CN114983955A - Slowly-melting tiger plum buccal tablet and preparation method thereof - Google Patents

Slowly-melting tiger plum buccal tablet and preparation method thereof Download PDF

Info

Publication number
CN114983955A
CN114983955A CN202210525792.9A CN202210525792A CN114983955A CN 114983955 A CN114983955 A CN 114983955A CN 202210525792 A CN202210525792 A CN 202210525792A CN 114983955 A CN114983955 A CN 114983955A
Authority
CN
China
Prior art keywords
enzymolysis
preparation
follows
starch
treatment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202210525792.9A
Other languages
Chinese (zh)
Other versions
CN114983955B (en
Inventor
王大冲
张恒
黄凤君
罗召丰
金洁
周银锋
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Huiyinbi Group Zhejiang Qiqi Pharmaceutical Co ltd
Original Assignee
Huiyinbi Group Zhejiang Qiqi Pharmaceutical Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Huiyinbi Group Zhejiang Qiqi Pharmaceutical Co ltd filed Critical Huiyinbi Group Zhejiang Qiqi Pharmaceutical Co ltd
Priority to CN202210525792.9A priority Critical patent/CN114983955B/en
Publication of CN114983955A publication Critical patent/CN114983955A/en
Application granted granted Critical
Publication of CN114983955B publication Critical patent/CN114983955B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/04Sulfur, selenium or tellurium; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/04Drugs for disorders of the respiratory system for throat disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10Preparation or pretreatment of starting material
    • A61K2236/19Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/37Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02PCLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P20/00Technologies relating to chemical industry
    • Y02P20/50Improvements relating to the production of bulk chemicals
    • Y02P20/54Improvements relating to the production of bulk chemicals using solvents, e.g. supercritical solvents or ionic liquids

Abstract

The invention discloses a slowly-melting Humei buccal tablet and a preparation method thereof. The Humei buccal tablet provided by the invention melts slowly in the oral cavity, is long in buccal time and has a good treatment effect on pharyngitis.

