Unlock instant, AI-driven research and patent intelligence for your innovation.

A quantitative detection method for edetate disodium and sodium pyrosulfite in Shenqi Fuzheng injection

A quantitative detection method, the technology of edetate disodium, is applied in the direction of measuring devices, instruments, scientific instruments, etc., which can solve the problems of quality and safety hazards, additives that have not established a public quality control method, and the deviation of feeding amount, etc., to achieve optimization Use, ensure the quality and safety of drugs, and ensure the effect of drug safety

Active Publication Date: 2018-06-29
LI MIN PHARM FAB OF LIVZON PHARM GRP +1
View PDF6 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the metal complexing agent disodium edetate and the antioxidant sodium metabisulfite are added to Shenqi Fuzheng injection, there is no published quality control method for the additives
Uncertain factors such as emotional instability of personnel during the production process may lead to deviations in the amount of feeding, bringing quality and safety hazards

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A quantitative detection method for edetate disodium and sodium pyrosulfite in Shenqi Fuzheng injection
  • A quantitative detection method for edetate disodium and sodium pyrosulfite in Shenqi Fuzheng injection
  • A quantitative detection method for edetate disodium and sodium pyrosulfite in Shenqi Fuzheng injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1 Instruments and reagents

[0043] 1.1 Instrument: Ion chromatograph: DIONEX ICS-2000 (Dionex); Chromatographic column: IonPac AS11-HC (4×250mm) (Dion); Guard column: IonPac AH11-HC (4×50mm) (Dion company); Detector: conductivity detector (Dion Corporation); eluent tank: EGCII KOH (090581489019). Millipore pure water meter.

[0044] 1.2 Reagent: edetate disodium reference substance (batch number: 20100311, Hangzhou Liren Pharmaceutical Co., Ltd.); sodium metabisulfite reference substance (batch number: 20100301, Hunan Erkang Pharmaceutical Co., Ltd.). Sep-Pak Cartridges Vac C18 3cc Cartridges (Waters). Shenqi Fuzheng Injection was provided by Limin Pharmaceutical Factory of Livzon Group. The reagents acetonitrile and formic acid used in the experiment were chromatographically pure, and the water was ultrapure water.

[0045] 2 Methods and Results

[0046] 2.1 Preparation of the test solution: Accurately measure 1mL of Shenqi Fuzheng Injection, purify it through a ...

Embodiment 2

[0097] Example 2 Screening of Shenqi Fuzheng Injection Dilution Multiples

[0098] Preparation of the test solution:

[0099] Test solution 1: dilute 10 times

[0100] Precisely measure 1mL of Shenqi Fuzheng Injection, purify it through a C18 small column, elute with deionized water, set the volume to a 10mL measuring bottle, and set the volume to obtain the product.

[0101] Test solution 2: dilute 20 times

[0102] Precisely measure 1mL of Shenqi Fuzheng Injection, purify it through a C18 column, elute with deionized water, set the volume to a 10mL measuring bottle, then precisely measure 2.5mL into a 5mL measuring bottle, and set the volume to obtain the product.

[0103] Test solution 3: dilute 50 times

[0104] Precisely measure 1mL of Shenqi Fuzheng Injection, purify it through a C18 small column, elute with deionized water, set the volume to a 10mL measuring bottle, then precisely measure 10mL into a 50mL measuring bottle, and set the volume to obtain the product.

...

Embodiment 3

[0115] Embodiment 3 chromatographic column is selected

[0116] Compare AS11-HC and Biobasic two kinds of ion chromatographic columns, experimental condition is described with reference to embodiment 1, experimental result is as chromatographic Figure 9 and 10 .

[0117] The baseline of the AS11-HC graph is stable, and the resolution is better than that of the Biobasic graph. Therefore choose AS11-HC ion chromatography column.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The present invention establishes a quantitative detection method for quantitatively analyzing disodium edetate and sodium pyrosulfite in Shenqi Fuzheng injection, comprising the following steps: preparing disodium edetate and sodium pyrosulfite reference solution; preparing Shenqi Fuzheng injection Need testing solution; Adopt ion chromatography quantitative analysis above-mentioned reference substance solution and need testing solution; According to reference substance and sample ion chromatogram figure EDTA2- and SO32-, SO42-Ion chromatography peak area, according to the S element in the solution According to the principle of conservation, the contents of edetate disodium and sodium pyrosulfite in the sample are calculated according to the molar ratio and molecular weight of edetate disodium and EDTA2-, sodium metabisulfite and SO32-, SO42- respectively.

Description

technical field [0001] The present invention relates to a method and application for controlling the safety of Shenqi Fuzheng Injection, specifically a method for detecting the additives added in Shenqi Fuzheng Injection by establishing an ion chromatography method, disodium edetate and sodium metabisulfite The applied method belongs to the field of drug analysis technology and safety control. Background technique [0002] Shenqi Fuzheng Injection is a national protected variety of traditional Chinese medicine. The protected variety number is ZYB2072004073. It is a large Chinese medicine infusion made from the extraction of Astragalus and Codonopsis. It is used for the adjuvant treatment of lung cancer and gastric cancer due to Qi deficiency. It can treat heart and cerebrovascular diseases. [0003] The components of Shenqi Fuzheng Injection are complex. According to the public information in ZL 201210436493.4, there are as many as 18 characteristic peaks in its fingerprint...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/02
Inventor 黄文华刘潇潇宋艳刚刘学华杨立伟胡淑毅
Owner LI MIN PHARM FAB OF LIVZON PHARM GRP