Insulin spray for oral cavity and its prepn process

An oral spray and preparation technology, which is applied in the direction of aerosol delivery, medical preparations containing active ingredients, peptide/protein components, etc., can solve the problems of insufficient stability of preparations and affecting absorption rate, etc., and achieve safe use, The hypoglycemic effect is good, and the effect of hypoglycemic effect is better

Inactive Publication Date: 2002-02-13
HUAZHONG UNIV OF SCI & TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this preparation, the average particle size of each component is 427.2nm, which not only affects the improvement of absorption rate, but also t

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Insulin 20000u

[0019] Soy Lecithin 30.0g

[0020] Propylene glycol 45.0g

[0021] Borneol 1.2g

[0022] Absolute ethanol 3.0ml

[0023] Phenol 2.0g

[0024] Phosphate buffer (pH=7.4) appropriate amount

[0025] Full volume 1000ml

[0026] Take soybean lecithin according to the prescription, add propylene glycol and ethanol solution of borneol, stir evenly and add 555ml of phenol-containing phosphate buffer solution with pH=7.4, the above components are used as excipients in the insulin oral spray formula, and conduct ultrasonic for 1.5 hours, the ultrasonic conditions are: the duty cycle is 60%, the temperature is controlled at 50°C-60°C, and the ultrasonic frequency is 18KHz. Insulin was dissolved in 345 ml of phenol-containing phosphate buffer, pH = 7.0, and slowly added to the sonicated excipient solution, and sonication was continued for 4 minutes.

[0027] The insulin oral spray prepared according to this formula is stored in a refrigerator at 2-8°C for 1 ...

Embodiment 2

[0030] Insulin 40000u

[0031] Soy Lecithin 25.0g

[0032] Propylene glycol 75.0g

[0033] Borneol 1.2g

[0034] Absolute ethanol 4.0ml

[0035] Phenol 2.0g

[0036] Phosphate buffer (pH=7.4) appropriate amount

[0037] Full volume 1000ml

[0038] Get soybean lecithin according to the prescription, add the ethanol solution of propylene glycol and borneol, stir and add 540ml of phenol-containing phosphate buffer solution with pH=7.4, the above components are used as excipients in the insulin oral spray formula, and conduct ultrasonic Treat for 1 hour, the ultrasonic conditions are: the duty cycle is 50%, the temperature is controlled at 40-55°C, and the ultrasonic frequency is 20KHz. Insulin was dissolved in 360 ml of phenol-containing phosphate buffer, pH=7.4, and slowly added to the sonicated excipient solution, and sonication was continued for 5 minutes.

[0039] The insulin oral spray prepared according to this formula is stored in a refrigerator at 2-8°C for 1 year wi...

Embodiment 3

[0042] Insulin 60000u

[0043] Soy Lecithin 35.0g

[0044] Propylene glycol 80.0g

[0045] Borneol 1.4g

[0046] Absolute ethanol 4.0ml

[0047] Phenol 2.0g

[0048] Phosphate buffer (pH=7.4) appropriate amount

[0049] Full volume 1000ml

[0050] Take soybean lecithin according to the prescription, add the ethanol solution of propylene glycol and borneol, stir evenly and add 545ml of phenol-containing phosphate buffer solution with pH=7.4, the above components are used as excipients in the insulin oral spray formula, and conduct ultrasonic After 2 hours of treatment, the ultrasonic conditions are: the duty cycle is 70%, the temperature is controlled at 55°C-70°C, and the ultrasonic frequency is 25KHz. Insulin was dissolved in 360 ml of phenol-containing phosphate buffer, pH=7.5, and slowly added to the sonicated excipient solution, and sonication was continued for 3 minutes.

[0051] The insulin oral spray prepared according to this formula is stored in a refrigerator ...

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PUM

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Abstract

The present invention relates to medicine and its production and aims at raising biological utilization of oral absorption and strengthening the stability of the preparation. The insulin spray for oral cavity contains insulin 10000-70000 U, soybean lecithin 5-50 g and propylene glycol 25-80 g as well as borneol 1.2-10g, absolute ethyl alcohol 1-15 ml and phenol 2-5 g, the rest is pH 6.8-7.8 buffering phosphate solution, in each 1000 ml of microemulsion. The preparation process includes mixing soybean lecithin with propylene glycol, borneol and ethanol solution, addition of phenol containing buffering phosphate solution, supersonic treatment to obtain emulsified oil phase, the dissolution of insulin in the buffering solution, further mixing and supersonic treatment.

Description

technical field [0001] The invention relates to a medicine and a production method thereof, in particular to a medicine spray for human oral mucosa absorption and a preparation method thereof. Background technique [0002] Insulin is easily degraded by gastric acid and a variety of digestive enzymes in the gastrointestinal tract, so it cannot be taken orally and can only be administered by injection. It must be injected half an hour before meals to control blood sugar, and it must be administered for a lifetime, which makes patients feel painful and inconvenient. Therefore, the study of safety, convenience and effectiveness, especially non-injection drug administration preparations, will greatly facilitate disease patients. Insulin non-injection route of administration has become a hot research topic in domestic and foreign pharmaceutical circles since the 1970s, and great progress has been made especially since the 1990s. There are several alternative routes of insulin ad...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/107A61K9/14A61K38/28A61L9/04
CPCA61K38/28A61K9/1075A61K9/006
Inventor 徐辉碧黄开勋高秋华高中洪杨继林
Owner HUAZHONG UNIV OF SCI & TECH
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