Description

Slowly-melting tiger plum buccal tablet and preparation method thereof
Technical Field
The invention relates to a tiger plum buccal tablet, in particular to a slowly-melting tiger plum buccal tablet and a preparation method thereof. Belongs to the technical field of pharmaceutical preparation.
Background
Pharyngitis is nonspecific inflammation of the pharynx, is a general name of inflammation caused by infection of the pharynx with various microorganisms, and can be classified into acute pharyngitis and chronic pharyngitis.
Acute pharyngitis is acute inflammation of pharyngeal mucosa and tissues under the mucosa, pharyngeal lymphatic tissues are often involved, early inflammation can be limited, the whole pharyngeal cavity can be involved with the progress of the disease, and the acute pharyngitis is more common in autumn, winter and spring. It is mainly manifested as dry, burning, painful throat, obvious pain in swallowing, congestion and swelling of throat.
The chronic pharyngitis can be divided into chronic simple pharyngitis, chronic hypertrophic pharyngitis and atrophic pharyngitis, wherein the chronic simple pharyngitis is more common, the pathological changes are mainly in mucous membrane layers, the mucous membrane layers are manifested by chronic congestion of pharyngeal mucous membranes, hyperplasia of mucous membranes and connective tissues under the mucous membranes, the mucous glands can be enlarged, the secretion function is enhanced, and the secretion of mucous is increased. The patient often expectorates phlegm in the pharynx, or feels foreign body sensation in the pharynx, unable to expectorate and unable to swallow. Chronic pharyngitis is characterized by complex etiology, stubborn symptoms, easy relapse, difficult cure and the like, and the main etiology comprises: improper treatment of acute pharyngitis; inflammation irritation of adjacent organs such as rhinitis, sinusitis, and tonsillitis; harmful irritating gases are often inhaled; the food is spicy and pungent if the food is frequently eaten; allergic factors, etc. Chronic pharyngitis is seen in adults, has long course of disease, is easy to relapse, has stubborn symptoms and is difficult to cure.
The acute pharyngitis and the chronic pharyngitis can cause great pain to patients and seriously affect the life quality, particularly, the acute pharyngitis and the chronic pharyngitis in the acute attack period have strong physical discomfort and are very necessary to be taken, but the current western medicines have no specific effect. Some traditional Chinese medicinal materials have obvious curative effect on pharyngitis, but the traditional Chinese medicinal materials are inconvenient to decoct and take and limit the popularization and the use of the traditional Chinese medicinal materials, so that the traditional Chinese medicinal materials are processed into a preparation which is convenient to take, and the preparation has good clinical application prospect.
The Humei preparation is a very common Chinese patent medicine for pharyngitis, and patent application CN109876045A discloses a Humei preparation, which takes giant knotweed rhizome, dark plum fruit and menthol as main components, takes cane sugar, mannitol, steviosin and starch as auxiliary materials, adopts a controllable spray granulation technology, adopts a sprayer to disperse liquid materials into fine liquid drops, generates hot air flow to blow the powder materials at the bottom so as to evaporate the liquid materials, and bonds the blown powder materials to prepare proper particles. The product obtained by the technology of the patent can be prepared into preparations such as buccal tablets and the like.
The patent application CN1091651A discloses a Humei preparation and its preparation process, which is prepared from traditional Chinese medicinal materials giant knotweed rhizome and dark plum fruit and right amount of white sugar, the giant knotweed rhizome and dark plum fruit are decocted with water according to the proportion of 1: 0.2-0.8, concentrated, ethanol is added until the alcohol content reaches 60-80%, the filtrate is concentrated into liquid extract after recovering ethanol, and right amount of white sugar powder is added to be mixed to prepare granules or block-shaped Humei electuary, Humei buccal tablets and Humei oral liquid. Wherein, the tiger plum buccal tablet can be directly taken orally, is convenient to take and has good drug effect.
The lozenge is a common preparation form which is convenient to carry and take, so the tiger plum lozenge is an ideal tiger plum preparation product. In the two patent technologies, starch is used as a disintegrating agent when preparing the tiger plum buccal tablet. The melting process of the buccal tablet in the oral cavity is not influenced by the temperature of the oral cavity, but also by the erosion of saliva and the abrasion of tongue coating, so the melting time is not long. The tiger plum buccal tablets in the market are frequently taken, the taking process is complicated, the medicines need to be taken frequently and taken again, inconvenience is brought, and the existing fast-paced life cannot be met completely, so that the tiger plum buccal tablets slow down the melting process and prolong the buccal time, and the tiger plum buccal tablets are very beneficial to relieving pharyngeal discomfort, so that a better treatment effect on pharyngitis is achieved.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides the slowly-melting Humei buccal tablet and the preparation method thereof, wherein the slowly-melting Humei buccal tablet is slowly melted in the oral cavity, has long buccal time and has good treatment effect on pharyngitis.
In order to achieve the purpose, the invention adopts the following technical scheme:
a preparation method of a slowly-melting damnacanthus lozenge comprises the following specific steps in parts by weight:
