Method for establishing heat-clearing and detoxifying oral liquid HPLC fingerprint spectrum

A heat-clearing and detoxifying, fingerprinting technology, applied in the direction of resisting vector-borne diseases, instruments, measuring devices, etc., can solve problems such as failure to obtain components, and achieve good baseline separation, good reproducibility, and good peak shape.

Active Publication Date: 2022-01-11
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are few relevant patent publications and literature reports on the quality control of Qingrejiedu Oral Liquid by the fingerprint of traditional Chinese medicine at home and abroad. You Lihua et al., only 9 common peaks can be determined in the HPLC fingerprint study of Qingrejiedu Oral Liquid, and many components have not been obtained. , failed to achieve comprehensive evaluation and control of the formulation

Method used

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  • Method for establishing heat-clearing and detoxifying oral liquid HPLC fingerprint spectrum
  • Method for establishing heat-clearing and detoxifying oral liquid HPLC fingerprint spectrum
  • Method for establishing heat-clearing and detoxifying oral liquid HPLC fingerprint spectrum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Establishment of HPLC Standard Fingerprint of Qingrejiedu Oral Liquid

[0033] 1 Instruments and reagents

[0034] 1.1 Instrument

[0035] WatersArc ultra-high performance liquid chromatography (Waters Company), Waters 2489UV / Vis detector (Waters Company); KQ-50 ultrasonic cleaning machine (Kunshan Ultrasonic Instrument Co., Ltd.).

[0036] 1.2 Reagent

[0037] Twelve batches of Qingrejiedu Oral Liquid were provided by Lunan Houpu Pharmaceutical Co., Ltd. The sample batch numbers are shown in Table 1. Acetonitrile was chromatographically pure, water was purified water, and the rest of the reagents were analytically pure.

[0038] Table 1 Batch No. of Test Samples of Qingrejiedu Oral Liquid

[0039]

[0040] 2 Methods and results

[0041] 2.1 Chromatographic conditions: Waters Xselect HSS T3 chromatographic column, 4.6×150mm, particle size 2.5μm; mobile phase: acetonitrile as mobile phase A, 0.1% phosphoric acid solution by volume as mobile phase B; dete...

Embodiment 2

[0063] Example 2 Establishment of HPLC Standard Fingerprint of Qingrejiedu Oral Liquid

[0064] 1 Instruments and reagents

[0065] 1.1 Instrument

[0066] Waters Arc ultra-high performance liquid chromatography (Waters Company), Waters 2489UV / Vis detector (Waters Company); KQ-50 ultrasonic cleaning machine (Kunshan Ultrasonic Instrument Co., Ltd.).

[0067] 1.2 Reagent

[0068] Twelve batches of Qingrejiedu Oral Liquid were provided by Lunan Houpu Pharmaceutical Co., Ltd. The sample batch numbers are shown in Table 1. Acetonitrile was chromatographically pure, water was purified water, and the rest of the reagents were analytically pure.

[0069] 2 Methods and Results

[0070] 2.1 Chromatographic conditions: Waters Xselect HSS T3 chromatographic column, 4.6×150mm, particle size 2.5μm; mobile phase: acetonitrile as mobile phase A, 0.05% phosphoric acid solution by volume as mobile phase B; detection wavelength: 220nm; Flow rate: 1.0ml / min; Column temperature: 25°C; Injecti...

Embodiment 3

[0079] Example 3 Establishment of HPLC Standard Fingerprint of Qingrejiedu Oral Liquid

[0080] 1 Instruments and reagents

[0081] 1.1 Instrument

[0082] Agilent ultra-high performance liquid chromatography (Agilent Company), LC / MSD detector (Agilent Company); KQ-50 ultrasonic cleaning machine (Kunshan Ultrasonic Instrument Co., Ltd.).

[0083] 1.2 Reagent

[0084] Twelve batches of Qingrejiedu Oral Liquid were provided by Lunan Houpu Pharmaceutical Co., Ltd. The sample batch numbers are shown in Table 1. Acetonitrile was chromatographically pure, water was purified water, and the rest of the reagents were analytically pure.

[0085] 2 Methods and Results

[0086] 2.1 Chromatographic conditions: Agilent ZORBAX SB-Aq chromatographic column, 250×4.6mm, particle size 5μm; mobile phase: acetonitrile as mobile phase A, 0.2% phosphoric acid solution by volume as mobile phase B; detection wavelength: 260nm ; Flow rate: 0.6ml / min; Column temperature: 30°C; Injection volume: 2μl;...

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Abstract

The invention belongs to the field of traditional Chinese medicine preparation analysis, and particularly discloses a method for establishing a heat-clearing and detoxifying oral liquid HPLC fingerprint spectrum. The method comprises the following steps: preparing a reference substance solution and a test solution, determining HPLC chromatographic conditions and manufacturing an HPLC standard fingerprint spectrum. The invention also discloses the HPLC standard fingerprint spectrum of the heat-clearing and detoxifying oral liquid obtained by the method, and the fingerprint spectrum has 30 common peaks. The quality detection method disclosed by the invention is simple and convenient to operate, high in stability and good in reproducibility, obtained spectrum characteristic peaks are comprehensive, the quality of the heat-clearing and detoxifying oral liquid can be comprehensively evaluated and controlled by comparing common peaks of a standard fingerprint spectrum, the internal quality of a preparation can be accurately evaluated, and the safety and effectiveness of clinical medication are ensured.

Description

technical field [0001] The invention discloses a method for establishing an HPLC fingerprint of an oral liquid for clearing away heat and detoxification and the fingerprint thereof, belonging to the field of analysis of traditional Chinese medicine preparations. Background technique [0002] Qingrejiedu Oral Liquid is recorded in the Chinese Pharmacopoeia 2015 Edition. It is composed of gypsum, honeysuckle, scrophulariaceae, rehmannia root, forsythia, gardenia, sweetdiding, scutellaria baicalensis, gentian, isatidis, Anemarrhena, and Radix Ophiopogon. It is used for fever, red face, irritability and thirst, sore throat and other symptoms caused by excessive heat and toxins. Influenza and upper respiratory tract infection see the above syndromes. Gypsum in the prescription is pungent, sweet and cold, clearing away heat and purging fire; Vent the fire of the triple burner, Scutellaria baicalensis clears the fire of the lungs, gentian clears the fire of the liver and gallbladd...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/86G01N30/02G01N30/34
CPCG01N30/88G01N30/8686G01N30/02G01N30/34G01N2030/8809Y02A50/30
Inventor 袁晓梅邓丽华关永霞
Owner SHANDONG NEWTIME PHARMA
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