CN109953984A - A kind of compound hydrochloric acid totokaine film and preparation method thereof - Google Patents
A kind of compound hydrochloric acid totokaine film and preparation method thereof Download PDFInfo
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- CN109953984A CN109953984A CN201910157444.9A CN201910157444A CN109953984A CN 109953984 A CN109953984 A CN 109953984A CN 201910157444 A CN201910157444 A CN 201910157444A CN 109953984 A CN109953984 A CN 109953984A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
- A61K31/24—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
- A61K31/245—Amino benzoic acid types, e.g. procaine, novocaine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
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Abstract
The invention discloses a kind of compound hydrochloric acid totokaine films and preparation method thereof.The compound hydrochloric acid totokaine film is made of tetracaine hydrochloride, gentamicin sulphate, hydrocortisone, sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water.It when dosing object is into filmogen, is stirred using FLUKO FA25 high-shearing dispersion emulsifying machine, compared with traditional artificial stirring, medical fluid is homogeneous, fine and smooth, and work efficiency is high.Replace original artificial plastic film mulch mode using electronic plastic film mulch device during plastic film mulch, situations such as it is low to solve production efficiency, medicine film uneven thickness, and limit test of weight variation is against regulation in quality examination.Electronic plastic film mulch device is easy to operate, accurately controls plastic film mulch rate and film thickness, and plastic film mulch is uniform, and flatness is good, and thickness is controllable, and production efficiency greatly improves.Topical application of the present invention treats canker sore, has the function of anti-inflammatory, analgesic, with strong points, significant in efficacy, patient is easy to receive, and is ideal Aphthasol object.
Description
Technical field
The present invention relates to a kind of compound hydrochloric acid totokaine films and preparation method thereof.The invention belongs to pharmaceutical production technology necks
Domain.
Background technique
Recurrent oral ulceration (recurrent oral ulcer, ROU) is common oral keritonocytes, and when morbidity bursts
Ulcer position pain, and the duration is longer.Because it has the characteristics that recurrent exerbation, bring great pain to patients.ROU may
It is related with the factors such as local trauma, pressure, diet, drug, hormone and vitamin and microelement deficiencies, primary pathogenic event
Still in research.
Film (Films) is to dissolve drug or be dispersed in manufactured film-form dosage form in filmogen, for mouth
Clothes or mucous membrane application.Pelliculae pro cavo oris (Oral films, OFs), be called orodispersible film (Oradispersible films),
Oral quick-dissolving film preparation (Oral Fast dissolving Films, Fast dissolving films, Oral
Dissolvable films, Orally dissolving strips) etc., feature is to directly act on affected part, it is rapid-action and
Persistent；Medicament contg is accurate, and stability is good；It is light-weight, it is small in size, using convenient.
Film can be tenaciously adhered on mucous membrane by adhesion member, resisted saliva to a certain extent and swallowed clear
Except effect, be conducive to protect ulcer surface, extend the action time of drug, preferably performance drug effect, and ulcer generation can be reduced
Frequency and the severity for mitigating ulcer generation are the first-line therapies of current treatment ROU.
Summary of the invention
The purpose of the present invention is to provide a kind of compound hydrochloric acid totokaine films and preparation method thereof.
In order to achieve the above object, present invention employs following technological means:
A kind of compound hydrochloric acid totokaine film of the invention, by tetracaine hydrochloride, gentamicin sulphate, hydrocortisone,
Sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water are made.
Wherein, it is preferred that the parts by weight of each raw material are as follows: tetracaine hydrochloride 0.3-0.5 parts by weight, gentamicin sulphate
0.1-0.3 parts by weight, hydrocortisone 0.1-0.3 parts by weight, sodium carboxymethylcellulose (CMC-Na) 0.5-2 parts by weight, poly- second
Enol (PVA) 5-15 parts by weight, glycerol 1-4 parts by weight, purified water 70-90 parts by weight.
Pelliculae pro cavo oris prepared by the present invention is with the dosage of sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol
To investigate factor, using the residence time in the appearance of film, release, oral cavity as comprehensive evaluation index, orthogonal test analysis is carried out,
Filter out medicine film optimum formula and preparation process.Wherein, it is preferred that the mass ratio 10:100 of polyvinyl alcohol and purified water, carboxylic first
The mass ratio 5:100 of the mass ratio 2:100 of base sodium cellulosate and purified water, glycerol and purified water.