(1) firstly, drying and crushing giant knotweed and dark plum, mixing to obtain mixed powder with the particle size of 30-50 meshes, then ultrasonically dispersing the mixed powder in water, carrying out enzymolysis, concentrating, and carrying out supercritical carbon dioxide extraction to obtain an extract;
(2) mixing rhamnolipid, polyethylene glycol and peppermint oil to obtain a premixed solution, ultrasonically dispersing the extract in water to prepare a dispersion solution, slowly dripping the dispersion solution into the premixed solution at a constant speed while stirring, continuously stirring for 30-40 minutes after dripping is finished, performing spray drying to obtain a premix, preparing the premix into a soft material, and granulating to obtain particles;
(3) then carrying out double-screw extrusion treatment and superfine grinding on corn starch to obtain pretreated starch, then ultrasonically dispersing the pretreated starch in water, heating and pasting to prepare starch milk, continuously adding cyclodextrin glucosyltransferase and selenocarrageenan into the starch milk, carrying out enzymolysis treatment, carrying out high-speed jet treatment, and drying to obtain modified starch;
(4) and finally, uniformly mixing 1-2 parts of particles, 10-12 parts of modified starch, 10-12 parts of sodium carboxymethyl cellulose, 80-90 parts of cane sugar and 8-10 parts of essence, and tabletting to obtain the tiger plum buccal tablet.
Preferably, in the step (1), the mass ratio of the giant knotweed rhizome to the dark plum fruit to the water is 100: 30-40: 300-350.
Preferably, in the step (1), the enzyme used in the enzymolysis is cellulase and pectinase, and the dosage of the cellulase and the pectinase is 0.1-0.2% and 0.08-0.12% of the mass of the polygonum cuspidatum respectively; the enzymolysis conditions are as follows: and (3) setting the pH value to be 5-6, carrying out enzymolysis at the temperature of 45-55 ℃, and carrying out enzymolysis for 2-3 hours.
Preferably, in the step (1), after enzymolysis, the mixture is concentrated to 35-45% of the original volume.
Preferably, in the step (1), the supercritical carbon dioxide extraction process conditions are as follows: the temperature is 45-50 ℃, the pressure is 35-45 MPa, and the extraction time is 5-7 hours.
Preferably, in the step (2), the mass ratio of the extract to the water to the premixed solution is 20-30: 80-90: 90-100, and the mass ratio of the rhamnolipid, the polyethylene glycol and the peppermint oil in the premixed solution is 1: 2-3: 0.8-1.
Preferably, in the step (2), the dropping time of the dispersion liquid is 30 to 40 minutes.
Preferably, in the step (3), the mass ratio of the corn starch, the water, the cyclodextrin glucosyltransferase and the selenocarrageenan is 10-15: 40-50: 0.1-0.2: 4-5.
Preferably, in the step (3), the process conditions of the twin-screw extrusion treatment are as follows: the rotating speed is 60-80 r/min, and the temperature is 70-80 ℃; the technological conditions of the superfine grinding are as follows: the pressure is 10-12 MPa, the feeding speed is 150-200 r/min, and the materials are crushed to the particle size of less than 10 mu m.
Preferably, in the step (3), the heating gelatinization process conditions are as follows: treating at 85-95 ℃ for 20-30 minutes.
Preferably, in the step (3), the process conditions of the enzymolysis treatment are as follows: and (3) setting the pH value to be 5-6, carrying out enzymolysis at the temperature of 50-60 ℃ for 3-4 hours.
Preferably, in the step (3), the process conditions of the high-speed jet treatment are as follows: treating for 2-3 times under 300-400 MPa.
Preferably, in the step (4), the tablet weight of the buccal tablet is 0.6 g.
A slowly-thawing buccal tablet is prepared from rhizoma anemones Flaccidae by the above method.
The invention has the beneficial effects that:
firstly, the giant knotweed rhizome and the dark plum are made into particles, then the particles are uniformly mixed with the modified starch, the sodium carboxymethyl cellulose, the sucrose and the essence, and the mixture is tabletted to prepare the tiger plum buccal tablet. The Humei buccal tablet provided by the invention melts slowly in the oral cavity, is long in buccal time and has a good treatment effect on pharyngitis.
1. When preparing the granules, firstly, drying and crushing the giant knotweed and the dark plum, mixing to obtain mixed powder, then ultrasonically dispersing the mixed powder in water, carrying out enzymolysis, concentrating, and carrying out supercritical carbon dioxide extraction to obtain the extract. The polygonum cuspidatum and the dark plum are crushed and then subjected to enzymolysis treatment, so that the effective components in the polygonum cuspidatum and the dark plum are favorably and fully dissociated, and the content of the effective components in the buccal tablet is increased and the curative effect is improved by combining supercritical carbon dioxide extraction.
The rhamnolipid, the polyethylene glycol and the peppermint oil are mixed to obtain a premixed solution, then the extract is ultrasonically dispersed in water to prepare a dispersion solution, the dispersion solution is slowly dripped into the premixed solution at a constant speed while stirring, the premixed solution is continuously stirred for 30-40 minutes after dripping is finished, spray drying is carried out to obtain a premixed material, the premixed material is prepared into a soft material, and granules are obtained after granulation. That is, the effective components obtained by extracting giant knotweed rhizome and dark plum are included by the premixed solution, so that the slow-release effect is achieved, the melting speed of the buccal tablet is slowed down, the buccal time is prolonged, and the better curative effect is obtained.
