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Method for detecting dihydroartemisinin crystal form in dihydroartemisinin tablet

A technology of dihydroartemisinin tablets and dihydroartemisinin, which is applied in the field of medicine, can solve the problems of unreported crystal forms of dihydroartemisinin, and achieve the effects of good durability, precision and high stability

Pending Publication Date: 2020-08-07
KPC PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the research on the crystal form of dihydroartemisinin in dihydroartemisinin tablets has not been reported yet.

Method used

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  • Method for detecting dihydroartemisinin crystal form in dihydroartemisinin tablet
  • Method for detecting dihydroartemisinin crystal form in dihydroartemisinin tablet
  • Method for detecting dihydroartemisinin crystal form in dihydroartemisinin tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: Preparation of Dihydroartemisinin Tablets (170509-02)

[0026] Take the raw and auxiliary materials of prescription quantity respectively, make dihydroartemisinin contain 18%, lactose contain 52%, microcrystalline cellulose contain 18%, sodium carboxymethyl starch contains 8%, polyvinylpyrrolidone contains 3.7%, stearin Magnesium acid contains 0.3%. Lactose, microcrystalline cellulose, sodium carboxymethyl starch, and polyvinylpyrrolidone are passed through a 80-mesh sieve. Add the above-mentioned raw and auxiliary materials into the hopper of the mixer for mixing, and perform tablet compression after mixing.

Embodiment 2

[0027] Example 2: Preparation of Dihydroartemisinin Tablets (170509-03)

[0028] Take the raw and auxiliary materials of prescription quantity respectively, make dihydroartemisinin contain 10%, lactose contain 40%, microcrystalline cellulose contain 30%, sodium carboxymethyl starch contains 15%, polyvinylpyrrolidone contains 4.5%, stearin Magnesium acid contains 0.5%. Lactose, microcrystalline cellulose, sodium carboxymethyl starch, and polyvinylpyrrolidone are passed through a 80-mesh sieve. Add the above-mentioned raw and auxiliary materials into the hopper of the mixer for mixing, and perform tablet compression after mixing.

Embodiment 3

[0029] Example 3: Preparation of Dihydroartemisinin Tablets (170509-04)

[0030] Take the raw and auxiliary materials of recipe quantity respectively, make dihydroartemisinin contain 15%, lactose contain 35%, microcrystalline cellulose contain 32%, carboxymethyl starch sodium contains 13%, polyvinylpyrrolidone contains 4.2%, stearin Magnesium acid contains 0.8%. Lactose, microcrystalline cellulose, sodium carboxymethyl starch, and polyvinylpyrrolidone are passed through a 80-mesh sieve. Add the above-mentioned raw and auxiliary materials into the hopper of the mixer for mixing, and perform tablet compression after mixing.

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Abstract

The invention relates to the technical field of medicines, and discloses a method for detecting a dihydroartemisinin crystal form in a dihydroartemisinin tablet. According to the detection method disclosed by the invention, the dihydroartemisinin tablet to be detected is scanned by utilizing an X-ray powder diffraction method, and the crystal form of dihydroartemisinin in the dihydroartemisinin tablet is judged according to whether an exclusive characteristic peak exists or not. Tests show that the detection method disclosed by the invention is high in stability; when the X-ray powder diffraction scanning speed and the X-ray powder diffraction scanning time slightly change, the detection result of the dihydroartemisinin tablet is not influenced; and the dihydroartemisinin tablets are repeatedly detected by different XRD instruments on different days and different persons, the detection result of the dihydroartemisinin tablets is not influenced, the durability and the precision are good, and the method can be widely applied to the crystal form identification of the dihydroartemisinin in the dihydroartemisinin tablets.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for detecting crystal forms of dihydroartemisinin in dihydroartemisinin tablets. Background technique [0002] Dihydroartemisinin is a derivative of artemisinin, an effective antimalarial monomer isolated from Herba Artemisiae Annuae, and its chemical name is: (3R, 5aS, 6R, 8aS, 9R, 12S, 12aR)-octahydro-3,6,9-trimethyl-3,12-oxo-12H-pyrano[4,3-j]-1,2-benzodisepin-10(3H) -alcohol, molecular formula C 15 h 24 o 5 , the molecular weight is 284.35, and the structural formula is as shown in formula I. [0003] [0004] With the deepening of research on dihydroartemisinin, it is found that its biological activity presents diversity. Studies have shown that in addition to the definite antimalarial activity, bisartemisinin also has antitumor, anti-inflammation, anti-fibrosis, anti-arrhythmia, anti-fungal, anti-pregnancy, anti-arrhythmia, anti-parasite, and radiosensitiza...

Claims

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Application Information

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IPC IPC(8): G01N23/20
CPCG01N23/20
Inventor 黄照昌王洪静曾涛方芳李滢张敏
Owner KPC PHARM INC
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