CN113332251A - Live bacteria preparation of bacillus coagulans - Google Patents
Live bacteria preparation of bacillus coagulans Download PDFInfo
- Publication number
- CN113332251A CN113332251A CN202010142263.1A CN202010142263A CN113332251A CN 113332251 A CN113332251 A CN 113332251A CN 202010142263 A CN202010142263 A CN 202010142263A CN 113332251 A CN113332251 A CN 113332251A
- Authority
- CN
- China
- Prior art keywords
- tablet
- powder
- preparation
- pellet core
- bacillus coagulans
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/742—Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
Abstract
A live bacterial preparation of bacillus coagulans, which is a tablet; the viable bacteria tablet is prepared by preparing micro-pills from powder of Bacillus coagulans HQ-1, wrapping with gelatin, cooling, and mixing with other medicinal adjuvants. The preparation method of the live bacteria preparation comprises the following steps: preparing a pellet core wrapped with fungus powder; preparing a gelatin solution; wrapping gelatin solution outside the pellet core, and cooling to obtain hard capsule; mixing with other medicinal adjuvants and syrup, and making into powder or pill; and then compressed into tablets. The viable bacteria tablet can fully protect the effective component bacteria powder in the stomach and intestinal tract, and the effective component bacteria powder can be melted and dissolved on the affected part, so that the utilization rate of the bacteria powder is high.
Description
Technical Field
The invention belongs to the technical field of biological medicines, and particularly relates to a live bacillus coagulans preparation and a preparation method thereof.
Background
In the prior art, a bacillus coagulans viable tablet (for example, chinese patent publication No. CN109706092A, "a plasmin-producing bacillus coagulans strain and a method for preparing plasmin and viable tablet") is widely used for adjuvant treatment of digestive tract diseases, such as pylorus, duodenum, jejunum, etc. In the using process, the formula of the viable bacteria tablet determined according to the drug effect is found, and no matter what the formula is, the viable bacteria tablet can not be accurately used for the affected part of pylorus, duodenum or jejunum because the gastric acid resistant degree is difficult to control, so that the actual effect is lower than the expected effect.
Disclosure of Invention
In order to solve the technical problems, the invention provides a novel live bacillus coagulans preparation and a preparation method thereof. The method specifically comprises the following steps:
a live bacterial preparation of bacillus coagulans, which is a tablet; the viable bacteria tablet is prepared by preparing micro-pills from powder of Bacillus coagulans HQ-1, wrapping with gelatin, cooling, and mixing with other medicinal adjuvants.
A preparation method of the live bacterial preparation comprises the following steps:
1) heating sucrose and purified water for dissolving, and cooling to obtain syrup;
2) placing starch in a granulator at normal temperature, and starting the granulator; spraying syrup and powder of Bacillus coagulans HQ-1; taking out until the required pellet core is prepared;
3) standing the pellet cores, cooling at 5-10 ℃, and screening for later use;
4) swelling medicinal solid gelatin in warm water bath, and cooling to room temperature to obtain gel;
5) heating the gel to obtain a solution;
6) placing the pellet core obtained in the step 3) in granulation, and starting the granulator; meanwhile, spraying the solution prepared in the step 5); after mixing uniformly, spraying cold air into the granulator until the gel is solidified to obtain a pellet core wrapped with the hard capsule shell;
7) weighing the pharmaceutic adjuvant and the pellet core according to the formula proportion, granulating while spraying the syrup prepared in the step 1) during granulation, and obtaining powder or pills according to the size of the pellets after the syrup is uniform;
8) before the syrup is not solidified, the product of the step 7) is sent into a tablet machine for tabletting, and then the tablet is obtained.
In the step 2), the starch, the sucrose and the fungus powder in the pellet core accord with the mass ratio of the tablet formula.
In the step 7), the pharmaceutical excipients, the sucrose, the starch and the fungus powder of the tablet accord with the mass ratio of the formula of the tablet.
The idea created by the invention is that based on the formula of the tablet, only the physical form of the bacterial powder in the tablet is changed, so that the bacterial powder can realize enteric coating under the protection of the hard capsule shell. In the production process, all the components conform to the formula and are put in different process stages.
At the normal temperature of 25 ℃, the starch pellet core is matched with syrup to wrap the bacterial powder, and the core effective component of the tablet is obtained.
The gelatin used to make the capsules is then made into a solution. The process adopts a preparation method of a medicinal hard shell capsule, and generally comprises swelling solid gelatin in a water bath at 50 ℃, cooling to room temperature to obtain gel, and heating to obtain a solution. By its nature, gelation is generally less than 35 ℃ between 35 ℃ and 40 ℃ and dissolution is greater than 40 ℃.
Spraying the solution onto the pellet core surface, and spraying cold gas (carbon dioxide gas at about 10 deg.C) to obtain pellet core covered with hard shell capsule.
In the production process, the pellet core is prepared by controlling the particle size and sieving to obtain the pellet core with small particles.
In the process of pressing the tablets, a fixed number of pellet cores are selected according to the quality and the size of the tablets and are wrapped by pharmaceutic adjuvant.
