Fingerprint determination method and quality control method of Guyin decoction

A standard fingerprint and fingerprint technology, which is applied in the fingerprint determination method and quality control field of Guyin decoction substance reference, can solve the problems of inability to effectively control the production process and product quality, and inability to better guarantee the clinical efficacy, etc. Reduce the possibility of manual processing, ensure stability and safety of use, and good reproducibility

Active Publication Date: 2022-07-22
HUNAN YINENG BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There are many types of raw materials for Guyin decoction, and the substance reference components are complex. In the existing technology, only a single component is analyzed for quality, and there is no comprehensive and systematic quality control method to reflect the quality status of the main substance reference components in Guyin decoction and finished products. , cannot effectively control the production process and product quality, and cannot better guarantee its clinical efficacy

Method used

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  • Fingerprint determination method and quality control method of Guyin decoction
  • Fingerprint determination method and quality control method of Guyin decoction
  • Fingerprint determination method and quality control method of Guyin decoction

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Embodiment 1 Fingerprint determination method of Guyin decoction material benchmark

[0063] 1.1 Instruments and reagents

[0064] Instruments: Waters 2695-2996 high performance liquid chromatograph (Waters, USA); SHIMADZU (Shimadzu) AUW120D 1 / 100,000 electronic balance (Shimadzu, Japan), BSA124S 1 / 10,000 electronic balance (Sartorius, Germany).

[0065] Reagents: 5-Hydroxymethylfurfural (batch number: 111626-201711, purity 90.8%), morroniside (batch number: 111998-201602, purity 96.3%), chlorogenic acid (batch number: 110753-201817, purity 96.3%) 96.8%), loganin (lot number: 111640-201707, 99.2% purity), hypericin (lot number: 111521-201004, 93.9% purity), 3,6'-di-sucrose (lot number: 111848) -201604, 96.7% purity, China National Institute for Food and Drug Control), ammonium glycyrrhizinate (batch number: 110731-201720, 97.7% purity), Schisandrin A (batch number: 110857-201714, 99.9% purity) reference substances were all Purchased from China National Institute for F...

Embodiment 2

[0135] The quality control method of embodiment 2 Guyinjian standard granules

[0136] (1) according to the method in 1.2.1(1) in Example 1, prepare the standard fingerprint of Guyin decoction substance benchmark, adopt the assay method in Example 1 to establish the standard fingerprint of Guyin decoction substance benchmark;

[0137] (2) get Guyinjian standard granule need testing solution, obtain fingerprint according to the assay method in embodiment 1;

[0138] (3) Comparing the fingerprint obtained in step (2) with the standard fingerprint obtained in step (1), if the product conforms, it is a qualified product, and if it does not conform, it is an unqualified product.

[0139] The requirements to be met include: the fingerprint of the test sample should present 12 characteristic peaks, of which 8 peaks should have the same retention time as the corresponding reference peaks in the standard fingerprint; peaks corresponding to the hyperin reference It is an S peak, and th...

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Abstract

The invention provides a fingerprint spectrum determination method and a quality control method for the reference substance of Guyin decoction. The invention confirms 12 common characteristic peaks in the process of establishing the fingerprint spectrum of the Guyin decoction substance reference, solves the problems of difficulty in separating the fingerprint characteristic peaks and the interference of impurity peaks, and ensures the chemical composition stability and use safety of the substance reference , which provides an important reference for the quality control of the subsequent preparations, effectively controls the quality of the Guyin decoction substance benchmark, and enables the classic prescriptions to get more formal quality control.

Description

technical field [0001] The invention relates to the field of drug quality control, in particular to a fingerprint determination method and a quality control method for a substance reference of Guyin decoction. Background technique [0002] Guyinjian comes from "Jingyue Quanshu" (Ming · Zhang Jingyue): "to treat yin deficiency and slippage, with turbidity and stranguria, and the lack of solidity due to deficiency of menstrual water. , Rehmannia three or five dollars, yam two dollars (fried), dogwood one and a half dollars, Polygalaceae seven cents (fried), licorice one or two dollars (fried), fourteen schisandra seeds, dodder two, three dollars (fried). Two cups of water, fry for seven minutes, and take it warm for food." It is one of the 100 catalogs in the "Catalogue of Ancient Classic Names (First Batch)" issued by the State Administration of Traditional Chinese Medicine. [0003] The classic Chinese medicine prescriptions are outstanding representatives of Chinese medic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/8686G01N30/8631
Inventor 张杰陈阳
Owner HUNAN YINENG BIOLOGICAL PHARMA
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