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Chemical medicine composition for treating helicobacter pylori infection

A Helicobacter pylori and composition technology, applied in the field of medicine, can solve the problems of limited improvement in patient compliance, side effects, and treatment that is not necessary

Pending Publication Date: 2020-05-22
龚跃明
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Because there are many types of drugs and large doses (for example, the recommended single dose of amoxicillin can reach 1000 mg, and if you take common 250 mg capsules, you need to take four capsules at a time for this drug alone), patients often need to take close to or even exceed the dose at one time. 10 pills (tablets) of medicines, not only poor compliance, but also frequent misuse of certain medicines such as missing or taking too much or too little, which may affect the curative effect in the slightest, and cause serious side effects in severe cases
[0008] To sum up, it is necessary and significant to develop a composition with a reasonable composition and easy administration for the treatment of Hp infection. However, such products are rarely seen in the world at present [U.S. FDA approved PYLERA (bismuth potassium citrate 140 in 2006] / Metronidazole 125 / Tetracycline Hydrochloride 125) is on the market; Talicia (Omeprazole 10mg / Amoxicillin 250mg / Rifabutin 12.5mg) is expected to be launched in the US in the first quarter of 2020; there are only a few combined packaging products in China (Multiple preparations in one package) are on sale, and have limited significance in improving patient compliance]

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017]Example 1 (non-limiting): In the present invention, HP-positive gastric mucosa specimens taken from the gastroscope department of the Gastroenterology Department of the Rehabilitation Hospital Affiliated to Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Rehabilitation Hospital) were tested in a micro-aerobic environment at 37°C (with AnaeroPackTM-MicroAero Microscope). Oxygen-generating bags and sealed tanks) cultured in Skirrow medium supplemented with glucose-6-phosphate for 48 hours and confirmed by staining, morphology and rapid urease test, and then carried out in vitro antibacterial test by micro-broth doubling dilution method , the results showed that the MICs of fosfomycin trometamol and netilmicin sulfate were 1.0mg / L and 0.06mg / L in single use, and 0.125.mg / L and 0.008 in combination mg / L, FIC is 0.26, indicating that the two have a strong synergistic effect.

Embodiment 2

[0018] Embodiment 2 (non-limiting): The present invention has produced three kinds of composition samples comprising different components and carried out a preliminary stability investigation of 90 days at 40 degrees Celsius and 75% RH (only the content of each component has been investigated. situation), one of the three combined samples was fosfomycin tromethamine + netilmicin sulfate, the other was fosfomycin tromethamine + netilmicin sulfate + sodium bicarbonate, and the third was Fosfomycin tromethamine + netilmicin sulfate + sodium bicarbonate + omeprazole + bismuth potassium citrate. Based on the similar molecular weights of netilmicin sulfate and gentamicin sulfate (the former is 1441.54, the latter is 1506.8) and similar antibacterial effects, refer to the usual oral dosage of gentamicin sulfate for adults (240-640 mg per day, divided into 4 minutes). The test dose of netilmicin sulfate was determined to be 450 mg / d near the median value, and it was taken in three div...

Embodiment 3

[0019] Example 3 (non-limiting): In order to test the in vivo effect of the composition, six adult patients who were diagnosed as HP positive by the C-14 physical examination of the Rehabilitation Hospital Affiliated to Chengdu University of Traditional Chinese Medicine, the inventor and the family, including parents, brothers, wives and children, were divided into three groups: The three groups took the three kinds of powders in the above-mentioned Example 2 respectively, and two people who had been treated with triple therapy containing proton pump inhibitors and two antibacterial drugs but failed to eradicate took fosfomycin trometamol + netilmicin sulfate + sodium bicarbonate + omeprazole + bismuth potassium citrate, and then two people took fosfomycin tromethamine + netilmicin sulfate + sodium bicarbonate, and the other two took fosfomycin tromethamine + Netilmicin sulfate, the taking time is set as 7 days, three times a day, each time a bag of powder and 3g of sucrose dis...

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Abstract

The invention discloses a chemical medicine composition for treating helicobacter pylori (Hp) infection of adults through oral administration. The composition at least comprises fosfomycin or pharmaceutical salts such as a sodium salt, a calcium salt, fosfomycin trometamol and aminoglycoside medicines of the fosfomycin of a common dosage of an adult, and the aminoglycoside medicines are selected from tobramycin, netilmicin, etimicin, isepamicin, amikacin and common salts such as sulfate, of the medicines.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a chemical drug composition for oral treatment of Helicobacter pylori infection. . Background technique [0002] Helicobacter pylori (Hp) is a spiral-shaped gram-negative bacterium, microaerophilic, belonging to Helicobacteriaceae, which colonizes the gastric mucosa of at least 50% of the world's population. The prevalence of Hp shows large regional differences in developed regions such as Western Europe, North America, and Oceania, and the infection rate is between 25% and 37%, showing a rapid downward trend. The Hp infection rate is as high as 70%-87%, which is related to factors such as geography and basic health conditions (ClinicalFocus, July5, 2018, Vol33, No7, P634). At present, the Hp infection rate in my country is about 50% ("Gastroenterology" 2017 No. 22, No. 6, p. 347). [0003] The main cause of chronic gastritis, gastritis-related dyspepsia and peptic ulcer is Hp infection,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/665A61K31/7048A61K31/4439A61K33/245A61K33/00A61P31/04
CPCA61K31/4439A61K31/665A61K31/7048A61K33/00A61K33/245A61K45/06A61P31/04A61K2300/00
Inventor 龚跃明
Owner 龚跃明
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