CN102824367A - Yin-nourishing granulation-promoting membrane and preparation method thereof - Google Patents
Yin-nourishing granulation-promoting membrane and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of medicine, and relates to a traditional Chinese medicine oral membrane for clearing heat, removing toxicity, relieving pain, and promoting granulation, and a preparation method thereof. The traditional Chinese medicine oral membrane is prepared by the following raw materials of realgar, artificial calculus bovis, indigo naturalis, borneol, phellodendron, gentian, licorice, polyvinyl alcohol, carboxymethylcellulose sodium, and gelatin. Through forming technology research, pharmacodynamic tests show that the yin-nourishing granulation-promoting membrane of the invention has significant effect, can promote healing of ulcer surfaces, improve tolerance of human body to pain threshold. The invention provides a new traditional Chinese medicine preparation for the treatment of oral inflammatory symptoms such as stomatitis, oral ulcer, and the like.
Description
Technical field
The present invention relates to a kind of Chinese medicinal composition preparation, be meant a kind of heat-clearing and toxic substances removing that has especially, the nourishing yin and promoting granulation film of pain relieving promoting muscle growth functions.
Background technology
Oral ulcer is that clinically commonly encountered diseases, sickness rate is higher.Especially be more common in the women, due to illness gesture is touching, brings very big misery to the patient, is seriously perplexing people's life, work.Nourishing yin shengjisan is the preparation that the applicant uses at present, in long-term clinical, has obtained good curative effect.Because the restriction of preparation technique and level, there are some problems in nourishing yin shengjisan, receives washing away of saliva of buccal cavity as there being medicine behind the containing powder; Be difficult for the firm attachment affected part, be prone to scatter with saliva, short in the lesions position holdup time; So that local drug concentration is low, and action time is short, and ulcer healing is slow; Use inconvenience, not only affected the treatment but also pollute shortcoming such as oral cavity.Requirement apart from modern oral preparation still has certain gap, therefore, is necessary keeping under the former effective in cure prerequisite, carries out the dosage form innovation.
Summary of the invention
The object of the present invention is to provide a kind of nourishing yin and promoting granulation film pharmaceutical composition.Have heat-clearing and toxic substances removing, the pain relieving promoting muscle growth functions is mainly used in stomatitis and oral ulcer, and has no side effect, the method for making science.
The method for preparing that also has a purpose to be to provide a kind of nourishing yin and promoting granulation film of the present invention.
For realizing above-mentioned purpose, the technical scheme that the present invention takes is: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 10～15 weight portions, artificial Calculus Bovis's 2.5～7.5 weight portions, Borneolum Syntheticum 10～15 weight portions;
Polyvinyl alcohol 35～40 weight portions, sodium carboxymethyl cellulose 5～10 weight portions, gelatin 95～100 weight portions, benzene
Sodium formate 1.5～2 weight portions, glycerol 150～200 weight portions, tween 80 35～40 weight portions.
Described nourishing yin and promoting granulation film pharmaceutical composition also includes following raw materials in weight portion:
Indigo Naturalis 10～15 weight portions.
Described nourishing yin and promoting granulation film pharmaceutical composition also includes following raw materials in weight portion:
Cortex Phellodendri 2.5～7.5 weight portions, Radix Gentianae 2.5～7.5 weight portions.
Described nourishing yin and promoting granulation film pharmaceutical composition also includes following raw materials in weight portion:
Radix Glycyrrhizae 10～15 weight portions.
A kind of method for preparing of nourishing yin and promoting granulation film, its main feature is may further comprise the steps:
(1) pulverize: cross 100～120 mesh sieves by the weight portion proportioning of claim after with Realgar, Calculus Bovis, Indigo Naturalis medicine pulverize separately, subsequent use;
(3) enclose: Borneolum Syntheticum is being used beta-cyclodextrin inclusion compound with anhydrous alcohol solution, and inclusion method is a Borneolum Syntheticum and the ratio of beta-schardinger dextrin-is 0.5～1:3～6, beta-schardinger dextrin-: H
2O (g:mL) is 0.5～1:6～12, and the enclose temperature is 45～50 ℃, enclose 30～35 minutes;
(4) film material preparation: by the weight portion proportioning weighing polyvinyl alcohol of claim, sodium carboxymethyl cellulose, gelatin add 10～15 times of amount distilled water swellings respectively and spend the night, and heating dissolving fully in 90～95 ℃ of water-baths is subsequent use;
(5) film-forming method: with Cortex Phellodendri, Radix Gentianae, Radix Glycyrrhizae extract clear paste and Realgar, Calculus Bovis, Indigo Naturalis, Borneolum Syntheticum clathrate by the weight portion proportioning of claim, sodium benzoate, glycerol, tween 80 mix homogeneously mix with film material liquid by the weight portion proportioning of claim; Leave standstill; Liquid to be mixed does not have bubble, bed board, and room temperature is dried; Cut into 1cm * 10cm film bar, packing.
