Quantitative detection method of edetate disodium and sodium pyrosulfite in Shenqifuzheng injection

A quantitative detection method, the technology of edetate disodium, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of additives that have not established a public quality control method, quality and safety hazards, and feeding amount deviations, etc., to achieve guaranteed Drug quality and safety, optimized use, and the effect of ensuring drug safety

Active Publication Date: 2015-11-11
LI MIN PHARM FAB OF LIVZON PHARM GRP +1
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  • 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

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  • Quantitative detection method of edetate disodium and sodium pyrosulfite in Shenqifuzheng injection
  • Quantitative detection method of edetate disodium and sodium pyrosulfite in Shenqifuzheng injection
  • Quantitative detection method of edetate disodium and sodium pyrosulfite in Shenqifuzheng injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1 Instruments and reagents

[0043] 1.1 Instruments: Ion Chromatography: DIONEXICS-2000 (Dion Corporation); Chromatographic Column: IonPacAS11-HC (4×250mm) (Dion Corporation); Guard Column: IonPacAH11-HC (4×50mm) (Dion Corporation); Detector: Conductivity detector (Dion Corporation); eluent tank: EGCIIKOH (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 VacC 183cc 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 Injectio...

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.

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Abstract

The invention provides a quantitative detection method for quantitatively analyzing edetate disodium and sodium pyrosulfite in a Shenqifuzheng injection. The quantitative detection method comprises the following steps: preparing edetate disodium and sodium pyrosulfite reference solutions; preparing a Shenqifuzheng injection test article solution; quantitatively analyzing the reference solutions and the test article solution by adopting ion chromatography; according to the ion chromatographic peak areas of EDTA<2-> as well as SO3<2-> and SO4<2-> in ion chromatograms of reference substances and a sample and according to the principle of conservation of the element S in the solutions, respectively converting the contents of edetate disodium and sodium pyrosulfite in the sample according to the mole ratio of edetate disodium to EDTA<2->, the mole ratio of sodium pyrosulfite to SO3<2->, the mole ratio of sodium pyrosulfite to SO4<2-> and the molecular weights of the substances.

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 composition of Shenqi Fuzheng Injection is complex. According to the public information in ZL201210436493.4, there are as many as 18 characteristic peaks in its fingerprint;...

Claims

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Application Information

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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
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