Method for detecting hairyvein agrimony and preparation and quality control of formula granules of hairyvein agrimony

A quality control method and a technology for formula granules, which are applied in medical preparations containing active ingredients, measuring devices, pharmaceutical formulas, etc., can solve the problems of complex detection methods, etc., and achieve high cream yield, guaranteed effectiveness, and effective control. Effect

Active Publication Date: 2022-05-13
BEIJING KANGRENTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The second problem solved by the present invention is that the existing detection methods need to adopt different chromatographic conditions to detect the composition and content of the flavonoids and lactones active ingredients in Agrimony formula granules respectively, which leads to the problem of complicated detection methods. The invention provides a detection method for the water-soluble components of Agrimony, which can simultaneously achieve the purpose of accurately measuring the components and contents of flavonoids, lactones, and phenolic acids at the same time

Method used

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  • Method for detecting hairyvein agrimony and preparation and quality control of formula granules of hairyvein agrimony
  • Method for detecting hairyvein agrimony and preparation and quality control of formula granules of hairyvein agrimony
  • Method for detecting hairyvein agrimony and preparation and quality control of formula granules of hairyvein agrimony

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Embodiment 1

[0052] The invention discloses a method for detecting Agrimony and Agrimony formula granules, which comprises obtaining a test sample of Agrimony and preparing it into a test solution, and obtaining a characteristic spectrum of the test solution by using high performance liquid chromatography.

[0053] Specifically, the chromatographic conditions of the high performance liquid chromatography in this example are: using octadecyl bonded silica gel as a filler (column length is 100 mm, column inner diameter is 2.1 mm, particle size is 1.8 μm), and acetonitrile Be mobile phase A, use 0.2% phosphoric acid solution as mobile phase B, carry out gradient elution according to the provisions in Table 1; the flow rate is 0.4ml per minute; the column temperature is 35°C; the detection wavelength is 254nm. The number of theoretical plates should not be less than 3000 based on the peak of protocatechuic acid.

[0054] Table 1

[0055]

[0056] Preparation of reference solution: Take 1.0...

Embodiment 2

[0063] A method for preparing Agrimony formula granules, comprising: taking 6600g Agrimony decoction pieces, extracting twice, decocting for the first time, adding 15 times the amount of water, boiling (100° C.) for 1.5 hours; second decocting, adding 12 times the amount of water, boiling (100 ℃) extraction for 1.5 hours; filter while it is hot with a 150-mesh filter cloth, combine the two filtrates, and concentrate the filtrate under reduced pressure at 70°C to a density of 1.20-1.30 (60°C); carry out belt drying of the above-mentioned concentrated extract, and set the drying temperature Set the temperature below 100°C and pulverize to obtain extract powder; the above extract powder is added with appropriate amount of maltodextrin, and dry granulated to make 1000g; the packaging specification is 2g / bag full aluminum film, 100g / bottle, 250g / bottle , sealed storage.

[0064] In this example, 17 batches of Agrimony decoction pieces and the formula granules prepared therefrom wer...

Embodiment 3

[0068] A method for quality control of Agrimony formula granules, comprising obtaining the characteristic spectrum of Agrimony formula granules, the characteristic spectrum at least includes the corresponding In the characteristic spectrum of Agrimony formula granules, the characteristic peaks of protocatechuic acid, ellagic acid, isoquercitrin, quercetin and quercetin are peak 1-peak 5 respectively, and isoquercetin The characteristic peak where dermatosin is located is the reference peak S 1 , the peak 2 and the reference peak S 1 The relative retention time of quercetin is 0.94 ± 0.09; peak 6 is also included in the characteristic spectrum, and the characteristic peak where quercetin is located is the reference peak S 2 , peak 6 and reference peak S 2 The relative retention time is 1.02±0.1. Obtain the ratio of the peak area of ​​peak 2 to the total peak area of ​​the six characteristic peaks, and the ratio should not be lower than 0.26; the content of protocatechuic aci...

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Abstract

The invention provides a hairyvein agrimony detection method and a preparation and quality control method of hairyvein agrimony formula granules, and solves the problem that the content of main components of the hairyvein agrimony formula granules is inconsistent with that of main components of traditional Chinese medicine standard decoction. The quality control method of the hairyvein agrimony formula granules provided by the invention comprises the following steps: acquiring a characteristic chromatogram of the hairyvein agrimony formula granules, and the characteristic chromatogram at least comprises chromatographic peaks corresponding to protocatechuic acid, ellagic acid, isoquercitrin, quercitrin and quercetin. The characteristic spectrum comprises a peak 1 and a peak 5, the characteristic peaks of protocatechuic acid, ellagic acid, isoquercitrin, quercitrin and quercetin are respectively a peak 1 to a peak 5, the characteristic spectrum further comprises a peak 6, the peak of quercetin is taken as a reference peak S2, and the relative retention time of the peak 6 and the reference peak S2 is 1.02 +/-0.1. According to the method, the common control of active ingredients such as flavonoids and phenolic acids is realized, the overall quality control of the hairyvein agrimony formula granules is realized, and the effects of accurately, objectively and effectively controlling the quality of the hairyvein agrimony formula granules and ensuring the effectiveness of clinical medication are achieved.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicine detection and quality control, in particular to a method for the detection of Agrimony and the preparation and quality control of its formula granules. Background technique [0002] Agrimonia is the dry aerial part of Agrimonia pilosa Ledeb., a plant in the Rosaceae family. Have astringent to stop bleeding, cut off malaria, stop dysentery, detoxify, the effect of tonifying deficiency. It has pharmacological effects such as antiarrhythmia, anticoagulant and antithrombotic, antitumor, anti-inflammatory and analgesic, lowering blood sugar, lowering blood pressure, and enhancing the body's immune function. Clinically, it is mainly used for the treatment of hemostasis, anti-tumor, urinary, respiratory, digestive system diseases and gynecological diseases. Agrimony contains volatile oils, trace elements, agrimonin, agrimones, tannins, sterols, organic acids, phenolic acids, flavonoids, poly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/86G01N30/06A61K36/73A61K9/16
CPCG01N30/8631G01N30/06A61K36/73A61K9/16A61K2236/331A61K2236/39A61K2236/51Y02A50/30
Inventor 张志强沈建梅马智玲杜微波王晓亚
Owner BEIJING KANGRENTANG PHARMA
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