Carbazochrome sodium sulfonate and content assay method for semicarbazide hydrochloride in carbazochrome sodium sulfonate preparation

A technology of semicarbazide hydrochloride and 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 not applicable to carbosulfonodium, etc., achieving good application prospects, convenient operation, effect of satisfying novelty

Active Publication Date: 2019-06-14
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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  • Carbazochrome sodium sulfonate and content assay method for semicarbazide hydrochloride in carbazochrome sodium sulfonate preparation
  • Carbazochrome sodium sulfonate and content assay method for semicarbazide hydrochloride in carbazochrome sodium sulfonate preparation
  • Carbazochrome sodium sulfonate and content assay method for semicarbazide hydrochloride in carbazochrome sodium sulfonate preparation

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Embodiment 1

[0045] The determination of the content of semicarbazide hydrochloride in embodiment 1 carbosulfonium sodium

[0046] Sample to be tested Sodium carbosulfonate

[0047] (1) Sample preparation and derivatization reaction

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

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

Embodiment 2

[0066] The determination of the content of semicarbazide hydrochloride in embodiment 2 carbosulfonium sodium injection

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

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

[0069] a. Blank solution: Take 4ml of methanol and appropriate amount of water, put it 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 of NCA solution, and dilute with water, shake well ; The solution was reacted at room temperature for 2 hours.

[0070] b. Reference substance solution: take 10mg of semicarbazide hydrochloride, weigh it accurately, put it in a 100ml volumetric flask, add an appropriate amount of water to dissolve it, and dilute to the mark, shake well; accurately measure 5ml to a 50ml volumetric flask, add water to dilute to the mark Shake well, as the reference substance stock solution. Precisely measure 1....

Embodiment 3

[0087] The determination of the content of semicarbazide hydrochloride in embodiment 3 carbosulfonium sodium chloride injection

[0088] The sample to be tested is carbosulfonium sodium chloride injection. The specification is 100ml: 80mg

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

[0090] a. Blank solution: Take 4ml of methanol and appropriate amount of water, put it 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 of NCA solution, and dilute with water, shake well ; The solution was reacted at room temperature for 2 hours.

[0091] b. Reference substance solution: take 10mg of semicarbazide hydrochloride, weigh it accurately, put it in a 100ml volumetric flask, add an appropriate amount of water to dissolve it, and dilute to the mark, shake well; accurately measure 1ml to a 50ml volumetric flask, add water to dilute to the mark Shake well, as the refere...

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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, in particular to a method for determining the content of semicarbazide hydrochloride in sodium carbosulfonate and its preparation. Background technique [0002] Sodium carbosulfonate, the chemical name is 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazone-2-sodium sulfonate, which has the structural formula shown in formula I : [0003] Sodium carbosulfonate is originally developed by Mitsubishi Tanabe Pharmaceutical Co., Ltd. (MITSUBISHI TANABE company), trade name: Adona alona, ​​which is adapted to the bleeding tendency (such as purpura, etc.) caused by the weakening of capillary resistance and the enhancement of permeability; Fundus hemorrhage, renal hemorrhage, and uterine bleeding oozing from the skin or mucous membrane and intima due to weakening of capillary resistance; abnormal bleeding during and after surgery caused by weakening of capillary resistance. [0004] Semicarbazide hydr...

Claims

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Application Information

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Patent Type & Authority Applications(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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