Flunarizine hydrochloride pills and preparation method thereof

A technology of flunarizine hydrochloride and dropping pills, which is applied in the fields of pill delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc. It can solve the problem of difficulty in controlling pill roundness due to differences in pill weight, low dissolution rate and dissolution rate , affect flunarizine hydrochloride and other issues, and achieve the effects of controllable pellet weight difference and pellet roundness, fast absorption and distribution, and high yield

Inactive Publication Date: 2010-06-02
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the flunarizine hydrochloride preparations currently on the market in my country only have capsules, which not only has a single dosage form, but also because flunarizine hydrochloride is very slightly dissolved in water, the disintegration time is long, and the dissolution rate and dissolution rate are low. Difficult and bedridden patients, especially stroke patients and epilepsy patients, are inconvenient to take and have poor compliance, which affects the full play of the clinical therapeutic effect of flunarizine hydrochloride
[0009] Although flunarizine hydrochloride capsules and drop pills are disclosed in the prior art, the production of existing drop pills is difficult to control the roundness of the weight difference and the pellets due to the limitations of technology, technology, equipment and other conditions. The qualified product rate is low, and there is no flunarizine hydrochloride salt dripping pills produced by improving the process technology and equipment disclosed in the literature, especially the dissolution performance is excellent, the weight difference of the pills and the roundness of the pills are controllable, and the yield rate is high and stable. Flunarizine Hydrochloride Dropping Pills with Good Properties and Fast Absorption and Distribution

Method used

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  • Flunarizine hydrochloride pills and preparation method thereof
  • Flunarizine hydrochloride pills and preparation method thereof
  • Flunarizine hydrochloride pills and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Flunarizine Hydrochloride 1.5g

[0041] Macrogol 4000 18g

[0042] Macrogol 6000 3.5g

[0043] —————————————

[0044] drops made of 1000 capsules

[0045] Preparation

[0046] Weigh and pulverize flunarizine hydrochloride raw material according to the prescription ratio, pass through an 80-mesh sieve, mix evenly with polyethylene glycol 4000 and polyethylene glycol 6000 bases, heat and melt, and stir well; Diameter cylindrical concave nozzle dripper drop system, use a drop pill forming machine to form pellets, use 50℃~-10℃ dimethyl silicone oil coolant gradient cooling, drop into pellets, deoil, and screen out the appropriate size Dropping pills, packaged, ready to use.

Embodiment 2

[0048] Flunarizine Hydrochloride 1.5g

[0049] Macrogol 4000 18g

[0050] Macrogol 6000 3.5g

[0051] ———————————

[0052] drops made of 1000 capsules

[0053] Preparation

[0054] Weigh and pulverize flunarizine hydrochloride raw material according to the prescription ratio, pass through an 80-mesh sieve, mix evenly with polyethylene glycol 4000 and polyethylene glycol 6000 bases, heat and melt, and stir well; Diameter cylindrical concave nozzle dripper drop system, use drop pill forming machine to form pills, use 50℃~-10℃ liquid paraffin coolant gradient cooling, drip into pills, deoil, and screen out suitable size drop pills , packaged, ready to serve.

Embodiment 3

[0056] Flunarizine Hydrochloride 1.5g

[0057] Macrogol 4000 18g

[0058] Macrogol 6000 3.5g

[0059] ———————————

[0060] drops made of 1000 capsules

[0061] Preparation

[0062] Weigh and pulverize flunarizine hydrochloride raw material according to the prescription ratio, pass through an 80-mesh sieve, mix evenly with polyethylene glycol 4000 and polyethylene glycol 6000 bases, heat and melt, and stir well; Diameter cylindrical concave nozzle dripper drop system, use drop pill forming machine to form pills, use 50℃~-10℃ vegetable oil coolant gradient cooling, drop into pills, deoil, and screen out the appropriate size of dropping pills, Pack and serve.

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Abstract

The invention discloses flunarizine hydrochloride pills which are prepared through the following steps: after evenly mixing 1-10 parts of flunarizine hydrochloride and 10-100 parts of matrices by weight, heating and melting the mixture, mixing up, using a diameter-limited cylindrical concave type pipe dripper for making drops under the heat-retaining condition of 70-95 DEG C, using a pill forming machine to form pills and using a coolant at temperature of 50-minus 10 DEG C for gradient cooling. Compared with the flunarizine hydrochloride capsules, the invention is characterized by fast in vitro dissolution, high dissolution and rapid in vivo absorption and distribution. Compared with the current pill production technology, the invention is characterized in that the prepared flunarizine hydrochloride pills have small pill weight different and good pill sphericity, high yield and more stable quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a flunarizine hydrochloride dropping pill and a preparation method thereof. Background technique [0002] Flunarizine hydrochloride is white or off-white crystal or crystalline powder; it is very slightly soluble in water and slightly soluble in methanol or ethanol; its English name is Flunarizine Hydrochloride, and its chemical name is (E)-1-[bis(4- Fluorophenyl)methyl]-4-(2-propenyl-3-phenyl)-piperazine dihydrochloride; its structural formula is 2HCl, the molecular formula is C 26 h 26 f 2 N 2 2HCl, [0003] The molecular weight is 477.42. [0004] Flunarizine hydrochloride is a selective calcium channel blocker and a selective calcium influx blocker to protect brain cells. It blocks or alleviates other ischemic injuries by antagonizing the intracellular calcium overload of the vestibulo-cochlear nucleus, and achieves brain protection and anti-vertigo effects....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61P9/10A61P25/06A61P25/08A61P25/00A61P21/02A61P17/02A61P9/14A61P13/12A61P27/16A61J3/06
Inventor 钱进陶琳穆正义廖新华王晓霞熊水根刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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