CN109453141A - A kind of preparation method for treating chronic pharyngitis film - Google Patents
A kind of preparation method for treating chronic pharyngitis film Download PDFInfo
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- CN109453141A CN109453141A CN201811410239.0A CN201811410239A CN109453141A CN 109453141 A CN109453141 A CN 109453141A CN 201811410239 A CN201811410239 A CN 201811410239A CN 109453141 A CN109453141 A CN 109453141A
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- rubber cement
- chronic pharyngitis
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- 201000007100 Pharyngitis Diseases 0.000 title claims abstract description 19
- 238000002360 preparation method Methods 0.000 title claims description 23
- 239000003814 drug Substances 0.000 claims abstract description 67
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims abstract description 22
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 22
- 229940041616 menthol Drugs 0.000 claims abstract description 22
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 16
- 239000004014 plasticizer Substances 0.000 claims abstract description 12
- 239000003086 colorant Substances 0.000 claims abstract description 9
- 238000003756 stirring Methods 0.000 claims description 43
- 239000004568 cement Substances 0.000 claims description 42
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 32
- 238000010345 tape casting Methods 0.000 claims description 26
- 239000000463 material Substances 0.000 claims description 19
- 239000012141 concentrate Substances 0.000 claims description 17
- 239000000706 filtrate Substances 0.000 claims description 17
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 17
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 15
- 230000001476 alcoholic effect Effects 0.000 claims description 15
- 238000010438 heat treatment Methods 0.000 claims description 15
- 239000002904 solvent Substances 0.000 claims description 15
- 239000012467 final product Substances 0.000 claims description 13
- 230000001954 sterilising effect Effects 0.000 claims description 13
- 239000007788 liquid Substances 0.000 claims description 11
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 5
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 229920002472 Starch Polymers 0.000 claims description 5
- 229960000913 crospovidone Drugs 0.000 claims description 5
- 229920001223 polyethylene glycol Polymers 0.000 claims description 5
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 5
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 5
- 239000008107 starch Substances 0.000 claims description 5
- 235000019698 starch Nutrition 0.000 claims description 5
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims description 2
- 239000012676 herbal extract Substances 0.000 claims description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 244000246386 Mentha pulegium Species 0.000 abstract description 15
- 235000016257 Mentha pulegium Nutrition 0.000 abstract description 15
- 235000004357 Mentha x piperita Nutrition 0.000 abstract description 15
- 235000001050 hortel pimenta Nutrition 0.000 abstract description 15
- PFTAWBLQPZVEMU-DZGCQCFKSA-N (+)-catechin Chemical compound C1([C@H]2OC3=CC(O)=CC(O)=C3C[C@@H]2O)=CC=C(O)C(O)=C1 PFTAWBLQPZVEMU-DZGCQCFKSA-N 0.000 abstract description 14
- 235000006226 Areca catechu Nutrition 0.000 abstract description 14
- 244000080767 Areca catechu Species 0.000 abstract description 14
- 241000208671 Campanulaceae Species 0.000 abstract description 14
- 241000931705 Cicada Species 0.000 abstract description 14
- 241001547125 Fritillaria thunbergii Species 0.000 abstract description 14
- 240000004980 Rheum officinale Species 0.000 abstract description 14
- 235000008081 Rheum officinale Nutrition 0.000 abstract description 14
- 235000021282 Sterculia Nutrition 0.000 abstract description 14
- 229940059107 sterculia Drugs 0.000 abstract description 14
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- 229940079593 drug Drugs 0.000 abstract description 8
- 239000000284 extract Substances 0.000 abstract description 8
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- 239000000126 substance Substances 0.000 abstract 2
- 240000001058 Sterculia urens Species 0.000 abstract 1
- 238000013019 agitation Methods 0.000 description 17
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- 241000934878 Sterculia Species 0.000 description 13
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- 239000002002 slurry Substances 0.000 description 10
- 208000024891 symptom Diseases 0.000 description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- VNFPBHJOKIVQEB-UHFFFAOYSA-N clotrimazole Chemical compound ClC1=CC=CC=C1C(N1C=NC=C1)(C=1C=CC=CC=1)C1=CC=CC=C1 VNFPBHJOKIVQEB-UHFFFAOYSA-N 0.000 description 6