2. The modified starch is prepared by the following method: carrying out double-screw extrusion treatment and superfine grinding on corn starch to obtain pretreated starch, then ultrasonically dispersing the pretreated starch in water, heating and pasting to prepare starch milk, continuously adding cyclodextrin glucosyltransferase and selenocarrageenan into the starch milk, carrying out enzymolysis treatment, carrying out high-speed jet treatment, and drying to obtain the starch. The corn starch is subjected to double-screw extrusion treatment and superfine grinding, so that the starch structure is fully expanded, subsequent gelatinization is promoted, the starch particles are highly expanded, cyclodextrin and amylopectin are generated along with the enzymolysis of cyclodextrin glucosyltransferase, the selenocarrageenan and the starch are crosslinked to form a three-dimensional network structure, the water solubility is reduced, the melting speed of the buccal tablet is delayed, and the buccal time is prolonged.
3. The peppermint oil in the premixed solution and the selenium in the seleno-carrageenan have synergistic effect on the giant knotweed rhizome and the dark plum fruit, and the curative effect can be further improved.
Detailed Description
The present invention will be further illustrated by the following examples, which are intended to be merely illustrative and not limitative.
Example 1:
a preparation method of a slowly-melting Humei buccal tablet comprises the following specific steps:
(1) firstly, drying and crushing 100g of giant knotweed and 30g of dark plum, mixing to obtain mixed powder with the particle size of 30 meshes, then ultrasonically dispersing the mixed powder into 300g of water, adding cellulase and pectinase, carrying out enzymolysis, concentrating until the volume of enzymolysis liquid is 35% of that of enzymolysis liquid obtained by enzymolysis, and carrying out supercritical carbon dioxide extraction to obtain an extract;
(2) mixing rhamnolipid, polyethylene glycol and peppermint oil according to the mass ratio of 1: 2: 0.8 to obtain a premixed solution, then ultrasonically dispersing 20g of extract into 80g of water to prepare a dispersion solution, slowly dripping the dispersion solution into 90g of the premixed solution at a constant speed while stirring, wherein the dripping time is 30 minutes, continuously stirring for 30 minutes after the dripping is finished, performing spray drying to obtain a premix, preparing the premix into a soft material, and granulating to obtain granules;
(3) then carrying out double-screw extrusion treatment and superfine grinding on 10g of corn starch to obtain pretreated starch, then ultrasonically dispersing the pretreated starch in 40g of water, heating and pasting for 20 minutes at 85 ℃ to prepare starch milk, continuously adding 0.1g of cyclodextrin glucosyltransferase and 4g of selenocarrageenan into the starch milk, carrying out enzymolysis treatment, high-speed jet treatment and drying to obtain modified starch;
(4) and finally, uniformly mixing 1g of granules with 10g of modified starch, 10g of sodium carboxymethyl cellulose, 80g of sucrose and 8g of essence, and tabletting to obtain the tiger plum buccal tablet, wherein the tablet weight is 0.6 g.
In the step (1), the dosage of the cellulase and the pectinase is respectively 0.1 percent and 0.08 percent of the mass of the giant knotweed; the enzymolysis conditions are as follows: the pH value is 5, the enzymolysis temperature is 45 ℃, and the enzymolysis time is 2 hours.
In the step (1), the process conditions of the supercritical carbon dioxide extraction are as follows: the temperature is 45 ℃, the pressure is 35MPa, and the extraction time is 5 hours.
In the step (3), the process conditions of the twin-screw extrusion treatment are as follows: the rotating speed is 60r/min, and the temperature is 70 ℃; the technological conditions of the superfine grinding are as follows: pulverizing under 10MPa and feeding speed of 150r/min to particle diameter below 10 μm.
In the step (3), the technological conditions of the enzymolysis treatment are as follows: pH 5, enzymolysis temperature 50 deg.C, enzymolysis time 3 hours.
In the step (3), the process conditions of the high-speed jet flow treatment are as follows: treating at 300MPa for 2 times.
Example 2:
a preparation method of a slowly-melting Humei buccal tablet comprises the following specific steps:
(1) firstly, drying and crushing 100g of giant knotweed and 40g of dark plum, mixing to obtain mixed powder with the particle size of 50 meshes, then ultrasonically dispersing the mixed powder into 350g of water, adding cellulase and pectinase, carrying out enzymolysis, concentrating until the volume of enzymolysis liquid obtained by enzymolysis is 45%, and carrying out supercritical carbon dioxide extraction to obtain an extract;
(2) mixing rhamnolipid, polyethylene glycol and peppermint oil according to the mass ratio of 1: 3: 1 to obtain a premixed solution, then ultrasonically dispersing 30g of extract into 90g of water to prepare a dispersion solution, slowly dripping the dispersion solution into 100g of the premixed solution at a constant speed while stirring, wherein the dripping time is 40 minutes, continuously stirring for 40 minutes after the dripping is finished, performing spray drying to obtain a premix, preparing the premix into a soft material, and granulating to obtain particles;
(3) then carrying out double-screw extrusion treatment and superfine grinding on 15g of corn starch to obtain pretreated starch, then ultrasonically dispersing the pretreated starch in 50g of water, heating and pasting for 30 minutes at 95 ℃ to prepare starch milk, continuously adding 0.2g of cyclodextrin glucosyltransferase and 5g of selenocarrageenan into the starch milk, carrying out enzymolysis treatment, carrying out high-speed jet treatment, and drying to obtain modified starch;
(4) and finally, uniformly mixing 2g of granules with 12g of modified starch, 12g of sodium carboxymethyl cellulose, 90g of sucrose and 10g of essence, and tabletting to obtain the tiger plum buccal tablet, wherein the tablet weight is 0.6 g.
