CN115364058A - Preparation method of traditional Chinese medicine instant granules - Google Patents
Preparation method of traditional Chinese medicine instant granules Download PDFInfo
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- CN115364058A CN115364058A CN202111060802.8A CN202111060802A CN115364058A CN 115364058 A CN115364058 A CN 115364058A CN 202111060802 A CN202111060802 A CN 202111060802A CN 115364058 A CN115364058 A CN 115364058A
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- traditional chinese
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- 239000008187 granular material Substances 0.000 title claims abstract description 41
- 239000003814 drug Substances 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 32
- 239000000463 material Substances 0.000 claims abstract description 30
- 239000002245 particle Substances 0.000 claims abstract description 26
- 238000001035 drying Methods 0.000 claims abstract description 11
- 238000000034 method Methods 0.000 claims abstract description 9
- 238000001125 extrusion Methods 0.000 claims abstract description 8
- 238000005520 cutting process Methods 0.000 claims abstract description 7
- 238000003756 stirring Methods 0.000 claims abstract description 7
- 238000010298 pulverizing process Methods 0.000 claims abstract description 3
- 238000007873 sieving Methods 0.000 claims abstract description 3
- 238000004090 dissolution Methods 0.000 abstract description 16
- 229940126680 traditional chinese medicines Drugs 0.000 abstract description 2
- 238000002156 mixing Methods 0.000 description 8
- 239000000843 powder Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 6
- 239000000203 mixture Substances 0.000 description 4
- 238000012216 screening Methods 0.000 description 4
- 238000009736 wetting Methods 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000011796 hollow space material Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
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
- A61K9/14—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
- A61K9/1682—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
-
- 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
-
- 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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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a preparation method of traditional Chinese medicine instant granules, and relates to the technical field of traditional Chinese medicines. A preparation method of traditional Chinese medicine instant granules comprises the following steps: (1) Pulverizing the Chinese medicinal dry extract to 60-200 mesh to obtain pulverized material; (2) Adding an ethanol solution into the crushed material, and uniformly stirring to obtain a wet mixed material; (3) Extruding the wet mixed material into cylindrical strip-shaped particles through extrusion equipment, and drying under reduced pressure to obtain a dry material; (4) Cutting the dried material, and sieving to obtain 10-30 mesh instant granule. The sample prepared by the method has beautiful appearance, generates a large amount of bubbles during dissolution, can obviously shorten the dissolution time, does not need stirring, and can be widely applied to the preparation of various soluble granules.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, and relates to a preparation method of traditional Chinese medicine instant granules.
Background
Granules are granular preparations prepared by mixing the medicines with proper auxiliary materials, and can be generally divided into soluble granules, suspension granules, effervescent granules, enteric granules, sustained-release granules, controlled-release granules and the like.
The soluble granules in the current market are generally long-strip-shaped granules, are extruded and dried products under normal pressure, have attractive appearance, and can be dissolved in water after being added with water, and the common using method is to mix 1 bag (generally about 10 g) of granules with hot water for about 5 minutes until the granules are completely dissolved or slightly turbid.
However, the common soluble granules have the disadvantages of relatively long dissolution time, long stirring time and poor solubility, and in order to solve the technical problem, the chinese patent CN 105878300A provides a preparation method of a medicinal instant tablet, and although the medicine prepared by the method is fast in dissolution, the medicine has poor mechanical strength and low hardness, and is easy to be broken and crushed when being subjected to external force in each link of production, transportation and use.
In order to overcome the defects of the existing soluble granules, the invention develops a preparation method of traditional Chinese medicine instant granules.
Disclosure of Invention
The invention aims to provide a preparation method of traditional Chinese medicine instant granules.
The invention is realized by the following technical scheme:
a preparation method of traditional Chinese medicine instant granules comprises the following steps:
(1) Pulverizing the Chinese medicinal dry extract to 60-200 mesh to obtain pulverized material;
(2) Adding an ethanol solution into the crushed material, and uniformly stirring to obtain a wet mixed material;
(3) Extruding the wet mixed material into cylindrical strip-shaped particles through extrusion equipment, and drying under reduced pressure to obtain a dry material;
(4) Cutting the dried material, and sieving to obtain 10-30 mesh instant granule.
Further, adding auxiliary materials into the crushed material in the step (1), uniformly stirring, and then adding an ethanol solution.
The mass fraction of the ethanol solution in the step (2) is 80-99%.
