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Povidone-iodine vaginal expansion suppository and its preparation method and detection method

A vaginal expansion suppository, povidone-iodine technology, applied in the directions of suppository delivery, measuring device, pharmaceutical formulation, etc., can solve the problems of short validity period of suppository, volatile, small contact surface of active ingredients, etc., to avoid secondary infection, prevent outflow effect

Active Publication Date: 2016-01-13
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

[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

Method used

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  • Povidone-iodine vaginal expansion suppository and its preparation method and detection method
  • Povidone-iodine vaginal expansion suppository and its preparation method and detection method
  • Povidone-iodine vaginal expansion suppository and its preparation method and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092]

[0093] Preparation:

[0094] 1) Preparation of drug-containing matrix:

[0095] a. placing cocoa butter and carbomer in a water bath for heating and melting to obtain a melt;

[0096] b. adding povidone-iodine to the melt of step a, and mixing uniformly to obtain a drug-containing matrix;

[0097] 2) Preparation of expansive suppositories: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 conical suppositories, each weighing about 3.2g.

Embodiment 2

[0099]

[0100] Preparation:

[0101] 1) Preparation of drug-containing matrix:

[0102] a. heat and melt tallow tallow and alginic acid in a water bath to obtain a melt;

[0103] B. the preparation of povidone-iodine microcapsules: add povidone-iodine in glyceryl stearate and polyvinylpyrrolidone, grind to uniform, make povidone-iodine grind; Add water at a ratio of 1:3 to obtain an aqueous solution; mix the povidone-iodine ground material and the aqueous solution evenly, and emulsify at high speed to obtain povidone-iodine colostrum; place povidone-iodine colostrum in a high-pressure homogenizer Medium emulsification to obtain a povidone-iodine emulsion; the povidone-iodine emulsion is spray-dried to obtain povidone-iodine microcapsules with a particle size range of 5 μm;

[0104] c. adding povidone-iodine microcapsules to the melt in step a, and mixing uniformly to obtain a drug-containing matrix;

[0105] 2) Preparation of expansive suppositories: Pour the drug-conta...

Embodiment 3

[0107]

[0108] Preparation:

[0109] 1) Preparation of drug-containing matrix:

[0110] a. Polyethylene glycol 400 and polyethylene glycol 6000 are heated and melted in a water bath to obtain a melt;

[0111] b. Preparation of povidone-iodine microcapsules: add povidone-iodine to glyceryl stearate and cellulose acetate phthalate, and grind until uniform to obtain povidone-iodine grind; Add water at a volume ratio of 1:3 to obtain an aqueous solution; mix the povidone-iodine ground material and the aqueous solution evenly, and emulsify in high-speed shear to obtain povidone-iodine colostrum; place povidone-iodine colostrum under high pressure Emulsifying in a homogenizer to obtain a povidone-iodine emulsion; spray-drying the povidone-iodine emulsion to obtain povidone-iodine microcapsules with a particle size range of 5 μm;

[0112] c. mix povidone-iodine microcapsules and nonoxynol-10 evenly to prepare a mixture;

[0113] d. Add the mixture of step c to the melt of step...

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Abstract

The invention relates to a povidone-iodine vaginal expansion suppository and a preparation method and a detection method thereof. The expansion suppository comprises a drug-containing matrix and an expansion carrier formed of povidone-iodine and a matrix; the present invention combines povidone-iodine with capsule material and Pre-gelatinized starch is made into microcapsules, which reduces the effect of povidone-iodine, and at the same time plays the role of slow drug release; nonoxynol-10, caprylic capric acid macrogolglyceride is also added in the drug-containing matrix , stearyl alcohol and aluminum magnesium silicate, the expansion suppository has high stability, is not easy to deform, not rancid, not easy to melt, and has good lubricity; and the provided povidone iodine vaginal expansion suppository adopts the original The seven leading technologies have beneficial effects such as preventing the outflow of medicinal liquid and preventing secondary infection.

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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K31/79A61K47/36A61K47/32A61K47/38A61K47/14A61P15/02A61P31/04A61P31/10G01N33/15G01G17/00
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司