CN110200926A - Composite reactive freeze-dried powder and its preparation method and application - Google Patents
Composite reactive freeze-dried powder and its preparation method and application Download PDFInfo
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- CN110200926A CN110200926A CN201910636016.4A CN201910636016A CN110200926A CN 110200926 A CN110200926 A CN 110200926A CN 201910636016 A CN201910636016 A CN 201910636016A CN 110200926 A CN110200926 A CN 110200926A
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- Prior art keywords
- freeze
- dried powder
- composite reactive
- preparation
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/40—Shaping or working of foodstuffs characterised by the products free-flowing powder or instant powder, i.e. powder which is reconstituted rapidly when liquid is added
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- A—HUMAN NECESSITIES
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- Y—GENERAL 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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The present invention relates to a kind of composite reactive freeze-dried powders and its preparation method and application, described method includes following steps: raw material is cleaned up, then it crushes, it extracts again, it is then centrifuged for separating, then is concentrated with reverse osmosis concentration device, and collect concentrate, then the concentrate is freeze-dried, obtains composite reactive freeze-dried powder；Wherein, the raw material is at least one of fresh Rosa roxburghii Tratt or fresh blueberry；At the extraction, the weight ratio of the raw material and water is 1:(3~5).The preparation method of composite reactive freeze-dried powder of the invention, the preparation method is simple, and low energy consumption, and solvent can recycle, and production process is completely saved without discharging of waste liquid, active constituent；The composite reactive freeze-dried powder prepared by the method for the invention has effects that significantly to treat canker sore, gastric ulcer and other peptic ulcers, can be used for the exploitation of drug and health food, have good commercial promise and medical prospect.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of composite reactive freeze-dried powder and its preparation method and application.
Background technique
Recurrent oral ulceration is the highest a kind of disease of disease incidence in oral keritonocytes, common cold, indigestion,
Situations such as nervous, gloomy not happy, can accidentally cause the generation of the disease, lip, cheek, lingual margin etc. are apt to occur in, in any of mucous membrane
Position can occur.
Modern medicine believes that, recurrent oral ulceration has very close relationship with immune first.Some patients show as
Immune deficiency, some patients then show as autoimmune response；Followed by there is relationship with heredity, in clinic, recurrent oral
The morbidity of ulcer has apparent Family inherited inclination, if one side of parent or multi-party with recurrent aphthous ulcer, their son
Female is just easier illness than common people；In addition, the breaking-out of recurrent oral ulceration, also related with some diseases or symptom, such as
Disease of digestive system: gastric ulcer, duodenal ulcer, chronic or metastatic hepatitis, colitis etc., in addition partial eclipse, indigestion,
Fever, sleep insufficiency, over fatigue, operating pressure be big, the change of menstrual cycle etc..With the work of one or more factors
It jumps, be alternately present immunity of organisms decline, cause the frequent breaking-out of recurrent oral ulceration.
The treatment of recurrent oral ulceration includes that local treatment and systemic therapy are obtained since local treatment toxic side effect is low
To the approval of people.The oral local administration occurred in recent years, comply with one's wishes can paste, Dobell, watermelon crystal buccal tablet etc. it is convenient to take, but
There is place as one wishes not to the utmost, natural drug demand of the market to treatment canker sore in terms of analgesic, sterilization, healing
Urgently.
The Etiological of digestive tract ulcer includes the effect of helicobacter pylori infections, gastric acid and pepsin, non-steroid at present
Body anti-inflammatory agent, inherent cause, stomach and duodenum power abnormality and mental element etc..It has been generally acknowledged that peptic ulcer is
Due to damage factor (i.e. the cause of disease) and defending factors mucus bicarbonate barrier, Mucosal blood flow, prostaglandin and epidermal growth factor
It is possible to that ulcer occurs when damage factor is greater than defending factors caused by dysequilibrium between son etc..
The treatment method of peptic ulcer mainly includes gastric acid inhibitory, protection stomach lining and elimination helicobacter pylori at present.
