CN112641854A - Traditional Chinese medicine composition for clearing heat and reducing internal heat and preparation method thereof - Google Patents
Traditional Chinese medicine composition for clearing heat and reducing internal heat and preparation method thereof Download PDFInfo
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- CN112641854A CN112641854A CN202011466541.5A CN202011466541A CN112641854A CN 112641854 A CN112641854 A CN 112641854A CN 202011466541 A CN202011466541 A CN 202011466541A CN 112641854 A CN112641854 A CN 112641854A
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- 239000000203 mixture Substances 0.000 title claims abstract description 35
- 239000003814 drug Substances 0.000 title claims abstract description 24
- 238000002360 preparation method Methods 0.000 title claims abstract description 20
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 36
- 239000000853 adhesive Substances 0.000 claims abstract description 27
- 230000001070 adhesive effect Effects 0.000 claims abstract description 27
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 20
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 19
- 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 claims abstract description 19
- 229930195725 Mannitol Natural products 0.000 claims abstract description 19
- 239000008101 lactose Substances 0.000 claims abstract description 19
- 239000000594 mannitol Substances 0.000 claims abstract description 19
- 235000010355 mannitol Nutrition 0.000 claims abstract description 19
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 18
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 18
- 229910052602 gypsum Inorganic materials 0.000 claims abstract description 16
- 239000010440 gypsum Substances 0.000 claims abstract description 16
- 238000000034 method Methods 0.000 claims abstract description 16
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims abstract description 11
- 229940041616 menthol Drugs 0.000 claims abstract description 11
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims abstract description 9
- 240000004980 Rheum officinale Species 0.000 claims abstract description 8
- 235000008081 Rheum officinale Nutrition 0.000 claims abstract description 8
- 229940079593 drug Drugs 0.000 claims abstract description 6
- 230000008569 process Effects 0.000 claims abstract description 4
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 26
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 26
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 23
- 229920002472 Starch Polymers 0.000 claims description 22
- 238000001035 drying Methods 0.000 claims description 22
- 238000002156 mixing Methods 0.000 claims description 22
- 239000008107 starch Substances 0.000 claims description 21
- 235000019698 starch Nutrition 0.000 claims description 21
- 239000000843 powder Substances 0.000 claims description 18
- 239000008187 granular material Substances 0.000 claims description 17
- 239000000463 material Substances 0.000 claims description 16
- 239000002002 slurry Substances 0.000 claims description 15
- 239000007921 spray Substances 0.000 claims description 13
- 239000000047 product Substances 0.000 claims description 11
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 8
- 239000011230 binding agent Substances 0.000 claims description 7
- 230000001717 pathogenic effect Effects 0.000 claims description 7
- 238000005507 spraying Methods 0.000 claims description 7
- 241000334154 Isatis tinctoria Species 0.000 claims description 6
- 238000005469 granulation Methods 0.000 claims description 6
- 230000003179 granulation Effects 0.000 claims description 6
- 238000005550 wet granulation Methods 0.000 claims description 6
- 239000000706 filtrate Substances 0.000 claims description 5
- 239000007864 aqueous solution Substances 0.000 claims description 4
- 235000013305 food Nutrition 0.000 claims description 4
- 230000006870 function Effects 0.000 claims description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 239000006188 syrup Substances 0.000 claims description 2
- 235000020357 syrup Nutrition 0.000 claims description 2
- 229960003943 hypromellose Drugs 0.000 claims 1
- 238000005336 cracking Methods 0.000 abstract description 7
- 238000004090 dissolution Methods 0.000 abstract description 4
- 238000012217 deletion Methods 0.000 abstract description 2
- 230000037430 deletion Effects 0.000 abstract description 2
- 238000004806 packaging method and process Methods 0.000 abstract description 2
- 239000007910 chewable tablet Substances 0.000 description 18
- 229940068682 chewable tablet Drugs 0.000 description 14
- 238000007873 sieving Methods 0.000 description 12
- 239000003826 tablet Substances 0.000 description 12
- 230000000052 comparative effect Effects 0.000 description 11
- 238000010298 pulverizing process Methods 0.000 description 10
- 239000007788 liquid Substances 0.000 description 7
- 238000001914 filtration Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 239000002245 particle Substances 0.000 description 5
- 239000007779 soft material Substances 0.000 description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 241000219061 Rheum Species 0.000 description 4
- 235000009411 Rheum rhabarbarum Nutrition 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 238000009835 boiling Methods 0.000 description 3
