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Orally-disintegrating progesterone tablet and preparation method thereof

A technology for oral disintegrating tablets and progesterone, which is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. Improved medication compliance, fast disintegration, and low side effects

Inactive Publication Date: 2014-06-25
邵娜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the existing progesterone preparations in China mainly include: capsules, capsules, gels, sustained-release gels, soft capsules, transdermal creams, injections, etc., and there is no orally disintegrating progesterone tablet on the market.

Method used

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  • Orally-disintegrating progesterone tablet and preparation method thereof
  • Orally-disintegrating progesterone tablet and preparation method thereof
  • Orally-disintegrating progesterone tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022]

[0023]

[0024] Pre-mix the progesterone raw material with mannitol and partially cross-linked polyvinylpyrrolidone in a three-phase granulator; add polyvinylpyrrolidone 50% alcohol aqueous solution to the mixed powder in the previous step to granulate; pour out the wet granules and spread them on a tray, place Dry in an oven at 60oC for 5 hours; sieve through a 26-mesh granule; pour aspartame, orange essence and remaining cross-linked polyvinylpyrrolidone and the granules obtained in the previous step into a three-dimensional mixer and mix for 30 minutes, then add hard Magnesium fatty acid is mixed for 1 to 2 minutes; the mixed material is poured into the hopper of the tablet press, the weight and pressure of the tablet are adjusted, and the tablet is pressed and the hardness of the tablet is kept at 20-40N; double-aluminum cold-formed blister packaging.

Embodiment 2

[0026]

[0027] Pre-mix the progesterone raw material with mannitol and partially cross-linked polyvinylpyrrolidone in a three-phase granulator; add polyvinylpyrrolidone 50% alcohol aqueous solution to the mixed powder in the previous step to granulate; pour out the wet granules and spread them on a tray, place Dry in an oven at 60oC for 4 hours. Sieve through a 26-mesh granule; pour aspartame, orange essence and remaining cross-linked polyvinylpyrrolidone and the granules obtained in the previous step into a three-dimensional mixer and mix for 30 minutes, then add magnesium stearate and mix for 1 to 2 minutes Pour the mixed material into the hopper of the tablet press, adjust the weight and pressure of the tablet, press the tablet and keep the hardness of the tablet at 20-40N; double-aluminum cold-formed blister packaging.

Embodiment 3

[0029]

[0030] Pre-mix the progesterone raw material with mannitol and partially cross-linked polyvinylpyrrolidone in a three-phase granulator; add polyvinylpyrrolidone 50% alcohol aqueous solution to the mixed powder in the previous step to granulate; pour out the wet granules and spread them on a tray, place Dry in an oven at 60oC for 7 hours; sieve through a 26-mesh granule; pour aspartame, orange essence and remaining cross-linked polyvinylpyrrolidone and the granules obtained in the previous step into a three-dimensional mixer and mix for 30 minutes, then add hard Magnesium fatty acid is mixed for 1 to 2 minutes; the mixed material is poured into the hopper of the tablet press, the weight and pressure of the tablet are adjusted, and the tablet is pressed and the hardness of the tablet is kept at 20-40N; double-aluminum cold-formed blister packaging.

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Abstract

The invention discloses an orally-disintegrating progesterone tablet which is reasonable in formula and good in bioavailability and a preparation method of the orally-disintegrating progesterone tablet. The orally-disintegrating progesterone tablet comprises a main medicament progesterone of which the content is 5%-20% and an auxiliary material consisting of a disintegrating agent, a diluting agent / an adhesive, a binding agent, a sweetening agent, a flavoring agent, a lubricating agent and the like. By adopting a modern preparation process, the preparation method of the orally-disintegrating progesterone tablet can be used for preparing a product with stable quality and providing a safe and effective orally-disintegrating progesterone tablet for the masses of patients.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a progesterone orally disintegrating tablet and a preparation method thereof. Background of the invention [0002] Progesterone, also known as progesterone and progesterone, is a progestogen that can make endometrial glands grow during menstruation, uterine congestion, and endometrium thickening, preparing for the implantation of fertilized eggs in the endometrium. After the fertilized egg is implanted, it will make it produce the placenta, reduce the excitability of the pregnant uterus and inhibit its activity, so that the fetus can grow safely. Under the joint action of estrogen, it promotes the full development of the breasts and prepares for the secretion of milk. In addition, it can also inhibit ovarian ovulation. It is suitable for functional uterine bleeding, dysmenorrhea, menorrhagia, amenorrhea, threatened abortion, habitual abortion and advanced breast cancer. Adv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/57A61K47/32A61P5/34
Inventor 黄巍邵娜吴秀华
Owner 邵娜
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