Wherein, it is preferred that the parts by weight of each raw material are as follows: 0.4 parts by weight of tetracaine hydrochloride, 0.2 weight of gentamicin sulphate
Measure part, 0.2 parts by weight of hydrocortisone, 1.6 parts by weight of sodium carboxymethylcellulose (CMC-Na), 8 weight of polyvinyl alcohol (PVA)
Part, 4 parts by weight of glycerol, 80 parts by weight of purified water.
Further, the invention also provides a kind of method for preparing the compound hydrochloric acid totokaine film, including it is following
Step:
(1) weigh tetracaine hydrochloride respectively according to parts by weight described in any of the above item, gentamicin sulphate, hydrogenation can
Pine, sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water；
(2) by weighed sodium carboxymethylcellulose (CMC-Na) and polyvinyl alcohol (PVA), appropriate purified water is added to impregnate abundant
It after swelling, sets and is dissolved by heating in water-bath, avoid stirring, dissolve it naturally completely, obtain film slurry, cooling is spare；
(3) by weighed tetracaine hydrochloride, gentamicin sulphate, the suitable purified water ultrasonic dissolution of hydrocortisone,
Obtain medical fluid；
(4) medical fluid that weighed glycerol, step (3) obtain is mixed with the film slurry that step (2) obtains, remaining purifying is added
Water stirs evenly, and sets in 60 DEG C of water and keeps the temperature de-bubbled, obtains medicine slurry；
(5) medicine slurry for obtaining step (4) is placed in electronic plastic film mulch device, thickness needed for adjusting film, and plastic film mulch is naturally dry
Dry, demoulding is divided cut-parts, is dispensed after sterilizing.
Wherein, it is preferred that the temperature of water-bath is 85-90 DEG C in step (2).
Wherein, it is preferred that FLUKO FA25 high-shearing dispersion emulsifying machine revolving speed 10000-28000rpm is used in step (4)
It stirs evenly.
Wherein, it is preferred that every hydrochloric totokaine 6mg.
Further, the invention also provides the compound hydrochloric acid totokaine films treats stomatocace medicine in preparation
In application.
Wherein, it is preferred that the drug is pelliculae pro cavo oris.
Compared to the prior art, the beneficial effects of the present invention are:
1. medicine film is made with anti-inflammatory, analgesic in a kind of compound hydrochloric acid totokaine film provided by the invention and preparation method thereof
Effect, be mainly used for canker sore.
2. compound hydrochloric acid totokaine film is when dosing object is into filmogen, using FLUKO FA25 high cut disperse emulsification
Machine revolving speed 10000-28000rpm is stirred, and carries out plastic film mulch after standing.Compared with traditional artificial stirring, emulsification is uniform, medical fluid quality
Uniformly, fine and smooth, work efficiency is high.
3. compound hydrochloric acid totokaine film replaces original artificial plastic film mulch mode using electronic plastic film mulch device during plastic film mulch,
It is low to solve production efficiency, situations such as medicine film uneven thickness, limit test of weight variation is against regulation in quality examination.Electronic plastic film mulch
Device is easy to operate, accurately controls plastic film mulch rate and film thickness, and plastic film mulch is uniform, and flatness is good, and thickness is controllable, and production efficiency is big
Width improves.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
The preparation of 1 compound hydrochloric acid totokaine film of embodiment
The following steps are included:
(1) parts by weight as described below weigh respectively tetracaine hydrochloride, gentamicin sulphate, hydrocortisone,
Sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water:
0.4 parts by weight of tetracaine hydrochloride, 0.2 parts by weight of gentamicin sulphate, 0.2 parts by weight of hydrocortisone, carboxymethyl
1.6 parts by weight of sodium cellulosate (CMC-Na), 8 parts by weight of polyvinyl alcohol (PVA), 4 parts by weight of glycerol, 80 parts by weight of purified water.
(2) by weighed sodium carboxymethylcellulose (CMC-Na) and polyvinyl alcohol (PVA), appropriate purified water is added to impregnate abundant
It after swelling, sets and is dissolved by heating in 85-90 DEG C of water-bath, avoid stirring, dissolve it naturally completely, obtain film slurry, cooling is spare；
(3) by weighed tetracaine hydrochloride, gentamicin sulphate, the suitable purified water ultrasonic dissolution of hydrocortisone,
Obtain medical fluid；
(4) medical fluid that weighed glycerol, step (3) obtain is mixed with the film slurry that step (2) obtains, remaining purifying is added
Water is stirred evenly using FLUKO FA25 high-shearing dispersion emulsifying machine revolving speed 10000rpm, sets in 60 DEG C of water and keep the temperature de-bubbled, obtain
To medicine slurry；
(5) obtained medicine slurry is placed in electronic plastic film mulch device, thickness needed for adjusting film, plastic film mulch spontaneously dries, and takes off
Film, divides cut-parts, and every hydrochloric totokaine 6mg is dispensed after sterilizing.
