CN117547515A - Oral tablet containing fritillary bulb and preparation method thereof - Google Patents
Oral tablet containing fritillary bulb and preparation method thereof Download PDFInfo
- Publication number
- CN117547515A CN117547515A CN202311546873.8A CN202311546873A CN117547515A CN 117547515 A CN117547515 A CN 117547515A CN 202311546873 A CN202311546873 A CN 202311546873A CN 117547515 A CN117547515 A CN 117547515A
- Authority
- CN
- China
- Prior art keywords
- fritillary bulb
- drying
- preparation
- montmorillonite
- powder
- 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
Links
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 35
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 12
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- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims description 30
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- 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)
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- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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Abstract
The invention discloses a preparation method of an oral tablet containing fritillary bulb, which comprises the following steps: s1, decocting fritillary bulb in water, and filtering to obtain fritillary bulb extract and filter residues; mixing rhizoma bletilla, semen Armeniacae amarum, radix Codonopsis, fructus Siraitiae Grosvenorii and Bulbus Lilii, decocting in water to obtain filtrate, mixing Bulbus Fritillariae Ussuriensis extractive solution and filtrate, and concentrating to obtain mixed concentrate; s2, adding filter residues into absolute ethyl alcohol for leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues and crushing to obtain fritillary bulb powder; s3, adding the composite modifier, mannitol, sodium alginate and an auxiliary agent into the mixed concentrated solution and the fritillary bulb alcohol extract, uniformly mixing, and drying to obtain mixed powder; s4, uniformly mixing fritillary bulb powder and mixed powder, preparing wet granules, drying, finishing the granules, adding magnesium stearate, uniformly mixing, and tabletting to obtain the finished product. The oral tablet has the effects of treating canker sore, relieving discomfort of oral cavity and throat, clearing heat and purging pathogenic fire, relieving cough and reducing sputum, and has wide application prospect.
Description
Technical Field
The invention belongs to the technical field of oral health care, and particularly relates to an oral tablet containing fritillary bulb and a preparation method thereof.
Background
Canker sores are one of the most common oral mucosal diseases and are clinically characterized by recurrent oral mucosal ulcerative lesions. One or more yellow and white ulcer points of soybean or pea size can be seen in the mucosa in the oral cavity during attack, the yellow and white ulcer points are round or oval, the center is concave, a yellow and white pseudofilm is arranged on the surface, and red and halation is seen around the yellow and white ulcer points; the canker sore brings a lot of inconvenience and pain to people: such as oral cavity heat, pungency, salt, wine and other irritating foods, can cause the oral cavity irritation and pain which are difficult to bear. According to statistics of related people, on average, every 50 people have canker sores with different degrees, and if the canker sores are not healed for a long time, the canker sores are likely to cause oral cancers. The disease can be seen at any age, but is often associated with insomnia, constipation, fatigue, mental stress, menstrual cycle, and vitamin deficiency in young and old.
Western medicine for treating stomatitis and canker sore mainly treats local treatment. The traditional Chinese medicine mainly uses the formula of clearing heat and benefiting diaphragm, warming kidney and tonifying spleen, and cold and cooling and reducing diarrhea, and the smooth stool is the key for treating recurrent oral ulcer.
Western medicines are mostly used for treating acute pharyngitis, stomatitis, canker sore and the like by adopting local treatment or applying antibacterial and antiviral medicines, and generally can achieve good treatment effect. The Western medicine is often not ideal in treating chronic pharyngitis, radically curing stomatitis and canker sore or reducing the times of ulcer attacks and the like. For example, when the symptoms such as pharyngitis, stomatitis and canker sore are caused, the oral cavity is repeatedly rinsed by using 2% boric acid solution, 3% saline water and 1:5000 furacilin solution, or the oral cavity is coated with 2% iodized glycerol and 5% strong protein silver solution, or the oral cavity is filled with iodine lozenge, domiphen bromide, peppermint and the like, so that the oral cavity has a certain effect of relieving symptoms; for chronic pharyngitis, physical methods such as electric coagulation, freezing or laser treatment, ultraviolet irradiation, diathermy, etc. are used. However, the traditional Chinese medicine composition is mainly used for improving local symptoms, has no obvious curative effect, has strong toxic and side effects, is easy to cause the enhancement of bacterial drug resistance, treats both symptoms and root causes, and brings pains to patients no matter how the traditional Chinese medicine composition is used for treating the local symptoms. Clinical applications of traditional Chinese medicine include: ultrasonic atomization of Chinese medicinal decoction, oral administration of Chinese medicinal materials, acupuncture therapy, massage therapy, skin scraping therapy, etc. These methods have positive efficacy, but besides the oral administration of traditional Chinese medicine, the other 4 methods can complete the treatment by means of special auxiliary tools or special staff, and the compliance of patients is poor. Because of convenient use, obvious effect and good patient compliance, the oral traditional Chinese medicine is still an important component for treating throat and oral inflammation.
