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Arginine acetate oral preparation and clinical application thereof

A technology of oral preparations of arginine acetate, which is applied in the field of drugs with non-specific immune enhancement, and can solve the problems of affecting blood pH value, stimulation, and the literature reports of oral preparations of arginine acetate have not been seen yet.

Inactive Publication Date: 2004-01-07
YIFAN XINFU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the commercially available arginine for treatment at home and abroad has only two kinds of L-arginine and arginine hydrochloride; but they are used as raw materials to prepare preparations for oral administration, and there are following defects: L-arginine base It is strong in nature, and its pH is between 10.5 and 12.0. After oral administration, it stimulates the gastrointestinal tract strongly, which will cause symptoms of stomach discomfort, and long-term large-scale application can affect the pH value of blood, while arginine hydrochloride is acidic, and its pH is between 4.7-6.2, and the content of chloride ion is high, reaching 16.5%-17.1%. After oral administration, it also stimulates the gastrointestinal tract to a certain extent, which will not only cause stomach discomfort, but also cause metabolic acidosis and hyperchloremia if used for a long time
After literature search, only the 13th edition of the Japanese Pharmacopoeia, the 23rd edition of the United States Pharmacopoeia and the 2000 edition of the Chinese Pharmacopoeia contained arginine hydrochloride and its injection; no literature reports on oral preparations of arginine acetate have been seen

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0036] Example 1 Preparation of arginine acetate granules

[0037] formula

[0038] Arginine acetate 2500g

[0039] Cane sugar 300g

[0040] Dextrin 177g

[0041] Xylitol 20.0g

[0042] Orange flavor

[0043] Make 1000 bags

[0044]Preparation process: Weigh arginine acetate, sucrose, and dextrin according to the formula, and then mix the powder with the prescribed amount of xylitol, mix evenly by equal volume addition mixing method, crush, and pass through an 80 mesh sieve; It becomes a uniform soft material and granulates through a 16-mesh sieve. Dry for 4 hours below 60°C, collect powder, spray appropriate amount of orange flavor, use 14 mesh sieve to sizing, send for inspection, pass the inspection, sub-package, and package.

example 2

[0045] Example 2 Preparation of arginine acetate capsules

[0046] formula

[0047] Arginine acetate 400g

[0048] Dextrin 50g

[0049] Sucrose 50g

[0050] Made into 1000 tablets

[0051] Preparation process: Weigh arginine acetate, sucrose, and dextrin according to the amount of the formula, mix them evenly, crush, and pass through an 80-mesh sieve; make a uniform soft material, and pass through a 16-mesh sieve to granulate. Dry for 4 hours below 60°C, collect the powder, use a 14-mesh sieve to sizing, send for inspection, pass the inspection, and put it into hard capsules or enteric-coated capsules.

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PUM

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Abstract

The present invention relates to a nonspecific immunoenhancement medicine, and it is an arginine acetate oral preparation, its medicinal effect component is agrinine acetate, its pH value is 6.0-7.5,and it has no chloride ion acid radical, after it is taken in, it does not produce irritation to gastrointestinal tract, and it can be taken in for a long period, it also does not produce hyperchloremia, and it is mainly used for curing serious burn and serious scald, and for making auxiliary therapy of tumor patient and patient after major operation.

Description

1. Technical Field [0001] The invention belongs to a medicine, and specifically relates to a medicine with a non-specific immune enhancement effect. 2. Background technology [0002] Arginine is a conditional essential amino acid. It can improve the body's immune function, promote protein synthesis, reduce catabolism, and protect the gastrointestinal mucosa. It is currently a focus of research on nutritional pharmacology. Studies have found that arginine can improve protein metabolism in burn rats and promote wound healing. Intestinal supplementation of arginine for burn patients can reduce the degree of intestinal damage after burns, improve immune function, and shorten the length of hospitalization. At present, there are only two kinds of arginine that are commercially available for treatment at home and abroad, L-arginine and arginine hydrochloride; but using them as raw materials to prepare oral preparations has the following defects: L-arginine base Strong sex, pH is 10.5~12...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/197A61P1/04
Inventor 王兰周尤忠义彭曦江朝容
Owner YIFAN XINFU PHARMA CO LTD
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