CN112972413A - Traditional Chinese medicine effervescent tablet containing policosanol and preparation method thereof - Google Patents

Traditional Chinese medicine effervescent tablet containing policosanol and preparation method thereof Download PDF

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Publication number
CN112972413A
CN112972413A CN202110279135.6A CN202110279135A CN112972413A CN 112972413 A CN112972413 A CN 112972413A CN 202110279135 A CN202110279135 A CN 202110279135A CN 112972413 A CN112972413 A CN 112972413A
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China
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parts
chinese medicine
traditional chinese
policosanol
effervescent tablet
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Inventor
涂越
刘建平
欧阳克氙
郭雄昌
蔡力创
蒋亮
刘会平
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Era Biotechnology Shenzhen Co ltd
INSTITUTE OF BIOLOGICAL RESOURCES JIANGXI ACADEMY OF SCIENCES
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Era Biotechnology Shenzhen Co ltd
INSTITUTE OF BIOLOGICAL RESOURCES JIANGXI ACADEMY OF SCIENCES
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Priority to CN202110279135.6A priority Critical patent/CN112972413A/en
Publication of CN112972413A publication Critical patent/CN112972413A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/346—Platycodon
    • 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)
    • A61K36/35—Caprifoliaceae (Honeysuckle family)
    • A61K36/355—Lonicera (honeysuckle)
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • 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
    • A61K36/534—Mentha (mint)
    • 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
    • A61K36/538—Schizonepeta
    • 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)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/634—Forsythia
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals

Abstract

The invention relates to a traditional Chinese medicine effervescent tablet containing policosanol and a preparation method thereof, belonging to the field of traditional Chinese medicine preparations, wherein the traditional Chinese medicine effervescent tablet containing policosanol comprises the following raw materials in parts by weight: 5-10 parts of policosanol microcapsule powder, 10-20 parts of mint, 25-35 parts of honeysuckle flower, 25-35 parts of fructus forsythiae, 5-20 parts of bamboo leaf, 5-25 parts of platycodon grandiflorum, 10-20 parts of burdock, 10-20 parts of liquorice, 10-20 parts of fermented soybean and 5-15 parts of schizonepeta spike. The traditional Chinese medicine effervescent tablet disclosed by the invention is added with policosanol in the honeysuckle and forsythia powder, so that the efficacy of the honeysuckle and forsythia powder is enriched, the immunity can be improved, the anti-fatigue effect is achieved, the oxidation resistance is achieved, the blood fat is adjusted, and the traditional Chinese medicine effervescent tablet has the efficacy of resisting inflammation, clearing away heat and toxic materials and protecting liver.

Description

Traditional Chinese medicine effervescent tablet containing policosanol and preparation method thereof
Technical Field
The invention relates to the field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine effervescent tablet containing policosanol and a preparation method thereof.
Background
Polycosanol is a naturally occurring higher alcohol, mainly comprises octacosanol, is white powder or flaky crystal in appearance, and is mainly present in natural products such as cane wax, rice bran wax, wheat germ oil, beeswax, insect wax and the like. Multiple studies show that policosanol has unique physiological functions of enhancing endurance, resisting fatigue, reducing blood fat, resisting inflammation, protecting liver and the like.
The Yinqiao powder is a famous prescription from Wen Bing tiao Bian, has the efficacies of pungent and cool natured drugs, expelling surficial evils, clearing heat and removing toxicity, and is a common traditional Chinese medicine prescription for clinically treating influenza. However, with the change of times and life style, the diet and physique of modern people are changed, and more people have the phenomena of burning fire, sore throat and headache due to work and rest and irregular diet, so that the application range and the curative effect of the Yinqiao powder are necessarily improved. In addition, the powder is not easy to carry, and in the prior art, the efficacy of the CN100400034C is still to be examined although the Yinqiao powder is prepared into tablets. There is no report on the combined use of policosanol and Yinqiao powder.