The Chinese patent application number 201410767241.9 discloses a fritillary bulb and snow pear lozenge based on superfine grinding and a preparation method thereof, comprising the following steps: decocting radix Ophiopogonis, bulbus Lilii, and flos Farfarae, and collecting supernatant to obtain radix Ophiopogonis mixed superfine lyophilized powder; decocting fresh fructus Pyri with crystal sugar, and collecting supernatant to obtain superfine lyophilized powder; superfine pulverizing Bulbus Fritillariae Cirrhosae to obtain superfine powder; mixing radix Ophiopogonis, fructus Pyri superfine lyophilized powder, bulbus Fritillariae Cirrhosae superfine powder, diluent starch, dextrin, mannitol, and magnesium stearate, making soft material with ethanol as wetting agent, extrusion granulating, drying, finishing, and tabletting to obtain Bulbus Fritillariae Cirrhosae and fructus Pyri buccal tablet; the lozenge obtained by the patent has good taste and throat wetting effect, wherein the superfine powder is adopted to directly treat the fritillaria cirrhosa, so that the extraction operation is omitted, the process is simplified, the total content of the traditional Chinese medicine active ingredients in the lozenge is correspondingly low, the traditional Chinese medicine active ingredients are difficult to release in the oral cavity, the treatment effect is slow, and the use effect is affected; in addition, the existing lozenge is mostly prepared by directly tabletting traditional Chinese medicine components and auxiliary materials, and the traditional Chinese medicine active components are not subjected to any protection treatment, and are easily influenced by environment and storage time in the storage process.
Therefore, the research and development of the oral tablet for treating the canker sore and improving the curative effect and the utilization rate of fritillary bulb has important significance.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide an oral tablet containing fritillary bulb and a preparation method thereof.
In order to achieve the above purpose, the present invention provides the following technical solutions:
a preparation method of an oral tablet containing fritillary bulb comprises the following steps:
s1, decocting fritillary bulb in water, and filtering to obtain fritillary bulb extract and fritillary bulb filter residues; mixing rhizoma bletilla, semen Armeniacae amarum, radix Codonopsis, fructus Siraitiae Grosvenorii and Bulbus Lilii, decocting in water to obtain filtrate, mixing Bulbus Fritillariae Ussuriensis extractive solution and filtrate, concentrating under reduced pressure to 1/4 of the original volume to obtain mixed concentrated solution;
s2, adding the fritillary bulb filter residues in the step S1 into absolute ethyl alcohol, leaching, filtering after leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues, crushing, and sieving with a 100-mesh sieve to obtain fritillary bulb powder;
s3, adding a composite modifier, mannitol, sodium alginate and an auxiliary agent into the mixed concentrated solution in the step S1 and the fritillary bulb alcohol extract in the step S2, uniformly mixing, and drying to obtain mixed powder;
s4, uniformly mixing the fritillary bulb powder in the step S2 and the mixed powder in the step S3, granulating, drying, finishing, adding magnesium stearate, uniformly mixing, and tabletting to obtain the fritillary bulb-containing oral tablet.
Preferably, in step S1, the weight of each raw material is: 30-35 parts of fritillary bulb, 20-25 parts of bletilla striata, 7-14 parts of almond, 3-6 parts of dangshen, 5-15 parts of fructus momordicae and 10-15 parts of lily; the feed liquid ratio of the fritillary bulb to the water is 1:8-12, and the feed liquid ratio of the total amount of the bletilla striata, the almond, the codonopsis pilosula, the momordica grosvenori and the lily to the water is 1:10-15; the decoction time is 1-2h.
Preferably, in the step S2, the feed liquid ratio of the second fritillary bulb filter residue to the absolute ethyl alcohol is 1:5-8, the leaching temperature is 50-60 ℃ and the leaching time is 0.5-1h.
