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Progesterone sustained-release composition and preparation method thereof

A slow-release composition and progesterone technology, which is applied in the direction of drug combination, pharmaceutical formula, drug delivery, etc., can solve the problems of large muscle irritation and poor patient compliance, and achieve simple preparation process, accurate dosage, Ease of use

Pending Publication Date: 2022-03-04
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Progesterone injection contains oily substances that are more irritating to muscles, and the patient's compliance is not good. Currently, only progesterone sustained-release gel can be administered once a day among vaginal preparations, and other dosage forms require 2 to 3 injections per day. Second dose

Method used

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  • Progesterone sustained-release composition and preparation method thereof
  • Progesterone sustained-release composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Core composition 1000 pieces / g Progesterone 200 Microcrystalline cellulose 85 Granular lactose 125 Hydroxypropylketolane K15M 90 Kapom 934P 210 Citrate 100 Sodium bicarbonate 180 Magnesium stearate 10 total 1000

[0036] Preparation Process: Paltalone is pulverized first, each accessory is 30 mesh sieve, then referred to as part of the amount of progesterone, microcrystalline cellulose, granulated lactose, hydroxypropylttellulose, carbum, sodium bicarbonate 30 min was mixed in the mixer, then mixed with magnesium stearate for 5 min, and a 3.5 * 10.5 mm shaped punching piece, the sheet hardness was about 10 kg, and the range was 8 to 12 kg.

Embodiment 2

[0038] Core composition 1000 pieces / g Progesterone 200 Microcrystalline cellulose 85 Granular lactose 125 Hydroxypropylketolane K15M 210 Kapom 934P 90 Citrate 100 Sodium bicarbonate 180 Magnesium stearate 10 total 1000

[0039] Preparation Process: Paltalone is pulverized first, each accessory is 30 mesh sieve, then referred to as part of the amount of progesterone, microcrystalline cellulose, granulated lactose, hydroxypropylttellulose, carbum, sodium bicarbonate 30 min was mixed in the mixer, then mixed with magnesium stearate for 5 min, and a 3.5 * 10.5 mm shaped punching piece, the sheet hardness was about 10 kg, and the range was 8 to 12 kg.

Embodiment 3

[0041] Core composition 1000 pieces / g Progesterone 200 Microcrystalline cellulose 85 Granular lactose 125 Hydroxypropylketolane K15M 150 Kapom 934P 150 Citrate 100 Sodium bicarbonate 180 Magnesium stearate 10 total 1000

[0042] Preparation Process: Paltalone is pulverized first, each accessory is 30 mesh sieve, then referred to as part of the amount of progesterone, microcrystalline cellulose, granulated lactose, hydroxypropylttellulose, carbum, sodium bicarbonate 30 min was mixed in the mixer, then mixed with magnesium stearate for 5 min, and a 3.5 * 10.5 mm shaped punching piece, the sheet hardness was about 10 kg, and the range was 8 to 12 kg.

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Abstract

The present invention belongs to the field of pharmaceutical preparations, and provides a progesterone sustained-release composition and a preparation method thereof, the progesterone sustained-release composition comprises: (a) an active component comprising progesterone or a pharmaceutically acceptable salt or hydrate thereof; (b) a filler; (c) a sustained release material; and (d) an effervescing agent. Compared with progesterone vaginal sustained-release gels, vaginal tablets, vaginal suppositories and soft capsules which are frequently used in the market at present, the prepared vaginal sustained-release tablets are relatively simple in process, stable in quality and suitable for commercialized production, patients can conveniently take the vaginal sustained-release tablets by themselves, the number of times of administration can be reduced, and the effect equivalent to that of other progesterone vaginal sustained-release preparations is achieved. Through the combination of the filler, the sustained-release material and the effervescing agent, an ideal drug release rate can be obtained, the sustained-release material has certain biological adhesion, and after the tablet is disintegrated in the vagina, the vaginal adhesion can be maintained for a long time, so that the effect of slowly releasing the drug is achieved.

Description

Technical field [0001] The present invention relates to the field of pharmaceutical preparations, and more particularly to a progesterone sustained release composition and a preparation method thereof. Background technique [0002] Progesterone is also known as progesterone, yellow body hormone, is an ovarian secretion of bioactive main progesterone, molecular formula C 21 Hide 30 O 2 . Progesterone can protect the endometrium of women, during female pregnancy, progesterone hormone can support and guarantee the early growth and development of the fetus, and can play a certain calming effect on the uterus. [0003] In auxiliary reproductive technology (ART), women need to supplement exogenous progesterone for yellow body after transplanted embryos, usually in the transplantation embryo, the yellow body is supported for about 10 weeks, during which every day needs Supplement of progesterone. [0004] The preparation route for progesterone supplemented in the auxiliary reproductive ...

Claims

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Application Information

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IPC IPC(8): A61K9/46A61K31/57A61K47/38A61K47/32A61P15/00A61P15/06
CPCA61K31/57A61K9/0034A61K9/0007A61K9/2095A61K9/2054A61K9/2027A61P15/00A61P15/06
Inventor 文毅陈金脱朱春莉王璐
Owner 南京康川济医药科技有限公司
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