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Pharmaceutical product comprising transnasal dexmedetomidine composition

A technology of dexmedetomidine and a composition, applied in the field of pharmaceutical preparations, can solve problems such as product deterioration, increase in foreign bodies, deepening color, etc., and achieve the effects of satisfying clinical sedation, excellent stability, and avoiding inflammation problems

Active Publication Date: 2020-08-04
JIANGSU HENGRUI MEDICINE CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] During the process of preparing or placing the pharmaceutical composition of dexmedetomidine for a long time, problems such as increased foreign matter and deepened color may occur, resulting in product deterioration

Method used

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  • Pharmaceutical product comprising transnasal dexmedetomidine composition
  • Pharmaceutical product comprising transnasal dexmedetomidine composition
  • Pharmaceutical product comprising transnasal dexmedetomidine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Preparation prescription:

[0039]

[0040] Use a stainless steel container to prepare, weigh the prescribed amount of edetate disodium, add about 70% of the total volume to purified water, and stir to dissolve. Add the prescribed amount of dexmedetomidine hydrochloride to the above solution, and stir to dissolve. Adjust the pH value of the solution to 6.0 with sodium hydroxide, and add purified water to the full amount. After contacting with stainless steel for 4 hours, the liquid medicine is divided into 5ml medium borosilicate glass molded bottles, and the cap is screwed on by the spray pump.

Embodiment 2

[0042]Each preparation product of Example 1 was placed in a constant temperature and humidity chamber at 40°C and 60°C, and the stability of the product was investigated with content, related substances and other items as the main inspection indicators. Detection method: detection by high performance liquid chromatography system, the chromatographic column is Waters X-BridgeTM Shield RP18 (5μm, 4.6×250mm), mobile phase A is 0.1M sodium phosphate buffer solution (add 1% triethylamine, adjust pH to 3.5), mobile phase B is methanol, detection wavelength: 214nm. The test results are shown in the table below.

[0043]

[0044] The results show that there is no significant difference in the stability of the preparation without EDTA-2Na compared with adding 0.005%, 0.01%, 0.02% EDTA-2Na. In addition, after preparation 1 was placed under various conditions, the preparation system was still colorless and clear, with a good appearance.

Embodiment 3

[0046]

[0047] Use a stainless steel container to prepare, weigh the benzalkonium chloride and sodium chloride of the prescription amount, add about 90% of the total volume of the preparation in purified water, stir at room temperature until dissolved, then add the prescription amount of dexmedetomidine hydrochloride, continue to stir until Dissolve, adjust the pH to 6.0 with 0.1M sodium hydroxide, add purified water to the full amount, and continue stirring until the mixture is uniform. Use a peristaltic pump to filter the prepared drug solution through a 0.45 μm filter disc (PES), and finally fill it into a 5 ml medium borosilicate glass molded bottle, and screw the cap with a spray pump.

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PUM

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Abstract

The present invention relates to a pharmaceutical product comprising a transnasal dexmedetomidine composition. Specifically, the present invention relates to a pharmaceutical product comprising a nasal administration dexmedetomidine pharmaceutical composition and a device, the product having excellent stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical product and a preparation method comprising a nasally administered dexmedetomidine pharmaceutical composition and a device. Background technique [0002] Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative hypnotic, anxiolytic, analgesic and sympathetic block effects, and is an effective sedative, analgesic and anesthesia auxiliary drug . Dexmedetomidine hydrochloride was first jointly developed by Abbott of the United States and Olean of Finland, and is currently on the market in more than 30 countries and regions around the world. The drug provides a unique type of sedation, that is, "sedation with preserved consciousness", and can reduce the amount of anesthesia and analgesic drugs during the operation, effectively inhibit the stress state during the perianesthesia period, improve the patient's hemodynamics, and h...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K31/4174A61K47/02A61K47/18A61P25/20A61P29/00A61P23/00A61M15/00A61M11/00
CPCA61K9/0043A61K31/4174A61K47/02A61K47/186A61P25/20A61P29/00A61P23/00A61M15/0068A61M15/0001A61M11/00
Inventor 仝新勇邹爱峰王海凤周银王萍萍
Owner JIANGSU HENGRUI MEDICINE CO LTD
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