The method for preparing of described nourishing yin and promoting granulation film is characterized in that further comprising the steps of:
(2) extract, be condensed into extractum: Cortex Phellodendri, Radix Gentianae, Radix Glycyrrhizae are added 8～12 times of water gagings respectively or ethanol decocts 2～3 times by the weight portion proportioning of claim 1 to 4; Each 1～2 hour, merge extractive liquid, filtered; Filtrating concentrates; Obtaining concentration is liquor capacity: medical material weight be medicine clear paste or the filtrating of 1:1 to be concentrated into relative density be 1.10～1.12, temperature is 50 ℃ clear paste, and is subsequent use.
Advantage of the present invention is: theoretical according to Chinese medicine, screening free of contamination crude drug is that raw material is processed, and oral is pasted the clothes mode; Reach therapeutical effect, improve level of human health, optimize the human life quality oral ulcer and stomatitis; Remarkable, nontoxic, the good stability of its effect
Nourishing yin shengjisan is developed into the nourishing yin and promoting granulation membrane through form improvement, and medicine membrane of oral cavity can become colloidal sol after water logging, stick to mucomembranous surface, and the release of medicine is lasting in the film; Keep topical remedy's valid density, and make disease damage position obtain mechanical protection, so more can palliate the agonizing sufferings than other administering modes such as buccal tablet, powder, gargarism etc.; Improve curative effect, thereby obtain extensive use both domestic and external, make it to be more conducive to bring into play drug effect through form improvement; More numerous patients accept, and meet the modern medicinal agents requirement, make this famous medicine be able to inherit down to improve constantly; Be numerous patients' service better, reform successfully, will bring glad tidings to the patient like said preparation.This preparation is nontoxic, and is non-stimulated, and high-efficiency and economic, and the easy purposes that is easy to get of prescription is wide.The principle that meets pharmacoeconomics research.In development of the West Regions and medical reform, has the value of clinical application.
Nourishing yin and promoting granulation membrane volume of the present invention is little, dose is little, easy to carry, keep natural characteristic, meet that people in modern is recovered one's original simplicity, the demand of uphold nature.And favorable solubility is easy to absorb, and sealing is preserved, its good stability.Production equipment is simple, and production cost is low, is the bonded product of traditional Chinese medicine and modern technologies; Both embodied the advance of modern pharmaceutical technology; The advantage that has kept traditional powder again not only meets middle medical drugs characteristics but also is suitable for mechanization production, is applicable to that also grass-roots unit produces; And be blackish green joint strip, good looking appearance.
Description of drawings:
Fig. 1 is a preparation process flow chart of the present invention.
The specific embodiment
Below principle of the present invention and characteristic are described, institute gives an actual example and only is used to explain the present invention, is not to be used to limit scope of the present invention.
Embodiment 1: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 10 grams, artificial Calculus Bovis's 2.5 grams, Borneolum Syntheticum 10 grams;
Polyvinyl alcohol 35 grams, sodium carboxymethyl cellulose 5 grams, gelatin 95 grams, sodium benzoate 1.5 grams, glycerol 150 grams, tween 80 35 grams.
Embodiment 2: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 12 grams, artificial Calculus Bovis's 5 grams, Borneolum Syntheticum 12 grams;
Polyvinyl alcohol 37 grams, sodium carboxymethyl cellulose 8 grams, gelatin 98 grams, sodium benzoate 1.7 grams, glycerol 175 grams, tween 80 37 grams.
Embodiment 3: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 15 grams, artificial Calculus Bovis's 7.5 grams, Borneolum Syntheticum 15 grams;
Polyvinyl alcohol 40 grams, sodium carboxymethyl cellulose 10 grams, gelatin 100 grams, sodium benzoate 2 grams, glycerol 200 grams, tween 80 40 grams.
