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Sodium prasterone sulfate sustained-release capsule and preparation method thereof

A technology of pratestosterone sulfate sodium and sustained-release capsules is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., which can solve the problems that need to be deepened, and achieve the effects of improving safety and reducing toxic and side effects.

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] 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 capsule and preparation method thereof
  • Sodium prasterone sulfate sustained-release capsule and preparation method thereof
  • Sodium prasterone sulfate sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] In this embodiment, the drug-loaded pellet core was prepared according to the prescription shown in Table 1 below and the operation steps described below:

[0053] Preparation:

[0054] Pass prasterone sulfate sodium through an 80-mesh sieve, weigh the sieved prasterone sulfate sodium and the blank ball core according to the prescription amount shown in Table 1, and use a centrifugal granulator and a fluidized bed to granulate respectively. After the granulation is completed, the drug-loaded pellet core is obtained.

[0055] Table 1

[0056]

[0057] Investigation on the preparation process of drug-loaded pellet core:

[0058] The preparation of drug-loaded pellet cores by fluidized bed and centrifugal granulator was investigated, and the content uniformity of drug-loaded pellet cores prepared by the two methods was compared. The results are shown in Table 2.

[0059] Table 2

[0060] Preparation

centrifugal granulator

fluidized bed

conte...

Embodiment 2

[0066] ①Preparation of drug-loaded pellet core

[0067] prescription:

[0068] Prasterone Sulfate Sodium 200g

[0069] Blank ball core (sucrose ball core) 274g

[0070] 8% PVP-k30 solution (solvent is 90% ethanol) 150g

[0071] Preparation Process:

[0072] Pass prasterone sulfate sodium through an 80-mesh sieve, weigh the prescription amount, and pour it into the hopper of the centrifugal granulator. Pour blank pellet cores into a centrifugal granulator for granulation, set the air inlet pressure to 0.7 bar, atomization pressure to 2 bar, thimble pressure to 1 bar, feeding speed to 3 rpm, peristaltic pump efficiency to 10%, and turntable speed to 135rpm, spray 8% PVP-k30 solution (the solvent is 90% ethanol), and the drying temperature is 55°C. After the granulation is finished, about 480 g of drug-loaded pellet cores are obtained.

[0073] ②Drug-loaded pill core sustained-release layer coating

[0074] prescription:

[0075]

[0076] Preparation Process:

[0077]...

Embodiment 3

[0080] ①Preparation of drug-loaded pellet core

[0081] prescription:

[0082] Prasterone Sulfate Sodium 200g

[0083] Blank ball core (sucrose ball core) 274g

[0084] 8% PVP-k30 solution (solvent is 90% ethanol) 150g

[0085]Preparation Process:

[0086] Pass prasterone sulfate sodium through an 80-mesh sieve, weigh the prescription amount, and pour it into the hopper of the centrifugal granulator. Pour the blank pellet core into the centrifugal granulator for granulation, set the air inlet pressure to 0.7bar, atomization pressure to 2bar, thimble pressure to 1bar, feeding speed to 3rpm, peristaltic pump efficiency to 10%, turntable speed to 135rpm, spray 8% PVP -k30 solution (solvent is 90% ethanol), dried at 55°C. After the granulation is finished, about 480 g of drug-loaded pellet cores are obtained.

[0087] ②Drug-loaded pill core sustained-release layer coating

[0088] prescription:

[0089]

[0090] Preparation Process:

[0091] Add the prescribed amount o...

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Abstract

The invention provides a sodium prasterone sulfate sustained-release capsule and a preparation method thereof. The sodium prasterone sulfate sustained-release capsule comprises sodium prasterone sulfate and auxiliary materials acceptable on pharmacy. The sodium prasterone sulfate sustained-release capsule can achieve 12-hour sustained release, and is stable in quality, high in bioavailability and good in medication compliance.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to prasterone sulfate sodium sustained-release capsules 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 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 technical problems in the related art at least to a certain extent....

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/5685A61P15/00
Inventor 王学海许勇涂荣华王伟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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