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Quality detection method and production method of radix puerariae decoction established based on fingerprint spectrum

A quality detection method and fingerprint technology, which is applied in the field of preparation technology of Baihe Dihuang Tang solid preparation, to achieve the effect of improving detection stability and avoiding waste

Active Publication Date: 2021-06-29
广东志道医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, more technical obstacles are brought to the establishment of the fingerprint detection method of Pueraria decoction

Method used

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  • Quality detection method and production method of radix puerariae decoction established based on fingerprint spectrum
  • Quality detection method and production method of radix puerariae decoction established based on fingerprint spectrum
  • Quality detection method and production method of radix puerariae decoction established based on fingerprint spectrum

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] The determination of the optimization condition of embodiment 1, fingerprint chromatogram

[0068] Based on the quality control of the Gegentang granule preparation process based on fingerprints, the following steps were explored:

[0069] Group experiment 1.1 Chromatographic conditions and system suitability pre-test:

[0070] 1.1 Chromatographic column selection: Since puerarin, the component to be tested, is a flavonoid component, a chromatographic column with octadecylsilane bonded silica gel as a filler is selected. The chromatographic columns used in this test are: A is Agela Venusil MPC18 (4.6×250mm, 5μm); B is Phenomenex Gemini C18 (4.6×250mm, 5μm); C is: Techway JADE-PAK ODS-AQ (4.6×250mm, 5μm).

[0071] 1.2 Detection wavelength selection:

[0072] Take the puerarin reference substance, dissolve it in methanol, perform UV scanning in the range of 200-400nm, and record the UV scanning spectrum. For the results, please refer to figure 1 , figure 1 It is th...

Embodiment 2

[0102] Embodiment 2: carry out verification and sample detection to the determined standard fingerprint model;

[0103] 2.1 Verify the accuracy of the standard fingerprint model

[0104] Precisely weigh 19.70 mg of puerarin reference substance (batch number: 110752-201514, purity 95.5%, China National Institute for Food and Drug Control), add methanol to dissolve and dilute to 20 ml to obtain a reference substance stock solution with a concentration of 0.9408 mg / ml I. Precisely measure 0.5ml, 1.0ml and 1.5ml of reference substance stock solution I, place in a stoppered conical flask, accurately weigh 0.1g of the test product of known content (lot number: 20200220, content 9.6mg / g), place In the above-mentioned conical flask, measure the content according to the proposed content determination method, calculate the recovery rate of puerarin is 100.0%, RSD=0.80% (n=9), the results are shown in Table 1:

[0105] Table 1 Test results of sample addition recovery rate of Gegentang ...

Embodiment 3

[0123] Example 3. Explore and screen different extraction solvents (ie, extraction agents):

[0124] 3.1. Instruments and reagents

[0125] 3.1.1 Instruments

[0126] Thin-layer automatic imager (CAMAG TLC VISUALIZER2, CAMAG, Switzerland), thin-layer heating plate (CAMAG TLC PLATE HEATERⅢ, CAMAG, Switzerland), electronic balance (METTLER ME2002E, METTLER TOLEDO Instruments (Shanghai) Co., Ltd.) , electronic balance (METTLER MS 204TS, METTLER TOLEDO Instruments (Shanghai) Co., Ltd.), ultrasonic cleaner (KQ-300DE, Kunshan Ultrasonic Instrument Co., Ltd.), medical centrifuge (Xiangyi H1850 Hunan Xiangyi Laboratory Instrument Development Co., Ltd.), constant temperature water bath (HWS-26 type), plane chromatographic spotter (SPDY-1A, Nanjing Microlite Scientific Instrument Co., Ltd.), silica gel G thin-layer prefabricated plate (Qingdao Ocean Chemical Factory), Silicone G thin-layer prefabricated board (Merck, Germany).

[0127] 3.1.2 Reagents and reagents

[0128] Pueraria r...

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Abstract

The invention provides a production method of radix puerariae decoction established based on a simplified fingerprint spectrum, which comprises the following steps: exploring a fingerprint chromatography system with optimal chromatographic parameters by using a test sample in advance, then testing a standard control sample of a single medicine by using the chromatography system, exploring and determining fingerprint peaks of a small amount of specific components at one time, and determining the content of the specific components according to the fingerprint peaks. Therefore, a simplified qualitative and quantitative fingerprint model is established. The simplified fingerprint model can be used for preliminarily and qualitatively screening radix puerariae soup products with unqualified quality, and can be used for carrying out quantitative analysis on qualified products. Then comprehensive analysis is carried out on qualified products in combination with a more comprehensive thin-layer chromatography identification method. The method has the technical effects that the quality detection process is simplified, the effect of accurate quantitative analysis is reserved, and the detection efficiency is improved.

Description

technical field [0001] The invention relates to a quality control method for a preparation process of Gegen Decoction, in particular to a preparation process of a solid preparation of Baihe Dihuang Decoction. Background technique [0002] Gegen Decoction comes from Zhang Zhongjing's "Treatise on Febrile Diseases" in the Han Dynasty. The current standard of Gegen Tang granules is included in the 2015 edition of the Chinese Pharmacopoeia, which is used for colds and colds. Symptoms include: fever and aversion to cold, nasal congestion and runny nose, cough and throat itching, expectoration of thin and white phlegm, no sweat, headache and body pain, neck and back Strong urgency and discomfort, thin white or thin white fur, floating or tight pulse. [0003] Gegen Decoction is derived from the classic prescriptions of traditional Chinese medicine, including 60g of kudzu root, 45g of ephedra, 30g of cassia twig, 45g of ginger, 30g of licorice root, 30g of red peony root, 45g of j...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86G01N30/90
CPCG01N30/02G01N30/06G01N30/8686G01N30/90
Inventor 龙飞方铁铮杨亮姚振弘罗莉妮陈文记丁远杰杨凯
Owner 广东志道医药科技有限公司