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Analytical method for measuring raw medicine content of thiohydroxylamine tropine by non-aqueous titrimetry

A technology of thioamine tropine and analysis method, which is applied in the field of quality control of thioamine tropine raw materials and can solve problems such as no literature reports and the like

Active Publication Date: 2008-12-10
JIANGSU INST OF NUCLEAR MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

So far, there are no domestic reports on this

Method used

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  • Analytical method for measuring raw medicine content of thiohydroxylamine tropine by non-aqueous titrimetry
  • Analytical method for measuring raw medicine content of thiohydroxylamine tropine by non-aqueous titrimetry
  • Analytical method for measuring raw medicine content of thiohydroxylamine tropine by non-aqueous titrimetry

Examples

Experimental program
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Effect test

Embodiment 1

[0013] Preparation of 0.02mol / L perchloric acid titration solution: Take 750mL of anhydrous glacial acetic acid, add 1.7mL of perchloric acid (70-72%), shake well, slowly add 15.4mL of acetic anhydride dropwise at room temperature, and add while adding Shake, then shake evenly after adding, let it cool, add an appropriate amount of anhydrous glacial acetic acid to make 1000mL, shake well, and place it for 24 hours for later use.

Embodiment 2

[0015] Calibration of perchloric acid titration solution: take about 32.0mg of standard potassium hydrogen phthalate dried at 105°C to constant weight, accurately weigh, add 2mL of glacial acetic acid, heat to dissolve, let cool, add 18mL of acetic anhydride, Potentiometric titration (Appendix VIIA, Part II of Chinese Pharmacopoeia 2005 Edition) was titrated with perchloric acid titration solution, and the titration result was corrected with a blank test. Every 1mL of perchloric acid titration solution (0.02mol / L) is equivalent to 4.084mg of potassium hydrogen phthalate. According to the consumption of this liquid and the amount of potassium hydrogen phthalate taken, calculate the concentration of this liquid.

[0016] C=W / 204(V 样 -V 空 )

[0017] where: V 样 It is the volume (mL) of perchloric acid consumed when titrating potassium hydrogen phthalate to the end point; V 空 is the volume of perchloric acid consumed when titrating the blank to the end point (mL); C is the con...

Embodiment 3

[0019] Titration of Thiaminetropine bulk drug: Take about 20.0 mg of self-made TRODAT-1 hydrochloride (preparation method reference: Fang Ping, et al., Chinese Journal of Pharmaceutical Industry 2000, 31: 244-247), accurately weighed , add 2 mL of glacial acetic acid, stir and dissolve at room temperature, add 18 mL of acetic anhydride, titrate with perchloric acid titration solution according to the potentiometric titration method (Chinese Pharmacopoeia 2005 edition two appendix VIIA), and the titration result is corrected with a blank test (Chinese Pharmacopoeia 2005 edition Part II Appendix VIIA). Every 1mL perchloric acid titration solution (0.02mol / L) is equivalent to 3.58mg of C 21 h 34 ClN 3 S 2 · 3HCl.

[0020] Content% of TRODAT-1=(V 样 -V 空 )×C×537 / 3W×100%

[0021] Titration curve as figure 1 As shown, the titration end point is determined by the first derivative method, such as figure 2 shown.

[0022] where: V 样 It is the volume (mL) of perchloric acid c...

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Abstract

The invention discloses an analysis method for determining the hydroxamamide tropine raw drug content through a non-aqueous titration method and relates to the hydroxamamide tropine raw drug quality control technology field. The method for determining the content of hydroxamamide tropine is provided, the process of which is as follows: glacial acetic acid-acetic oxide is used as a solvent for the quantitative dissolution of the hydroxamamide tropine. Then, perrchloric acid titrating solution is sued as titrant, and a potentiometric titration method is adopted for the titration. The method has the advantages of small sample amount, simple operation, good precision, and the like, and can be applied to the routine analysis and the quality control of hydroxamamide tropine raw drugs.

Description

technical field [0001] The invention discloses an analysis method for determining the content of thiaminetropine bulk medicine by non-aqueous titration, and relates to the technical field of quality control of thiaminetropine bulk medicine. Background technique [0002] Technetium [ 99m Tc] Thiaminetropine ( 99m Tc-TRODAT-1, Chinese chemical name: Technetium [ 99m Tc]-2β-[N,N′-bis(2-mercaptoethyl)ethylenediamine]methyl-3β-(4-chlorophenyl)tropane is a radiopharmaceutical successfully developed in the 1990s , it has high specificity and selectivity with dopamine transporter (DAT) (Kung HF, et al., Eur J Nucl Med 1996, 23: 1527-30; Kung MP, et al., Eur J Nucl Med 1997, 24 :372-80), using this drug as an imaging agent, combined with the widely used clinical single photon emission computed tomography (SPECT) technology, can provide valuable information for the diagnosis and research of many neuropsychiatric diseases. A large number of clinical studies at home and abroad have ...

Claims

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Application Information

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IPC IPC(8): G01N27/44
Inventor 陈正平李晓敏王颂佩唐婕刘春仪陆春雄蒋泉福
Owner JIANGSU INST OF NUCLEAR MEDICINE
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