Clinically usually using western medicines such as ranitidine, Omeprazole, colloidal bismuth pectins, but that there are the courses for the treatment of is long, there is sense of discomfort after medication
And toxic side effect, market are in urgent need efficient, less toxic novel anti-ulcer medicament, biologically active natural drug is more next
More it is valued by people.
Summary of the invention
An object of the present invention is to provide a kind of preparation methods of composite reactive freeze-dried powder.
A kind of preparation method of composite reactive freeze-dried powder of the invention, includes the following steps: to clean up raw material, then
Crush, then at a temperature of 0 DEG C~35 DEG C, take water as a solvent, extracted using continuous flow upstream ultrasonic wave extraction equipment, then from
Heart separation, then be concentrated with reverse osmosis concentration device, and collect concentrate, then the concentrate is freeze-dried, is answered
Close activated freeze dried powder；Wherein, the raw material is at least one of fresh Rosa roxburghii Tratt or fresh blueberry；At the extraction, the raw material
Weight ratio with water is 1:(3~5).
The preparation method of composite reactive freeze-dried powder of the invention, the preparation method is simple, and low energy consumption, and solvent can recycle benefit
With production process is completely saved without discharging of waste liquid, active constituent；The composite reactive freeze-dried powder tool prepared by the method for the invention
There is the effect of significant treatment canker sore, gastric ulcer and other peptic ulcers, can be used for opening for drug and health food
Hair has good commercial promise and medical prospect.
In addition, the preparation method of above-mentioned composite reactive freeze-dried powder of the invention, can also have following additional technology special
Sign:
Further, when crushing, raw material is ground into 60 mesh~100 mesh particle.
It is another object of the present invention to the composite reactive freeze-dried powders for proposing to prepare using the method.
It is another object of the present invention to the preparation methods for proposing a kind of composite reactive freeze-dried powder oral disintegrating tablet.
A kind of preparation method of composite reactive freeze-dried powder oral disintegrating tablet, by the composite reactive freeze-dried powder and filler and disintegration
Agent is mixed according to preset ratio, and adhesive is then added and is prepared into softwood, then squeezes granulation with 15 mesh~30 meshes, then
Dry 8h~12h adds lubricant and mixes, then then with 15 mesh~30 mesh sieves at a temperature of 30 DEG C~45 DEG C
Compacting, obtains composite reactive freeze-dried powder oral disintegrating tablet；Wherein, the parts by weight of the composite reactive freeze-dried powder are 40 parts~60 parts,
The parts by weight of the filler are 20 parts~40 parts, and the parts by weight of the disintegrating agent are 8 parts~15 parts, the lubricant
Parts by weight are 0.5 part~2 parts, and the parts by weight of described adhesive are 1 part~2 parts.
Further, it with mannitol is 5:(1~25 according to weight ratio that the filler, which is microcrystalline cellulose) it mixes.
Further, the disintegrating agent is at least one of cross-linked carboxymethyl konjak starch sodium and crospovidone.
Further, the lubricant is at least one of magnesium stearate, talcum powder or superfine silica gel powder.
Further, described adhesive is the mixture of dehydrated alcohol or dehydrated alcohol and glycerol.
Another object of the present invention is to propose that the composite reactive freeze-dried powder is burst in preparation treatment canker sore, stomach
Application in the drug of ulcer and other peptic ulcers.
Another object of the present invention is to propose the dosage form of the composite reactive freeze-dried powder, including tablet, capsule,
Oral disintegrating tablet, powder, pill, granule, syrup, solution, emulsion, injection, spray, gelling agent, creme, tincture, bar
Cloth agent or emplastrum.
Additional aspect and advantage of the invention will be set forth in part in the description, and will partially become from the following description
Obviously, or practice through the invention is recognized.
Specific embodiment
The embodiment of the present invention is described below in detail, the embodiment is exemplary, it is intended to it is used to explain the present invention, and
It is not considered as limiting the invention.
