CN107961219B - Medicinal pellet core and preparation method thereof - Google Patents
Medicinal pellet core and preparation method thereof Download PDFInfo
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- CN107961219B CN107961219B CN201610912368.4A CN201610912368A CN107961219B CN 107961219 B CN107961219 B CN 107961219B CN 201610912368 A CN201610912368 A CN 201610912368A CN 107961219 B CN107961219 B CN 107961219B
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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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
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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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Medicinal Preparation (AREA)
Abstract
The pellet core of the invention comprises main materials, diluent and adhesive, and is prepared by using glucose as the main material, so that the pellet core can be used as a base pill for further medicine application, and can also be provided for patients in clinical treatment as a product for supplementing sugar.
Description
Technical Field
The invention belongs to the field of medicinal preparations, and particularly relates to a medicinal pellet core and a preparation method thereof.
Background
The medicinal pellet core is a near-spherical particle prepared from inert auxiliary materials or main medicaments and auxiliary materials. The inert pellet core is usually used as a matrix and a carrier in production. The drug-containing pellet cores have different purposes according to the difference among various types, for example, the drug-containing pellet cores are further coated with functional coatings to obtain the sustained-release or delayed-release pellets with different drug release properties. In terms of properties, the pellet core generally requires good roundness, low friability, smooth surface, good flatness and good fluidity, and meets the requirements of further medicine application and coating procedures or filling procedures. The preparation method of the pellet core has various methods, and the main preparation processes comprise extrusion-spheronization, centrifugal coating, powder direct pressing and the like. The auxiliary materials used by the inert pellet core and the drug-containing pellet core are usually microcrystalline cellulose, sucrose, starch, dextrin and the like, and basically the more expensive glucose and the monohydrate glucose with poor granulation property are not used as the auxiliary materials.
Chinese patent 200610052636.6 entitled "medicinal pellet core and its preparation method" discloses a medicinal pellet core and its preparation method, wherein the pellet core is prepared from at least medicinal starch or microcrystalline cellulose as main material, and adhesive to obtain pellet core with particle size of 0.3-2.5 mm; wherein, the main material is 60 to 95 percent, the adhesive is 3 to 25 percent, and the water is 2 to 15 percent. The preparation method comprises mixing the main material and binder, granulating in a granulator to obtain round granules, drying, and sieving to obtain pellet core. Chinese patent 200810196364.6 "preparation method of medicinal pellet core" discloses a medicinal pellet core and its preparation method, the components are: 50-72% of medicinal starch, 25-45% of cane sugar and the balance of purified water. The preparation method comprises the steps of preparing syrup, preparing the cores for pills, drying, screening and packaging. The preparation of the pellet cores in the two patents needs less equipment and has simple process realization, but the particle size uniformity, the roundness and the surface smoothness cannot reach satisfactory levels, and the quality of finished products is also unstable.
In summary, how to simplify the process and equipment for preparing pellet cores in the prior art and obtain pellet cores with good properties such as uniform particle size, high yield, good roundness, good surface smoothness and better reproducibility becomes a problem to be solved urgently.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a medicinal pellet core with excellent properties and indexes and a preparation method of the pellet core, which has the advantages of simple process, low requirement on equipment level and convenience for industrial production.
One of the purposes of the invention is to provide a medicinal pellet core which comprises a main material, a diluent and a binding agent, wherein the main material is glucose, and the glucose can be selected from anhydrous glucose, monohydrate glucose or a mixture of the anhydrous glucose and the monohydrate glucose. The diluent is selected from one or more of the following: microcrystalline cellulose, starch, pregelatinized starch, lactose, mannitol, dextrin; the binder is selected from one or more of the following: polyvinylpyrrolidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, starch slurry, dextrin, Arabic gum, ethyl cellulose and konjac powder. The inventor finds that when the medicinal pellet core is prepared, the binder and the diluent are added simultaneously, compared with the binder or the diluent only, the obtained pellet core has the advantages of uniform particle size, good roundness, good surface smoothness, difficulty in crushing and better properties.
The pellet core of the invention comprises 55-90 wt% of all main materials, preferably 65-85 wt%; the mass percentage of all the diluents is 10-35%, preferably 15-25%; the mass percentage of the total binder is 1% to 8%, preferably 1% to 5%, and more preferably 1.5% to 3%.
Further, the pellet core of the pellet specifically comprises a mother core component and a centrifugal coating component. The first part of the main material, the diluent and the adhesive used in the preparation of the mother nucleus is called a mother nucleus component, the second part of the main material, the diluent and the adhesive used in the centrifugal packaging is called a centrifugal packaging component, and the main material, the diluent and the adhesive used in the mother nucleus component and the centrifugal packaging component can be the same or different.
