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A kind of content determination method of semicarbazide hydrochloride in sodium carbosulfonate and its preparation

A technology of semicarbazide hydrochloride and sodium carbosulfonate, which is applied in the field of drug analysis, can solve the problems of affecting detection efficiency and accuracy, affecting the accuracy of results, and long reaction equilibrium time, etc., achieving good application prospects, convenient operation, and satisfying novelty requirements. sexual effect

Active Publication Date: 2020-06-16
CHENGDU TIANXIN PHARMA HEALTH CARE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the reaction equilibrium time of this method is long, the specificity is poor, and the recovery rate is high, which affects the accuracy of the results, and will cause the pre-column derivatization reaction of the sodium carbene sulfonate preparation containing excipients to slow down, affecting the detection efficiency and accuracy. Suitable for the detection of sodium carbosulfonate and its preparations

Method used

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  • A kind of content determination method of semicarbazide hydrochloride in sodium carbosulfonate and its preparation
  • A kind of content determination method of semicarbazide hydrochloride in sodium carbosulfonate and its preparation
  • A kind of content determination method of semicarbazide hydrochloride in sodium carbosulfonate and its preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 Determination of the content of semicarbazide hydrochloride in sodium carnosulfonate

[0046] Sodium carnosulfonate

[0047] (1) Sample preparation and derivatization reaction

[0048] a. Blank solution: Take 4ml methanol and appropriate amount of water, put them in a 10ml volumetric flask, use hydrochloric acid solution (3→1000) to adjust the pH to between 3.5~5.5, shake well, and then add 1.0ml 2-naphthaldehyde (NCA) The solution is made to volume with water and shaken up; this solution is reacted at room temperature for 2 hours.

[0049] b. Reference solution: Take 10mg of semicarbazide hydrochloride, accurately weigh it, put it in a 100ml volumetric flask, add appropriate amount of water to dissolve, and dilute to the mark, shake well; accurately measure 5ml to 50ml volumetric flask, add water to dilute to the mark Shake well, as a reference substance stock solution; accurately measure 1.0ml into a 10ml volumetric flask, add 4ml methanol and an appropriate amount...

Embodiment 2

[0066] Example 2 Determination of the content of semicarbazide hydrochloride in sodium carnosulfone injection

[0067] The specification of the sample to be tested is 20ml: 100mg.

[0068] (1) Preparation and derivation process of test and reference products

[0069] a. Blank solution: Take 4ml methanol and appropriate amount of water, put them in a 10ml volumetric flask, use hydrochloric acid solution (3→1000) to adjust the pH to 3.5~5.5, shake well, then add 1.0ml NCA solution, and dilute to volume with water, shake well ; This solution was reacted at room temperature for 2 hours.

[0070] b. Reference solution: Take 10mg of semicarbazide hydrochloride, accurately weigh it, put it in a 100ml volumetric flask, add appropriate amount of water to dissolve, and dilute to the mark, shake well; accurately measure 5ml to 50ml volumetric flask, add water to dilute to the mark Shake well as a reference stock solution. Precisely measure 1.0ml into a 10ml volumetric flask, add 4ml methanol a...

Embodiment 3

[0087] Example 3 Determination of the content of semicarbazide hydrochloride in sodium carnosulfonate and sodium chloride injection

[0088] The specification of the sample to be tested is 100ml: 80mg.

[0089] (1) Preparation and derivation process of test and reference products

[0090] a. Blank solution: Take 4ml methanol and appropriate amount of water, put them in a 10ml volumetric flask, use hydrochloric acid solution (3→1000) to adjust the pH to 3.5~5.5, shake well, then add 1.0ml NCA solution, and dilute to volume with water, shake well ; This solution was reacted at room temperature for 2 hours.

[0091] b. Reference solution: Take 10mg of semicarbazide hydrochloride, accurately weigh it, put it in a 100ml volumetric flask, add appropriate amount of water to dissolve, and dilute to the mark, shake well; accurately measure 1ml to 50ml volumetric flask, add water to dilute to the mark Shake well as a reference stock solution. Precisely measure 1.0ml into a 10ml volumetric fla...

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Abstract

The invention provides carbazochrome sodium sulfonate and a detection sample preparation method for a carbazochrome sodium sulfonate preparation. The method comprises the steps that a to-be-detected sample, a semicarbazide hydrochloride reference sample and a blank are taken respectively, water and methanol are added for dissolving, the pH value is regulated to be 2.0-8.0, shaking is performed, a2-naphthaldehyde solution is added, the volume is fixed with water, the solution is shaken and placed under room temperature for a reaction for 1h-5h, the solution is filtered, filtrate is added again, n-hexane is added for extraction and centrifugation, the bottom-layer aqueous solution is taken, extraction and centrifugation are repeated, and then carbazochrome sodium sulfonate is obtained. Theinvention furthermore provides carbazochrome sodium sulfonate and a content assay method for semicarbazide hydrochloride in the carbazochrome sodium sulfonate preparation. Through the method, the semicarbazide hydrochloride content in carbazochrome sodium sulfonate preparations with different dosage forms are assayed; and the method has good universality and specificity, is high in sensitivity, convenient to operate, and proper in analysis time, provides an effective guarantee for quality control over carbazochrome sodium sulfonate and the semicarbazide hydrochloride content in the carbazochrome sodium sulfonate preparations, guarantees medication safety and has a good application prospect.

Description

Technical field [0001] The invention belongs to the field of drug analysis, and specifically relates to a method for determining the content of semicarbazide hydrochloride in sodium carnosulfonate and its preparation. Background technique [0002] Sodium carnosulfonate, the chemical name is 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazide-2-sodium sulfonate, with the structural formula shown in formula I : [0003] Sodium carnosulfonate was originally researched by Japan's Tanabe Mitsubishi Pharmaceutical Co., Ltd. (MITSUBISHI TANABE), trade name: Adona Alona, ​​adapted to the bleeding tendency (such as purpura, etc.) caused by the weakening of capillary resistance and the enhancement of permeability; Fundus bleeding, renal bleeding and uterine bleeding caused by weakening of capillary resistance and exuding from the skin or mucous membrane and intima; abnormal bleeding during and after surgery caused by weakening of capillary resistance. [0004] Semicarbazide hydrochlorid...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/02
Inventor 张海李昕琦罗丹徐海英
Owner CHENGDU TIANXIN PHARMA HEALTH CARE CO LTD
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