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Fringed pink formula granule quality control method

A quality control method and technology for formula granules, which are applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as the influence of the quality of Qumai formula granules, and achieve the effects of improving the yield of paste, increasing the amount of leaching, and ensuring stability.

Active Publication Date: 2021-12-07
BEIJING KANGRENTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And the inventor finds that in fact different raw materials will also have a great impact on the quality of Qumai formula granules

Method used

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  • Fringed pink formula granule quality control method
  • Fringed pink formula granule quality control method
  • Fringed pink formula granule quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The invention discloses a quality control method of Qumai formula granules, which uses different batches of Qumai decoction pieces to prepare Qumai formula granules. The preparation process is as follows:

[0039] Take an appropriate amount of Qumai decoction pieces, decoct twice, add 15 times of water to the first decoction, boil for 1 hour, add 13 times of water for the second decoction, boil for 1 hour, filter, and concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.00-1.05 pure extract, spray-dried with 10% dextrin, or 1% SiO 2Spray drying, or belt drying with 0% excipients into fine powder, adding appropriate amount of dextrin, dry granulation, packaging specifications are 1g / bag composite film, 100g / bottle, 250g / bottle, sealed storage.

[0040] 1. Calculate the ratio of the peak area of ​​the specified value of 1.06 to the peak area of ​​the reference peak S and the similarity of the characteristic spectrum of Qumai formula granules...

Embodiment 2

[0073] In this embodiment, conventional methods are used to verify the precision, repeatability and stability of the characteristic map, as follows:

[0074] Take 6 parts of the test solution, obtain its characteristic spectrum, calculate the similarity with the reference material of the control medicinal material, and calculate the RSD. Results The similarities between the characteristic spectra of the 6 test product solutions and the reference materials of the control medicinal materials were between 0.850 and 0.851, both were greater than 0.80, and the RSD was 0.1%, which indicated that the characteristic spectra had good repeatability.

[0075] Using Waters UPLC H-Class, PDA detector, take the test solution, obtain its characteristic spectrum, calculate the similarity with the control medicinal material reference substance, and calculate the RSD. Results Among the characteristic maps obtained by Waters UPLC H-Class and PDA detector, the similarity between each characterist...

Embodiment 3

[0078] This embodiment provides the process of verifying the accuracy, intermediate precision, repeatability and stability of the total flavonoid content detection method, as follows:

[0079] Accuracy: Accurately weigh 10.558mg of rutin reference substance, put it in a 500ml volumetric flask, add 50% ethanol to set the scale, shake well, and set aside. Take a sample with a known content under the repeatability item, grind it finely, take about 0.05g, and accurately weigh it, a total of six parts, accurately add 50ml of rutin reference solution (19.553μg / ml) to each sample, and then accurately add 50 % ethanol 50ml, measure the absorbance of solution by above-mentioned preferred method, and calculate the content of total flavonoids. Results The measured recoveries ranged from 92.50% to 97.62%, the average recovery rate was 95.1%, and the RSD value was 2.0%, which met the recovery requirements of methodological verification, indicating that the results measured by this method w...

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Abstract

The invention provides a fringed pink formula granule quality control method which comprises the following steps: obtaining a characteristic spectrum of a test sample by adopting a high performance liquid chromatography, and marking at least two characteristic peaks in the characteristic spectrum; the labeling rule being as follows: taking the characteristic peak of the cowherb seed flavonoid glycoside as a reference peak S, the relative retention time of the other characteristic peak being within + / -10% of a specified value, and the specified value being 1.06; using the dianthus superbus decoction pieces as a test sample to obtain a characteristic chromatogram of the dianthus superbus decoction pieces, calculating the ratio of the peak area with the specified value of 1.06 in the characteristic chromatogram to the peak area of a characteristic peak of a reference peak S, and using the dianthus superbus decoction pieces with the ratio of 2-5.2 as raw materials of the dianthus superbus formula granules. The method has the advantages that the extract yield and the extract amount of the fringed pink formula granules are effectively increased, and the stability of the total flavonoid content can be guaranteed.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicine preparation, in particular to a quality control method for Qumai formula granules. Background technique [0002] Qumai is a perennial herb of Caryophyllaceae, and its dry aerial parts are used as medicine. Qumai is bitter in taste, cold in nature, enters the heart and small intestine meridians, and has the effects of diuretic and relieving stranguria, promoting blood circulation and stimulating menstruation. For hot stranguria, bloody stranguria, stone stranguria, difficulty urinating, stranguria with stranguria, astringent pain, amenorrhea and stasis. The main components are flavonoids and saponins, and contain a small amount of alkaloids and volatile oils. Pharmacological effects include anti-tumor, diuretic, uterine stimulation, antibacterial, immune regulation, anti-oxidation, hemolysis, pain relief, etc. Among them, flavonoids have significant curative effects in anti-inflammato...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/72G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/72G01N30/74G01N30/8634Y02A50/30
Inventor 张志强付静沈建梅杜微波陈敬然
Owner BEIJING KANGRENTANG PHARMA
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