The mother core comprises the following components in percentage by weight: 55-80%, preferably 60-70%, more preferably 60-65% of the first part of the main material; the first part of the diluent is 15 to 40 percent, preferably 20 to 35 percent, and more preferably 25 to 30 percent; the first part of adhesive is 1-10%, preferably 1-8%, more preferably 2-5%; the proportions of the centrifugal coating components are as follows: 70-95% of the second part of main material, preferably 75-90%, more preferably 80-85%; the second part of the diluent is 10 to 30 percent, preferably 10 to 25 percent, and more preferably 15 to 20 percent; the second part of the adhesive is 1 to 7 percent, preferably 1 to 5 percent, and more preferably 1.5 to 3 percent. The invention increases the yield of the obtained pellet core by properly selecting the raw materials and the addition amount of each part, improves the property parameters of the pellet core, and obtains a product which has uniform particle size, good roundness, good surface smoothness, is not easy to break and is more suitable for preparation application.
The dosage ratio of the mother nucleus component to the pericardium dissociating component is 1: 1.2 to 3, preferably 1:1.5 to 2.5.
The pellet core of the pellet can be coated with one or more layers of functional coatings, so that the pellet core has different release effects such as slow release, controlled release, quick release and the like or can be released under different pH conditions or different in vivo environments.
The invention also aims to provide a preparation method of the pellet core, and the inventor finds that when glucose is used as a main material in an experiment to prepare the pellet core through direct granulation, if the proportion of the main material is large, the particle texture is crisp and easy to break, and if the proportion of the main material is small, the content requirement cannot be met, so that the pellet core with proper proportion of the main material and excellent properties is obtained.
The preparation method of the pellet core specifically comprises the following steps:
1) crushing and sieving the components, weighing the components according to the prescription amount, dissolving the adhesive in water to prepare an adhesive aqueous solution, placing the first part of the main materials and the diluent in a wet granulator, uniformly mixing, adding the first part of the adhesive aqueous solution to prepare a mother nucleus with the size distributed in a certain range, and carrying out the next operation after sieving.
2) And starting the centrifugal packaging machine, putting the prepared mother nucleus into the centrifugal packaging machine, adjusting the rotating speed, supplying powder by using the second part of main materials and the diluent while spraying the second part of adhesive solution, and performing lamination and powder coating operation on the mother nucleus. Finally, the pellet cores with the particle size distribution in a certain range are obtained through screening.
After the pellet core is prepared, the pellet core can be screened according to the particle size to obtain a product with the particle size meeting the requirement, for example, the particle size of the pellet core prepared in the invention can be 0.2 mm-1.0 mm, preferably 0.3-0.85 mm, such as 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm and the like.
Detailed Description
One, example 1. monohydrate dextrose pellet core, wherein the dosage ratio of the parent nucleus component to the centrifugal coating component is 1: 1.3.
The preparation method comprises the following steps:
a. pulverizing and sieving each component, weighing each component according to the prescription amount, dissolving PVP K-30 in water to prepare binder aqueous solution, placing monohydrate glucose and MCC101 in the mother nucleus component in a wet granulator, mixing uniformly, and adding the binder aqueous solution to prepare the mother nucleus.
b. Starting a centrifugal wrapping machine, putting the prepared mother nucleus into the centrifugal wrapping machine, adjusting the rotating speed, supplying powder by using dextrose monohydrate and MCC101 in the centrifugal wrapping components, spraying a binder solution, performing lamination powder-coating operation on the mother nucleus, and finally screening the prepared pellets.
Example 2 Anhydrous glucose pellet cores wherein the ratio of parent nucleus component to centrifuge coating component is 1:2.
The preparation method comprises the following steps:
a. pulverizing and sieving each component, weighing each component according to the prescription amount, dissolving PVP K-30 in water to prepare binder aqueous solution, placing anhydrous glucose and MCC101 in the mother nucleus component in a wet granulator, mixing uniformly, and adding the binder aqueous solution to prepare the mother nucleus.
b. Starting a centrifugal wrapping machine, putting the prepared mother nucleus into the centrifugal wrapping machine, adjusting the rotating speed, supplying powder by using anhydrous glucose and starch in centrifugal wrapping components, spraying a binder solution, performing lamination powder-coating operation on the mother nucleus, and finally screening the prepared pellets.
Example 3 Anhydrous glucose pellet cores wherein the ratio of parent nucleus component to centrifuge coating component is 1: 2.5.
