61K47/42A61K47/26A61K47/16A61P3/10
Inventor 汤玥朱家壁张勇陈西敬
Owner CHINA PHARM UNIV
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