- 208000002173 dizziness Diseases 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 206010010774 Constipation Diseases 0.000 description 2
- 208000002399 aphthous stomatitis Diseases 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 239000011363 dried mixture Substances 0.000 description 2
- 239000003651 drinking water Substances 0.000 description 2
- 235000020188 drinking water Nutrition 0.000 description 2
- 230000007613 environmental effect Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 238000011010 flushing procedure Methods 0.000 description 2
- 238000009776 industrial production Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 238000002791 soaking Methods 0.000 description 2
- 238000001694 spray drying Methods 0.000 description 2
- 208000004371 toothache Diseases 0.000 description 2
- 238000003809 water extraction Methods 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 206010051625 Conjunctival hyperaemia Diseases 0.000 description 1
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- 208000007117 Oral Ulcer Diseases 0.000 description 1
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- 208000002193 Pain Diseases 0.000 description 1
- 201000007100 Pharyngitis Diseases 0.000 description 1
- 206010042674 Swelling Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000007661 gastrointestinal function Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 208000018997 giddiness Diseases 0.000 description 1
- 239000001341 hydroxy propyl starch Substances 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 235000013828 hydroxypropyl starch Nutrition 0.000 description 1
- 210000003026 hypopharynx Anatomy 0.000 description 1
- 210000000214 mouth Anatomy 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 238000010926 purge Methods 0.000 description 1
- 230000002040 relaxant effect Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 235000013599 spices Nutrition 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
Classifications
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- 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)
- A61K36/85—Verbenaceae (Verbena family)
- A61K36/855—Clerodendrum, e.g. glorybower
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/03—Organic compounds
- A23L29/045—Organic compounds containing nitrogen as heteroatom
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
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- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
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- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/30—Extraction of the material
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Abstract
The invention discloses a traditional Chinese medicine composition for clearing heat and reducing internal heat, which is prepared from the following components: folium isatidis, rheum officinale, gypsum, menthol, mannitol, lactose, silicon dioxide and an adhesive. The invention also discloses a preparation method of the traditional Chinese medicine composition. The tablet pressed by the formula has the advantages of smooth and attractive surface, impact resistance and fast disintegration, solves the problem that the integrity of the tablet is influenced by sticking, cracking, edge knocking and the like of the pressed tablet, can be quickly disintegrated and released, greatly improves the dissolution rate and the release rate, obviously improves the stability of the product, and also effectively solves the problems of edge deletion and the like of the product caused by drug impact in the process of multi-dose packaging and transportation of the product.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a traditional Chinese medicine composition for clearing heat and reducing internal heat and a preparation method thereof.
Background
The pressure of life is huge in modern life, and the people often catch fire. A series of symptoms caused by excessive internal heat, such as sore throat, toothache, dizziness, aphtha, constipation, etc. The ideal effect cannot be achieved by simple body regulation, and other diseases are easily induced, so that the treatment needs to be carried out by using medicines. The chewable tablet mainly comprises folium Isatidis, radix et rhizoma Rhei, Gypsum Fibrosum, and Mentholum, has effects of clearing heat and purging pathogenic fire, and relaxing bowels, and can be used for treating laryngopharynx swelling and pain, toothache, dizziness, giddiness, oral ulcer, nasal ulcer, conjunctival congestion, constipation, etc. Chewable tablet is a tablet which is swallowed after being dissolved by chewing or sucking in the oral cavity, and is usually added with auxiliary materials such as lactose, edible spices and the like to adjust the taste, and the surface area of the tablet is increased after being chewed, so that the dissolution and absorption of the medicine in the body can be promoted. Is convenient for administration, and can be swallowed, chewed, sucked or dispersed with water. Even in water-deficient state, the oral liquid can ensure that the oral liquid can be taken on time, has good compliance, is especially suitable for the old, children and patients with difficult swallowing and poor gastrointestinal function, and can reduce the burden of the oral liquid on the gastrointestinal tract.