- 229940063175 lotrimin Drugs 0.000 description 6
- 238000012216 screening Methods 0.000 description 6
- 239000000470 constituent Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 239000008186 active pharmaceutical agent Substances 0.000 description 4
- 230000028327 secretion Effects 0.000 description 4
- 206010011224 Cough Diseases 0.000 description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 235000019441 ethanol Nutrition 0.000 description 3
- 210000004400 mucous membrane Anatomy 0.000 description 3
- 210000003800 pharynx Anatomy 0.000 description 3
- 239000008279 sol Substances 0.000 description 3
- 239000000758 substrate Substances 0.000 description 3
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 2
- 206010036790 Productive cough Diseases 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 235000019658 bitter taste Nutrition 0.000 description 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 2
- 208000037976 chronic inflammation Diseases 0.000 description 2
- 230000006020 chronic inflammation Effects 0.000 description 2
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- 239000000835 fiber Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000007937 lozenge Substances 0.000 description 2
- 235000013372 meat Nutrition 0.000 description 2
- 235000015091 medicinal tea Nutrition 0.000 description 2
- 210000004379 membrane Anatomy 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- 239000006187 pill Substances 0.000 description 2
- 230000035807 sensation Effects 0.000 description 2
- 235000019615 sensations Nutrition 0.000 description 2
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 206010070245 Foreign body Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 206010062717 Increased upper airway secretion Diseases 0.000 description 1
- 208000001705 Mouth breathing Diseases 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 206010068319 Oropharyngeal pain Diseases 0.000 description 1
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 1
- IUKLSMSEHKDIIP-BZMYINFQSA-N Verticine Chemical compound C([C@@H]1[C@@H](O)C[C@H]2[C@@H]3CC[C@@H]4[C@]5(C)O)[C@@H](O)CC[C@]1(C)[C@H]2C[C@H]3[C@@H]4CN1[C@H]5CC[C@H](C)C1 IUKLSMSEHKDIIP-BZMYINFQSA-N 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 238000007872 degassing Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 208000017574 dry cough Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 210000003563 lymphoid tissue Anatomy 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 210000001989 nasopharynx Anatomy 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 210000001331 nose Anatomy 0.000 description 1
- 229940037201 oris Drugs 0.000 description 1
- 210000003695 paranasal sinus Anatomy 0.000 description 1
- 238000003359 percent control normalization Methods 0.000 description 1
- IUKLSMSEHKDIIP-UHFFFAOYSA-N petine Natural products CC1(O)C2CCC3C4CC(O)C5CC(O)CCC5(C)C4CC3C2CN2C1CCC(C)C2 IUKLSMSEHKDIIP-UHFFFAOYSA-N 0.000 description 1
- 208000026435 phlegm Diseases 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
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- A61K35/64—Insects, e.g. bees, wasps or fleas
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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- 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
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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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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/04—Drugs for disorders of the respiratory system for throat disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction 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 or decoction
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- A—HUMAN NECESSITIES
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- A61K2236/00—Isolation 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
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- Health & Medical Sciences (AREA)
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Abstract
The present invention relates to a kind of for treating the Huang Shi sound oral film of chronic pharyngitis, it is mixed with by the excipient substance that the sterculia seed, campanulaceae, cicada slough, Radix Glycyrrhizae, Fructus Forsythiae, rheum officinale, Rhizoma Chuanxiong, terminalia flesh, fritillaria thunbergii, peppermint, catechu, menthol are prepared into drug extract and prepare film forming agent, wherein the excipient substance includes filmogen, plasticizer, disintegrating agent, colorant, their mass ratio is 1:1-1.5:0.3-0.6:0.06-0.12:0.02-0.05.
Description
Technical field
The present invention relates to traditional Chinese medicine preparation field more particularly to a kind of treat chronic pharyngitis film.