The mass ratio of the crushed material in the step (2) to the ethanol solution is (100).
The vacuum pressure of the reduced pressure drying in the step (3) is 0.04-0.08MPa, and the temperature is 40-70 ℃.
After being crushed, the Chinese medicinal dry paste powder can be added with auxiliary materials or not added with any auxiliary materials, is wet-mixed by using ethanol solution to prepare cylindrical strip-shaped particles, and is dried under reduced pressure, so that the Chinese medicinal dry paste powder can be widely applied to the technical field of preparation and forming of Chinese medicaments; wherein the Chinese medicinal dry extract powder is pulverized and sieved with 60-200 mesh sieve to greatly increase the specific surface area of the medicinal granule and promote the quick dissolution of the medicament; the ethanol solution is used for wet mixing, the granules are extruded and formed, and the internal space of the granules can be expanded to form a hollow space by using reduced pressure drying, so that the specific surface area of the medicament is further increased, the dissolving time is shortened, and the mechanical strength of the product is not influenced.
The sample prepared by the method has beautiful appearance, generates a large amount of bubbles during dissolution, can obviously shorten the dissolution time, does not need stirring, and can be widely applied to the preparation of various soluble granules.
Detailed Description
The present invention is further illustrated by the following examples.
Example 1
A preparation method of Chinese medicinal instant granule comprises:
(1) 10Kg of the Chinese medicinal dry paste is crushed to 100 meshes;
(2) Adding 4Kg of ethanol solution with the mass fraction of 95 percent into 10Kg of Chinese medicinal dry paste powder, and mixing the mixture evenly by wetting;
(3) Extruding the wet mixture into cylindrical strip-shaped particles with the diameter of 1.4mm by using extrusion equipment, and drying under reduced pressure at the vacuum pressure of 0.04-0.06MPa and the temperature of 55 ℃;
(4) And cutting the dried particles, and screening to obtain particles of 10-20 meshes.
The bulk density of the resulting drug particles was measured at 0.41g/mL for a dissolution time of 18s.
Example 2
A preparation method of Chinese medicinal instant granule comprises:
(1) Crushing 45g of the traditional Chinese medicine dry paste and 55g of sucrose powder to 200 meshes, and uniformly mixing;
(2) Adding 30g of ethanol solution with the mass fraction of 90% into the mixture, and uniformly wet-mixing;
(3) Extruding the wet mixture into cylindrical strip-shaped particles by using an extrusion device, wherein the diameter of the particles is 0.8mm, the vacuum pressure is 0.07-0.08MPa, and the temperature is 65 ℃ for drying;
(4) The dried granules were chopped and sieved to obtain 14-20 mesh granules.
The bulk density of the resulting drug was measured to be 0.39g/mL, and the dissolution time was measured to be 16s.
Example 3
A preparation method of Chinese medicinal instant granule comprises:
(1) 10Kg of Chinese medicine dry paste is crushed into 60 meshes;
(2) Adding 3.5Kg of ethanol solution with the mass fraction of 99 percent into 10Kg of the Chinese medicinal dry paste powder, and uniformly mixing by wetting;
(3) Extruding the wet mixed material into cylindrical strip-shaped particles with the diameter of 1.0mm by using extrusion equipment, and drying under reduced pressure at the vacuum pressure of 0.05-0.06MPa and the temperature of 70 ℃;
(4) And (4) cutting the dried particles, and screening to obtain particles of 20-30 meshes.
The bulk density of the resulting drug particles was measured at 0.38g/mL for a dissolution time of 15s.
Example 4
A preparation method of Chinese medicinal instant granule comprises:
(1) Crushing 10Kg of Chinese medicine dry paste to 1500 meshes;
(2) Adding 3Kg of ethanol solution with the mass fraction of 80 percent into 10Kg of the traditional Chinese medicine dry paste powder, and uniformly mixing by wetting;
(3) Extruding the wet mixed material into cylindrical strip-shaped particles with the diameter of 1.2mm by using extrusion equipment, and drying under reduced pressure at the vacuum pressure of 0.04-0.06MPa and the temperature of 40 ℃;
(4) And cutting the dried particles, and screening to obtain particles with 15-20 meshes.
The bulk density of the resulting drug particles was measured at 0.38g/mL for a dissolution time of 15s.
