Anethol trithione soft capsule and preparation method thereof

A technology of anisitrazine and soft capsules is applied in the field of anisitrazine soft capsules and preparation thereof, and can solve the problems of no statistical significance, inability to detect blood drug concentration, inability to achieve equivalence and the like

Active Publication Date: 2008-06-25
江苏万高药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Not only the peak time of the two samples is later than that of the tablet, but the peak concentration is also unusually low, and a large number of subjects cannot detect the blood drug concentration, and the individual differences of the two soft capsule samples are more extensive than those of the tablet , not statistically ...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Prescription of contents of anetellithin soft capsule:

[0093] Anetthio: 25mg

[0094] Soybean Oil: 240mg

[0095] Tween-80: 20mg

[0096] Beeswax: 8mg

[0097] Hydrogenated Palm Oil: 7mg

[0098] Make 1 capsule (0.3g)

[0099] Preparation Process

[0100] Take the raw material of anethrose, grind it into fine powder of anethrose over 120 mesh, add it to the prescribed amount of Tween-80, fully disperse and stir evenly, and the dispersion time should not be less than 20 minutes, as the spare solution 1.

[0101] Take the prescribed amount of soybean oil, add beeswax and hydrogenated palm oil, heat to melt the suspending agent, stir evenly, let cool to about 40 degrees; If there are air bubbles, add an appropriate amount of defoamer, and then press into soft capsules.

Embodiment 2

[0103] Anetellithin: 12.5mg

[0104] Salad oil: 365.5mg

[0105] Tween-80: 62mg

[0106] Glyceryl monostearate: 35mg

[0107] Hydrogenated palm oil: 25mg

[0108] Make 1 capsule (0.5g)

[0109] Preparation Process

[0110] Take the raw material of anethrose, grind it into fine powder of anethrose over 150 mesh, add it to the prescribed amount of Tween-80, fully disperse and stir evenly, and the dispersion time should not be less than 20 minutes, as the spare solution 1.

[0111] Take the prescribed amount of salad oil, add glyceryl monostearate and hydrogenated palm oil, heat to melt the suspending agent, stir evenly, let cool to about 50 degrees; pour the solution into the above standby solution 1, stir again, If there are bubbles, add an appropriate amount of defoamer, and then press into a soft capsule.

Embodiment 3

[0113] Anetthio: 50mg

[0114] Canola oil: 290mg

[0115] Tween-80: 28mg

[0116] Mixed fatty acid glycerides: 24mg

[0117] Soy Lecithin: 8mg

[0118] Makes 1 capsule (0.4g)

[0119] Preparation Process

[0120] Take the prescribed amount of Tween-80 and soybean lecithin, stir well until the mixture is uniform, and use it as spare solution 1.

[0121] Take the raw material of anethrose, grind it into a fine powder of anethrose over 180 mesh, add it into the above-mentioned standby solution 1, disperse it fully and stir evenly, and the dispersion time should not be less than 20 minutes, and use it as the standby solution 2.

[0122] Take the prescribed amount of soybean oil, add beeswax and hydrogenated palm oil, heat to melt the suspending agent, stir well, let cool to about 35 degrees; pour the solution into the above standby solution 2, stir well again, if there are bubbles, add appropriate After adding defoamer, it is compressed into soft capsule.

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PUM

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Abstract

The invention provides a soft capsule containing an anethol trithione. The soft capsule contains the anethol trithione, a substrate, a suspending agent and a surface active agent, wherein, the weight proportion of the three matters is as follows: the anethol trithione: the substrate: the suspending agent: the surface agent is equal to 1: 2 through 75: 0.1 through 10: 0.3 through 15. The substrate can be a sesame oil, a groundnut oil, a corn oil, an olive oil, a sunflower seed oil, a soybean oil, a salad oil, a cotton oil, or a colza oil or a mixture made from a plurality of these oils. The suspending agent can be a beeswax, a yellow wax, a white wax, a mixed wax, a palm oil, a hydrogenated vegetable oil, a sterin, an aluminum monostearate, a glycerin monostearate, a fatty glyceride, a fatty glyceride mixed, an aerosil, or a silicon dioxide or a mixture made from a plurality of these matters. The surface active agent is tween. The soft capsule can strengthen the beneficial effect of the anethol trithione in human body, and meanwhile shows a relativity in and out of the human body.

Description

technical field [0001] The invention provides a kind of medicine oral preparation containing anethiol and its preparation method, specifically a soft capsule containing anethione, which is further developed by utilizing the existing active ingredient anethione, and the purpose is to develop a kind of enhanced The soft capsule dosage form of the beneficial effect of trisulfide in vivo shows the correlation both in vivo and in vitro. Background technique [0002] Anethol Trthione (English name is Anethol Trthione) is an active ingredient that promotes choleresis and protects the liver. It can promote the increase of intracellular glutathione content. , increase the secretion of bile pigment, enhance the detoxification function of the liver, and is one of the ideal drugs for the treatment of gallstones, chronic hepatitis and acute and chronic cholecystitis. Due to the definite clinical curative effects of anetis trithion on liver protection, choleretic, saliva-inducing, digest...

Claims

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Application Information

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IPC IPC(8): A61K31/385A61K9/48A61K47/44A61K47/34A61K47/14A61K47/04A61P1/16A61K47/10A61K47/20A61K47/26
Inventor 姚俊华
Owner 江苏万高药业股份有限公司
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