Embodiment 4, the method for preparing of said nourishing yin and promoting granulation film, and its main feature is may further comprise the steps:
(1) pulverize: press embodiment 1 to 3 weight portion proportioning with Realgar, Calculus Bovis medicine pulverize separately after mistake 100 mesh sieves, subsequent use;
(2) enclose: Borneolum Syntheticum is being used beta-cyclodextrin inclusion compound with anhydrous alcohol solution, and inclusion method is a Borneolum Syntheticum and the ratio of beta-schardinger dextrin-is 0.5～1:3～6, beta-schardinger dextrin-: H
2O (g:mL) is 0.5～1:6～12, and the enclose temperature is 45～50 ℃, enclose 30～35 minutes;
(3) film material preparation: press embodiment 1 to 3 weight portion proportioning, weighing polyvinyl alcohol, sodium carboxymethyl cellulose, gelatin add 10～15 times of amount distilled water swellings respectively and spend the night, and heating is dissolved fully in 90～95 ℃ of water-baths, and is subsequent use;
(4) film-forming method: press Realgar, Calculus Bovis, the Borneolum Syntheticum clathrate of embodiment 1 to 3 weight portion proportioning, sodium benzoate, glycerol, tween 80 mix homogeneously mix with the film material liquid of step (3); Leave standstill; Liquid to be mixed does not have bubble, bed board, and room temperature is dried; Cut into 1cm * 10cm film bar, packing.
Compound basis of the present invention is following:
The medicinal reducing the minister-fire in side, the kidney invigorating water, heat clearing and damp drying, the Cortex Phellodendri of eliminating fire and detoxication, 5 with alleviating pain and detumescence, and the article of removing the necrotic tissue and promoting granulation, Calculus Bovis remove the volt fire, Borneolum Syntheticum pulvis refrigerans fire stagnation, reducing swelling and alleviating pain, yin nourishing presses down fire, heat-clearing and toxic substances removing, reducing swelling and alleviating pain, putrefaction-removing granulation-promoting.
Realgar: warm in nature, acrid in the mouth is bitter, and is poisonous, goes into the heart, liver two warps, and main effect is dampness, dispel the wind, detoxifcation, parasite killing.Realgar is a sulfide-based mineral Realgar family Realgar, the main realgar (As that contains
2S
2), its content must not be less than 90%.Realgar has very obvious suppression effect to staphylococcus aureus.In addition; We also study the influence of the phagocytic function of leukocyte and reticuloendothelial system with regard to Realgar; The result shows that Realgar does not have obvious influence to total white blood cells and neutrophil percentage; But ability obvious stimulation non-specific immunity, this inhibitory action that shows Realgar also realizes through the defence capability that improves body except that direct effect.
The artificial Calculus Bovis: Calculus Bovis is sweet, cool, and GUIXIN, Liver Channel have the effect of " cool liver endogenous wind stopping is eliminated phlegm for resuscitation heat-clearing and toxic substances removing ", control the high fever coma, and middle wind-phlegm fan faints from fear and twitches, infantile convulsion, and epilepsy is gone mad, laryngopharynx swelling and pain, aphtha of the mouth and tongue, carbuncle furuncle etc.Modern pharmacological research confirms that Calculus Bovis has antipyretic-antalgic, and the antiinflammatory antioxidation is removed free radical, and antitumor improves immune effect, is used widely clinically.Clinical in recent years widely-used In vitro cultured Calculus Bovis is as the ideal substitute of natural Calculus Bovis.Calculus Bovis beginning is stated from Shennong's Herbal, and medicinal existing two thousand years is historical in China, is used for treating calentura coma, delirium, convulsions tic, wind-phlegm fan, epilepsy disease such as go mad.The artificial Calculus Bovis is formulated with reference to the principal component of natural Calculus Bovis by bilein, cholic acid, Hyodeoxycholic Acid, taurine, bilirubin, cholesterol, trace element etc.Natural Calculus Bovis and artificial breeding of bezoar have significant antiinflammatory action.
Borneolum Syntheticum: work hard, be slightly cold, cool in nature, have the effect of the refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.Borneolum Syntheticum can be divided into Borneolum Syntheticum (Borneolum Syntheticum), Blumeae preparatum Tabellae (L-borneolum) and natural Broneolum Syntheticum (Borneolum); The three is all by " Chinese pharmacopoeia 2010 editions is included; Wherein Borneolum Syntheticum is a borneolum syntheticum, and Blumeae preparatum Tabellae is left-handed Borneolum Syntheticum, and natural Broneolum Syntheticum is a dextro Borneolum Syntheticum.Be the fat-soluble monoterpenes material of micromolecule.Modern study proves that it has anti-inflammatory and antalgic and increases the effect of biomembrane barrier permeability.
Embodiment 5: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 10 grams, artificial Calculus Bovis's 2.5 grams, Borneolum Syntheticum 10 grams; Indigo Naturalis 10 grams.
Polyvinyl alcohol 35 grams, sodium carboxymethyl cellulose 5 grams, gelatin 95 grams, sodium benzoate 1.5 grams, glycerol 150 grams, tween 80 35 grams.