Preferably, the preparation method of the composite modifier in the step S3 is as follows:
(a) Adding montmorillonite into deionized water, adding citric acid, stirring at 70-80deg.C for 1-2 hr, filtering, washing, and drying to obtain pretreated montmorillonite, adding pretreated montmorillonite into acetic acid solution, adding chitosan, stirring for reaction, filtering, washing, and drying to obtain modified montmorillonite;
(b) Adding beta-cyclodextrin into N, N-dimethylformamide, uniformly stirring, adding maleic anhydride, performing constant-temperature reaction, adding dichloromethane to precipitate after the reaction is finished, and then filtering, washing and drying to obtain modified beta-cyclodextrin;
(c) Adding the modified montmorillonite in the step (a) and the modified beta-cyclodextrin in the step (b) into deionized water, uniformly stirring, adding EDC and NHS, heating for reaction, and filtering, washing and drying after the reaction is finished to obtain the composite modifier.
Preferably, in the step (a), the mass ratio of montmorillonite, deionized water and citric acid is 50:500:20-30; the mass ratio of the pretreated montmorillonite to the chitosan is 50:3-6, and the mass concentration of the acetic acid solution is 10%; the temperature of the stirring reaction is 50-60 ℃ and the time is 2-4h.
Preferably, in the step (b), the mass ratio of the beta-cyclodextrin to the maleic anhydride is 15-20:10-20; the temperature of the constant temperature reaction is 65-80 ℃ and the time is 4-7h.
Preferably, the mass ratio of the modified montmorillonite, the modified beta-cyclodextrin, the EDC and the NHS in the step (c) is 20-30:20-30:5-7:3-5; the temperature of the heating reaction is 40-50 ℃ and the time is 6-10h.
Preferably, in the step S3, the mass ratio of the mixed concentrated solution, the fritillary alcohol extract, the composite modifier, the mannitol, the sodium alginate and the auxiliary agent is 20-30:15-25:50-60:10-15:5-10:6-10; the auxiliary agent is a mixture of microcrystalline cellulose, maltodextrin and fructo-oligosaccharide with the mass ratio of 1:1-2:1-2.
Preferably, in the step S4, the mass ratio of the fritillary bulb powder, the mixed powder and the magnesium stearate is 50-70:30-40:3-6, and the drying temperature is 60-70 ℃.
The invention also provides the fritillary bulb-containing oral tablet prepared by the method.
Fritillary bulb is a perennial herb, belongs to the genus fritillaria of the family liliaceae, also called fritillary bulb, is a dry bulb as a medicine, is one of fritillary medicinal materials, takes alkaloid as main active ingredients, and non-alkaloid ingredients comprise terpenes, saponins and adenosine compounds. The fritillary bulb has the traditional effects of clearing heat and moistening lung, resolving phlegm and relieving cough, and the modern pharmacological effects also prove that the fritillary bulb has the effects of calming, resisting ulcer, resisting platelet aggregation, resisting inflammation and the like.
Rhizoma bletilla has effects of astringing, stopping bleeding, detumescence, and promoting granulation, and can be used for treating hemoptysis, carbuncle, swelling, pyocutaneous disease, and chapped skin.
The semen Armeniacae amarum is prepared from seed of Prunus armeniaca Linne of Rosaceae. Harvesting mature fruits in summer, removing pulp and core shells, taking seeds and sun-drying. The main functions are as follows: descending qi, relieving cough and asthma, and relaxing bowel.
The radix codonopsis pilosulae has the functions of strengthening spleen, tonifying lung, nourishing blood and promoting fluid production.
Momordica grosvenori has effects of clearing lung-heat, relieving sore throat, eliminating phlegm, relieving cough, loosening bowel to relieve constipation.
The lily has the effects of nourishing yin, moistening lung, descending qi, relieving cough, clearing heat, reducing pathogenic fire, calming heart, soothing nerves, coordinating intestines and stomach, maintaining beauty and keeping young.
Compared with the prior art, the invention has the following beneficial effects:
(1) The fritillary bulb alone is decocted with water, and is matched with bletilla striata, almond, dangshen, momordica grosvenori and lily to obtain concentrated solution after decoction, fritillary bulb filter residues are subjected to alcohol extraction, a large amount of water-insoluble active ingredients such as steroid alkaloids in fritillary bulb are extracted, then the concentrated solution and fritillary bulb alcohol extract are mixed with a compound modifier, mannitol, sodium alginate and an auxiliary agent, so that the active ingredients in the extract are loaded in the modifier, the slow release of the active ingredients of the traditional Chinese medicine is facilitated, the action time of the tablet is prolonged, and finally mixed powder and fritillary bulb powder are mixed and tableted, so that substances which are not extracted in fritillary bulb powder are absorbed in intestinal tracts, and the utilization rate of the active ingredients in fritillary bulb is improved; the raw material formula is simple and reasonable, has the effects of treating canker sore, relieving oral cavity and throat discomfort, clearing heat and purging fire, relieving cough and reducing sputum, and the traditional Chinese medicine and the buccal tablet are fused, have good taste, are convenient to carry, can be slowly released, have great development and application popularization values, and can be widely applied to the fields of modern traditional Chinese medicines and foods.
