CN117503723A - Radix Lamiophlomidis Rotatae granule for preparing radix Lamiophlomidis Rotatae capsule and its preparation method - Google Patents
Radix Lamiophlomidis Rotatae granule for preparing radix Lamiophlomidis Rotatae capsule and its preparation method Download PDFInfo
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- CN117503723A CN117503723A CN202311498366.1A CN202311498366A CN117503723A CN 117503723 A CN117503723 A CN 117503723A CN 202311498366 A CN202311498366 A CN 202311498366A CN 117503723 A CN117503723 A CN 117503723A
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- 239000002775 capsule Substances 0.000 title claims abstract description 59
- 239000008187 granular material Substances 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 21
- 241001191006 Phlomoides rotata Species 0.000 claims abstract description 110
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 56
- 239000000843 powder Substances 0.000 claims abstract description 44
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 28
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 26
- 239000002994 raw material Substances 0.000 claims abstract description 22
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 21
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 21
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 21
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 21
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims abstract description 20
- 239000000945 filler Substances 0.000 claims abstract description 16
- 238000004519 manufacturing process Methods 0.000 claims abstract description 7
- 239000002245 particle Substances 0.000 claims description 40
- 229920002261 Corn starch Polymers 0.000 claims description 19
- 239000008120 corn starch Substances 0.000 claims description 19
- 238000000034 method Methods 0.000 claims description 18
- 238000007908 dry granulation Methods 0.000 claims description 9
- 230000008569 process Effects 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 3
- 239000000454 talc Substances 0.000 claims 2
- 235000012222 talc Nutrition 0.000 claims 2
- 229910052623 talc Inorganic materials 0.000 claims 2
- 230000000052 comparative effect Effects 0.000 description 20
- 238000001035 drying Methods 0.000 description 9
- 238000010521 absorption reaction Methods 0.000 description 7
- 238000011049 filling Methods 0.000 description 7
- 238000012360 testing method Methods 0.000 description 6
- 238000001514 detection method Methods 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 238000005550 wet granulation Methods 0.000 description 4
- 208000032843 Hemorrhage Diseases 0.000 description 3
- 208000002193 Pain Diseases 0.000 description 3
- 208000034158 bleeding Diseases 0.000 description 3
- 230000000740 bleeding effect Effects 0.000 description 3
- 238000005429 filling process Methods 0.000 description 3
- 230000036407 pain Effects 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 238000010298 pulverizing process Methods 0.000 description 2
- 238000007873 sieving Methods 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 238000003809 water extraction Methods 0.000 description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 1
- 208000005171 Dysmenorrhea Diseases 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- 206010018291 Gingival swelling Diseases 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 206010024453 Ligament sprain Diseases 0.000 description 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 1
- 206010027514 Metrorrhagia Diseases 0.000 description 1
- 208000010040 Sprains and Strains Diseases 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 206010049514 Traumatic fracture Diseases 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000003631 expected effect Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Classifications
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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
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
-
- 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
- A61K9/1611—Inorganic compounds
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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
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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Abstract
The invention relates to the technical field of lamiophlomis rotata capsules, in particular to lamiophlomis rotata granules for preparing lamiophlomis rotata capsules and a preparation method thereof. The formula is 5 weight portions, and the raw materials of the lamiophlomis rotata granule comprise 2.5-4.2 weight portions of lamiophlomis rotata extract powder, 0.1-1 weight portion of talcum powder, 0-1 weight portion of microcrystalline cellulose, 0-0.25 weight portion of silicon dioxide and the balance of filler. The lamiophlomis rotata granule has improved hygroscopicity, bulk density and fluidity, and can reduce production cost and quality risk.
Description
Technical Field
The invention relates to the technical field of lamiophlomis rotata capsules, in particular to lamiophlomis rotata granules for preparing lamiophlomis rotata capsules and a preparation method thereof.
Background
The lamiophlomis rotata capsule has the effects of activating blood and relieving pain, removing blood stasis and stopping bleeding, and is clinically used for incision pain, bleeding, traumatic fracture, sprain, rheumatalgia, metrorrhagia, dysmenorrhea, gum swelling and pain, bleeding and the like after various surgical operations. The preparation method is shown in the process flow chart of fig. 6.
