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Naloxone hydrochloride spraying agent for mouth and nose

A technology of naloxone hydrochloride and nasal spray, which is applied in the field of medicine, can solve the problems of drug decomposition, unstable chemical properties, limited use occasions, etc., and achieves fast onset of effect, controllable dosage, and small toxic and side effects. Effect

Inactive Publication Date: 2007-09-19
薛京 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although these naloxone hydrochloride preparations have the advantages of fast onset of action, high bioavailability, and easy dose adjustment and control, but because the molecular structure of naloxone hydrochloride contains a phenolic hydroxyl structure, its chemical properties are unstable, so when it is used During the preparation of aqueous injection preparations, the drug may be decomposed due to heat sterilization
Although the powder injection preparation can avoid the decomposition and deterioration of the drug caused by high temperature and has a relatively long storage period, it needs to be injected by professionally trained medical staff to the patient just like the water injection preparation, so the occasion of use is limited. extremely restrictive

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1: Naloxone hydrochloride spray

[0014] prescription:

[0015] Naloxone Hydrochloride 0.4g

[0016] Polyvinylpyrrolidone 0.6g

[0017] Geranylazepine 5ml

[0018] Caprylic Monoglyceride 0.05g

[0019] Citric acid 0.3g

[0020] Ethylparaben 0.1g

[0021] Dilute to 1000ml with water for injection

[0022] Preparation method: fully mix and dissolve the above prescription quantities of naloxone hydrochloride, polyvinylpyrrolidone, geranylazepine, caprylic monoglyceride, citric acid, and ethylparaben, and finally add Add water for injection to full volume to make a clear solution. After passing the sampling inspection, the obtained solution is distributed into spray pumps or quantitative drop pumps.

Embodiment 2

[0023] Embodiment 2: Naloxone hydrochloride spray

[0024] prescription:

[0025] Naloxone Hydrochloride 0.4g

[0026] Hydroxypropyl-β-cyclodextrin 0.8g

[0027] Laurylazepine 3ml

[0028] Macrogol 4000 1.0g

[0029] Tween 80 1.0g

[0030] Sorbic acid 0.1g

[0031] Dilute to 1000ml with water for injection

[0032] Preparation method: fully mix the above prescription amount of naloxone hydrochloride, hydroxypropyl-β-cyclodextrin, laurylazepine, polyethylene glycol 4000, Tween 80, and sorbic acid and dissolve them all , and finally add water for injection to the full amount to make a clear solution. After passing the sampling inspection, the obtained solution is distributed into spray pumps or quantitative drop pumps.

Embodiment 3

[0033] Embodiment 3: Naloxone hydrochloride spray

[0034] prescription:

[0035] Naloxone Hydrochloride 0.4g

[0036] Carboxymethylcellulose 1.0g

[0037] Citric acid 0.3g

[0038] Dilute to 1000ml with water for injection

[0039] Preparation method: Fully mix and dissolve the naloxone hydrochloride, carboxymethyl cellulose, and citric acid in the above prescription amount, and finally add water for injection to the full amount to make a clear solution. After passing the sampling inspection, the obtained solution is distributed into spray pumps or quantitative drop pumps.

[0040] The naloxone hydrochloride oral and nasal cavity spray provided by the invention is a colorless or off-white transparent liquid, and the dosage is within the range of 1-4ml each time.

[0041] In order to verify the efficacy of the naloxone hydrochloride oral and nasal cavity sprays provided by the present invention, the inventor has carried out a nasal cavity absorptio...

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PUM

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Abstract

The invention discloses a naloxone hydrochloride spraying agent for oral or nasal cavity, which is prepared by naloxone hydrochloride, naloxone free alkali or the other naloxone acceptable in medicine having a ratio by weight of 1:2.5~10 with pharmaceutic edjuvant based on general spraying agent preparation process. Active ingredient of the naloxone hydrochloride spraying agent for oral or nasal cavity in the invention can directly participate intracorporeal circulation after absorbed by capillary tube under oral or nasal mucosa of a patient, thus has advantages of fast absorption and high bioavailability, without stimulating to the oral or nasal mucosa. In particular, the drugs of the invention can be taken with no requirement of use situation, so that it is convenient for using which dosage is controllable and has little side effect.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a naloxone hydrochloride oral and nasal cavity spray. Background technique [0002] The chemical name of naloxone hydrochloride is 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride anhydrate, monohydrate or dihydrate. It is an opioid receptor antagonist, which has no intrinsic activity itself, but can competitively antagonize various opioid receptors, has a strong affinity for μ receptors, has the characteristics of rapid effect and strong antagonism, and is mainly used clinically. It is used to treat symptoms such as respiratory depression and coma caused by overdose of narcotic analgesics, which can cause patients to be highly excited and make their cardiovascular function hyperactive. The currently clinically used naloxone hydrochloride preparations are water injection preparations and powder injection preparations administered through subcutaneous, intramuscular or intr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K9/12A61P11/02A61Q11/00
Inventor 薛京赵艳
Owner 薛京
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