Quality control method and application of P. urinaria L. capsule

A quality control method, capsule technology, applied in the field of biomedicine, to achieve the effect of wide application prospects, correct supply and demand, and stable quality

Pending Publication Date: 2021-09-28
朱明浩
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] But at present, as a medicine, only "Yexiazhu Tablets" and "Yexiazhu Capsules" are available as unilateral preparations.

Method used

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  • Quality control method and application of P. urinaria L. capsule
  • Quality control method and application of P. urinaria L. capsule
  • Quality control method and application of P. urinaria L. capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Embodiment 1: raw material control

[0084] The medicinal material of Phyllostachys urinaria used conforms to the 2005 edition of Yunnan Provincial Standards for Chinese Medicinal Materials: Yun YCBZ0010-2005, and was identified as P.urinaria L. by Kunming Institute of Botany, Chinese Academy of Sciences.

[0085] This artificially cultivated variety is an excellent variety that has been domesticated and selected from wild products distributed in Yunnan. Among them, the content of Corilagin is ≥0.8‰; it is better than wild varieties. Its yield can reach 2200kg / mu (medicinal material ~ 440kg / mu).

[0086] According to the requirements of GAP, there is no pollution source in the surrounding area (within 1km), the soil is loose and breathable, relatively fertile, sandy soil is better, pH5.8-7; sunny; farmyard manure is mainly used on the plot, and appropriate amount of superphosphate and urea, Deep plow and mix well to make a bed; the whole plot is high, with a width of ...

Embodiment 2

[0092] Embodiment 2: preparation method quality control

[0093] Prescription: Phyllostachys 5200g

[0094] Preparation method: take 5000 g of Phyllostachys phylloxera coarse powder (40 mesh), and cold soak three times with 10 times the amount of 80% ethanol. (4 times the amount for the first time, 3 times the amount for the second and third times, 16 hours each time) Filtration, the filtrate is controlled at a temperature 80 mesh) crushed in a clean area and qualified for bacterial inspection, mix well, dry at 60°C, crush, sieve, quality inspect, granulate, and fill capsules to make 1000 capsules. . Flowchart such as figure 1 shown.

Embodiment 3

[0095] Embodiment 3: product quality control

[0096] 1) Identification of Phyllostachys phylloxera

[0097]Take 2g of the content of this product, add 20ml of ethanol, shake for 2 hours, filter, concentrate the filtrate to 2ml, add 2g of silica gel (100-200 mesh), mix well, evaporate the solvent, put it into a chromatographic column, and diethyl ether 8ml for elution, discard the ether solution, add 8ml of ethanol for elution, evaporate to dryness; add 1ml of methanol to dissolve, and use it as the test sample. Another 2 g of Phyllanthus phylloxera reference substance medicinal material was taken, and the reference substance medicinal material solution was prepared in the same way. According to the test of thin-layer chromatography (Appendix VIB of the Chinese Pharmacopoeia 2005 edition), 10 μL of the above two solutions were obtained, and were respectively spotted on the same silica gel G thin-layer plate, with chloroform-methanol (7.5:1) as the developing solvent, Unfold,...

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Abstract

The invention relates to a quality control method and application of P. urinaria L. capsules, and belongs to the technical field of biological medicines. Control is carried out in three aspects of raw material control, preparation method quality control and product quality control. According to the invention, modern medicine production management is integrated into quality control, the quality of medicines rely on production, and a perfect quality standard and a relatively high and reasonable method and standard for detecting the content of the active ingredient corilagin are established through whole-process quality control from the source. Pharmacological tests prove that the P. urinaria L. capsules have the effects of preventing and treating hepatic cell injury and hepatic fibrosis, and have wide application prospects.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a quality control method and application of Yexiazhu capsules. Background technique [0002] Phyllanthus phylloxera is a widely distributed species. There are more than 600 species in the world, and there are 33 species and 4 varieties in my country. For more than 30 years, extensive and in-depth research has been carried out at home and abroad. The chemical components found in Phyllostachys phylloxera include flavonoids, tannins, coumarins, steroids, lignans, phenolic acids, organic acids, etc. 70 Various. Among them, gallic acid has the highest content, and Corilagin has been identified as one of its active ingredients. Using different samples of Phyllanthus phylloxera, we found that Phyllanthus phylloxera has many physiological activities: anti-virus, anti-tumor, anti-bacterial, anti-thrombosis, immune regulation, liver protection, anti-oxidation, inhibition ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/90A61K36/47A61K9/48A61P1/16
CPCG01N30/02G01N30/90A61K36/47A61K9/48A61P1/16A61K2236/333A61K2236/39A61K2236/51
Inventor 朱明浩郑金丹张汝法
Owner 朱明浩
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