CN115105532A - Preparation method of human bile freeze-dried powder - Google Patents
Preparation method of human bile freeze-dried powder Download PDFInfo
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- CN115105532A CN115105532A CN202210604525.0A CN202210604525A CN115105532A CN 115105532 A CN115105532 A CN 115105532A CN 202210604525 A CN202210604525 A CN 202210604525A CN 115105532 A CN115105532 A CN 115105532A
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- 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
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- 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
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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Abstract
The invention discloses a preparation method of human bile freeze-dried powder. The preparation method comprises the following steps: sequentially carrying out filtration, centrifugation, ceramic membrane concentration and nanofiltration membrane concentration on the collected bile of the patient; quick freezing into solid, vacuum drying at certain temperature and pressure, and grinding to obtain lyophilized human bile powder. The bile required by the preparation of the human bile freeze-dried powder is from the patient, and does not have ethical disputes; the preparation method of the invention has simple steps and low cost, can realize the conversion from bile to bile freeze-dried powder through the steps of impurity removal, freeze-drying, sterilization and the like, and in the conversion process, the effective components of the bile are reserved, and no chemical product or reagent is added in the whole process, thereby having practical significance of clinical application.
Description
Technical Field
The invention relates to a preparation method of human bile freeze-dried powder, belonging to the technical field of biological medicines.
Background
Bile of an obstructive jaundice patient is drained to the outside of the body after a skin-liver puncture drainage operation or a biliary surgery operation, so that bile salt in the intestine is deficient, and the digestion and absorption of fat can be influenced; absorption of fat-soluble vitamins and calcium; the metabolism of endotoxin in the intestinal tract and the normal barrier function of intestinal mucosa; as well as the appetite and intestinal motility of the patient.
The drained sterile bile can be reused after oral administration, and the enterohepatic circulation of bile salt can be recovered, so that the original physiological function of the bile salt can be exerted. The bile is bitter and astringent in taste and has irritation to gastric mucosa, and oral administration of bile has poor taste, nausea, emesis, epigastric discomfort and the like, so that clinical application of the bile is influenced.
Disclosure of Invention
The invention aims to provide a preparation method of human bile freeze-dried powder which has simple and ingenious steps and has clinical utilization significance by using a freeze-drying method.
In order to realize the purpose, the invention provides a preparation method of human bile freeze-dried powder, which comprises the following steps:
step 1: sequentially carrying out filtration, centrifugation, ceramic membrane concentration and nanofiltration membrane concentration on the collected aseptic bile of the patient;
step 2: carrying out quick-freezing treatment on the bile treated in the step 1;
and step 3: and (3) carrying out sublimation drying and desorption drying on the solid material obtained by the treatment in the step (2) in sequence to obtain a solid material with cellular meshes, then grinding the solid material into powder to obtain the human bile freeze-dried powder, wherein the temperature of the material is kept not more than 40 ℃ in the desorption drying process.
Preferably, the specification of the filter screen filtered in the step 1 is 80-120 meshes, the rotating speed of centrifugation is 3500-4500 rpm, and the temperature of centrifugation is 2-8 ℃.
Preferably, the aperture of the ceramic membrane used for the ceramic membrane concentration in the step 1 is 0.5 μm, and the pressure before the membrane is 0.2 MPa; the aperture of a nanofiltration membrane adopted by the nanofiltration membrane concentration is 0.03 mu m, and the pressure before the membrane is 0.2 MPa.
Preferably, the temperature of the pre-freezing treatment in the step 2 is-50 ℃, and the freezing time is 5-8 h.
Preferably, the vacuum degree of sublimation drying in the step 3 is 80-120 Pa, the temperature is-40 ℃ to-30 ℃, and the time is 12-15 hours; the vacuum degree of the desorption drying is 80-100 Pa, the heating temperature is 60-65 ℃, the time is 12-24 h, and the material temperature is kept at 20-40 ℃ in the desorption drying process.
The invention also provides the application of the human bile freeze-dried powder prepared by the preparation method of the human bile freeze-dried powder in preparing human bile freeze-dried powder capsules.
Compared with the prior art, the invention has the beneficial effects that:
(1) the bile required by the preparation of the human bile freeze-dried powder is from the patient, and does not have ethical disputes; the preparation method has simple steps and low cost, can realize the conversion from the bile to the bile freeze-dried powder through the steps of impurity removal, freeze-drying, sterilization and the like, and in the conversion process, the effective components of the bile are reserved, and no chemical product or reagent is added in the whole process, thereby having practical significance of clinical application;
(2) the preparation method of the invention overcomes the defects that patients with bile bitter taste are not easy to accept, and oral bile stimulates gastric mucosa and causes adverse reaction, increases the compliance of the patients, is particularly suitable for being popularized and applied in patients with long-term biliary obstruction, and has wide application prospect.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail below.
