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Construction of standard characteristic map of Kangfu tincture and its quality detection method

A technology of characteristic map and construction method, which is applied in the field of quality control of Chinese patent medicines, can solve the problems of Kangfu tincture composition and content differences, difficulty in comprehensively and accurately reflecting the quality status of Kangfu tincture, etc., and achieve the effect of high separation, simple and quick operation

Active Publication Date: 2020-01-03
ANHUI ANKE YULIANGQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen from the above that the current research on the quality control method of Kangfu tincture only involves the detection of the ingredients of single raw materials. As a result of the joint action of the ingredients, there is a large difference between the ingredients and content of Kangfu tincture and the ingredients and content of its raw materials. It is difficult to fully and accurately reflect the quality of Kangfu tincture by using the method of detecting the ingredients of single-flavored raw materials

Method used

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  • Construction of standard characteristic map of Kangfu tincture and its quality detection method
  • Construction of standard characteristic map of Kangfu tincture and its quality detection method
  • Construction of standard characteristic map of Kangfu tincture and its quality detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: HPLC determination of Kangfu tincture test solution under different conditions

[0022] 1. Instruments and medicines

[0023] Instrument: Waters high performance liquid chromatography, 2489 detector.

[0024] Reagents: phosphoric acid, acetic acid (analytical grade); methanol (chromatographic grade, SIGAMA); Kangfu tincture (Anke Yuliangqing Pharmaceutical Co., Ltd., batch number 20161001); rutin reference substance (purity 99.9%), batch number 100080-200306.

[0025] 2. Methods and results

[0026] 2.1 Preparation of test solution

[0027] (1) Take 10ml of Kangfu Tincture, evaporate the ethanol on a water bath, add 4ml of ammonia water, add ether and shake and extract 3 times, 30ml each time, combine the ether solution, evaporate to dryness, dilute the residue with methanol and dilute to 25ml, filter, and take Continue filtrate as need testing solution A.

[0028] (2) Take 10ml of Kangfu tincture, evaporate to dryness in a water bath, add 50% methanol...

Embodiment 2

[0060] Example 2: Construction of the standard characteristic map of Kangfu tincture

[0061] 1. Instruments and medicines

[0062] Instrument: Waters high performance liquid chromatography, 2489 detector.

[0063] Reagent: acetic acid (analytical pure); methanol (chromatographic grade, SIGAMA); 15 batches of standard Kangfu tincture provided by Anhui Ankeyu Liangqing Pharmaceutical Co., Ltd. 20160901, 20160801, 20160702, 20160701, 20160603, 20160602, 20160601, 20160401, the above 15 batches of standard Kangfu tincture are numbered S1-S15 in sequence; the rutin reference substance (purity 99.9%), the batch number is 100080-200306.

[0064] 2. Chromatographic conditions

[0065] The chromatographic column uses octadecylsilane bonded silica gel as a filler (column length is 250mm, inner diameter is 4.6mm, particle size is 5μm); methanol is used as mobile phase A, 1% acetic acid is used as mobile phase B, and the mobile phase is Gradient elution of phase A and phase B with a r...

Embodiment 3

[0084] Embodiment 3: the quality inspection of Kangfu tincture

[0085] 1. Instruments and reagents

[0086] Instrument: Waters high performance liquid chromatography, 2489 detector.

[0087]Drugs: phosphoric acid (analytical purity); methanol (chromatographic grade, SIGAMA); Kangfu tincture provided by Anhui Ankeyu Liangqing Pharmaceutical Co., Ltd., batch number 20170605; rutin reference substance (purity 99.9%), batch number 100080-200306.

[0088] 2. Chromatographic conditions

[0089] The chromatographic column is filled with octadecylsilane bonded silica gel (column length is 250mm, inner diameter is 4.6mm, particle size is 5μm); methanol is used as mobile phase A, 1% acetic acid is used as mobile phase B, and the mobile phase is Gradient elution of phase A and phase B with a ratio of 6-40:94-60, the time of gradient elution and the ratio of mobile phase are: 0-3min, phase A 6%→7%, phase B 94%→93%; 3~6min, phase A 7%→9%, phase B 93%→91%; 6~12min, phase A 9%→12%, phase...

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Abstract

The invention relates to a quality control technology of a Chinese patent drug and in particular relates to a construction of a standard characteristic spectrum of Kangfu tincture and a quality detection method of the Kangfu tincture. The quality detection method of the Kangfu tincture comprises the following steps: preparing and determining a chromatogram of Kangfu tincture to be detected and a chromatogram of a reference substance rutin according to methods of a standard sample solution and a reference substance solution; comparing the chromatogram of the Kangfu tincture to be detected withthe constructed standard characteristic spectrum; if the chromatogram of the Kangfu tincture to be detected has 20 characteristic peaks in the standard characteristic spectrum and a peak correspondingto a reference substance peak is an S peak, calculating relative retention time of each characteristic peak and the S peak; if the relative standard deviation between the relative retention time of each characteristic peak and the relative retention time of each characteristic peak in the standard characteristic spectrum is no more than + / -5 percent, judging that the quality of the Kangfu tincture is qualified; otherwise, judging that the quality of the Kangfu tincture is unqualified, so as to rapidly detect and judge the quality of the Kangfu tincture.

Description

technical field [0001] The invention relates to the technical field of quality control of Chinese patent medicines, in particular to the construction of a standard characteristic map of Kangfu tincture and its quality detection method. Background technique [0002] Kangfu tincture is a Chinese patent medicine that has been on the market for many years. The current implementation standard is the national drug standard WS3-B-2785-97-2016. Kangfu Tincture is composed of three flavors of Rhizoma Polygonum, Capricornus and Menthol. It has the effects of moisturizing skin, relieving itching, killing insects and deodorizing, and can be used for pruritus, eczema, neurodermatitis and other skin pruritus. [0003] As a Chinese patent medicine, Kangfu tincture is the result of the joint action of various active ingredients such as flavonoids, alkaloids and phenolic acids. The research related to the quality control method of Kangfu Tincture in the prior art is as follows: (1) Chinese ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 刘道芳刘海兵田湘玲程济东
Owner ANHUI ANKE YULIANGQING PHARMA