Progesterone vaginal expansion suppository and its preparation method and detection method

A vaginal expansive suppository and progesterone technology, applied in suppository delivery, measuring devices, pharmaceutical formulations, etc., can solve the problems of difficult cleaning, uneven dispersion, poor absorption of vaginal mucosa, etc., and achieve the effect of preventing outflow

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] Existing progesterone preparations include progesterone oral preparations, injections and suppositories. Because suppositories do not have the side effects of oral preparations and injections, they are widely used; For menstrual disorders, such as amenorrhea and dysfunctional uterine bleeding, corpus luteum insufficiency, threatened abortion and habitual abortion (caused by corpus luteum insufficiency), premenstrual tension syndrome; due to the poor water solubility of progesterone, the absorption of vaginal mucosa Poor, so the bioavailability of the suppository made is poor; the content of progesterone in the progesterone suppository is small, resulting in uneven dispersion, so that after the suppository enters the vagina, the drug concentration in different parts of the vaginal mucosa varies greatly; There are technical problems such as not easy to clean and easy to contaminate clothes; the contact surface between active ingredients and the human body is small, resulting in insufficient absorption and failure to exert the best curative effect of the formula

Method used

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  • Progesterone vaginal expansion suppository and its preparation method and detection method
  • Progesterone vaginal expansion suppository and its preparation method and detection method
  • Progesterone vaginal expansion suppository and its preparation method and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089]

[0090] Preparation:

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

[0092] a. placing balsamic butter and glycerin gelatin in a water bath for heating and melting to obtain a melt;

[0093] b. adding progesterone 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 spherical suppositories, each weighing about 3.4g.

Embodiment 2

[0096]

[0097] Preparation:

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

[0099] a. heating and melting the semi-synthetic fatty acid glyceride in a water bath to obtain a melt;

[0100] b. adding cross-linked dextran gel and sodium carboxymethylcellulose into a mortar, fully grinding to a paste, continuing to grind, adding progesterone, and grinding evenly to obtain an inclusion compound;

[0101]c. adding the clathrate to the melt in step a, and mixing evenly 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 cylindrical suppositories, each weighing about 1.4g.

Embodiment 3

[0104]

[0105] Preparation method: make 100 torpedo-shaped suppositories according to the method in Example 2, each weighing about 5.0g.

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PUM

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Abstract

The invention relates to a progesterone vaginal expansion suppository and its preparation method and detection method. The expansion suppository comprises a drug-containing matrix and an expansion carrier formed by progesterone and a matrix; the drug-containing matrix also includes cross-linked dextran gel, carboxylated Sodium methylcellulose, monolauroyl glycerin, glycerol diacetate, glycerin and sodium citrate; cross-linked sephadex and sodium carboxymethylcellulose form inclusion complexes with progesterone; this The inventive progesterone vaginal expansion suppository has beneficial effects such as high bioavailability and uniform drug dispersion.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a progesterone vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Progesterone, the chemical name is pregna-4-ene-3,20-dione, which is white or off-white crystalline powder; odorless, tasteless; easily soluble in chloroform, in ethanol, ether, vegetable oil Soluble in medium, insoluble in water; progesterone is a natural progesterone secreted by the corpus luteum of the ovary, which has a significant morphological effect on the endometrium stimulated by estrogen in the body; it is a hormone necessary to maintain pregnancy; clinically For the reactive diagnosis of threatened abortion, habitual abortion and other amenorrhea or the cause of amenorrhea. [0003] Existing progesterone preparations include progesterone oral preparations, injections and suppositories. Because suppositories do not have the side effects ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K31/57A61K47/36A61K47/38A61K47/10A61P7/04A61P15/00A61P15/06G01B21/10G01G17/00
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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