Embodiment 1
Embodiment 1 proposes a kind of compound Rosa roxburghii Tratt activated freeze dried powder oral disintegrating tablet, and preparation method includes the following steps:
10 kilograms of fresh Rosa roxburghii Tratt is taken, 2 kilograms of fresh blueberry, the above raw material is cleaned up with distilled water, is ground into 60-100 mesh
Particle, under the conditions of 5 DEG C, extracted using continuous flow upstream ultrasonic wave extraction equipment, using water as Extraction solvent, extracting solution pass through from
After heart separation, it is concentrated through reverse osmosis concentration device (Hefei intelligence pavilion UF membrane skill Co., Ltd), obtains concentrate and reverse osmosis water.Reverse osmosis
It is permeable to be recycled as Extraction solvent, realize greenization production.Concentrate obtains compound Rosa roxburghii Tratt activity and freezes by freeze-drying
Dry powder obtains compound Rosa roxburghii Tratt activated freeze dried powder by freeze-drying, and 1.3 kilograms of weight.
Embodiment 2
Embodiment 2 proposes a kind of compound Rosa roxburghii Tratt activated freeze dried powder oral disintegrating tablet, and preparation method includes the following steps:
Compound 200 grams of Rosa roxburghii Tratt activated freeze dried powder powder are taken, 100 grams of microcrystalline cellulose (MCC), is crosslinked carboxylic by 20 grams of mannitol
Above-mentioned material is sufficiently mixed uniformly by 25 grams of methyl konjak starch sodium in three-dimensional mixer, is obtained mixture, is added in mixture
Enter dehydrated alcohol 6ml softwood, squeezed and pelletized with 20 meshes, freeze-day with constant temperature 8 hours at 30 DEG C, 20 mesh sieves are added 5 grams firmly
Fatty acid magnesium mixes, and is pressed into the compound Rosa roxburghii Tratt activated freeze dried powder oral disintegrating tablet that every slice weight is 500mg.
Compound Rosa roxburghii Tratt activated freeze dried powder oral disintegrating tablet disintegration time mensuration
Referring to Chinese Pharmacopoeia version disintegration time mensuration method in 2010, compound Rosa roxburghii Tratt activated freeze dried powder oral disintegrating tablet 6 are taken, with
Water is medium, and temperature is that (37.0 ± 1) DEG C measures l piece every time, the timing since tablet contacts the water surface, until particle is all logical
The time for crossing sieve is disintegration time.6 are measured altogether calculates Mean disintegration time.Compound Rosa roxburghii Tratt activated freeze dried powder oral disintegrating tablet is flat
Equal disintegration time is 26 seconds.
Embodiment 3
Embodiment 3 proposes a kind of compound Rosa roxburghii Tratt activated freeze dried powder tablet, and preparation method includes the following steps:
Compound Rosa roxburghii Tratt activated freeze dried powder tablet is prepared according to the following ratio:
After mixing by compound Rosa roxburghii Tratt activated freeze dried powder and starch, particle is made, magnesium stearate is added and talcum powder is mixed
10000 are pressed into after closing uniformly.
Embodiment 4
Embodiment 4 proposes a kind of compound Rosa roxburghii Tratt activated freeze dried powder capsule, and preparation method includes the following steps:
Compound Rosa roxburghii Tratt activated freeze dried powder capsule is prepared according to the following ratio:
1000 grams of compound Rosa roxburghii Tratt activated freeze dried powder
800 grams of starch
After mixing by compound Rosa roxburghii Tratt activated freeze dried powder and starch, encapsulated to be made 5000.
Embodiment 5
Embodiment 5 proposes a kind of active freeze-dried pulvis of compound Rosa roxburghii Tratt, and preparation method includes the following steps:
The active freeze-dried pulvis of compound Rosa roxburghii Tratt is prepared according to the following ratio:
1000 grams of compound Rosa roxburghii Tratt activated freeze dried powder
300 grams of microcrystalline cellulose
Powder is made in compound Rosa roxburghii Tratt activated freeze dried powder and microcrystalline cellulose after mixing, tubulature cillin bottle is made
2000 bottles.
