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Fingerprint of Fushiming capsules and its application in quality control and component analysis

A fingerprint and capsule technology, which is applied in the field of drug analysis, can solve the problems of complex components, low separation degree of chemical components, and lack of quality control standards and component analysis methods for dipilide capsules, and achieves the treatment of diabetic retina. Lesion, significant curative effect, easy quality control and application effect

Active Publication Date: 2019-09-03
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

[0055] 1. Instruments, materials and reagents

[0056] 1.1 Instruments and materials

[0057]

[0058] 1.2 Drugs and reagents

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

Embodiment 2

[0102] Example 2 Pharmacodynamic studies of 8 kinds of component pharmaceutical compositions

[0103] 1. Instruments, materials and reagents

[0104] 1.1 Instruments and materials

[0105]

[0106]

[0107] 1.2 Drugs and reagents

[0108] Fushiming Capsule Powder, provided by the Institute of Drug Research, Air Force Military Medical University, batch number 20170301. Calcium dobesilate capsules are commercial 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%), orange cassiacin reference substance (batch number: 111900-201605 , purity: 98.3%), ligustilide reference substance (batch number: 111737-201608, purity: 99.2%) were purchased from China National Ins...

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Abstract

The invention relates to a fingerprint of Fushiming capsules and its application in quality control and component analysis. In the invention, an HPLC mobile phase is optimized, and 33 chromatographicpeaks are determined as a fingerprint common peak of the Fushiming capsules by analyzing chromatograms of 10 batches of Fushiming capsule samples, wherein the peak area of the common peak accounts formore than 90% of the total peak area, and a HPLC fingerprint spectrum common mode of the Fushiming capsules is determined, 33 common peaks are calibrated, and the similarity is 0.994 to 1.000; and the contents of 5-HMF, puerarin, 3'-methoxy puerarin, daidzin, formononetin, daidzein, aurantio obtusin, and ligustilide in 10 batches of preparations are determined. The HPLC fingerprint spectrum method and the content determination method of the Fushiming capsules established by the invention have the advantages of good analysis and evaluation capability, accuracy, simplicity, convenience, stability, reliability and the like. Therefore, the methods are effective evaluation methods for the quality of the present preparation.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to the fingerprint of Fushiming capsule and its application in quality control and component analysis. Background technique [0002] Fushiming Capsules are made from 12 traditional Chinese medicinal materials including American ginseng, astragalus root, rehmannia glutinosa, angelica, cassia seed, safflower, pearl, kudzu root, medlar, leech, loofah, and osmanthus twig. The clinical experience of the preparation in the hospital. It has the effects of nourishing qi and activating blood, nourishing yin and tonifying kidney, dredging collaterals and improving eyesight. It is mainly used for diabetic fundus retinopathy caused by qi deficiency and blood stasis, liver and kidney deficiency, and venous block. 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 ac...

Claims

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Application Information

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Patent Type & Authority Applications(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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