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Freeze-dried powder needle preparations taking dantrolene sodium as activity component and preparation technique thereof

A technology of freeze-dried powder injection and dantrolene sodium, which is applied in the field of medicine

Inactive Publication Date: 2008-09-03
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, dantrolene sodium used in China is mainly capsules, and its oral absorption rate and availability still have certain limitations.

Method used

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  • Freeze-dried powder needle preparations taking dantrolene sodium as activity component and preparation technique thereof
  • Freeze-dried powder needle preparations taking dantrolene sodium as activity component and preparation technique thereof
  • Freeze-dried powder needle preparations taking dantrolene sodium as activity component and preparation technique thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1 dantrolene sodium freeze-dried powder injection

[0020] prescription:

[0021]

[0022] Preparation:

[0023] Weigh the prescribed amount of dantrolene sodium and add 80% water for injection to dissolve it to make dantrolene sodium solution, add the prescribed amount of mannitol, adjust the pH value from 9.0 to 10.5, heat the liquid to about 60°C, Add 0.1% active carbon for needles, stir for 30min, and then adopt 0.22 μm microporous membrane fine filtration after filtering and decarbonizing. After the intermediate is tested and qualified, it is aseptically filled in a 5ml vial (theoretical amount of each bottle is 2ml). The liquid medicine is placed in a freeze-drying box and frozen for 4 hours to lower the temperature to about -45°C; for the first sublimation for 12 hours, the temperature rises to about -5°C; for the second sublimation for 4 hours, the temperature rises to 30°C, After pressing the cap, take it out, tie the cap, and you have it.

Embodiment 2

[0024] Embodiment 2: Dantrolene sodium freeze-dried powder injection

[0025] prescription:

[0026]

[0027] Preparation:

[0028] Weigh the prescribed amount of dantrolene sodium and add it to 80% water for injection heated to about 60°C to dissolve, then add the prescribed amount of dextran to adjust the pH value from 9.0 to 10.5, add 0.1% activated carbon for needles according to the prepared amount, keep warm and stir for 30 minutes, Filtration, decarbonization, and fine filtration with a 0.22 μm microporous membrane. After the intermediate is qualified, it is aseptically filled in a 2.7ml vial (theoretical amount of each bottle is 1ml), and the medicinal solution is placed in a freeze-drying box. Freeze for 3 hours to lower the temperature to about -45°C; for the first sublimation for 8 hours, the temperature rises to about -5°C; Instantly.

Embodiment 3

[0029] Embodiment 3: Dantrolene sodium freeze-dried powder injection

[0030] prescription:

[0031]

[0032] Preparation:

[0033] Weigh the prescribed amount of dantrolene sodium and add it to 80% water for injection heated to about 60°C to dissolve, then add the prescribed amount of glycine, sodium metabisulfite, sodium calcium edetate, stir and dissolve, adjust the pH value to 9.0-10.5, Add 0.1% activated carbon for needles according to the prepared amount, heat and stir for 30min, filter, decarbonize, and then finely filter with a 0.22 μm microporous membrane. After the intermediate is qualified, it is aseptically filled in a 5ml vial (theoretical 2ml), put the drug solution in a freeze-drying box, freeze for 3 hours, and make the temperature drop to about -45°C; the first sublimation takes 14-16 hours, and the temperature rises to about -5°C; the second sublimation is 4-6 After 1 hour, the temperature rises to 30°C, vacuum-press the lid, take it out, tie the lid, an...

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Abstract

The invention relates to lyophilized powder for injection with dantrolene sodium as an active ingredient and a preparation method and uses thereof. The lyophilized powder is a pharmaceutical composition formed by mixing dantrolene sodium as the active ingredient and pharmaceutically-acceptable adjuvant, and is mainly suitable for spastic hypermyotonia state caused by upper motor neuron damage due to various reasons, such as apoplexy, cerebral trauma, spinal injury and multiple sclerosis. A lyophilized powder for intravenous injection can be prepared by using dantrolene sodium as a raw material and adding certain types and proportion of adjuvants according to the technical proposal given in the invention.

Description

technical field [0001] The invention relates to a freeze-dried powder preparation with dantrolene sodium as an active ingredient and a preparation process thereof, belonging to the technical field of medicine. Background technique [0002] Dantrolene sodium, its chemical name is 1-{[5-(4-nitrophenyl)-2-furyl]methylene}amino-2,4-imidazolidinedione sodium salt 3.5 crystal water. [0003] Its structural formula is as follows: [0004] [0005] Dantrolene sodium is a muscle relaxant used directly on skeletal muscle. Its main site of action is the sarcoplasmic reticulum of skeletal muscle, which weakens muscle contraction by inhibiting the release of calcium ions from the sarcoplasmic reticulum. Dantrolene sodium is different from general muscle relaxants. Its unique mechanism is to directly act on skeletal muscle, and inhibit muscle contraction by inhibiting the release of calcium ions from the sarcoplasmic reticulum, thereby improving the patient's motor skills and increas...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4178A61P21/02
Inventor 陈瑞晶
Owner FUKANGREN BIO PHARMA
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