The specific process is as follows:
pulverizing radix Lamiophlomidis Rotatae, decocting in water for 1 hr for three times, mixing decoctions, filtering, concentrating the filtrate to appropriate amount, drying below 80deg.C, pulverizing, adding appropriate amount of starch, granulating, drying, encapsulating, and making into 1000 granule. However, the dry extract powder formed by water extraction, concentration and drying of the lamiophlomis rotata is sensitive to damp and heat, has strong hygroscopicity and viscosity, and can cause increase of production cost and time cost in the processes of granulating and capsule filling after being uniformly mixed with a proper amount of corn starch. The specific aspects are as follows: (1) during wet granulation (including drying): the extract powder is sensitive to water and temperature, and then the spray nozzle is easy to be blocked during wet granulation; and the pot is easy to collapse during drying. (2) In the capsule filling process, because the fluidity of particles is small, the blanking in a hopper is not smooth, and the blanking needs to be manually assisted. Meanwhile, the particles are strong in moisture absorption and greasiness, when the capsule is filled, the die and the punch are repeatedly adhered to each other, so that the equipment is repeatedly cleaned, the production time is prolonged, and the production cost is increased. (3) The bulk density of the particles is small, so that the particles overflow the capsule body, and the quality of the capsule is at risk.
In view of this, the present invention has been made.
Disclosure of Invention
The invention aims to provide a lamiophlomis rotata granule for preparing lamiophlomis rotata capsules and a preparation method thereof. The moisture absorption, bulk density and fluidity of the lamiophlomis rotata particles provided by the embodiment of the invention are improved, so that the production cost and quality risk can be reduced.
The invention is realized in the following way:
in a first aspect, the present invention provides a granule of lamiophlomis rotata for preparing lamiophlomis rotata capsule, wherein the raw materials comprise, by weight, 2.5-4.2 parts of lamiophlomis rotata extract powder, 0.1-1 part of talcum powder, 0-1 part of microcrystalline cellulose, 0-0.25 part of silicon dioxide and the balance of filler, with 5 parts by weight as a prescription.
In an alternative embodiment, the raw materials comprise 3 to 3.70 parts by weight of the lamiophlomis rotata extract powder, 0.25 to 0.75 part by weight of the talcum powder, 0 to 0.75 part by weight of the microcrystalline cellulose, 0.05 to 0.2 part by weight of the silicon dioxide and the balance of the filler in a prescription amount of 5 parts by weight.
In an alternative embodiment, the raw materials comprise 3 to 3.5 parts by weight of the lamiophlomis rotata extract powder, 0.25 to 0.5 part by weight of the talcum powder, 0 to 0.5 part by weight of the microcrystalline cellulose, 0.05 to 0.1 part by weight of the silicon dioxide and the balance of the filler in a prescription amount of 5 parts by weight.
In an alternative embodiment, the filler comprises corn starch and pregelatinized starch.
In an alternative embodiment, the particles of the lamiophlomis rotata have a particle ratio of more than 30% and an angle of repose of not more than 40 DEG and a bulk density of not less than 0.75g/cm 3 Tap density of not less than 0.95g/cm 3 。
In a second aspect, the present invention provides a method for preparing the lamiophlomis rotata granule for preparing a lamiophlomis rotata capsule according to the previous embodiment, comprising: mixing the raw materials for forming the lamiophlomis rotata granules, and performing dry granulation.
In an alternative embodiment, the method comprises: the lamiophlomis rotata extract powder, talcum powder, microcrystalline cellulose, silicon dioxide and filler are mixed for dry granulation.
In a third aspect, the present invention provides a lamiophlomis rotata capsule prepared by the lamiophlomis rotata granules for preparing lamiophlomis rotata capsules according to the previous embodiments.
In a fourth aspect, the present invention provides a method for preparing a lamiophlomis rotata capsule according to the foregoing embodiment, including: the materials forming the capsule are mixed and then filled into the capsule.
The invention has the following beneficial effects: according to the embodiment of the invention, the particles can be prepared by adopting specific raw materials and limiting the proportion of the raw materials, the bulk density, the fluidity, the hygroscopicity and the viscosity of the prepared lamiophlomis rotata particles can be improved, the risk of the particles overflowing the capsule body is improved, and the performance of the formed lamiophlomis rotata capsule can be further improved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a graph of the results of test 1 provided in an embodiment of the present invention;
FIG. 2 is a graph of the results of test 2 provided by an embodiment of the present invention;
FIGS. 3-4 are graphs of the results of test 3 provided by embodiments of the present invention;
FIG. 5 is a schematic diagram of an apparatus for detecting an angle of repose according to an embodiment of the present invention;
fig. 6 is a process flow diagram of preparing a lamiophlomis rotata capsule in the prior art provided by the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
The inventor researches find that the reasons for the blockage of a spray nozzle, the drying and the collapse of a pot, the adhesion of a mold, the capsule overflow and the like are easy to occur in the preparation process of the conventional lamiophlomis rotata capsule, and the reasons for the reasons are poor bulk density, flowability, moisture absorption resistance and greasiness resistance of the lamiophlomis rotata granule filled with the capsule.
