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Compound estradiol valerate tablet and its preparation process

A technology of compound estradiol valerate tablets and estradiol valerate is applied in pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc. Improves dissolution, facilitates packaging and transportation, and improves bioavailability

Inactive Publication Date: 2005-07-06
HAINAN PULIN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Because estradiol valerate is the valerate ester of estradiol, it is almost insoluble in water, and the tablets prepared by conventional preparation methods have low bioavailability, which affects clinical efficacy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Compound Estradiol Valerate Tablets Prescription Composition

[0017] Estradiol Valerate 2.0g

[0018] Norethindrone 0.7g

[0019] Lactose 49.0g

[0020] Starch 21.0g

[0021] Hypromellose 2.1g

[0022] Magnesium stearate 0.56g

[0023] Micronized silica gel 0.19g

[0024] Made into tablets 1000 pieces

[0025] Specific preparation:

[0026] (1) Pass the original and auxiliary materials through a 100-mesh sieve.

[0027] (2) Mix lactose and starch evenly according to the prescription amount to obtain mixed auxiliary materials.

[0028] (3) Accurately weigh the two medicines, mix them evenly, add the mixed excipients in the method of equal incremental dilution, mix them evenly, and finally add hypromellose.

[0029] (4) Mix at a high speed in a high-speed mixer for 3 minutes, spray with an appropriate amount of pure water, and granulate under suitable operating conditions.

[0030] (5) The wet granules are sieved through a 16-mesh sieve, added with magnesium st...

Embodiment 2

[0038] Compound Estradiol Valerate Tablets Prescription Composition

[0039] Estradiol Valerate 2.0g

[0040] Norethindrone 0.7g

[0041] Lactose 49.0g

[0042] Starch 21.0g

[0043] Hypromellose 2.1g

[0044] Magnesium stearate 0.56g

[0045] Micronized silica gel 0.19g

[0046] Made into tablets 1000 pieces

[0047] Specific preparation:

[0048] (1) The raw material of estradiol valerate is ultrafinely pulverized, and the auxiliary materials are passed through a 100-mesh sieve.

[0049] (2) Mix lactose and starch evenly according to the prescription amount to obtain mixed auxiliary materials.

[0050] (3) Accurately weigh the two medicines, mix them evenly, add the mixed excipients in the method of equal incremental dilution, mix them evenly, and finally add hypromellose.

[0051] (4) Mix at a high speed in a high-speed mixer for 3 minutes, spray with an appropriate amount of pure water, and granulate under suitable operating conditions.

[0052] (5) The wet granu...

Embodiment 3

[0059] Compound Estradiol Valerate Tablets Prescription Composition

[0060] Estradiol Valerate 2.0g

[0061] Norethindrone 0.7g

[0062] Lactose 49.0g

[0063] Starch 21.0g

[0064] Povidone K30 2.1g

[0065] Magnesium stearate 0.56g

[0066] Micronized silica gel 0.19g

[0067] Made into tablets 1000 pieces

[0068] Specific preparation:

[0069] (1) The raw material of estradiol valerate is ultrafinely pulverized, and the auxiliary materials are passed through a 100-mesh sieve.

[0070] (2) Mix lactose and starch evenly according to the prescription amount to obtain mixed auxiliary materials.

[0071] (3) Povidone K30 is prepared into 10% alcohol solution.

[0072] (4) Accurately weigh the two medicines, mix them uniformly, add the mixed auxiliary materials with the method of equal incremental dilution, mix them evenly, mix them at a high speed in a high-speed mixer for 3 minutes, spray an appropriate amount of alcohol solution of povidone K30, and Granulated unde...

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Abstract

The invention relates to a compound estradiol valerate tablet and its preparation process, wherein the active constituents of the tablet include oestradiol valerate and norethisterone, and at least include a crumbling agent, a soluble deflocculating agent with binding property, a binding agent and a lubricating agent. The tablet has rather good bioavailability in vivo and increased dissolving degree externally.

Description

technical field [0001] The invention relates to a compound estradiol valerate tablet, and also relates to a method for producing the tablet. Background technique [0002] Because estradiol valerate is the valerate ester of estradiol, it is almost insoluble in water, and the tablets prepared by conventional preparation methods have low bioavailability, which affects clinical efficacy. Contents of the invention [0003] The purpose of the present invention mainly provides the compound estradiol valerate tablet that has improved bioavailability, and this tablet product quality is stable, has good hardness simultaneously, can be convenient to pack and transport, is convenient to industrialized production again. The tablet has enhanced bioavailability in vivo and enhanced dissolution rate in vitro. [0004] In order to realize the above-mentioned purpose of the invention, the present invention has adopted following technica...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/565A61P5/30
Inventor 范敏华
Owner HAINAN PULIN PHARMA
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