Disclosure of Invention
In order to solve the defects of the prior art, the invention aims to provide a traditional Chinese medicine effervescent tablet containing policosanol and a preparation method thereof. The traditional Chinese medicine effervescent tablet containing policosanol provided by the invention is added with the policosanol in the honeysuckle flower and forsythia powder, so that the efficacy of the honeysuckle flower and forsythia powder is enriched, and the traditional Chinese medicine effervescent tablet has the efficacies of clearing away heat and toxic materials, resisting inflammation and viruses and protecting liver.
In order to solve the technical problems, the invention provides the following technical scheme:
the invention provides a traditional Chinese medicine effervescent tablet containing policosanol, which comprises the following raw materials in parts by weight: 5-10 parts of policosanol microcapsule powder, 10-20 parts of mint, 25-35 parts of honeysuckle flower, 25-35 parts of fructus forsythiae, 5-20 parts of bamboo leaf, 5-25 parts of platycodon grandiflorum, 10-20 parts of burdock, 10-20 parts of liquorice, 10-20 parts of fermented soybean and 5-15 parts of schizonepeta spike.
Preferably, the traditional Chinese medicine effervescent tablet further comprises auxiliary materials, wherein the auxiliary materials comprise an acid source, an alkali source, a sweetening agent, an adhesive and a lubricant.
Preferably, the acid source is one or more of malic acid, tartaric acid, fumaric acid, adipic acid and lactic acid; the alkali source is one or two of potassium bicarbonate and calcium carbonate.
Preferably, the sweetener is one or more of fructo-oligosaccharide, erythritol and stevioside.
Preferably, the binder is ethanol; the lubricant is PEG 6000.
Preferably, the preparation of the polycosanol microcapsule powder comprises the following steps:
(1) mixing and emulsifying policosanol, tween 60 and water, and performing dynamic high-pressure micro-jet treatment to obtain nano emulsion;
(2) embedding the mixture of the nano emulsion, sulfobutyl ether-beta-cyclodextrin, hydrophilic colloid and oligosaccharide, and then carrying out secondary dynamic high-pressure microjet treatment to obtain microcapsule emulsion; drying the microcapsule emulsion to obtain the policosanol microcapsule powder.
The invention also provides a preparation method of the traditional Chinese medicine effervescent tablet, which comprises the following steps:
(1) pulverizing herba Menthae, flos Lonicerae, fructus forsythiae, folium Bambusae, radix Platycodi, fructus Arctii, Glycyrrhrizae radix, semen Sojae Preparatum and herba Schizonepetae, mixing with water, decocting, and filtering to obtain Chinese medicinal liquid;
(2) adding sweetener into the Chinese medicinal liquid, stirring, vacuum concentrating, and drying to obtain Chinese medicinal powder;
(3) and uniformly mixing the traditional Chinese medicine powder with policosanol microcapsule powder, a lubricant, an acid source and an alkali source, and tabletting to obtain the traditional Chinese medicine effervescent tablet.
Preferably, the acid source and the alkali source are respectively crushed and sieved before being mixed uniformly, and are granulated and dried together with the adhesive.
Preferably, the decocting temperature is 95-100 ℃, and the decocting time is 30-90 min.
Preferably, the total mass ratio of the traditional Chinese medicine powder, the acid source, the alkali source, the sweetener and the lubricant is 80: 80-100: 80-100: 10-30: 3-10.
The active components of the traditional Chinese medicine effervescent tablet are prepared from policosanol and traditional Chinese medicine components of mint, honeysuckle flower, weeping forsythia, bamboo leaf, platycodon root, great burdock achene, liquorice, fermented soybean and schizonepeta spike, the policosanol is added into the honeysuckle and forsythia powder, the effect of the honeysuckle and forsythia powder is enriched, and the traditional Chinese medicine effervescent tablet has the effects of clearing away heat and toxic materials, removing dryness and relieving sore throat due to wind-cold. Meanwhile, the added auxiliary materials such as the acid source, the alkali source, the sweetening agent and the like are generally suitable for all people, can be dissolved by directly putting into water, are convenient to carry and comfortable in taste, are suitable for the taste of contemporary people, and also meet the requirement of industrial production.
