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Creation method and detection method for fingerprint spectrum of compound holly bark preparation

A technology of fingerprint spectrum and construction method, which is applied in the construction method and detection field of the fingerprint spectrum of compound Jiubing preparations, can solve the problems of difficulty in comprehensively characterizing the physical and chemical characteristics of compound Jiubing preparations, and achieves comprehensive monitoring of product quality, completeness and effectiveness. Judgment, high precision effect

Active Publication Date: 2015-07-22
GUANGZHOU XINGQUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The above methods of identifying the raw materials or measuring the content of individual components are difficult to fully characterize the physical and chemical characteristics of the compound jiubing preparation. Therefore, the quality control method for the compound jiubing preparation needs to be further improved

Method used

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  • Creation method and detection method for fingerprint spectrum of compound holly bark preparation
  • Creation method and detection method for fingerprint spectrum of compound holly bark preparation
  • Creation method and detection method for fingerprint spectrum of compound holly bark preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] This example is a method for constructing the fingerprint of the compound jiubing preparation.

[0057] 1. Instruments and materials

[0058] 1. Instrument

[0059] KQ-100B type ultrasonic cleaner (Kunshan Ultrasonic Instrument Co., Ltd.); T-214 electronic analytical balance (Denver company); Waters2695-2996 high performance liquid chromatography system, Empower workstation, including quaternary gradient pump, automatic sampler ( Waters Corporation).

[0060] 2. Reagents

[0061] Glacial acetic acid (chromatographically pure, Tianjin Institute of Chemical Reagents); methanol (chromatographically pure, TEDIA Company); water was ultrapure water.

[0062] The reference substances were syringin reference substance (National Institute for the Control of Pharmaceutical and Biological Products, batch number 111574-200603) and α-cyperone reference substance (for identification, National Institute for the Control of Pharmaceutical and Biological Products, batch number 110748200...

Embodiment 2

[0199] In this embodiment, a method for detecting the fingerprint of Compound Jiubing includes the following steps:

[0200] (1) Preparation of reference substance solution:

[0201] Accurately weigh about 12 mg of the syringin reference substance, add appropriate amount of methanol, and prepare a solution containing 1.22 mg per 1 ml to obtain the syringin reference substance solution;

[0202] Use a micro-sampler to draw 200ul of α-cyperone reference substance, add appropriate amount of methanol, and prepare a solution containing 10 μl per 1ml to obtain α-cyperone reference substance solution.

[0203] (2) Preparation of the test solution:

[0204] Take 2 capsules of the sample to be tested (batch number: LG40004 Compound Jiubing Capsules, provided by Guangzhou Baiyunshan Xingqun (Pharmaceutical) Co., Ltd.), remove the capsule shell, mix the contents, accurately weigh 0.5g, and place In a stoppered Erlenmeyer flask, accurately add 10ml of methanol with a volume fraction of ...

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Abstract

The invention discloses a creation method and a detection method for a fingerprint spectrum of a compound holly bark preparation. The creation method comprises the following steps: (1) preparing reference solutions, that is to say, preparing a syringin reference solution and an alpha-cyperone reference solution from methanol respectively; (2) performing reflux or ultrasonic extraction by methanol with the volume fraction being 50-70%, and preparing a test solution of the compound holly bark preparation; (3) precisely sucking the test solution and the reference solutions respectively, injecting the sucked test solution and reference solutions into a high-performance liquid chromatographic instrument, and performing testing by adopting specific chromatographic conditions. The fingerprint spectrum created with the creation method has 19 characteristic common peaks, so that the physical and chemical characteristics of the compound holly bark preparation can be comprehensively represented and the one-sidedness of integral quality judgment of the compound holly bark preparation due to measurement of one or two chemical components is avoided; moreover, the creation method has the advantages of simplicity and convenience for operation, stable result, high precision, good reproducibility and the like.

Description

technical field [0001] The invention relates to the field of quality control of traditional Chinese medicine preparations, in particular to a construction method and a detection method of a fingerprint of a compound jiubing preparation. Background technique [0002] The compound Jiubingying preparation is made from Chinese herbal medicines Jiubing, Dongfengju and Cyperus Cyperi, extracted with water, and made according to the conventional pharmaceutical process. Compound Jiubing preparations are listed in Volume 10 of the Ministry of Health's Pharmaceutical Standards for Traditional Chinese Medicine Prescriptions, which contain Compound Jiubing Capsules, which are very popular traditional Chinese medicine preparations. [0003] The national standard mainly adopts thin-layer chromatography for the quality control of compound Jiubing capsules, and identifies the reference medicinal materials of Jiubing, Dongfengju and Cyperus cyperus respectively, so as to judge whether there ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 蒋莉娟姚江雄许招懂方铁铮
Owner GUANGZHOU XINGQUN PHARMA
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