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Method for Determination of Free Ammonia in Compound Amino Acid Injection

A compound amino acid and free ammonia technology, which is applied in the field of medicine, can solve the problems of unsuitable detection of free ammonia and achieve excellent technical effects

Active Publication Date: 2022-03-22
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the inventors have found that the above-mentioned Zhang Yongliang literature method for detecting free ammonia in biological samples (ie, myocardial tissue) is not suitable for detecting free ammonia in commercially available compound amino acid injections.

Method used

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  • Method for Determination of Free Ammonia in Compound Amino Acid Injection
  • Method for Determination of Free Ammonia in Compound Amino Acid Injection
  • Method for Determination of Free Ammonia in Compound Amino Acid Injection

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Embodiment 1

[0043] Embodiment 1: Detection of free ammonia in compound amino acid injection

[0044] 1. Instruments and equipment:

[0045] Amino acid analyzer (Hitachi L-8900 type); sodium ion type sulfonic acid group strong acid cation exchange resin as filler chromatographic column (specification: 4.6mm×60mm, 3μm)

[0046] 2. Preparation of buffer (mobile phase) for separation:

[0047] Prepare buffers B1, B2, B3, B4 and B5 for amino acid separation according to the following table 1:

[0048] Table 1: Buffer preparation table for separation

[0049] Reagent B1 B2 B3 B4 B5 water 700ml 700ml 700ml 700ml 700ml Sodium citrate, measured as its dihydrate 6.19g 7.74g 13.31g 26.67g - sodium hydroxide 0.24g 0.8g - - 8.0g Sodium chloride 5.66g 7.07g 3.74g 54.35g - Citric acid, measured as its monohydrate 19.8g 22.0g 12.8g 6.1g - ethanol 135.0ml 25.0ml 9.0ml - 100.0ml Add water to volume 1000ml 1000ml 1000ml 1...

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Abstract

The invention discloses a method for measuring free ammonia in compound amino acid injection, the method comprising the following steps: providing an amino acid analyzer and a chromatographic column; preparing a buffer solution for separation and analysis; preparing a derivatization reaction reagent; the flow rate of the mobile phase is 0.40 ml / min, the flow rate of the derivatizing reagent is 0.35ml / min, the column temperature is 57°C, the reactor temperature is 135°C, the detection wavelength is 570nm, the injection volume is 5μl, and the gradient is eluted; the preparation of the test solution; the preparation of the reference solution Formulation and chromatographic determination. Wherein, during chromatographic determination, calculate the concentration of free ammonia in the test solution with the peak area according to the external standard method, and calculate the content of free ammonia in the compound amino acid injection according to the preparation method of the test solution. It also relates to the compound amino acid injection determined by the method of the invention. The method of the present invention exhibits excellent technical effects as described in the description, such as rapidity, simplicity, sensitivity and stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a detection method of medicines, in particular to a detection method of compound amino acid injection, and the method is especially used for measuring free ammonia in compound amino acid injection. The inventive method exhibits excellent technical effects as described in the present invention. Background technique [0002] Compound Amino Acid Injection is a sterilized aqueous solution prepared from a variety of amino acids. It is mainly used for patients who cannot take nutrition orally or through the intestines and whose nutrition cannot meet their needs. This product is infused intravenously to meet the body's need to obtain amino acids and synthesize proteins. need. [0003] At present, there are more than 500 domestically produced drugs related to "compound amino acid injection" included in the State Food and Drug Administration. There are as many as 5 kinds. [0004] Durin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/04G01N30/86G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/04G01N30/8634G01N30/74G01N2030/067G01N2030/047
Inventor 邵天舒郭雷周长明王铁松郭洪祝
Owner BEIJING INST FOR DRUG CONTROL
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