Detailed Description
The invention provides a traditional Chinese medicine effervescent tablet containing policosanol, which comprises the following raw materials in parts by weight: 5-10 parts of policosanol microcapsule powder, 10-20 parts of mint, 25-35 parts of honeysuckle flower, 25-35 parts of fructus forsythiae, 5-20 parts of bamboo leaf, 5-25 parts of platycodon grandiflorum, 10-20 parts of burdock, 10-20 parts of liquorice, 10-20 parts of fermented soybean and 5-15 parts of schizonepeta spike.
The traditional Chinese medicine effervescent tablet comprises 10-20 parts by weight of mint, preferably 12-17 parts by weight, and more preferably 15 parts by weight. The traditional Chinese medicine effervescent tablet comprises 10-20 parts by weight of burdock, preferably 14-19 parts by weight, and more preferably 18 parts by weight. In the invention, the mint and the burdock have the effects of dispelling wind and heat, detoxifying and relieving sore throat.
The traditional Chinese medicine effervescent tablet comprises 25-35 parts by weight of honeysuckle flower, preferably 28-33 parts by weight, and more preferably 30 parts by weight. The traditional Chinese medicine effervescent tablet comprises 25-35 parts by weight of fructus forsythiae, preferably 28-33 parts by weight, and more preferably 30 parts by weight. In the invention, the honeysuckle and the forsythia have the effects of pungent and cool property, exterior syndrome penetrating, heat clearing and detoxifying.
The traditional Chinese medicine effervescent tablet comprises 10-20 parts by weight of fermented soybean, preferably 12-18 parts by weight, and more preferably 15 parts by weight. The traditional Chinese medicine effervescent tablet comprises 5-15 parts of schizonepeta spike by weight, preferably 10-13 parts of schizonepeta spike by weight, and more preferably 12 parts of schizonepeta spike by weight. In the invention, the fermented soybean and the schizonepeta spike have the effects of relieving exterior syndrome and eliminating pathogenic factors.
The traditional Chinese medicine effervescent tablet comprises 5-20 parts of bamboo leaves by weight, preferably 10-15 parts of bamboo leaves by weight, and more preferably 12 parts of bamboo leaves by weight. In the invention, the bamboo leaves have the effects of clearing heat and promoting fluid production.
The traditional Chinese medicine effervescent tablet comprises 5-25 parts by weight of platycodon grandiflorum, preferably 10-20 parts by weight of platycodon grandiflorum, and more preferably 18 parts by weight of platycodon grandiflorum. In the invention, the platycodon grandiflorum has the efficacy of benefiting lung and relieving cough.
The traditional Chinese medicine effervescent tablet comprises 10-20 parts by weight of liquorice, preferably 12-18 parts by weight, and more preferably 15 parts by weight. In the invention, the liquorice has the effects of harmonizing the medicines and protecting the stomach and calming the middle energizer.
The traditional Chinese medicine effervescent tablet comprises 5-10 parts by weight of policosanol microcapsule powder, preferably 6-8 parts by weight. In the present invention, the preparation of the polycosanol microcapsule powder comprises the following steps:
(1) mixing and emulsifying policosanol, an emulsifier and water, and then carrying out dynamic high-pressure micro-jet treatment to obtain nano emulsion;
(2) embedding the mixture of the nano emulsion, sulfobutyl ether-beta-cyclodextrin, hydrophilic colloid and oligosaccharide, and then carrying out secondary dynamic high-pressure microjet treatment to obtain microcapsule emulsion; drying the microcapsule emulsion to obtain the policosanol microcapsule powder.
In the present invention, the polycosanols comprise octacosanol; the content of the octacosanol in the polycosanol is preferably 13-95% by mass. The present invention does not require any particular type of component of the polycosanols other than octacosanol. The polycosanols of the present invention are not particularly limited in their source, and may be prepared using commercially available products known to those skilled in the art or using preparative methods known to those skilled in the art. In particular embodiments of the present invention, the polycosanols are preferably prepared; the polycosanol is preferably prepared by a process comprising: mixing rice bran wax, absolute ethyl alcohol, aviation kerosene and sodium hydroxide, heating to boil, stirring and refluxing for 4.5 hours, washing for 3 times by using hot water, standing to remove a lower-layer water phase, washing a supernatant to be neutral, and sequentially cooling overnight, vacuum-filtering, desolventizing a filter cake and drying to obtain the polycosanol. In the present invention, the volume ratio of the rice bran wax, the absolute ethyl alcohol and the aviation kerosene is preferably 1: 3: 7; the mass ratio of the rice bran wax to the sodium hydroxide is 1: 0.12.
