Heparin aerosol inhalation solution preparation and preparation method thereof

An atomized inhalation and preparation technology, applied in the field of pharmacy, can solve the problems that the diameter of the atomized particles cannot meet the requirements of lung absorption, it is difficult to control the absorption amount, and increase the risk of bleeding, etc., so as to improve the imbalance of blood coagulation and fibrinolysis system, Avoid the first-pass effect of the liver and improve the effect of systemic blood coagulation abnormalities

Inactive Publication Date: 2019-01-25
BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no research and development specifically for heparin nebulization preparations. Clinically, heparin nebulization is mostly replaced by heparin injection, which is an off-label drug, and the diameter of the nebulized particles cannot meet the requirements for lung absorption, and long-term use will cause adverse effects. irreversible damage to the lungs
At the same time, heparin injection is mainly used for subcutaneous injection and intravenous administration, but the onset of subcutaneous injection is slow, and it is difficult to control the absorption amount, while intravenous administration will increase the risk of bleeding

Method used

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  • Heparin aerosol inhalation solution preparation and preparation method thereof
  • Heparin aerosol inhalation solution preparation and preparation method thereof
  • Heparin aerosol inhalation solution preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0036] Embodiment 1: Preparation of 140000IU / 20 milliliter single-dose heparin solution preparation for nebulized inhalation (100)

[0037] prescription:

[0038]

[0039] Preparation:

[0040] Measure heparin sodium according to the prescription, add it to 1600ml of water for injection, stir to dissolve completely, and then add the prescribed amount of sodium chloride, dipalmitate phosphatidylcholine and tyloxapol, after ultrasonic dissolution, add purified water to the obtained solution to 2000ml , and then add an appropriate amount of sodium citrate to adjust the pH to 5-6; use a 0.45 micron filter membrane for primary filtration, a 0.22 micron filter membrane for fine filtration, fill in an ampoule, and sterile filter; filling and sealing, each 20ml .

Embodiment 2

[0041] Embodiment 2: Preparation of 2000IU / 1 milliliter single dose, multi-standard heparin sodium nebulized inhalation solution preparation (1000ml) prescription:

[0042]

[0043] Measure heparin sodium according to the prescription, add it to 700ml of water for injection, stir to dissolve completely, and then add the prescribed amount of sodium chloride, dipalmitate phosphatidylcholine and tetratyxapol, after ultrasonic dissolution, add purified water to the obtained solution to 1000ml , then add an appropriate amount of sodium citrate, adjust the pH to 7-8; use a 0.45 micron filter membrane for primary filtration, a 0.22 micron filter membrane for fine filtration, fill in an ampoule, and sterile filter; filling, sealing, can be filled Into 1, 2, 3, 5, 10, 20ml each specification.

Embodiment 3

[0044] Embodiment 3: Preparation of 50000IU / 2 ​​milliliter single-dose heparin solution preparation for aerosol inhalation (1000 sticks)

[0045] prescription:

[0046]

[0047] Preparation:

[0048]Measure heparin calcium according to the prescription, add it to 1600ml of water for injection, stir to dissolve completely, and then add the prescribed amount of sodium chloride, dipalmitate phosphatidylcholine and tyloxapol, after ultrasonic dissolution, add purified water to the obtained solution to 2000ml , then add an appropriate amount of sodium citrate to adjust the pH to 6-7; use a 0.45 micron filter membrane for primary filtration, and a 0.22 micron filter membrane for fine filtration, fill and seal in ampoules, and sterile filter; filling and sealing, each 2ml .

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Abstract

The invention discloses a novel atomized inhalation solution preparation of heparin pharmaceutically acceptable salt and derivative thereof and a preparation method thereof; a liquid preparation for atomizing inhalation comprises a pharmaceutically acceptable salt of heparin, a surfactant, an isotonic agent, an appropriate amount of a PH modulator and purify water, and can be used for treating lung diseases, in particular chronic obstructive pulmonary disease (COPD), acute lung injury and acute respiratory distress syndrome.

Description

technical field [0001] The invention relates to a heparin solution preparation for atomized inhalation and a preparation method thereof, belonging to the field of pharmacy. Background technique [0002] Heparin drugs belong to mucopolysaccharide drugs, a class of substances composed of hexuronic acid, hexosamine and their sulfated, acetylated derivatives as structural units, including heparin, low molecular weight heparin and ultra low molecular weight heparin. Heparin is extracted from the small intestinal mucosa, lungs and other tissues of pigs, cattle, sheep and other animals. The molecular weight distribution is 3000Da-50000Da, and the average molecular weight is about 15000Da. Low-molecular-weight heparin refers to low-molecular-weight components obtained from heparin by fractionation, or low-molecular-weight heparin fragments obtained by enzymatic, chemical or physical degradation of heparin, and components with a molecular weight of less than 8000Da account for more t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/727A61K47/24A61P11/00A61P7/02A61P11/10
CPCA61K9/0078A61K9/08A61K31/727A61K47/24
Inventor 胡杰康志云吴珍珍
Owner BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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