Recombinant human interferon alpha 2a vaginal expansion suppository and preparation and detection methods thereof

A technology of recombinant human interferon and vaginal expansion suppository, applied in the directions of suppository delivery, drug combination, pharmaceutical formulation, etc., can solve the problems of easily contaminated clothing, unsatisfactory, slow onset of effect, etc., to avoid secondary infection and prevent outflow. Effect

Active Publication Date: 2014-04-30
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage form development of recombinant human interferon α2а has been very unsatisfactory, which has affected the application of recombinant human interferon α2а. The current marketed preparations mainly include tablets and suppositories; but after the tablet is inserted into the vagina, recombinant human interferon α2а is difficult to dissolve and difficult It plays a role, and the adaptability of the tablet to the human vagina is not good; while the general suppository has the disadvantages of slow disintegration, difficulty in absorption, inconvenient use, slow onset of action, and contamination of clothing. The therapeutic effect is affected by the patient's position when using it. Drugs are difficult to access to the affected area on the ventral side of the posterior fornix of the vagina
Chinese patent CN1970079A discloses an efferves

Method used

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  • Recombinant human interferon alpha 2a vaginal expansion suppository and preparation and detection methods thereof
  • Recombinant human interferon alpha 2a vaginal expansion suppository and preparation and detection methods thereof
  • Recombinant human interferon alpha 2a vaginal expansion suppository and preparation and detection methods thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091]

[0092] Preparation:

[0093] 1) Preparation of matrix:

[0094] Mix semi-synthetic litsea cubeba and gum arabic, heat and melt in a water bath to obtain a melt;

[0095] 2) Pour the matrix into the plug mold, insert the sliver, cool and shape, and make 100 conical matrix plug cores;

[0096] 3) Spray the recombinant human interferon α2a on the matrix plug core prepared in step 2) in a discontinuous spray form, and form a drug-containing layer on the matrix plug core to obtain the recombinant human interferon α2а vaginal expansion suppositories, each weighing about 3.3g.

Embodiment 2

[0098]

[0099] Preparation:

[0100] 1) Preparation of matrix:

[0101] a. Mix semi-synthetic palm oil ester and propylene glycol stearate, place in a water bath and heat and melt to obtain a melt;

[0102] b. mixing cetyl alcohol with the melt of step a to obtain a matrix;

[0103] 2) Pour the matrix into the plug mold, insert the sliver, cool and shape, and make 100 cylindrical matrix plug cores;

[0104] 3) Spray the recombinant human interferon α2a on the matrix plug core prepared in step 2) in a discontinuous spray form, and form a drug-containing layer on the matrix plug core to obtain the recombinant human interferon α2а vaginal expansion suppositories, each weighing about 3.3g.

Embodiment 3

[0106]

[0107] Preparation method: make 100 rod-shaped suppositories according to the method in Example 2, each weighing about 4.9g.

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Abstract

The invention relates to a recombinant human interferon alpha 2a vaginal expansion suppository and preparation and detection methods thereof. The expansion suppository comprises a medicated mucous layer, a substrate layer and an expansion carrier; the medicated mucous layer consists of recombinant human interferon alpha 2a and a protective agent, wherein the protective agent improves the stability of recombinant human interferon alpha 2a; when in local application, the medicated mucous layer can form mucosa by which the medicated mucous layer can be attached on vaginal skin to promote skin absorption so as to further improve the bioavailability of the suppository. The expansion suppository is characterized in that a substrate further comprises a specific hardening agent. Due to the adoption of six unique leading technologies, the recombinant human interferon alpha 2a vaginal expansion suppository has the beneficial effects of preventing outflow of liquid medicine, being high in stability and lasting in curative effect, and preventing superinfection, etc.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a recombinant human interferon α2а vaginal expansive suppository and a preparation method and detection method thereof. Background technique [0002] Recombinant human interferon α2а is a kind of multifunctional and highly active inducible protein produced by leukocytes and lymphocytes, which is unstable when exposed to light and humidity; it is mainly used for the treatment of cervicitis clinically, mainly relying on its wide Spectrum antiviral effect and immune regulation function on the body. The dosage form development of recombinant human interferon α2а has been very unsatisfactory, which has affected the application of recombinant human interferon α2а. The current marketed preparations mainly include tablets and suppositories; but after the tablet is inserted into the vagina, recombinant human interferon α2а is difficult to dissolve and difficult It plays a role, and t...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K38/21A61P15/00A61P31/12A61P37/02G01N33/15G01N5/04
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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