Therefore, the embodiment of the invention provides the lamiophlomis rotata granule for preparing the lamiophlomis rotata capsule, which takes 5 parts by weight as a prescription amount, and comprises the raw materials of 2.5-4.2 parts by weight of lamiophlomis rotata extract powder, 0.1-1 part by weight of talcum powder, 0-1 part by weight of microcrystalline cellulose, 0-0.25 part by weight of silicon dioxide and the balance of filler.
The expression of 5 parts by weight as a prescribed amount means that the total amount of the raw materials forming the lamiophlomis rotata particles is 5 parts by weight.
The preparation of the extract powder of the lamiophlomis rotata is a preparation method which is known in the prior art, for example, the lamiophlomis rotata is crushed, water is added for decoction for three times, each time for 1 hour, decoction liquid is combined, filtration and filtrate concentration are carried out, the specific extraction conditions are also known in the art, and the embodiment of the invention is not described in detail. Or the existing common lamiophlomis extract powder sold in the market can be directly purchased.
According to the invention, the hygroscopicity and the viscosity of the formed lamiophlomis rotata particles in the filling process can be reduced by adopting the talcum powder, the microcrystalline cellulose and the silicon dioxide, so that the fluidity of the particles is improved, and the risk of the particles overflowing the capsule body is further solved.
Further, the raw materials comprise 3-3.70 parts by weight of the lamiophlomis rotata extract powder, 0.25-0.75 part by weight of talcum powder, 0-0.75 part by weight of microcrystalline cellulose, 0.05-0.2 part by weight of silicon dioxide and the balance of filler in terms of 5 parts by weight of a prescription amount. Preferably, the raw materials comprise 3-3.5 parts of the lamiophlomis rotata extract powder, 0.25-0.5 part of talcum powder, 0-0.5 part of microcrystalline cellulose, 0.05-0.1 part of silicon dioxide and the balance of filler.
Wherein the filler comprises corn starch and pregelatinized starch.
The ratio of particles with 20 meshes to 80 meshes in the formed lamiophlomis rotata particles is more than 30%, the repose angle is not higher than 40 degrees, and the bulk density is not lower than 0.75g/cm 3 Tap density is not lower than 0.95g/cm 3 。
The present invention provides a method for preparing the lamiophlomis rotata granule for preparing the lamiophlomis rotata capsule according to the previous embodiment, comprising: mixing the raw materials for forming the lamiophlomis rotata granules, and performing dry granulation. Specifically, the lamiophlomis rotata extract powder, talcum powder, microcrystalline cellulose, silicon dioxide and a filler are mixed for dry granulation.
According to the embodiment of the invention, dry granulation is adopted without drying, so that the activity of the lamiophlomis rotata can be ensured, and the bulk density, the fluidity, the hygroscopicity and the viscosity of the formed lamiophlomis rotata granules are improved by being matched with auxiliary materials.
The invention provides a lamiophlomis rotata capsule which is prepared from lamiophlomis rotata granules for preparing the lamiophlomis rotata capsule.
The invention provides a preparation method of the lamiophlomis rotata capsule in the previous embodiment, which comprises the following steps: the materials forming the capsule are mixed and then filled into the capsule.
The features and capabilities of the present invention are described in further detail below in connection with the examples.
The lamiophlomis rotata extract powder used in the following examples and comparative examples was prepared using the same water extraction method and conditions, and this method is well known and will not be described in detail in this example.
Example 1
The embodiment provides a preparation method of lamiophlomis rotata particles, which comprises the following steps:
3 parts by weight of lamiophlomis rotata extract powder, 0.5 part by weight of talcum powder, 0.05 part by weight of silicon dioxide and 1.45 parts by weight of corn starch are weighed and mixed for 10 minutes. And then granulating by adopting a dry method, wherein the granulating parameters are as follows:
horizontal feed rate: 30rpm (spiral speed 20 rpm); extrusion speed: 5cm/s (press roll rotation speed: 8 rpm); extrusion thickness: 2mm (press roll gap: 0.5-2 mm); working pressure: 150bar; finishing speed: 100rpm; finishing screen cloth: 20 mesh.