Background technique
Chronic pharyngitis is to swallow mucous membrane, under mucous membrane and the chronic inflammation of lymphoid tissue.Chronic pharyngitis is more common in adult, children
Also it may occur in which.Constitutional symptom is unobvious, based on local symptom.Various chronic pharyngitis symptom is substantially similar and varied,
If pharyngeal discomfort sense, foreign body sensation, pharyngeal secretion are not easy to bring up, pharyngeal gargalesthesia, burn feeling, dry sensation or excitement, can also have
Hypodynia sense.Since pharynx rear wall is usually because of secretion adherency more sticky caused by pharyngeal chronic inflammation, and due to nose, nasal sinus, nasopharynx
Portion's lesion causes night mouth breathing, often occurs irritable cough and nausea when from morning.Since foreign body in pharynx sense can behave as
Frequently swallow.Pharyngeal secretion it is few and be not easy expectoration person often show as habitually dry cough and clear one's throat expectoration movement, if firmly
Pharyngeal mucosa hemorrhage can be caused by coughing or clearing one's throat, and cause band blood in secretion.This disease is common in clinic, and the course of disease is long, symptom
It is easy recurrent exerbation.
" Chinese Pharmacopoeia " version in 2015 discloses Lotrimin Sol Lotrimin, by the sterculia seed, campanulaceae, cicada slough, Radix Glycyrrhizae, Fructus Forsythiae, rheum officinale,
Rhizoma Chuanxiong, terminalia flesh, fritillaria thunbergii, peppermint, catechu, menthol are prepared, have dispelling wind and heat, reducing phlegm and resolving masses, relieving sore-throat open sound it
Effect.Huang Shi sound class medicament, which is mainly pill but also has, currently on the market is prepared into lozenge, medicinal tea.Pill is for children
Dysphagia is also easy to produce with old man patient and is not easy the problems such as taking, lozenge and medicinal tea since the influence of Chinese medicine odor is also not easy to take
With.Therefore need to increase dosage form to meet the needs of different patients.
Drug and the processed manufactured film-like preparation of suitable filmogen include: for oral or mucous membrane, pelliculae pro cavo oris
Orodispersible film, medicine membrane of oral cavity, sublingual film, oral film, oral instant membrane, oral film, the molten film of mouth etc.,
But Chinese medicine prepares the Chinese medicine that film forming agent difficulty is more, especially in extract containing bitter ingredient or fibre composition, preparation
Film forming agent is given to take and make troubles.
Summary of the invention
It is an object of the invention to provide a kind of preparation method of film for Huang Shi sound prescription.
The present invention provides a kind of Huang Shi sound film, the film has the medicinal material in Huang Shi sound prescription by extracting
It is prepared into Huang Shi sound film together to Chinese medical extract, using extract as drug ingedient and filmogen.
Fibre composition to make Huang Shi sound film of the present invention avoid the bitterness in Chinese medical extract and wherein contain causes to take
Medicine is difficult, and the present invention finds a kind of suitable preparation method after study, solves the problems of the prior art.
For this purpose, the present invention provides a kind of Huang Shi sound films, by the sterculia seed, campanulaceae, cicada slough, Radix Glycyrrhizae, Fructus Forsythiae, rheum officinale, river
The Chinese medicines such as rhizome of chuanxiong, terminalia flesh, fritillaria thunbergii, peppermint, catechu, menthol are prepared into active pharmaceutical ingredient, further increase with filmogen
Modeling agent, disintegrating agent, colorant etc. are prepared by mixing into Huang Shi sound film, and wherein filmogen is polyvinyl alcohol (PVA), colorant
For titanium dioxide (TiO2), herbal extract, filmogen, plasticizer, disintegrating agent, colorant mass ratio be 1:1-1.5:
0.3-0.6:0.06-0.12:0.02-0.05.
Wherein, plasticizer is one or more of sorbierite, polyethylene glycol (PEG) and glycerol.
Wherein, disintegrating agent is one or more of sodium carboxymethylcellulose (CMC), pre-paying starch, crospovidone.
Wherein, the preparation method of the active pharmaceutical ingredient, be it is improved, avoid bitter taste and cellulosic
In the presence of, preparation method of the invention the following steps are included:
(1) add suitable quantity of water to decoct secondary, each certain time the 11 taste medicinal materials for removing menthol in Huang Shi sound prescription, close
And decocting liquid, it staticly settles, filters, filtrate is concentrated into right amount；
(2) heating stirring is to being completely dissolved after mixing PVA with water, sequentially adds plasticizer, disintegrating agent, in above-mentioned (1)
Concentrate, colorant, stir evenly and rubber cement solution are made；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Further, heating temperature is 40 DEG C -60 DEG C in step (1).
