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Traditional Chinese medicament freeze-drying injection and preparation method thereof

A technology for freeze-dried injections and traditional Chinese medicines, which can be used in freeze-dried transportation, pharmaceutical formulations, drug combinations, etc., and can solve the problems of undisclosed preparation methods of freeze-dried injections

Active Publication Date: 2011-06-15
HEBEI YILING MEDICINE INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This patent does not disclose freeze-dried injection and its preparation method

Method used

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  • Traditional Chinese medicament freeze-drying injection and preparation method thereof
  • Traditional Chinese medicament freeze-drying injection and preparation method thereof

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Effect test

Embodiment 1

[0058] Raw material weight ratio:

[0059] Total ginseng saponin extract 50g Epimedium total flavonoid extract 40g Hydroxypropyl-β-cyclodextrin 800g

[0060] Preparation:

[0061] a. Dissolve hydroxypropyl-β-cyclodextrin in 4000ml of water to make a 20% solution, add 750ml (5.33%) of Epimedium total flavonoids extract into water and heat to dissolve, slowly add hydroxypropyl-β-cyclodextrin in stages In the dextrin solution, keep warm at 80°C±1°C, stir dynamically for inclusion, and the inclusion time is 3 hours. Add 100ml (50%) of the total ginseng saponins extract to water and heat to dissolve, add it to the inclusion solution, and continue inclusion for 1 hour;

[0062] b. Add water to adjust the total amount of the solution to 6000ml, adjust the pH to 7.5 with 10% sodium hydroxide solution, add 24 grams of activated carbon (that is, contain 0.4% activated carbon), boil for 10 minutes, filter with a clarified plate while it is hot, and filter out the activated carbon , and...

Embodiment 2

[0069] Raw material weight ratio:

[0070] Total Ginseng Saponin Extract 35g Epimedium Total Flavonoid Extract 55g Hydroxypropyl-β-Cyclodextrin 900g

[0071] Preparation:

[0072] a. Dissolve 3000ml of hydroxypropyl-β-cyclodextrin in water to make a 30% solution, add 1800ml (3.11%) of the total flavonoids extract of Epimedium to dissolve, and slowly add hydroxypropyl-β-cyclodextrin in stages In the essence solution, keep warm at 50±1°C, stir dynamically for inclusion, and the inclusion time is 8 hours. Add 105ml (33.3%) of total ginseng saponins extract to water and heat to dissolve, add to the inclusion solution, and continue inclusion for 2 hours;

[0073] b, add water to adjust the total amount of the solution to 6000ml, adjust the pH to 6.2 with 20% sodium hydroxide solution, add 6 grams of gac (containing 0.1% gac), boil for 10 minutes, filter while hot with a sand filter stick, filter gac, Then filter with 0.22μm microporous membrane, and dilute to 6000ml with water; ...

Embodiment 3

[0080] Raw material weight ratio:

[0081] Total Ginseng Saponin Extract 65g Epimedium Total Flavonoid Extract 25g Hydroxypropyl-β-cyclodextrin 650g

[0082] Preparation:

[0083] a. Dissolve hydroxypropyl-β-cyclodextrin with 4000% water to make a 16.3% solution, add 250ml (10%) of Epimedium total flavonoids extract to heat and dissolve, slowly add hydroxypropyl-β-cyclodextrin in stages In the dextrin solution, keep warm at 90°C±1°C, stir dynamically for inclusion, and the inclusion time is 3 hours. Add 130ml (50%) of the total ginseng saponins extract to water and heat to dissolve, add it to the inclusion solution, and continue inclusion for 1 hour;

[0084] b, add water to adjust the total amount of the solution to 6000ml, adjust the pH to 8.5 with 5% sodium hydroxide solution, add 30 grams of activated carbon (containing 0.5% activated carbon), boil for 6 minutes, suction filter while it is hot, filter out the activated carbon, and then use 0.22 Filter with μm microporous...

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Abstract

The invention provides a traditional Chinese medicinal composition freeze-drying injection and a preparation method thereof. The traditional Chinese medicament freeze-drying injection is prepared from raw materials comprising ginseng and epimedium herb by extraction and refinement of a modern process and then by a freeze-drying process. The traditional Chinese medicament preparation meets technical requirements of the State Food and Drug Administration (SFDA) on the traditional Chinese medicament injection and is clinically applied to treatment on amyotrophy and myasthenia gravis caused by diseases such as motor neuron diseases (amyotrophic lateral sclerosis, progressive spinal muscular atrophy, progressive bulbar palsy and primary lateral sclerosis), progressive myodystrophy, congenital myopathy and the like. The traditional Chinese medicament freeze-drying injection is administrated clinically through intravenous, intramuscular or acupoint injection.

Description

technical field [0001] The invention relates to a traditional Chinese medicine freeze-dried injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Traditional Chinese medicine injection is the inheritance and development of traditional ethnic medicine, and it is a high-quality product in the "quintessence of China"; its safety and effectiveness have been proven in clinical practice; however, the potential safety hazard of water injection is much greater than that of powder injection. As the storage time prolongs and the environment changes, large insoluble particles will appear in the aqueous injection. Once these particles enter the blood vessels of the human body, serious adverse reactions are likely to occur. Aqueous injections are also susceptible to contamination during storage and transportation. The freeze-dried powder is solid, and there will be no problem of large particle precipita...

Claims

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Application Information

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IPC IPC(8): A61K36/296A61K9/19A61K47/40A61P25/28
Inventor 宋剑贾继明王贵金刘兴国蔡燕郑亚杰裴彩云王胜超赵韶华安军永王超郑立发
Owner HEBEI YILING MEDICINE INST
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