Preparation method of sterile andrographolide bulk drug

A technology of Yanhuning and raw materials, applied in the field of preparation of sterile raw materials of Yanhuning, can solve the problems of easy hydrolysis, adverse reactions, instability of Yanhuning, etc., and achieve the effects of stable quality and high purity

Active Publication Date: 2019-11-19
WUHAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Yanhuning is relatively unstable, easy to hydrolyze, and easy to produce impurities. It is easy to cause more adverse reactions in clinical use. In recent years, Yanhuning has a high probability of adverse reactions in clinical use. Yanhuning injection is the clinical Common dosage forms used, injections require sterility, and Yanhuning is relatively unstable. Therefore, a high-quality, high-stability Yanhuning sterile raw material drug is provided, which can be directly subpackaged by sterile raw material drug, which can reduce inflammation. Huning injection preparation process, or reduce the use of stabilizer excipients in the preparation, greatly improving the clinical safety and effectiveness of Yanhuning injection

Method used

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  • Preparation method of sterile andrographolide bulk drug
  • Preparation method of sterile andrographolide bulk drug
  • Preparation method of sterile andrographolide bulk drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1. Under B-level sterile conditions, add 30Kg of Yanhuning to the reaction kettle, add 120L of water and ethanol mixture (10% ethanol by volume) at 5°C, stir to dissolve, filter through 0.45μm Membrane filtration, obtain filtrate; Then slowly add the mixed solution of 480L diethyl ether and acetone (the volume ratio of diethyl ether and acetone is 7:3) to gained filtrate, cool down to 1 ℃ after adding, stand and crystallize for 4 hours, the obtained crystal is used Wash twice with acetone and dry to obtain the refined product of Yanhuning raw material;

[0023] 2. Under A-level sterile conditions, dissolve the refined product of Yanhuning raw material obtained in step 1 in water for injection; filter the aqueous solution through a 0.22 μm filter membrane and place it in a freeze-drying tray, and control the freeze-drying tray The thickness of the medium solution is 1.5cm; then pre-freeze: put the freeze-drying plate in a freezer that has been cooled to -35°C in advance,...

Embodiment 2

[0025] 1. Under B-level sterile conditions, add 30Kg of Yanhuning to the reaction kettle, add 120L of water and ethanol mixture (15% ethanol by volume) at 10°C, stir to dissolve, and filter through 0.45μm Membrane filtration, obtain filtrate; Then slowly add the mixed solution of 480L diethyl ether and acetone (the volume ratio of diethyl ether and acetone is 7:3) to gained filtrate, cool down to 3 ℃ after adding, stand and crystallize for 4 hours, the obtained crystal is used Wash twice with acetone and dry to obtain the refined product of Yanhuning raw material;

[0026] 2. Under A-level sterile conditions, dissolve the refined product of Yanhuning raw material obtained in step 1 in water for injection; filter the aqueous solution through a 0.22 μm filter membrane and place it in a freeze-drying tray, and control the freeze-drying tray The thickness of the medium solution is 2cm; then pre-freeze: put the freeze-drying plate in a freezer that has been cooled to -25°C in advan...

Embodiment 3

[0028] 1. Under B-level aseptic conditions, add 30Kg of Yanhuning to the reaction kettle, add 120L of water and ethanol mixture (13% ethanol by volume) at 6°C, stir to dissolve, and filter through 0.45μm Membrane filtration, obtain filtrate; Then slowly add the mixed solution of 480L diethyl ether and acetone (the volume ratio of diethyl ether and acetone is 7:3) to gained filtrate, cool down to 2 ℃ after adding, stand and crystallize for 4 hours, the obtained crystal is used Wash twice with acetone and dry to obtain the refined product of Yanhuning raw material;

[0029] 2. Under A-level sterile conditions, dissolve the refined product of Yanhuning raw material obtained in step 1 in water for injection; filter the aqueous solution through a 0.22 μm filter membrane and place it in a freeze-drying tray, and control the freeze-drying tray The thickness of the medium solution is 1.8cm; then pre-freeze: put the freeze-drying plate in a freezer that has been cooled to -29°C in adva...

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Abstract

The invention relates to a preparation method of a sterile andrographolide bulk drug. The preparation method comprises the following steps: adding an andrographolide bulk drug into a water-ethanol mixed solution, carrying out stirring for dissolving, then performing filtering, adding a diethyl ether-acetone mixed solution into the obtained filtrate, carrying out cooling to 1-3 DEG C, then performing standing for crystallization, and washing and drying the obtained crystal so as to obtain a refined product of the andrographolide bulk drug; and dissolving the obtained refined product of the andrographolide bulk drug in water for injection, carrying out filtering, putting the obtained filtered solution into a freeze-drying tray, controlling the thickness of the solution in the freeze-drying tray to be 1.5-2 cm, putting the freeze-drying tray into a freezer which is cooled to -35 DEG C to -25 DEG C in advance, carrying out standing for 3-4 hours, and then successively performing sublimating, drying and crushing to obtain the sterile andrographolide bulk drug. The sterile andrographolide bulk drug prepared by the method disclosed in the invention is extremely good in quality and stability; the safety of clinical use of the sterile andrographolide bulk drug is improved; and the clinical promotion and application of the sterile andrographolide bulk drug are facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of Yanhuning aseptic raw material drug. Background technique [0002] Yanhuning, chemical name: 14-dehydroxy-11,12-didehydroandrographolide-3,19- [0003] Potassium disuccinate half ester sodium salt monohydrate. The plant andrographolide extract of this strain - andrographolide is dehydrated andrographolide half-ester potassium succinate sodium salt refined by esterification, dehydration, and salt formation. [0004] Yanhuning has heat-clearing, detoxifying and antiviral effects, and is mainly used for viral pneumonia and viral upper respiratory tract infections. It can inhibit early capillary permeability increase, inflammatory exudation and edema, can specifically excite the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis of ACTH in the anterior pituitary; it has inactivated adenovirus, influenza...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D307/58A61K9/19
CPCC07D307/58A61K9/0019A61K9/19Y02A50/30
Inventor 胡汉昆曾宪涛李胜高卫杨雨飞叶旭军苏亚霞林嫚婷刘亮吴建华
Owner WUHAN UNIV
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