Embodiment 6
Compound Rosa roxburghii Tratt activated freeze dried powder anti-oral ulcer experimental study
(1) experiment purpose: the certain number of Oral ulcer model rat is given once daily in the Oral ulcer model manufactured with phenol
Compound Rosa roxburghii Tratt activated freeze dried powder, observe compound Rosa roxburghii Tratt activated freeze dried powder whether play the role of mitigate ulcer.
(2) test medicine and reagent
Dobell (Beijing Sihuan Medicine Science and Technology Co., Ltd)；Phenol
Animal: wistar rat, male, 230-280 grams of weight, The 2nd Army Medical College Experimental Animal Center provides.
(3) experimental method
Experimental rat 50 are taken, dosage: 10% chloral hydrate anesthesia 0.35ml/100 grams, will contain 90% benzene after anesthesia
Lower end plastic dropper (internal diameter 3mm) of phenol cotton balls is flat on the cheek film at rats with left bicker about 1mm, calcination 30 minutes, can
See at this and forms the white damage of 3mm diameter.Be grouped at random after 24 hours, every group 10,5 groups, i.e., model group (auxiliary material 4 times/
Day, not drug containing)；Compound Rosa roxburghii Tratt activated freeze dried powder high dose group (4 times/day, 5mg/ times)；Agent in compound Rosa roxburghii Tratt activated freeze dried powder
Amount group (4 times/day, 1mg/ times)；Compound Rosa roxburghii Tratt activated freeze dried powder low dose group (4 times/day, 0.2mg/ times)；Positive controls: China
Plain piece group (4 times/day, 5mg/ times), compound Rosa roxburghii Tratt activated freeze dried powder and Dobell are ground into a powder before use, and administration is to cover wound
Face is degree, and successive administration 5 days, next day observation ulcer area size (in terms of the diameter of ulcer) product was burst before administration and every time after administration
Ulcer healing state (ulcer being visible by naked eyes is recovery from illness), first administration to last dose is recorded as 1,2,3,4,5,6 day respectively.
Ulcer area size is examined with t, and ulcer healing rate is examined with X2.
(4) experimental result
Ulcer area compares (table 1): compound Rosa roxburghii Tratt activated freeze dried powder high dose group was compared with model group, from administration the 3rd day
Off-test is played, corresponding relatively there were significant differences daily；Dobell group plays test on the 3rd day compared with model group, from administration
Terminate, corresponding relatively there were significant differences daily；Compound Rosa roxburghii Tratt activated freeze dried powder middle dose group is compared with model group, from administration the 3rd
It plays off-test, and corresponding relatively there were significant differences daily；Compound Rosa roxburghii Tratt activated freeze dried powder low dose group compared with model group,
Off-test is played within the 5th day from administration, corresponding relatively there were significant differences daily.
Influence of the compound Rosa roxburghii Tratt activated freeze dried powder of table 1 to rat ulcer area
Note: compared with model group, p < 0.05 *,
Healing rate compares (table 2): model group and compound Rosa roxburghii Tratt activated freeze dried powder low dose group play examination in first day from administration
End is tested, ulcer does not all heal；Compound Rosa roxburghii Tratt activated freeze dried powder high dose group just has ulcer healing from administration the 3rd day, arrives
Off-test, for healing rate up to 95%, Dobell group has ulcer healing from administration the 4th day, arrives off-test, healing rate reaches
58%；Compound Rosa roxburghii Tratt activated freeze dried powder middle dose group has ulcer healing from administration the 4th day, arrives off-test, and healing rate reaches
60%.
Influence of the compound Rosa roxburghii Tratt activated freeze dried powder of table 2 to rat ulcer healing time
Note: compared with model group, p < 0.05 *
Experimental result shows that compound Rosa roxburghii Tratt activated freeze dried powder is significant in efficacy to canker sore, can be obviously promoted ulcer surface
Healing, significant effect are better than Dobell.
