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Powder snuff of insulin for administration of lung and its preparing process

A technology for insulin and powder spray, which is applied in the field of insulin powder spray and its preparation, and can solve the problems of difficulty in absorbing moisture and the like

Inactive Publication Date: 2002-10-09
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The technical problem to be solved by the present invention is: to prepare an insulin powder aerosol, select a carrier compatible with insulin, so that the obtained insulin powder has a small diameter and a light powder quality, and not only the solubility, bulk density, angle of repose, fog Chemical properties are good, and not easy to absorb moisture

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0123] Take 0.18 g of citric acid and add about 200 ml of water to dissolve it, add 3 g of insulin, stir and add an appropriate amount of dilute hydrochloric acid to dissolve all the insulin, and obtain solution 1. Add 21.0g of mannitol, 6.0g of threonine and 3.6g of sodium citrate into about 400ml of water to dissolve to obtain solution 2; mix solution 1 and solution 2, add water to 2000ml, and adjust the pH to 7.4 with dilute sodium hydroxide solution Stir continuously until the solution is clear, filter through a 0.2 μm microporous membrane, and spray dry. The conditions are that the inlet temperature is 100° C., the outlet temperature is 65° C., the air flow rate is 90%, and the nozzle air flow rate is 800 ml / min. The white insulin-containing powder was obtained, the insulin content was measured, and the powder was divided into hard capsules.

Embodiment 2

[0125] Take 1.5 g of insulin, add appropriate amount of 0.1 mol / L hydrochloric acid to 100 ml to dissolve all the insulin, and obtain solution 1. Add 9g of mannitol and 4.5g of leucine into about 200ml of water to dissolve to obtain solution 2; mix solution 1 and solution 2, add water to 1000ml, adjust the pH to about 7.4 with dilute sodium hydroxide solution, and keep stirring until the solution is clear , filtered through a 0.2 μm microporous membrane, and spray-dried. The conditions are that the inlet temperature is 100° C., the outlet temperature is 65° C., the air flow rate is 90%, and the nozzle air flow rate is 800 ml / min. The white insulin-containing powder was obtained, the insulin content was measured, and the powder was divided into hard capsules.

Embodiment 3

[0127] Take citric acid and add about 100ml of water to dissolve it, add 1.5g of insulin, stir and add an appropriate amount of dilute hydrochloric acid to completely dissolve the insulin, and obtain solution 1. Add 12g of mannitol, 1.5g of threonine and 1.8g of sodium citrate into about 200ml of water to dissolve to obtain solution 2; mix solution 1 and solution 2, add water to 1000ml, and adjust the pH to about 7.4 with dilute sodium hydroxide solution , stirred continuously until the solution was clear, filtered through a 0.2 μm microporous membrane, and spray-dried. The conditions were that the inlet temperature was 110° C., the outlet temperature was 70° C., the air flow rate was 90%, and the nozzle air flow rate was 800 ml / min. The white insulin-containing powder was obtained, the insulin content was measured, and the powder was divided into hard capsules.

[0128] Observation results of spray-dried powder morphology: The capsule content powder was observed with an opti...

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PUM

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Abstract

A powder snuff of insulin for administration of lung is prepared from insulin, polyhydroxy glucol and amino acids through spray drying. Its advantages are small diameter of powder particles, light weight, and high solubility, stack density and atomizing performance.

Description

technical field [0001] The invention relates to an insulin powder mist and a preparation method thereof, in particular to an insulin powder mist capable of being 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 its role is to participate in glucose metabolism. In a pathological state, pancreatic islet cells cannot secrete enough insulin, and the blood sugar concentration will rise at this time, leading to diabetes. The long-term hyperglycemia state not only makes the patient's body thin and weak, but also induces other diseases, such as cataract, stroke, myocardial infarction, and kidney disease. According to WHO statistics, in 1995, there were 135 million people in the world suffering from diabetes, of which 16 million were in China, and the incidence rate is currently increasing year by year. It is estimated that by 2025 the world will reach 300 milli...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K38/28A61P3/10
Inventor 朱家壁陈西敬
Owner CHINA PHARM UNIV
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