Preparation method of Yunv decoction reference substance and quality control method of fingerprint spectrum

A technology for standard fingerprints and reference materials, which is applied in the preparation of reference materials for Yunujian and the quality control of fingerprints, and can solve problems such as inconsistencies

Active Publication Date: 2021-08-20
SPH XING LING SCI & TECH PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the fingerprint of Yunujian has been established in the patent of "a HPLC fingerprint determination method of standard soup of Yunujian" published at present, the prescription of Yunujian used is "15g of raw gypsum, 15g of rehmannia glutinosa, 6g of Radix Ophiopogon japonicus, 6g of Anemarrhena anemarrhena 4.5g, Achyranthes bidentata 4.5g", which is obviously inconsistent with the prescription of Yunu Jiantang included in the "Catalogue of Ancient Classical Prescriptions (First Batch)" published by the State Administration of Traditional Chinese Medicine and the prescription of Yunu Jian recorded in "Jingyue Quanshu". At the same time, although 25 characteristic common peaks were specified in the fingerprint of Yunujian published by it, only 3 common peaks were identified through comparison with reference substances: mangiferin, β-ecdysterone, and verbascoside, and they were only speculated through the mass spectrometry database. 12 characteristic peaks
[0006] In addition, although the fingerprints of 17 characteristic common peaks in Yunu Fried Rice were also established in Lei Liyan et al. Still only 5 common peaks were identified: 5-hydroxymethylfurfural, mangiferin, verbascoside, ecdysterone and methyl ophiopogon dihydrohomoisoflavone A

Method used

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  • Preparation method of Yunv decoction reference substance and quality control method of fingerprint spectrum
  • Preparation method of Yunv decoction reference substance and quality control method of fingerprint spectrum
  • Preparation method of Yunv decoction reference substance and quality control method of fingerprint spectrum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] In parts by weight, take 18.65g of raw gypsum, 37.3g of Rehmannia glutinosa, 5.6g each of Zhimu and Achyranthes bidentata, 7.4g of Radix Ophiopogon japonicus, add 6 times the amount of water to soak for 30 minutes, decoct once, and decoct at 100°C for 5 minutes. Simmer at 88°C for 30min, and concentrate the obtained water extract at 50°C with a concentration pressure of -0.09Mpa to 1:1, then freeze the concentrate at -80°C for 12h, and then dry at -50°C After 20 hours, the extract powder was obtained after pulverization, that is, the reference substance sample 1 of Yunujian # .

Embodiment 2

[0105] 1. Preparation of the test substance and reference substance

[0106] Get the Jade Nv Decoction reference material sample 1 prepared in Example 1 # 3g, add 50ml of 75% ethanol aqueous solution, sonicate for 30min, let it cool and filter, take the subsequent filtrate, concentrate to near dryness, add 50% methanol aqueous solution to dissolve and dilute to 5ml volumetric flask, pass through 0.45μm microporous membrane to obtain The test solution 1#.

[0107] Take 5-hydroxymethylfurfural, neomangiferin, mangiferin, β-ecdysterone, verbascoside, isoverbacoside and Ophiopogon japonicus methyl flavanone A reference substances, add methanol to dissolve and dilute to volume, shake well, Filter through a 0.45 μm microporous membrane, and take the subsequent filtrate to obtain the reference substance solution.

[0108] 2. Chromatographic conditions

[0109] The chromatographic conditions of high performance liquid chromatography are: chromatographic column: Welchrom C 18 Chrom...

Embodiment 3

[0118] Adopt the detection method of the fingerprint of the Jade Nyme decoction reference material set up in the above-mentioned embodiment 2 to detect 15 batches of Jade Nyme decoction reference material samples, obtain the fingerprint of the test solution and the fingerprint of the reference substance solution, the obtained test sample The AIA format of the fingerprint data was imported into the 2012 version of the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" issued by the National Pharmacopoeia Commission, and the chromatographic peaks that existed in the chromatograms of the reference substances of 15 batches of Yunujian were selected as the common characteristic peaks , 15 batches of Yunujian reference material fingerprints of the common model control chart, see the results Figure 10 .

[0119] Such as Figure 10 In the common model control spectrum shown, when comparing the fingerprints of 15 batches of Yunujian reference substances for sim...

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Abstract

The invention provides a preparation method of a Yunv decoction reference substance. The invention provides a Yunv decoction reference substance and a preparation containing the Yunv decoction reference substance. The invention also provides a detection method of the fingerprint spectrum of the Yunv decoction reference substance. In addition, the invention provides a construction method of the standard fingerprint spectrum of the Yunv decoction reference substance and a quality control method of the fingerprint spectrum of the Yunv decoction reference substance. According to the preparation method of the Yunv decoction reference substance and the quality control method of the fingerprint spectrum, Yunv decoction with excellent quality can be obtained, the quality of theYunv decoction is stable, the reject ratio of theYunv decoction is low, the high performance liquid fingerprint spectrum of the Yunv decoction is also established, the internal quality of the Yunv decoction can be integrally controlled, and a scientific test basis is provided for better establishing an overall quality control and evaluation system of the Yunv decoction.

Description

technical field [0001] The invention belongs to the technical field of the preparation of traditional Chinese medicine and the quality control and detection of its components, and relates to a method for preparing a reference material of Yu Nv Jian and a method for quality control of fingerprints, and in particular to a method for preparing a reference material of Jade Nv Jian, and a method for preparing a reference material of Jade Nv Jian. The detection method of the fingerprint, the construction method of the standard fingerprint of Yunujian, and the quality control method of the fingerprint of the reference substance of Yunujian. Background technique [0002] Yunu Jian comes from Volume 51 of "Jingyue Quanshu Xinfang Bazhen", created by Zhang Jingyue, a famous doctor in Ming Dynasty. In the prescription, if the gypsum clears the stomach fire, it is the monarch medicine; if the rehmannia glutinosa nourishes the water, it is the minister medicine. The combination of the tw...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/34G01N30/36G01N30/86A61K36/8968A61P1/02A61P3/10A61K33/06
CPCG01N30/02G01N30/06G01N30/14G01N30/34G01N30/36G01N30/8631G01N30/8679G01N30/89A61K33/06A61K36/804A61K36/8968A61K36/8964A61K36/21A61P1/02A61P3/10A61K2236/331A61K2236/39A61K2236/51A61K2300/00Y02A50/30
Inventor丁越王丹丹张彤高崎夏振江朱国琴曹旖岚江美芳
OwnerSPH XING LING SCI & TECH PHARM CO LTD