However, many domestic enterprises have the problems of high sticking, cracking and friability of the pressed tablets, and cannot realize industrial production and large-scale market supply. Many manufacturers try to solve the sticking and cracking problem by controlling the moisture content and the particle size of the particles, but since the moisture content of the particles is difficult to control in large-scale mass industrial production, the particle size and the moisture content of the particles are not uniform, and the effect of solving the sticking and cracking problem is very little. The adhesive for pharmacy solves the problems of sticking and cracking.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for clearing heat and reducing internal heat and a preparation method thereof. The invention also provides an adhesive for pharmacy, which prevents sticking and cracking.
In a first aspect, the invention provides a traditional Chinese medicine composition for clearing heat and reducing internal heat, which comprises the following components: folium isatidis, rheum officinale, gypsum, menthol, mannitol, lactose, silicon dioxide and an adhesive.
Specifically, the composition is prepared from the following components in parts by weight: 420 parts of folium isatidis 380, 90-110 parts of rheum officinale, 45-55 parts of gypsum, 50-80 parts of menthol, 90-110 parts of mannitol, 40-60 parts of lactose, 3-7 parts of silicon dioxide and 40-45 parts of adhesive.
Preferably, the components are as follows in parts by weight: 410 parts of dyers woad leaf 390-containing material, 95-105 parts of rhubarb, 45-50 parts of gypsum, 60-70 parts of menthol, 95-105 parts of mannitol, 45-55 parts of lactose, 4-6 parts of silicon dioxide and 40-45 parts of adhesive.
Further preferably, the components are as follows in parts by weight: 400 parts of dyers woad leaf 390-.
Still more preferably, the components are in parts by weight as follows: 400 parts of folium isatidis, 100 parts of rheum officinale, 50 parts of gypsum, 65 parts of menthol, 100 parts of mannitol, 50 parts of lactose, 5 parts of silicon dioxide and 41-42 parts of adhesive.
The weight parts of the above components may be in the unit of μ g, mg, g, kg, etc. known in the medical field, or may be multiples thereof, such as 1/10 times, 1/100 times, 10 times, 100 times, etc.
The adhesive is selected from one or more of syrup, hydroxypropyl methylcellulose, starch and polyvinylpyrrolidone.
Preferably, the adhesive is a mixture of starch and polyvinylpyrrolidone, wherein the mass ratio of the starch to the polyvinylpyrrolidone is (8-12): 1, and preferably 10: 1.
The composition is prepared by a method comprising the following steps:
extracting folium Isatidis with water to obtain extract, mixing with radix et rhizoma Rhei powder and Gypsum Fibrosum powder, and spray granulating; adding mannitol, lactose, silicon dioxide and adhesive, and granulating by wet method; drying, and spraying ethanol-dissolved Mentholum to obtain the composition.
Preferably, the dyers woad leaf is decocted and extracted for 2-3 times by 8-10 times of water, the filtrate is combined, concentrated into an extract, and heated to 75-85 ℃ for drying.
Preferably, after spray granulation, drying is carried out at 70-80 ℃, and the moisture of the granules is controlled to be 5.5-6.5%.
Preferably, after wet granulation, drying at 55-65 ℃ is carried out, and the moisture of the granules is not more than 5.0%.
Preferably, the binder is made into an 8% to 10% slurry or aqueous solution.
As a preferred embodiment, the adhesive of the present invention is prepared by: respectively weighing starch and polyvinylpyrrolidone according to a mass ratio of 10:1, preparing starch slurry with a concentration of 8-10% by adopting a slurry flushing method, dissolving polyvinylpyrrolidone in purified water to prepare polyvinylpyrrolidone solution with a concentration of 8-10%, and mixing the starch slurry and the polyvinylpyrrolidone solution to obtain the starch-polyvinylpyrrolidone composite material.
