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Quality control method for effective parts of pomelo flavedo and pomelo flavedo preparation

A quality control method and technology of effective parts, which can be used in measuring devices, instruments, scientific instruments, etc., can solve the problems of not representing the overall efficacy of traditional Chinese medicine preparations, reducing the accuracy and specificity of identification, and unable to solve the problems of adulteration of counterfeit products. Quick operability, avoid product counterfeiting, and advanced methods

Inactive Publication Date: 2013-10-23
SUN YAT SEN UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Traditional Chinese medicine emphasizes the role of the whole, and most of it is not aimed at a certain target, nor is it a simple addition of several components. The detection of only a single component reduces the accuracy and specificity of identification, and cannot represent the overall efficacy of traditional Chinese medicine preparations. Its inherent quality cannot solve the problems such as adulteration of counterfeit products

Method used

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  • Quality control method for effective parts of pomelo flavedo and pomelo flavedo preparation
  • Quality control method for effective parts of pomelo flavedo and pomelo flavedo preparation
  • Quality control method for effective parts of pomelo flavedo and pomelo flavedo preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1 Instruments and reagents

[0026] 1.1 Instrument: high performance liquid chromatography (Dionex Ultimate 3000); chromatographic column: ZORBAX Eclipse Plus C 18 , 4.6 mm × 250 mm, 5 μm.

[0027] 1.2 Test drug:

[0028] 1.2.1 Reference substances and reference medicinal materials: naringin (for content determination, China Institute for the Control of Pharmaceutical and Biological Products, batch number 110722-200309); new eriocitrin (Sigma-Alkrich company, batch number: 1326322, purity: 98.6% ); Rhodorin (Sigma-Alkrich company, batch number: 023H0743, purity: 99.0%); hesperidin hydrate (prepared by Guangzhou Modern Chinese Medicine Quality Research and Development Center, confirmed by UV, IR, MS, NMR spectrum, purity: 98.5%); prunin (ChromaDex, Canada, purity>98%); 7-(2''-α-rhamnosyl-6''-(3''''-hydroxy-3''''- Methylglutaryl)-β-D-glucosyl)naringenin (prepared by Guangzhou Modern Traditional Chinese Medicine Quality Research and Development Center, confirmed by UV,...

Embodiment 2

[0063] 1 Instruments and reagents

[0064] 1.1 Instrument: high performance liquid chromatography (Dionex Ultimate 3000); chromatographic column: ZORBAX Eclipse Plus C 18 , 4.6 mm × 250 mm, 5 μm.

[0065] 1.2 Test drug: 10 batches of the active part of Huajuhong or its capsules, developed and produced by Guangzhou Modern Chinese Medicine Quality Research and Development Center. The methanol used in the liquid chromatography in the experiment is chromatographically pure, the rest of the reagents used are analytically pure, and the water is ultrapure water.

[0066] 2. Method and Results

[0067] 2.1 Preparation of the test solution: Take 0.25g of the active part powder, accurately weigh it, put it in a 100ml measuring bottle, add an appropriate amount of methanol for ultrasonic treatment (power 360W, frequency 35kHz) for 15 minutes, add methanol to dilute to the mark, and shake well. Filter through a 0.45 μm microporous membrane as the test solution.

[0068] 2.2 Preparat...

Embodiment 3

[0109] Sample detection: take the following different sources of the citrus red medicinal material to prepare the effective part or its preparation sample as the test sample test set, prepare the operation according to the method under "Preparation of the test sample solution", inject the sample, and detect the fingerprint. Using the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System 2009 Edition" for evaluation, the results show that: Huazhou pomelo (produced in Guangdong) and the control fingerprint similarity is greater than 0.90; Shatian pomelo (produced in Guangxi), Meizhou pomelo (produced in Guangdong), The similarities between the three batches of test product solutions from pomelo (produced in Fujian) and the control fingerprints were all less than 0.90. The similarity results are shown in Table 19:

[0110] Table 19 Test set sample similarity results

[0111]

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Abstract

The present invention discloses a quality control method for effective parts of pomelo flavedo and a pomelo flavedo preparation. According to the present invention, a methanol solution containing neoeriocitrin, prunin, naringin, rhoifolin, meranzin hydrate, 7-(2''-alpha-rhamnose-6''-(3''''-hydroxy-3''-methylglutaryl)-beta-D-glucosyl)naringenin, and naringenin is used as a reference; a methanol extract of pomelo flavedo effective parts or the pomelo flavedo preparation is used as a test sample; in particular chromatographic conditions, the high performance liquid chromatographic (HPLC) fingerprint analysis method is used to establish fingerprints and control fingerprints of a reference HPLC and a test sample HPLC, whether a drug is qualified is determined by comparing peaks of the test sample with corresponding peaks of the reference, and similarity evaluation results with the control fingerprint; and contents of various active ingredients in the test sample are simultaneously determined by a method of multi-component quantitive by one marker, and the quality of the drug is evaluated according to the contents of the active ingredients. The method can achieve scientific, comprehensive, rapid and accurate monitoring of the quality of effective parts and the preparation in production. The production process stability is controlled, the quality is ensured to be stable, uniform and controllable, and the method has the advantages of being advanced, good stability and reproducibility, and high operability.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine analysis. Specifically, it relates to a quality control method for the effective part of Huajuhong and the active ingredients of its preparation. Background technique [0002] Huajuhong is a characteristic traditional Chinese medicine in Lingnan, which was recorded in the 2010 edition of "Pharmacopoeia of the People's Republic of China" (Part One). Huajuhong is the dry young fruit or dry outer pericarp of Citrus grandis (L.) Osbeck and its cultivar Huazhou pomelo Citrus grandis ‘Tomentosa’. It has the effects of regulating qi and widening the middle, drying dampness and resolving phlegm. It is used to treat cough with excessive phlegm, food accumulation and alcohol injury, vomiting and nausea. [0003] According to the Flora of China, Huazhou pomelo is a cultivated variety of pomelo. Most of the orange medicinal materials on the market today are mainly sourced from pomelo. ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 彭维苏薇薇邹威刘孟华朱芳绘王永刚李沛波
Owner SUN YAT SEN UNIV
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