Embodiment 6: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 12 grams, artificial Calculus Bovis's 5 grams, Borneolum Syntheticum 12 grams; Indigo Naturalis 12 grams.
Polyvinyl alcohol 37 grams, sodium carboxymethyl cellulose 8 grams, gelatin 98 grams, sodium benzoate 1.7 grams, glycerol 175 grams, tween 80 37 grams.
Embodiment 7: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 15 grams, artificial Calculus Bovis's 7.5 grams, Borneolum Syntheticum 15 grams; Indigo Naturalis 15 grams.
Polyvinyl alcohol 40 grams, sodium carboxymethyl cellulose 10 grams, gelatin 100 grams, sodium benzoate 2 grams, glycerol 200 grams, tween 80 40 grams.
Embodiment 8: the method for preparing of described nourishing yin and promoting granulation film, and its main feature is may further comprise the steps:
(1) pulverize: press embodiment 5 to 7 weight portion proportionings with Realgar, Calculus Bovis, Indigo Naturalis medicine pulverize separately after mistake 100 mesh sieves, subsequent use;
(2) enclose: Borneolum Syntheticum is being used beta-cyclodextrin inclusion compound with anhydrous alcohol solution, and inclusion method is a Borneolum Syntheticum and the ratio of beta-schardinger dextrin-is 0.5～1:3～6, beta-schardinger dextrin-: H
2O (g:mL) is 0.5～1:6～12, and the enclose temperature is 45～50 ℃, enclose 30～35 minutes;
(3) film material preparation: press embodiment 54 to 7 weight portion proportioning weighing polyvinyl alcohol, sodium carboxymethyl cellulose, gelatin add 10～15 times of amount distilled water swellings respectively and spend the night, and heating is dissolved fully in 90～95 ℃ of water-baths, and is subsequent use;
(4) film-forming method: press Realgar, Calculus Bovis, the Borneolum Syntheticum clathrate of embodiment 5 to 7 weight portion proportionings, sodium benzoate, glycerol, tween 80 mix homogeneously mix with the film material liquid of step (3); Leave standstill; Liquid to be mixed does not have bubble, bed board, and room temperature is dried; Cut into 1cm * 10cm film bar, packing.
Indigo Naturalis: property is salty-cold, and sweet in the mouth is flat, returns liver, lung, stomach warp, has heat-clearing and toxic substances removing, the blood cooling and ecchymoses removing effect such as swollen of loosing.Cure mainly epidemic febrile disease intenseness of heat, macule, haematemesis, hemoptysis, pediatric epilepsy scared, diseases such as skin ulcer is swollen, erysipelas, snake bite and insect sting.Modern pharmacology research shows that the pharmacological action with antalgic and inflammation relieving, its main chemical compositions are indirubin and indigo.
Embodiment 8: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 10 grams, artificial Calculus Bovis's 2.5 grams, Borneolum Syntheticum 10 grams; Indigo Naturalis 10 grams.Cortex Phellodendri 2.5 grams, Radix Gentianae 2.5 grams.
Polyvinyl alcohol 35 grams, sodium carboxymethyl cellulose 5 grams, gelatin 95 grams, sodium benzoate 1.5 grams, glycerol 150 grams, tween 80 35 grams.
Embodiment 9: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 12 grams, artificial Calculus Bovis's 5 grams, Borneolum Syntheticum 12 grams; Indigo Naturalis 12 grams.Cortex Phellodendri 5 grams, Radix Gentianae 5 grams.
Polyvinyl alcohol 37 grams, sodium carboxymethyl cellulose 8 grams, gelatin 98 grams, sodium benzoate 1.7 grams, glycerol 175 grams, tween 80 37 grams.
Embodiment 10: a kind of nourishing yin and promoting granulation film pharmaceutical composition, and its main feature is to include following raw materials in weight portion:
Realgar 15 grams, artificial Calculus Bovis's 7.5 grams, Borneolum Syntheticum 15 grams; Indigo Naturalis 15 grams.Cortex Phellodendri 7.5 grams, Radix Gentianae 7.5 grams.
Polyvinyl alcohol 40 grams, sodium carboxymethyl cellulose 10 grams, gelatin 100 grams, sodium benzoate 2 grams, glycerol 200 grams, tween 80 40 grams.
