Bezoar vitro bred and solid oral preparation containing the bezoar

A technology for cultivating bezoar and solid preparations in vitro, which is applied in the directions of medical preparations containing active ingredients, anti-inflammatory agents, and pill delivery, etc., to achieve the effects of easy control and excellent clinical efficacy.

Active Publication Date: 2008-10-15
江苏华阳制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The national drug regulatory department stipulates that for the clinical acute and severe diseases containing bezoar in the national drug standard prescription and the new drug containing bezoar approved by the national drug regulatory department, the bezoar in the prescription can be replaced by cultivated bezoar and in vitro cultivated bezoar. The same amount of feeding is used, but artificial bezoar should not be substituted

Method used

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  • Bezoar vitro bred and solid oral preparation containing the bezoar
  • Bezoar vitro bred and solid oral preparation containing the bezoar

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] (1) Take 1000ml of fresh ox bile.

[0047] (2) Add the following components:

[0048] Bilirubin 300g

[0049] Cholic acid 100g

[0050] Deoxycholic acid 50g

[0051] Cholesterol 10

[0052] Magnesium sulfate 10g

[0053] Ferrous Sulfate 5g

[0054] Calcium hydrogen phosphate 10g

[0055] Taurine 15g

[0056](3) Mix the above components with 100ml of β-glucuronidase suspension evenly, seal it, keep it in a shaking water bath at 37±1°C for 5 hours, then measure the pH value of ox bile every 1 hour, when the pH is at 3 ~4:00, stop shaking the water bath.

[0057] (4) The above-mentioned mixture is separated with a centrifuge to remove the precipitate, washed with distilled water, and the content of bilirubin and cholic acid is measured, and bilirubin and cholic acid are added to make the bilirubin content 41% and the content of cholic acid in the mixture 12.6%.

[0058] (5) Add an appropriate amount of distilled water to the mixture obtained in step (4) (accordin...

Embodiment 2

[0062] (1) Take 1000ml of fresh ox bile.

[0063] (2) Add the following components:

[0064] Bilirubin 310g

[0065] Cholic acid 80g

[0066] Deoxycholic acid 40g

[0067] Cholesterol 15

[0068] Magnesium Sulfate 15g

[0069] Ferrous Sulfate 8g

[0070] Calcium hydrogen phosphate 10g

[0071] Taurine 25g

[0072] (3) Mix the above components with 100ml of β-glucuronidase suspension evenly, seal it, keep it in a shaking water bath at 37±1°C for 5 hours, then measure the pH value of ox bile every 1 hour, when the pH is at 3 ~4:00, stop shaking the water bath.

[0073] (4) above-mentioned mixture is separated precipitation with centrifuge, washes with distilled water, measures bilirubin and cholic acid content, adds bilirubin and cholic acid, makes bilirubin content be 43% in the mixture, the content of cholic acid The content is 11.3%.

[0074] (5) Add an appropriate amount of distilled water to the mixture obtained in step (4) (according to the ratio of adding 50ml o...

Embodiment 3

[0078] Acetaminophen 250g

[0079] Chlorpheniramine Maleate 1g

[0080] Caffeine 15g

[0081] In vitro cultured bezoar 10g

[0082] Ethanol (40%) appropriate amount

[0083] Magnesium stearate 0.4g

[0084]

[0085] Makes 1000 capsules

[0086] Add the weighed chlorpheniramine maleate, caffeine, and in vitro cultured bezoar (prepared according to the method in Example 1) into a high-efficiency wet mixer and mix for 10 minutes, then mix with acetaminophen in equal increments uniform. Add the prepared ethanol with a weight percentage of 40%, adjust the rotating speed of the high-efficiency wet mixing granulator, make granules, dry and granulate. After weighing the prescribed amount of magnesium stearate and mixing the granules evenly, fill the No. 1 capsule to get final product.

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Abstract

The invention provides an in vitro cultured bezoar and a solid oral preparation containing the same. The bezoar is cultured in vitro by simulating ox gallstone formation by using natural oxgall and adding specific components, wherein the specific components contains bilirubin, cholic acid, deoxycholic aicd, cholesterol, magnesium sulfate, ferrous sulfate, calcium hydrogen phosphate and taurine, wherein the obtained content of cholic acid in vitro cultured bezoar is not less than 6%, and the content of bilirubin is not less than 35%. The in vitro cultured bezoar is used for preparing solid oral preparations for treating common cold. The quality indexes of the obtained in vitro cultured bezoar meet national standards; and clinical test shows that the therapeutic effect of the in vitro cultured bezoar is better than that of the artificial bezoar.

Description

technical field [0001] The invention relates to an in vitro cultured bezoar and a solid oral preparation containing it. Background technique [0002] Bezoar is a precious medicine commonly used in traditional Chinese medicine. Its functions are to clear away heat and detoxify, calm convulsions and reduce swelling, strengthen the heart and gallbladder, etc. The natural occurrence rate of natural bezoar is only 0.921%, and the source of medicine is scarce. Since 1972, the national drug supervision and management department has successively approved three bezoar substitutes, namely artificial bezoar, cultivated bezoar and in vitro cultured bezoar. [0003] The national drug regulatory department stipulates that for the clinical acute and severe diseases containing bezoar in the national drug standard prescription and the new drug containing bezoar approved by the national drug regulatory department, the bezoar in the prescription can be replaced by cultivated bezoar and in vit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/413A61K9/20A61K9/48A61P31/00A61P29/00A61P11/00A61K31/167A61K31/185A61K31/409A61K31/4402A61K31/522A61K31/575A61K33/06A61K33/26A61K33/42
Inventor 冯井胜吴永亮
Owner 江苏华阳制药有限公司
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