when the octacosanol accounts for more than 15 percent of the polycosanol, the invention also preferably rectifies the polycosanol crude product; in the present invention, the working pressure of the rectification is preferably 20 to 50Pa, more preferably 30 to 40 Pa; the temperature of the kettle is preferably 200-250 ℃, more preferably 210-240 ℃, and most preferably 220-230 ℃; the reflux ratio is preferably 1: (5-20), more preferably 1 (8-16), most preferably 1: (10-13); after the distillation is finished, the invention preferably collects the fraction with the overhead temperature of 220 ℃ and 230 ℃.
In the present invention, the emulsifier is preferably tween 60. The method for mixing and emulsifying the polycosanol, the emulsifier and the water is not particularly limited in the present invention. In a specific embodiment of the present invention, the specific steps of mixing and emulsifying the polycosanol, the emulsifier and the water are preferably as follows: mixing polycosanol and an emulsifier, heating to 90-100 ℃, and mixing with boiling water. In the invention, the hydrophilic colloid preferably comprises one or more of xanthan gum, pectin and carrageenan; the oligosaccharide preferably comprises one or more of fructooligosaccharide, galactooligosaccharide and chitosan oligosaccharide. In the invention, the mass ratio of the sulfobutyl ether-beta-cyclodextrin to the hydrophilic colloid to the oligosaccharide is preferably (2-10): 0.5-1): 1.
In the invention, the pressure of the dynamic high-pressure micro-jet treatment is preferably 150-165MPa, and more preferably 160 MPa; the number of the dynamic high-pressure microjet treatments is preferably 3 to 5, more preferably 4. The method of drying is not particularly limited in the present invention, and spray drying is preferable in the embodiment of the present invention; the air inlet temperature of the spray drying is preferably 180-190 ℃, the air outlet temperature is preferably 100-110 ℃, and the feeding speed is preferably 4-5L/h. The policosanol microcapsule powder prepared by the method is more stable, the embedded material has higher safety in vivo, and the method is suitable for the public.
In the invention, the traditional Chinese medicine effervescent tablet also comprises auxiliary materials, wherein the auxiliary materials comprise an acid source, an alkali source, a sweetening agent, an adhesive and a lubricant. In the invention, the acid source is preferably one or more of malic acid, tartaric acid, fumaric acid, adipic acid and lactic acid; when the acid sources are more than two of the specific choices, the proportion of the specific substances is not limited in any way, and the specific substances can be mixed according to any proportion. In the invention, the alkali source is preferably one or two of potassium bicarbonate and calcium carbonate; when the alkali source is two of the above specific choices, the invention has no special limitation on the proportion of the specific substances, and the specific substances can be mixed according to any proportion. In the invention, the sweetening agent is preferably one or more of fructo-oligosaccharide, erythritol and stevioside; when the sweetener is two of the above specific choices, the proportion of the specific substances is not limited in any way, and the specific substances can be mixed according to any proportion. In the invention, the adhesive is preferably ethanol, and the ethanol is preferably ethanol with the mass fraction of 70-95%; the lubricant is preferably PEG 6000.
In the invention, the total mass ratio of the traditional Chinese medicine powder, the acid source, the alkali source, the sweetener and the lubricant is preferably 80: 80-100: 80-100: 10-30: 3-10, more preferably 80:90:90:20: 8.
The invention also provides a preparation method of the traditional Chinese medicine effervescent tablet, which comprises the following steps:
(1) pulverizing herba Menthae, flos Lonicerae, fructus forsythiae, folium Bambusae, radix Platycodi, fructus Arctii, Glycyrrhrizae radix, semen Sojae Preparatum and herba Schizonepetae, mixing with water, decocting, and filtering to obtain Chinese medicinal liquid;
(2) adding sweetener into the Chinese medicinal liquid, stirring, vacuum concentrating, and drying to obtain Chinese medicinal powder;
(3) and uniformly mixing the traditional Chinese medicine powder with policosanol microcapsule powder, a lubricant, an acid source and an alkali source, and tabletting to obtain the traditional Chinese medicine effervescent tablet.
