Povidone-iodine vaginal swelling suppository, as well as preparation method and detection method thereof

Abstract

The invention relates to a povidone-iodine vaginal swelling suppository, as well as a preparation method and a detection method thereof. The swelling suppository comprises a drug-containing matrix formed by povidone-iodine and a matrix, and a swelling carrier, wherein povidone-iodine, a capsule material and pregelatinized starch are used to prepare a micro-capsule, so that the volatilization of povidone-iodine can be reduced, and the effect of slowly releasing a drug can be achieved; nonoxynol-10, polyethylene glycol glyceride octoate caprate, stearyl alcohol and magnesium aluminum silicate are also added into the drug-containing matrix. The prepared swelling suppository is high in stability, and difficult in deformation or rancidity or melting and has good lubricating performance; seven original advanced technologies are adopted, so that the povidone-iodine vaginal swelling suppository has the beneficial effects of preventing liquid medicine from overflowing, avoiding secondary infection and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a povidone-iodine vaginal expansive suppository and a preparation method and a detection method thereof. Background technique [0002] Povidone-iodine, the chemical name is a compound of 1-vinyl-2-pyrrolidone homopolymer and iodine, the effective content of iodine is 9-12%; it is a yellow-brown to reddish-brown amorphous powder; in water or ethanol Dissolved, insoluble in ether or chloroform. [0003] Prior art discloses the preparation of multiple povidone-iodine, comprises tablet, oral liquid, gel, ointment and suppository etc.; The most widely, the 2010 edition of the Chinese Pharmacopoeia records povidone-iodine suppository, which is clinically used to treat candida vulvovaginosis, bacterial vaginosis and mixed infectious vaginitis, and has achieved remarkable curative effect; in addition, CN102335120 discloses A kind of povidone-iodine effervescent suppository is discl...

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Problems solved by technology

[0003] Prior art discloses the preparation of multiple povidone-iodine, comprises tablet, oral liquid, gel, ointment and suppository etc.; The most widely, the 2010 edition of the Chinese Pharmacopoeia records povidone-iodine suppository, which is clinically used to treat candida vulvovaginosis, bacterial vaginosis and mixed infectious vaginitis, and has achieved remarkable curative effect; in addition, CN102335120 discloses A kind of povidone-iodine effervescent suppository is disclosed, and this suppository comprises povidone-iodine, sodium bicarbonate, tartaric acid, S-40, polyethylene glycol 6000; CN1679621 discloses a kind of povidone-iodine capsule suppository, and it comprises polyvinyl chloride The mixture of povidone iodine, polyethylene glycol-32 glycerol laurate and stabilizer is injected into hard capsules; however, because povidone iodine has multiple iodine forms and is volatile; the validity period of the suppository is short and the quality cannot be guaranteed. Unsatisfactory stability and poor adhesion; the usual technical means is to reduce the volatilization of povidone-iodine by adding the stabilizer potassium iodate, but the effect is still not ideal; Clothing; the active ingredient has a small contact surface with the human body, resulting in insufficient absorption, and technical problems such as failure to exert the best curative effect of the formula

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