Further, in step (2), alcoholic solvent is the ethanol water of 20%-80% mass fraction.
It is currently preferred formula and the preparation method is as follows:
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong, scold
40 part of 11 20 parts of sub- meat, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6-10 times to measure, and water decoction is secondary, and each 1-2 is small
When, collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring is to being completely dissolved after taking 12-15gPVA to mix with water, sequentially add PEG0.6-1.0g, CMC3-5g, on
State concentrate 8-12g, TIO in (1)20.2-0.5g.Rubber cement solution is uniformly made in magnetic agitation at 40 DEG C -60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, it is molten that rubber cement in above-mentioned steps (3) is added on the medicine film layer
Liquid continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
The present invention be most preferably formulated and the preparation method is as follows:
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong, scold
It is secondary that 40 part of 11 20 parts of sub- meat, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time, closes
And decocting liquid, it staticly settles, filters, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring is to being completely dissolved after taking 15gPVA to mix with water, sequentially adds PEG0.8g, CMC5g, dense in above-mentioned (1)
Contracting liquid 10g, TIO20.3g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, it is molten that rubber cement in above-mentioned steps (3) is added on the medicine film layer
Liquid continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Formula and preparation method of the invention is obtained by screening, and screening process is as follows:
The preparation of active pharmaceutical ingredient is screened:
6 times of amount water are added to decoct 11 taste medicinal materials in Huang Shi sound prescription in addition to menthol secondary, 1 hour every time, collecting decoction,
It staticly settles, filters, filtrate is concentrated into appropriate (relative density 1.35-1.40), and concentrate is active constituent 1；
Add 8 times of amount water to decoct 11 taste medicinal materials in Huang Shi sound prescription in addition to menthol secondary, 1.5 hours every time, merges and decoct
Liquid staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40), and concentrate is active constituent 2；
Add 10 times of amount water to decoct 11 taste medicinal materials in Huang Shi sound prescription in addition to menthol secondary, 2 hours every time, merges and decoct
Liquid staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40), and concentrate is active constituent 3；
Add 6 times of amount water to decoct 11 taste medicinal materials in Huang Shi sound prescription in addition to menthol secondary, 1.5 hours every time, merges and decoct
Liquid staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40), and concentrate is active constituent 4；
The assay that above-mentioned concentrate is carried out to peimine and Peininine, determines the preparation method of active pharmaceutical ingredient,
Assay the results are shown in Table 1.
The screening of filmogen:
Filmogen being dissolved in the ethyl alcohol of certain mass score, magnetic agitation dissolves under certain temperature, solution left standstill is deaerated,
According to certain specification film on substrate, dry, cooling, demoulding carries out disintegration time test, and test result is shown in Table 2.
The screening of plasticizer:
Filmogen is dissolved in the ethyl alcohol of certain mass score, magnetic agitation dissolves under certain temperature, in the molten of stirring and dissolving
Plasticizer is added in liquid, continues magnetic agitation dissolution, stands degassing, according to certain specification film on substrate, drying is cold
But, demoulding, carries out disintegration time and elasticity modulus test, and test result is shown in Table 3.
The screening of disintegrating agent:
Filmogen is dissolved in the ethyl alcohol of certain mass score, magnetic agitation dissolves under certain temperature, in the molten of stirring and dissolving
Plasticizer is added in liquid, continues magnetic agitation dissolution, adds disintegrating agent, continues magnetic agitation dissolution, stands de-
Gas, according to certain specification film on substrate, dry, cooling, demoulding carries out disintegration time test, and test result is shown in Table 4.
The screening of colorant:
Since effective component extracts color is deeper in the prescription, and TIO2Covering power is high, stablizes, good weatherability, therefore preferably
For the colorant of this preparation.
The invention has the beneficial effects that:
Menthol in the present invention is placed on except remaining Chinese medicine film layer, can cover the bad smell of Chinese medical extract, and
Have peppermint fragrance, improve mouthfeel, can increase patient medication comfort, and Chinese medical extract be all add water to cook and
At therefore drug ingedient is all water soluble ingredient, into can quickly dissolve in patient mouthful.
