Burned Rhizoma drynariae formula granule characteristic spectrum and establishing method thereof

A technology of feature map and formula granules, applied in the field of feature map and establishment of the formula granules of Rhizoma Drynariae

Active Publication Date: 2016-10-26
SICHUAN NEO GREEN PHARMA TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this document is about the extraction process and content determination of Tanggu Drynaria Formula Granules. The content determination part only measures the content of naringin, and does not control other components. It only measures the content of a certain component, which is specific. Not strong

Method used

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  • Burned Rhizoma drynariae formula granule characteristic spectrum and establishing method thereof
  • Burned Rhizoma drynariae formula granule characteristic spectrum and establishing method thereof
  • Burned Rhizoma drynariae formula granule characteristic spectrum and establishing method thereof

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preparation example Construction

[0027] Preparation of the reference solution Take an appropriate amount of 5-hydroxymethylfurfural, protocatechuic acid, and naringin reference substance, add methanol to make a solution containing 20μg, 80μg, and 60μg per 1ml to obtain the reference solution.

[0028] Preparation of the test solution: Take an appropriate amount of this product, grind it finely, take about 0.2g, accurately weigh it, place it in a stoppered conical flask, accurately add 50ml of methanol, close the plug, weigh it, heat and reflux for 40 minutes, let it cool , Then weigh the weight, use methanol to make up the lost weight, shake well, filter, and take the filtrate to obtain the test solution.

[0029] Determination method: Precisely draw 10μl each of the reference solution and the test solution, inject it into the liquid chromatograph, measure, and record the chromatogram to obtain the characteristic map of the hot dry bone formula particles;

[0030] The chromatographic conditions are: octadecyl silane...

Embodiment 1

[0035] 1. Materials, reagents and instruments

[0036] 1.1 Experimental instrument

[0037] Agilent 1200series high performance liquid chromatograph;

[0038] Chromatographic column: Philomon luna 5u C18(2)4.6*250mm (methodological investigation)

[0039] 1.2 Reagents and reagents

[0040] Methanol is chromatographically pure, water is ultra-pure water, and the rest of the reagents are analytical pure.

[0041] Naringin (Chinese Institute for the Control of Pharmaceutical and Biological Products 110722-201312, content of 94.7%), 5-hydroxymethylfurfural (China Institute for the Control of Pharmaceutical and Biological Products 111626-201509, content of 97.8%), protocatechuic acid (medium inspection 110809-200604),

[0042] Bone-fried dry bone formula granules (batch number: new green 1501087, 1403058, 1408098, 1404042, 1509078, 1404172, 1409058)

[0043] 2. Preparation of test solution

[0044] According to the preparation method of the test product solution in the embodiment, the above bat...

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Abstract

The invention relates to the technical field of pharmaceutical analysis, in particular to a burned Rhizoma drynariae formula granule characteristic spectrum and an establishing method thereof. The establishing method includes that octadecylsilane chemically bonded silica is used as a filling agent, methanol is used as a mobile phase A, a 0.1v/v% phosphoric acid solution is used as a mobile phase B, and gradient elution is performed according to regulations in the following table; detection wavelength is 290 nm, column temperature is 20 DEG C, and flow speed is 1.0ml/min; number of theoretical plates should not be lower than 50000 if being calculated according to naringin peak; six characteristic peaks should be presented in a test piece characteristic spectrum, and relative retention time should be within +/-5% of specified values; the specified values are 0.299 (peak 1), 0.446(peak 2), 0.557(peak 3), 0.579(peak 4), 0.911(peak 5) and 1.00(peak 6). According to characteristics of formula granules, specific identification and multi-component integral quality control are enhanced, and the characteristic spectrum of the variety is established for comprehensive quality control.

Description

Technical field [0001] The present invention relates to the technical field of drug analysis, in particular to a characteristic map of Radix Rhizoma Drynariae formula granule and its establishment method. Background technique [0002] Rhizoma Drynariae is the dried rhizome of the Polypodiaceae Quercus fern, which is used for healing and relieving pain, strengthening the kidney and strengthening bones, and for external use to dispel wind and freckle. The quality standards of this medicinal material and its decoction pieces are included in the 2015 edition of the Chinese Pharmacopoeia. However, there is a lack of corresponding quality standards for the granules of Tanggu Rianbu formula. [0003] At present, there is a publication about the determination method of Tanggu Drynaria Formula Granules in "Optimization of Extraction Process and Content Determination of Tanggu Drynaria Formula Granules", which uses HPLC to determine the content of naringin, the mobile phase methanol-acetic a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 周厚成胡昌江周维李文兵冯健
Owner SICHUAN NEO GREEN PHARMA TECH DEV
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