Dinoprostone vaginal expansion suppository, preparation method and detection method thereof

Abstract

The invention relates to a dinoprostone vaginal expansion suppository and a preparation method and a detection method thereof. The expansion suppository comprises a drug-containing matrix formed by dinoprostone and a matrix and an expansion carrier; the drug-containing matrix also includes triethylene glycol mono Lauric acid ester, modified starch, peach gum, polyvinyl acetate and linoleic acid glyceride; the dinoprostone vaginal expansive suppository has beneficial effects such as high bioavailability, uniform content distribution, long-acting slow drug release and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a dinoprostone vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Dinoprostone, also known as prostaglandin E2 (PGE2), is a white crystal with a low melting point and is insoluble in water; it has a contraction effect on the uterus of all stages of pregnancy, and it is relatively mild; it has transformation and expansion on the cervix Effect; dinoprostone has various forms of topical drug preparations, including vaginal tablets or vaginal suppositories, vaginal tablets have a disintegration process, and the onset of action is slow; vaginal suppositories have fast onset of action and a wide range of applications; existing dinoprostone Ketone suppositories are indicated for the initiation and / or continued ripening of the cervix at full-term pregnancy (after 38 weeks of gestation). [0003] Due to the poor solubili...

AI Technical Summary

Problems solved by technology

[0002] Dinoprostone, also known as prostaglandin E2 (PGE2), is a white crystal with a low melting point and is insoluble in water; it has a contraction effect on the uterus of all stages of pregnancy, and it is relatively mild; it has transformation and expansion on the cervix Effect; dinoprostone has various forms of topical drug preparations, including vaginal tablets or vaginal suppositories, vaginal tablets have a disintegration process, and the onset of action is slow; vaginal suppositories have fast onset of action and a wide range of applications; existing dinoprostone Ketone suppositories are indicated for the initiation and / or continued ripening of the cervix at term (after 38 weeks of gestation)

[0003] Due to the poor solubility of dinoprostone, the common dinoprostone vaginal suppository has low bioavailability and unstable drug release rate; Uneven distribution affects the overall curative effect of the suppository; moreover, the dinoprostone suppository is not easy to clean and easily contaminates clothes; the active ingredient has a small contact surface with the human body, resulting in insufficient absorption and failure to exert the best curative effect of the prescription.

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