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Sodium prasterone sulfate sustained-release tablet and preparation method thereof

A technology of prasterone sulfate sodium and slow-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing 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 method thereof
  • Sodium prasterone sulfate sustained-release tablet and preparation method thereof
  • Sodium prasterone sulfate sustained-release tablet and preparation method thereof

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preparation example Construction

[0049] 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:

[0050] (1) Prasterone Sulfate Sodium, skeleton material and filler are mixed;

[0051] (2) Add binder to the mixture obtained in step (1), and make soft material successively, granulate, and dry;

[0052] (3) Sizing the granules obtained through the drying, adding a lubricant, mixing evenly, and compressing into tablets to obtain the prasterone sulfate sodium sustained-release tablets.

[0053] Thus, the present invention has prepared Prasterone Sulfate Sodium Sustained-release Tablets by adopting the above-mentioned wet granulation tableting technology. According to a specific embodiment of the present invention, the prasterone sulfa...

Embodiment 1

[0066]

[0067]

[0068] Preparation:

[0069] (1) Pass through an 80-mesh sieve after the raw and auxiliary materials are pulverized respectively, and set aside;

[0070] (2) Take by weighing prasterone sulfate sodium and hydroxypropyl methylcellulose E15 of prescription quantity and mix for 3 minutes, add microcrystalline cellulose and lactose of prescription quantity and mix for 2 minutes;

[0071] (3) Add an appropriate amount of ethanol to make a soft material, pass through a 24-mesh sieve to granulate, and dry in an oven at 60 degrees Celsius for 1 hour;

[0072] (4) Cross a 26-mesh sieve for granulation, add magnesium stearate in the prescribed amount, mix evenly, and compress the tablet, and the pressure is controlled at 6-7 kg during tablet compression.

Embodiment 2

[0074] (Specification 100mg, 1000 tablets):

[0075]

[0076] Preparation:

[0077] (1) Pass through a 60-mesh sieve after the raw and auxiliary materials are pulverized respectively, and set aside;

[0078] (2) Take by weighing prasterone sulfate sodium and hydroxypropyl methylcellulose K4M of prescription quantity and mix for 3 minutes, add microcrystalline cellulose and lactose of prescription quantity and mix for 2 minutes;

[0079] (3) adding an appropriate amount of ethanol to make a soft material, passing through an 18-mesh sieve to granulate, and drying in an oven at 40 degrees Celsius for 2 hours;

[0080] (4) Cross a 26-mesh sieve for granulation, add magnesium stearate in the prescribed amount, mix evenly, and compress the tablet, and the pressure is controlled at 7-8 kg during tablet compression.

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Abstract

The invention provides a sodium prasterone sulfate sustained-release tablet and a preparation method 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 in the embodiment 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, in particular, the invention relates to prasterone sulfate sodium sustained-release tablets and a preparation method thereof. Background technique [0002] Prasterone sulfate sodium is mainly used clinically to ripen the cervix before induction of labor at term. [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 micronized prasterone or prasterone sulfate sodium and its application, and the medicine can be prepared into an ordinary tablet for oral administration. [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 technical problems in the related art at least to a ce...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/5685A61K47/38A61K47/34A61K47/32A61K47/44A61K47/36A61K47/14A61K47/12A61K47/10A61P15/04A61P15/12A61P15/02
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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