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Sodium prasterone sulfate sustained-release tablet and preparation process thereof

A technology of prasterone sulfate sodium and sustained-release tablets, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, organic active ingredients, etc., and can solve problems that need to be deepened

Active Publication Date: 2015-10-21
HUBEI BIO PHARMA IND TECHCAL INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the current research on prasterone sulfate sodium preparations still needs to be deepened.

Method used

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  • Sodium prasterone sulfate sustained-release tablet and preparation process thereof
  • Sodium prasterone sulfate sustained-release tablet and preparation process thereof
  • Sodium prasterone sulfate sustained-release tablet and preparation process thereof

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preparation example Construction

[0052] According to the second aspect of the present invention, the present invention also proposes a method for preparing the aforementioned prasterone sulfate sodium sustained-release tablet. The preparation method of the prasterone sulfate sodium sustained-release tablet according to specific embodiments of the present invention comprises:

[0053] (1) The prasterone sulfate sodium, skeleton material, filler and lubricant are pulverized respectively.

[0054] According to a specific embodiment of the present invention, in this step, the sodium prasterone sulfate, the skeleton material, the filler and the lubricant are pulverized to a particle size of 60-200 mesh. Thus, the solubility and bioavailability of Prasterone Sulfate Sodium can be effectively improved, and if the particle size is too high or too low, the solubility and bioavailability of the obtained Prasterone Sulfate Sodium Sustained-release Tablets are not ideal. In a preferred embodiment of the present inventio...

Embodiment 1

[0065]

[0066]

[0067] Preparation:

[0068] (1) Crushing the raw and auxiliary materials respectively and passing through a 60-mesh sieve for subsequent use;

[0069] (2) Premix the prescribed amount of prasterone sulfate sodium and polyoxyethylene WSR301 for 3 minutes, then add microcrystalline cellulose, polyethylene glycol and lactose and mix for 2 minutes.

[0070] (3) Add an appropriate amount of magnesium stearate, mix well, and compress into tablets, and the pressure is controlled at 8-9 kg during tablet compression.

Embodiment 2

[0072]

[0073] Preparation:

[0074] (1) Crushing the raw and auxiliary materials respectively and passing through an 80-mesh sieve for subsequent use;

[0075] (2) Weigh the prescribed amount of prasterone sulfate sodium and polyoxyethylene WSR303 and pre-mix for 4 minutes, then add microcrystalline cellulose, polyethylene glycol and lactose and mix for 2 minutes.

[0076] (3) Add an appropriate amount of magnesium stearate, mix evenly, and compress into tablets, and the pressure is controlled at 9-10 kg during tablet compression.

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Abstract

The invention provides a sodium prasterone sulfate sustained-release tablet and a preparation process thereof. The sodium prasterone sulfate sustained-release tablet comprises by weight, 10% to 90% of sodium prasterone sulfate, 5% to 75% of framework matierals, 0.1% to 80% of filler and 0.1% to 5% of lubricant. The sodium prasterone sulfate sustained-release tablet only needs to be taken once a day and is good in patient compliance. The stable blood concentration can be provided, the limited concentration can be kept for a long time, and thus, the toxic and side effects of the medicine are reduced, and the safety of the medicine is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, the invention relates to prasterone sulfate sodium sustained-release tablets and a process for preparing prasterone sulfate sodium sustained-release tablets. Background technique [0002] Prasterone sulfate sodium is currently marketed in the form of injection and injection powder, which is mainly used clinically to ripen the cervix before induction of labor in full-term pregnancy. [0003] CN1509719 discloses a new application of prasterone sulfate sodium for treating menopausal syndrome, especially women's senile and atrophic vaginitis. CN102429912 discloses a pharmaceutical composition prepared by micronizing prasterone or prasterone sulfate sodium and its application. [0004] However, the current research on prasterone sulfate sodium preparations still needs to be deepened. Contents of the invention [0005] The present invention aims to solve one of the...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/5685A61K47/34A61P15/00A61P15/04A61P15/12A61P15/02
Inventor 王学海许勇涂荣华申际丽黄璐陈海靓田华何珩肖强于静杨菁胡越
Owner HUBEI BIO PHARMA IND TECHCAL INST
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