Medicinal preparations for treating inner ear diseases by transtympanic administration

A pharmaceutical preparation and drug delivery technology, which is applied in the field of pharmaceutical preparations for the treatment of inner ear diseases, can solve the problems of difficulty passing through the blood-inner ear barrier, short biological half-life, and large molecular weight, so as to improve local bioavailability, reduce drug concentration, Avoid the effect of blocking

Inactive Publication Date: 2010-04-07
GUANGDONG PHARMA UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, interferon is mainly administered by injection, and interferon belongs to polypeptide protein, which has poor stability in the body, is easily degraded by the enzyme system after systemic administration, and is quickly cleared or degraded after injection. In addition, its molecular weight (about 19kD) is relatively large, so it is more difficult to pass through the blood-inner ear barrier, and the interferon that actually reaches the target tissue (cochlea) is less effective. In order to achieve the curative effect, frequent, high-dose and long-term administration is required.

Method used

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  • Medicinal preparations for treating inner ear diseases by transtympanic administration
  • Medicinal preparations for treating inner ear diseases by transtympanic administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1 prepares solution

[0024] Human interferon α2b 10ml (4.6×10 8 IU);

[0025] Human albumin 1.0g;

[0026] Physiological saline was added to 100ml.

[0027] Take 70ml of normal saline into a 100ml graduated cylinder, add human serum albumin, stir to dissolve it fully, then add human interferon α2b and mix well, dilute to 100ml with normal saline, mix well and filter through a 0.45μm filter membrane.

[0028] The concentration of human interferon-alpha in the preparation prepared above was determined to be 41.5 μg / ml by double-antibody sandwich enzyme-linked immunosorbent assay (ELISA). Using healthy white red-eyed guinea pigs with normal tympanic membranes and weighing 250-300 g as experimental animals, the animals were randomly divided into human interferon α 2b tympanic injection group and human interferon α 2b Intravenous injection group; each group has 2 guinea pigs as the control group, injected with normal saline. Human interferon α 2b intratympan...

Embodiment 2

[0033] Embodiment 2 prepares solution

[0034] Human interferon α2b 10ml (4.6×10 8 IU);

[0035] Tween 80 (Tween 80) 0.01g;

[0036] Physiological saline was added to 100ml.

[0037] Take 70ml of normal saline into a 100ml graduated cylinder, add human serum albumin, stir to dissolve it fully, then add human interferon α2b and mix well, dilute to 100ml with normal saline, mix well and filter through a 0.45μm filter membrane.

[0038] Healthy white red-eyed guinea pigs with normal tympanic membranes and a body weight of 250-300 g were used as experimental animals, and the animals were randomly divided into two groups: ① Normal control group: 10 guinea pigs, 5 animals were taken for each cochlear tissue, homogenized, and the SOD activity and NO content; ②Human interferon group: 10 guinea pigs, daily intratympanic injection of human interferon α2b 0.1ml for 5 consecutive days, after 5 days, take cochlear tissue from 5 animals, homogenate, and measure SOD activity and NO conten...

Embodiment 3

[0043] Embodiment 3 prepares solution

[0044] Human interferon gamma 20ml (1.6×10 8 IU);

[0045] Tween 20 (Tween 20) 0.01g;

[0046] Mannitol 4.0g;

[0047] Sodium acetate 0.82g;

[0048] Add water for injection to 100ml.

[0049] Take 70ml of water for injection into a 100ml graduated cylinder, add sodium acetate, mannitol and Tween 20 in sequence, stir to dissolve, then add human interferon gamma and mix well, dilute with water for injection to 100ml, mix well and filter with a 0.45μm filter membrane to get the product .

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Abstract

The invention discloses medicinal preparations for treating inner ear diseases by transtympanic administration, which comprise interferon or interferon derivatives thereof serving as a main composition. The medicinal preparations are various transtympanica administration preparations consisting of the interferon and medicinal auxiliary materials, such as a liquid agent, spraying agent, a gelata, an ointment, a fine granule or microparticles and compound preparations combined by other formulations. The medicinal preparations are quick and efficient for treating the inner ear diseases, can improve the concentration of the medicament in the inner ear, have high local biological utilization, and avoid frequent, large-quantity and long-term administration.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a pharmaceutical preparation for treating inner ear diseases administered through a round window. Background technique [0002] The inner ear is an important part of human perception of the world, and it is also a sensitive organ. Inner ear diseases include Meniere's disease, vertigo, viral infection, deafness, etc., especially deafness has brought great suffering to patients. Deafness is an ancient topic and the center of otology research, and it is a common disease both at home and abroad. There are about 120 million hearing disabled people in the world; about 10% of people in the United States suffer from sensorineural hearing impairment; the hearing and speech disabled population in my country is 20.57 million, ranking first among the five types of disabled people. Moreover, with the development of industry, deafness caused by industrial noise continues unabated; with the aging of o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K47/48A61P27/16A61K47/54A61K47/60
Inventor 陈钢温露
Owner GUANGDONG PHARMA UNIV
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