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Puerarin sodium phosphate injection and preparation method thereof

A technology of sodium puerarin phosphate and puerarin phosphate, which is applied in the field of injections whose main drug is sodium puerarin phosphate and its preparation, and can solve problems such as instability of puerarin injection

Active Publication Date: 2014-05-14
SHENZHEN XINGYIN PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These phenomena indicate that the puerarin injections on the market are unstable.

Method used

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  • Puerarin sodium phosphate injection and preparation method thereof
  • Puerarin sodium phosphate injection and preparation method thereof
  • Puerarin sodium phosphate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] 2.5% sodium puerarin phosphate, 0.90% sodium chloride, 0.10% sodium bisulfite, 0.20% benzyl alcohol, hydrochloric acid to adjust the pH value to 6.0. Its preparation process is as follows:

[0013] Weigh 100g of sodium puerarin phosphate, 36.0g of sodium chloride, 4.0g of sodium bisulfite, and 8.0g of benzyl alcohol, dissolve completely with 80% water for injection of the prescribed amount, adjust the pH to 6.0 with hydrochloric acid, add 4g of activated carbon, and Adsorb the pyrogen for 30 minutes under stirring, decarburize and filter, and add water for injection to 4000ml. Then it is sterilized and filtered through a 0.22 μm microporous membrane, filled into a 7ml sterilized vial (4ml / bottle), and sealed with a cap.

[0014] 1000 bottles of Puerarin Sodium Phosphate Injection were prepared in this example, and its stability and clinical drug safety were investigated through accelerated tests and animal blood vessel irritation, muscle irritation, hemolysis and anaph...

Embodiment 2

[0047] 5.0% sodium puerarin phosphate, 4.00% glucose, 0.50% ascorbic acid, 0.50% chlorobutanol, and sodium hydroxide to adjust the pH value to 7.0. Its preparation process is as follows:

[0048] Weigh 200.0 g of sodium puerarin phosphate, 160.0 g of glucose, 25.0 g of ascorbic acid, and 25.0 g of chlorobutanol, dissolve completely with 80% water for injection of the prescribed amount, adjust the pH to 7.0 with sodium hydroxide, add 4 g of activated carbon, Adsorb pyrogen for 30 minutes under stirring, decarburize and filter, add water for injection to 4000ml. Then it is sterilized and filtered through a 0.22 μm microporous membrane, filled into a 7ml sterilized vial (4ml / bottle), and sealed with a cap.

[0049]1000 bottles of Puerarin Sodium Phosphate Injection were prepared in this example, and its stability and clinical drug safety were investigated through accelerated tests and animal blood vessel irritation, muscle irritation, hemolysis and anaphylaxis experiments.

[0...

Embodiment 3

[0082] 10.0% sodium puerarin phosphate, 5.0% mannitol, 1.50% sodium thiosulfate, 1.00% chlorobutanol, and sodium hydroxide to adjust the pH value to 8.0. Its preparation process is as follows:

[0083] Weigh 400.0g of sodium puerarin phosphate, 200.0g of mannitol, 25.0g of sodium thiosulfate, and 25.0g of chlorobutanol, and dissolve them completely with 80% of the prescribed amount of water for injection, adjust the pH to 8.0 with sodium hydroxide, and add 4g activated carbon, adsorb pyrogen for 30 minutes under stirring, decarbonize and filter, add water for injection to 4000ml, then pass through 0.22μm microporous filter membrane to sterilize and filter, fill in 7ml sterilized vials (4ml / bottle), Press the Seza cover.

[0084] 1000 bottles of Puerarin Sodium Phosphate Injection were prepared in this example, and its stability and clinical drug safety were investigated through accelerated tests and animal blood vessel irritation, muscle irritation, hemolysis and anaphylaxis ...

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Abstract

The invention relates to a puerarin sodium phosphate injection and a preparation method thereof. The puerarin sodium phosphate injection comprises puerarin sodium phosphate, a preservative, an isoosmotic adjusting agent, a pH value adjusting agent, an antioxygen, a local analgetic and injection water, wherein due to the addition of the antioxygen, the stability of the puerarin sodium phosphate injection can be improved, and due to the addition of the local analgetic, the pain of a patient can be lightened and no influence is caused to a main drug. The preparation method of the puerarin sodium phosphate injection mainly comprises the steps: weighing, dissolving, adsorbing a heat source by active carbon, filtering, metering volume, end-filtering, sub-packaging, plugging and covering. The puerarin sodium phosphate injection is used for adjuvant therapy of the coronary heart disease, the stenocardia, the myocardial infarction, the retina artery and vein occlusion, sudden deafness, ischemic cerebrovascular disease and the like. The puerarin sodium phosphate injection is stable in quality, accurate in treatment effect, and beneficial to acceptation by a patient.

Description

technical field [0001] The invention relates to the field of preparations, in particular to an injection whose main drug is puerarin sodium phosphate and a preparation method thereof. Another authorized invention patent of our company, CN10171267.6, has disclosed the structure and preparation method of puerarin sodium phosphate. Background technique [0002] Puerarin is the main active ingredient in the traditional Chinese medicine puerarin, a flavonoid glycoside, chemically named 7,4'-dihydroxy-8-β-D-glucose isoflavone, and the molecular formula is C 21 h 20 o 9 , molecular weight 416.38, CAS number 82373-94-3. Puerarin has the functions of improving immunity, enhancing myocardial contractility, protecting myocardial cells, lowering blood pressure, and anti-platelet aggregation. It is widely used in the treatment of clinical hypertension, coronary heart disease, acute cerebral infarction, diabetes and other diseases. [0003] However, the water solubility of puerarin i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/665A61P9/12A61P9/10A61P3/10
Inventor 姚志勇支钦李新宇舒遂智李云开张建松邱焕杰
Owner SHENZHEN XINGYIN PHARML
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