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Cinnarizine powder injection containing HPCD, its solid preparation and preparation method

A technology of solid preparations and cinnarizine, which is applied in the field of medicine and can solve problems such as the preparation process and stability system reports of CN powder injections that have not been seen.

Inactive Publication Date: 2004-07-28
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After literature search, there is no systematic report on the prescription, preparation process and stability of CN powder injection or other solid preparations in domestic and foreign literature, and no patent application in China

Method used

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  • Cinnarizine powder injection containing HPCD, its solid preparation and preparation method
  • Cinnarizine powder injection containing HPCD, its solid preparation and preparation method
  • Cinnarizine powder injection containing HPCD, its solid preparation and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Embodiment 1: the preparation of cinnarizine powder injection (freeze-drying method)

[0092] prescription:

[0093] Cinnarizine 4.0g (1.08×10 -2 mol)

[0094] Hydroxypropyl-β-cyclodextrin 100g (8.3×10 -2 mol)

[0095] Hydrochloric acid amount

[0096] Appropriate amount of sodium hydroxide

[0097] Water for injection 1000ml

[0098] Preparation Process:

[0099] Dissolve the prescribed amount of hydroxypropyl-β-cyclodextrin in an appropriate amount of water, and adjust the pH to 1.5 with hydrochloric acid. Take another prescribed amount of cinnarizine and add it to the above aqueous solution, stir and ultrasonically dissolve it, then add sodium hydroxide to adjust the pH to 3.0 to make a clear solution, and then add mannitol as a skeleton material or an isotonic regulator , Stir and heat in a water bath to make a homogeneous solution. And add water to a sufficient amount. Then filter through a sterile G6 lysis funnel. After passing the inspection, the filtr...

Embodiment 2

[0100] Embodiment 2: the preparation of cinnarizine powder injection (spray drying method)

[0101] prescription:

[0102] Cinnarizine 4.0g (1.08×10 -2 mol)

[0103] Hydroxypropyl-β-cyclodextrin 100g (8.3×10 -2 mol)

[0104] Hydrochloric acid amount

[0105] Appropriate amount of sodium hydroxide

[0106] Water for injection 1000ml

[0107] Preparation Process:

[0108] Take the prescribed amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water; adjust the pH to 1.5 with hydrochloric acid. Take another prescribed amount of cinnarizine and add it to the above aqueous solution, stir and ultrasonically dissolve it, then add sodium hydroxide to adjust the pH to 3.0 to make a clear solution, and add water to a sufficient amount. Then filter through a sterile G6 lysis funnel. After the filtrate is qualified, the obtained powder is mixed with the prescribed amount of glucose by spray drying method, and then aseptically packaged to obtain the ...

Embodiment 3

[0109] Embodiment 3: the preparation of cinnarizine tablet

[0110] prescription:

[0111] Cinnarizine 4.0g (1.08×10 -2 mol)

[0112] Hydroxypropyl-β-cyclodextrin 100g (8.3×10 -2 mol)

[0113] Hydrochloric acid amount

[0114] Appropriate amount of sodium hydroxide

[0115] Filler 20%-80%

[0116] Binder 10%-20%

[0117]Disintegrant 0.5%-5%

[0118] Lubricant 0.3%-1.5%

[0119] Water for injection 1000ml

[0120] Preparation Process:

[0121] Take the prescribed amount of hydroxypropyl-β-cyclodextrin and dissolve it in an appropriate amount of water; adjust the pH to 1.5 with hydrochloric acid. Take another prescribed amount of cinnarizine and add it to the above aqueous solution, stir and ultrasonically dissolve it, then add sodium hydroxide to adjust the pH to 3.0 to make a clear solution, and add water to a sufficient amount. Then filter with a sterilized G6 vertical dissolution funnel, and freeze-dry to obtain the inclusion compound freeze-dried powder. Take a...

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Abstract

The present invention relates to a cinnarizine powder injection containing HPCD, its solid preparation and preparation method. It has good solubility and stability. It adopts the hydroxypropyl-beta-cyclodextrin (HP-beta-CD) as inclusion compound to prepare the invented cinnarizine powder injection containing the water soluble cyclodextrin derivative-HP-beta-CD capable of raising solubility of medicine in water. It mainly includes the solid dosage forms of tablet, capsule and granules preparation. It also provides its preparation method and concrete steps.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a HPCD-containing cinnarizine powder injection, a solid preparation thereof and a preparation method thereof. Background technique: [0002] CN is a new type of diphenylpiperazine calcium ion channel antagonist, and its expansion of cardiovascular and cerebrovascular effects and therapeutic effects on angina pectoris have been confirmed in early studies. CN directly dilates vascular smooth muscle, significantly improves cerebral circulation and coronary circulation, and has an antagonistic effect on vasoconstrictor drugs such as 5-hydroxytryptamine, epinephrine, bradykinin, vasopressin, and dopamine, which can relieve vasospasm and prevent vascular fragility. change. Oral administration of this product has no effect on blood pressure, and it can cause a short-term drop in blood pressure after intravenous injection, but it is absorbed quickly. The antispasmodic effect is stron...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K9/20A61K9/48A61K31/495A61K47/40A61P9/10
Inventor 张天虹赵春顺林昀何仲贵
Owner SHENYANG PHARMA UNIVERSITY