Ornidazole vaginal expansion suppository and preparation and detection methods thereof

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...

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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

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