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Flunarizine hydrochloride capsules and preparation method thereof

A technology of flunarizine hydrochloride and capsules, which is applied to the oral capsule preparation of flunarizine hydrochloride and the field of preparation thereof, can solve the problems such as insufficient quality stability, unfavorable clinical medication safety, decreased dissolution rate and the like

Inactive Publication Date: 2015-03-04
SHIJIAZHUANG HUAXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After research and analysis, it is found that the current flunarizine hydrochloride oral solid preparation products have insufficient quality stability: the quality stability of the product is poor, and during long-term storage, the content of active ingredients is significantly reduced, and the content of impurities is significantly increased. The dissolution rate drops significantly, and the quality is not stable enough, which is not conducive to ensuring the safety of clinical medication

Method used

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  • Flunarizine hydrochloride capsules and preparation method thereof
  • Flunarizine hydrochloride capsules and preparation method thereof
  • Flunarizine hydrochloride capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The preparation of embodiment 1 flunarizine hydrochloride capsules

[0029] prescription:

[0030]

[0031] Preparation:

[0032] a) get flunarizine hydrochloride crude product 100g, add ethanol 600ml to dissolve, obtain flunarizine hydrochloride ethanolic solution;

[0033] b) Add flunarizine hydrochloride 2-5% activated carbon by weight to the ethanol solution of flunarizine hydrochloride obtained in step a), stir and decolorize at 40-50° C. for 0.5-1 hour, filter, and collect the filtrate;

[0034] c) Add 60ml of N,N-dimethylformamide to the filtrate obtained in step b), concentrate under reduced pressure, the concentration temperature is 30°C, the vacuum degree is -0.08MPa~-0.1MPa, and concentrate until flunarizine hydrochloride and The weight g)-volume ml ratio of ethanol is 1:1.8;

[0035] d) Cool down the concentrated solution obtained in step c) to 1°C, stir and crystallize, the stirring time is 1.5 hours, the stirring speed is 45 rpm, and the crystals are...

Embodiment 2

[0039] The preparation of embodiment 2 flunarizine hydrochloride capsules

[0040] prescription:

[0041]

[0042] Preparation:

[0043] a) get flunarizine hydrochloride crude product 100g, add ethanol 500ml to dissolve, obtain flunarizine hydrochloride ethanolic solution;

[0044]b) Add flunarizine hydrochloride 2-5% activated carbon by weight to the ethanol solution of flunarizine hydrochloride obtained in step a), stir and decolorize at 40-50° C. for 0.5-1 hour, filter, and collect the filtrate;

[0045] c) Add 50ml of N,N-dimethylformamide to the filtrate obtained in step b), concentrate under reduced pressure, the concentration temperature is 25°C, the vacuum degree is -0.08MPa~-0.1MPa, and concentrate until flunarizine hydrochloride and The weight g)-volume ml ratio of ethanol is 1:1.6;

[0046] d) Cool down the concentrated solution obtained in step c) to 0°C, stir and crystallize, the stirring time is 1 hour, the stirring speed is 30 rpm, and the crystals are sep...

Embodiment 3

[0050] The preparation of embodiment 3 flunarizine hydrochloride capsules

[0051] prescription:

[0052]

[0053] Preparation:

[0054] a) get flunarizine hydrochloride crude product 100g, add ethanol 700ml to dissolve, obtain flunarizine hydrochloride ethanolic solution;

[0055] b) Add flunarizine hydrochloride 2-5% activated carbon by weight to the ethanol solution of flunarizine hydrochloride obtained in step a), stir and decolorize at 40-50° C. for 0.5-1 hour, filter, and collect the filtrate;

[0056] c) Add 70ml of N,N-dimethylformamide to the filtrate obtained in step b), concentrate under reduced pressure, the concentration temperature is 35°C, the vacuum degree is -0.08MPa~-0.1MPa, and concentrate until flunarizine hydrochloride and The weight g)-volume ml ratio of ethanol is 1:1.8;

[0057] d) Cool down the concentrated solution obtained in step c) to 2°C, stir and crystallize, the stirring time is 2 hours, the stirring speed is 60 rpm, and the crystals are s...

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Abstract

The invention relates to an oral capsule preparation of flunarizine hydrochloride and a preparation method thereof, belonging to the technical field of medicines. The capsule comprises the following components in parts by weight: 58-60 parts of flunarizine hydrochloride, 114-115 parts of starch, 212.6-213 parts of 63 percent ethanol, 35.3-35.5 parts of sodium carboxymethyl starch and 11.6-12 parts of magnesium stearate. The flunarizine hydrochloride disclosed by the invention has high quality stability, the quality of the flunarizine hydrochloride capsules is stable and controllable, and safety and effectiveness of clinical application are ensured.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to an oral capsule preparation of flunarizine hydrochloride and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Flunarizine hydrochloride, chemical name: (E)-1-[bis(4-fluorophenyl)methyl]-4-(2-propenyl-3-phenyl)-piperazine dihydrochloride, molecular formula :C 26 h 26 f 2 N 2 2HCl, molecular weight: 477.42, chemical structure as follows [0003] [0004] Flunarizine hydrochloride is a calcium channel blocker that can prevent cell damage caused by intracellular pathological calcium overload caused by ischemia and other reasons. It is suitable for cerebral arteriosclerosis, cerebral thrombosis, cerebral embolism, cerebral circulation disorder caused by hypertension, cerebral hemorrhage, cerebral circulation disorder caused by arachnoid, cerebral hemorrhage, etc. Indications: Vasodilators. For the treatment of cerebral a...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/495A61P9/10A61P7/04
Inventor 张硕张云王敏薛星郭瑜马海波吴少聪
Owner SHIJIAZHUANG HUAXIN PHARMA
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