(2) According to the preparation method of the fritillary bulb-containing oral tablet, the added composite modifier takes montmorillonite as a raw material, firstly, the montmorillonite is subjected to acidification modification, so that interlayer lattices are cracked, interlayer spacing is increased, the specific surface area and adsorption capacity of the modified montmorillonite are obviously improved, adsorption of the effective components in concentrated solution by the modifier is facilitated, and then chitosan is modified to enable chitosan to be intercalated between montmorillonite layers, so that the adsorption performance of the montmorillonite is further improved, and meanwhile, the reaction sites of the montmorillonite are also increased; then, the beta-cyclodextrin is modified by maleic anhydride, so that carboxyl is introduced into the outer cavity of the beta-cyclodextrin, the molecular hydrophilicity of the beta-cyclodextrin is improved, and the subsequent reaction is facilitated; then, the modified montmorillonite reacts with the modified beta-cyclodextrin to lead the beta-cyclodextrin to be introduced into the surface of the montmorillonite, and the hydrophobic cavity of the beta-cyclodextrin can be coated with the active ingredients in the fritillary bulb alcohol extract, so that the lozenge has a slow release function; by combining montmorillonite and beta-cyclodextrin as composite carrier, the loading of the composite modifier to concentrated solution and ethanol extract can be effectively improved, the total amount and sustained release performance of active ingredients in the buccal tablet are ensured, the active ingredients can be continuously released when the tablet is taken in the oral cavity, the acting time and the utilization rate of the active ingredients in the oral cavity are ensured, and the oral ulcer is effectively treated and the discomfort of the oral cavity and the throat is relieved.
Detailed Description
The technical solutions of the present invention will be clearly and completely described in connection with the embodiments, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
A preparation method of an oral tablet containing fritillary bulb comprises the following steps:
s1, adding 350g of water into 35g of fritillary bulb, decocting for 2 hours, and filtering to obtain fritillary bulb extract and fritillary bulb filter residues; mixing 25g of rhizoma bletillae, 14g of almond, 6g of codonopsis pilosula, 15g of fructus momordicae and 15g of lily, adding 750g of water, decocting for 2 hours to obtain filtrate, mixing fritillary bulb extract and filtrate, and concentrating the filtrate under reduced pressure to 1/4 of the original volume to obtain mixed concentrate for later use;
s2, adding 30g of fritillary bulb filter residues in the step S1 into 210g of absolute ethyl alcohol, leaching for 1h at 55 ℃, filtering after leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues, crushing the fritillary bulb residues, and sieving the fritillary bulb residues with a 100-mesh sieve to obtain fritillary bulb powder;
s3, adding 55g of composite modifier, 13g of mannitol, 7g of sodium alginate and 8g of auxiliary agent into 25g of mixed concentrated solution in the step S1 and 20g of Ping Beimu alcohol extract in the step S2, uniformly mixing, and drying to obtain mixed powder;
s4, uniformly mixing 60g of fritillary bulb powder in the step S2 with 35g of mixed powder in the step S3, granulating, drying at 65 ℃, finishing, adding 5g of magnesium stearate, uniformly mixing, and tabletting to obtain the fritillary bulb-containing oral tablet.
In step S3, the preparation method of the composite modifier is as follows:
(a) Adding 50g of montmorillonite into 500g of deionized water, adding 25g of citric acid, stirring for 1.5h at 75 ℃, filtering, washing and drying after the reaction is completed to obtain pretreated montmorillonite, adding 500mL of acetic acid solution with the mass concentration of 10% into 50g of pretreated montmorillonite, adding 5g of chitosan, stirring for reacting for 3h at 55 ℃, filtering, washing and drying after the reaction is completed to obtain modified montmorillonite;
(b) Adding 18g of beta-cyclodextrin into 300mL of N, N-dimethylformamide, uniformly stirring, adding 15g of maleic anhydride, reacting at a constant temperature of 75 ℃ for 6 hours, adding dichloromethane to precipitate after the reaction is finished, and filtering, washing and drying to obtain modified beta-cyclodextrin;
(c) Adding 25g of modified montmorillonite in the step (a) and 25g of modified beta-cyclodextrin in the step (b) into 500mL of deionized water, uniformly stirring, adding 6g of EDC and 4g of NHS, reacting at 45 ℃ for 8h, filtering, washing and drying after the reaction is completed, thus obtaining the composite modifier.