In a second aspect, the present invention provides a preparation method of the Chinese medicinal composition, which comprises the following steps:
extracting folium Isatidis with water to obtain extract, mixing with radix et rhizoma Rhei powder and Gypsum Fibrosum powder, and spray granulating; adding mannitol, lactose, silicon dioxide and adhesive, and granulating by wet method; drying, and spraying ethanol-dissolved Mentholum to obtain the composition.
Preferably, the dyers woad leaf is decocted and extracted for 2-3 times by 8-10 times of water, the filtrate is combined, concentrated into an extract, and heated to 75-85 ℃ for drying.
Preferably, after spray granulation, drying is carried out at 70-80 ℃, and the moisture of the granules is controlled to be 5.5-6.5%.
Preferably, after wet granulation, drying at 55-65 ℃ is carried out, and the moisture of the granules is not more than 5.0%.
Preferably, the binder is made into an 8% to 10% slurry or aqueous solution.
As a preferred embodiment, the adhesive of the present invention is prepared by: respectively weighing starch and polyvinylpyrrolidone according to a mass ratio of 10:1, preparing starch slurry with a concentration of 8-10% by adopting a slurry flushing method, dissolving polyvinylpyrrolidone in purified water to prepare polyvinylpyrrolidone solution with a concentration of 8-10%, and mixing the starch slurry and the polyvinylpyrrolidone solution to obtain the starch-polyvinylpyrrolidone composite material.
As a preferred embodiment, the preparation method of the Chinese medicinal composition of the present invention comprises the following steps:
decocting folium Isatidis with 8-10 times of water for 2-3 times, mixing filtrates, concentrating into extract, heating to 75-85 deg.C, and sieving to obtain folium Isatidis extract powder; respectively pulverizing radix et rhizoma Rhei and Gypsum Fibrosum, mixing with folium Isatidis extract powder in fluidized bed, spray granulating, drying at 70-80 deg.C, and controlling water content at 5.5% -6.5%; adding mannitol and lactose, mixing, pulverizing, sieving, and mixing with silicon dioxide; adding adhesive, wet granulating, and drying at 60 + -5 deg.C until the water content of the granule is not more than 5.0%; spraying ethanol-dissolved Mentholum into the dried granules, mixing, and tabletting.
As a preferred embodiment, the preparation method of the Chinese medicinal composition of the present invention comprises the following steps:
1. preparation of folium isatidis extract: 1) putting the medicinal materials into an extraction tank, wherein the finely-divided medicinal materials need to be put into a gauze bag, adding 10 times of water to submerge the medicinal materials, and soaking for about 1 hour; 2) decocting twice, the first time for 2 hours, filtering the liquid medicine through a 160-mesh screen, the second time for decocting, adding 8 times of drinking water into the dregs of a decoction, boiling for 1 hour, and filtering the liquid medicine through the 160-mesh screen; 3) concentrating, namely concentrating the filtered liquid medicine to a relative density of 1.20-1.25 g/ml (50 ℃) through triple effect concentration. The water extraction method has the advantages of no use of organic solvent, environmental protection and high safety.
2. Treatment of rhubarb and gypsum
1) Pulverizing radix et rhizoma Rhei into fine powder, and sieving with 100 mesh sieve.
2) Crushing gypsum: sieving gypsum with 100 mesh sieve by universal pulverizer, and pulverizing into fine powder.
3. Spray granulation of the extract: adding a small amount of extract barrel cleaning water into the folium isatidis extract, heating to 75-85 ℃, and filtering by a 200-mesh screen. Adding radix et rhizoma Rhei powder and Gypsum Fibrosum powder into fluidized bed material container, fluidizing and mixing, spray granulating with spray drying granulator, drying at 70-80 deg.C, and controlling water content at 5.5% -6.5%.
