Andrographolide sulfonic acid sodium lyophilized powder for injection and its preparing method

A technology of sodium ester sulfonate and freeze-dried powder injection, applied in the field of medicine, can solve the problems of inconvenient storage and transportation, unreasonable design, poor stability of water injection, etc. The effect of stability

Inactive Publication Date: 2005-07-20
刘力
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, at present, only Xiyanping water needles are available in the market. Xiyanping injection is unstable when exposed to heat. In the solution state, the decomposition increases. , the stability of the water needle is poor, and its storage and transportation are not convenient
And the water injection only has 50mg / 1ml, 125mg / 2ml, and 250mg / 2ml specifications, while the clinical daily intramuscular injection of 50-100mg and intravenous infusion of Xiyanping injection doses are 250-500mg, which reflects the high quality of Xiyanping injection. The unit dose of the main drug of the needle is low, and its design is unreasonable from the perspective of pharmaceutical preparations
Therefore, this not only wastes more than 1-2 times of packaging materials, but also consumes more labor resources, which is a great waste of social wealth! And it is very inconvenient to use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Under clean conditions, take 50g of andrographolide sodium sulfonate, 200g of arginine, 10g of 2-hydroxypropyl β-cyclodextrin, and 2g of sodium bisulfite in an appropriate amount of water for injection at 20°C and stir. Dissolve; adjust the pH value with dilute hydrochloric acid, add 5g activated carbon for needle, stir for 20min, filter and decarburize with 10μm titanium filter rod, after the pH value and content determination pass, filter with 0.45-0.8um microporous membrane, and then 0.2~ Filtration with 0.22um microporous filter membrane; sterilize and remove heat source, and dispense into vials according to the dose so that the unit dose of andrographolide sodium sulfonate in each vial is 50mg, add a rubber stopper, and place the aliquoted vial In a freeze dryer, freeze for 2 hours, make the temperature reach -60℃, make the vacuum degree in the machine 10Pa, slowly increase the temperature, and dry at -20℃, low temperature vacuum for 18 hours, raise the temp...

Embodiment 2

[0024] Example 2: Under clean conditions, respectively take andrographolide sodium sulfonate 25g, sodium chloride 10g, mannitol 10g, 2-hydroxypropyl β-cyclodextrin 5g, L-cysteine ​​hydrochloride 0.1 g Dissolve in an appropriate amount of water for injection at 20°C; adjust pH with gluconic acid and sodium hydroxide, filter with 5μm titanium filter rod, add water for injection, after the pH value and content are determined to be qualified, two ultrafiltration sterilization and removal The heat source is divided into vials according to the dose, so that the unit dose of andrographolide sodium sulfonate in each vial is 25 mg, and a rubber stopper is added. The vials are placed in a freeze dryer and frozen for 2 hours. Bring the temperature to -50°C, make the vacuum inside the machine 10Pa, dry in low-temperature vacuum for 30 hours, raise the temperature to 30°C, dry in vacuum for 10 hours, fill with nitrogen, and press the cover to get it, and control the weight percentage of its mo...

Embodiment 3

[0025] Example 3: Under clean conditions, take 100 g of andrographolide sodium sulfonate, 1000 g of glucose, 100 g of arginine, 20 g of 3-hydroxypropyl β-cyclodextrin, 50 g of sodium gluconate, and 2 g of sodium metabisulfite at 20°C. Dissolve in appropriate amount of water for injection, stir and dissolve; adjust pH with hydrochloric acid and sodium hydroxide, filter and decarbonize with 10μm titanium filter rod, add water for injection, stir well, after the pH value and content are qualified, two ultrafiltration sterilization and heat removal , Divided into vials according to the dose, so that the unit dose of andrographolide sodium sulfonate in each vial is 100mg, add a rubber stopper, put the aliquoted vials in a freeze dryer, freeze for 2 hours, make The temperature reaches -38℃, the vacuum degree inside the machine is 10Pa, and the temperature is increased slowly, low temperature vacuum drying at -38℃~-5℃ for 30 hours, the temperature is raised to 30℃, and vacuum drying for ...

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PUM

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Abstract

The present invention relates to an andrographolide sodium sulfonate freeze-dried powder injection preparation. Said freeze-dried powder injection preparation contains unit dose 10-1500 mg of andrographolide sodium sulfonate, and at least contains one pharmaceutically-acceptable carrier, said carrier includes excipient, pH regulating agent, anti-oxidant and stabilizing agent. Said invented powder injection preparation can be mainly used for curing the diseases of bronchitis, cystauchenitis, urethritis, pelvic inflammation, acute icterohepatitis anjd prostatitis, etc. Besides, said invention also provides its preparation process.

Description

Technical field [0001] The invention relates to the field of medicine, in particular to andrographolide sodium sulfonate freeze-dried powder injection preparation and a preparation method thereof. Background technique [0002] Andrographis paniculata is a herbaceous plant in the Acanthaceae family. It is also known as "Happiness at first sight" and "Blancaria sinensis". It has a bitter taste and has the effects of clearing heat and detoxification and drying dampness. It is mostly used for the onset of febrile disease, fever and headache, lung-heat asthma, damp-heat diarrhea. It has the effect of clearing away heat and dampness, so it is often used for jaundice of liver and gallbladder fever. Modern pharmacological studies have shown that Andrographis paniculata has antibacterial, antiviral, and anti-inflammatory effects, especially in antiviral effects, and has an inactivating effect on certain viruses. However, because its main medicinal ingredient is andrograp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/365A61P1/16A61P11/00A61P13/02A61P13/08A61P15/00A61P31/04A61P31/12
Inventor 刘力
Owner 刘力
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