Embodiment 7
Compound Rosa roxburghii Tratt activated freeze dried powder anti-gastric-ulcer experimental study
(1) experiment purpose: rats acetic acid Ulceration model is used, it is a certain amount of multiple that rats models of gastric ulcer is given once daily
Rosa roxburghii Tratt activated freeze dried powder is closed, the effect that compound Rosa roxburghii Tratt activated freeze dried powder mitigates ulcer is observed.
(2) material
SD rat, half male and half female, weight 200g ± 20g are provided by The 2nd Army Medical College Experimental Animal Center.
Ranitidine (Arstwyth (Foshan) pharmaceutical Co. Ltd)
(3) method
SD rat 30, after fasting 12h, by Okabe method (Okabe S.Chronieity of acetic and
Unclear in the rat Stomach [J] .Am JDig Dis, 1972,17:619.) improvement carries out modeling.Rat abdominal cavity
After injecting the anesthesia of 3% yellow Jackets, skin is sterilized with cotton ball soaked in alcohol, opens abdominal cavity, starched in glandular stomach portion antetheca sinus body intersection
Film surface, which sticks, to be impregnated with circular filter paper (diameter 5mm) 30 seconds of glacial acetic acid, is repeated 3 times, is closed abdomen sewing-up cut.Postoperative routine feeding,
Animal was grouped at random in 2nd day, every group 6, respectively blank group, ranitidine group, compound each dosage of Rosa roxburghii Tratt activated freeze dried powder
Group (300mg/kg, 100mg/kg, 50mg/kg).Started to be administered in the grouping same day, is administered once/d, continuous 5d.After the last administration
Cervical dislocation puts to death animal after 12h, cuts open the belly and takes stomach, cut off along greater curvature, with brine gastric content, stomach is fixed on
In 10% formaldehyde, stomach is lain on glass surface ware after 15min, digimatic calipers accurate measuring ulcer is used under magnifying glass
The major diameter and minor axis in face, and ulcer area is calculated (on Wang Beiying, Li Yikui new Chinese medicine development technology and method [M]
Extra large science tech publishing house, 2001:506,515,505.).
Data processed result withIt indicates, it is for statistical analysis with SPSS software package.Using one-way analysis of variance
(One-Way ANOVA) is examined globality difference, is then examined using Tukey ' s and carry out comparison among groups.
(4) result
Influence to rats acetic acid type gastric ulcer: compound Rosa roxburghii Tratt activated freeze dried powder is high, middle dose group can obviously reduce rat
Ulcer index (P < 0.05), promotes the healing of ulcer.It the results are shown in Table 3.
The compound Rosa roxburghii Tratt activated freeze dried powder of table 3 causes the therapeutic effect of rat gastric ulcer to acetic acid
Note: compared with blank group, p < 0.05 *
Experimental result shows that compound Rosa roxburghii Tratt activated freeze dried powder Dichlorodiphenyl Acetate type gastric ulcer is significant in efficacy, can be obviously promoted ulcer
The healing in face, reduces the appearance of gastric perforation, and reduces stomach lining bleeding area, and significant effect is better than ranitidine.It mentions
It gives instructions in reply and closes the effect that Rosa roxburghii Tratt activated freeze dried powder can promote gastric mucosa to heal, there is preferable treatment effect to chronic gastric ulcer
Fruit.
To sum up, the preparation method of composite reactive freeze-dried powder of the invention, the preparation method is simple, and low energy consumption, and solvent can be with
It recycles, production process is completely saved without discharging of waste liquid, active constituent；The composite reactive prepared by the method for the invention freezes
Dry powder has effects that significantly to treat canker sore, gastric ulcer and other peptic ulcers, can be used for drug and health care is eaten
The exploitation of product has good commercial promise and medical prospect.