Film of the invention takes simplicity, is especially suitable for children and the elderly takes, and dissolves out and absorb very fast.
Preparation method simple process of the invention, is conducive to large-scale industrial production.
Specific embodiment
Embodiment 1
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring is to being completely dissolved after taking 12gPVA to mix with water, sequentially adds sorbierite 0.6g, CMC4g, above-mentioned
(1) concentrate 10g, TIO in20.3g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 2
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring is to being completely dissolved after taking 13gPVA to mix with water, sequentially add PEG0.8g, pre-paying starch 5g,
Concentrate 10g, TIO in above-mentioned (1)20.4g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 3
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring sequentially adds glycerol 1.0g, crospovidone to being completely dissolved after taking 14gPVA to mix with water
Concentrate 10g, TIO in 6g, above-mentioned (1)20.2g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 4
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring sequentially adds PEG0.7g, CMC3g, above-mentioned (1) to being completely dissolved after taking 15gPVA to mix with water
Middle concentrate 10g, TIO20.5g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 5
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring sequentially adds sorbierite 0.9g, pre-paying starch to being completely dissolved after taking 12gPVA to mix with water
Concentrate 10g, TIO in 4g, above-mentioned (1)20.3g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 6
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring sequentially adds glycerol 1.1g, crospovidone to being completely dissolved after taking 14gPVA to mix with water
Concentrate 10g, TIO in 5g, above-mentioned (1)20.4g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 7
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring sequentially adds PEG0.8g, CMC5g, above-mentioned (1) to being completely dissolved after taking 15gPVA to mix with water
Middle concentrate 10g, TIO20.3g.Rubber cement solution is uniformly made in magnetic agitation at 60 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 8
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring sequentially adds PEG0.8g, CMC5g, above-mentioned (1) to being completely dissolved after taking 15gPVA to mix with water
Middle concentrate 10g, TIO20.3g.Rubber cement solution is uniformly made in magnetic agitation at 50 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Embodiment 9
(1) by 5 parts of the sterculia seed, 50 parts of campanulaceae, 20 parts of cicada slough, 50 parts of Radix Glycyrrhizae, 50 parts of Fructus Forsythiae, 20 parts of rheum officinale, 20 parts of Rhizoma Chuanxiong,
It is secondary that 40 part of 11 20 parts of terminalia flesh, 60 parts of fritillaria thunbergii, 40 parts of peppermint, catechu taste medicinal material add 6 times of amount water to decoct, and 1.5 hours every time,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into appropriate (relative density 1.35-1.40)；
(2) heating stirring sequentially adds PEG0.8g, CMC5g, above-mentioned (1) to being completely dissolved after taking 15gPVA to mix with water
Middle concentrate 10g, TIO20.3g.Rubber cement solution is uniformly made in magnetic agitation at 40 DEG C；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, glue in above-mentioned steps (3) is added on the medicine film layer
Slurry solution continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
By obtained medicine film cut, sterilizing to get.
Reference examples
It is treated using Lotrimin Sol Lotrimin.
Blank group
Any method is not used to treat
Beneficial effects of the present invention are further illustrated below by test:
Test method: each embodiment select respectively 7-50 years old patients with chronic pharyngitis 30 tested, men and women is fifty-fifty, takes
Huang Shi sound film (area 1.0cm obtained by embodiment 1-92), reference examples Lotrimin Sol Lotrimin, daily in the morning, afternoon and evening respectively use one
Secondary, film uses 2 every time.Blank group does not take any drug.
Test is checked after 7 days, is counted effective, is improved, invalid sufferer number, calculates its total effective rate.Efficacy determination
Standard: 1. effective: without obvious pharyngitis symptom, to feel pharyngeal comfortable；2. improving: still having pharyngitis symptom, but than being delayed before medication
Solution；3. invalid: symptom is not improved.
Test result is shown in Table 5.