4. And (3) granulating: 1) pulverizing the above dried mixture with a pulverizer, sieving with 80 mesh sieve, mixing mannitol and lactose, pulverizing, sieving with 100 mesh sieve, adding into a mixer with silicon dioxide, and mixing for 30 min. 2) Adding the above mixed materials into a wet granulating machine, adding 8-10% starch slurry and 8-10% polyvinylpyrrolidone mixture to make soft material, and sieving with 20 mesh sieve. 3) Carrying out fluidized bed drying on the granulated material, and controlling the temperature range to be 60 +/-5 ℃; the water content of the granules is controlled within 5.0 percent.
5. Total mixing: dissolving Mentholum with appropriate amount of medicinal ethanol, spraying dissolved Mentholum into the dried material, and mixing for 10 min.
6. And (6) tabletting.
In a third aspect, the invention provides a preparation with the functions of clearing heat and reducing pathogenic fire, and the preparation comprises the traditional Chinese medicine composition for clearing heat and reducing pathogenic fire and auxiliary materials acceptable in food, health-care products or medicines.
In a fourth aspect, the invention provides an application of the traditional Chinese medicine composition or the preparation in preparation of food, health-care products or medicines with the functions of clearing heat and reducing fire.
The invention has the beneficial effects that:
the invention changes the prior single adhesive composition by improving and innovating the adhesive, is formed by combining starch and polyvinylpyrrolidone, can control the granularity of the granules through starch slurry, can ensure the roundness and the moisture control of the granules through the polyvinylpyrrolidone, and has better integrity through adopting the combined adhesive. The tablet extruded by the formula has the advantages of smooth and attractive tablet surface, impact resistance and fast disintegration, solves the problem that the integrity of the tablet is influenced by tablet sticking, tablet cracking, edge knocking and the like, can be rapidly disintegrated and released, greatly improves the dissolution rate and the release rate, remarkably improves the stability of the product, and also effectively solves the problems of edge deletion and the like of the medicine caused by medicine impact in the process of multi-dose packaging and transportation of the product.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.
Example 1
The heat clearing and fire reducing chewable tablet comprises the following components in part by weight:
400g of dyers woad leaf, 100g of rhubarb, 50g of gypsum, 65g of menthol, 100g of mannitol, 50g of lactose, 5g of silicon dioxide, 38g of starch and 3.8g of polyvinylpyrrolidone.
The preparation method of the chewable tablet for clearing heat and reducing pathogenic fire comprises the following steps:
1. preparation of folium isatidis extract: 1) putting the medicinal materials into an extraction tank, wherein the finely-divided medicinal materials need to be put into a gauze bag, adding 10 times of water to submerge the medicinal materials, and soaking for about 1 hour. 2) Decocting twice, the first time for 2 hr, filtering with 160 mesh sieve, the second time for boiling, adding 8 times of drinking water into the residue, boiling for 1 hr, and filtering with 160 mesh sieve. 3) Concentrating, namely concentrating the filtered liquid medicine to a relative density of 1.20-1.25 g/ml (50 ℃) through triple effect concentration. The water extraction method has the advantages of no solvent, environmental protection and high safety.
2. Treatment of rhubarb and gypsum
1) Pulverizing radix et rhizoma Rhei into fine powder, and sieving with 100 mesh sieve.
2) Crushing gypsum: sieving gypsum with 100 mesh sieve by universal pulverizer, and pulverizing into fine powder.
3. Spray granulation of the extract: adding a small amount of extract barrel cleaning water into the folium isatidis extract, heating to 75-85 ℃, and filtering by a 200-mesh screen. Adding radix et rhizoma Rhei powder and Gypsum Fibrosum powder into fluidized bed material container, fluidizing and mixing, spray granulating with spray drying granulator, drying at 70-80 deg.C, and controlling water content at 5.5% -6.5%.
4. And (3) granulating: 1) pulverizing the above dried mixture with a pulverizer, sieving with 80 mesh sieve, mixing mannitol and lactose, pulverizing, sieving with 100 mesh sieve, adding into a mixer with silicon dioxide, and mixing for 30 min. 2) Adding the mixed material into a wet granulating machine, adding a mixture of 8% starch slurry and 8% polyvinylpyrrolidone to prepare a soft material, and sieving the soft material with a 20-mesh sieve to size the granules. 3) Carrying out fluidized bed drying on the granulated material, and controlling the temperature range to be 60 +/-5 ℃; the water content of the granules is controlled within 5.0 percent.
