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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 delivery, pharmaceutical formulations, drug combinations, etc., and can solve problems such as undisclosed freeze-dried injection preparation methods.

Active Publication Date: 2014-11-26
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] Ginseng total saponins extract 50g Epimedium total flavonoids extract 40g Hydroxypropyl-β-cyclodextrin 800g

[0060] Preparation:

[0061] a. Dissolve hydroxypropyl-β-cyclodextrin with 4000ml of water to make a 20% solution. Add 750ml (5.33%) of the total flavonoids extract of Epimedium to heat to dissolve, and slowly add hydroxypropyl-β-ring in portions In the dextrin solution, keep the temperature at 80°C±1°C, dynamically stir and clathrate for 3 hours, add 100ml (50%) of the total ginsenoside extract to water to dissolve it by heating, add it to the clathrate solution, and continue to clathrate 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, containing 0.4% activated carbon), boil for 10 minutes, filter with a clear plate while it is hot, and filter out the activated carbon , Then filter with 0.22μm m...

Embodiment 2

[0069] Raw material weight ratio:

[0070] Total ginseng saponins extract 35 grams Epimedium total flavonoids extract 55 grams Hydroxypropyl-β-cyclodextrin 900 grams

[0071] Preparation:

[0072] a. Dissolve hydroxypropyl-β-cyclodextrin in 3000ml of water to make a 30% solution, add 1800ml (3.11%) of the total flavonoids extract of Epimedium to dissolve in water, and slowly add hydroxypropyl-β-cyclodextrin in portions In the refined solution, keep the temperature at 50±1°C, dynamically stir the inclusion for 8 hours, add 105ml (33.3%) of the total ginsenoside extract and heat to dissolve it, add it to the inclusion solution, and continue the 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 activated carbon (containing 0.1% activated carbon), boil for 10 minutes, filter with a sand filter while hot, and filter out the activated carbon. Then filter with 0.22μm micr...

Embodiment 3

[0080] Raw material weight ratio:

[0081] Ginseng total saponins extract 65g Epimedium total flavonoids extract 25g Hydroxypropyl-β-cyclodextrin 650g

[0082] Preparation:

[0083] a. Dissolve hydroxypropyl-β-cyclodextrin with water 4000 to make a 16.3% solution, add 250ml (10%) of total flavonoids extract of Epimedium to heat to dissolve, add hydroxypropyl-β-ring slowly in batches In the dextrin solution, keep the temperature at 90°C±1°C, dynamically agitate and clathrate for 3 hours. Add 130ml (50%) of total ginsenoside extract to heat to dissolve it, add it to the clathrate solution, and continue to clathrate 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% of activated carbon), boil for 6 minutes, filter while hot, filter out the activated carbon, and then use 0.22 Filter with a μm microporous membrane and dilute to 6000ml with water;

...

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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 freeze-dried Chinese medicine injection and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Traditional Chinese medicine injection is the inheritance and development of traditional national medicine, and it is a fine product of the "quintessence of the country"; its safety and effectiveness have been clinically proven; however, the safety hazard of water injection is much greater than that of powder injection. With the prolongation of storage time and environmental changes, large insoluble particles will appear in water injections. Once these particles enter the blood vessels of the human body, serious adverse reactions will easily occur. Aqueous injections are also susceptible to contamination during storage and transportation. The freeze-dried powder is solid and will not cause the problem of large particles precipitation. In addition, the productio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K36/296A61K47/40A61P25/28
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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