Table 1: the result of active constituent difference preparation method
Table 2: the disintegration time limited result of the filmogen of different quality containing
| PVA mass (g) | 12 | 13 | 14 | 15 |
| Disintegration time limited (sec) | 36 | 38 | 39 | 39 |
Table 3: different plasticizer disintegration time limiteds and elasticity modulus result
| Plasticizer | Sorbierite | PEG | Glycerol |
| Disintegration time limited (sec) | 46 | 43 | 45 |
| Elasticity modulus (MPa) | 36 | 40 | 35 |
Table 4: the disintegration time limited result of different disintegrating agents
| Disintegrating agent | Pre-paying starch | Crospovidone | CMC |
| Disintegration time limited (sec) | 38 | 35 | 30 |
Table 5: clinical comparison test result of the sample to chronic pharyngitis
| Patient's (example) | It is effective | It improves | In vain | Total effective rate | |
| Embodiment 1 | 30 | 22 | 7 | 1 | 96.7% |
| Embodiment 2 | 30 | 23 | 6 | 1 | 96.7% |
| Embodiment 3 | 30 | 21 | 8 | 1 | 96.7% |
| Embodiment 4 | 30 | 24 | 5 | 1 | 96.7% |
| Embodiment 5 | 30 | 22 | 7 | 1 | 96.7% |
| Embodiment 6 | 30 | 21 | 8 | 1 | 96.7% |
| Embodiment 7 | 30 | 26 | 4 | 0 | 100% |
| Embodiment 8 | 30 | 25 | 5 | 0 | 100% |
| Embodiment 9 | 30 | 24 | 6 | 0 | 100% |
| Control group | 30 | 25 | 5 | 1 | 96.7% |
| Blank group | 30 | 0 | 0 | 30 | 0% |
By the test result of embodiment 1-9 it is found that Huang Shi sound film of the invention is non-to the therapeutic effect of chronic pharyngitis
Chang Xianzhu.
Above-described embodiment is the preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto, this technology
The several improvements and modifications that the technical staff in field carries out according to the technique and scheme of the present invention also should be regarded as protection model of the invention
It encloses.
Claims (6)
1. a kind of preparation method for treating chronic pharyngitis film, which comprises the following steps:
(1) add 6 times of amount water decoctions secondary Huang Shi sound prescription Chinese medicinal materials, 1.5 hours every time, collecting decoction staticly settled, filter
It crosses, filtrate is concentrated into right amount；
(2) heating stirring is to being completely dissolved after taking filmogen to mix with water, sequentially adds plasticizer, disintegrating agent and above-mentioned (1)
Middle concentrate, colorant.It stirs evenly and rubber cement solution is made；
(3) it separately takes PVA to be added in alcoholic solvent, menthol is added while stirring, stirs evenly and rubber cement solution is made；
(4) it takes rubber cement the tape casting obtained by step (2) that medicine film layer is made, it is molten that rubber cement in above-mentioned steps (3) is added on the medicine film layer
Liquid continues that medicine film is made using the tape casting, spontaneously dries to obtain the final product；
(5) by obtained medicine film cut, sterilizing to get.
2. the preparation method for the treatment of chronic pharyngitis film as described in claim 1, it is characterised in that: herbal extract, film forming
Material, plasticizer, disintegrating agent, colorant mass ratio be 1:1-1.5:0.3-0.6:0.06-0.12:0.02-0.05.
3. as described in claim 1 treatment chronic pharyngitis film preparation method, it is characterised in that: plasticizer be sorbierite,
One or more of polyethylene glycol (PEG) and glycerol.
4. the preparation method for the treatment of chronic pharyngitis film as described in claim 1, it is characterised in that: disintegrating agent is that carboxymethyl is fine
Tie up one or more of plain sodium (CMC), pre-paying starch, crospovidone.
5. the preparation method for the treatment of chronic pharyngitis film as described in claim 1, it is characterised in that: alcoholic solvent 20%-
The ethanol water of 80% mass fraction.
6. the preparation method for the treatment of chronic pharyngitis film as described in claim 1, it is characterised in that: the heating in step (1)
Temperature is 40 DEG C -60 DEG C.
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Address after: 214028 Changjiang South Road, new Wu District, Wuxi, Jiangsu Province, No. 12 Applicant after: Wuxi Jiyu Shanhe Pharmaceutical Co., Ltd Address before: 214028 No. 12 Changjiang South Road, New District, Jiangsu, Wuxi Applicant before: WUXI JIMIN KEXIN SHANHE PHARMACEUTICAL Co.,Ltd. |
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