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Pharmaceutical composition containing ambroxol and erdosteine or acetylcysteine and application thereof

A technology of acetylcysteine ​​and composition, which is applied in the directions of drug combination, medical preparation containing active ingredients, drug delivery, etc., can solve the problem that the water solubility of ambroxol hydrochloride is not ideal, and the limitation of preparation application and clinical application, etc. question

Inactive Publication Date: 2007-07-04
JIANGSU HENGRUI MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Ambroxol hydrochloride is rapidly absorbed orally, and its elimination half-life is 2 to 3 hours. Its preparation forms mainly include tablets, sustained-release pellets, capsules, solutions, syrups, water injections and other compound preparations. However, due to the insoluble water solubility of ambroxol hydrochloride It is too ideal, so its preparation application and clinical application are subject to certain restrictions

Method used

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  • Pharmaceutical composition containing ambroxol and erdosteine or acetylcysteine and application thereof
  • Pharmaceutical composition containing ambroxol and erdosteine or acetylcysteine and application thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0041] Experimental Example 1 Effects on Excretion of Phenol Red in the Respiratory Tract of Mice

[0042] 1), test method

[0043] 360 healthy male mice were randomly divided into 12 groups, respectively negative control group, erdosteine ​​group, compound erdosteine ​​ambroxol (equal quality) 6 dosage groups, ambroxol hydrochloride low, medium, High-dose group and potassium iodide group. The test sample was orally administered once a day for 3 consecutive days, with an administration volume of 0.4ml / 20g, and the negative control group was orally administered normal saline of the same volume. Fasting 1 day before the last administration, intraperitoneally inject 2.5% phenol red solution 500mg / kg, 0.4ml / 20g 0.5 hours after the last administration. After another 0.5 hour, overdose of anesthesia was given to kill the animal, the trachea was separated, an injection needle was inserted, rinsed with 2ml of normal saline, and 0.1ml of 1M NaOH was added to the rinse solution for co...

experiment example 2

[0054] Effect of Experimental Example 2 on Rabbit Sputum Secretion

[0055] 1) Experimental method

[0056] 80 rabbits were randomly divided into 8 groups, which were respectively compound erdosteine ​​ambroxol (mass ratio 2: 1) 1, 2, 4 and 8 mg / kg four dosage groups and ambroxol hydrochloride 2, 4 and 8 mg / kg. 8mg / kg three dose groups, negative control group and erdosteine ​​4mg / kg group. Animals were intraperitoneally anesthetized with urethane, intubated with a tracheal tube, and connected to a device that constantly provided preheated (37° C.) and constant humidity (80%) breathing air. A fixed graduated cylinder is connected to the lower end of the cross-shaped endotracheal tube to collect secretions. To prevent condensation, all animals breathed freely and provided the required amount of breathing air in a cotton-padded enclosure. After 2 hours of stable observation, the experimental drug was delivered to the stomach through the esophagus. Immediately after administra...

experiment example 3

[0066] Effect of Experimental Example 3 on Movement of Dog Trachea Cilia in Vitro

[0067] 1), test method

[0068] Grass dog about 10kg, male and female, separate the trachea quickly after anesthesia, and put O 2 Tyrode's solution, save for later use. During the experiment, the trachea was cut to a length of 0.5-1 cm. Cut it in the middle, divide it into two pieces longitudinally, take a single piece and put it obliquely on cotton moistened with Tyrode solution at 37°C (throat end facing upward). Put the hair (0.2mm) at the lower end of the trachea, observe with a low-power microscope, and record the time required for the hair to run 2mm, observe 3 times, and put the tracheal piece into Tyrode's solution at 37°C for rinsing after each observation . Then put it into the nutrient solution containing the medicinal solution for 5 minutes, and observe 3 times in the same way. Calculate the difference in hair running time before and after administration, and compare it with th...

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Abstract

The invention relates to ambroxol, erdosteine or the medicinal composition of the pharmaceutically usable salts of the two and their use, ambroxol and acetylcysteine or the medicinal composition of the pharmaceutically usable salts of the two and their use, the kit containing these compositions, and the use of these pharmaceutical compositions in preparing expectorant medicaments. The invention also relates to the cooperative compositions of ambroxol and erdosterne, ambroxol and acetylcysteine, and the use of these cooperative compositions in treating viscous phlegm and phlegm difficulty caused by chronic bronchitis and bronchial asthma.

Description

technical field [0001] The present invention relates to a kind of pharmaceutical composition and application thereof, described pharmaceutical composition contains ambroxol and erdosteine ​​or the pharmaceutically acceptable salt of both thereof, described pharmaceutical composition can also contain ambroxol and Acetylcysteine ​​or a pharmaceutically acceptable salt of the two, and the application of the combination of such drugs in the preparation of drugs for preventing and treating various inflammations and expectorant-related diseases such as respiratory congestion and infection, especially the application in expectorant . Background technique [0002] Ambroxol is the active metabolite of bromhexine, which has low toxicity, definite curative effect, and stronger expectorant effect than bromhexine. The drug was used clinically in the form of hydrochloride in 1984. Ambroxol hydrochloride has been widely used in the treatment of respiratory diseases in many countries such ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/381A61K9/08A61K9/14A61K9/12A61K9/16A61K9/20A61K9/48A61P11/00A61P11/10A61K31/137
Inventor 孙飘扬袁开红
Owner JIANGSU HENGRUI MEDICINE CO LTD
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