Comparative example 1
The preparation method provided in reference to example 1 is used for preparing the lamiophlomis rotata granules, and the only difference is that the selection and the proportion of the raw materials are different, specifically: 3 parts by weight of the extract powder of lamiophlomis rotata, 2 parts by weight of corn starch are weighed and mixed for 10 minutes.
Comparative example 2
The preparation method provided in reference to example 1 is used for preparing the lamiophlomis rotata granules, and the only difference is that the selection and the proportion of the raw materials are different, specifically: 3 parts by weight of lamiophlomis rotata extract powder, 0.5 part by weight of microcrystalline cellulose, 0.05 part by weight of silicon dioxide and 1.45 parts by weight of corn starch are weighed.
Test 1
The lamiophlomis rotata granules of example 1 and comparative examples 1-2 were tested for bulk density, angle of repose and moisture pick-up and greasiness, respectively, wherein bulk density was measured using the "fixed mass method", see in particular the chinese pharmacopoeia version 2020, four 0993 bulk density and tap density assay.
The angle of repose was measured as follows: the angle of repose measuring tool principle is seen in fig. 5:
1) The center point of the adjusting funnel is aligned with the center of the powder disc, and then the funnel fixing frame is locked.
2) And sieving the powder to be tested, and automatically flowing out of the hopper and accumulating the powder in a powder tray.
3) When the powder is carefully formed in the powder disk, a symmetrical powder cone is formed. (note: the height of the funnel bottom should be kept at a distance of about 2-4cm from the powder cone tip), the height of the powder pile is read by a scale on the main body support and the cone radius is measured, and the angle of repose a is calculated:
the calculation formula is as follows:
tan (a) =cone height/cone radius.
Method for measuring hygroscopicity and greasiness of particles: and (3) taking a proper amount of the prepared lamiophlomis rotata capsule particles, spreading the lamiophlomis rotata capsule particles at the bottom of a culture dish (with the diameter of about 9.5 cm), exposing the particles at the bottom of the culture dish in a laboratory environment for 60min, pouring the particles at the bottom of the culture dish, observing the powder state of the particles adhered at the bottom of the culture dish, wherein the more the particles adhere, the stronger the hygroscopicity and the viscosity are, the worse the moisture absorption and viscosity resistance are, the more the capsule filling is unfavorable, and otherwise, the moisture absorption and viscosity resistance are good, and the capsule filling is favorable. The measurement data are shown in Table 1 and FIG. 1.
TABLE 1 detection results
| Measurement item | Comparative example 1 | Example 1 | Comparative example 2 |
| Bulk Density (kg/L) | 0.7545 | 0.8042 | 0.7445 |
| Angle of repose (°) | 45.3 | 28.63 | 36.14 |
As can be seen from table 1 and fig. 1, the lamiophlomis rotata granules provided in the examples of the present invention are excellent in flowability and moisture absorption and greasiness resistance.
Examples 2 to 4
Examples 2-4 the preparation method provided in reference to example 1 produced lamiophlomis rotata particles, differing only in the raw materials, in particular as follows:
example 2:3 parts of lamiophlomis rotata extract powder, 0.25 part of talcum powder, 0.05 part of silicon dioxide and 1.7 parts of corn starch.
Example 3:3 parts of lamiophlomis rotata extract powder, 0.25 part of microcrystalline cellulose, 0.05 part of silicon dioxide and 1.7 parts of corn starch.
Example 4:3 parts of lamiophlomis rotata extract powder, 0.25 part of talcum powder, 0.5 part of microcrystalline cellulose, 0.05 part of silicon dioxide and 1.2 parts of corn starch.
Comparative example 3
The comparative example provides a preparation method of lamiophlomis rotata particles, which comprises the following steps:
3 parts by weight of lamiophlomis rotata extract powder, 0.25 part by weight of talcum powder, 0.05 part by weight of silicon dioxide and 1.7 parts by weight of corn starch are weighed, and 50% ethanol is used as a wetting agent. Wet granulation was used, and the granulation parameters were as follows:
sieving the wet granule with 20 mesh sieve, drying at 60deg.C until the water content is not higher than 5%, and grading.