Example 1
The embodiment provides a preparation method of human bile freeze-dried powder, which comprises the following steps:
(1) first, collecting drained sterile bile every 6h, and freezing and storing at-20 ℃ for later use. After certain bile is collected, unfreezing, filtering by using a filter screen, wherein the mesh of the filter screen is 80 meshes, then carrying out low-temperature centrifugation (4 ℃) treatment by using a horizontal centrifuge under the condition of 3500 revolutions per minute, concentrating by using a ceramic membrane, wherein the membrane aperture is 0.5 mu m, the pressure before the membrane is 0.2MPa, concentrating by using a nanofiltration membrane, the membrane aperture is 0.03 mu m, and the pressure before the membrane is 0.2 MPa;
(2) placing the bile processed by the steps into a quick-freezing bin for quick freezing at-50 ℃ for 5 hours;
(3) putting the frozen solid material into a freeze drying bin, vacuumizing the drying bin at a vacuum degree of 80-120 Pa, sublimating and drying the solid material under a certain vacuum degree environment, controlling the temperature to be-40-30 ℃ and the time to be 12h, wherein the vacuumizing speed is basically consistent with the sublimating speed of the material under the conditions, and a dynamic balance is formed. After sublimation drying, carrying out resolution drying, wherein the vacuum degree of the resolution drying is 80-100 Pa, simultaneously starting heat radiation, the heating temperature is 60 ℃, the material temperature is controlled to be 20-40 ℃, the temperature of the heat radiation is to keep the temperature of the material below 40 ℃ all the time in the resolution drying process, after the process is kept for 12 hours, the obtained material of the freeze drying bin is a solid matter with honeycomb meshes, and then grinding solid powder into powder, namely the human bile freeze-dried powder. The bile freeze-dried powder capsule is prepared by using the human bile freeze-dried powder for later use.
Example 2
The embodiment provides a preparation method of human bile freeze-dried powder, which comprises the following steps:
(1) first, collecting drained sterile bile every 6h, and freezing and storing at-20 ℃ for later use. After certain bile is collected, unfreezing, filtering by using a filter screen with the mesh of 100 meshes, then carrying out low-temperature centrifugation treatment (4 ℃) by using a horizontal centrifuge at 4000 revolutions per minute, concentrating by using a ceramic membrane with the membrane aperture of 0.5 mu m and the pressure before the membrane of 0.2MPa, concentrating by using a nanofiltration membrane with the membrane aperture of 0.03 mu m and the pressure before the membrane of 0.2 MPa;
(2) placing the bile processed by the steps into a quick-freezing bin for quick freezing at the temperature of minus 50 ℃ for 6 hours;
(3) putting the frozen solid material into a freeze drying bin, vacuumizing the drying bin at a vacuum degree of 80-120 Pa, sublimating and drying the solid material under a certain vacuum degree environment, controlling the temperature to be-40-30 ℃ and the time to be 15h, wherein the vacuumizing speed is basically consistent with the sublimating speed of the material under the conditions, and a dynamic balance is formed. After sublimation drying, carrying out resolution drying, wherein the vacuum degree of the resolution drying is 80-100 Pa, simultaneously starting heat radiation, the heating temperature is 65 ℃, the material temperature is controlled to be 20-40 ℃, the temperature of the heat radiation is to keep the temperature of the material below 40 ℃ all the time in the resolution drying process, after the process is kept for 18h, the obtained material is a solid matter with honeycomb meshes, and then grinding solid powder into powder, namely the human bile freeze-dried powder. The bile freeze-dried powder capsule is prepared by using the human bile freeze-dried powder for standby.
Example 3
The embodiment provides a preparation method of human bile freeze-dried powder, which comprises the following steps:
(1) first, collecting drained sterile bile every 6h, and freezing and storing at-20 ℃ for later use. After certain bile is collected, unfreezing, filtering by using a filter screen, wherein the mesh of the filter screen is 120 meshes, then carrying out low-temperature centrifugation treatment (2 ℃) by using a horizontal centrifuge at 4500 revolutions per minute, concentrating by using a ceramic membrane, wherein the membrane aperture is 0.5 mu m, the pressure before the membrane is 0.2MPa, concentrating by using a nanofiltration membrane, the membrane aperture is 0.03 mu m, and the pressure before the membrane is 0.2 MPa;
(2) placing the bile processed by the steps into a quick-freezing bin for quick freezing at the temperature of minus 50 ℃ for 8 hours;
(3) putting the frozen solid material into a freeze drying bin, vacuumizing the drying bin at a vacuum degree of 80-120 Pa, sublimating and drying the solid material under a certain vacuum degree environment, controlling the temperature at-40 ℃ to-30 ℃ and the time at 15h, wherein the vacuumizing speed is basically consistent with the sublimating speed of the material under the conditions, and a dynamic balance is formed. After sublimation drying, carrying out resolution drying, wherein the vacuum degree of the resolution drying is 80-100 Pa, simultaneously starting heat radiation, the heating temperature is 60 ℃, the material temperature is controlled to be 20-40 ℃, the temperature of the heat radiation is to keep the temperature of the material below 40 ℃ all the time in the resolution drying process, after the process is kept for 24 hours, the obtained material is a solid matter with honeycomb meshes, and then grinding solid powder into powder, namely the human bile freeze-dried powder. The bile freeze-dried powder capsule is prepared by using the human bile freeze-dried powder for later use.
