CN105343162A - Preparation method and detection method of lamiophlomis rotata kudo oral slow-release adhesive film - Google Patents

Preparation method and detection method of lamiophlomis rotata kudo oral slow-release adhesive film Download PDF

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CN105343162A
CN105343162A CN201510862975.XA CN201510862975A CN105343162A CN 105343162 A CN105343162 A CN 105343162A CN 201510862975 A CN201510862975 A CN 201510862975A CN 105343162 A CN105343162 A CN 105343162A
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pad pasting
lamiophlomidis rotatae
radix lamiophlomidis
oral cavity
slow release
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徐斌
石宇远
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    • 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)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N19/00Investigating materials by mechanical methods
    • G01N19/04Measuring adhesive force between materials, e.g. of sealing tape, of coating
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N21/3151Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths using two sources of radiation of different wavelengths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N2021/3155Measuring in two spectral ranges, e.g. UV and visible

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Abstract

The invention discloses a preparation method and a detection method of a lamiophlomis rotata kudo oral slow-release adhesive film. The preparation method at least comprises the steps that firstly, lamiophlomis rotata kudo freeze-dried powder is prepared; secondly, the lamiophlomis rotata kudo oral slow-release adhesive film is prepared. Extract of the traditional Chinese medicine lamiophlomis rotata kudo is used as the main medicinal component for preparing the oral ulcer adhesive film which can directly act on an ulcer affected part, the medicine releases quickly, the pharmaceutical effect is more stable, the medication curative effect is faster, and the adhesive film is high in bioavailability and strong in analgesic effect; the double-layer oral adhesive film prepared with chitosan-sodium alga acid-polyvinyl alcohol as the main film-forming material is strong in adhesive force, long in adhesion time, capable of making medicine release time more lasting, not prone to fall off when a patient eats food or drinks water and capable of effectively relieving the pain of the patient.