In the step (1), the dosage of the cellulase and the pectinase is respectively 0.2 percent and 0.12 percent of the mass of the giant knotweed; the enzymolysis conditions are as follows: the pH value is 6, the enzymolysis temperature is 55 ℃, and the enzymolysis time is 3 hours.
In the step (1), the process conditions of the supercritical carbon dioxide extraction are as follows: the temperature is 50 ℃, the pressure is 45MPa, and the extraction time is 7 hours.
In the step (3), the process conditions of the twin-screw extrusion treatment are as follows: the rotating speed is 80r/min, and the temperature is 80 ℃; the technological conditions of the superfine grinding are as follows: pulverizing under pressure of 12MPa and feeding speed of 200r/min to particle size of below 10 μm.
In the step (3), the process conditions of the enzymolysis treatment are as follows: pH 6, enzymolysis temperature 60 deg.C, enzymolysis time 4 hours.
In the step (3), the process conditions of the high-speed jet flow treatment are as follows: treating at 400MPa for 3 times.
Example 3:
a preparation method of a slowly-melting Humei buccal tablet comprises the following specific steps:
(1) firstly, drying and crushing 100g of giant knotweed and 35g of dark plum, mixing to obtain mixed powder with the particle size of 40 meshes, then ultrasonically dispersing the mixed powder into 330g of water, adding cellulase and pectinase, carrying out enzymolysis, concentrating until the volume of enzymolysis liquid is 40% of that of enzymolysis liquid obtained by enzymolysis, and carrying out supercritical carbon dioxide extraction to obtain an extract;
(2) mixing rhamnolipid, polyethylene glycol and peppermint oil according to the mass ratio of 1: 2.5: 0.9 to obtain a premixed solution, then ultrasonically dispersing 25g of extract into 85g of water to prepare a dispersion solution, slowly dripping the dispersion solution into 95g of the premixed solution at a constant speed while stirring, wherein the dripping time is 35 minutes, continuously stirring for 35 minutes after the dripping is finished, performing spray drying to obtain a premix, preparing the premix into a soft material, and granulating to obtain granules;
(3) then carrying out double-screw extrusion treatment and superfine grinding on 12g of corn starch to obtain pretreated starch, ultrasonically dispersing the pretreated starch in 45g of water, heating and pasting for 25 minutes at 90 ℃ to prepare starch milk, continuously adding 0.15g of cyclodextrin glucosyltransferase and 4.5g of selenocarrageenan into the starch milk, carrying out enzymolysis treatment, carrying out high-speed jet treatment, and drying to obtain modified starch;
(4) and finally, uniformly mixing 1.5g of granules with 11g of modified starch, 11g of sodium carboxymethyl cellulose, 85g of sucrose and 9g of essence, and tabletting to obtain the tiger plum buccal tablet, wherein the tablet weight is 0.6 g.
In the step (1), the dosage of the cellulase and the pectinase is respectively 0.15 percent and 0.1 percent of the mass of the giant knotweed; the enzymolysis conditions are as follows: the pH value is 5, the enzymolysis temperature is 50 ℃, and the enzymolysis time is 2.5 hours.
In the step (1), the process conditions of the supercritical carbon dioxide extraction are as follows: the temperature is 48 ℃, the pressure is 40MPa, and the extraction time is 6 hours.
In the step (3), the process conditions of the twin-screw extrusion treatment are as follows: the rotating speed is 70r/min, and the temperature is 75 ℃; the technological conditions of the superfine grinding are as follows: under 12MPa and at a feed rate of 180r/min, pulverizing to particle size of less than 10 μm.
In the step (3), the process conditions of the enzymolysis treatment are as follows: the pH value is 6, the enzymolysis temperature is 55 ℃, and the enzymolysis time is 3.5 hours.
In the step (3), the process conditions of the high-speed jet flow treatment are as follows: treating at 400MPa for 3 times.
Comparative example 1
A preparation method of a Humei buccal tablet comprises the following specific steps:
(1) firstly, drying and crushing 100g of giant knotweed and 30g of dark plum, mixing to obtain mixed powder with the particle size of 30 meshes, then ultrasonically dispersing the mixed powder into 300g of water, adding cellulase and pectinase, carrying out enzymolysis, concentrating until the volume of enzymolysis liquid obtained by enzymolysis is 35%, carrying out supercritical carbon dioxide extraction to obtain an extract, preparing the extract into a soft material, and granulating to obtain granules;
(2) then carrying out double-screw extrusion treatment and superfine grinding on 10g of corn starch to obtain pretreated starch, then ultrasonically dispersing the pretreated starch in 40g of water, heating and pasting for 20 minutes at 85 ℃ to prepare starch milk, continuously adding 0.1g of cyclodextrin glucosyltransferase and 4g of selenocarrageenan into the starch milk, carrying out enzymolysis treatment, carrying out high-speed jet treatment, and drying to obtain modified starch;
(3) and finally, uniformly mixing 1g of granules with 10g of modified starch, 10g of sodium carboxymethylcellulose, 80g of sucrose and 8g of essence, and tabletting to obtain the tiger plum buccal tablet, wherein the tablet weight is 0.6 g.
In the step (1), the dosage of the cellulase and the pectinase is respectively 0.1 percent and 0.08 percent of the mass of the giant knotweed; the enzymolysis conditions are as follows: the pH value is 5, the enzymolysis temperature is 45 ℃, and the enzymolysis time is 2 hours.
In the step (1), the process conditions of the supercritical carbon dioxide extraction are as follows: the temperature is 45 ℃, the pressure is 35MPa, and the extraction time is 5 hours.
