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Levonorgestrel tablet and preparation process thereof

A technology of levonorgestrel and tablet cores, applied in the field of chemical pharmacy, can solve the problems of low dissolution rate and dissolution rate of tablets, unsatisfactory curative effect of oral contraceptives, low bioavailability, etc.

Inactive Publication Date: 2014-06-25
邵娜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Levonorgestrel is generally administered orally, but the drug is a poorly soluble drug, insoluble in water, ethanol, isopropanol, acetone, ethyl acetate and other solvents, the dissolution rate and dissolution rate of tablets prepared by conventional preparation technology are low, resulting in low bioavailability
[0005] Existing oral contraceptives are unsatisfactory in curative effect and other aspects

Method used

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Examples

Experimental program
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Effect test

Embodiment Construction

[0044] The present invention is further explained below in conjunction with the examples, but the examples do not limit the present invention in any form.

[0045] (1) Making tablet cores: pass levonorgestrel, lactose, pregelatinized starch, hydroxypropyl methylcellulose, and sodium starch glycolate through a 100-mesh sieve, and add them to the wet mixing granulator in equal increments Mix well to get mixed powder; dissolve polysorbate-80 in 30-50 times ethanol, add to the above mixed powder, mix, then add 12% pregelatinized starch for pulping to the mixed powder, Make 18-40 mesh granules, dry at 60-70°C, granulate with 24-mesh sieve, collect when the moisture is 1.0-3.0%, and make tablet cores for later use;

[0046] (2) Coating: the stomach-soluble film coating premix is ​​formulated with 80% ethanol into a 11% suspension, stirred and mixed for 60 minutes for later use; the tablet cores are poured into the coating pot, and the speed of the coating pot is adjusted to 2~3 rpm...

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PUM

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Abstract

The invention discloses a levonorgestrel tablet and a preparation process thereof. The tablet is prepared from levonorgestrel, lactose, pregelatinized starch, hydroxypropyl methyl cellulose, carboxymethyl starch sodium, polysorbate-80, 12% pregelatinized starch for slushing, aerosil, magnesium stearate and gastric-soluble film coating premixed agent. The preparation process comprises the following steps: preparing a tablet core, coating and the like. Application on 30 females indicates that the levonorgestrel tablet has a good contraception effect, hardly influences erythrocyte sedimentation rate, has the total effective rate of 95 percent, and has the characteristics of few administration times, smooth plasma concentration, long duration and the like.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a levonorgestrel tablet and a preparation process thereof. Background of the invention [0002] The chemical name of levonorgestrel is (-)-13-ethyl-17-hydroxy-18,19-bis-demethyl-17α-pregna-4-en-20-yn-3-one, which is a Progesterone, from January 1, 2001, began to have an over-the-counter drug status in the UK, and its oral administration is mainly used for female emergency contraception. Molecular formula C21H28O2, relative molecular mass 312.47. This product is white or white crystalline powder; soluble in chloroform, slightly soluble in methanol, insoluble in water. [0003] Pharmacological action: Levonorgestrel is a progestogen, which mainly acts on the hypothalamus and pituitary gland. It can reduce or disappear the peak levels of follicle-stimulating hormone and luteinizing hormone in the middle period of menstruation, and inhibit ovulation. Levonorgestrel can thin the...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/567A61K47/38A61P15/18
Inventor 黄巍邵娜吴秀华
Owner 邵娜
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