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Acetylcysteine compound and acetylcysteine solution being used for inhalation and containing same

A technology of acetylcysteine ​​and its compound, which is applied in the field of acetylcysteine ​​solution for inhalation, can solve problems such as the difference in solubility of crystalline drugs, large free energy per unit surface, and easy hydration of the surface between particles, so as to improve the inhalation Moist, quick onset, easy to use effect

Active Publication Date: 2014-10-15
湖南华纳大药厂手性药物有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compounds with different crystal structures are in different energy states due to the difference in molecular arrangement order. Generally, amorphous drugs have greater potential energy, and the bonding strength between particles is smaller than that of crystal forms. The total unit surface free The energy is large, and the surface between the particles is easy to hydrate, resulting in a difference in solubility from that of crystalline drugs

Method used

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  • Acetylcysteine compound and acetylcysteine solution being used for inhalation and containing same
  • Acetylcysteine compound and acetylcysteine solution being used for inhalation and containing same
  • Acetylcysteine compound and acetylcysteine solution being used for inhalation and containing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] [Example 1] Preparation of acetylcysteine ​​compound

[0041] 1) Dissolve 12kg of acetylcysteine ​​in 10L of water to obtain a 1.2kg / L aqueous solution of acetylcysteine;

[0042] 2) Add 0.01% (w / v) activated carbon to the acetylcysteine ​​aqueous solution obtained in step 1), stir, suction filter, and take the filtrate;

[0043] 3) Add 50L of mixed solvent A to the filtrate obtained in step 2) with a flow rate of 13L / min under stirring at a speed of 50r / min to form a turbid solution, wherein said mixed solvent A is tetrahydrofuran and n-butanol by volume A mixed solvent with a ratio of 2:1;

[0044] 4) Place the turbid solution obtained in step 3) at a frequency of 3.5kHz and an intensity of 0.6W·cm -2 Under the ultrasonic field of 6L / min, 120L of mixed solvent B was added to it at a flow rate of 6L / min. After the addition, crystals were precipitated, wherein said mixed solvent B was a mixed solvent composed of diethyl ether and isopropyl ether at a ratio of 5:1;

...

Embodiment 2

[0048] [Example 2] Preparation of acetylcysteine ​​compound

[0049] 1) Dissolve 26kg of acetylcysteine ​​in 10L of water to obtain a 2.6kg / L aqueous solution of acetylcysteine;

[0050] 2) Add 0.01% (w / v) activated carbon to the acetylcysteine ​​aqueous solution obtained in step 1), stir, suction filter, and take the filtrate;

[0051] 3) Add 100L of mixed solvent A to the filtrate obtained in step 2) at a flow rate of 20L / min under stirring at a speed of 60r / min to form a turbid solution, wherein said mixed solvent A is tetrahydrofuran and n-butanol by volume A mixed solvent with a ratio of 5:1;

[0052] 4) Place the turbid solution obtained in step 3) at a frequency of 6.5kHz and an intensity of 4W·cm -2 Under the ultrasonic field of 12L / min, 180L of mixed solvent B was added to it at a flow rate of 12L / min. After the addition, crystals were precipitated, wherein said mixed solvent B was a mixed solvent composed of diethyl ether and isopropyl ether at a ratio of 7:1;

[...

Embodiment 3

[0055] [Example 3] Preparation of acetylcysteine ​​compound

[0056] 1) Dissolve 20kg of acetylcysteine ​​in 10L of water to obtain a 2.0kg / L aqueous solution of acetylcysteine;

[0057] 2) Add 0.01% (w / v) activated carbon to the acetylcysteine ​​aqueous solution obtained in step 1), stir, suction filter, and take the filtrate;

[0058] 3) Add 80L of mixed solvent A at a flow rate of 16L / min to the filtrate obtained in step 2) under stirring at a speed of 55r / min to form a turbid solution, wherein said mixed solvent A is tetrahydrofuran and n-butanol by volume A mixed solvent with a ratio of 4:1;

[0059] 4) Place the turbid solution obtained in step 3) at a frequency of 4.5kHz and an intensity of 2W·cm -2 Under the ultrasonic field of 8L / min, 150L of mixed solvent B was added to it at a flow rate of 8L / min. After the addition, crystals were precipitated, wherein said mixed solvent B was a mixed solvent composed of diethyl ether and isopropyl ether at a ratio of 6:1;

[006...

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Abstract

The invention belongs to the technical field of medicines and particularly relates to an acetylcysteine compound and an acetylcysteine solution being used for inhalation and containing the same. The acetylcysteine compound is a hydrate crystal, and the molecular formula of the acetylcysteine compound is C5H9NO3S*H2O. An X-ray powder diffraction spectrogram obtained through measurement of the acetylcysteine compound by using Cu-K alpha rays is shown in figure 1. According to the new-crystal-form acetylcysteine compound, the hygroscopicity of the compound can be significantly improved; the acetylcysteine solution which is used for inhalation and prepared from the new-crystal-form acetylcysteine compound is convenient to use, focus-targeted, fast in acting and good in curative effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an acetylcysteine ​​compound and an acetylcysteine ​​solution for inhalation containing the compound. Background technique [0002] Acetylcysteine, the English name is Acetylcysteine, and the chemical name is N-acetyl-3-mercaptoalanine. Molecular formula: C 5 h 9 NO 3 S, molecular weight: 163.20. The chemical structural formula is as follows: [0003] [0004] Acetylcysteine ​​is a cysteine ​​derivative, which belongs to the mucolytic drug, mainly breaks the disulfide bond (-S-S) of the acidic glycoprotein polypeptide in the mucus sputum through the sulfhydryl group in the molecule, and DNA in the purulent sputum Cracking, no matter for white viscous sputum or mucopurulent sputum, can exert a strong sputum-dissolving effect, thereby reducing the viscosity of sputum and making it easier to cough up. [0005] Acetylcysteine ​​is an antioxidant, has a strong fr...

Claims

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Application Information

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IPC IPC(8): C07C323/59C07C319/28A61K9/72A61P11/10
Inventor 蒋银妹
Owner 湖南华纳大药厂手性药物有限公司
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