Ornidazole vaginal expansion suppository and preparation and detection methods thereof

A technique for vaginal expansion suppository and detection method, applied in the field of ornidazole vaginal expansion suppository and its preparation, can solve the problems of vaginal irritation, easily polluted clothes, low stability, etc., achieve high bioavailability, and avoid secondary infection , stable effect

Active Publication Date: 2014-04-30
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

[0005] The curative effect of ornidazole is better than metronidazole, slightly better than tinidazole; clinically mainly used for trichomonas vaginitis; preparations of ornidazole mainly include tablets, capsules, injections, suppositories, etc.; After taking the medicine, capsules and capsules are absorbed into the blood through the gastrointestinal tract, and then reach the lesion from the blood. The amount of active ingredients reaching the lesion has been greatly reduced, and there will be nausea, vomiting and other gastrointestinal adverse reactions; injection administration is likely to aggravate the patient's liver , the burden on the kidneys, which affects its application; so based on the characteristics of suppositories, it has been widely used; CN101632658 discloses a kind of ornidazole effervescent suppository, which includes ornidazole, sodium bicarbonate, monohydrate Citric acid, semi-synthetic fatty acid glyceride and polysorbate 80; This effervescent suppository has a wide range of effects, and its curative effect can reach deep vagina or folds; But the bioavailability of this effervescent suppository is poor, and its stability is low, further Affect its curative effect; Ji Cunyuan et al. (Ji Cunyuan, Yang Qiuli et al. Research on Ornidazole Suppository Preparation Technology [J], Northwest Pharmaceutical Journal, 2006, 21(2): 73-74) disclosed a preparation technology of Ornidazole Suppository, which The water-soluble matrix used in suppositories has strong irritation to the vagina; moreover, ordinary ornidazole suppositories are not easy to clean and easily contaminate clothes; the active ingredient has a small contact surface with the human body, resulting in insufficient absorption and failure to exert the maximum effect of the prescription. Technical issues such as good curative effect

Method used

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  • Ornidazole vaginal expansion suppository and preparation and detection methods thereof
  • Ornidazole vaginal expansion suppository and preparation and detection methods thereof
  • Ornidazole vaginal expansion suppository and preparation and detection methods thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091]

[0092] Preparation:

[0093] 1) Preparation of drug-containing matrix:

[0094] a. heating and melting the semi-synthetic fatty acid glyceride in a water bath to obtain a melt;

[0095] B. take the ornidazole of recipe quantity, pulverize, cross 80 mesh sieves, add the molten matter of step a and mix homogeneously, make the matrix containing medicine;

[0096] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 spherical suppositories, each weighing about 3.2g.

Embodiment 2

[0098]

[0099] Preparation method: make 100 torpedo-shaped suppositories according to the method of Example 1, each weighing about 5.0g.

Embodiment 3

[0101]

[0102] Preparation:

[0103] 1) Preparation of drug-containing matrix:

[0104] a. Coxmol, polyoxyethylene monostearate and Tween 60 are placed in a water bath and heated to melt to obtain a melt;

[0105] b. take the ornidazole of recipe quantity, pulverize, cross 100 mesh sieves, disperse in ethyl lactate under stirring, continue to stir, add diglyceryl monostearate and propylene glycol diethyl ester again, mix well, Prepare the emulsion;

[0106] c. adding the emulsion of step b to the melt of step a, and mixing uniformly to obtain a drug-containing matrix;

[0107] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 bullet-shaped suppositories, each weighing about 2.7g.

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Abstract

The invention relates to an ornidazole vaginal expansion suppository and preparation and detection methods thereof. The expansion suppository comprises a medicated substrate and an expansion carrier, wherein the medicated substrate consists of ornidazole and a substrate; the medicated substrate also comprises bitriglycerol monostearate, propylene glycol diacetate, an oil phase, sodium alginate, methylparaben and propylparaben. The ornidazole vaginal expansion suppository has the beneficial effects of high bioavailability, high stability, and difficulty in rancidifying; in addition, Due to the adoption of six unique leading technologies, the ornidazole vaginal expansion suppository realizes the beneficial effects of preventing outflow of liquid medicine, and preventing superinfection, etc.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to an ornidazole vaginal expansive suppository and a preparation method and a detection method thereof. Background technique [0002] Ornidazole, whose chemical name is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, has the following structural formula: [0003] [0004] Ornidazole is white or slightly yellow crystalline powder; odorless, bitter in taste, gradually turns yellow when exposed to light, easily soluble in ethanol and slightly soluble in water. [0005] The curative effect of ornidazole is better than metronidazole, slightly better than tinidazole; clinically mainly used for trichomonas vaginitis; preparations of ornidazole mainly include tablets, capsules, injections, suppositories, etc.; After taking the medicine, capsules and capsules are absorbed into the blood through the gastrointestinal tract, and then reach the lesion from the blood. The amount o...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K31/4164A61K47/44A61K47/34A61K47/36A61K47/14A61P33/02A61P15/02G01G17/00G01N33/15A61K47/10
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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