In the invention, the decoction is preferably carried out twice; the decocting temperature is preferably 95-100 deg.C, and the decocting time is preferably 30-90 min. The method of vacuum concentration in the present invention is not particularly limited, and a vacuum concentration method that is conventional in the art may be employed.
In the invention, the acid source and the alkali source are preferably respectively crushed, sieved, granulated and dried together with the adhesive before being uniformly mixed. In the present invention, the particle size of the acid source and the alkali source is preferably not less than 160 mesh. The method of granulating and drying is not particularly limited in the present invention, and a method of granulating and drying known in the art may be used.
In the present invention, the tabletting method is not particularly limited, and a tabletting machine which is conventional in the art may be used. In a particular embodiment of the invention, the tablet press is preferably a rotary tablet press. In the invention, the temperature during tabletting is preferably 18-30 ℃; the relative humidity of the pressed tablet is preferably less than or equal to 50 percent; the rotating speed of the tablet press is preferably 12-20 r/min; the tablet press pressure is preferably 200-300 KN.
Except for the policosanol microcapsule, the traditional Chinese medicine raw materials, the medicines and the equipment are known products and can be prepared by adopting conventional commercial products.
In order to further illustrate the present invention, the following embodiments are described in detail, but they should not be construed as limiting the scope of the present invention.
Example 1
1. Preparing policosanol with the content of octacosanol of 15 percent by mass
Taking 10kg of rice bran wax, adding 3 times of volume of absolute ethyl alcohol, 7 times of volume of aviation kerosene and 0.12 time of sodium hydroxide, heating in a water bath to boil, stirring and refluxing for reaction for 4.5 hours, washing for 3 times by using 5 times of volume of hot water, removing a lower-layer water phase, washing until the pH value is about 7, cooling the upper-layer clear liquid overnight, carrying out vacuum filtration to obtain a filter cake, desolventizing the filter cake, and drying to obtain the policosanol.
2. Preparation of Polycosanol microcapsule powder
Mixing policosanol (containing 15% octacosanol) and tween 60, heating the obtained mixed solution to 95 ℃, mixing the mixed solution with boiling water, carrying out dynamic high-pressure microjet treatment (160 MPa for 4 times) to obtain nano emulsion, and dripping the nano emulsion into a mixed solution of sulfobutyl ether-beta-cyclodextrin, xanthan gum and galacto-oligosaccharide (the mass ratio of the sulfobutyl ether-beta-cyclodextrin, the hydrophilic colloid and the oligosaccharide is 2:1: 1) while stirring to obtain mixed emulsion; and (4) carrying out secondary dynamic high-pressure micro-jet treatment (160 MPa) on the mixed emulsion to obtain the microcapsule emulsion. And (3) carrying out spray drying on the microcapsule emulsion (the air inlet temperature is 185 ℃ and the air outlet temperature is 105 ℃), wherein the feeding speed of the microcapsule emulsion is 5L/h, and then obtaining policosanol microcapsule powder.
3. Preparation of effervescent tablet of Chinese medicine containing policosanol
18 parts of mint, 30 parts of honeysuckle, 30 parts of fructus forsythiae, 12 parts of bamboo leaves, 18 parts of platycodon grandiflorum, 18 parts of burdock, 15 parts of liquorice, 15 parts of fermented soybean and 12 parts of schizonepeta spike, wherein 1500 parts of water are added for boiling, the mixture is decocted for 1 hour at 95 ℃, filtrate is obtained by filtration, 1000 parts of water is added for boiling filter residue, the mixture is decocted for 1 hour at 95 ℃ to obtain secondary filtrate, 12 parts of erythritol and stevioside are added after the two filtrates are combined, and the weight ratio of the erythritol to the stevioside is 1:1 compounding with a sweetening agent, and concentrating in vacuum to obtain the traditional Chinese medicine powder.