In the step (2), the process conditions of the twin-screw extrusion treatment are as follows: the rotating speed is 60r/min, and the temperature is 70 ℃; the technological conditions of the superfine grinding are as follows: the pressure is 10MPa, the feeding speed is 150r/min, and the powder is crushed to the particle size of less than 10 mu m.
In the step (2), the technological conditions of the enzymolysis treatment are as follows: pH 5, enzymolysis temperature 50 deg.C, enzymolysis time 3 hours.
In the step (2), the process conditions of the high-speed jet flow treatment are as follows: treating at 300MPa for 2 times.
Comparative example 2
A preparation method of a Humei buccal tablet comprises the following specific steps:
(1) firstly, drying and crushing 100g of giant knotweed rhizome and 30g of dark plum fruit, mixing to obtain mixed powder with the particle size of 30 meshes, then ultrasonically dispersing the mixed powder into 300g of water, adding cellulase and pectinase, carrying out enzymolysis, concentrating until the volume of enzymolysis liquid obtained by enzymolysis is 35%, and carrying out supercritical carbon dioxide extraction to obtain an extract;
(2) mixing rhamnolipid, polyethylene glycol and peppermint oil according to the mass ratio of 1: 2: 0.8 to obtain a premixed solution, then ultrasonically dispersing 20g of extract into 80g of water to prepare a dispersion solution, slowly dripping the dispersion solution into 90g of the premixed solution at a constant speed while stirring, wherein the dripping time is 30 minutes, continuously stirring for 30 minutes after the dripping is finished, performing spray drying to obtain a premix, preparing the premix into a soft material, and granulating to obtain particles;
(3) then carrying out double-screw extrusion treatment and superfine grinding on 10g of corn starch to obtain pretreated starch, then ultrasonically dispersing the pretreated starch in 40g of water, heating and pasting at 85 ℃ for 20 minutes to prepare starch milk, carrying out high-speed jet treatment, and drying to obtain modified starch;
(4) and finally, uniformly mixing 1g of granules with 10g of modified starch, 10g of sodium carboxymethyl cellulose, 80g of sucrose and 8g of essence, and tabletting to obtain the tiger plum buccal tablet, wherein the tablet weight is 0.6 g.
In the step (1), the dosage of the cellulase and the pectinase is respectively 0.1 percent and 0.08 percent of the mass of the giant knotweed; the enzymolysis conditions are as follows: the pH value is 5, the enzymolysis temperature is 45 ℃, and the enzymolysis time is 2 hours.
In the step (1), the process conditions of the supercritical carbon dioxide extraction are as follows: the temperature is 45 ℃, the pressure is 35MPa, and the extraction time is 5 hours.
In the step (3), the process conditions of the twin-screw extrusion treatment are as follows: the rotating speed is 60r/min, and the temperature is 70 ℃; the technological conditions of the superfine grinding are as follows: the pressure is 10MPa, the feeding speed is 150r/min, and the powder is crushed to the particle size of less than 10 mu m.
In the step (3), the process conditions of the high-speed jet flow treatment are as follows: treating at 300MPa for 2 times.
Test examples
Clinical research is carried out on the Humei buccal tablets obtained in the examples 1-3 and the comparative examples 1 and 2 respectively, and the specific method comprises the following steps:
120 cases of patients with acute pharyngitis of 18-50 years old are selected, and are randomly and averagely divided into 6 groups, wherein each group comprises 20 cases, the first 5 groups are respectively taken with the Humei buccal tablets obtained in examples 1-3 and comparative examples 1 and 2, and the last 1 group is taken with the Jinsangzi throat tablets as a control group. The buccal tablet is taken 2 times a day once, and 2 times a day for 2 times a week. The complete buccal time of the tiger plum buccal tablet in the oral cavity is recorded, and the average value of each group is taken.
And (3) judging the curative effect:
and (3) curing: pharyngeal symptom disappears, and normal examination is carried out;
improvement: the pharyngeal symptoms are obviously relieved;
and (4) invalidation: no obvious change in symptoms.
The results are shown in tables 1 and 2.
TABLE 1 complete hydration time
Complete buccal time (min)
Example 1 20.2
Example 2 20.5
Example 3 21.2
Comparative example 1 16.4
Comparative example 2 15.6
TABLE 2 curative effect on acute pharyngitis
Cure (example) Improvement (example) Invalid (example) Cure rate (%)
Control group 5 8 7 25
Example 1 19 1 0 95
Example 2 19 1 0 95
Example 3 20 0 0 100
Comparative example 1 15 5 0 75
Comparative example 2 14 6 0 70
As can be seen from tables 1 and 2, the buccal tablets obtained in examples 1 to 3 have long complete buccal time, which shows that the buccal tablets have slow melting, longer buccal time, one tablet at a time and 2 times a day, and have high cure rate and good curative effect on acute pharyngitis.
The premix liquid is omitted in the preparation of the particles in the comparative example 1, the steps of cyclodextrin glucosyltransferase and selenocarrageenan enzymolysis treatment are omitted in the comparative example 2, the melting speed of the obtained tiger plum buccal tablet is obviously increased, the curative effect is poor, the inclusion of the premix liquid, the subsequent enzymolysis treatment, the addition of the selenocarrageenan and the like synergistically slow down the melting speed, and the improvement of the curative effect is facilitated.
Although the present invention has been described with reference to the specific embodiments, it is not intended to limit the scope of the present invention, and various modifications and variations can be made by those skilled in the art without inventive changes based on the technical solution of the present invention.

