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Method for detecting exocarpium citrus grandis Tanke compound

A detection method and technology for phlegm cough with orange red, applied in the field of analysis and detection, can solve the problems of poor specificity, imperfect quality standards, inconvenient quality management work, etc., achieve good reproducibility and feasibility, improve quality control level, improve quality The effect of the control system

Active Publication Date: 2015-08-19
GUANGZHOU XIANGXUE PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current quality standards for Juhong Tanke Decoction and Juhong Tanke Granules only have simple physical and chemical identification items, which have poor specificity and cannot effectively control product quality
Although the orange red phlegm and cough liquid has specific thin-layer chromatography identification and single component content determination items, the sample processing methods, detection methods and content limits of the two dosage forms are different, and the orange red phlegm and cough liquid (sucrose-free type) was tested simultaneously The TLC identification of Huajuhong and Baibu, while Juhong phlegm and cough liquid (with sugar) only conducts TLC identification of Huajuhong medicinal materials
[0004] At present, the orange red phlegm and cough series preparations lack comprehensive quality control methods, and the current quality standards are imperfect and inconsistent, which brings a lot of inconvenience to the quality management work

Method used

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  • Method for detecting exocarpium citrus grandis Tanke compound
  • Method for detecting exocarpium citrus grandis Tanke compound
  • Method for detecting exocarpium citrus grandis Tanke compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 The construction of the standard fingerprint of Juhongtanke preparation

[0041] 1 Instruments and reagents

[0042] 1.1 Instrument

[0043] The high-performance liquid chromatograph is a Waters Alliance HPLC system, and the chromatographic column is a C18 chromatographic column (5 μm, 4.6 mm×250 mm).

[0044] 1.2 Reagents

[0045] Acetonitrile, methanol, formic acid, and glacial acetic acid are chromatographically pure; water is ultrapure; other reagents are analytically pure.

[0046] 1.3 Reagent

[0047] The 21 batches of orange red phlegm and cough liquid (sucrose-free type) were all produced by Huazhou Traditional Chinese Medicine Factory, a subsidiary of Guangzhou Xiangxue Pharmaceutical Co., Ltd.

[0048] 2. Methods and results

[0049] 2.1 Preparation of the test solution

[0050] Precisely measure 5ml of the test sample, add methanol equivalent to 10 times the amount of the test sample, ultrasonically treat for 30min, filter through a 0.22μm mic...

Embodiment 2

[0093] The multi-component content detection method of embodiment 2 orange red phlegm cough preparation

[0094] 1 Instruments and reagents

[0095] 1.1 Instrument

[0096] The high-performance liquid chromatograph is a Waters Alliance HPLC system, and the chromatographic column is a Waters X-Bridge C18 column (4.6mm×250mm, 5 μm).

[0097] 1.2 Reagents

[0098] Acetonitrile, methanol, formic acid, and glacial acetic acid are chromatographically pure; water is ultrapure; other reagents are analytically pure.

[0099] 1.3 Reagent

[0100] 1.3.1 Reference substance

[0101] The reference substances of naringin and rhubaricin were purchased from China Institute for the Control of Pharmaceutical and Biological Products.

[0102] 1.3.2 Test product

[0103] 12 batches of orange red phlegm and cough liquid products were produced by Huazhou Traditional Chinese Medicine Factory under Guangzhou Xiangxue Pharmaceutical Co., Ltd.

[0104] 2 Methods and results

[0105] 2.1 Prepara...

Embodiment 3

[0140] Determination of multiple active ingredients in the sucrose-free orange-red phlegm and cough liquid in embodiment 3

[0141] 1 Instruments and reagents

[0142] 1.1 Instrument

[0143] The high-performance liquid chromatograph is a Waters Alliance HPLC system, and the chromatographic column is a Waters X-Bridge C18 column (5 μm, 4.6 mm×250 mm).

[0144] 1.2 Reagents

[0145] Acetonitrile, methanol, and glacial acetic acid are chromatographically pure; water is ultrapure; other reagents are analytically pure.

[0146] 1.3 Reagent

[0147] 1.3.1 Reference substance

[0148] The reference substances of naringin, rhoglutinin, amygdalin and schisandrin A were purchased from China National Institute for the Control of Pharmaceutical and Biological Products. Hesperidone hydrate and isohesperidone were purchased from Shanghai Yuanye Biotechnology Co., Ltd.

[0149] 1.3.2 Test product

[0150] Sucrose-free orange phlegm and cough liquid (batch number: 20141118) is produce...

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Abstract

The invention discloses a method for detecting an exocarpium citrus grandis Tanke compound. The method comprises an exocarpium citrus grandis Tanke compound fingerprint spectrum and multi-component content determination detection methods. An HPLC fingerprint spectrum detection method comprises the following steps: (1) preparing a test solution; and (2) determining, namely precisely sucking the test solution, injecting into a high performance liquid chromatograph for determination to obtain a fingerprint spectrum of the exocarpium citrus grandis Tanke compound. According to the method, the one-sidedness that a single chemical component is quantitatively controlled in the existing quality standard, the inherent quality of the product can be effectively represented, a scientific method for comprehensively evaluating the exocarpium citrus grandis Tanke compound is provided and a quality control system can be further improved.

Description

technical field [0001] The invention relates to the technical field of analysis and detection, in particular to a detection method for an orange red phlegm cough preparation. Background technique [0002] Juhong phlegm and cough preparation is made of 8 traditional Chinese medicines such as Huajuhong, Bitter Almond, Pinellia (made) or Shui Pinxia, ​​Mibabu, Baiqian, Poria, Schisandra and Licorice, etc., and is refined by modern preparation technology. It is a class A non-prescription drug for cough, suitable for the treatment of acute tracheo-bronchitis, acute exacerbation of chronic bronchitis, pharyngitis, cold and other diseases. Cited from the "Erchen Decoction" in the "Taiping Huimin Heji Bureau Prescription" in the Song Dynasty, the orange red phlegm and cough prescription reuses the authentic and precious Chinese medicinal material "Huajuhong" in southern China, and adds bitter almonds, Baiqian, Baibu, and Schisandra. It is a representative prescription for warming a...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 王艳慧黄洁文邱少鹏江晓伍军连林生张健
Owner GUANGZHOU XIANGXUE PHARMA CO LTD
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