In the description of this specification, reference term " one embodiment ", " some embodiments ", " example ", " specifically show
The description of example " or " some examples " etc. means specific features, structure, material or spy described in conjunction with this embodiment or example
Point is included at least one embodiment or example of the invention.In the present specification, schematic expression of the above terms are not
It must be directed to identical embodiment or example.Moreover, particular features, structures, materials, or characteristics described can be in office
It can be combined in any suitable manner in one or more embodiment or examples.In addition, without conflicting with each other, the skill of this field
Art personnel can tie the feature of different embodiments or examples described in this specification and different embodiments or examples
It closes and combines.
Although the embodiments of the present invention has been shown and described above, it is to be understood that above-described embodiment is example
Property, it is not considered as limiting the invention, those skilled in the art within the scope of the invention can be to above-mentioned
Embodiment is changed, modifies, replacement and variant.
Claims (10)
1. a kind of preparation method of composite reactive freeze-dried powder, which comprises the steps of:
Raw material is cleaned up, is then crushed, then at a temperature of 0 DEG C~35 DEG C, takes water as a solvent, uses continuous flow upstream ultrasonic wave
Extract equipment extracts, and is then centrifuged for separating, then is concentrated with reverse osmosis concentration device, and collect concentrate, then by institute
Concentrate freeze-drying is stated, composite reactive freeze-dried powder is obtained；Wherein, the raw material is at least in fresh Rosa roxburghii Tratt or fresh blueberry
It is a kind of；At the extraction, the weight ratio of the raw material and water is 1:(3~5).
2. the preparation method of composite reactive freeze-dried powder according to claim 1, which is characterized in that when crushing, by raw material powder
It is broken into 60 mesh~100 mesh particle.
3. utilizing the composite reactive freeze-dried powder of the preparation of method described in as claimed in claim 1 or 22.
4. a kind of preparation method of composite reactive freeze-dried powder oral disintegrating tablet, which is characterized in that will be described as claimed in claim 3 compound
Activated freeze dried powder is mixed with filler and disintegrating agent according to preset ratio, and adhesive is then added and is prepared into softwood, then uses
15 mesh~30 meshes squeeze granulation, and then dry 8h~12h at a temperature of 30 DEG C~45 DEG C, then whole with 15 mesh~30 meshes
Grain, adds lubricant and mixes, then suppress, obtain composite reactive freeze-dried powder oral disintegrating tablet；Wherein, the composite reactive freeze-drying
The parts by weight of powder are 40 parts~60 parts, and the parts by weight of the filler are 20 parts~40 parts, the parts by weight of the disintegrating agent
Number is 8 parts~15 parts, and the parts by weight of the lubricant are 0.5 part~2 parts, and the parts by weight of described adhesive are 1 part~2
Part.
5. the preparation method of composite reactive freeze-dried powder oral disintegrating tablet according to claim 4, which is characterized in that the filler
With mannitol it is 5:(1~25 according to weight ratio for microcrystalline cellulose) it mixes.
6. the preparation method of composite reactive freeze-dried powder oral disintegrating tablet according to claim 4, which is characterized in that the disintegrating agent
At least one of cross-linked carboxymethyl konjak starch sodium and crospovidone.
7. the preparation method of composite reactive freeze-dried powder oral disintegrating tablet according to claim 4, which is characterized in that the lubricant
At least one of magnesium stearate, talcum powder or superfine silica gel powder.
8. the preparation method of composite reactive freeze-dried powder oral disintegrating tablet according to claim 4, which is characterized in that described adhesive
For dehydrated alcohol or the mixture of dehydrated alcohol and glycerol.
9. composite reactive freeze-dried powder as claimed in claim 3 is burst in preparation treatment canker sore, gastric ulcer and other digestibilities
Application in the drug of ulcer.
10. the dosage form of composite reactive freeze-dried powder as claimed in claim 3 include tablet, capsule, oral disintegrating tablet, powder, pill,
Granula, syrup, solution, emulsion, injection, spray, gelling agent, creme, tincture, cataplasm or emplastrum.
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Application publication date: 20190906 |
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