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A kind of detection method of scutellarin raw material and its preparation

A technology of scutellarin and a detection method, applied in the field of medicine, can solve the problems of incomplete elution, affecting the accuracy of scutellarin content determination results, quality control errors and the like

Active Publication Date: 2017-05-31
KPC PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the polarity of the degradation products in scutellarin raw materials and its preparations is very different from that of scutellarin, resulting in incomplete elution, which will cause quality control errors and affect the quality of related substances in scutellarin raw materials and its preparations. Control and accuracy of scutellarin content determination results

Method used

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  • A kind of detection method of scutellarin raw material and its preparation
  • A kind of detection method of scutellarin raw material and its preparation
  • A kind of detection method of scutellarin raw material and its preparation

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Experimental program
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Effect test

Embodiment 1

[0065] The instrument used is: LC-20AD high performance liquid chromatograph produced by Shimadzu: including Shimadzu LC-20AD pump, DGU-20ASR combined online degassing device, SIL-20A automatic sampler, SPD-M20A diode array detection Instrument, CTO-20AC column thermostat, Lcsolution workstation, chromatographic column is Luna C18150×4.6mm. Mettler XP205 electronic balance. The reference substances of scutellarin were all purchased from China Institute for the Control of Pharmaceutical and Biological Products (batch number 110842-201207, purity 92.1%). The raw materials of scutellarin and scutellarin for injection were provided by Kunming Pharmaceutical Group Co., Ltd. Experimental water is ultrapure water; phosphoric acid, methanol, and acetonitrile are chromatographically pure.

[0066] Octadecane-bonded silica gel was used as filler, acetonitrile was used as mobile phase A, 0.02% phosphoric acid aqueous solution was used as mobile phase B, and gradient elution was perform...

Embodiment 2

[0077] Used chromatograph, filling agent, mobile phase are identical with embodiment 1.

[0078] Take a sample of scutellarin for injection, dissolve it in water to make a 0.5 mg / mL test solution; take part of the test solution and dilute it with water to make a 5 μg / mL reference solution.

[0079] Take 10 μL of the reference substance solution and inject it into the liquid chromatograph, adjust the detection sensitivity so that the peak height of the main component is about 10% of the full scale of the record;

[0080] Take each 10 μL of the reference substance solution and the test solution and inject it into the liquid chromatograph for detection, and record the chromatogram to 2 times of the retention time of the main component peak.

[0081] Wherein the number is 20150126-01 scutellarin for injection The chromatogram of the test product solution is as follows figure 2 As shown, all related substance peaks are displayed. Chromatographic analysis results are shown in Tab...

Embodiment 3

[0089] The instrument used is: LC-20AD high performance liquid chromatograph produced by Shimadzu, including Shimadzu LC-20AD pump, DGU-20ASR combined online degassing device, SIL-20A autosampler, SPD-M20A diode array detection Instrument, CTO-20AC column thermostat, Lcsolution workstation, chromatographic column is Luna C18150×4.6mm. Mettler XP205 electronic balance. The reference substance of scutellarin (also known as scutellarin, batch number 110842-201207) was purchased from China Institute for the Control of Pharmaceutical and Biological Products. The raw materials of scutellarin and scutellarin for injection were provided by Kunming Pharmaceutical Group Co., Ltd., and the experimental water was ultrapure water; formic acid, methanol, and acetonitrile were chromatographically pure.

[0090]Octadecane-bonded silica gel was used as filler, acetonitrile was used as mobile phase A, 0.05% formic acid aqueous solution was used as mobile phase B, and gradient elution was perfo...

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Abstract

The invention belongs to the field of medicines, and in particular relates to a method for detecting scutellarin, and particularly a method for detecting a raw material and a preparation of scutellarin. The method for detecting the raw material and the preparation of scutellarin comprises the following steps: providing a test solution and a reference solution; carrying out gradient elution by taking octadecylsilane chemically bonded silica as a filling agent, taking acetonitrile as a mobile phase A, taking aqueous acid or an aqueous solution of phosphate as a mobile phase B, detecting the test solution and the reference solution in a liquid chromatograph, and analyzing by an external standard method so as to obtain the content of scutellarin. The method is simple to operate, is good in reproducibility, is high in specificity, is complete in elution, is high in accuracy, can enhance the quality control standard of the bulk pharmaceutical chemicals and the preparation thereof of scutellarin in the process of preparing scutellarin by the detecting method, can detect the quality of the raw material of scutellarin and the preparation thereof accurately so as to guarantee to obtain the raw material of scutellarin and preparation thereof with stable quality.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a detection method of scutellarin, especially a detection method of scutellarin raw materials and preparations thereof. Background technique [0002] Scutellarin, also known as scutellarin, its systematic name is 4', 5, 6-trihydroxyflavone-7β-O-glucuronide, and it is the main pharmacological substance in Yunnan national medicine scutellaria breviscapus and its extract preparations. active ingredient. [0003] Scutellarin can achieve its obvious protective effect on acute cerebral ischemia through multiple mechanisms: it can inhibit platelet aggregation, inhibit coagulation function in vivo and promote fibrinolytic activity, thereby inhibiting thrombus formation; through inhibiting the activation of protein kinase C Cerebral vasospasm shrinks, increases local cerebral blood flow, improves cerebral microcirculation, reduces inflammatory cell adhesion and infiltration, and prote...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 董知旭王珺张伟张国丽杨兆祥
Owner KPC PHARM INC
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