Preparation method of Polygonum chinense formula particles and quality control method thereof
A quality control method and technology for formula granules, which are applied in pharmaceutical formulas, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Large-scale production, easy to take, scientific effect of production
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Embodiment 1
[0024] Preparation of Fotan Mother Formula Granules:
[0025] (1) Weigh raw materials: 5760g of hot charcoal mother decoction pieces;
[0026] (2) Put the decoction pieces of Huo Tan mother into the extraction tank, decoct twice, add water 8 times the amount of the decoction pieces for the first time, decoct for 1 hour, add 7 times the amount of water for the second time, decoct for 1 hour, and filter the liquid medicine After passing, the filtrates are combined, pumped into the concentration tank, concentrated (vapor pressure is between 0.04-0.09Mpa, vacuum degree -0.04-0.08MPa), concentrated to an extract with a relative density of 1.07-1.09 (80°C), while hot Pass through a 200-mesh sieve and set aside;
[0027] (3) Take the extract obtained in step 2, add 0.17g of maltodextrin, mix well, heat to 70°C, spray dry (control the inlet air temperature at 175-185°C, and the outlet air temperature at 85-95°C), and collect the dry paste powder ,spare;
[0028] (4) Grind the dry p...
Embodiment 2
[0030] Quality control method for TLC identification of Fotan mother formula granules:
[0031] (1) Take 1g of Fotan mother formula granule powder, add 20ml of methanol (containing 1ml of hydrochloric acid), reflux extraction for 2 hours, filter, evaporate the filtrate to dryness, add 20ml of ether to dissolve the residue, shake and extract for 30 minutes, and evaporate the ether extract to dryness , the residue was dissolved in 2ml of diethyl ether, used as the test solution, and set aside;
[0032] (2) Take 5g of coarse powder of Fotan mother pair, add 50ml of water, boil for 40 minutes, filter, evaporate the filtrate to dryness, add 20ml of methanol (containing 1ml of hydrochloric acid) to the residue, and make a control solution in the same way as in step 1, and set aside;
[0033] (3) Referring to the "Chinese Pharmacopoeia" 2015 edition of the fourth general rule 0502 thin-layer chromatography test, absorb 10 µl each of the test solution and the control solution of Fotan...
Embodiment 3
[0036] Determination of moisture, particle size, solubility, loading difference and extractables in Fotan mother formula granules:
[0037] The moisture, particle size, solubility, and leaching substances in the finished products of 6 batches of Fotan mother formula granules prepared by the above method were tested. Water content, solubility, and loading differences are tested by conventional methods. The extract was determined according to the hot soak method under the alcohol-soluble extract test method ("Chinese Pharmacopoeia" 2015 edition four general rules 2201), using 70% ethanol as solvent. The inspection results are shown in Table 1, indicating that all indicators meet the standards.
[0038] Table 1 Various test results
[0039] batch number moisture Solubility Loading difference granularity Leachate 1 3.1 qualified qualified qualified 42.1 2 3.3 qualified qualified qualified 47.0 3 4.0 qualified qualified quali...
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