5. Total mixing: dissolving Mentholum with appropriate amount of medicinal ethanol, spraying dissolved Mentholum into the dried material, and mixing for 10 min.
6. Tabletting: each tablet weighs 0.5 g.
Example 2
The heat clearing and fire reducing chewable tablet comprises the following components in part by weight:
compared with the example 1, the prescription is different in that: 95g of mannitol and 4g of silicon dioxide.
The preparation method of the chewable tablet for clearing heat and reducing pathogenic fire comprises the following steps:
compared with the example 1, the difference of the formula is that 8 percent of starch slurry and 10 percent of polyvinylpyrrolidone mixture are added to prepare soft materials during wet granulation.
Example 3
The heat clearing and fire reducing chewable tablet comprises the following components in part by weight:
compared with the example 1, the prescription is different in that: 105g of mannitol and 45g of lactose.
The preparation method of the chewable tablet for clearing heat and reducing pathogenic fire comprises the following steps:
compared with the example 1, the difference of the formula is that 10 percent of starch slurry and 10 percent of polyvinylpyrrolidone mixture are added to prepare soft materials during wet granulation.
Comparative example 1
The comparative example provides a chewable tablet for clearing heat and reducing internal heat, which is different from the chewable tablet in example 1 only in that the prescription contains 30g of starch and 12g of polyvinylpyrrolidone.
Comparative example 2
The comparative example provides a chewable tablet for clearing heat and reducing internal heat, which is different from the chewable tablet in example 1 only in that the prescription contains 30g of starch and 3g of polyvinylpyrrolidone.
Comparative example 3
The comparative example provides a chewable tablet for clearing heat and reducing internal heat, which is different from the chewable tablet in example 1 only in that the prescription contains 50g of starch and 5g of polyvinylpyrrolidone.
Experimental example 1
1. Indexes such as compressibility, tablet impact resistance and dissolution rate of the tablet are respectively considered by taking the tablet weight of 0.5g as a standard.
The results of examining the indexes of the products of examples 1 to 3 and comparative examples 1 to 3 are shown in Table 1.
TABLE 1 indices of the products of examples 1-3 and comparative examples 1-3
2. Product stability
The stability of the products of examples 1 to 3 and comparative examples 1 to 3 was examined and the results are shown in Table 2.
TABLE 2 stability of the products of examples 1-3 and comparative examples 1-3
3. Comparative experiment of heat-clearing and fire-reducing chewable tablets prepared by adopting different adhesives
The heat-clearing and fire-reducing chewable tablets prepared by adopting different adhesives have obvious advantages compared with the heat-clearing and fire-reducing chewable tablets prepared by adopting a single adhesive, and specific experimental data are shown in table 3.
TABLE 3 comparison of heat-clearing and fire-reducing chewable tablets prepared with different binders
Although the invention has been described in detail hereinabove by way of general illustrations, embodiments and experiments, it will be apparent to those skilled in the art that modifications or improvements can be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.
Claims (10)
1. The traditional Chinese medicine composition for clearing heat and reducing internal heat is characterized by being prepared from the following components in parts by weight: 380-420 parts of folium isatidis, 90-110 parts of rheum officinale, 45-55 parts of gypsum, 50-80 parts of menthol, 90-110 parts of mannitol, 40-60 parts of lactose, 3-7 parts of silicon dioxide and 40-45 parts of adhesive.