The preparation method comprises the following steps:
a. pulverizing and sieving each component, weighing each component according to the prescription amount, dissolving PVP K-30 in water to prepare binder aqueous solution, placing anhydrous glucose and MCC101 in the mother nucleus component in a wet granulator, mixing uniformly, and adding the binder aqueous solution to prepare the mother nucleus.
b. Starting a centrifugal wrapping machine, putting the prepared mother nucleus into the centrifugal wrapping machine, adjusting the rotating speed, supplying powder by using anhydrous glucose and MCC101 in centrifugal wrapping components, spraying a binder solution, performing lamination powder-coating operation on the mother nucleus, and finally screening the prepared pellets.
Example 4. monohydrate dextrose pellet cores wherein the ratio of parent core component to centrifuge coating component is 1: 2.5.
The preparation method comprises the following steps:
a. pulverizing and sieving each component, weighing each component according to the prescription amount, dissolving PVP K-30 in water to prepare binder aqueous solution, placing monohydrate glucose and MCC101 in the mother nucleus component in a wet granulator, mixing uniformly, and adding the binder aqueous solution to prepare the mother nucleus.
b. Starting a centrifugal wrapping machine, putting the prepared mother nucleus into the centrifugal wrapping machine, adjusting the rotating speed, supplying powder by using dextrose monohydrate and MCC101 in the centrifugal wrapping components, spraying a binder solution, performing lamination powder-coating operation on the mother nucleus, and finally screening the prepared pellets.
II, measuring the characters or properties:
1) physical yield of pellet cores: the ratio of the total mass of the dried pellet cores to the total feeding amount. The higher the physical yield, the higher the material utilization and the lower the material loss.
Sieving yield of pellet cores: and (4) screening the dried pellet cores, calculating the percentage of the screened pellet cores (20-80 meshes) in the total amount of the pellet cores, and calculating the screening yield. The higher the sieve yield, the more concentrated the representative particle size. The screening yields of examples 1 to 4 were all above 92%.
Comprehensive yield: the overall yield is the physical yield × the sieve yield, and the higher the overall yield is, the better the overall yield is. The overall yields of examples 1 to 4 were all above 80%.
2) Roundness and surface flatness of the pellet core: the surface state of the pill core is observed by a high-power microscope, and the pill core can be observed to be round and smooth, and the surface of the pill core is smooth and flat.
Claims (17)
1. The medicinal pellet core is characterized by comprising a main material, a diluent and a binder, wherein the main material is glucose, and the diluent is selected from one or more of the following substances: microcrystalline cellulose, starch, pregelatinized starch, lactose, mannitol, dextrin; the binder is selected from one or more of the following: polyvinylpyrrolidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, starch slurry, dextrin, Arabic gum, ethyl cellulose and konjac powder, wherein the mass percent of the main materials in the pellet core is 55-90%, the mass percent of the diluent in the pellet core is 10-35%, the mass percent of the binder is 1-8%, and the condition is that the sum of the percentages of the components in the pellet core is 100%;
wherein the pellet core comprises a mother core and a centrifugal packaging component, the mother core comprises a first part of main materials, a diluent and an adhesive, the centrifugal packaging component comprises a second part of main materials, a diluent and an adhesive, the main materials, the diluent and the adhesive used in the mother core and the centrifugal packaging component are the same or different,
wherein the mother nucleus comprises the following components in percentage by weight: 55-80% of the first part of main materials, 15-40% of the first part of diluents and 1-10% of the first part of adhesives, wherein the sum of the percentages of the components in the first part of main materials is 100%; wherein the centrifugal coating components have the following proportions: the second part of the main material is 70-95%, the second part of the diluent is 10-30%, and the second part of the adhesive is 1-7%, provided that the sum of the percentage of each component in the second part of the main material is 100%.
2. The pellet core of claim 1, wherein the mass percentage of the main material in the pellet core is 65-85%.
3. The pellet core of claim 1 wherein said glucose is dextrose monohydrate, dextrose anhydrate or a mixture of both.
4. The pellet core of claim 1, wherein the diluent accounts for 15-25% by mass of the pellet core, and the binder accounts for 1-5% by mass of the pellet core.
5. The pellet core of claim 4, wherein said binder is present in an amount of 1.5% to 3% by weight.
6. The pellet core of claim 1, wherein the ratio of parent nucleus ingredients is: 60% -70% of the first part of main materials, 20% -35% of the first part of diluents and 1% -8% of the first part of adhesives; the proportion of the centrifugal coating components is as follows: 75-90% of the second part of main material, 10-25% of the second part of diluent and 1-5% of the second part of adhesive.