Crushing potassium bicarbonate, sieving with a 160-mesh sieve, mixing 215 parts of the crushed potassium bicarbonate, adding 95% ethanol adhesive, granulating and drying, crushing tartaric acid, sieving with a 160-mesh sieve, mixing 215 parts of the crushed tartaric acid, adding 95% ethanol adhesive, granulating and drying, uniformly mixing the traditional Chinese medicine powder, the potassium bicarbonate powder and the tartaric acid powder, adding 5 parts of policosanol microcapsule powder and 6.5 parts of PEG 6000, and tabletting by using a tabletting machine to obtain the effervescent tablet containing policosanol, honeysuckle and forsythia powder.
Example 2
1. Preparation of policosanol with the content of octacosanol of 50% by weight
At a working pressure of 20Pa, a kettle temperature of 210 ℃ and a reflux ratio of 1: the polycosanol (containing 15% octacosanol) prepared in example 1 was distilled under 10 deg.C, and the distillate at the column top temperature of 220-.
2. Preparation of Polycosanol microcapsule powder
Polycosanol (containing 50% octacosanol) microcapsule powder was prepared in the same manner as in example 1 except that polycosanol was used in an amount of 50% octacosanol, and the procedure was the same as described above.
3. Preparation of effervescent tablet of Chinese medicine containing policosanol
18 parts of mint, 30 parts of honeysuckle, 30 parts of fructus forsythiae, 12 parts of bamboo leaves, 18 parts of platycodon grandiflorum, 18 parts of burdock, 15 parts of liquorice, 15 parts of fermented soybean and 12 parts of schizonepeta spike, 1800 parts of water is added for boiling, the mixture is decocted for 1 hour at 95 ℃ and filtered to obtain filtrate, 1000 parts of water is added for boiling filter residue, the mixture is decocted for 1 hour at 95 ℃ to obtain secondary filtrate, and after the two filtrates are combined, 20 parts of fructo-oligosaccharide and erythritol are added according to the proportion of 1:1 compounding with a sweetening agent, and concentrating in vacuum to obtain the traditional Chinese medicine powder.
Crushing potassium bicarbonate, sieving with a 160-mesh sieve, mixing 200 parts of the crushed potassium bicarbonate, adding 95% ethanol adhesive into the mixture, granulating and drying, crushing tartaric acid, sieving with a 160-mesh sieve, mixing 200 parts of the crushed tartaric acid, adding 95% ethanol adhesive into the mixture, granulating and drying, uniformly mixing the traditional Chinese medicine powder, the potassium bicarbonate powder and the tartaric acid powder, adding 10 parts of policosanol microcapsules and 8 parts of PEG 6000 into the mixture, and tabletting the mixture by using a tabletting machine to obtain the traditional Chinese medicine effervescent tablet containing policosan.
Example 3
1. Preparing policosanol with the octacosanol content of 95 percent by mass
At the working pressure of 50Pa, the kettle temperature of 230 ℃ and the reflux ratio of 1: the polycosanol (50% octacosanol) prepared in example 2 was distilled under 20 deg.C and the distillate collected at 220-230 deg.C from the top of the column was collected to obtain polycosanol (95% octacosanol).
2. Preparation of Polycosanol microcapsule powder
Polycosanol (containing 50% octacosanol) microcapsule powder was prepared in the same manner as in example 1 except that polycosanol was used in an amount of 95% octacosanol.
3. Preparation of effervescent tablet of Chinese medicine containing policosanol
18 parts of mint, 30 parts of honeysuckle, 30 parts of fructus forsythiae, 12 parts of bamboo leaves, 18 parts of platycodon grandiflorum, 18 parts of burdock, 15 parts of liquorice, 15 parts of fermented soybean and 12 parts of schizonepeta spike, 1800 parts of water is added for boiling, the mixture is decocted for 1 hour at 95 ℃ and filtered to obtain filtrate, 1000 parts of water is added for boiling filter residue, the mixture is decocted for 1 hour at 95 ℃ to obtain secondary filtrate, 25 parts of fructo-oligosaccharide is added after the two filtrates are combined, and the traditional Chinese medicine powder is obtained through vacuum concentration.