The auxiliary agent is a mixture of microcrystalline cellulose, maltodextrin and fructo-oligosaccharide with the mass ratio of 1:1:2.
Example 2
A preparation method of an oral tablet containing fritillary bulb comprises the following steps:
s1, adding 350g of water into 35g of fritillary bulb, decocting for 2 hours, and filtering to obtain fritillary bulb extract and fritillary bulb filter residues; mixing 25g of rhizoma bletillae, 14g of almond, 6g of codonopsis pilosula, 15g of fructus momordicae and 15g of lily, adding 750g of water, decocting for 1h to obtain filtrate, mixing fritillary bulb extract and filtrate, and concentrating under reduced pressure to 1/4 of the original volume to obtain mixed concentrate for later use;
s2, adding 30g of fritillary bulb filter residues in the step S1 into 210g of absolute ethyl alcohol, leaching for 1h at 50 ℃, filtering after leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues, crushing the fritillary bulb residues, and sieving the fritillary bulb residues with a 100-mesh sieve to obtain fritillary bulb powder;
s3, adding 55g of composite modifier, 13g of mannitol, 7g of sodium alginate and 8g of auxiliary agent into 25g of mixed concentrated solution in the step S1 and 20g of Ping Beimu alcohol extract in the step S2, uniformly mixing, and drying to obtain mixed powder;
s4, uniformly mixing 60g of fritillary bulb powder in the step S2 with 35g of mixed powder in the step S3, granulating, drying at 60 ℃, finishing, adding 5g of magnesium stearate, uniformly mixing, and tabletting to obtain the fritillary bulb-containing oral tablet.
In step S3, the preparation method of the composite modifier is as follows:
(a) Adding 50g of montmorillonite into 500g of deionized water, adding 20g of citric acid, stirring for 2 hours at 70 ℃, filtering, washing and drying after the reaction is completed to obtain pretreated montmorillonite, adding 500mL of acetic acid solution with the mass concentration of 10% into 50g of pretreated montmorillonite, adding 4g of chitosan, stirring for reacting for 4 hours at 50 ℃, filtering, washing and drying after the reaction is completed to obtain modified montmorillonite;
(b) Adding 15g of beta-cyclodextrin into 300mL of N, N-dimethylformamide, uniformly stirring, adding 10g of maleic anhydride, reacting at a constant temperature of 65 ℃ for 7 hours, adding dichloromethane to precipitate after the reaction is finished, and filtering, washing and drying to obtain modified beta-cyclodextrin;
(c) Adding 20g of modified montmorillonite in the step (a) and 20g of modified beta-cyclodextrin in the step (b) into 500mL of deionized water, uniformly stirring, adding 5g of EDC and 3g of NHS, reacting at 40 ℃ for 10h, filtering, washing and drying after the reaction is completed, thus obtaining the composite modifier.
The auxiliary agent is a mixture of microcrystalline cellulose, maltodextrin and fructo-oligosaccharide with the mass ratio of 1:1:2.
Example 3
A preparation method of an oral tablet containing fritillary bulb comprises the following steps:
s1, adding 350g of water into 35g of fritillary bulb, decocting for 1h, and filtering to obtain fritillary bulb extract and fritillary bulb filter residues; mixing 25g of rhizoma bletillae, 14g of almond, 6g of codonopsis pilosula, 15g of fructus momordicae and 15g of lily, adding 750g of water, decocting for 2 hours to obtain filtrate, mixing fritillary bulb extract and filtrate, and concentrating the filtrate under reduced pressure to 1/4 of the original volume to obtain mixed concentrate for later use;
s2, adding 30g of fritillary bulb filter residues in the step S1 into 210g of absolute ethyl alcohol, leaching for 0.5h at 60 ℃, filtering after leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues, crushing the fritillary bulb residues, and sieving the fritillary bulb residues with a 100-mesh sieve to obtain fritillary bulb powder;
s3, adding 55g of composite modifier, 13g of mannitol, 7g of sodium alginate and 8g of auxiliary agent into 25g of mixed concentrated solution in the step S1 and 20g of Ping Beimu alcohol extract in the step S2, uniformly mixing, and drying to obtain mixed powder;
s4, uniformly mixing 60g of fritillary bulb powder in the step S2 with 35g of mixed powder in the step S3, granulating, drying at 70 ℃, finishing, adding 5g of magnesium stearate, uniformly mixing, and tabletting to obtain the fritillary bulb-containing oral tablet.
