Taurolidine quality checking method

A quality inspection method, the technology of taurolidine, is applied in the direction of removing certain components such as weighing, measuring devices, material inspection products, etc., which can solve the problem of lack of inspection methods, inability to control product quality well, and insufficient inspection items. Comprehensive and other problems, to achieve the effect of convenient operation, good reproducibility, and product quality assurance

Inactive Publication Date: 2008-10-15
CHANGCHUN MAILING BIOLOGICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the existing taurolidine quality standard, the detection items are not comprehensive enough, lack mature detection methods, and can not control product quality well. The present invention has invented a new quality d...

Method used

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  • Taurolidine quality checking method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Quality Research and Analysis of Taurolidine and Specific Operation Results

[0019] Appearance traits

[0020] Method: visual inspection

[0021] Check the appearance of taurolidine samples, and the results showed that the samples were all white or off-white crystalline powder; odorless.

[0022] Solubility A suitable amount of taurolidine raw material was used for solubility test with different solvents. The results are shown in Table 1.

[0023] Table 1 Taurolidine dissolution test results

[0024]

Solvent

Dimethyl

Sulfoxide

Water

Methanol

Ethanol

Acetone

Chloroform

0.1mol / L

Hydrochloric acid solution

0.1mol / L

Sodium hydroxide solution

Liquid

Weigh the sample

(mg)

10.2

10.1

10.4

10.7

10.4

10.5

10.8

10.3

[0025]

Dissolved body

Produ...

Embodiment 2

[0056] Quality Research and Analysis of Taurolidine and Specific Operation Results

[0057] Tauramide hydrochloride: Take taurolidine and add phosphate buffer solution (pH 7.2) to make a solution containing 30mg per 1ml as the test solution; take tauramide hydrochloride reference substance and add phosphate buffer solution (pH7.2) Make a solution containing 2mg per 1ml as a reference solution. According to thin-layer chromatography (Chinese Pharmacopoeia 2005 Edition Two VB) test, draw 5μl of the test solution and 6μl of the reference solution, and place them on the same silica gel G thin-layer plate with 0.1% sodium carboxymethylcellulose as a binder. On the top, use ethyl acetate-methanol-concentrated ammonia solution (9:2:1.5) as a developing agent, unfold, dry, spray with 5% ninhydrin-acetone solution, and heat at 105°C until the spots appear clear.

[0058] Results In the chromatogram of the test substance, the impurity spots corresponding to the spots of the tauramide hydroc...

Embodiment 3

[0078] Quality Research and Analysis of Taurolidine and Specific Operation Results

[0079] Tauramide hydrochloride: Take taurolidine hydrochloride and add phosphate buffer solution (pH 7.2) to make a solution containing 10mg per 1ml as the test solution; take tauramide hydrochloride reference substance and add phosphate buffer solution (pH7.2) Make a solution containing 1mg per 1ml as a reference solution. According to thin-layer chromatography (Chinese Pharmacopoeia 2005 Edition Two VB) test, draw 15μl of the test solution and 6μl of the reference solution, and place them on the same silica gel G thin-layer plate with 0.1% sodium carboxymethylcellulose as the adhesive. On the top, use ethyl acetate-methanol-concentrated ammonia solution (9:2:1.5) as a developing agent, unfold, dry, spray with 5% ninhydrin-acetone solution, and heat at 105°C until the spots appear clear.

[0080] Results In the chromatogram of the test substance, the impurity spots corresponding to the spots of t...

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Abstract

The invention provides a quality detection method for Taurolidine. The method uses thin-layer chromatography, gas phase chromatography and titering process to detect the quality of the Taurolidiene. The quality detection method for Taurolidine has the advantages of rapidness, accuracy, convenient operation and excellent reproduction quality, and ensures the product quality of the Taurolidine.

Description

[0001] Invention title [0002] The invention discloses a quality detection method of taurolidine, which is used for quality control of taurolidine products and belongs to the technical field of chemical drug detection. Background technique: [0003] The chemical name of taurolidine involved in the present invention is 4,4′-methylenebis-(tetrahydro-2H-1,2,4-thiadiazine)-1,1,1′,1′ Oxide, molecular formula: C 7 H 16 N 4 O 4 S 2 , Molecular weight: 284.348. [0004] The existing taurolidine quality standards have insufficient testing items, lack of mature testing methods, and cannot control product quality well. The present invention has invented a new quality testing method for taurolidine testing, including traits. , Identification, inspection, and content determination items make the quality control of taurolidine more scientific and strict, and the detection method more accurate. Summary of the invention [0005] The invention discloses a quality detection method of taurolidine, ...

Claims

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Application Information

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IPC IPC(8): G01N33/15G01N30/00G01N30/90G01N30/02G01N5/04G01N27/42
Inventor 于洪年武杰杜宏明高强苏中
Owner CHANGCHUN MAILING BIOLOGICAL ENG CO LTD
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