Medicament microcapsule and method for preparing injection thereof

A Yanhuning injection and drug technology, which is applied in the field of pharmaceutical microcapsule preparations, can solve problems such as unqualified quality, easy oxidation and hydrolysis, and lower pH value, and achieve the effects of ensuring quality stability, avoiding oxidation and hydrolysis, and reducing production costs

Inactive Publication Date: 2008-10-08
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Most of the Yanhuning injections currently on the market have serious quality problems after half a year of storage. This is determined by the physical and chemical properties of the raw materials of Yanhuning. Yanhuning is very unstable in aqueous solution. It is easy to be oxidized and hydrolyzed, showing that the color of the solution is deepened, the content is significantly reduced, related substances exceed the standard, and the pH value is lowered and other quality problems
Although many manufacturers add a large number of additives in the production process to stabilize the changes in raw materials and improve the quality of drugs, the effect is minimal

Method used

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  • Medicament microcapsule and method for preparing injection thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] (1) Take Yanhuning 40g, suspend it on the fluidized bed, mix 15.3g acetone solution containing 50% chitosan with 4g ethanol solution to form a film solution, and add it to the reactor in spray form within 20 minutes In the process, dry at a temperature of 60°C to form a film to form microcapsules of Yanhuning;

[0052] (2) Take the prepared Yanhuning microcapsules, add 1600ml water for injection, stir and dissolve;

[0053] (3) Adjust the pH value to 6.5 with 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution, add 2000ml of water for injection, and stir evenly;

[0054] (4) Add 1.01 g of medicinal charcoal, stir for 20 minutes, and decarbonize by coarse filtration;

[0055] (5) Use φ0.22um microporous filter membrane to filter, fill and seal with nitrogen;

[0056] (6) Sterilization (100°C circulating steam for 30 minutes), leak detection.

Embodiment 2

[0058] (1) Take Yanhuning 80g, suspend it on the fluidized bed, mix 35.7g chitosan acetone solution containing 50% and 8g ethanol solution evenly to form a film solution, and add it to the reactor in the form of spray within 15 minutes , dried at a temperature of 70°C to form a film, forming microcapsules of Yanhuning;

[0059] (2) Take the prepared Yanhuning microcapsules, add 4000ml water for injection, stir and dissolve;

[0060] (3) Adjust the pH value to 6.4 with 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution, add 5000ml of water for injection, and stir evenly;

[0061] (4) Add 2.50 g of medicinal charcoal, stir for 20 minutes, and decarbonize by coarse filtration;

[0062] (5) Use φ0.22um microporous filter membrane to filter, fill and seal with nitrogen;

[0063] (6) Sterilization (100°C circulating steam for 30 minutes), leak detection.

Embodiment 3

[0065] (1) Take Yanhuning 200g, suspend it on the fluidized bed, mix 72.2g chitosan acetone solution containing 50% and 20g ethanol solution evenly to form a film-forming solution, and add it to the reactor in the form of spray within 25 minutes In the process, dry at a temperature of 50°C to form a film to form microcapsules of Yanhuning;

[0066] (2) Take the prepared Yanhuning microcapsules, add 8000ml water for injection, stir and dissolve;

[0067] (3) Adjust the pH value to 6.6 with 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution, add 10000ml of water for injection, and stir evenly;

[0068] (4) Add 5.02g medicinal charcoal again, stir for 20 minutes, and decarbonize by coarse filtration;

[0069] (5) Use φ0.22um microporous filter membrane to filter, fill and seal with nitrogen;

[0070] (6) Sterilization (100°C circulating steam for 30 minutes), leak detection.

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Abstract

The invention relates to a medicinal microcapsule, taking the potassium sodium dehydroandroan drographolide succinate as medicinal active component, which is characterized in that the potassium sodium dehydroandroan drographolide succinate is coated by macromolecular polysaccharide membrane into the microcapsule. The invention also relates to a preparation method for potassium sodium dehydroandroan drographolide succinate injection; the potassium sodium dehydroandroan drographolide succinate is coated by the macromolecular polysaccharide membrane into the microcapsule and then made into the injection. The invention adopts the micro-capsule embedding technique to process the raw materials of the potassium sodium dehydroandroan drographolide succinate, thereby greatly improving the stability of the potassium sodium dehydroandroan drographolide succinate in aqueous solution, ensuring the mass stability of parenteral solution produced and being favorable for storing the product for a long time.

Description

technical field [0001] The invention relates to a drug microcapsule preparation, in particular to a method for preparing a stable Yanhuning injection from the drug microcapsule. It belongs to the field of medicine. Background technique [0002] Yanhuning is the plant Andrographis paniculata extract-andrographolide refined through esterification, dehydration, and salt formation, and it is dehydrated andrographolide half-ester potassium succinate sodium salt. The chemical name of Yanhuning is 14-dehydro-11,12-didehydroandrographolide-3,19-disuccinic acid half ester potassium sodium salt. Yanhuning can inhibit early capillary permeability increase and inflammatory exudation and edema, can specifically stimulate the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis of ACTH in the anterior pituitary; The effect of various viruses such as viruses, influenza viruses, respiratory viruses, etc. It is suitable for viral pneumonia and vira...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K9/08A61K31/365A61K47/36A61P31/12A61P11/00
Inventor 邱民
Owner HAINAN LINGKANG PHARMA CO LTD
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