High performance liquid chromatography (HPLC) standard fingerprint spectrum of lucid ganoderma capsule preparation and construction method and application of standard fingerprint spectrum

A standard fingerprint and fingerprint technology, applied in the field of drug analysis, can solve problems such as difficulty in comprehensively monitoring the production process stability of finished products and intermediate products, lack of quality control methods, and inability to fully reflect characteristics, so as to avoid singleness and one-sidedness, Simple method, good specific effect

Active Publication Date: 2014-08-27
INFINITUS (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, Ganoderma lucidum preparations still lack comprehensive and effective quality control methods, and the quality standards are not perfect, so it is difficult to comprehensively monitor the quality of finished products and intermediate products and the stability of the production process
Ling Yuanyu et al reported the determination of the content of polysaccharides in Ganoderma lucidum capsules by anthrone method in the literature "Determination of Polysaccharide Content in Lingzhihuang Capsules", Basic Chinese Medicine Journal, 1997, 11(3): 40, but it was limited to the detection of individual components. Does not fully reflect the characteristics of the product

Method used

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  • High performance liquid chromatography (HPLC) standard fingerprint spectrum of lucid ganoderma capsule preparation and construction method and application of standard fingerprint spectrum
  • High performance liquid chromatography (HPLC) standard fingerprint spectrum of lucid ganoderma capsule preparation and construction method and application of standard fingerprint spectrum
  • High performance liquid chromatography (HPLC) standard fingerprint spectrum of lucid ganoderma capsule preparation and construction method and application of standard fingerprint spectrum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] 1. Instruments and reagents

[0057] Instrument: Agilent1200 high performance liquid chromatography (quaternary pump, column thermostat, DAD detector and Agilent1200 chromatographic workstation), American Agilent Company; laboratory-specific ultrapure water machine, Chongqing Lidi Modern Water Technology Equipment Co., Ltd.; BP211D type Analytical balance, German Sartorius company; HWS24 electric heating constant temperature water bath, Shanghai Yiheng Technology Co., Ltd.; KQ-400KPE ultrasonic cleaning instrument, Kunshan Ultrasonic Instrument Co., Ltd.

[0058] Control substance:

[0059]

[0060] Ganoderma Lucidum Capsule: a product of Infinitus (China) Co., Ltd., it is a capsule. Ganoderma lucidum preparation is mainly made of medicinal materials such as Ganoderma lucidum, Atractylodes macrocephala, Polygonatum, Lycium barbarum, Poria cocos, Radix Ophiopogon japonicus, Cuscuta seed, Schisandra chinensis, Coix seed, and licorice.

[0061] Control raw materials: ...

Embodiment 2

[0109] 1, instrument, reagent are the same as embodiment 1.

[0110] 2. Determination conditions of high performance liquid chromatography

[0111] Chromatographic column: Kromasil100-5C 18 (4.6×250mm i.d., 5μm); mobile phase: acetonitrile as mobile phase A, and 0.15% by volume phosphoric acid aqueous solution as mobile phase B; detection wavelength: 252nm; column temperature: 30°C; flow rate: 1.0mL / min. Adopt the gradient elution mode identical with embodiment 1:

[0112] 3. Establishment of HPLC fingerprints

[0113] 1) Preparation of test sample and reference substance

[0114] Preparation of Ganoderma lucidum test solution: Take 0.5 g of the content of Ganoderma lucidum capsule, accurately weigh it, place it in a conical flask with a stopper, add 30 mL of methanol precisely, seal it tightly, weigh it, and ultrasonically treat it for 30 minutes (power 500W, frequency 40KHz), let stand to cool, then weighed, make up for the lost weight with methanol, shake well, filter...

Embodiment 3

[0119] 1, instrument, reagent are the same as embodiment 1.

[0120] 2. Determination conditions of high performance liquid chromatography

[0121] Chromatographic column: Kromasil100-5C 18 (4.6×250mm i.d., 5μm); mobile phase: acetonitrile as mobile phase A, and 0.05% phosphoric acid aqueous solution as mobile phase B; detection wavelength: 252nm; column temperature: 25°C; flow rate: 1.0mL / min. The same gradient elution method as in Example 1 was adopted.

[0122] 3. Establishment of HPLC fingerprints

[0123] 1) Preparation of test sample and reference substance

[0124] Preparation of Ganoderma lucidum test solution: Take 2.0 g of Ganoderma lucidum capsule content, accurately weighed, place in a conical flask with a stopper, add 40 mL of methanol precisely, seal the plug, weigh, and ultrasonically treat for 60 minutes (power 500W, frequency 40KHz), let stand to cool, then weighed, make up for the lost weight with methanol, shake well, filter, discard the initial filtra...

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Abstract

The invention discloses a high performance liquid chromatography (HPLC) standard fingerprint spectrum of a lucid ganoderma capsule preparation and a construction method and application of the standard fingerprint spectrum. The construction method comprises the following steps: preparing a test solution and a reference substance solution, and carrying out linear gradient elution, wherein a mobile phase A is acetonitrile, a mobile phase B is 0.05-0.15 percent (v/v) phosphoric acid aqueous solution, the detection wavelength is 252nm, the column temperature is 25-35 DEG C, the flow velocity is 1.0mL/min; measuring through HPLC, obtaining a lucid ganoderma capsule fingerprint spectrum, and taking a common characteristic peak of at least 14 batches of fingerprint spectrums as the characteristic peak of the standard fingerprint spectrum, wherein the standard fingerprint spectrum totally has 40 characteristic peaks, and the numbers of characteristic peaks belonging to lucid ganoderma, bighead atractylodes rhizome, rhizoma polygonati, the seed of Chinese dodder, schisandra chinensis, liquorice and the fruit of Chinese wolfberry are respectively 20, 3, 3, 5, 1, 5 and 2. According to the method and the standard fingerprint spectrum, the overall quality of the lucid ganoderma preparation can be comprehensively and accurately evaluated, and the quality and drug effect of the lucid ganoderma preparation are guaranteed.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to an analysis and detection method of ganoderma lucidum preparation, in particular to an HPLC standard fingerprint of ganoderma lucidum preparation and its construction method and application. Background technique [0002] Drug fingerprint refers to the spectrum of common peaks that can mark the characteristics of traditional Chinese medicine raw materials, decoction pieces, intermediate products, finished products, etc. after appropriate processing and using certain analysis methods. Drug fingerprints can objectively reveal and reflect the integrity and characteristics of the internal quality of drugs, and are used to evaluate the authenticity, effectiveness, stability and consistency of drugs. The clinical efficacy of a drug is not the effect of a single active ingredient or the simple addition of the effects of multiple active ingredients, especially for compound preparation...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 高新开程敏谭丽容吴小莉
Owner INFINITUS (CHINA) CO LTD
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