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Sodium prasterone sulfate dispersible tablet and preparation method thereof

A technology of prasterone sulfate sodium and dispersible tablets, which is applied in the direction of non-active ingredient medical preparations, active ingredient-containing medical preparations, pharmaceutical formulas, etc., can solve problems that need to be deepened, and achieve good uniformity and preparation methods. Simple, good-tasting effect

Inactive 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] Therefore, the research on prasterone sulfate sodium preparations still needs to be deepened at present.

Method used

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  • Sodium prasterone sulfate dispersible tablet and preparation method thereof
  • Sodium prasterone sulfate dispersible tablet and preparation method thereof
  • Sodium prasterone sulfate dispersible tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0038] Embodiment 1: the prescription screening of Prasterone Sulfate Sodium Dispersible Tablets

[0039] Take the prasterone sulfate sodium dispersible tablet of 100 mg as an example.

[0040] The preparation method comprises the following steps:

[0041] 1) mixing prasterone sulfate sodium and a solubilizer, and micronizing it to particles with a particle size of 0.5-50 microns (μm), for subsequent use;

[0042] 2) Utilize a blender to uniformly mix the filler microcrystalline cellulose, the disintegrating agent crospovidone, the flavoring agent and magnesium stearate with the granules obtained in the above step 1;

[0043] 3) Utilize a high-speed tablet press to compress the powder obtained in the above step 2 to obtain prasterone sulfate sodium dispersible tablets.

[0044] The prescription screening is shown in Table 1, and the prescription screening results are shown in Table 2.

[0045] Table 1 Prescription Screening Form

[0046]

[0047]

[0048] Table 2 Pre...

Embodiment 2

[0052] Prescription: prasterone sulfate sodium 10g, sodium lauryl sulfate 2g, microcrystalline cellulose 17.2g, crospovidone 0.4g, sucrose 10g, magnesium stearate 0.4g, made into 100 tablets.

[0053] Preparation Process:

[0054] 1) Mixing prasterone sodium sulfate and sodium lauryl sulfate in the prescribed amount, micronized to particles with a particle size of 0.5-50 microns (μm), and set aside;

[0055] 2) Utilize the mixing machine to mix the microcrystalline cellulose, crospovidone, sucrose and magnesium stearate in the prescribed amount with the above-mentioned step 1;

[0056] 3) Utilize a high-speed tablet press to compress the powder in the above step 2 to obtain prasterone sulfate sodium dispersible tablets.

[0057] In addition, the prasterone sulfate sodium dispersible tablet preparation prepared by this prescription has been carried out 30 days influence factor experiment, to investigate the stability of pharmaceutical preparation, the stability data experiment...

Embodiment 3

[0063] Prescription: prasterone sulfate sodium 10g, sodium lauryl sulfonate 2g, microcrystalline cellulose 20g, croscarmellose sodium 0.4g, sucrose 10g, magnesium stearate 0.4g, made into 100 tablets.

[0064] Preparation process: with embodiment 2.

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Abstract

The invention discloses a sodium prasterone sulfate dispersible tablet and a preparation method thereof. The sodium prasterone sulfate dispersible tablet comprises sodium prasterone sulfate, solutizer, filler, a disintegrating agent, a flavoring agent and a lubricant. The sodium prasterone sulfate is in the micro powder form with the grain diameter ranging from 0.5 micrometer to 50 micrometers. The mass ratio of the sodium prasterone sulfate to the solutizer to the filler to the disintegrating agent to the flavoring agent to the lubricant is 1:(0.2-0.3):(1-2):(0.03-0.05):(0.5-2):(0.03-0.05). The sodium prasterone sulfate dispersible tablet can rapidly take an effect; the safety and curative effect of medicines are effectively improved; toxic and side effects are reduced; dosing is facilitated; and the taste is good.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to prasterone sulfate sodium dispersible tablets and a preparation method thereof. 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 use. [0004] Therefore, 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 certain extent. For this re...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5685A61K47/20A61K47/38A61K47/32A61P15/00A61P15/12A61P15/02
Inventor 王学海许勇涂荣华吴迪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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