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Puerarin injection

A technology for puerarin for injection, applied in the field of puerarin injection preparations, can solve problems such as increased production cost, inability to solve solubility, inability to guarantee stability, etc. Effect

Active Publication Date: 2007-04-04
BEIJING SAISHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Current research shows that the concentration of puerarin injection can only reach 50mg / ml, and the preparation of large-scale preparations can only be prepared by increasing the amount, which increases the production cost; if the solubility is solved, the stability cannot be guaranteed, and if the solution is stable property, it cannot solve the solubility

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] [Example 1] Preparation of Puerarin Injection (Specification: 2ml: 100mg)

[0035] 1. Dosing: Accurately weigh 107.5g of puerarin, 21.5g of arginine, 860ml of propylene glycol, 21.5g of nicotinamide and an appropriate amount of water for injection, add them to dissolve, adjust the pH value to 3.5-5.5, add water for injection to make up to 21500ml , and stir evenly to make a 50mg / ml drug solution.

[0036] 2. Ultrafiltration: The above medicinal solution is ultrafiltered through an ultrafiltration column with a molecular weight cut-off of 8000 Daltons.

[0037] 3. Filtration: After ultrafiltration, the medicinal solution is quickly passed through a 0.22 μm sterilizing filter for sterilizing filtration.

[0038] 4. Filling and sealing: divide the filtered liquid medicine into 2.15ml / cartridges into clean ampoules, and seal.

[0039] 5. Sterilization: Sterilize with circulating steam at 115°C for 30 minutes.

[0040] 6. Others: light inspection, quality inspection, labe...

Embodiment 2

[0041] [Example 2] Preparation of Puerarin Injection (Specification: 5ml: 400mg)

[0042] 1. Dosing: Accurately weigh 424g of puerarin, 265g of arginine, 1590ml of propylene glycol, 106g of nicotinamide and an appropriate amount of water for injection, add to dissolve, adjust the pH to 3.5-5.5, add water for injection to make up to 5300ml, and stir well , to make 80mg / ml drug solution.

[0043] 2. Ultrafiltration: The above medicinal solution is ultrafiltered through an ultrafiltration column with a molecular weight cut-off of 8000 Daltons.

[0044] 3. Filtration: After ultrafiltration, the medicinal solution is quickly passed through a 0.22 μm sterilizing filter for sterilizing filtration.

[0045] 4. Filling and sealing: divide the filtered liquid medicine into clean ampoules according to 5.3ml / cartridge, and seal.

[0046] 5. Sterilization: Sterilize with circulating steam at 115°C for 30 minutes.

[0047]6. Others: light inspection, quality inspection, labeling, packagi...

Embodiment 3

[0049] [Example 3] Preparation of puerarin injection freeze-dried powder (specification is 0.1g / bottle)

[0050] 1. Dosing: Accurately weigh 100g of puerarin, 20g of arginine, 10g of nicotinamide and appropriate amount of water for injection, add to dissolve, adjust the pH value to 7.0-9.0, add water for injection to make up to 1000ml, stir evenly, and prepare 100mg / ml drug solution.

[0051] 2. Ultrafiltration: The above medicinal solution is ultrafiltered through an ultrafiltration column with a molecular weight cut-off of 8000 Daltons.

[0052] 3. Filtration: After ultrafiltration, the medicinal solution is quickly passed through a 0.22 μm sterilizing filter for sterilizing filtration.

[0053] 4. Filling and sealing: the filtered liquid medicine is divided into 2ml vials according to 1.0ml / cartridge.

[0054] 5. Freeze-drying: The freeze-drying conditions are 2.5 hours of pre-freezing (20°C--45°C), sublimation of 2.5 hours (-45°C--40°C) + 7 hours (-40°C-0°C), and drying ...

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PUM

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Abstract

An injection or freeze-dried powder injection of kakonein is proportionally prepared from kakonein, propanediol, alkaline amino acid (arginine and / or lysine), and nicotinamide.

Description

technical field [0001] The invention relates to a puerarin injection preparation. Background technique [0002] Puerarin is the main active ingredient in the traditional Chinese medicine puerarin, and its chemical name is 8-β-D-glucopyranose-4′, 7-dihydroxyisoflavone. The single component of puerarin was extracted and made into injection, which was approved as a national-level fourth-class new drug in 1993. The extraction process of puerarin has been continuously improved, and the raw material drug of puerarin can reach more than 97%. Clinical studies have shown that puerarin can lower blood pressure, slow down heart rate, dilate coronary arteries, increase blood flow in coronary arteries and brain, reduce vascular resistance, reduce myocardial oxygen consumption, improve metabolism of ischemic myocardium, improve microcirculation, and resist heart rhythm. malfunction etc. Moreover, as puerarin is widely used clinically, its clinical symptoms are also continuously expande...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61P9/06A61P9/12A61P9/10
Inventor 马骉孔双泉宋梦薇姜桂荣曾辉单连慧
Owner BEIJING SAISHENG PHARMA
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