Comparative example 4
The preparation method provided in reference to comparative example 3 is used for preparing lamiophlomis rotata granules, and the only difference is that the raw materials are: 3 parts of lamiophlomis rotata extract powder, 0.25 part of microcrystalline cellulose, 0.05 part of silicon dioxide and 1.7 parts of corn starch.
Comparative example 5
The preparation method provided in reference to comparative example 3 is used for preparing lamiophlomis rotata granules, and the only difference is that the raw materials are: 3 parts of lamiophlomis rotata extract powder, 0.25 part of talcum powder, 0.5 part of microcrystalline cellulose, 0.05 part of silicon dioxide and 1.2 parts of corn starch.
Test 2
Bulk density, tap density, angle of repose, moisture, particle size distribution of the lamiophlomis rotata granules of examples 2-4 and comparative examples 3-5 were examined and the smoothness of the granulation process was described, respectively, with reference to table 2 and fig. 2.
TABLE 2 detection results
Therefore, the dry granulation provided by the embodiment of the invention can improve the bulk density of the lamiophlomis rotata granules formed by the existing wet granulation and then the dry granulation, thereby improving the problems of moisture absorption resistance, smoothness in filling and the like of the lamiophlomis rotata granules.
Examples 5 to 7 and comparative examples 6 to 8
Examples 5-7 the preparation of lamiophlomis rotata granules with reference to the preparation provided in example 1 differs only in the raw materials, in particular as follows:
example 5: 2.5 parts by weight of lamiophlomis rotata extract powder, 1 part by weight of talcum powder, 0.25 part by weight of silicon dioxide and 1.25 parts by weight of corn starch are weighed.
Example 6: 3.7 parts by weight of lamiophlomis rotata extract powder, 0.35 part by weight of talcum powder, 0.5 part by weight of microcrystalline cellulose, 0.1 part by weight of silicon dioxide and 0.35 part by weight of corn starch are weighed.
Example 7: 3.25 parts by weight of lamiophlomis rotata extract powder, 0.5 part by weight of talcum powder, 0.05 part by weight of silicon dioxide and 1.2 parts by weight of corn starch are weighed.
Comparative example 6: 3.25 parts by weight of lamiophlomis rotata extract powder, 0.5 part by weight of microcrystalline cellulose, 0.05 part by weight of silicon dioxide and 1.2 parts by weight of corn starch are weighed.
Comparative example 7: 3.25 parts by weight of lamiophlomis rotata extract powder, 0.5 part by weight of maltose, 0.05 part by weight of silicon dioxide and 1.2 parts by weight of corn starch are weighed.
Comparative example 8: 3.25 parts by weight of lamiophlomis rotata extract powder, 0.5 part by weight of lactose, 0.05 part by weight of silicon dioxide and 1.2 parts by weight of corn starch are weighed.
Test 3
The lamiophlomis rotata granules obtained in examples 5 to 7 and comparative examples 6 to 8 were tested for bulk density, tap density, angle of repose and hygroscopicity, and the results are shown in fig. 3 and table 3.
The lamiophlomis rotata granules obtained in example 7 and comparative examples 6 to 8 were subjected to capsule filling, and the smoothness of filling, the difference in the capsule filling amount and whether the granules overflowed the capsule were examined, and the results are shown in fig. 4 and table 4.
TABLE 3 detection results
TABLE 4 detection results
As can be seen from the results of tables 3, 4, 3 and 4, the examples of the present invention provide lamiophlomis rotata particles having a bulk density of greater than 0.75g/cm 3 Tap density is higher than 0.95g/cm 3 The process is smooth when the capsule is filled. The lamiophlomis rotata particles provided by the comparative example have poor bulk density, tap density and hygroscopicity, and cannot achieve the expected effect. The capsule is easier to be stuck and washed when being filled; although the capsule loading differences are within a controlled range, there is a risk of particles spilling over the capsule.
