Preparation method for oral insulin enteric-coated preparations

A technology of enteric-coated preparations and insulin, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc. It can solve the unpredictable and reproducible effects of absorption, difficulty in absorbing encapsulated drugs, and easy absorption that cannot be taken orally. problem, to achieve the effect of improving inconvenience and pain, easy operation and simple process flow

Inactive Publication Date: 2015-09-30
NORTHEAST FORESTRY UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

With the progress of research, people found that liposomes are not stable enough as a carrier, they are easy to aggregate and fuse, making the absorption of encapsulated drugs difficult
However, many researchers still believe that liposome as an oral drug delivery system is questionable. They believe that liposome encapsulation does not make oral absorption easy, and the impact on absorption is also unpredictable and reproducible, so Oral administration of insulin liposomes remains a subject of controversy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0023] First activate the silicon dioxide for 4 hours, disperse 25mg of insulin and 100mg of silicon dioxide in 100ml of hydrochloric acid solution with pH=0.5, adsorb and load the drug at 10°C for 6 hours, and filter. The obtained solid is silicon dioxide loaded with insulin. Disperse silicon dioxide of insulin in 10ml of acetone solution, then add 20mg of hypromellose peptide ester (HPMCP) enteric-coated material to the acetone solution, mix well and pour this acetone solution into 10ml of 0.5mg / ml In the PVA solution, the coating is deposited for 30 minutes, filtered, and the obtained solid is freeze-dried, and then prepared into a powder with suitable auxiliary materials and molding technology.

example 2

[0025] First activate the silicon dioxide for 5 hours, disperse 25mg of insulin and 100mg of silicon dioxide in 100ml of hydrochloric acid solution with pH=0.8, adsorb and load the drug at 10°C for 6 hours, and filter. The obtained solid is silicon dioxide loaded with insulin. Disperse silicon dioxide of insulin in 10ml of acetone solution, then add 20mg of hypromellose peptide ester (HPMCP) enteric-coated material to the acetone solution, mix well and pour this acetone solution into 10ml of 0.5mg / ml In the PVA solution, the coating is deposited for 60 minutes, filtered, and the obtained solid is freeze-dried, and then prepared into tablets with suitable auxiliary materials and molding technology.

example 3

[0027] First activate the silicon dioxide for 6 hours, disperse 250mg of insulin and 1000mg of silicon dioxide in 100ml of hydrochloric acid solution with pH = 0.8, adsorb and load the drug at 20°C for 8 hours, and filter. The obtained solid is silicon dioxide loaded with insulin. Disperse silicon dioxide of insulin in 100ml of acetone solution, then add 200mg of hypromellose peptide ester (HPMCP) enteric-coated material to the acetone solution, mix well and pour this acetone solution into 100ml of 0.5mg / ml In the PVA solution, the coating is deposited for 90 minutes, filtered, and the obtained solid is freeze-dried, and then prepared into granules with suitable auxiliary materials and molding technology.

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PUM

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Abstract

The invention provides a preparation method for oral insulin enteric-coated preparations. The preparation method is characterized in that firstly, insulin is dissolved in hydrochloric acid solution, then mesoporous silica is activated in a vacuum mode and then dispersed into the solution, and the mesoporous silica adsorbs and carries the insulin at a proper temperature; the silicon dioxide carrying the insulin is separated from the hydrochloric acid solution and then dispersed to acetone solution, a cellulose derivative type enteric coating material is added into the acetone solution, and the acetone solution is injected into water-soluble solution containing PVA after the cellulose derivative type enteric coating material is completely dissolved; a coating deposition reaction is conducted, then the coated silicon dioxide carrying the insulin is separated out, dried in a frozen mode and made into oral insulin enteric-coated preparations of the specifications of powder, tablets, granules, capsules, suspensions, pills and the like with the cooperation of proper auxiliary materials and forming technologies. The oral insulin enteric-coated preparations obtained through the preparation method can relieve the pain and inconvenience brought by traditional insulin, and the oral insulin enteric-coated preparations have the advantages that the operation process is simple, cost is low, and expanded production is easy.

Description

technical field [0001] The invention relates to a method for preparing an oral insulin enteric-coated preparation, in particular to a method for preparing an oral insulin enteric-coated slow-release preparation by using mesoporous silicon dioxide as a carrier. technical background [0002] With the development of society, the continuous improvement of people's living standards, coupled with the reduction of exercise and poor eating habits, lead to more and more people suffering from diabetes in modern times. According to statistics, nearly 5% of the world's 6 billion people suffer from diabetes, and it is expected that it will continue to show an increasing trend in the next 20 years. Insulin is currently the drug of choice for the treatment of type Ⅰ diabetes and type Ⅱ diabetes. Since insulin is a protein polypeptide hormone, it is easily destroyed by gastrointestinal proteases when administered orally. Therefore, the current form of insulin administration is mostly inject...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/20A61K9/48A61K9/16A61K9/10A61K38/28A61K47/38A61K47/04A61P3/10
Inventor 祖元刚赵修华李媛媛黄延年王玲玲单常
Owner NORTHEAST FORESTRY UNIVERSITY
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