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Flunarizine hydrochloride capsule preparation and preparation method thereof

A technology for flunarizine hydrochloride and preparation, which is applied in the field of flunarizine hydrochloride capsule preparation and preparation thereof, can solve the problem of unrealized, unsatisfactory requirements for consistency evaluation of generic drugs, unclear similarity and in vivo bioequivalence It can save manpower and material resources, have excellent stability, and achieve the effect of simple process.

Active Publication Date: 2021-08-17
CHIATAI QINGCHUNBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the products obtained by these technical solutions have been improved, they have not achieved or have not clearly demonstrated the similarity of the in vitro dissolution curve and in vivo bioequivalence with the original preparations, and do not meet the requirements for the consistency evaluation of generic drugs.

Method used

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  • Flunarizine hydrochloride capsule preparation and preparation method thereof
  • Flunarizine hydrochloride capsule preparation and preparation method thereof
  • Flunarizine hydrochloride capsule preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] 1. Quality composition of flunarizine hydrochloride preparation: 5.9 parts of flunarizine hydrochloride, 0.8 parts of silicon dioxide, 30 parts of corn starch, 15 parts of talcum powder, 18 parts of lactose GranuLac70, 90 parts of lactose GranuLac200, 3 parts of stearic acid magnesium.

[0039] 2. Preparation: Premix 0.59 kg of flunarizine hydrochloride and 0.08 kg of silicon dioxide for 10 minutes according to the formula, sieve through a granulator with a sieve aperture of 1.5 mm, then continue to mix for 15 minutes, and then add in equal increments 3kg of cornstarch, 1.8kg of lactose GranuLac70 and 9.0kg of lactose GranuLac200 were mixed evenly, and finally 1.5kg of talcum powder and 0.3kg of magnesium stearate were added, mixed evenly, and filled into capsules.

Embodiment 2

[0041] 1. Formula: 5.9 parts of flunarizine hydrochloride, 0.6 parts of colloidal silicon dioxide, 25 parts of corn starch, 12 parts of talcum powder, 29 parts of lactose GranuLac70, 87 parts of lactose GranuLac200, 1.0 part of magnesium stearate.

[0042] 2. Preparation: Premix 0.59kg of flunarizine hydrochloride, 0.06kg of colloidal silicon dioxide, 2.5kg of cornstarch and 1.2kg of talcum powder for 15 minutes, sieve through a granulator with a sieve aperture of 0.6mm, and continue mixing for 30 minutes , and then add 2.9kg of lactose GranuLac70 and 8.7kg of lactose GranuLac200 according to the method of equal increase, mix well, finally add 0.1kg of magnesium stearate, mix well and then fill the capsule.

Embodiment 3

[0044] 1. Formula: 5.9 parts of flunarizine hydrochloride, 0.5 parts of colloidal silicon dioxide, 20 parts of corn starch, 12 parts of talcum powder, 40 parts of lactose GranuLac70, 80 parts of lactose GranuLac200, 1.5 parts of magnesium stearate.

[0045] 2. Preparation: Premix 0.59kg of flunarizine hydrochloride, 0.05kg of colloidal silicon dioxide, and 2.0kg of corn starch according to the formula for 10 minutes, sieve through a granulator with a sieve aperture of 1.0mm, and then continue to mix for 20 minutes. Then add 4.0 kg of lactose GranuLac70 and 8.0 kg of lactose GranuLac200 in equal increments, mix well, and finally add 1.2 kg of talcum powder and 0.15 kg of magnesium stearate, mix well, and fill the capsules.

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Abstract

The invention discloses a flunarizine hydrochloride capsule preparation and a preparation method thereof. The flunarizine hydrochloride capsule preparation is prepared from the following raw materials in parts by weight: 2-10 parts of flunarizine hydrochloride, 100-150 parts of lactose, 10-40 parts of starch, 0.1-1 part of a flow aid and 2-20 parts of a lubricant. The flunarizine hydrochloride capsule prepared by the invention is placed for 3 months under a high-temperature experimental condition, the dissolution curve of the flunarizine hydrochloride capsule in a medium with a pH value of 3.0 has no obvious change, and an f2 value is greater than 50; and the dissolution curve of an original developed preparation is obviously reduced, and the f2 value is 12.7. The in-vitro dissolution curve stability of the flunarizine hydrochloride capsule prepared by the invention is superior to the in-vitro dissolution curve stability of the original preparation.

Description

[0001] (1) Technical field [0002] The invention relates to a flunarizine hydrochloride capsule preparation and a preparation method thereof. [0003] (2) Background technology [0004] Flunarizine hydrochloride is a selective calcium antagonist, which can block excessive calcium ions from transmembrane into cells, prevent intracellular calcium overload, and prevent a large amount of calcium from entering neurons during ischemia and hypoxia, improving brain microcirculation And neuron metabolism, inhibition of cerebral vasospasm, platelet aggregation and increased blood viscosity, etc., in addition to cell membrane stabilization. Clinically, it is mainly used for the preventive treatment of typical (with aura) or atypical (without aura) migraine and the symptomatic treatment of vertigo caused by vestibular dysfunction. [0005] The Chinese invention patent with the application number 200610001531.8 discloses a flunarizine hydrochloride capsule and its preparation method. The ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/495A61K47/36A61P25/06A61P1/08A61P25/00
CPCA61K31/495A61K9/4866A61P25/06A61P1/08A61P25/00
Inventor 陈世友张育乐骆可刘晓云
Owner CHIATAI QINGCHUNBAO PHARMA
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