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

Inactive Publication Date: 2019-07-09
安徽济人药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no unified standard, and all manufacturers are based on enterprise standards for production and quality control, resulting in uneven quality of Fotan mother formula granules

Method used

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  • Preparation method of Polygonum chinense formula particles and quality control method thereof
  • Preparation method of Polygonum chinense formula particles and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

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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Abstract

The invention discloses a preparation method of Polygonum chinense formula particles and a quality control method thereof. The Polygonum chinense formula particles are prepared by adopting Polygonum chinense tablets as raw materials through two-time water extraction, vacuum concentration, spray drying, dry method pelletization and other technologies. The equivalent crude drug amount of each gram of Polygonum chinense formula particles is 16-17 g, and the Polygonum chinense formula particles are subjected to quality identification by adopting the thin layer chromatography. On the basis of traditional Chinese medicine soap, by combining a modern high-tech extracting device, the pharmacy technology and the thin layer scanning technology, referring to the Polygonum chinense chemical ingredientresearch, extracting technology research and thin layer chromatography identifying method research are performed on Polygonum chinense, and the Polygonum chinense formula particles for direct dissolution before clinics can be obtained. The particles can achieve full-component extraction, production is scientific, the quality is controllable, and large-scale production can be achieved. The particles have the advantages of being convenient to use, sanitary and convenient to store.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine products, in particular to a preparation method and a quality control method of Huo Tan mother formula granules. Background technique [0002] Fotanmu, sour in nature and flavor, sweet and cold, has the effects of clearing heat and dampness, cooling blood and detoxifying, and is used for damp-heat diarrhea, dysentery, jaundice, and sore throat. [0003] Fotanmu is mostly used as medicine in decoction pieces and decocted before use. The quality of the decoction pieces is unstable and uncontrollable, and the quality of decoction is difficult to guarantee. It is inconvenient to take and difficult to store. Traditional Chinese medicine formula granules are a series of products made of high-quality medicinal materials (Chinese herbal decoction pieces) that meet the processing specifications, extracted, concentrated, and granulated by modern high-tech to ensure the original characte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/704A61K9/16A61K47/36A61P1/12A61P1/16A61P11/04G01N30/90G01N30/95
CPCA61K9/1652A61K36/704A61K2236/331A61K2236/39A61K2236/51A61P1/12A61P1/16A61P11/04G01N30/90G01N30/95
Inventor 朱月信陈培胜成守玲孟繁民
Owner 安徽济人药业股份有限公司
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