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Oral cavity instant membrane agent containing rizatriptan benzoate and preparation method thereof

A technology of rizatriptan benzoate and oral instant film, which is applied in the field of medicine, can solve problems such as rising, drug recrystallization, and uneven drug distribution, and achieve simple process, shortened production cycle, and stable drug production quality Effect

Active Publication Date: 2019-05-10
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the process of solvent volatilization, the local drug concentration will continue to rise, which is likely to cause recrystallization of the drug, especially for insoluble drugs, which are more likely to precipitate, resulting in problems such as uneven distribution of the drug in the film
In addition, the heating process is also a severe test for drugs with poor thermal stability.

Method used

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  • Oral cavity instant membrane agent containing rizatriptan benzoate and preparation method thereof
  • Oral cavity instant membrane agent containing rizatriptan benzoate and preparation method thereof
  • Oral cavity instant membrane agent containing rizatriptan benzoate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] prescription:

[0043] Rizatriptan Benzoate 363.25mg

[0044] Polyvinyl alcohol 18-88 1.651g

[0045] Preparation method: dissolve polyvinyl alcohol 18-88 in 30ml of water, add rizatriptan benzoate, stir to dissolve it, and let stand for 3 hours to remove air bubbles. Inhale the above mixed solution into the syringe, control the liquid flow to 0.6ml / h, the electrospinning voltage to 15kV, and the receiving distance to 15cm, and wrap the receiving plate with aluminum foil to start collecting the nanofiber membrane. The collected nanofibrous membranes were dried in a vacuum desiccator for 3 days. Then remove the film and cut into films containing rizatriptan 5 / 10mg each.

Embodiment 2

[0047] prescription:

[0048] Rizatriptan Benzoate 363mg

[0049] Polyvinylpyrrolidone K60 1.65g

[0050] Preparation method: Dissolve polyvinylpyrrolidone K60 in 35ml of water, add rizatriptan benzoate, stir to dissolve, and let stand for 3 hours to remove air bubbles. Inhale the above mixed solution into the syringe, control the flow rate to 0.6ml / h, the electrospinning voltage is 16kV, the receiving distance is 15cm, wrap the receiving plate with aluminum foil, and start collecting the nanofiber membrane. The obtained nanofibrous film is placed in a vacuum desiccator and dried for 3 days, and the film is removed and cut into films containing 5 / 10 mg of rizatriptan.

Embodiment 3

[0052] prescription:

[0053] Rizatriptan Benzoate 363.25mg

[0054] Polyoxyethylene alcohol N-80 1.65g

[0055] Preparation method: dissolve polyoxyethylene N-80 in 30ml of water, add rizatriptan benzoate, stir to dissolve it, and let stand for 3 hours to remove air bubbles. Inhale the above mixed solution into the syringe, control the flow rate of 0.6 ml / h, the voltage of electrospinning is 18kV, the receiving distance is 16cm, the receiving plate is wrapped with aluminum foil, and the nanofiber membrane is collected. The nanofibrous membrane that collects is placed in vacuum desiccator and dried for 3 days, defilmed, and cut into each film containing rizatriptan 5 / 10mg to get final product.

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Abstract

The invention belongs to the technical field of medicines, and relates to an oral cavity instant membrane agent containing rizatriptan benzoate prepared by using an electrostatic spinning technology.The formula of the oral cavity instant membrane agent comprises, 1 part of the rizatriptan benzoate, 1-300 parts of a membrane forming material and 0-50 parts of other auxiliaries. An oral cavity instant membrane is obtained through the electrostatic spinning technology, the electrostatic spinning conditions are that the voltage is 5-20 kV, the proceeding speed is 0.1-10 ml / h, the receiving distance is 5-20 cm, the temperature is 5-60 DEG C, and the humidity is 10-70%. The oral cavity instant membrane agent is composed of nano polymer fibers formed by electrostatic spinning, and the diameter of the nano polymer fibers is 10-1000 nm. The rizatriptan benzoate is uniformly distributed without a fixed form state. The oral cavity instant membrane agent containing the rizatriptan benzoate has higher specific surface area and porosity and faster dissolution rate, the effect comes up faster, the biological utilization rate is higher, and the pain of a patient with migraine can be rapidly relieved.

Description

technical field [0001] The invention belongs to the technical field of medicines, relates to an oral instant film, in particular to an oral instant film containing rizatriptan benzoate and a preparation method thereof. Background technique [0002] Migraine is a chronic disease, clinically manifested as intense and intermittent headache on one side, which brings great pain to the patient and seriously affects the quality of life of the patient. Epidemiological investigation shows that the incidence rate of migraine in my country is 4.2-14.6%, and the incidence rate of women (18%) is higher than that of men (6%). About 80% of migraine patients will be accompanied by nausea, vomiting or other symptoms of intestinal disorders, which seriously affects the compliance and effective absorption of oral medicines. Therefore, it is of great significance to develop dosage forms with rapid onset and good compliance for the treatment of migraine. [0003] The first triptan drug, sumatr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/32A61K47/10A61K47/38A61K47/36A61K31/4196A61P25/06
Inventor 杨明世寸冬梅郭雄
Owner SHENYANG PHARMA UNIVERSITY
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