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A characteristic map of drynaria rhizome formula granules and its establishment method
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A technology of formula granules and characteristic maps, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as lack of specificity, and achieve the effect of strong specificity
Active Publication Date: 2018-08-17
SICHUAN NEO GREEN PHARMA TECH DEV
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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
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[0027] Preparation of reference solution: Take an appropriate amount of 5-hydroxymethylfurfural, protocatechuic acid, and naringin reference substances, add methanol to make solutions containing 20 μg, 80 μg, and 60 μg per 1 ml, respectively, 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, put it in a stoppered Erlenmeyer flask, accurately add 50ml of methanol, seal it tightly, weigh it, heat and reflux for 40 minutes, let it cool , and then weighed, make up the lost weight with methanol, shake well, filter, take the filtrate to obtain the test solution.
[0029] Determination method Precisely draw 10 μl each of the reference substance solution and the test solution, inject it into the liquid chromatograph, measure, record the chromatogram, and obtain the characteristic spectrum of the drynariarhizome formula particles;
[0030] The chromatographic co...
Embodiment 1
[0035] 1. Materials, reagents and instruments
[0036] 1.1 Experimental Instruments
[0037] Agilent 1200series high performance liquid chromatograph;
[0038] Chromatographic column: Phenomenon luna 5u C18(2) 4.6*250mm (methodological investigation)
[0039] 1.2 Reagents and reagents
[0040] Methanol was chromatographically pure, water was ultrapure water, and other reagents were analytically pure.
[0041] Naringin (National Institute for the Control of Pharmaceutical and Biological Products 110722-201312, the content is 94.7%), 5-hydroxymethylfurfural (National Institute for the Control of Pharmaceutical and Biological Products 111626-201509, the content is 97.8%), protocatechuic acid (China Institute 110809-200604),
[0042] Hot bone drynaria formula granules (batch number: new green 1501087, 1403058, 1408098, 1404042, 1509078, 1404172, 1409058)
[0043] 2. Preparation of the test solution
[0044] According to the preparation method of the test solution in the embo...
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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 invention relates to the technical field of drug analysis, in particular to a characteristic map of drynariarhizome formula granules and a method for establishing the same. Background technique [0002] Rhizoma Rhizoma Rhizoma Rhizoma Drynariae is the dried rhizome of Quercus fern in the family of Rhizomes. However, there is a lack of corresponding quality standards about the Tanggu drynaria formula granules. [0003] At present, there is "Extraction Process Optimization and Content Determination of Tanggu Drynaria Formula Granules" published about the assay method of Drynariae Formula Granules, which adopts HPLC to measure the content of naringin, mobile phase methanol-acetic acid-water (35 :4:65), the detection wavelength is 283nm. Results: The optimal extraction process was soaking for 0.5h, adding 10.8 times the amount of water and extracting twice, 0.5h each time; the mass fraction of naringin was 0.77%, and the paste yield was 12.6%. Nari...
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