In the powder, the pill or the tablet prepared by the method, the starch and the sucrose are common auxiliary materials in the preparation process of food/medicine, and the starch and the sucrose have no negative influence on the quality of gastrointestinal diseases basically under a trace condition.
The viable bacteria tablet adopts a new idea to design a mechanism and a preparation process thereof, is based on the existing equipment, and is suitable for the formula of the viable bacteria tablet with multiple purposes. The viable bacteria tablet can fully protect the effective component bacteria powder in the stomach and intestinal tract, and the effective component bacteria powder can be melted and dissolved on the affected part, so that the utilization rate of the bacteria powder is high.
Detailed Description
The present solution is further illustrated below with reference to examples:
the live bacterial preparation of bacillus coagulans in this example, which is a tablet; the formula can be according to the formula of the existing tablets with various active ingredients as live bacteria.
The viable bacteria tablet is prepared by preparing micro pills from bacillus coagulans HQ-1 powder, wrapping gelatin, cooling, and mixing with other medicinal adjuvants.
A preparation method of the live bacterial preparation comprises the following steps:
1) heating sucrose and purified water for dissolving, and cooling to obtain syrup;
2) placing starch in a granulator at normal temperature, and starting the granulator; spraying syrup and powder of Bacillus coagulans HQ-1; taking out until the required pellet core is prepared;
3) standing the pellet cores, cooling at 5-10 ℃, and screening for later use;
4) swelling medicinal solid gelatin in warm water bath (50 deg.C) for 2 hr (mass concentration is more than 2%), and cooling to room temperature to obtain gel;
5) heating the gel at 40 ℃ to obtain a solution;
6) placing the pellet core obtained in the step 3) in granulation, and starting the granulator; meanwhile, spraying the solution prepared in the step 5); after mixing uniformly, spraying cold air into the granulator until the gel is solidified to obtain a pellet core wrapped with the hard capsule shell;
7) weighing the pharmaceutic adjuvant and the pellet core according to the formula proportion, granulating while spraying the syrup prepared in the step 1) during granulation, and obtaining powder or pills according to the size of the pellets after the syrup is uniform;
8) before the syrup is not solidified, the product of the step 7) is sent into a tablet machine for tabletting, and then the tablet is obtained.
In the step 2), the starch, the sucrose and the fungus powder in the pellet core accord with the mass ratio of the tablet formula.
In the step 7), the pharmaceutical excipients, the sucrose, the starch and the fungus powder of the tablet accord with the mass ratio of the formula of the tablet.
Claims (4)
1. A viable bacteria preparation of bacillus coagulans is characterized in that the viable bacteria preparation is a tablet; the viable bacteria tablet is prepared by preparing micro-pills from powder of Bacillus coagulans HQ-1, wrapping with gelatin, cooling, and mixing with other medicinal adjuvants.
2. A method for preparing a live bacterial preparation according to claim 1, characterized in that it comprises the steps of:
1) heating sucrose and purified water for dissolving, and cooling to obtain syrup;
2) placing starch in a granulator at normal temperature, and starting the granulator; spraying syrup and powder of Bacillus coagulans HQ-1; taking out until the required pellet core is prepared;
3) standing the pellet cores, cooling at 5-10 ℃, and screening for later use;
4) swelling medicinal solid gelatin in warm water bath, and cooling to room temperature to obtain gel;
5) step 4), heating the gel to obtain a solution;
6) placing the pellet core obtained in the step 3) in granulation, and starting the granulator; meanwhile, spraying the solution prepared in the step 5); after mixing uniformly, spraying cold air into the granulator until the gel is solidified to obtain a pellet core wrapped with the hard capsule shell;
7) weighing the pharmaceutic adjuvant and the pellet core according to the formula proportion, spraying the syrup prepared in the step 1) while granulating in granulation, and tabletting in a tabletting machine after the syrup is uniform to obtain the tablet.
3. The preparation method of claim 2, wherein in the step 2), the starch, the sucrose and the fungal powder in the pellet core are in accordance with the mass ratio of the tablet formulation.
4. The preparation method of claim 2, wherein in the step 7), the pharmaceutical excipients, the sucrose, the starch and the fungus powder of the tablet are in accordance with the mass ratio of the tablet formulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010142263.1A CN113332251A (en) | 2020-03-01 | 2020-03-01 | Live bacteria preparation of bacillus coagulans |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010142263.1A CN113332251A (en) | 2020-03-01 | 2020-03-01 | Live bacteria preparation of bacillus coagulans |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113332251A true CN113332251A (en) | 2021-09-03 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010142263.1A Pending CN113332251A (en) | 2020-03-01 | 2020-03-01 | Live bacteria preparation of bacillus coagulans |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113332251A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114796510A (en) * | 2022-06-02 | 2022-07-29 | 梅州华普医院有限公司 | A Chinese medicinal composition for treating rheumatism, cervical spondylosis, arthritis, and lumbar spondylitis |
-
2020
- 2020-03-01 CN CN202010142263.1A patent/CN113332251A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114796510A (en) * | 2022-06-02 | 2022-07-29 | 梅州华普医院有限公司 | A Chinese medicinal composition for treating rheumatism, cervical spondylosis, arthritis, and lumbar spondylitis |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20210903 |
|
| WD01 | Invention patent application deemed withdrawn after publication |