Construction method of characteristic map of Yizhiren formula granules and its quality detection method

A technology of formula granules and characteristic map, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of lack of quality standard Yizhiren formula particles, unstable volatile oil properties, and few Yizhiren formula particles, etc. Monitoring, simple method, good reproducibility

Active Publication Date: 2022-07-05
GUANGDONG YIFANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the nature of the volatile oil of Yizhiren is unstable and volatile, which leads to the loss of most of the preparations during production and storage, which affects the efficacy of the medicine. The content of volatile oil in it, if the content of volatile oil in Yizhiren formula granules is too low, it is difficult to exert the same medicinal effect as traditional Chinese medicine decoction
[0005] At present, there are few researches on the quality of Yizhiren Formula Granules, especially for the detection of its volatile oil, and there is a lack of good quality standards to ensure the stable quality of Yizhiren Formula Granules

Method used

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  • Construction method of characteristic map of Yizhiren formula granules and its quality detection method
  • Construction method of characteristic map of Yizhiren formula granules and its quality detection method
  • Construction method of characteristic map of Yizhiren formula granules and its quality detection method

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Experimental program
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Effect test

preparation example Construction

[0052] Preparation of reference substance solution: take the reference substance of grapefruit ketone and kaempferol, dissolve with solvent to obtain reference substance solution;

[0053] Preparation of the test solution: take Yizhiren formula granules, add an extraction solvent for extraction, filter the extract, and take the subsequent filtrate to obtain the test solution;

[0054] The reference substance solution and the test solution are injected into an ultra-high performance liquid chromatograph for detection. The mobile phase A used by the ultra-high performance liquid chromatograph is acetonitrile, and the mobile phase B is a volume fraction of 0.05% to 0.15%. Formic acid aqueous solution, elution mode is gradient elution.

[0055] In one specific embodiment, the gradient elution includes the following procedures:

[0056] 0 ~ 10min, the volume percentage of mobile phase A increased from 8% to 16%;

[0057] 10-25min, the volume percentage of mobile phase A increased...

Embodiment 1

[0089] This embodiment is a method for constructing a characteristic map of Yizhiren formula granules.

[0090] 1. Chromatographic conditions and system applicability experiment: Chromatographic column: Agilent ZORBAX SB-C18 column, 2.1mm×100mm, 1.8um; acetonitrile is used as mobile phase A, and 0.1 mL of formic acid solution per 100 mL of water is used as mobile phase B , the gradient elution is shown in Table 2; the column temperature is 30°C, the flow rate is 0.3ml / min, the detection wavelength is 254nm, and the number of theoretical plates should not be less than 100,000 calculated according to the yuzuone peak.

[0091] Table 2

[0092] time (minutes) Mobile phase A (%) Mobile phase B (%) 0～10 8～16 92～84 10～25 16～23 84～77 25～35 23～73 77～27 35～38 73～8 27～92

[0093] 2. Preparation of the solution

[0094] Preparation of reference substance solution: take appropriate amount of naringenone and kaempferol reference substance, accura...

Embodiment 2

[0118] The present embodiment is a method for determining the content of yuzuone in Yizhiren formula granules.

[0119] 1. Chromatographic conditions and system applicability experiment: Chromatographic column: Agilent ZORBAX SB-C18 column, 2.1mm×100mm, 1.8um; acetonitrile is used as mobile phase A, and 0.1 mL of formic acid solution per 100 mL of water is used as mobile phase B , the gradient elution is shown in Table 5; the column temperature is 30°C, the flow rate is 0.3ml / min, the detection wavelength is 254nm, and the number of theoretical plates should not be less than 100,000 calculated according to the juvenone peak.

[0120] table 5

[0121] time (minutes) Mobile phase A (%) Mobile phase B (%) 0～10 8～16 92～84 10～25 16～23 84～77 25～35 23～73 77～27 35～38 73～8 27～92

[0122] 2. Preparation of the solution

[0123] Preparation of the reference substance solution of the index components: take about 5 mg of the reference substance o...

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Abstract

The invention relates to a method for constructing a characteristic map of Yizhiren formula granules and a quality detection method thereof. The construction method includes the following steps: preparation of reference substance solution: taking the reference substance of naringenone and kaempferol, adding solvent and dissolving to obtain the reference substance solution; preparation of the test substance solution: taking the formula granules of Yizhiren, adding extraction The solvent is extracted, the extract is filtered, and the subsequent filtrate is taken to obtain the test solution; the reference substance solution and the test solution are injected into the ultra-high performance liquid chromatograph for detection, and the ultra-high performance liquid chromatograph adopts the Mobile phase A is acetonitrile, mobile phase B is formic acid aqueous solution with a volume fraction of 0.05-0.15%, and the elution mode is gradient elution. The feature map constructed by this construction method can reflect the characteristics of Yizhiren formula granules more comprehensively, especially realizes the detection of volatile oil in Yizhiren formula granules, and can well control the quality of Yizhiren formula granules.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine detection, in particular to a method for constructing a characteristic map of Yizhiren formula granules and a quality detection method thereof. Background technique [0002] Alpinia Oxyphylla Miq (Alpinia Oxyphylla Miq) is the dry ripe fruit of the perennial herb of Zingiberaceae. It is used for abdominal pain, vomiting and diarrhea caused by insufficiency of kidney qi and inability to ingest it, eating less and more saliva, etc. Mainly produced in Hainan, Guangdong, Guangxi and other places, it is one of the authentic medicinal materials in Hainan and one of the four major southern medicines. Modern pharmacology shows that Yizhiren has various pharmacological effects, and more and more studies have shown that the main component of Yizhiren that exerts its medicinal effect is volatile oil: for example, Luo Qin and others believe that the volatile oil of Yizhiren It has obvio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679G01N2030/065
Inventor 刘燎原邓颂李燕珍崔婷干丽魏梅程学仁孙冬梅
Owner GUANGDONG YIFANG PHARMA
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