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Injection puerarin containing tromethamine and preparation method of injection puerarin

The technology of tromethamine and puerarin is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, pharmaceutical formulas, etc. Insoluble particles are easy to exceed the standard and other problems, so as to achieve the effect of less insoluble particles, high clarity and good resolubility

Inactive Publication Date: 2016-04-13
ZHEJIANG ZHENYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the poor water solubility of puerarin, it needs to use organic solvents or alkaline substances to dissolve, and the reconstitution of freeze-dried powder injection is poor, and the insoluble particles are easy to exceed the standard

Method used

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  • Injection puerarin containing tromethamine and preparation method of injection puerarin
  • Injection puerarin containing tromethamine and preparation method of injection puerarin
  • Injection puerarin containing tromethamine and preparation method of injection puerarin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] The preparation method of puerarin for injection (specification: 50mg):

[0016] Its formula is as follows:

[0017]

[0018] Under clean conditions, dissolve tromethamine in 1500ml water for injection, add puerarin, mannitol and sodium bisulfite, stir to dissolve puerarin completely, add needles to treat with activated carbon, filter, and replenish water for injection to 2000ml. The obtained clarified solution was filled in controlled vials, and freeze-dried according to the freeze-drying process to make puerarin freeze-dried powder injection.

Embodiment 2

[0020] The preparation method of puerarin for injection (specification: 0.1g):

[0021] Its formula is as follows:

[0022]

[0023] Under clean conditions, dissolve tromethamine in 1500ml water for injection, add puerarin, mannitol and sodium bisulfite, stir to dissolve puerarin completely, add needles to treat with activated carbon, filter, and replenish water for injection to 2000ml. The obtained clarified solution was filled in controlled vials, and freeze-dried according to the freeze-drying process to make puerarin freeze-dried powder injection.

Embodiment 3

[0025] The preparation method of puerarin for injection (specification: 0.2g):

[0026] Its formula is as follows:

[0027]

[0028] Under clean conditions, dissolve tromethamine in 3000ml water for injection, add puerarin, mannitol and sodium bisulfite, stir to completely dissolve puerarin, add needles to treat with activated carbon, filter, and replenish water for injection to 4000ml. The obtained clarified solution was filled in controlled vials, and freeze-dried according to the freeze-drying process to make puerarin freeze-dried powder injection.

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Abstract

The invention relates to a puerarin freeze-dried powder injection and a preparation method thereof. The injection mainly comprises puerarin and tromethamine. Tromethamine used in the injection can obviously increase the redissolution speed of the puerarin freeze-dried powder injection; the amount of insoluble particles is reduced; and clinic security is improved.

Description

technical field [0001] The invention belongs to the technical field of freeze-dried powder injection preparation, and relates to a puerarin freeze-dried powder injection and a preparation method thereof. technical background [0002] Puerarin is the main active ingredient in Pueraria root, a traditional Chinese medicine. At present, the main clinical dosage form is injection powder, with specifications of 50mg, 0.1g, 0.2g and 0.4g. Due to the poor water solubility of puerarin, it needs to use organic solvents or alkaline substances to dissolve, and the reconstitution of freeze-dried powder injection is poor, and the insoluble particles are easy to exceed the standard. Chinese patent ZL99100213.X discloses a puerarin pharmaceutical composition and a preparation method thereof. The preparation method of the medicine is to dissolve puerarin with alkaline substances allowed under different pharmacological conditions, such as sodium hydroxide, sodium bicarbonate, lysine, arginin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/352A61K47/18
Inventor 沈剑锋俞建生杨丽敏徐燕陈赛男石飞燕吴丽萍
Owner ZHEJIANG ZHENYUAN PHARMA CO LTD
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