Crushing potassium bicarbonate, sieving with a 160-mesh sieve, mixing 200 parts of the crushed potassium bicarbonate, adding 95% ethanol adhesive into the mixture, granulating and drying, crushing tartaric acid, sieving with a 160-mesh sieve, mixing 200 parts of the crushed tartaric acid, adding 95% ethanol adhesive into the mixture, granulating and drying, uniformly mixing the traditional Chinese medicine powder, the potassium bicarbonate powder and the tartaric acid powder, adding 9 parts of policosanol microcapsules and 10 parts of PEG 6000 into the mixture, and tabletting the mixture by using a tabletting machine to obtain the traditional Chinese medicine effervescent tablet containing policosan.
Example 4
Animal experiments
By taking mice with acute pharyngitis as a model, 36 mice with the age of 3-4 weeks C57BL/6 are selected and randomly divided into 3 groups according to the weight: a blank control group, a pharyngitis model group and an experimental group taking the Chinese medicinal effervescent tablets in example 1.
Spraying 15% ammonia water to pharynx of the two groups of mice with throat sprayer, 3 times each time, 1 time each in the morning and afternoon, and continuously for 3 days. After death on day 7, the pharyngeal mucosa and the tissues below the pharyngeal mucosa were sectioned for observation:
a. no proliferative edema and no inflammatory cell infiltration, as (-);
b. mucosal epithelium hyperplasia with edema, small infiltration of inflammatory cells, scored (+);
c. mucosal epithelium hyperplasia with vascular engorgement, epithelial necrosis, inflammatory cell infiltration, scored as (++);
d. proliferation of the mucosal epithelium, keratinization, vascular congestion, epithelial cell necrosis, and massive inflammatory cell infiltration, which are designated (+++).
The specific results are shown in table 1 below:
TABLE 1 Effect of Polycosanol Chinese medicinal effervescent tablets on acute pharyngitis model mouse pharyngeal histopathology
Index (I) Blank control group Pharyngitis model group Experimental group
Number of animals (only) 12 12 12
- 12 1 5
+ 0 2 4
++ 0 4 3
+++ 0 5 0
It can be seen that most animals had symptoms such as pharyngeal congestion and swelling from the day after modeling, while the mice in the blank control group had no symptoms, indicating successful modeling. In addition, after administration treatment, the symptoms of the experimental group mice basically disappear, and the result shows that the traditional Chinese medicine effervescent tablet containing policosanol has good effects of clearing heat and removing toxicity, and has better relieving and treating effects on the acute pharyngitis of the mice.
Example 5
The clinical implementation case is as follows:
for a woman who is aged 40 years and suffers from mild pharyngitis accompanied by excessive internal heat, the traditional Chinese medicine effervescent tablet containing policosanol in the embodiment 1 of the invention is taken one tablet each day in the morning and at night, and after lasting for 4 days, the excessive internal heat symptom disappears, and the pharyngitis is improved.
Xu women, 55 years old, and wind-heat type common cold, the traditional Chinese medicine effervescent tablet containing policosanol in the embodiment 2 of the invention is administered one tablet in the morning and at the evening every day, and after lasting for one week, the common cold symptom disappears and returns to normal.
Mr. dang, age 29, has mild gastritis and has a tendency of aggravation of gastritis accompanied by stomachache symptoms due to recent frequent drinking of wine, and the stomachache symptoms are obviously relieved by administering the effervescent tablet of the traditional Chinese medicine containing policosanol in the embodiment 3 of the invention one tablet in the morning, at noon and at night every day for 10 days.
According to the embodiments, the traditional Chinese medicine effervescent tablet disclosed by the invention is added with policosanol in the honeysuckle and forsythia powder, so that the efficacy of the honeysuckle and forsythia powder is enriched, and the traditional Chinese medicine effervescent tablet has good efficacies of clearing away heat and toxic materials, removing dryness and treating wind-cold pharyngalgia when being used together. Meanwhile, the added auxiliary materials such as the acid source, the alkali source, the sweetening agent and the like are generally suitable for all people, can be dissolved by directly putting into water, are convenient to carry, have comfortable mouthfeel and quick response, are suitable for the taste of contemporary people, and also meet the requirement of industrial production.
