Recombinant human interferon α2а vaginal expansion suppository and its preparation method and detection method

Abstract

The invention relates to a recombinant human interferon α2а vaginal expansive suppository and a preparation method and a detection method thereof. The expansive suppository includes a drug-containing mucous layer, a matrix layer and an expansion carrier formed by recombinant human interferon α2а and a protective agent; the protective The drug improves the stability of recombinant human interferon α2а; at the same time, when it is applied topically, the drug-containing mucous layer can form a mucous membrane, and the drug-containing mucous layer can be adsorbed on the vaginal skin to promote skin absorption and further improve the biological activity of the drug. Utilization; Further, the matrix of the suppository also includes a specific hardening agent; and the recombinant human interferon α2а vaginal expansion suppository provided by the present invention adopts six original leading technologies, which has the advantages of preventing the outflow of medicinal liquid, high stability, and high efficacy. Long-lasting, beneficial effects such as preventing secondary infection.

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 white blood cells and lymphocytes, which is unstable when exposed to light and humidity; it is mainly used in the treatment of cervicitis clinically, mainly relying on its broad 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...

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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