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Allylestrenol tablet and preparation method thereof

A technology of allylestradiol tablets and allylestradiol, which is applied in the directions of pill delivery, pharmaceutical formulations, medical preparations of inactive ingredients, etc., can solve the problems of small size, difficult mixing and the like, and achieves low cost and increased Efficacy of efficacy, improved solubility and dissolution rate

Active Publication Date: 2018-06-22
CHANGZHOU NO 4 PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The purpose of the present invention is to provide an allylestradiol tablet, which overcomes the problems of the existing process such as the generation of dust when the dissolution rate is increased through micronization, which affects the health of the staff, and the difficulty of mixing due to small specifications during the production process. technical defects, and the tablet quality is stable, the dissolution rate is fast, the dissolution rate is high, the bioavailability of the drug is improved, the dosage is reduced, the adverse drug reaction is reduced, and the production process is simple and efficient, which is suitable for industrial application

Method used

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  • Allylestrenol tablet and preparation method thereof
  • Allylestrenol tablet and preparation method thereof
  • Allylestrenol tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Allylestradiol tablets (5 mg / tablet) were prepared using the ingredients listed in Table 1, 1000 tablets.

[0031] Table 1:

[0032]

[0033] Preparation Process:

[0034] Mix the allylestradiol raw material with polyethylene glycol 6000, put it into a hot melt extruder, control the heating temperature at 100-120°C, adjust the discharge speed so that the residence time of the material in the heating part of the equipment is 30-30°C 50 seconds. Cut the extrudate into small pieces and cool. After crushing with a pulverizer, add crospovidone and povidone K 30 , microcrystalline cellulose and mix evenly, then add silicon dioxide and magnesium stearate and mix for 5 minutes, press into tablets, and obtain.

Embodiment 2

[0036] Allylestradiol tablets (5 mg / tablet) were prepared using the ingredients listed in Table 2, 1000 tablets.

[0037] Table 2:

[0038]

[0039]

[0040] Preparation Process:

[0041] Mix the allylestradiol raw material with polyethylene glycol 4000, put it into a hot melt extruder, control the heating temperature at 90-130°C, adjust the discharge speed so that the residence time of the material in the heating part of the equipment is 20-20°C 60 seconds. Cut the extrudate into small pieces and cool. After crushing with a pulverizer, add sodium carboxymethyl starch and povidone K 30 , microcrystalline cellulose and mix evenly, then add silicon dioxide and magnesium stearate and mix for 5 minutes, press into tablets, and obtain.

Embodiment 3

[0043] Allylestradiol tablets (5 mg / tablet) were prepared using the ingredients listed in Table 3, 1000 tablets.

[0044] table 3:

[0045]

[0046] Preparation Process:

[0047] Mix the allylestradiol raw material with polyethylene glycol 6000, put it into a hot melt extruder, control the heating temperature at 90-130°C, adjust the discharge speed so that the residence time of the material in the heating part of the equipment is 20-20°C 60 seconds. Cut the extrudate into small pieces and cool. After pulverizing with a pulverizer, add crospovidone, hydroxypropyl methylcellulose, and lactose to mix evenly, then add silicon dioxide and magnesium stearate, mix for 5 minutes, and press into tablets to obtain the product.

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Abstract

The invention provides an allylestrenol tablet, which is prepared from allylestrenol and an accessory through uniform mixing and tabletting. The allylestrenol tablet is characterized in that the accessory is prepared from an internally added accessory and an externally added accessory; moreover, the allylestrenol and the internally added accessory are firstly uniformly mixed and prepared into drug-containing granule or powder; afterwards, the drug-containing granule or powder and the externally added accessory are uniformly mixed and tabletted to prepare the allylestrenol tablet, wherein the internally added accessory is a polyethylene glycol carrier material; the externally added accessory is a filling agent, a disintegrating agent, a binding agent, a fluidizer or a lubricant. The allylestrenol tablet provided by the invention is quite stable, is good in quality and a few in impurity; moreover, the dissolution characteristic is greatly improved compared with that of a original tablet;the dissolution degree is high; moreover, the dissolution rate is quick, and the prepared granule has favorable flowability and compressibility.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and specifically designs an allylestradiol tablet and a preparation method thereof. Background technique [0002] Allylestrenol [0003] Chemical name: (17β)-17-(2-propenyl)est-4-en-17-ol [0004] (17)-17-(2-Propenyl)estr-4-en-17-ol [0005] CAS:432-60-0 [0006] Structural formula: [0007] [0008] Allylestradiol, a synthetic progestin, is a synthetic orally active progesterone drug. The progesterone activity of allylestradiol is significantly stronger than progesterone, has no androgen activity, and can increase the activity of trophoblast cells to stimulate placental function, so it can be used for threatened abortion, especially for hormone-deficiency abortion. Allylestradiol’s natural chemical structure makes it effective for oral absorption, stable metabolism, high selectivity for progesterone receptors, no estrogen and androgen effects, can enhance the concentration and a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/10A61K31/565A61P15/06
CPCA61K9/2031A61K9/2095A61K31/565
Inventor 王菊香周达孙永强严益民屠永锐曹月华祁琪冯晓晖
Owner CHANGZHOU NO 4 PHARMA FACTORY
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