In step S3, the preparation method of the composite modifier is as follows:
(a) Adding 50g of montmorillonite into 500g of deionized water, adding 30g of citric acid, stirring for 1h at 80 ℃, filtering, washing and drying after the reaction is completed to obtain pretreated montmorillonite, adding 500mL of acetic acid solution with the mass concentration of 10% into 50g of pretreated montmorillonite, adding 6g of chitosan, stirring for reacting for 2h at 60 ℃, filtering, washing and drying after the reaction is completed to obtain modified montmorillonite;
(b) Adding 20g of beta-cyclodextrin into 300mL of N, N-dimethylformamide, uniformly stirring, adding 20g of maleic anhydride, reacting at the constant temperature of 80 ℃ for 4 hours, adding dichloromethane to precipitate after the reaction is finished, and then filtering, washing and drying to obtain modified beta-cyclodextrin;
(c) Adding 30g of modified montmorillonite in the step (a) and 30g of modified beta-cyclodextrin in the step (b) into 500mL of deionized water, uniformly stirring, adding 7g of EDC and 5g of NHS, reacting at 50 ℃ for 6h, filtering, washing and drying after the reaction is completed, thus obtaining the composite modifier.
The auxiliary agent is a mixture of microcrystalline cellulose, maltodextrin and fructo-oligosaccharide with the mass ratio of 1:1:2.
Comparative example 1
A preparation method of an oral tablet containing fritillary bulb comprises the following steps:
s1, adding 350g of water into 35g of fritillary bulb, decocting for 2 hours, and filtering to obtain fritillary bulb extract and fritillary bulb filter residues; mixing 25g of rhizoma bletillae, 14g of almond, 6g of codonopsis pilosula, 15g of fructus momordicae and 15g of lily, adding 750g of water, decocting for 2 hours to obtain filtrate, mixing fritillary bulb extract and filtrate, and concentrating the filtrate under reduced pressure to 1/4 of the original volume to obtain mixed concentrate for later use;
s2, adding 30g of fritillary bulb filter residues in the step S1 into 210g of absolute ethyl alcohol, leaching for 1h at 55 ℃, filtering after leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues, crushing the fritillary bulb residues, and sieving the fritillary bulb residues with a 100-mesh sieve to obtain fritillary bulb powder;
s3, adding 55g of composite modifier, 13g of mannitol, 7g of sodium alginate and 8g of auxiliary agent into 25g of mixed concentrated solution in the step S1 and 20g of Ping Beimu alcohol extract in the step S2, uniformly mixing, and drying to obtain mixed powder;
s4, uniformly mixing 60g of fritillary bulb powder in the step S2 with 35g of mixed powder in the step S3, granulating, drying at 65 ℃, finishing, adding 5g of magnesium stearate, uniformly mixing, and tabletting to obtain the fritillary bulb-containing oral tablet.
In step S3, the preparation method of the composite modifier is as follows:
(a) Adding 50g of montmorillonite into 500g of deionized water, adding 25g of citric acid, stirring for 1.5h at 75 ℃, filtering, washing and drying after the reaction is completed to obtain pretreated montmorillonite, adding 500mL of acetic acid solution with the mass concentration of 10% into 50g of pretreated montmorillonite, adding 5g of chitosan, stirring for reacting for 3h at 55 ℃, filtering, washing and drying after the reaction is completed to obtain modified montmorillonite;
(b) And (c) uniformly mixing 25g of modified montmorillonite and 25g of beta-cyclodextrin in the step (a) to obtain the composite modifier.
The auxiliary agent is a mixture of microcrystalline cellulose, maltodextrin and fructo-oligosaccharide with the mass ratio of 1:1:2.