The preparation of 2 compound hydrochloric acid totokaine film of embodiment
The following steps are included:
(1) parts by weight as described below weigh respectively tetracaine hydrochloride, gentamicin sulphate, hydrocortisone,
Sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water:
0.5 parts by weight of tetracaine hydrochloride, 0.2 parts by weight of gentamicin sulphate, 0.1 parts by weight of hydrocortisone, carboxymethyl
1 parts by weight of sodium cellulosate (CMC-Na), 15 parts by weight of polyvinyl alcohol (PVA), 12 parts by weight of glycerol, 90 parts by weight of purified water.
(2) by weighed sodium carboxymethylcellulose (CMC-Na) and polyvinyl alcohol (PVA), appropriate purified water is added to impregnate abundant
It after swelling, sets and is dissolved by heating in 85-90 DEG C of water-bath, avoid stirring, dissolve it naturally completely, obtain film slurry, cooling is spare；
(3) by weighed tetracaine hydrochloride, gentamicin sulphate, the suitable purified water ultrasonic dissolution of hydrocortisone,
Obtain medical fluid；
(4) medical fluid that weighed glycerol, step (3) obtain is mixed with the film slurry that step (2) obtains, remaining purifying is added
Water is stirred evenly using FLUKO FA25 high-shearing dispersion emulsifying machine revolving speed 20000rpm, sets in 60 DEG C of water and keep the temperature de-bubbled, obtain
To medicine slurry；
(5) obtained medicine slurry is placed in electronic plastic film mulch device, thickness needed for adjusting film, plastic film mulch spontaneously dries, and takes off
Film, divides cut-parts, and every hydrochloric totokaine 6mg is dispensed after sterilizing.
The preparation of 3 compound hydrochloric acid totokaine film of embodiment
The following steps are included:
(1) parts by weight as described below weigh respectively tetracaine hydrochloride, gentamicin sulphate, hydrocortisone,
Sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water:
0.3 parts by weight of tetracaine hydrochloride, 0.3 parts by weight of gentamicin sulphate, 0.3 parts by weight of hydrocortisone, carboxymethyl
2 parts by weight of sodium cellulosate (CMC-Na), 5 parts by weight of polyvinyl alcohol (PVA), 4 parts by weight of glycerol, 70 parts by weight of purified water.
(2) by weighed sodium carboxymethylcellulose (CMC-Na) and polyvinyl alcohol (PVA), appropriate purified water is added to impregnate abundant
It after swelling, sets and is dissolved by heating in 85-90 DEG C of water-bath, avoid stirring, dissolve it naturally completely, obtain film slurry, cooling is spare；
(3) by weighed tetracaine hydrochloride, gentamicin sulphate, the suitable purified water ultrasonic dissolution of hydrocortisone,
Obtain medical fluid；
(4) medical fluid that weighed glycerol, step (3) obtain is mixed with the film slurry that step (2) obtains, remaining purifying is added
Water is stirred evenly using FLUKO FA25 high-shearing dispersion emulsifying machine revolving speed 25000rpm, sets in 60 DEG C of water and keep the temperature de-bubbled, obtain
To medicine slurry；
(5) obtained medicine slurry is placed in electronic plastic film mulch device, thickness needed for adjusting film, plastic film mulch spontaneously dries, and takes off
Film, divides cut-parts, and every hydrochloric totokaine 6mg is dispensed after sterilizing.
The screening of 1 optimum formula of experimental example
One, experimental method:
1, the PVA and CMC-Na for taking recipe quantity add appropriate purified water to impregnate sufficiently swelling, are placed in 85-90 DEG C of water-bath and add
It is spare to obtain film slurry to clarifying for heat.
2, the tetracaine hydrochloride of recipe quantity, gentamicin sulphate, hydrocortisone, molten with suitable purified water ultrasound is taken
Solution, obtains medical fluid.
