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Method for analyzing and detecting sodium aescinate for injection

Active Publication Date: 2015-07-15
WUXI KAIFU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the detection methods of sodium aescinate mainly include ferric chloride colorimetry and acid-base titration method, which is to measure the total saponin content of sodium aescinate, which cannot fully reflect the type, quantity and content of each component in total saponin. Proportional relationship, product quality control is not comprehensive enough

Method used

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  • Method for analyzing and detecting sodium aescinate for injection
  • Method for analyzing and detecting sodium aescinate for injection
  • Method for analyzing and detecting sodium aescinate for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Chromatographic conditions: the mobile phase is acetonitrile-phosphoric acid solution (33:67), the pH is 2.1, the mass fraction of phosphoric acid solution is 0.42%, the flow rate is 1ml / min, the detection wavelength is 220nm, and the chromatographic column is filled with octadecyl-bonded silica gel Reagent, column temperature: 30°C, injection volume: 2.5mg / ml, 20μl.

[0036] Preparation of the test solution: Take an appropriate amount of sodium aescinate for injection (batch number: 120404), add methanol to dissolve and dilute to make a solution containing 2.5mg per 1ml.

[0037] Take 20 μl of the test solution and inject it into the liquid chromatograph, and record the chromatogram.

[0038] Fingerprint of Sodium Aescinate for Injection to be Tested ( figure 2 ) and Standard Fingerprint of Sodium Aescinate for Injection ( figure 1 ) for comparison, the number of common peaks is the same, there are 6 common peaks, the order of the peaks is the same, the relative ret...

Embodiment 2

[0040] Chromatographic conditions: the mobile phase is acetonitrile-phosphoric acid solution (30:70), pH 2.5, the mass fraction of phosphoric acid solution is 0.42%, the flow rate is 1ml / min, the detection wavelength is 200nm, and the chromatographic column is made of octadecyl-bonded silica gel. Packing agent, column temperature: 30°C, injection volume: 1mg / ml, 20μl.

[0041] Preparation of the test solution: Take an appropriate amount of sodium aescinate for injection (batch number: 110102), add methanol to dissolve and dilute to make a solution containing 1mg per 1ml.

[0042] Take 20 μl of the test solution and inject it into the liquid chromatograph, and record the chromatogram.

[0043] The fingerprints of sodium aescinin for injection to be tested and the standard fingerprints of sodium aescinin for injection ( figure 1 ) for comparison, the number of common peaks is the same, there are 6 peaks in total, and the peak order is also the same, relative retention time: pea...

Embodiment 3

[0045] Chromatographic conditions: mobile phase is acetonitrile-phosphoric acid solution (40:60), pH is 1.5, mass fraction of phosphoric acid solution is 0.42%, flow rate is 1ml / min, detection wavelength is 220nm, chromatographic column is filled with octadecyl bonded silica gel Reagent, column temperature: 30°C, injection volume: 5mg / ml, 20μl.

[0046] Preparation of the test solution: Take an appropriate amount of sodium aescinate for injection (batch number: 120406), add methanol to dissolve and dilute to make a solution containing 5 mg per 1 ml.

[0047] Take 20 μl of the test solution and inject it into the liquid chromatograph, and record the chromatogram.

[0048] The fingerprints of sodium aescinin for injection to be tested and the standard fingerprints of sodium aescinin for injection ( figure 1 ) for comparison, the number of common peaks is the same, there are 6 peaks in total, and the peak order is also the same, relative retention time: peak A: 0.838, peak B: 1,...

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Abstract

The invention provides a method for analyzing and detecting sodium aescinate for injection, which is characterized in that a standard fingerprint chromatography of sodium aescinate for injection is established, so that an integral quality status of sodium aescinate for injection can be comprehensively reflected and controlled. The method comprises the following steps: 1)preparing the standard fingerprint chromatography of sodium aescinate for injection; 3) preparing a fingerprint chromatography of sodium aescinate for injection; and 3) analyzing the quality of sodium aescinate for injection. The chromatogram conditions for preparing fingerprint chromatography in the step 1) and step 2) are characterized in that a chromatographic column filler is C18 alkylsilane bonded silica glue, the column temperature is 30 DEG C, a mobile phase is composed of a phosphoric acid solution and an acetonitrile solution according to volume ratio of 60: 40-70: 30, the pH value of the mobile phase is 1.5-2.5, the sample amount is 20muml, and the UV detection wavelength is 200nm-220nm.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to an analysis and detection method of sodium aescinate for injection. Background technique [0002] Sodium aescinate is the total saponin extracted from the seeds of Sala, the main components are sodium aescinin A, B, C and D, and a small amount of sodium aescinin E, F. At present, the detection methods of sodium aescinate mainly include ferric chloride colorimetry and acid-base titration method, which is to measure the total saponin content of sodium aescinate, which cannot fully reflect the type, quantity and content of each component in the total saponin. Proportional relationship, product quality control is not comprehensive enough. Contents of the invention [0003] In view of the above problems, the present invention provides an analysis and detection method of sodium aescinin for injection, which comprehensively reflects and controls the overall quality status of s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 刘骞
Owner WUXI KAIFU PHARMA
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