Comparative example 2
A preparation method of an oral tablet containing fritillary bulb comprises the following steps:
s1, adding 350g of water into 35g of fritillary bulb, decocting for 2 hours, and filtering to obtain fritillary bulb extract and fritillary bulb filter residues; mixing 25g of rhizoma bletillae, 14g of almond, 6g of codonopsis pilosula, 15g of fructus momordicae and 15g of lily, adding 750g of water, decocting for 2 hours to obtain filtrate, mixing fritillary bulb extract and filtrate, and concentrating the filtrate under reduced pressure to 1/4 of the original volume to obtain mixed concentrate for later use;
s2, adding 30g of fritillary bulb filter residues in the step S1 into 210g of absolute ethyl alcohol, leaching for 1h at 55 ℃, filtering after leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues, crushing the fritillary bulb residues, and sieving the fritillary bulb residues with a 100-mesh sieve to obtain fritillary bulb powder;
s3, adding 55g of composite modifier, 13g of mannitol, 7g of sodium alginate and 8g of auxiliary agent into 25g of mixed concentrated solution in the step S1 and 20g of Ping Beimu alcohol extract in the step S2, uniformly mixing, and drying to obtain mixed powder;
s4, uniformly mixing 60g of fritillary bulb powder in the step S2 with 35g of mixed powder in the step S3, granulating, drying at 65 ℃, finishing, adding 5g of magnesium stearate, uniformly mixing, and tabletting to obtain the fritillary bulb-containing oral tablet.
In step S3, the preparation method of the composite modifier is as follows:
(a) Adding 18g of beta-cyclodextrin into 300mL of N, N-dimethylformamide, uniformly stirring, adding 15g of maleic anhydride, reacting at a constant temperature of 75 ℃ for 6 hours, adding dichloromethane to precipitate after the reaction is finished, and filtering, washing and drying to obtain modified beta-cyclodextrin;
(b) And uniformly mixing 25g of montmorillonite and 25g of modified beta-cyclodextrin to obtain the composite modifier.
The auxiliary agent is a mixture of microcrystalline cellulose, maltodextrin and fructo-oligosaccharide with the mass ratio of 1:1:2.
The oral tablet prepared in example 1 was subjected to pharmacodynamic experimental study, and the results were as follows:
1. test purpose: the canker sore model was produced by using phenol, and the canker sore model rats were given a certain number of oral tablet powders per day, and whether or not the canker sore-reducing effect was observed.
2. Test method
Rats were anesthetized with 100, 10% chloral hydrate, dose: after anesthesia, the lower end of a plastic dropper (inner diameter: 3 mm) of a 90% phenol cotton ball was placed flat on the cheek film at about 1mm of the left side angle of the rat, and burned for 30min, i.e., about 3mm of white lesions were seen. Immediately after 24 hours, 20 groups of 4, i.e. high dose groups (3 times/day, 0.4 mg/time); medium dose group (3 times/day, 0.2 mg/time); the low dose group (3 times/day, 0.1 mg/time), the high dose group, the medium dose group and the low dose group are the oral tablet of the step 1 of the invention, and are ground into powder; positive control group: huasu tablet group (3 times/day, 0.4 mg/time). Hua Supian is ground into powder before use, and administered to cover the wound surface, and ulcer healing is observed and recorded daily. The results are shown in table 1 below:
TABLE 1
The oral tablets containing fritillary bulb prepared in examples 1-3 and comparative examples 1-2 were subjected to a drug efficacy test.
The experimental object: the oral ulcer is characterized in that 150 groups of people with different degrees of oral ulcers are selected from people of different ages of 25-45 years old, the oral ulcer is divided into 5 groups randomly and averagely, oral tablets prepared in the examples 1-3 and the comparative examples 1-2 are taken respectively, each group has no statistical significance in the aspects of sex, age and oral ulcer characterization, smoking and alcohol inhibition and pungency food inhibition are required in the experimental period, other therapeutic drugs are not used, and the three groups of general data have no significant difference and are comparable.
Oral ulcer test method: it is administered 3 times daily, and is administered after meals.
Experimental examination indexes: the effect is shown: the oral ulcer heals completely after 2-3 days of treatment, and the pain symptoms disappear; the method is effective: the oral ulcer heals completely and the pain symptoms disappear after 4 to 7 days; invalidation: the ulcer surface was contracted within 7 days, but did not heal completely, and the pain symptoms were slightly or not improved.
