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Fingerprint of Fushiming Capsules and Its Application in Quality Control and Component Analysis

A fingerprint and component analysis technology, which is applied in the field of drug analysis, can solve the problems of Fushiming capsules with complex components, low separation of chemical components, and no quality control standards and component analysis methods for Fushiming capsules, so as to achieve the goal of treating diabetes Retinopathy, significant curative effect, easy quality control and application effect

Active Publication Date: 2022-07-19
XIAN LEJIAN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the complex composition of Fushiming Capsules, the separation degree of each chemical component is low under general conditions. At present, there are few research reports on the active ingredients of Fushiming Capsules. Quality Control Standards and Component Analysis Methods of Fushiming Capsules

Method used

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  • Fingerprint of Fushiming Capsules and Its Application in Quality Control and Component Analysis
  • Fingerprint of Fushiming Capsules and Its Application in Quality Control and Component Analysis
  • Fingerprint of Fushiming Capsules and Its Application in Quality Control and Component Analysis

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] The establishment of embodiment 1 fingerprint spectrum

[0055] 1. Instruments, materials and reagents

[0056] 1.1 Instruments and Materials

[0057]

[0058] 1.2 Drugs and Reagents

[0059] Di Shiming Capsules (Xi'an Lejian Biotechnology Co., Ltd., batch number: 20180506, 20180507, 20180508, 20180605, 20180508, 20180509, 20180607, 20180608, 20180609, 20180610, specification: 400mg / capsule) (S1~S10); Methyl furfural reference substance (batch number: 111626-201610, purity: 99.2%), puerarin reference substance (batch number: 110752-201615, purity: 95.4%), daidzein reference substance (batch number: 111738-201603, purity: 93.3%) ), Cassia orange reference substance (batch number: 111900-201605, purity: 98.3%), ligustilide reference substance (batch number: 111737-201608, purity: 99.2%) were purchased from China National Institute for Food and Drug Control. Formononetin reference substance (lot number: 486-62-4, purity: 98.0%), 3'-methoxypuerarin reference substance...

Embodiment 2

[0102] Example 2 Pharmacodynamic study of 8-component pharmaceutical composition

[0103] 1. Instruments, materials and reagents

[0104] 1.1 Instruments and Materials

[0105]

[0106]

[0107] 1.2 Drugs and Reagents

[0108] Di Shiming capsule powder, provided by the Institute of Materia Medica, Air Force Military Medical University, batch number 20170301. Calcium dobesilate capsules are commercially available products, batch number: 20161104, produced by Guizhou Tianan Pharmaceutical Co., Ltd., approval number: Guoyao Zhunzi H20010481. 5-Hydroxymethylfurfural reference substance (batch number: 111626-201610, purity: 99.2%), puerarin reference substance (batch number: 110752-201615, purity: 95.4%), daidzein reference substance (batch number: 111738-201603, purity: 93.3%), cassia orange reference substance (batch number: 111900-201605 , purity: 98.3%), ligustilide reference substance (batch number: 111737-201608, purity: 99.2%) were purchased from China National Inst...

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Abstract

The invention relates to the fingerprint of Fushiming capsules and its application in quality control and component analysis. The invention optimizes the HPLC mobile phase. The chromatograms of 10 batches of Fushiming capsule samples are analyzed and 33 chromatographic peaks are determined as: The fingerprints of Diushiming Capsules have common peaks, and the peak area of ​​the common peaks accounts for more than 90% of the total peak area. The common pattern of the HPLC fingerprints of Diushiming Capsules is determined, and 33 common peaks are demarcated, and the similarity is 0.994~ 1.000; and the contents of 5-HMF, puerarin, 3'-methoxypuerarin, daidzin, formononetin, daidzein, aurisin and ligustilide in 10 batches of preparations were determined. The HPLC fingerprint method and the content determination method of Fushiming capsule established by the invention have good analysis and evaluation ability, and have the advantages of accuracy, simplicity, stability and reliability. Therefore, this method can be used as an effective evaluation method for the quality of this preparation.

Description

technical field [0001] The invention belongs to the field of drug analysis, and particularly relates to a fingerprint of Fushiming capsules and its application in quality control and component analysis. Background technique [0002] Fushiming Capsule is made up of 12 Chinese medicinal materials, including American ginseng, Astragalus, Rehmannia glutinosa, Angelica sinensis, cassia seed, safflower, pearl, pueraria, wolfberry, leech, loofah, and cinnamon stick. Its prescription is Xijing, Fourth Military Medical University. Clinical experience of in-hospital preparations. It has the functions of invigorating qi and promoting blood circulation, nourishing yin and tonifying kidney, clearing collaterals and improving eyesight. Due to the complex composition of Fushiming Capsules and the low degree of separation of the chemical components under normal conditions, there are few reports on the research on the active ingredients of Fushiming Capsules. Quality control standard and c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王四旺何萌杉许璐张明科
Owner XIAN LEJIAN BIOTECH CO LTD
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