2. The composition according to claim 1, characterized in that the components are in parts by weight as follows: 390-410 parts of folium isatidis, 95-105 parts of rheum officinale, 45-50 parts of gypsum, 60-70 parts of menthol, 95-105 parts of mannitol, 45-55 parts of lactose, 4-6 parts of silicon dioxide and 40-45 parts of adhesive;
preferably, the components are in parts by weight as follows: 390-400 parts of folium isatidis, 100-105 parts of rheum officinale, 45-50 parts of gypsum, 65-70 parts of menthol, 100-105 parts of mannitol, 50-55 parts of lactose, 4-5 parts of silicon dioxide and 40-45 parts of adhesive;
more preferably, the components are in parts by weight as follows: 400 parts of folium isatidis, 100 parts of rheum officinale, 50 parts of gypsum, 65 parts of menthol, 100 parts of mannitol, 50 parts of lactose, 5 parts of silicon dioxide and 41-42 parts of adhesive.
3. The composition according to claim 1 or 2, wherein the binder is selected from one or more of syrup, hypromellose, starch and polyvinylpyrrolidone;
preferably, the binder is a mixture of starch and polyvinylpyrrolidone;
more preferably, the adhesive is formed by mixing starch and polyvinylpyrrolidone in a mass ratio of (8-12): 1.
4. The composition according to any one of claims 1 to 3, wherein the composition is prepared by a process comprising the steps of:
extracting folium Isatidis with water to obtain extract, mixing with radix et rhizoma Rhei powder and Gypsum Fibrosum powder, and spray granulating; adding mannitol, lactose, silicon dioxide and adhesive, and granulating by wet method; drying, and spraying ethanol-dissolved menthol to obtain the composition;
preferably, the dyers woad leaf is decocted and extracted for 2-3 times by 8-10 times of water, the filtrate is combined and concentrated into an extract, and the extract is heated to 75-85 ℃ for drying;
preferably, after spray granulation, drying at 70-80 ℃, and controlling the moisture of the granules at 5.5-6.5%;
preferably, after wet granulation, drying at 55-65 ℃, wherein the moisture of the granules is not more than 5.0%;
preferably, the binder is made into an 8% to 10% slurry or aqueous solution.
5. A process for the preparation of a composition according to any one of claims 1 to 4, characterized in that it comprises the following steps:
extracting folium Isatidis with water to obtain extract, mixing with radix et rhizoma Rhei powder and Gypsum Fibrosum powder, and spray granulating; adding mannitol, lactose, silicon dioxide and adhesive, and granulating by wet method; drying, and spraying ethanol-dissolved Mentholum to obtain the composition.
6. The method as claimed in claim 5, wherein the folium isatidis is decocted and extracted with 8-10 times of water for 2-3 times, the filtrates are combined, concentrated into an extract, and heated to 75-85 ℃ for drying.
7. The method according to claim 5, characterized in that after spray granulation, drying is carried out at 70-80 ℃, and the moisture content of the granules is controlled to be 5.5-6.5%; and/or, after wet granulation, drying at 55-65 ℃, wherein the moisture of the granules is not more than 5.0%.
8. The composition of claim 5, wherein the binder is prepared as an 8% to 10% slurry or aqueous solution.
9. A preparation with the function of clearing heat and reducing pathogenic fire, which is characterized by comprising the composition of any one of claims 1 to 4 and auxiliary materials acceptable in food, health products or medicines.
10. Use of the composition of any one of claims 1 to 4 or the composition prepared by the method of claims 5 to 8 or the preparation of claim 9 in preparing food, health product or medicine with heat clearing and fire reducing functions.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105310990A (en) * | 2014-12-04 | 2016-02-10 | 蚌埠丰原涂山制药有限公司 | Sticking-resistant and cracking-resistant paracetamol tablet and preparation method thereof |
| CN111494507A (en) * | 2020-06-18 | 2020-08-07 | 海南葫芦娃药业集团股份有限公司 | Preparation method of internal heat clearing tablets |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105310990A (en) * | 2014-12-04 | 2016-02-10 | 蚌埠丰原涂山制药有限公司 | Sticking-resistant and cracking-resistant paracetamol tablet and preparation method thereof |
| CN111494507A (en) * | 2020-06-18 | 2020-08-07 | 海南葫芦娃药业集团股份有限公司 | Preparation method of internal heat clearing tablets |
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