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Coagulated bacillus living formulation preparation method and uses for treating ulcerative colitis

A technology of Bacillus coagulans and ulcerative colitis, which is applied in the field of manufacture and application of live Bacillus coagulans preparations for the treatment of ulcerative colitis, and can solve the problems of experimental research and clinical research of Bacillus coagulans ulcerative colitis. Patent and other issues

Active Publication Date: 2006-06-21
北京普尔康医药高科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To sum up, in recent years, there have been no patents related to experimental and clinical research on the treatment of ulcerative colitis by Bacillus coagulans in relevant patents at home and abroad.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1 preparation of bacillus coagulans bacteria powder:

[0051] Take a tube of Bacillus coagulans, dissolve it in a sterilized 100ml Erlenmeyer flask filled with 10ml normal saline and appropriate amount of glass beads, activate it for 10 minutes, use a 1ml sterile pipette to draw 1ml bacterial suspension to inoculate a 50ml amplified flask Culture medium in a 250ml Erlenmeyer flask, placed in a rocking bed at 37°C constant temperature oscillation (190rpm) for 24 hours, transferred to a 2500ml baffle Erlenmeyer flask equipped with 450ml expansion medium, 37°C constant temperature oscillation culture for 24 hours, no microscopic examination Then transfer the miscellaneous bacteria into the seed tank with 4.5L expansion medium, aerobic culture (aeration volume 3:1) for 24 hours, and transfer to the fermenter with 45L fermentation medium after microscopic examination without miscellaneous bacteria , 37 ℃ aerobic culture (inflated volume 3:1) for 24 hours, microsco...

Embodiment 2

[0052] Embodiment 2 Bacillus coagulans live bacteria sheet, capsule manufacture:

[0053] According to the number of viable bacteria of Bacillus coagulans powder, add microcrystalline cellulose, mannitol and polyvinylpyrrolidone according to the following ratio, so that the number of viable bacteria is not lower than 1.0×10 6 cfu / g, compressed tablet. Manufacturing techniques can be found in "Tablets and Capsules" "Practical Pharmaceutical Preparation Technology" 1st Edition, People's Health Publishing House, pp. 1-30 (1999) referenced herein.

[0054] Formula of live Bacillus coagulans tablets

[0055] Composition % (weight)

[0056] Bacillus coagulans live bacteria powder 1.00 parts

[0057] Microcrystalline cellulose 55.00 parts

[0058] Mannitol 25.00 parts

[0059] Polyvinylpyrrolidone 19.00 parts

[0060] Components 1-4 in the above components are fully stirred evenly, and then compressed into tablets by unit dosage by conventional tablet compression technology.

...

Embodiment 3

[0067] The manufacture of embodiment 3 bacillus coagulans live bacteria powder

[0068] According to the number of live bacteria of Bacillus coagulans powder, add skimmed milk powder, glucose and starch according to the following ratio, so that the number of live bacteria is not less than 1.0×10 6 cfu / g bagged. For the manufacturing technique, please refer to "Powder", "Practical Pharmaceutical Preparation Technology" 1st edition, People's Health Publishing House, pp. 1-30 (1999) referenced here.

[0069] The formula of live bacillus coagulans powder

[0070] Composition % (weight)

[0071] Bacillus coagulans live bacteria powder 20.00 parts

[0072] Skimmed milk powder 30.00 parts

[0073] Glucose 30.00 parts

[0074] Starch 20.00 parts

[0075] Fully mix components 1 to 4 of the above components, and then use conventional powder filling technology to press the bag into a unit dose to make a powder.

[0076] About the manufacture of Bacillus coagulans granule, repeat i...

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PUM

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Abstract

The present invention discloses the preparation process and application of live coagulated bacillus preparation for treating ulcerous colitis. The present invention includes the curative effect of the preparation in treating experimental rat's ulcerous colitis, the clinical application of the preparation on patient of ulcerous colitis and the evaluation of the effectiveness and safety, as well as the recipe and preparation process of the preparation, live bacillus content, medicine carrier, preparation form, etc. The live coagulated bacillus preparation has the features of high treating effectiveness and safety, high stability, capacity of room temperature maintenance and no bad reaction caused by long term taking. The present invention provides one new way for treating ulcerous colitis.

Description

technical field [0001] The invention relates to a production method and application of a live bacillus coagulans preparation for treating ulcerative colitis. Background of the invention [0002] Ulcerative colitis (UC) is a chronic inflammatory disease of the rectum and colon with unknown etiology. The disease can occur at any age, and is more common between 20 and 50 years old. There is no significant difference in incidence between men and women. This disease is more common in Europe and the United States, and its incidence rate is about 79-140 / 100,000 people; Japan is lower, about 3.7-54 / 100,000 people. my country has not yet done the epidemiological survey, and it is estimated to be no less than Japan. But in recent years, inflammatory bowel disease has a clear upward trend. The mild remission rate of the disease is 70-80%; severe is 50%; severe fulminant mortality rate is as high as 25%. What is particularly worrying is that long-term chronic colitis can induce cancer...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/74A61K9/20A61K9/48A61K35/742A61P1/04
CPCA61K35/742C12N1/20A61P1/04
Inventor 崔云龙
Owner 北京普尔康医药高科技有限公司
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