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Fingerprint spectrum of Egui blood-nourishing preparation

A fingerprint and preparation technology, applied in the field of fingerprints of Agui nourishing blood preparations, can solve the problems of inability to monitor quality, no reports, and no establishment of fingerprints of Agui nourishing blood preparations, etc., and achieves good peak shape, easy operation, easy-to-identify effects

Pending Publication Date: 2021-06-22
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the quality control of Agui Yangxue preparation often selects several traditional Chinese medicine ingredients for identification, and mostly uses thin-layer chromatography, which cannot comprehensively monitor its quality
At present, there is no public report on the research on the fingerprint of Agui's blood-nourishing preparation, let alone the establishment of a fingerprint of Agui's blood-nourishing preparation. In terms of quality control, there is no report on the standard fingerprint of Agui's blood-nourishing preparation

Method used

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  • Fingerprint spectrum of Egui blood-nourishing preparation
  • Fingerprint spectrum of Egui blood-nourishing preparation
  • Fingerprint spectrum of Egui blood-nourishing preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: Screening of chromatographic conditions

[0027] (1) Screen different chromatographic columns to investigate the number of peaks, resolution and peak shape. (area normalization method, peaks below 0.05% are not counted)

[0028]

[0029] From the results, Agilent TC-C18 (250mm×4.6mm, 5um) had the most detection peaks and the best resolution. Agilent TC-C18 was selected to develop the HPLC characteristic fingerprint detection method for Agui Yangxue preparation.

[0030] (2) Screen different mobile phase salts to investigate the number of peaks, resolution and peak shape. Tested with Agilent TC-C18 (250mm×4.6mm, 5um) chromatographic column.

[0031] (area normalization method, peaks below 0.05% are not counted)

[0032]

[0033] From the results, the 30mmol / L triethylamine solution had the most detected peaks and the best resolution, and the 30mmol / L triethylamine solution was selected as the mobile phase salt for the HPLC characteristic fingerprin...

Embodiment 2

[0037] Example 2: Fingerprint Methodology Validation

[0038] 1. Instrument

[0039] Agilent1260 high performance liquid chromatography (Agilent, USA); PB-10 pH meter (Sartorius), BP-211D electronic analytical balance (Sartorius).

[0040] 2. Test solution

[0041] Acetonitrile (Tiandi, chromatographically pure), triethylamine (Chinese medicine, analytically pure), methanol (Tianjin Best Chemical, analytically pure), and water was Wahaha purified water.

[0042] 3. Reference substance

[0043] Paeoniflorin (batch number 110736-201842 China National Institutes for Food and Drug Control, content 97.4%)

[0044] 4. Sample

[0045] Agui Nourishing Blood Preparation (Lot No.: 180501, Kangpu Pharmaceutical Co., Ltd.)

[0046] 5. Chromatographic conditions: Octadecylsilane bonded silica gel as filler, acetonitrile as mobile phase A, acetonitrile-30mmol / L triethylamine (5:95) as mobile phase B, gradient elution, flow rate 1.0 ml·min-1, the column temperature is 35°C, the detecti...

Embodiment 3

[0060] Example 3 Common peaks and peak assignments

[0061] The 9 medicinal materials in the prescription of Agui Yangxue preparation were prepared separately according to the method of the above-mentioned Example 2, and the test solution was separately analyzed according to the above-mentioned chromatographic conditions, and the chromatograms of the Agui Yangxue preparation sample (180501) and each medicinal material were compared. Find peak assignments.

[0062] With reference to paeoniflorin reference substance, record the relative retention time of common peaks. There are 14 common peaks in the fingerprint. See Table 1 below, figure 2 .

[0063] Table 1 Fingerprint peak assignment

[0064]

[0065] figure 2 Agui blood nourishing preparation 180501 batches of test samples.

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Abstract

The invention discloses a fingerprint spectrum of an Egui blood-nourishing preparation. The fingerprint spectrum is an HPLC (High Performance Liquid Chromatography) characteristic fingerprint spectrum of the Egui blood-nourishing preparation. According to the invention, the HPLC characteristic fingerprint spectrum of the Egui blood-nourishing preparation is established, and the oneness and one-sidedness of the existing quality standard are overcome; and the quality information of the Egui blood-nourishing preparation can be comprehensively reflected, so that the purpose of more comprehensively and effectively controlling the product quality of the Egui blood-nourishing preparation can be achieved. For some active components which cannot be identified and active components are not clear, a fingerprint spectrum method can be adopted to prove that the product quality is consistent. The fingerprint spectrum of the Egui blood-nourishing preparation obtained by the method has many peaks, good peak shape, high similarity, accuracy and reliability, and is easy to identify. The method is simple and convenient to operate, stable, good in repeatability and objective and accurate in conclusion.

Description

technical field [0001] The invention belongs to the field of drug quality detection and specifically designs a fingerprint of Agui blood-nourishing preparation. Background technique [0002] The prescription of Agui Yangxue Granule prepared by Kangpu Pharmaceutical Co., Ltd. is: Angelica 386g, Codonopsis 24g, Radix Paeoniae Alba 24g, Zhilicorice 12g, Poria 24g, Astragalus 24g, Rehmannia glutinosa 24g, Rhizoma Chuanxiong 12g, Ejiao 24g. Mainly used for nourishing qi and blood. For Qi and blood deficiency, sallow complexion, dizziness and fatigue, less menstrual flow and pale color. [0003] At present, the quality control of Agui Yangxue preparation often selects several traditional Chinese medicine ingredients for identification, and mostly uses thin-layer chromatography, which cannot fully monitor its quality. [0004] Since traditional Chinese medicine and its compound preparations are multi-component complex systems, the evaluation of their quality should adopt detectio...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/32G01N30/34G01N30/54G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/14G01N30/32G01N30/34G01N30/54G01N30/74G01N30/8686G01N2030/047G01N2030/324
Inventor 曾灿丽肖利辉刘选张静梁致红刘娟
Owner KAMP PHARMA
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