Claims (6)
1. A preparation method of human bile freeze-dried powder is characterized by comprising the following steps:
step 1: sequentially carrying out filtration, centrifugation, ceramic membrane concentration and nanofiltration membrane concentration on the collected patient bile;
step 2: carrying out quick-freezing treatment on the bile treated in the step 1;
and step 3: and (3) carrying out sublimation drying and desorption drying on the solid material obtained by the treatment in the step (2) in sequence under a vacuum condition to obtain a solid material with cellular meshes, and then grinding the solid material into powder to obtain the human bile freeze-dried powder, wherein the temperature of the material is kept to be not more than 40 ℃ in the desorption drying process.
2. The preparation method of the human bile freeze-dried powder as claimed in claim 1, wherein the specification of the filter screen for filtering in the step 1 is 80-120 meshes, the rotation speed of the centrifugation is 3500-4500 rpm, and the temperature of the centrifugation is 2-8 ℃.
3. The method for preparing lyophilized human bile powder of claim 1, wherein the ceramic membrane used for ceramic membrane concentration in step 1 has a pore size of 0.5 μm and a pre-membrane pressure of 0.2 MPa; the aperture of a nanofiltration membrane used for nanofiltration membrane concentration is 0.03 mu m, and the pressure before the membrane is 0.2 MPa.
4. The method for preparing lyophilized human bile powder of claim 1, wherein the temperature of the quick freezing in step 2 is-50 ℃ and the time is 5-8 h.
5. The method for preparing lyophilized human bile powder of claim 1, wherein the degree of vacuum of sublimation drying in step 3 is 80-120 Pa, the temperature is-40 ℃ to-30 ℃, and the time is 12-15 h; the vacuum degree of the desorption drying is 80-100 Pa, the heating temperature is 60-65 ℃, the time is 12-24 h, and the material temperature is kept at 20-40 ℃ in the desorption drying process.
6. The use of the lyophilized human bile powder prepared by the method of any one of claims 1 to 5 in the preparation of a lyophilized human bile powder capsule.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210604525.0A CN115105532A (en) | 2022-05-31 | 2022-05-31 | Preparation method of human bile freeze-dried powder |
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| CN202210604525.0A CN115105532A (en) | 2022-05-31 | 2022-05-31 | Preparation method of human bile freeze-dried powder |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115837045A (en) * | 2023-01-03 | 2023-03-24 | 复旦大学附属中山医院 | Preparation method of medical lotus root juice freeze-dried powder |
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| CN106307545A (en) * | 2016-08-25 | 2017-01-11 | 青海省心脑血管病专科医院 | Preparing method of boxthorn leaf freeze-dried powder |
| CN108926539A (en) * | 2018-08-06 | 2018-12-04 | 安徽芜酒酒业有限公司 | A kind of preparation method of snake gall freeze-dried powder |
| JP2019048854A (en) * | 2009-04-24 | 2019-03-28 | イシューティカ ピーティーワイ リミテッド | Method for production of commercial nanoparticle and microparticle powders |
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2022
- 2022-05-31 CN CN202210604525.0A patent/CN115105532A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101099569A (en) * | 2007-08-01 | 2008-01-09 | 江苏省中国科学院植物研究所 | Vaccinium beacteatum Thunb freeze-dried powder injection and its preparation method and application |
| CN101785789A (en) * | 2009-01-22 | 2010-07-28 | 张雪峰 | Method for preparing animal gall powder |
| JP2019048854A (en) * | 2009-04-24 | 2019-03-28 | イシューティカ ピーティーワイ リミテッド | Method for production of commercial nanoparticle and microparticle powders |
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| CN102687875A (en) * | 2012-04-25 | 2012-09-26 | 大连棒棰岛海产股份有限公司 | Preparation method of freeze-dried powder of sea cucumber boiled liquid |
| CN105477003A (en) * | 2015-12-25 | 2016-04-13 | 成都市新功生物科技有限公司 | Method for preparing poultry artificial bear gall powder |
| CN106307545A (en) * | 2016-08-25 | 2017-01-11 | 青海省心脑血管病专科医院 | Preparing method of boxthorn leaf freeze-dried powder |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115837045A (en) * | 2023-01-03 | 2023-03-24 | 复旦大学附属中山医院 | Preparation method of medical lotus root juice freeze-dried powder |
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