Preparing process of insulin powder inhalant

A technology for dry powder inhalers and insulin, which is applied in the field of preparation of insulin dry powder inhalers, to achieve the effect of reducing the amount of inhalation into the lungs and making the preparation method simple and feasible

Inactive Publication Date: 2005-01-19
SHANGHAI XINGKANG PHARMA RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this type of substance is non-toxic, has no side effects, and can be dissolved in body fluids, so far, the inhalation dry powder inhalers marketed on the market are all micronized drugs and larger particle size carrier mixtures, or simply Micronized drug, administered by inhalation through a special inhaler

Method used

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  • Preparing process of insulin powder inhalant
  • Preparing process of insulin powder inhalant
  • Preparing process of insulin powder inhalant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] In this embodiment, a commercialized QYN-100 jet mill was used.

[0030] Insulin 20g, leucine 2g, mixed evenly, jet milling feed rate 5g / min, vibration frequency current 55mA, air inlet pressure (impact port pressure) 0.5mpa, feed inlet pressure 0.55mpa, to obtain insulin micronized particles A: Take 200g of mannitol fine powder (passed through a 200 mesh sieve), take 20g of it and leucine 4g and heat and dissolve it with 40ml water to make a soft material, pass through a 40 mesh sieve to granulate, put in an oven at 60°C for about 20 minutes, pass through 60 Mesh sieve for granulation, drying, select powder with 100-360 mesh sieve to obtain carrier B. Mix according to A:B (1:50), pack into capsules to get insulin dry powder inhalation.

Embodiment 2

[0032] In this embodiment, a commercialized QYN-100 jet mill was used.

[0033] After dissolving 2 g of leucine in water, add 20 g of insulin raw material, stir, freeze-dry, and airflow pulverize the freeze-dried powder, feed speed is about 5 g / min, vibration frequency current is 60 mA, air inlet pressure (impact port pressure) is 0.6 mpa. The inlet pressure was 0.7mpa to obtain micronized insulin granules A. The carrier was prepared as in Example 1, mixed according to A:B (1:50), and packed into capsules to obtain the insulin dry powder inhaler.

Embodiment 3

[0035] In this embodiment, a commercialized QYN-100 jet mill was used.

[0036] Add 10 g of insulin raw material, 8 g of mannitol and 0.1 g of poloxamer after dissolving 2 g of leucine in water, stir, freeze-dry, and air-flow pulverize the freeze-dried powder, feed speed is about 5 g / min, vibration frequency current is 60 mA, inlet pressure The impact port pressure) is 0.6mpa, and the feed port pressure is 0.7mpa to obtain insulin micronized particles A. The carrier is prepared as in Example 1, mixed according to A:B (1:50), and packed into capsules to obtain the insulin dry powder inhaler.

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Abstract

The invention discloses a method for preparing insulin dry powder inhalant. The process includes following steps: feeding insulin or physical or dry freezed composition of insulin and dispersal glidant into crushing chamber through nozzle, contacting with high speed air current, and crushing them to powder, mixing with medicinal acceptable carrier, collecting to capsule or aluminium plastic bubble cap or packing separately into inhalant apparatus. In the application process of the insulin dry powder inhalant of the invention, big carrier particles, will deposit in parslaryngea pharyngs, not entering into the lungs, insulin will enter into the lungs directly and be absorbed quickly. Foreign constituent absorbed into the lungs with pharmaceutical particles will not exceed 15% of insulin, thus exert no adverse effect to human body.

Description

technical field [0001] The invention relates to a preparation method of an insulin dry powder inhaler. Background technique [0002] As we all know, insulin is one of the most important endocrine hormones in the body, and it is a necessary regulatory substance to maintain normal glucose metabolism. The lack of insulin in the body will lead to increased blood sugar. Therefore, patients with type I diabetes and some patients with type II diabetes need to use exogenous insulin for treatment. treat. At present, insulin can only be administered by subcutaneous or intramuscular injection. Usually, the dose is divided into 4 times a day, subcutaneously injected 30 minutes before morning, noon, and dinner, and injected again before going to bed at night. Although there are medium and long-acting injections such as protamine zinc insulin, some patients still need to inject 2-4 times a day. Diabetes requires life-long medication. Long-term repeated injections will cause pain and inc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/72A61K38/28A61P3/10
Inventor 郑梁元吴志明
Owner SHANGHAI XINGKANG PHARMA RES & DEV
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