Description

The preparation method of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting and detection method thereof
Technical field
The present invention relates to a kind of preparation method of medicine, particularly relate to preparation method and the detection method thereof of a kind of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Background technology
Oral ulcer is also known as recurrent aphtha, and the traditional Chinese medical science is referred to as aphtha, and prevalence, up to 20%, occupies the first place of oral mucosal disease, and this cause of disease and mechanism of causing a disease are still not clear, and there is obvious individual variation.Sharp ache during oral ulcer morbidity, impact feed and speaking, when particularly meeting acid, the irritable food such as peppery, there is the thermal pain that significantly burns local, and brings huge misery and inconvenience to the body and mind of patient, work and life.
Radix Lamiophlomidis Rotatae is Labiatae Radix Lamiophlomidis Rotatae platymiscium, and this genus is only a kind of, has another name called unrivalled logical, and Tibetan language claims big bus, beats cloth bar, grows in the rubble beach of the ground height above sea level more than 3000 meters such as China Gansu, Qinghai, Sichuan, Yunnan, Tibet more.Its root and all herbal medicine, be that one of national folk common medicines such as covering Nahsi is hidden by China, have effect of promoting blood circulation and stopping pain removing stasis to stop bleeding.Paint bright grade in " the routine observation of curative effect of Radix Lamiophlomidis Rotatae capsule treatment recurrent aphtha 46 " literary composition, have sufficient elaboration to the curative effect of Radix Lamiophlomidis Rotatae in dental ulcer treatment.
The treatment of oral ulcer, generally based on topical therapeutic, sticks the appearance of the novel form such as agent, slow releasing agent in recent years, than conventional dosage forms, effectively can overcome mouthful innerlich anwenden easily by the shortcoming that saliva rinses out, and is expected to the difficult problem solving oral cavity medicine.
Summary of the invention
Object of the present invention: the preparation method and the detection method thereof that provide a kind of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, in the treatment of recurrent oral ulceration, significantly can shorten the course of disease, mitigation symptoms, promotes ulcer healing, and without other obvious adverse reaction.
To achieve these goals, technical scheme of the present invention is:
A preparation method for Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, the method at least comprises the steps:
Step 1: prepare Radix Lamiophlomidis Rotatae lyophilized powder.
Step 2: prepare Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
The preparation method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, described step 1 at least comprises as follows step by step:
Step 1.1: get the former medicine of Radix Lamiophlomidis Rotatae, rinses and cleans and dry, pulverizing.
Step 1.2: the former medicine of Radix Lamiophlomidis Rotatae through pulverizing being crossed 28 mesh sieves, taking 50g, adds 200mL deionized water and soaks.
Step 1.3: the deionized water after immersion and the former medicine of Radix Lamiophlomidis Rotatae are filtered through sterile centrifugation, gets supernatant and be Radix Lamiophlomidis Rotatae aqueous extract and store.
The preparation method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, in described step 1.2, the soaking temperature of described deionized water is 4 DEG C, and soak time is 36 hours.
The preparation method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, in described step 1.3, the storage temperature of described Radix Lamiophlomidis Rotatae aqueous extract is 4 DEG C.
The preparation method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, described step 2 at least comprises as follows step by step:
Step 2.1: get filmogen 50g, add respectively in 200ml Radix Lamiophlomidis Rotatae aqueous extract and deionized water and soak, described filmogen comprises chitosan, sodium alginate and polyvinyl alcohol, and the weight ratio of chitosan, sodium alginate and polyvinyl alcohol is 32:42:26.
Step 2.2: the Radix Lamiophlomidis Rotatae aqueous extract in heating for dissolving step 2.1 and deionized water, respectively add 10mL glycerol, and carry out successively respectively stirring evenly, film, dry or dry, open film.
Step 2.3: Radix Lamiophlomidis Rotatae aqueous extract is opened the pad pasting that the pad pasting after film is cut into 4cm*4cm, and pack into Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Step 2.4: deionized water is opened the pad pasting that the pad pasting after film is cut into 4cm*4cm, and pack into blank group pad pasting.
A detection method for Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, the method at least comprises the steps:
Step 1: the bioadhesion in vitro detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Step 2: the oral cavity adhesion time detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Step 3: the general flavone content detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
The detection method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, described step 1 at least comprises as follows step by step:
Step 1.1: the Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting getting one piece of 4cm*4cm, is fixed on 4 jiaos of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting on platform by clip.
Step 1.2: the Radix Polygalae Crotalarioidis inner membrance getting one piece of 4cm*4cm, sews up after soaking and be fixed on the rubber slab of another side buckle in the phosphatizing phthalate buffer of pH7.4.
Step 1.3: both can be made so that strain gauge is gently stretching to pulling force to separate after Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting and Radix Polygalae Crotalarioidis inner membrance are gently pressed 2 minutes.
Step 1.4: repeat step 1.1 to 1.3 5 times, the average adhesive force recording Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is 23 Ns.
The detection method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, in described step 1.2, the soak time of described Radix Polygalae Crotalarioidis inner membrance in phosphatizing phthalate buffer is 30 minutes, and soaking temperature is 30 DEG C.
The detection method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, described step 2 at least comprises as follows step by step:
Step 2.1: 100ml distilled water is put into beaker and is placed on magnetic stirrer, 37 DEG C of waters bath with thermostatic control, mixing speed 50 revs/min.
Step 2.2: be clipped in by Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting and clip put into water-bath and starts timing, record membrane dissolves or time of fragmentation.
Repeat step 2.1 and 2.2 5 times, the time of on average sticking recording Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is 200 minutes.
The detection method of above-mentioned Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, wherein, described step 3 take rutin as reference substance, with ultraviolet visible spectrophotometry, the content of total flavones in the slow release pad pasting of absorbance Radix Lamiophlomidis Rotatae oral cavity is measured at 500nm wavelength place, recording general flavone content in pad pasting, in rutin, is 24mg/g.
The film for treating oral ulcer that the present invention makes for primary medicinal component with Chinese medicine Radix Lamiophlomidis Rotatae extract, can be applied directly to ulcer affected part, and drug release is rapid, and drug effect is more stable, and medication curative effect is faster, and its bioavailability is high, and analgesic effect is strong; Be double-deck oral film prepared by main filmogen with chitosan one sodium alginate one polyvinyl alcohol, adhesive force is strong, and it is long to stick the time, pharmaceutical release time can be made more lasting, on the feed with difficult drop-off when drinking water, effectively can alleviate patient suffering.
Accompanying drawing explanation
Fig. 1 is the flow chart of the preparation method of Radix Lamiophlomidis Rotatae oral cavity of the present invention slow release pad pasting.
Fig. 2 is the flow chart of the detection bioadhesion in vitro of Radix Lamiophlomidis Rotatae oral cavity of the present invention slow release pad pasting.
Fig. 3 is the flow chart of the detection oral cavity adhesion time of Radix Lamiophlomidis Rotatae oral cavity of the present invention slow release pad pasting.
Detailed description of the invention
Embodiments of the invention are further illustrated below in conjunction with accompanying drawing.
Refer to shown in accompanying drawing 1, the preparation method of a kind of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, the method at least comprises the steps:
Step 1: prepare Radix Lamiophlomidis Rotatae lyophilized powder.
Step 2: prepare Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Described step 1 at least comprises as follows step by step:
Step 1.1: get the former medicine of Radix Lamiophlomidis Rotatae, rinses and cleans and dry, pulverizing.
Step 1.2: the former medicine of Radix Lamiophlomidis Rotatae through pulverizing being crossed 28 mesh sieves, taking 50g, adds 200mL deionized water and soaks.
Step 1.3: the deionized water after immersion and the former medicine of Radix Lamiophlomidis Rotatae are filtered through sterile centrifugation, gets supernatant and be Radix Lamiophlomidis Rotatae aqueous extract and store.
In described step 1.2, the soaking temperature of described deionized water is 4 DEG C, and soak time is 36 hours.
In described step 1.3, the storage temperature of described Radix Lamiophlomidis Rotatae aqueous extract is 4 DEG C.
Described step 2 at least comprises as follows step by step:
Step 2.1: get filmogen 50g, add respectively in 200ml Radix Lamiophlomidis Rotatae aqueous extract and deionized water and soak, described filmogen comprises chitosan, sodium alginate and polyvinyl alcohol.
Step 2.2: the Radix Lamiophlomidis Rotatae aqueous extract in heating for dissolving step 2.1 and deionized water, respectively add 10mL glycerol, and carry out successively respectively stirring evenly, film, dry or dry, open film.
Step 2.3: Radix Lamiophlomidis Rotatae aqueous extract is opened the pad pasting that the pad pasting after film is cut into 4cm*4cm, and pack into Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Step 2.4: deionized water is opened the pad pasting that the pad pasting after film is cut into 4cm*4cm, and pack into blank group pad pasting.
In described step 2.1, the weight ratio of chitosan, sodium alginate and polyvinyl alcohol in described 50g filmogen is 32:42:26.
Refer to shown in accompanying drawing 2 and accompanying drawing 3, the detection method of a kind of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, the method at least comprises the steps:
Step 1: the bioadhesion in vitro detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Step 2: the oral cavity adhesion time detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Step 3: the general flavone content detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
Described step 1 at least comprises as follows step by step:
Step 1.1: the Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting getting one piece of 4cm*4cm, is fixed on 4 jiaos of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting on platform by clip.
Step 1.2: the Radix Polygalae Crotalarioidis inner membrance getting one piece of 4cm*4cm, sews up after soaking and be fixed on the rubber slab of another side buckle in the phosphatizing phthalate buffer of pH7.4.
Step 1.3: both can be made so that strain gauge is gently stretching to pulling force to separate after Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting and Radix Polygalae Crotalarioidis inner membrance are gently pressed 2 minutes.
Step 1.4: repeat step 1.1 to 1.3 5 times, the average adhesive force recording Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is 23 Ns.
In described step 1.2, the soak time of described Radix Polygalae Crotalarioidis inner membrance in phosphatizing phthalate buffer is 30 minutes, and soaking temperature is 30 DEG C.
Described step 2 at least comprises as follows step by step:
Step 2.1: 100ml distilled water is put into beaker and is placed on magnetic stirrer, 37 DEG C of waters bath with thermostatic control, mixing speed 50 revs/min.
Step 2.2: be clipped in by Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting and clip put into water-bath and starts timing, record membrane dissolves or time of fragmentation.
Step 2.3: repeat step 2.1 and 2.2 5 times, the time of on average sticking recording Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is 200 minutes.
Step 3 with reference in 2010 editions Pharmacopoeias of People's Republic of China to the detection method of Radix Lamiophlomidis Rotatae capsule and standard, take rutin as reference substance, with ultraviolet visible spectrophotometry, the content of total flavones in the slow release pad pasting of absorbance Radix Lamiophlomidis Rotatae oral cavity is measured at 500nm wavelength place, it, in rutin, is 24mg/g that result records general flavone content in pad pasting.
The Therapeutic Method of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is as follows:
Clinical case is selected: " the oral ulcer diagnostic criteria " of showing according to Liu Shixia, and select Clinical mouth ulcer case, selected case answers compliance good, further consultation on time of trying one's best.Get rid of object: 1.. anemia of pregnant woman; 2.. abnormal mental state person; 3.. apply other treatment medicine for ulcer person simultaneously.
Experiment grouping: adopt random packet method (as shown in Table 1), 165 routine oral ulcer cases are divided into experimental group and matched group at random, sample content coincidence statistics standard.
Grouping situation tested by table 1
Therapeutic Method: experimental group adopts ulcer local to stick the treatment of Radix Lamiophlomidis Rotatae slow-release medicine-membrane, matched group ulcer topical application blank pad pasting.Two groups gargle all after the meal after use, three times on the one, the next day further consultation.
Criterion of cure: with pain disappearance, the healing of contrafluxion edema extinction, ulcer surface for healing standard, healing time after statistics medication is (by clinical inquiring, experimental group patient ulcer is sought medical advice after initiating for average 2.34 days, and matched group is gone to a doctor for average 2.33 days).
Statistical method: the Standardization Act adopting rate in enumeration data, calculates each group of standardization cure rate, statistical analysis is carried out in result X2 inspection.
Result: after experimental group and matched group case load are carried out standardization, carry out statistical analysis.Average cured time after experimental group treatment is 3.4 days, and the average healing after treatment of control group is 7.7 days.Through X2 inspection, p<0.05, has significant difference (see table 2).
Therapeutic effect (example) respectively organized by table 2
In sum, the film for treating oral ulcer that the present invention makes for primary medicinal component with Chinese medicine Radix Lamiophlomidis Rotatae extract, can be applied directly to ulcer affected part, and drug release is rapid, and drug effect is more stable, and medication curative effect is faster, and its bioavailability is high, and analgesic effect is strong; Be double-deck oral film prepared by main filmogen with chitosan one sodium alginate one polyvinyl alcohol, adhesive force is strong, and it is long to stick the time, pharmaceutical release time can be made more lasting, on the feed with difficult drop-off when drinking water, effectively can alleviate patient suffering.
The foregoing is only the preferred embodiments of the present invention; not thereby the scope of the claims of the present invention is limited; every equivalent structure transformation utilizing description of the present invention to do; or directly or indirectly use the technical field being attached to other Related products, be all in like manner included in scope of patent protection of the present invention.