7. The pellet core of claim 6, wherein the ratio of parent nucleus ingredients is: 60% -65% of the first part of main materials, 25% -30% of the first part of diluents and 2% -5% of the first part of adhesives; the proportion of the centrifugal coating components is as follows: the second part of the main material is 80-85%, the second part of the diluent is 15-20%, and the second part of the adhesive is 1.5-3%.
8. The pellet core of claim 1, wherein the ratio of the parent core component to the pericardial component is 1: 1.2 to 3.
9. The pellet core of claim 8, wherein the ratio of the parent nucleus component to the pericardium dissociating component is 1: 1.5-2.5.
10. The pellet core of claim 1, wherein the pellet core is prepared by preparing a mother core and then layering and powdering.
11. The pellet core of claim 10, wherein the pellet core is prepared by a process comprising:
1) crushing and sieving each component, weighing each component according to the prescription amount, dissolving the adhesive in water to prepare an adhesive aqueous solution, placing the first part of main materials and the diluent in a wet granulator, uniformly mixing, adding the first part of adhesive aqueous solution to prepare a mother nucleus with the size distributed in a certain range, and carrying out the next operation after sieving;
2) and starting the centrifugal wrapping machine, putting the prepared mother nucleus into the centrifugal wrapping machine, adjusting the rotating speed, supplying powder by using the second part of main materials and the diluent while spraying the second part of adhesive solution, performing lamination and powder coating operation on the mother nucleus, and finally obtaining the pellet core with the particle size distribution in a certain range after screening.
12. A pellet core according to any one of claims 1 to 11 wherein the particle size of the pellet core is in the range 0.3mm to 0.85 mm.
13. A pellet core according to any one of claims 1 to 11 wherein the particle size of the pellet core is from 0.3 to 0.7 mm.
14. A pellet core according to any of claims 1 to 11 wherein the pellet core is sized after preparation to produce a pellet core having a desired particle size.
15. A pellet core according to any one of claims 1 to 11 wherein the pellet core outer layer has one or more functional coatings.
16. Use of a pellet core according to any of claims 1-15 in the manufacture of a product for clinical treatment for administration to a patient as a supplemental carbohydrate.
17. Use of a pellet core according to any of claims 1-15 in the manufacture of a medicament for the treatment or prevention of a disorder of carbohydrate metabolism in a subject.
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| CN201610912368.4A CN107961219B (en) | 2016-10-19 | 2016-10-19 | Medicinal pellet core and preparation method thereof |
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| CN201610912368.4A CN107961219B (en) | 2016-10-19 | 2016-10-19 | Medicinal pellet core and preparation method thereof |
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| CN107961219B true CN107961219B (en) | 2022-02-25 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101342145A (en) * | 2008-09-03 | 2009-01-14 | 中国药科大学制药有限公司 | Medicinal fine pellet core and preparation method |
| CN101596319A (en) * | 2008-06-04 | 2009-12-09 | 永信药品工业(昆山)有限公司 | Medicinal core pellet |
| WO2014180453A1 (en) * | 2013-05-09 | 2014-11-13 | Fakutní Nemocnice Hradec Králové | Pharmaceutical composition with controlled release of metabolically active sugar |
| CN104644599A (en) * | 2015-01-15 | 2015-05-27 | 中国药科大学 | Novel isosorbide mononitrate micro-porous osmotic pump controlled-release preparation and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0823922A (en) * | 1994-07-15 | 1996-01-30 | Nikken Food Kk | Tablet pharmaceutical and its production |
| EP3597196A4 (en) * | 2017-03-16 | 2020-11-11 | Cosci Med-tech Co. Ltd. | Glucose pellet, and preparation method therefor and uses thereof |
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- 2016-10-19 CN CN201610912368.4A patent/CN107961219B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101596319A (en) * | 2008-06-04 | 2009-12-09 | 永信药品工业(昆山)有限公司 | Medicinal core pellet |
| CN101342145A (en) * | 2008-09-03 | 2009-01-14 | 中国药科大学制药有限公司 | Medicinal fine pellet core and preparation method |
| WO2014180453A1 (en) * | 2013-05-09 | 2014-11-13 | Fakutní Nemocnice Hradec Králové | Pharmaceutical composition with controlled release of metabolically active sugar |
| CN104644599A (en) * | 2015-01-15 | 2015-05-27 | 中国药科大学 | Novel isosorbide mononitrate micro-porous osmotic pump controlled-release preparation and preparation method thereof |
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