Claims (10)

1. A preparation method of a slowly-melting Humei buccal tablet is characterized by comprising the following specific steps in parts by weight:
(1) firstly, drying and crushing giant knotweed and dark plum, mixing to obtain mixed powder with the particle size of 30-50 meshes, then ultrasonically dispersing the mixed powder in water, carrying out enzymolysis, concentrating, and carrying out supercritical carbon dioxide extraction to obtain an extract;
(2) mixing rhamnolipid, polyethylene glycol and peppermint oil to obtain a premixed solution, ultrasonically dispersing the extract in water to prepare a dispersion solution, slowly dripping the dispersion solution into the premixed solution at a constant speed while stirring, continuously stirring for 30-40 minutes after dripping is finished, performing spray drying to obtain a premix, preparing the premix into a soft material, and granulating to obtain particles;
(3) then carrying out double-screw extrusion treatment and superfine grinding on corn starch to obtain pretreated starch, then ultrasonically dispersing the pretreated starch in water, heating and pasting to prepare starch milk, continuously adding cyclodextrin glucosyltransferase and selenocarrageenan into the starch milk, carrying out enzymolysis treatment, carrying out high-speed jet treatment, and drying to obtain modified starch;
(4) and finally, uniformly mixing 1-2 parts of particles, 10-12 parts of modified starch, 10-12 parts of sodium carboxymethyl cellulose, 80-90 parts of cane sugar and 8-10 parts of essence, and tabletting to obtain the tiger plum buccal tablet.
2. The preparation method according to claim 1, wherein in the step (1), the mass ratio of the giant knotweed rhizome to the dark plum fruit to the water is 100: 30-40: 300-350.
3. The preparation method according to claim 1, wherein in the step (1), the enzyme used in the enzymolysis is cellulase and pectinase, and the dosage of the cellulase and the pectinase is 0.1-0.2% and 0.08-0.12% of the mass of the giant knotweed respectively; the enzymolysis conditions are as follows: the pH value is 5-6, the enzymolysis temperature is 45-55 ℃, and the enzymolysis time is 2-3 hours.
4. The preparation method according to claim 1, wherein in the step (1), the supercritical carbon dioxide extraction process conditions are as follows: the temperature is 45-50 ℃, the pressure is 35-45 MPa, and the extraction time is 5-7 hours.
5. The preparation method according to claim 1, wherein in the step (2), the mass ratio of the extract to the water to the premixed solution is 20-30: 80-90: 90-100, and the mass ratio of the rhamnolipid, the polyethylene glycol and the peppermint oil to the premixed solution is 1: 2-3: 0.8-1.
6. The method according to claim 1, wherein the dispersion liquid is added dropwise in step (2) for 30 to 40 minutes.
7. The preparation method according to claim 1, wherein in the step (3), the mass ratio of the corn starch, the water, the cyclodextrin glucosyltransferase and the selenocarrageenan is 10-15: 40-50: 0.1-0.2: 4-5.
8. The preparation method according to claim 1, wherein in the step (3), the process conditions of the twin-screw extrusion treatment are as follows: the rotating speed is 60-80 r/min, and the temperature is 70-80 ℃; the technological conditions of the superfine grinding are as follows: the pressure is 10-12 MPa, the feeding speed is 150-200 r/min, and the powder is crushed to the particle size of less than 10 mu m.
9. The preparation method according to claim 1, wherein in the step (3), the heating gelatinization process conditions are as follows: treating at 85-95 ℃ for 20-30 minutes;
the technological conditions of the enzymolysis treatment are as follows: the pH value is 5-6, the enzymolysis temperature is 50-60 ℃, and the enzymolysis time is 3-4 hours;
the process conditions of the high-speed jet flow treatment are as follows: treating for 2-3 times under 300-400 MPa.
10. A slowly-melting Humei buccal tablet which is obtained by the preparation method of any one of claims 1-9.
CN202210525792.9A 2022-05-12 2022-05-12 Slowly-melted tiger plum lozenge and preparation method thereof Active CN114983955B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210525792.9A CN114983955B (en) 2022-05-12 2022-05-12 Slowly-melted tiger plum lozenge and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210525792.9A CN114983955B (en) 2022-05-12 2022-05-12 Slowly-melted tiger plum lozenge and preparation method thereof

