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

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...

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 effervescent tablet made of recombinant human interferon α2а as an active ingredient; although it can fully contact the drug with the lesion to exert its efficacy, it cannot solve the stability of recombinant human interferon α2а and the adaptability of preparations to the human body; and there are few studies on recombinant human interferon α2а suppositories in the prior art, and because the nature of recombinant human interferon α2а itself is unstable, after being made into suppositories, the stability is poor; and ordinary recombinant human interference Su α2а suppositories also have technical problems such as not being easy to clean and easily contaminating clothes; the contact surface between the active ingredient and the human body is small, resulting in insufficient absorption and failure to exert the best curative effect of the prescription.

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