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Ultra-high performance liquid chromatography detection method for active ingredient content and fingerprint spectrum of compound sophora flavescens injection

A technology of ultra-high performance liquid phase and Sophora flavescens injection, which is applied in the field of medicine, can solve the problems of poor chromatographic peak shape and inapplicability of compound Sophora flavescens injection, etc.

Pending Publication Date: 2022-06-03
SHANXI ZHENDONG PHARMA +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This method uses acetonitrile-ammonium acetate as the mobile phase, which is relatively similar to the fingerprint conditions in the standard, and the chromatographic peak shape of the injection is poor under these conditions.
[0005] In Weng Zebin et al. "Analysis of the chemical composition of alkaloids in Sophora flavescens seeds produced in Shanxi and its value as a resource", the combination of UPLC-QTOF-MS and UPLC-TQ-MS was used to analyze the alkaloids in the mature and dry seeds of Sophora flavescens The composition and content of resource chemical components, this method also uses acetonitrile-ammonium acetate as the mobile phase, which is not suitable for compound Kushen injection

Method used

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  • Ultra-high performance liquid chromatography detection method for active ingredient content and fingerprint spectrum of compound sophora flavescens injection
  • Ultra-high performance liquid chromatography detection method for active ingredient content and fingerprint spectrum of compound sophora flavescens injection
  • Ultra-high performance liquid chromatography detection method for active ingredient content and fingerprint spectrum of compound sophora flavescens injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] The test article of embodiment 1

[0099] name batch number source Compound Sophora flavescens injection 20181138 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181034 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181139 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181203 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181204 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181209 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181212 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181213 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection 20181214 Shanxi Zhendong Pharmaceutical Co., Ltd. Compound Sophora flavescens injection...

Embodiment 2

[0100] The test article of embodiment 2

[0101]

[0102]

[0103] reagent

[0104] name batch number source level Potassium dihydrogen phosphate 018823 MREAD HPLC Phosphoric acid 0160318 beijing chemical plant Analytical grade methanol 10985407 902 merck gmbh & co. kg HPLC

[0105] Embodiment 1 The detection method of active ingredient of compound Sophora flavescens injection

[0106] 1. Chromatographic conditions, sample preparation, system suitability requirements, calculation formula, limit requirements

[0107]

[0108] 2. Verify the specific content

[0109] 2.1 System suitability

[0110] (1) Experimental steps

[0111] Preparation of blank solution: 0.2% potassium dihydrogen phosphate solution-methanol=85:15 mixed solution, filtered to obtain.

[0112] Preparation of reference substance solution: Precisely weigh matrine reference substance, oxymatrine reference substance and oxymatrine reference substa...

Embodiment 3-1～3-4

[0403] Embodiment 3-1~3-4 UPLC condition exploration

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to an ultra-high performance liquid chromatography detection method for the active ingredient content and fingerprint spectrum of a compound sophora flavescens injection, the method adopts ultra-high performance liquid chromatography for detection, and the ultra-high performance liquid chromatography conditions are as follows: the chromatographic column is ACQUITY UPLC CSHTM C18, the specification is 1.7 [mu] m, 2.1 mm * 100 mm; the active ingredients are matrine, oxymatrine, methyl azoxymethanol primurin, sophocarpine, oxysophocarpine and sophoridine. The invention can provide an improved detection method of the compound sophora flavescens injection, six components in the compound sophora flavescens injection can be simultaneously determined, and the chromatographic fingerprint spectrum is constructed by using the method, so that a rapid and efficient technical method is provided for quality control of the compound sophora flavescens injection, and the inspection workload is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an improved UPLC detection method for compound Sophora flavescens injection. Background technique [0002] Fufang Kushen injection is a traditional Chinese medicine injection refined from two traditional Chinese medicines of Sophora flavescens and Baituling through modern scientific methods. For cancer pain, bleeding. Modern research has shown that it has various pharmacological effects such as anti-tumor, anti-inflammatory, analgesic, and improving body immunity. adjuvant therapy. [0003] Alkaloids are the main medicinal components of Compound Sophora flavescens injection. Existing National Drug Standard for Fufang Kushen Injection (WS) 3 -B-2752-97-2014) only contains the HPLC content determination method and fingerprint detection of matrine, oxymatrine and methyl oxymatrine primuloside, and lacks a more diverse scientific quality evaluation method. Ultra-hi...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/86
CPCG01N30/02G01N30/34G01N30/8679G01N30/8686G01N2030/047Y02A50/30
Inventor 段秀梅海丽娜王鹏飞秦文杰王红宇
Owner SHANXI ZHENDONG PHARMA
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