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Methylphenidatefrozen dry powder preparation for injection and preparation process thereof

A technology of freeze-dried powder injection and dexmethylphenidate, which is applied in the field of dextromethylphenidate freeze-dried powder injection and its preparation, and can solve problems such as inability to achieve therapeutic effect, unstable medicine, and slow onset of action

Inactive Publication Date: 2010-03-31
STAR LAKE BIOSCI CO INC ZHAOQING GUANGDONG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the methylphenidate hydrochloride tablets currently on the market have a slow onset of action and cannot achieve a good therapeutic effect.
Compared with tablets, injections have a faster onset of action, but the drugs are relatively unstable

Method used

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  • Methylphenidatefrozen dry powder preparation for injection and preparation process thereof
  • Methylphenidatefrozen dry powder preparation for injection and preparation process thereof
  • Methylphenidatefrozen dry powder preparation for injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1 Dexmethylphenidate hydrochloride freeze-dried powder injection

[0014] prescription:

[0015]

[0016]

[0017] Preparation:

[0018] Take by weighing the prescribed amount of sodium bisulfite, dexmethylphenidate hydrochloride and add 80% water for injection to dissolve to make a solution of dexmethylphenidate hydrochloride, add the prescribed amount of mannitol, adjust the pH value to 3.0-9.5, and heat the medicinal solution to At about 60°C, add 0.1% activated carbon for needles according to the prepared amount, stir for 30 minutes, filter and decarbonize, and then use a 0.22 μm microporous membrane for fine filtration. After the intermediate is qualified, it is aseptically filled in a 10ml vial (per The theoretical volume of the bottle is 5ml), put the liquid in a freeze-drying box, and freeze for 4 hours, so that the temperature drops to about -45°C; the first sublimation takes 12 hours, and the temperature rises to about -5°C; the second sublim...

Embodiment 2

[0019] Embodiment 2: Dexmethylphenidate hydrochloride freeze-dried powder injection

[0020] prescription:

[0021]

[0022] Preparation:

[0023] Weigh the prescribed amount of sodium thiosulfate and dexmethylphenidate hydrochloride and add it to 80% water for injection heated to about 60°C to dissolve, then add the prescribed amount of dextran, adjust the pH value to 3.0-9.5, add 0.1% injection according to the prepared amount Activated carbon, insulated and stirred for 30 minutes, filtered, decarbonized, and then finely filtered with a 0.22 μm microporous membrane. After the intermediate was tested and qualified, it was aseptically filled in a 5ml vial (theoretical amount of each bottle was 2ml), and the liquid was placed in Freeze in a freeze-drying box 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; for the second sublimation for 4 hours, the temperature rises to 30°C, after vacuum cappin...

Embodiment 3

[0024] Embodiment 3: Dexmethylphenidate hydrochloride freeze-dried powder injection

[0025] prescription:

[0026]

[0027]

[0028] Preparation:

[0029] Weigh the prescribed amount of dexmethylphenidate hydrochloride 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 to dissolve and adjust the pH value to 3.0-9.5 , add 0.1% activated carbon for needles according to the prepared amount, heat and stir for 30 minutes, 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 (each bottle Theoretical amount is 2ml), put the drug solution in a freeze-drying box, and freeze for 3 hours, so that the temperature drops to about -45°C; the first sublimation takes 14 to 16 hours, and the temperature rises to about -5°C; the second sublimation is 4~ After 6 hours, the...

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Abstract

The invention relates to a methylphenidatefrozen dry powder preparation for injection and a preparation process thereof; the preparation takes the salt of the methylphenidatefrozen as drug constituents and forms the drug composite by mixing acceptable accessories pharmaceutically; the preparation method is that: the salt of the methylphenidatefrozen is taken as raw material, the accessories with specific kinds and proportion are added, and the dry powder preparation for intravenous injection is prepared and developed by adopting the illustrative technological measures. The dry powder preparation is used for treating attention deficiency hyperkinetic disorder (hyperkinetic syndrome of children and mild brain functional maladjustment), and eliminating somnolence, lassitude and respiratory depression caused by soporifics.

Description

technical field [0001] The invention relates to a dextromethylphenidate freeze-dried powder preparation and a preparation process thereof, belonging to the technical field of pharmacy. Background technique [0002] Methylphenidate is a central nervous system stimulant, and its hydrochloride is commonly used. Can excite a variety of mental activities in the central nervous system, reflexively excite the respiratory center through carotid body chemoreceptors in small doses, directly excite the medullary respiratory center in large doses, treat various depressions, autonomic dysfunction, and eliminate hypnotics. Drowsiness, overdose of sedatives, narcolepsy, enuresis, nocturnal excursion, attention deficit hyperactivity disorder (including hyperactivity syndrome in children, mild brain dysfunction), the mechanism of action of methylphenidate hydrochloride in the treatment of attention deficit hyperactivity disorder is not yet clear Clearly, one theory is that methylphenidate i...

Claims

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Application Information

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IPC IPC(8): A61K31/4458A61K9/19A61P25/14A61P25/00
Inventor 杨少侠王斌
Owner STAR LAKE BIOSCI CO INC ZHAOQING GUANGDONG
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