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Construction method of flavonoid fingerprint spectrum in ginkgo leaf extract or preparation thereof

A fingerprint and construction method technology, which is applied in the field of construction of flavonoid fingerprints in ginkgo biloba extract or its preparations, can solve the problems of complicated operation steps and insufficient process simplicity, achieve excellent separation effect, improve work efficiency, Avoid the effects of liquid phase conditions

Active Publication Date: 2020-02-21
SHINEWAY PHARMA GRP LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the main active ingredients in Ginkgo biloba extract and its preparations are flavonoid glycosides and terpenoid lactone active substances, the other ingredients of Ginkgo biloba extract and preparations are quite different except for the active ingredients. Therefore, different methods are generally used. Instruments and different liquid phase test conditions are used to inject samples separately for testing, resulting in complicated operation steps and insufficient process simplicity

Method used

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  • Construction method of flavonoid fingerprint spectrum in ginkgo leaf extract or preparation thereof
  • Construction method of flavonoid fingerprint spectrum in ginkgo leaf extract or preparation thereof
  • Construction method of flavonoid fingerprint spectrum in ginkgo leaf extract or preparation thereof

Examples

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Embodiment 1

[0031] This embodiment provides a method for constructing a fingerprint of flavonoids in Shuxuening Injection, a preparation containing Ginkgo biloba extract, which includes the following steps:

[0032] Step a: Taking rutin as a reference substance, dissolving with 95% methanol in volume concentration to obtain a rutin reference substance solution with a concentration of 0.1 mg / mL.

[0033] Step b: Filter 1 mL of Shuxuening injection, a preparation containing Ginkgo biloba extract, with a 0.45 μm microporous filter membrane, and the obtained continuous filtrate is the test solution of the Ginkgo biloba extract injection.

[0034] Step c. Use high performance liquid chromatography to analyze the test solution and reference solution respectively by high performance liquid chromatography, wherein the chromatographic conditions of the high performance liquid chromatography are: the stationary phase is filled with phenylsilane bonded silica gel Chromatographic column, mobile phase A is 0...

Embodiment 2

[0040] This embodiment provides a method for constructing a fingerprint of flavonoids in Shuxuening Injection, a preparation containing Ginkgo biloba extract, as follows:

[0041] Using the method for constructing the fingerprint of Shuxuening injection as described in Example 1, the HPLC spectra of 13 batches of Shuxuening injection were established, such as figure 2 As shown, the fingerprints of 13 batches of samples were synthesized using the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" of the National Pharmacopoeia Commission, such as image 3 As shown, the HPLC fingerprint of Shuxuening injection composed of 36 common peaks is generated, and the chromatographic peak No. 15 is rutin. With reference to the control maps generated by 13 batches of samples, the similarity was calculated, and the similarity was all greater than 0.90.

Embodiment 3

[0070] This embodiment provides a method for constructing a fingerprint of flavonoids in Ginkgo biloba extract, which includes the following steps:

[0071] Step a: Taking rutin as a reference substance, dissolving in methanol with a volume concentration of 100% to obtain a rutin reference substance solution with a concentration of 0.08 mg / mL.

[0072] Step b: Dissolve the Ginkgo biloba extract in methanol with a volume concentration of 100% to prepare a solution with a concentration of 3 mg / mL, and filter to obtain the test solution of the Ginkgo biloba extract.

[0073] Step c. Use high performance liquid chromatography to analyze the test solution and reference solution respectively by high performance liquid chromatography, wherein the chromatographic conditions of the high performance liquid chromatography are: the stationary phase is filled with phenylsilane bonded silica gel Chromatographic column, mobile phase A is 0.1% formic acid aqueous solution, mobile phase B is acetonit...

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Abstract

The invention relates to the technical field of medicine detection, and particularly discloses a construction method of a flavonoid fingerprint spectrum in a ginkgo leaf extract or a preparation of the ginkgo leaf extract. The construction method comprises the following steps: constructing a fingerprint spectrum by adopting a high performance liquid chromatography, wherein the chromatographic conditions of the high performance liquid chromatography are as follows: a stationary phase is a chromatographic column taking phenylsilane bonded silica gel as a filler, a mobile phase A is a formic acidaqueous solution with the volume concentration of 0.05-0.2%, a mobile phase B is acetonitrile, a detector is an ultraviolet detector, the detection wavelength is 265 nm, and the column temperature is25-40 DEG C; enabling the flow rate as 0.2-0.45 mL / min, and performing gradient elution. The fingerprint spectrum provided by the invention provides a scientific basis for comprehensively establishing the quality control standard of the ginkgo leaf extract or the preparation of the ginkgo leaf extract.

Description

Technical field [0001] The present invention relates to the technical field of medical detection, in particular to a method for constructing a fingerprint of flavonoids in a ginkgo leaf extract or a preparation thereof. Background technique [0002] Ginkgo biloba extract has the function of dilating blood vessels and improving microcirculation. Preparations containing ginkgo biloba extract are mainly used for ischemic cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, cerebral embolism or cerebral vasospasm. [0003] Fingerprint is a chromatogram or spectrogram that can indicate the chemical characteristics of certain Chinese medicinal materials or their preparations after proper processing and using certain analytical methods. It is a comprehensive and quantifiable identification method. At present, it has become an international consensus to use fingerprints as a quality control method for traditional Chinese medicine extracts and preparations. ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/54G01N30/74G01N30/88
CPCG01N30/02G01N30/06G01N30/14G01N30/54G01N30/74G01N30/88G01N2030/027G01N2030/062G01N2030/146G01N2030/8809
Inventor 李响明周永妍李玉彩杨琴王雪莲王文鹏孙胜斌姜国志
Owner SHINEWAY PHARMA GRP LTD
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