Publications (2)

Publication Number Publication Date
CN114983955A true CN114983955A (en) 2022-09-02
CN114983955B CN114983955B (en) 2023-05-02

Family

ID=83026642

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210525792.9A Active CN114983955B (en) 2022-05-12 2022-05-12 Slowly-melted tiger plum lozenge and preparation method thereof

Country Status (1)

Country Link
CN (1) CN114983955B (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1091651A (en) * 1993-03-01 1994-09-07 湖南医科大学附属第二医院 " Humei " preparation and preparation technology thereof
CN106387654A (en) * 2016-09-09 2017-02-15 吉林农业大学 Preparation method of aging-resistant modified corn flour
CN109876045A (en) * 2019-03-07 2019-06-14 回音必集团浙江齐齐制药有限公司 A kind of " Humei " preparation and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1091651A (en) * 1993-03-01 1994-09-07 湖南医科大学附属第二医院 " Humei " preparation and preparation technology thereof
CN106387654A (en) * 2016-09-09 2017-02-15 吉林农业大学 Preparation method of aging-resistant modified corn flour
CN109876045A (en) * 2019-03-07 2019-06-14 回音必集团浙江齐齐制药有限公司 A kind of " Humei " preparation and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
蒋叔霏;: "虎梅颗粒中薄荷脑薄层色谱鉴别与虎杖苷含量测定" *
陈绿琦: "虎梅含片治疗急性咽炎的临床疗效观察" *

Also Published As

Publication number Publication date
CN114983955B (en) 2023-05-02

Similar Documents

Publication Publication Date Title
CN101167749A (en) Preparing method for improving toad venom taste
CN104383250A (en) Pummelo peel dispersible tablets with function of relieving cough and preparation method thereof
CN1742957A (en) Sangju effervescent tablet for treating common cold
CN1785340A (en) Compound bovine bezoar stomach clearing fast dispersion solid preparation and its preparation method
CN102451162A (en) Olanzapine medicine absorbed through oral mucosa
CN103239507A (en) Medicinal composition capable of being rapidly disintegrated and dissolved in oral cavity and preparation method thereof
CN114983955A (en) Slowly-melting tiger plum buccal tablet and preparation method thereof
CN103860523A (en) Chlorphenamine maleate oral fast dissolving film and preparation method thereof
CN1785336A (en) Tongyou dryness moistening fast dispersion solid preparation and its preparation method
CN100463671C (en) Vagina effervescent tablets contg. callicarpa nudiflora, and its prepn. method
EP1697050B1 (en) Fiber rich fraction of trigonella foenum-graceumseeds and its use as a pharmaceutical excipient
CN1785368A (en) Lingyang lung clearing fast dispersion solid preparation and its preparation method
WO2023125798A1 (en) Traditional chinese medicine composition and preparation method and application thereof
CN102358749B (en) Roxithromycin ambroxol tablet composite and preparing method thereof
WO2023274344A1 (en) Method for preparing mussaenda pubescens heat-clearing preparation
CN104225196A (en) Traditional Chinese medicine effervescent tablet for treating respiratory diseases and preparation method of traditional Chinese medicine effervescent tablet
CN101564471A (en) Preparation method of buccal tablets for treating laryngeal disease
CN102120016B (en) Method for preparing Sichuan fritillary bulb and fructus momordicae cough relieving tablets
CN109453141B (en) Preparation method of film agent for treating chronic pharyngitis
CN100546570C (en) Effervescence tablet for treating wind-cold type cold
CN1785259A (en) Jinsuo emission-arresting fast dispersing solid preparation and its preparation method
CN101209288B (en) Corydalis decumbentis orally disintegrating tablets
CN1785398A (en) Kunshun fast dispersion solid preparation and its preparation method
CN1282479C (en) Slowly-released traditional Chinese medicine adhering tablet for treating mouth mucous diseases and its prepn. method
JP2012070675A (en) Powder gum for tableting and tableting chewing gum

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant