Nasal spray containing human urinary kallidinogenase and preparation method thereof

A technology for urinary kallikrein and nasal spray, which is applied in the directions of biochemical equipment and methods, medical preparations containing active ingredients, peptidase, etc. and other problems, to achieve the effect of easy absorption, improvement of cerebral infarction, and reduction of stimulation

Pending Publication Date: 2021-09-03
JIANGSU SIMCERE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The characteristics of the nasal spray administration method determine that its requirements for drugs are different from those of injections. Human urinary kininogenase is usually prepared in the form of freeze-dried powder as an injection, but nasal sprays exist in liquid form. In addition, nasal administration must be non-irritating to the nasal mucosa, but the dosage forms of polypeptide protein nasal administration have the disadvantages that the excipients contained in them are usually more irritating to the nasal mucosa, and the drug solution itself has poor stability at room temperature. Therefore, the main solution of the present invention is to improve the stability of the drug solution, reduce the irritation of human urinary kininogenase as a nasal spray to the nasal mucosa, and strengthen its absorption in the nasal cavity

Method used

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  • Nasal spray containing human urinary kallidinogenase and preparation method thereof
  • Nasal spray containing human urinary kallidinogenase and preparation method thereof
  • Nasal spray containing human urinary kallidinogenase and preparation method thereof

Examples

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Effect test

Embodiment 1

[0033] Human urinary kininogenase 750PNA, chitosan 30g, disodium hydrogen phosphate 3g, sodium dihydrogen phosphate 6g, sodium chloride 5g, hydrolyzed gelatin 3g, appropriate amount of hydrochloric acid and sodium hydroxide.

[0034] Preparation:

[0035] Step 1, the preparation of chitosan solution:

[0036] Take 800ml of water for injection, heat it to 30-40°C, add 3g of disodium hydrogen phosphate and 6g of sodium dihydrogen phosphate, stir to dissolve, then slowly add 30g of chitosan into it, stir until completely dissolved, and prepare a chitosan solution .

[0037] Step 2, preparation of nasal spray containing human urinary kininogenase:

[0038] Cool the chitosan solution in step 1 to 5-15°C, slowly add 750PNA human urinary kininogenase while stirring, stir until the solution is clear and transparent, then add 5g sodium chloride and 3g hydrolyzed gelatin, stir evenly, Add water for injection to 950ml, check the pH value of the liquid medicine, and adjust the pH value...

Embodiment 2

[0041] Human urinary kininogenase 1500PNA, chitosan 50g, disodium hydrogen phosphate 3g, sodium dihydrogen phosphate 6g, sodium chloride 1g, hydrolyzed gelatin 3g, appropriate amount of hydrochloric acid and sodium hydroxide.

[0042] Preparation:

[0043] Step 1, the preparation of chitosan solution:

[0044] Take 800ml of water for injection, heat it to 30-40°C, add 3g of disodium hydrogen phosphate and 6g of sodium dihydrogen phosphate, stir to dissolve, then slowly add 50g of chitosan into it, stir until completely dissolved, and prepare a chitosan solution .

[0045] Step 2, preparation of nasal spray containing human urinary kininogenase:

[0046]Cool down the chitosan solution in step 1 to 5-15°C, slowly add 1500PNA human urinary kininogenase while stirring, stir until the solution is clear and transparent, then add 1g sodium chloride and 3g hydrolyzed gelatin, stir evenly, Add water for injection to 950ml, check the pH value of the liquid medicine, and adjust the pH...

Embodiment 3

[0049] Human urinary kininogenase 2000PNA, chitosan 65g, disodium hydrogen phosphate 3g, sodium dihydrogen phosphate 6g, sodium chloride 1g, hydrolyzed gelatin 3g, appropriate amount of hydrochloric acid and sodium hydroxide.

[0050] Preparation:

[0051] Step 1, the preparation of chitosan solution:

[0052] Take 800ml of water for injection, heat it to 30-40°C, add 3g of disodium hydrogen phosphate and 6g of sodium dihydrogen phosphate, stir to dissolve, then slowly add 65g of chitosan into it, and stir until completely dissolved to obtain chitosan solution;

[0053] Step 2, preparation of nasal spray containing human urinary kininogenase:

[0054] Cool down the chitosan solution in step 1 to 5-15°C, slowly add 2000PNA human urinary kininogenase while stirring, stir until the solution is clear and transparent, then add 1g of sodium chloride and 3g of hydrolyzed gelatin, stir evenly, Add water for injection to 950ml, check the pH value of the liquid medicine, and adjust t...

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PUM

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Abstract

The invention provides a nasal spray containing human urinary kallidinogenase and a preparation method thereof. The nasal spray contains a pharmaceutical active ingredient human urinary kallidinogenase, a buffering agent, a pH regulator, an osmotic pressure regulator, a protease protective agent and an absorption promoter, wherein the buffering agent is selected from a disodium hydrogen phosphate-sodium dihydrogen phosphate buffering system; the pH value of the nasal spray is 6.0-7.0; the pH regulator of the nasal spray is selected from hydrochloric acid and sodium hydroxide; the osmotic pressure regulator is selected from sodium chloride; and the protease protective agent is selected from one or more of hydrolyzed gelatin or albumin; and the absorption promoter is selected from chitosan. The nasal spray is non-toxic and non-allergic to nasal mucosa, is easily absorbed by the nasal mucosa, has good stability, can remarkably improve the cerebral infarction condition, can be carried about, and is convenient for subsequent treatment of cerebral infarction patients.

Description

technical field [0001] The present invention relates to a nasal administration preparation, in particular to an innovative preparation prepared from human urinary kininogenase for nasal administration, specifically a nasal administration system capable of treating acute cerebral infarction, which can prepare nasal A spray belongs to the technical field of pharmaceutical production. Background technique [0002] Acute cerebral infarction (Acute Cerebral Infarction, ACI) is a common acute ischemic encephalopathy. At present, there are more than 7 million patients with cerebrovascular diseases in my country, about 70% of which are acute ischemic encephalopathy, that is, acute cerebral infarction. A considerable proportion is accompanied by multiple risk factors, and they are high-risk individuals for recurrent cerebral infarction. With population aging, rapid economic development and changes in lifestyle, the incidence of acute cerebral infarction has increased significantly. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61K9/12A61K47/36A61K47/42A61K47/40A61P9/10
CPCA61K38/4853A61K9/12A61K9/0043A61K47/36A61K47/42A61K47/40A61P9/10C12Y304/21008
Inventor 钱勇刘艳红李玲夏金强任晋生
Owner JIANGSU SIMCERE PHARMA
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