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Dinoprostone vaginal swelling suppository and preparation method and detection method thereof

A vaginal expansive suppository and dinoprostone technology, which is applied in suppository delivery, pharmaceutical formulations, material inspection products, etc., can solve the problems of dinoprostone poor solubility, slow onset of action, insufficient absorption, etc., and achieve bioavailability And the effect of high stability, preventing outflow and uniform distribution

Active Publication Date: 2014-04-16
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

[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.

Method used

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  • Dinoprostone vaginal swelling suppository and preparation method and detection method thereof
  • Dinoprostone vaginal swelling suppository and preparation method and detection method thereof
  • Dinoprostone vaginal swelling suppository and preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089]

[0090] Preparation:

[0091] 1) Preparation of drug-containing matrix:

[0092] a. semi-synthetic coconut oil ester and stearin are placed in a water bath for heating and melting to obtain a melt;

[0093] b. adding dinoprostone to the melt in step a, and mixing uniformly to obtain a drug-containing matrix;

[0094] 2) Preparation of expansive suppositories: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 long oval suppositories, each weighing about 3.5g.

Embodiment 2

[0096]

[0097] Preparation:

[0098] 1) Preparation of drug-containing matrix:

[0099] a. semi-synthetic coconut oil ester and stearin are placed in a water bath for heating and melting to obtain a melt;

[0100] b. Place triethylene glycol monolaurate in a mortar, slowly add dinoprostone under grinding, continue grinding for 0.5h, and pass through a 120-mesh sieve to obtain a solid dispersion;

[0101]c. adding the solid dispersion of step b to the melt of step a, and mixing uniformly to obtain a drug-containing matrix;

[0102] 2) Preparation of expansive suppositories: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 stick-shaped suppositories, each weighing about 3.9g.

Embodiment 3

[0104]

[0105] Preparation:

[0106] 1) Preparation of drug-containing matrix:

[0107] a. Polyethylene glycol 400 and polyethylene glycol 1500 are placed in a water bath and heated to melt to obtain a melt;

[0108] b. Put triethylene glycol monolaurate in a mortar, slowly add modified starch under grinding, continue grinding, add dinoprostone while grinding, continue grinding for 0.5h, and pass through a 120-mesh sieve to obtain a solid dispersion body;

[0109] c. adding the solid dispersion of step b to the melt of step a, and mixing uniformly to obtain a drug-containing matrix;

[0110] 2) Preparation of expansive suppositories: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 cylindrical suppositories, each weighing about 2.7g.

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Abstract

The invention relates to a dinoprostone vaginal swelling suppository and a preparation method and a detection method thereof. The swelling suppository comprises a drug-containing substrate formed by dinoprostone and a matrix and a swelling carrier, wherein the drug-containing substrate also comprises triethylene glycol monolaurate, modified starch, peach gum, polyvinyl acetate and glycerol linoleate. The dinoprostone vaginal swelling suppository has the beneficial effects of high bioavailability, uniform content distribution and long-acting and slow drug release.

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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/5575A61K47/36A61P15/04G01N33/15G01N5/04
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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