3, the glycerol of recipe quantity is taken, then medical fluid is mixed with above-mentioned film slurry, remaining purified water is added, using FLUKO FA25
High-shearing dispersion emulsifying machine revolving speed 25000rpm is stirred evenly, and is set in 60 DEG C of water and is kept the temperature de-bubbled, obtains medicine slurry；
4, obtained medicine slurry being placed in electronic plastic film mulch device, thickness needed for adjusting film, plastic film mulch spontaneously dries, demoulding,
Divide cut-parts, every hydrochloric totokaine 6mg.
Two, the optimization of film prescription
1, Orthogonal Experiment and Design
On the basis of single factor exploration, to 3 principal elements for influencing film quality, using the orthogonal of 3 factor, 3 level
Design is optimized, and experimental factor and level are shown in Table 1, and wherein A factor is the mass ratio of PVA and purified water, and B factor is CMC-
The mass ratio of Na and purified water, C factor are the mass ratio of glycerol and purified water.
With ocular estimate score (film forming, uniformity and flexibility), the release of oral cavity residence time and 60min
(F60min) it is index, prescription is optimized.Orthogonal test scheme is shown in Table 2.
1 experimental factor water-glass of table
2 L9 (3 of table4) orthogonal test scheme
2, ocular estimate
Film forming: full marks 10 divide, weight coefficient 0.3.The extent of deterioration of the complexity and medicine slurry of investigating plastic film mulch (passes through
Machine residual quantity reflects), easier plastic film mulch, loss are fewer, and score is higher.
Uniformity: full marks 10 divide, weight coefficient 0.4.Investigating film has whether bubble-free and thickness uniformly (pass through difference
The thickness in site reflects), bubble less, difference in thickness it is smaller, score higher
Flexibility: full marks 10 divide, weight coefficient 0.3.Investigate the pliability of film and the ultimate strength of stretch-proof load
(being reflected by the maximum load of universal testing machine, elongation at break).
Appearance comprehensive score the results are shown in Table 3.
3 ocular estimate result of table
3, the residence time
To investigate this index, 18 people of volunteer is selected, wherein 9 people women of male, 9 people, be that body and oral cavity are strong
Kang Zhe is divided into 9 groups, numbers, every group 1 male 1 female.Medicine film made from 9 prescriptions is affixed in its oral cavity of subject of corresponding group and is appointed
It anticipates side, fasting for solids and liquids in test, record medicine film all dissolution or disappears duration in medicine-feeding part, calculates average
Value.It the results are shown in Table 4, the results of analysis of variance is shown in Table 5.
4, the measurement of release
Release is measured using slurry dish method.Stripping rotor is added in artificial saliva, medicine film (every 3cm × 4cm) sandwiches net dish,
Net dish is placed in beaker lower part again, and parallel with the slurry bottom surfaces of revolution, adjusting temperature is 37 ± 0.5 DEG C, revolving speed 50rmin-1,
60min sampling, is compared with blank film, and titration surveys the amount of tetracaine hydrochloride, calculates the release of tetracaine hydrochloride.As a result see
Table 4.The results of analysis of variance is shown in Table 5.
Table 4L9 (34) orthogonal experiments
5 orthogonal experiments variance analysis of table
By table 4 and table 5 it is found that the mass ratio of PVA and water is influence film appearance and the residence time in oral cavity it is main
Factor, when the ratio is 10:100, the indices of film appearance are good.The mass ratio of glycerol and water is to influence film appearance
With the secondary cause of the residence time in oral cavity.The principal element for influencing film release is the mass ratio of PVA and water, when the ratio
When less than 10:100, release of the film in 60min is greater than 75%.It is A2B2C2 by the optimization formulation that orthogonal design determines.
Claims (10)
1. a kind of compound hydrochloric acid totokaine film, which is characterized in that the compound hydrochloric acid totokaine film is by tetracaine hydrochloride, sulfuric acid
Gentamicin, hydrocortisone, sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water are made.
2. compound hydrochloric acid totokaine film as described in claim 1, which is characterized in that the parts by weight of each raw material are as follows: hydrochloric acid fourth
Cacaine 0.3-0.5 parts by weight, gentamicin sulphate 0.1-0.3 parts by weight, hydrocortisone 0.1-0.3 parts by weight, carboxymethyl are fine
Tie up plain sodium (CMC-Na) 0.5-2 parts by weight, polyvinyl alcohol (PVA) 5-15 parts by weight, glycerol 1-4 parts by weight, purified water 70-90 weight
Measure part.
3. compound hydrochloric acid totokaine film as described in claim 1, which is characterized in that the mass ratio of polyvinyl alcohol and purified water
The mass ratio 5:100 of the mass ratio 2:100 of 10:100, sodium carboxymethylcellulose and purified water, glycerol and purified water.