The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by the present specification, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (10)

1. A traditional Chinese medicine effervescent tablet containing policosanol is characterized by comprising the following raw materials in parts by weight: 5-10 parts of policosanol microcapsule powder, 10-20 parts of mint, 25-35 parts of honeysuckle flower, 25-35 parts of fructus forsythiae, 5-20 parts of bamboo leaf, 5-25 parts of platycodon grandiflorum, 10-20 parts of burdock, 10-20 parts of liquorice, 10-20 parts of fermented soybean and 5-15 parts of schizonepeta spike.
2. The effervescent traditional Chinese medicine tablet of claim 1, further comprising an auxiliary material, wherein the auxiliary material comprises an acid source, an alkali source, a sweetener, a binder and a lubricant.
3. The effervescent traditional Chinese medicine tablet of claim 2, wherein the acid source is one or more of malic acid, tartaric acid, fumaric acid, adipic acid and lactic acid; the alkali source is one or two of potassium bicarbonate and calcium carbonate.
4. The Chinese medicine effervescent tablet of claim 2, wherein the sweetener is one or more of fructo-oligosaccharide, erythritol and stevioside.
5. The effervescent tablet of claim 2, wherein the binder is ethanol; the lubricant is PEG 6000.
6. The effervescent tablet of claim 1, wherein the polycosanol microcapsule powder is prepared by the steps of:
(1) mixing and emulsifying policosanol, tween 60 and water, and performing dynamic high-pressure micro-jet treatment to obtain nano emulsion;
(2) embedding the mixture of the nano emulsion, sulfobutyl ether-beta-cyclodextrin, hydrophilic colloid and oligosaccharide, and then carrying out secondary dynamic high-pressure microjet treatment to obtain microcapsule emulsion; drying the microcapsule emulsion to obtain the policosanol microcapsule powder.
7. A preparation method of the traditional Chinese medicine effervescent tablet of any one of claims 1 to 6 is characterized by comprising the following steps:
(1) pulverizing herba Menthae, flos Lonicerae, fructus forsythiae, folium Bambusae, radix Platycodi, fructus Arctii, Glycyrrhrizae radix, semen Sojae Preparatum and herba Schizonepetae, mixing with water, decocting, and filtering to obtain Chinese medicinal liquid;
(2) adding sweetener into the Chinese medicinal liquid, stirring, vacuum concentrating, and drying to obtain Chinese medicinal powder;
(3) and uniformly mixing the traditional Chinese medicine powder with policosanol microcapsule powder, a lubricant, an acid source and an alkali source, and tabletting to obtain the traditional Chinese medicine effervescent tablet.
8. The method according to claim 7, wherein the acid source and the alkali source are separately crushed, sieved, granulated with a binder, and dried before being mixed.
9. The method according to claim 7, wherein the temperature of the decoction is 95-100 ℃ and the time of the decoction is 30-90 min.
10. The preparation method according to claim 7, wherein the total mass ratio of the traditional Chinese medicine powder, the acid source, the alkali source, the sweetener and the lubricant is 80: 80-100: 80-100: 10-30: 3-10.
CN202110279135.6A 2021-03-16 2021-03-16 Traditional Chinese medicine effervescent tablet containing policosanol and preparation method thereof Pending CN112972413A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1660732A (en) * 2004-12-31 2005-08-31 湖南太阳植物资源有限公司 Technique for extracting and preparing policosanol and application
CN1698586A (en) * 2005-06-10 2005-11-23 中国农业大学 Otacosane alcohol extract micro-encapsulation powder and preparation method thereof
CN1742956A (en) * 2005-09-30 2006-03-08 江西本草天工科技有限责任公司 Lonicera and Forsythia effervescent tablet for relieving internal heat or fever of humanbody

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1660732A (en) * 2004-12-31 2005-08-31 湖南太阳植物资源有限公司 Technique for extracting and preparing policosanol and application
CN1698586A (en) * 2005-06-10 2005-11-23 中国农业大学 Otacosane alcohol extract micro-encapsulation powder and preparation method thereof
CN1742956A (en) * 2005-09-30 2006-03-08 江西本草天工科技有限责任公司 Lonicera and Forsythia effervescent tablet for relieving internal heat or fever of humanbody

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