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
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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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