In conclusion, the lamiophlomis rotata particles prepared by the prior art have low bulk density, tap density and mobile phase, and have the problems of strong hygroscopicity, poor fluidity and overflow of the particle fine powder from the capsule body in the capsule filling process. After the dry granulating process provided by the embodiment of the invention is adopted, the drying time of the lamiophlomis rotata capsule particles is reduced, the time cost is reduced, the particle size distribution of the particles can be controlled to be not lower than 30% in the ratio of 20-80 meshes, and the bulk density is 0.75g/cm 3 The tap density reaches 0.95g/cm 3 The bulk density, fluidity, hygroscopicity and viscosity of the lamiophlomis rotata particles are improved, and the risk of the particles overflowing the capsule body is further solved.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. The lamiophlomis rotata granule for preparing lamiophlomis rotata capsule is characterized in that 5 parts by weight is taken as a prescription, and the raw materials comprise 2.5-4.2 parts by weight of lamiophlomis rotata extract powder, 0.1-1 part by weight of talcum powder, 0-1 part by weight of microcrystalline cellulose, 0-0.25 part by weight of silicon dioxide and the balance of filler.
2. The granule for preparing a capsule of lamiophlomis rotata as claimed in claim 1, wherein the raw materials comprise 3-3.70 parts by weight of the extract powder of lamiophlomis rotata, 0.25-0.75 parts by weight of the talc, 0-0.75 parts by weight of the microcrystalline cellulose, 0.05-0.2 parts by weight of the silica and the balance of the filler, in terms of 5 parts by weight as a prescribed amount.
3. The granule for preparing a capsule of lamiophlomis rotata as claimed in claim 1, wherein the raw materials comprise 3-3.5 parts by weight of the extract powder of lamiophlomis rotata, 0.25-0.5 parts by weight of the talc, 0-0.5 parts by weight of the microcrystalline cellulose, 0.05-0.1 parts by weight of the silica and the balance of the filler in a prescribed amount of 5 parts by weight.
4. The lamiophlomis rotata granule for the preparation of lamiophlomis rotata capsule of any one of claims 1 to 3, wherein the filler comprises corn starch and pregelatinized starch.
5. A process for the preparation of lamiophlomis rotata according to any one of claims 1-3The lamiophlomis rotata particles of the capsule are characterized in that the particles with 20 meshes to 80 meshes in the lamiophlomis rotata particles account for more than 30 percent, the repose angle is not more than 40 degrees, and the bulk density is not less than 0.75g/cm 3 Tap density is not lower than 0.95g/cm 3 。
6. A process for preparing the granules of lamiophlomis rotata according to claim 1, characterized by comprising: mixing the raw materials for forming the lamiophlomis rotata granules, and performing dry granulation.
7. The method of manufacturing according to claim 6, comprising: the lamiophlomis rotata extract powder, talcum powder, microcrystalline cellulose, silicon dioxide and filler are mixed for dry granulation.
8. A lamiophlomis rotata capsule, characterized in that it is prepared by the lamiophlomis rotata granule for preparing lamiophlomis rotata capsule according to claim 1.
9. A method of preparing the lamiophlomis rotata capsule of claim 8, comprising: the materials forming the capsule are mixed and then filled into the capsule.
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| CN202311498366.1A CN117503723A (en) | 2023-11-10 | 2023-11-10 | Radix Lamiophlomidis Rotatae granule for preparing radix Lamiophlomidis Rotatae capsule and its preparation method |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101829190A (en) * | 2010-06-03 | 2010-09-15 | 王保明 | Dandeng Tongnao tablets and preparation process thereof |
| CN103705571A (en) * | 2013-12-27 | 2014-04-09 | 成都九芝堂金鼎药业有限公司 | Hemostatic and pain-relieving capsule and preparation method thereof |
| CN115364166A (en) * | 2022-08-31 | 2022-11-22 | 重庆希尔安药业有限公司 | Preparation method of Wei Zhi kang capsules for improving process stability and product quality |
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- 2023-11-10 CN CN202311498366.1A patent/CN117503723A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101829190A (en) * | 2010-06-03 | 2010-09-15 | 王保明 | Dandeng Tongnao tablets and preparation process thereof |
| CN103705571A (en) * | 2013-12-27 | 2014-04-09 | 成都九芝堂金鼎药业有限公司 | Hemostatic and pain-relieving capsule and preparation method thereof |
| CN115364166A (en) * | 2022-08-31 | 2022-11-22 | 重庆希尔安药业有限公司 | Preparation method of Wei Zhi kang capsules for improving process stability and product quality |
Non-Patent Citations (1)
| Title |
|---|
| 国家药典委员会编: "中华人民共和国药典", vol. 2020, 31 May 2015, 中国医药科技出版社, pages: 1368 * |
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