4. compound hydrochloric acid totokaine film as described in claim 1, which is characterized in that the parts by weight of each raw material are as follows: hydrochloric acid fourth
0.4 parts by weight of cacaine, 0.2 parts by weight of gentamicin sulphate, 0.2 parts by weight of hydrocortisone, sodium carboxymethylcellulose (CMC-
Na) 1.6 parts by weight, 8 parts by weight of polyvinyl alcohol (PVA), 4 parts by weight of glycerol, 80 parts by weight of purified water.
5. a kind of method for preparing compound hydrochloric acid totokaine film according to any one of claims 1-4, which is characterized in that including
Following steps:
(1) tetracaine hydrochloride, gentamicin sulphate, hydrogen are weighed respectively according to the described in any item parts by weight of claim 1-4
Change cortisone, sodium carboxymethylcellulose (CMC-Na), polyvinyl alcohol (PVA), glycerol and purified water；
(2) by weighed sodium carboxymethylcellulose (CMC-Na) and polyvinyl alcohol (PVA), appropriate purified water is added to impregnate sufficiently swelling
Afterwards, it sets in water-bath and dissolves by heating, avoid stirring, dissolve it naturally completely, obtain film slurry, cooling is spare；
(3) it by weighed tetracaine hydrochloride, gentamicin sulphate, the suitable purified water ultrasonic dissolution of hydrocortisone, obtains
Medical fluid；
(4) medical fluid that weighed glycerol, step (3) obtain is mixed with the film slurry that step (2) obtains, remaining purified water is added,
It stirs evenly, sets in 60 DEG C of water and keep the temperature de-bubbled, obtain medicine slurry；
(5) medicine slurry for obtaining step (4) is placed in electronic plastic film mulch device, thickness needed for adjusting film, and plastic film mulch spontaneously dries,
Demoulding is divided cut-parts, is dispensed after sterilizing.
6. method as claimed in claim 5, which is characterized in that the temperature of water-bath is 85-90 DEG C in step (2).
7. method as claimed in claim 5, which is characterized in that use FLUKO FA25 high cut disperse emulsification in step (4)
Machine revolving speed 10000-28000rpm is stirred evenly.
8. method as claimed in claim 5, which is characterized in that every hydrochloric totokaine 6mg.
9. application of the described in any item compound hydrochloric acid totokaine films of claim 1-4 in preparation treatment stomatocace medicine.
10. application as claimed in claim 9, which is characterized in that the drug is pelliculae pro cavo oris.
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| CN201910157444.9A CN109953984A (en) | 2019-03-01 | 2019-03-01 | A kind of compound hydrochloric acid totokaine film and preparation method thereof |
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| CN201910157444.9A CN109953984A (en) | 2019-03-01 | 2019-03-01 | A kind of compound hydrochloric acid totokaine film and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003015748A2 (en) * | 2001-08-16 | 2003-02-27 | Access Pharmaceuticals, Inc. | Mucoadhesive erodible drug delivery device for controlled administration of pharmaceuticals and other active compounds |
| CN101278948A (en) * | 2008-05-23 | 2008-10-08 | 大连大学 | Biological medical membrane and method of preparing the same |
| CN101703775A (en) * | 2009-08-05 | 2010-05-12 | 厦门金日制药有限公司 | Medicinal composition for treating canker sore and local infection of body surface and reducing inflammation, product and application thereof |
| CN106344604B (en) * | 2016-08-28 | 2018-12-14 | 福州海王金象中药制药有限公司 | Compound gentamicin film preparation technique |
-
2019
- 2019-03-01 CN CN201910157444.9A patent/CN109953984A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003015748A2 (en) * | 2001-08-16 | 2003-02-27 | Access Pharmaceuticals, Inc. | Mucoadhesive erodible drug delivery device for controlled administration of pharmaceuticals and other active compounds |
| CN101278948A (en) * | 2008-05-23 | 2008-10-08 | 大连大学 | Biological medical membrane and method of preparing the same |
| CN101703775A (en) * | 2009-08-05 | 2010-05-12 | 厦门金日制药有限公司 | Medicinal composition for treating canker sore and local infection of body surface and reducing inflammation, product and application thereof |
| CN106344604B (en) * | 2016-08-28 | 2018-12-14 | 福州海王金象中药制药有限公司 | Compound gentamicin film preparation technique |
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