Pharmaceutical composition prepared with micronized prasterone or sodium prasterone sulfate and use thereof

A technology of prasterone sulfate sodium and prasterone, applied in the direction of drug combinations, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve the problem of no similar patents found for DHEA or DHEAS compositions

Active Publication Date: 2012-05-02
庞飞 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] After searching the literature, no similar patents on pharmacy, drug ef

Method used

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  • Pharmaceutical composition prepared with micronized prasterone or sodium prasterone sulfate and use thereof
  • Pharmaceutical composition prepared with micronized prasterone or sodium prasterone sulfate and use thereof
  • Pharmaceutical composition prepared with micronized prasterone or sodium prasterone sulfate and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0027] Embodiment 1, preparation of DHEA and DHEAS powder

[0028] DHEAS raw material: Jiangsu Yangzhou Pharmaceutical Factory;

[0029] DHEA raw material: Changzhou Jiaerke Pharmaceutical Group Co., Ltd.;

[0030] Jet Pulverizer (The Jet Pulverizer Company, Inc.);

[0031] Z R S -8 Drug Dissolution Apparatus (Tianjin University Radio Factory).

[0032] 1. 1. Preparation of DHEA particles with different particle sizes

[0033] Particles with a size of 50 mesh but less than 65 mesh obtained by the conventional sieving method are ordinary powder 1 (equivalent to 230-270 microns);

[0034] Particles that pass 100 mesh but are less than 120 mesh obtained by conventional sieving are general powder 2 (equivalent to 120-150 microns);

[0035] Obtain the superfine powder with a center of 10 micron normal distribution as micropowder 3 with an ultrafine jet mill;

[0036] Obtain the ultra-fine powder with a center of 0.5 micron normal distribution with the ultra-fine jet mill as fi...

Embodiment approach 2

[0042] Embodiment 2, Dissolution test of DHEAS film-coated tablets with different particle sizes

[0043] 2.1. Drugs to be tested: DHEAS common powder and micropowder as mentioned above (1. 2. Preparation of DHEAS particles with different particle sizes).

[0044] 2.2. Prescription: Each tablet weighs 100 (mg);

[0045] DHEAS: 50;

[0046] Sodium carboxymethyl cellulose: 30;

[0047] Cornstarch: 10;

[0048] Microcrystalline Cellulose: 6;

[0049] Magnesium stearate: appropriate amount;

[0050] 5% hydroxypropyl methylcellulose: appropriate amount.

[0051] 2.3. Process: Take DHEAS, sodium carboxymethyl cellulose, corn starch, and microcrystalline cellulose to make plain tablets according to conventional processes, then use hydroxypropyl methyl cellulose as a film-forming agent, and 70% alcohol solution as a solvent. Diethyl phthalate is used as a plasticizer coating to obtain film-coated tablets.

[0052] The obtained film-coated tablets are respectively: general powde...

Embodiment approach 3

[0061] Embodiment 3, Dissolution Test of Common Powder 1, Common Powder 2, Micropowder 3, and Micropowder 4 Capsules Prepared by DHEA

[0062] 3.1. Drugs to be tested: general powder and micropowder of the above (1. 1. DHEA particles with different particle sizes).

[0063] 3.2. Prescription: Each capsule weighs 100 (mg)

[0064] DHEA: 50;

[0065] Cornstarch: 25;

[0066] Microcrystalline Cellulose: 22;

[0067] 2%HMPC: appropriate amount;

[0068] Magnesium stearate: 0.6.

[0069] 3.3. Process: Take the common powder 1, common powder 2, micro-powder III, micro-powder IV and auxiliary materials prepared by DHEA respectively, prepare granules according to the conventional process, and pack them into capsules.

[0070] Corn starch in the prescription is used as disintegrant, dispersant and diluent. Hypromellose is the binder. Magnesium stearate is a lubricant. The general powder capsule 1, the general powder capsule 2, the micro powder capsule 3 and the micro powder cap...

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PUM

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Abstract

The invention relates to a pharmaceutical composition prepared with micronized prasterone or sodium prasterone sulfate and a use thereof. The pharmaceutical composition comprises the following pharmaceutical ingredients: the micronized prasterone or the sodium prasterone sulfate, wherein the granulation size is 1 micron to 120 microns, preferably normal distribution of 1 micron to 50 microns, further preferably normal distribution of 10 microns. The content of the pharmaceutical ingredient is 10 mg-200 mg, preferably 25 mg-100 mg. The pharmaceutical ingredients can be prepared as the product in any pharmaceutically acceptable dosage form. The invention further provides the use of the pharmaceutical composition in preparing the drugs for treating and/or preventing sexual dysfunction, osteoporosis, lupus erythematosus, aesthetic dermatology, postpone senility and woman urogenital atrophy syndrome.

Description

technical field [0001] The present invention relates to a medicine micronization technology, in particular to the pharmaceutical composition of micronized prasterone sulfate sodium and prasterone sulfate and its application in medicine, namely: a micronized prasterone sulfate or prasterone sulfate The pharmaceutical composition prepared by latestosterone sodium and its application in the preparation of medicines for treating and / or preventing sexual dysfunction, osteoporosis, lupus erythematosus, skin beautification and women's urogenital atrophy syndrome. Background technique [0002] Superfine pulverization is a new technology developed in recent decades. The particle size and crystal structure of the powder can be effectively improved after the material is ultrafinely pulverized. The micronization of the particles leads to a great increase in the surface area and void ratio of the material, which makes the ultrafine powder have unique physical and chemical properties, su...

Claims

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Application Information

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IPC IPC(8): A61K31/5685A61P15/00A61P19/10A61P17/00A61P15/02A61P13/02
Inventor 杨维稼李建新
Owner 庞飞
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