Claims (10)

1. a preparation method for Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, is characterized in that: the method at least comprises the steps:
Step 1: prepare Radix Lamiophlomidis Rotatae lyophilized powder;
Step 2: prepare Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
2. the preparation method of Radix Lamiophlomidis Rotatae oral cavity according to claim 1 slow release pad pasting, is characterized in that: described step 1 at least comprises as follows step by step:
Step 1.1: get the former medicine of Radix Lamiophlomidis Rotatae, rinses and cleans and dry, pulverizing;
Step 1.2: the former medicine of Radix Lamiophlomidis Rotatae through pulverizing being crossed 28 mesh sieves, taking 50g, adds 200mL deionized water and soaks;
Step 1.3: the deionized water after immersion and the former medicine of Radix Lamiophlomidis Rotatae are filtered through sterile centrifugation, gets supernatant and be Radix Lamiophlomidis Rotatae aqueous extract and store.
3. the preparation method of Radix Lamiophlomidis Rotatae oral cavity according to claim 2 slow release pad pasting, is characterized in that: in described step 1.2, and the soaking temperature of described deionized water is 4 DEG C, and soak time is 36 hours.
4. the preparation method of Radix Lamiophlomidis Rotatae oral cavity according to claim 2 slow release pad pasting, is characterized in that: in described step 1.3, and the storage temperature of described Radix Lamiophlomidis Rotatae aqueous extract is 4 DEG C.
5. the preparation method of Radix Lamiophlomidis Rotatae oral cavity according to claim 1 slow release pad pasting, is characterized in that: described step 2 at least comprises as follows step by step:
Step 2.1: get filmogen 50g, add respectively in 200ml Radix Lamiophlomidis Rotatae aqueous extract and deionized water and soak, described filmogen comprises chitosan, sodium alginate and polyvinyl alcohol, and the weight ratio of chitosan, sodium alginate and polyvinyl alcohol is 32:42:26;
Step 2.2: the Radix Lamiophlomidis Rotatae aqueous extract in heating for dissolving step 2.1 and deionized water, respectively add 10mL glycerol, and carry out successively respectively stirring evenly, film, dry or dry, open film;
Step 2.3: Radix Lamiophlomidis Rotatae aqueous extract is opened the pad pasting that the pad pasting after film is cut into 4cm*4cm, and pack into Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting;
Step 2.4: deionized water is opened the pad pasting that the pad pasting after film is cut into 4cm*4cm, and pack into blank group pad pasting.
6. a detection method for Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting, is characterized in that: the method at least comprises the steps:
Step 1: the bioadhesion in vitro detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting;
Step 2: the oral cavity adhesion time detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting;
Step 3: the general flavone content detecting Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting.
7. the detection method of Radix Lamiophlomidis Rotatae oral cavity according to claim 6 slow release pad pasting, is characterized in that: described step 1 at least comprises as follows step by step:
Step 1.1: the Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting getting one piece of 4cm*4cm, is fixed on platform by 4 jiaos of Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting by clip;
Step 1.2: the Radix Polygalae Crotalarioidis inner membrance getting one piece of 4cm*4cm, sews up after soaking and be fixed on the rubber slab of another side buckle in the phosphatizing phthalate buffer of pH7.4;
Step 1.3: both can be made so that strain gauge is gently stretching to pulling force to separate after Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting and Radix Polygalae Crotalarioidis inner membrance are gently pressed 2 minutes;
Step 1.4: repeat step 1.1 to 1.3 5 times, the average adhesive force recording Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is 23 Ns.
8. the detection method of Radix Lamiophlomidis Rotatae oral cavity according to claim 7 slow release pad pasting, is characterized in that: in described step 1.2, and the soak time of described Radix Polygalae Crotalarioidis inner membrance in phosphatizing phthalate buffer is 30 minutes, and soaking temperature is 30 DEG C.
9. the detection method of Radix Lamiophlomidis Rotatae oral cavity according to claim 6 slow release pad pasting, is characterized in that: described step 2 at least comprises as follows step by step:
Step 2.1: 100ml distilled water is put into beaker and is placed on magnetic stirrer, 37 DEG C of waters bath with thermostatic control, mixing speed 50 revs/min;
Step 2.2: Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is clipped in and clip puts into water-bath and starts timing, record membrane dissolves or time of fragmentation;
Repeat step 2.1 and 2.2 5 times, the time of on average sticking recording Radix Lamiophlomidis Rotatae oral cavity slow release pad pasting is 200 minutes.
10. the detection method of Radix Lamiophlomidis Rotatae oral cavity according to claim 6 slow release pad pasting, it is characterized in that: described step 3 take rutin as reference substance, with ultraviolet visible spectrophotometry, the content of total flavones in the slow release pad pasting of absorbance Radix Lamiophlomidis Rotatae oral cavity is measured at 500nm wavelength place, recording general flavone content in pad pasting, in rutin, is 24mg/g.
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CN107490541A (en) * 2016-06-12 2017-12-19 武汉武药科技有限公司 Paste the detection means and detection method of piece adhesion property in oral cavity
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CN113616627A (en) * 2021-09-23 2021-11-09 广东医科大学 Double-layer film agent for treating oral ulcer and preparation method thereof
CN115684514A (en) * 2022-11-24 2023-02-03 则正(济南)生物科技有限公司 Method for evaluating bioavailability of imitation drug and original drug and application thereof
CN115684514B (en) * 2022-11-24 2024-04-26 则正(济南)生物科技有限公司 Method for evaluating bioavailability of simulated medicine and original ground medicine and application thereof

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