Preparation method and quality control method of hamamelidaceae semiliquidambar cathayensis formula granules
A quality control method and technology for formula granules, which can be applied to pharmaceutical formulas, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of uneven quality of Banfenghe formula granules, etc. The effect of mass production, scientific production and easy storage
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0024] Preparation of Banfenghe formula granules:
[0025] (1) Weigh raw materials: 10980g of Banfenghe decoction pieces;
[0026] (2) Put the Banfenghe decoction pieces into the extraction tank, decoct twice, add 8 times the water of the decoction pieces for the first time, decoct for 2 hours, add 7 times the water of the decoction pieces for the second time, decoct for 1 hour, and the liquid Filtrate, combine the filtrates, pump them into the concentration tank, concentrate (the steam pressure is between 0.04-0.09Mpa, the vacuum degree is -0.04-0.08MPa), and concentrate to the extract with a relative density of 1.05-1.07 (80°C). Pass through a 200-mesh sieve and set aside;
[0027] (3) Take the extract obtained in step 2, add 0.33g 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 paste powder obtained in step 3,...
Embodiment 2
[0030] Quality control method for TLC identification of Banfenghe formula granules:
[0031] (1) Take 1g of Banfenghe formula granule powder, add 30ml of absolute ethanol, reflux in water bath for 30 minutes, filter, evaporate the filtrate to dryness, add 1ml of ethyl acetate-ethanol (2:1) to dissolve the residue, and use it as the test sample solution, spare;
[0032] (2) Take 10g of Banfenghe reference medicinal material, add 100ml of water, boil for 30 minutes, filter, evaporate the filtrate to dryness, add 30ml of absolute ethanol to the residue, and make a control solution in the same way as step 1, and set aside;
[0033] (3) Referring to the "Chinese Pharmacopoeia" 2015 edition of the fourth general rule 0502 thin-layer chromatography test, draw 1 µl of the test solution and 10 µl of the control solution of Fenghe, and respectively spot on the same silica gel GF 254 On a thin-layer plate, develop with toluene-ethyl acetate-formic acid (7:5:0.4) as the developing solven...
Embodiment 3
[0036] Determination of moisture, particle size, solubility, loading difference and extracts in Banfenghe formula granules:
[0037] The moisture, particle size, solubility, and extracts in the 6 batches of Banfenghe formula granules prepared by the above method were detected. 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 determination 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 2.8 qualified qualified qualified 50.4 2 4.3 qualified qualified qualified 67.0 3 3.4 qualified qualified qualified 60.4 4 3.5 qualifi...
PUM
Login to View More Abstract
Description
Claims
Application Information
Login to View More