The experimental results are shown in table 1 below:
TABLE 1
As can be seen from the table 1, the fritillary bulb-containing oral tablet prepared by the invention can rapidly and effectively treat canker sore, and the obvious effect rate is up to more than 80%, probably because the active ingredients in the tablet act on the oral cavity for a long time, thereby improving the curative effect and the utilization rate of the medicine and further reducing the treatment time.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (10)
1. A preparation method of an oral tablet containing fritillary bulb is characterized by comprising the following steps:
s1, decocting fritillary bulb in water, and filtering to obtain fritillary bulb extract and fritillary bulb filter residues; mixing rhizoma bletilla, semen Armeniacae amarum, radix Codonopsis, fructus Siraitiae Grosvenorii and Bulbus Lilii, decocting in water to obtain filtrate, mixing Bulbus Fritillariae Ussuriensis extractive solution and filtrate, concentrating under reduced pressure to 1/4 of the original volume to obtain mixed concentrated solution;
s2, adding the fritillary bulb filter residues in the step S1 into absolute ethyl alcohol, leaching, filtering after leaching to obtain fritillary bulb alcohol extract and fritillary bulb residues, drying the fritillary bulb residues, crushing, and sieving with a 100-mesh sieve to obtain fritillary bulb powder;
s3, adding a composite modifier, mannitol, sodium alginate and an auxiliary agent into the mixed concentrated solution in the step S1 and the fritillary bulb alcohol extract in the step S2, uniformly mixing, and drying to obtain mixed powder;
s4, uniformly mixing the fritillary bulb powder in the step S2 and the mixed powder in the step S3, granulating, drying, finishing, adding magnesium stearate, uniformly mixing, and tabletting to obtain the fritillary bulb-containing oral tablet.
2. The preparation method according to claim 1, wherein in step S1, the weight of each raw material is: 30-35 parts of fritillary bulb, 20-25 parts of bletilla striata, 7-14 parts of almond, 3-6 parts of dangshen, 5-15 parts of fructus momordicae and 10-15 parts of lily; the feed liquid ratio of the fritillary bulb to the water is 1:8-12, and the feed liquid ratio of the total amount of the bletilla striata, the almond, the codonopsis pilosula, the momordica grosvenori and the lily to the water is 1:10-15; the decoction time is 1-2h.
3. The preparation method according to claim 1, wherein the feed liquid ratio of the second fritillary bulb filter residue to the absolute ethanol in the step S2 is 1:5-8, and the leaching temperature is 50-60 ℃ for 0.5-1h.
4. The preparation method according to claim 1, wherein the preparation method of the composite modifier in step S3 is as follows:
(a) Adding montmorillonite into deionized water, adding citric acid, stirring at 70-80deg.C for 1-2 hr, filtering, washing, and drying to obtain pretreated montmorillonite, adding pretreated montmorillonite into acetic acid solution, adding chitosan, stirring for reaction, filtering, washing, and drying to obtain modified montmorillonite;
(b) Adding beta-cyclodextrin into N, N-dimethylformamide, uniformly stirring, adding maleic anhydride, performing constant-temperature reaction, adding dichloromethane to precipitate after the reaction is finished, and then filtering, washing and drying to obtain modified beta-cyclodextrin;
(c) Adding the modified montmorillonite in the step (a) and the modified beta-cyclodextrin in the step (b) into deionized water, uniformly stirring, adding EDC and NHS, heating for reaction, and filtering, washing and drying after the reaction is finished to obtain the composite modifier.
5. The method according to claim 4, wherein the mass ratio of montmorillonite, deionized water and citric acid in the step (a) is 50:500:20-30; the mass ratio of the pretreated montmorillonite to the chitosan is 50:3-6, and the mass concentration of the acetic acid solution is 10%; the temperature of the stirring reaction is 50-60 ℃ and the time is 2-4h.
6. The method according to claim 4, wherein the mass ratio of the beta-cyclodextrin to the maleic anhydride in the step (b) is 15-20:10-20; the temperature of the constant temperature reaction is 65-80 ℃ and the time is 4-7h.
7. The preparation method according to claim 4, wherein the mass ratio of the modified montmorillonite, the modified beta-cyclodextrin, the EDC and the NHS in the step (c) is 20-30:20-30:5-7:3-5; the temperature of the heating reaction is 40-50 ℃ and the time is 6-10h.
8. The preparation method of claim 1, wherein in the step S3, the mass ratio of the mixed concentrated solution, the fritillary bulb alcohol extract, the composite modifier, the mannitol, the sodium alginate and the auxiliary agent is 20-30:15-25:50-60:10-15:5-10:6-10; the auxiliary agent is a mixture of microcrystalline cellulose, maltodextrin and fructo-oligosaccharide with the mass ratio of 1:1-2:1-2.
9. The preparation method according to claim 1, wherein the mass ratio of fritillary bulb powder, mixed powder and magnesium stearate in the step S4 is 50-70:30-40:3-6, and the drying temperature is 60-70 ℃.
10. An oral tablet comprising fritillary bulb prepared by the method of any one of claims 1 to 9.
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