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

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

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0041] Example 1

[0042] 1 Instruments and reagents

[0043] 1.1 Instrument: Ion chromatograph: DIONEXICS-2000 (Dian Company); Chromatographic column: IonPacAS11-HC (4×250mm) (Dian Company); Guard column: IonPacAH11-HC (4×50mm) (Dian Company); Detector: Conductivity detector (Dian Company); eluent tank: EGCIIKOH (090581489019). Millipore pure water meter.

[0044] 1.2 Test drug: 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-PakCartridgesVacC183cc cartridge (Waters). Shenqi Fuzheng injection was provided by Livzon Group Limin Pharmaceutical Factory. The reagents acetonitrile and formic acid used in the experiment were all chromatographically pure, and the water was ultrapure water.

[0045] 2 methods and results

[0046] 2.1 Preparation of the test solution: accurately measure 1 mL of Shenqi Fuzheng injection, purify...

Example Embodiment

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

[0098] Preparation of test solution:

[0099] Test solution 1: Dilute 10 times

[0100] Precisely measure 1 mL of Shenqi Fuzheng injection, purify it through a C18 small column, eluting with deionized water, and use a constant volume of 10 mL measuring flask to obtain it.

[0101] Test solution 2: diluted 20 times

[0102] Precisely measure 1 mL of Shenqi Fuzheng injection, purify it through a C18 small column, eluting with deionized water, make a 10 mL volumetric flask, and then precisely measure 2.5 mL into a 5 mL volumetric flask, and get it.

[0103] Test solution 3: Dilute 50 times

[0104] Precisely measure 1 mL of Shenqi Fuzheng injection, purify it through a C18 small column, eluting with deionized water, and then accurately measure 10 mL into a 50 mL measuring flask, and then get it.

[0105] Test solution 4: diluted 100 times

[0106] Precisely measure 1 mL of Shenqi Fuzheng injection, purify it through a C...

Example Embodiment

[0115] Example 3 Column Selection

[0116] The two ion chromatography columns, AS11-HC and Biobasic, are compared. The experimental conditions are as described in Example 1. The experimental results are as Picture 9 with 10 .

[0117] The AS11-HC chart has a stable baseline and better resolution than the Biobasic chart. So 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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