Arginine acetate oral preparation and clinical application thereof

A technology of arginine acetate and oral preparations, applied in the field of medicines with non-specific immune enhancement effect, can solve the problems such as no literature report of arginine acetate oral preparations, strong gastrointestinal stimulation, influence on blood pH value and the like , to reduce animal mortality, protect gastrointestinal mucosa, and reduce catabolism

Inactive Publication Date: 2005-07-06
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

[0082] The preparation of example 1 arginine acetate particles

[0083] formula

[0084] Arginine acetate 2500g

[0085] Sucrose 300g

[0086] Dextrin 177g

[0087] Xylitol 20.0g

[0088] Orange flavor appropriate amount

[0089] Make 1000 bags

[0090] Preparation process: Weigh arginine acetate, sucrose, and dextrin according to the formula and mix them evenly, then mix the mixed powder and xylitol in the prescribed amount, mix evenly by equal-quantity incremental mixing, pulverize, and pass through an 80-mesh sieve; into a uniform soft material, and granulated through a 16-mesh sieve. Dry below 60°C for 4 hours, collect the powder, spray an appropriate amount of orange essence, sieve through a 14-mesh sieve, send for inspection, pass the inspection, sub-package, and pack.

example 2

[0091] The preparation of example 2 arginine acetate capsules

[0092] formula

[0093] Arginine acetate 400g

[0094] Dextrin 50g

[0095] Sucrose 50g

[0096] Makes 1000 capsules

[0097] Preparation process: weigh arginine acetate, sucrose, and dextrin according to the formula, mix evenly, pulverize, and pass through an 80-mesh sieve; make a uniform soft material, and pass through a 16-mesh sieve to granulate. Dry below 60°C for 4 hours, collect the powder, sieve through a 14-mesh sieve, send for inspection, pass the inspection, and pack into hard capsules or enteric-coated capsules.

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PUM

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Abstract

The present invention belongs to non-specific immunoenhancing drugs, which is an oral preparation of arginine acetate. Road will not produce irritation, long-term use will not produce hyperchloremia. As an immune-enhancing drug, it is mainly used clinically for patients with severe trauma, burns, major surgery, and cancer patients whose immune function is suppressed after radiotherapy and chemotherapy. It is safe, convenient, and effective.

Description

1. Technical field [0001] The invention belongs to medicaments, in particular to a medicament with non-specific immune enhancing effect. 2. Background technology [0002] Arginine is a conditionally essential amino acid, which can improve the immune function of the body, promote protein synthesis, reduce catabolism, and protect the gastrointestinal mucosa. It is currently a focus of research in "Nutritional Pharmacology". Studies have found that arginine can improve protein metabolism in burn rats and promote wound healing. Intestinal supplementation of arginine in burn patients can reduce the degree of intestinal damage after burn, improve immune function, and shorten hospitalization time. 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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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