Example 5
A preparation method of Chinese medicinal instant granule comprises:
(1) 10Kg of Chinese medicine dry paste is crushed into 150 meshes;
(2) Adding 3Kg of ethanol solution with the mass fraction of 80 percent into 10Kg of the traditional Chinese medicine dry paste powder, and uniformly mixing by wetting;
(3) Extruding the wet mixed material into cylindrical strip-shaped particles by using extrusion equipment, wherein the diameter of the particles is 1.2mm, and drying the particles at 50 ℃ under the normal pressure condition;
(4) And cutting the dried particles, and screening to obtain particles with 15-20 meshes.
The bulk density of the resulting drug particles was measured to be 0.56g/mL, and the dissolution time was measured to be 147s.
Example 6
The particles obtained in examples 1 to 5 were compared in terms of bulk density, dissolution time, specific surface area, and mechanical strength, and the results are shown in table 1 below,
examination item | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 |
Bulk density | 0.41g/mL | 0.55g/mL | 0.39g/mL | 0.54g/mL | 0.55g/mL |
Dissolution time | 18s | 15s | 16s | 17s | 151s |
Specific surface area | 34.7cm 2 /g | 35.2cm 2 /g | 35.6cm 2 /g | 34.9cm 2 /g | 5.3cm 2 /g |
Mechanical strength | 0.47N | 0.48N | 0.45N | 0.46N | 0.47N |
As can be seen from Table 1, the particles obtained by the methods described in examples 1 to 4 have a large specific surface area, comparable mechanical strength, shorter dissolution time and higher dissolution efficiency to those obtained by the conventional methods.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered as the technical solutions and the inventive concepts of the present invention within the technical scope of the present invention.
Claims (5)
1. A preparation method of traditional Chinese medicine instant granules is characterized by comprising the following steps:
(1) Pulverizing the Chinese medicinal dry extract to 60-200 mesh to obtain pulverized material;
(2) Adding an ethanol solution into the crushed material, and uniformly stirring to obtain a wet mixed material;
(3) Extruding the wet mixed material into cylindrical strip-shaped particles through extrusion equipment, and drying under reduced pressure to obtain a dry material;
(4) Cutting the dried material, and sieving to obtain 10-30 mesh instant granule.
2. The method for preparing the instant traditional Chinese medicine granule as claimed in claim 1, wherein the ethanol solution is added after the auxiliary materials are added to the crushed material in the step (1) and uniformly stirred.
3. The method for preparing instant traditional Chinese medicine granules according to claim 1, wherein the mass fraction of the ethanol solution in step (2) is 80-99%.
4. The method for preparing the instant traditional Chinese medicine granule as claimed in claim 1, wherein the mass ratio of the pulverized material of step (2) to the ethanol solution is 100-40.
5. The method for preparing instant traditional Chinese medicine granules according to claim 1, wherein the vacuum pressure of the reduced pressure drying in the step (3) is 0.04-0.08MPa, and the temperature is 40-70 ℃.
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CN202111060802.8A CN115364058A (en) | 2021-09-10 | 2021-09-10 | Preparation method of traditional Chinese medicine instant granules |
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CN202111060802.8A CN115364058A (en) | 2021-09-10 | 2021-09-10 | Preparation method of traditional Chinese medicine instant granules |
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105343156A (en) * | 2015-12-01 | 2016-02-24 | 江苏晨牌药业集团股份有限公司 | Angelica sinensis and radix astragali particles and preparation method thereof |
CN105616356A (en) * | 2014-11-07 | 2016-06-01 | 安徽中医药大学 | Peach seed-safflower Siwu granule originated from peach seed-safflower Siwu decoction, and preparation method thereof |
CN110585295A (en) * | 2019-10-22 | 2019-12-20 | 安徽鑫泰药业有限公司 | Compound itching-relieving granule and preparation method thereof |
-
2021
- 2021-09-10 CN CN202111060802.8A patent/CN115364058A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105616356A (en) * | 2014-11-07 | 2016-06-01 | 安徽中医药大学 | Peach seed-safflower Siwu granule originated from peach seed-safflower Siwu decoction, and preparation method thereof |
CN105343156A (en) * | 2015-12-01 | 2016-02-24 | 江苏晨牌药业集团股份有限公司 | Angelica sinensis and radix astragali particles and preparation method thereof |
CN110585295A (en) * | 2019-10-22 | 2019-12-20 | 安徽鑫泰药业有限公司 | Compound itching-relieving granule and preparation method thereof |
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