Nifuratel-nysfungin vaginal expandable suppository and its preparation method and detection method

Abstract

The invention relates to a nifuratel-nysfungin vaginal expandable suppository and its preparation method and detection method. The nifuratel-nysfungin vaginal expandable suppository comprises a drug-containing matrix comprising nifuratel, nysfungin and a matrix, and also comprises an expandable carrier. Through use of colloidal silicon dioxide in the drug-containing matrix, nysfungin hygroscopicity is reduced and suppository stability is improved. Nifuratel, nysfungin, povidone and hydroxypropyl methylcellulose form a skeleton clathrate so that nysfungin and nifuratel stability are further improved and the time of action produced by the active components on the vagina is further prolonged. Propylene glycol monostearate and Tween 80 can promote absorption of the active components by the vagina and suppository bioavailability is improved. The nifuratel-nysfungin vaginal expandable suppository utilizes seven novel lead-edge technologies and has the advantages of drug liquid leakage prevention, high stability, lasting curative effects and secondary infection prevention.

Description

Technical field [0001] The invention belongs to the field of vaginal suppositories, and particularly relates to a nifuratel-nystatin vaginal expansion suppository and a preparation method and a detection method thereof. Background technique [0002] Nystatin is a polyene antifungal antibiotic. It is a yellow or brownish-yellow powder, which attracts moisture, is unstable to light, air, acid and alkali, and is very slightly soluble in water. Clinically, it is mainly used for Candida albicans and other Candida infections. [0003] Nifuratel, the chemical name is: 5-[(methylthio)methyl]-3-[(5-nitrofurylidene)amino]-2-oxazolidinone, the structure is as follows: [0004] [0005] Nifuratel is a broad-spectrum antibiotic that has been marketed in more than 20 countries around the world. It is mainly used to treat vulvar and vaginal infections, vaginal discharge and urinary system infections caused by bacteria, trichomonas and candida. [0006] Nifurateil nystatin compound preparation is us...

AI Technical Summary

Problems solved by technology

[0007] Nifuratel-nystatin preparations mainly comprise vaginal gel at present, as, CN1927215 discloses the gel made by nysfuratel, nifuratel and gel matrix; Vaginal tablet, discloses as CN101332192 A vaginal tablet made of nystatin, nifuratel and auxiliary materials; the tablet affects the release of the drug due to the disintegration process; the gel has limited application because it is easy to breed bacteria, so clinically, Nifuratel-nystatin suppositories are the most widely used

[0008] Nifuratel-nystatin suppository was recorded in the "Compilation of Imported Drug Review Standards 2001"; there are not many studies on nifuratel-nystatin suppository in the prior art, because nystatin itself is unstable , directly make suppository, can reduce the stability of suppository; The dispersion between described nystatin and nifuratel is inhomogeneous; And the solubility of described nystatin and nifuratel is all poor, makes suppository Finally, it affects the bioavailability of the suppository; and the common nifuratel-nystatin suppository is not easy to clean, and it is easy to contaminate the clothes; the active ingredient has a small contact surface with the human body, which leads to insufficient absorption and does not play the best role of the prescription. efficacy and other technical issues

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