Embodiment 11: the method for preparing of described nourishing yin and promoting granulation film, and its main feature is may further comprise the steps:
(1) pulverize: press embodiment 7 to 9 weight portion proportionings with Realgar, Calculus Bovis, Indigo Naturalis medicine pulverize separately after mistake 100 mesh sieves, subsequent use;
(2) extract, be condensed into extractum: Cortex Phellodendri, Radix Gentianae are added 8～12 times of water gagings respectively or ethanol decocts 2～3 times by the weight portion proportioning of embodiment 8 to 10; Each 1～2 hour, merge extractive liquid, filtered; Filtrating concentrates; Obtaining concentration is liquor capacity: medical material weight be medicine clear paste or the filtrating of 1:1 to be concentrated into relative density be 1.10～1.12, temperature is 50 ℃ clear paste, and is subsequent use.
(3) enclose: Borneolum Syntheticum is being used beta-cyclodextrin inclusion compound with anhydrous alcohol solution, and inclusion method is a Borneolum Syntheticum and the ratio of beta-schardinger dextrin-is 0.5～1:3～6, beta-schardinger dextrin-: H
2O (g:mL) is 0.5～1:6～12, and the enclose temperature is 45～50 ℃, enclose 30～35 minutes;
(4) film material preparation: press embodiment 8 to 10 weight portion proportioning weighing polyvinyl alcohol, sodium carboxymethyl cellulose, gelatin add 10～15 times of amount distilled water swellings respectively and spend the night, and heating is dissolved fully in 90～95 ℃ of water-baths, and is subsequent use;
(5) film-forming method: press Realgar, Calculus Bovis, the Borneolum Syntheticum clathrate of embodiment 8 to 10 weight portion proportionings, sodium benzoate, glycerol, tween 80 mix homogeneously mix with the film material liquid of step (4); Leave standstill; Liquid to be mixed does not have bubble, bed board, and room temperature is dried; Cut into 1cm * 10cm film bar, packing.
Cortex Phellodendri: Cortex Phellodendri bitter in the mouth, cold in nature, return kidney, urinary bladder channel.The ability heat clearing and damp drying, eliminating fire and detoxication, detumescence putrefaction removing.Be used for diseases such as damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, hectic fever due to YIN-deficiency consumptive fever, sore swollen toxin.About the existing a large amount of research report of the pharmacological action of Cortex Phellodendri, conclude and get up to have following several aspect: the effect of antibacterium, fungus, virus and other pathogenic microorganisms; Arrhythmia, blood pressure lowering etc. are to the effect of cardiovascular system; Digestive system there are effects such as anti-alimentary tract ulcer, contraction or diastole intestinal tube, promotion pancreatic secretion; And central nervous system's inhibitory action is arranged, suppress the effect of cell immune response, the hypoglycemic activity heart etc.The active component of these pharmacological actions of Cortex Phellodendri has also comprised monomeric compounds such as berberine, phellodendrine, magnoline, palmatine, jateorhizine, obacunone, obakulactone except that extract, total alkaloids.Wherein main active is a berberine.
Radix Gentianae: nature and flavor: bitter, cold, return liver, gallbladder meridian.Has heat clearing and damp drying, eliminating pathogen in the liver gallbladder fire.Be used for jaundice due to damp-heat, swelling of the vulva pudendal pruritus, leukorrhagia, persistent erection of the penis, eczema pruritus, conjunctival congestion, deafness, hypochondriac pain, bitter taste, convulsion with spasms.Modern pharmacological research proves that gentiopicrin has effects such as significant liver protecting, antiinflammatory, resisting pathogenic microbes, central excitation and stomach-invigorating and gall bladder-invigorating, and is consistent basically to the application of Radix Gentianae with the traditional Chinese medical science.Chinese scholars has been separated from Radix Gentianae and has been obtained multiple Secoiridoid Glycosides composition; The polysaccharide composition is like gentianose; The alkaloids composition is like gentioflavine and erythricine.Main chemical constituent is the Secoiridoid Glycosides chemical compound in the Radix Gentianae.
Embodiment 12～17: a kind of nourishing yin and promoting granulation film pharmaceutical composition, its main feature are to include down raw materials in weight portion in the tabulation 1:
Polyvinyl alcohol 35 weight portions, sodium carboxymethyl cellulose 5 weight portions, gelatin 95 weight portions, sodium benzoate 1.5 weight portions, glycerol 150 weight portions, tween 80 35 weight portions.
Table 1
| Embodiment | Realgar | The artificial Calculus Bovis | Indigo Naturalis | Borneolum Syntheticum | Cortex Phellodendri | Radix Gentianae | Radix Glycyrrhizae |
| 12 | 10 | 2.5 | 10 | 10 | 2.5 | 2.5 | 10 |
| 13 | 11 | 3.5 | 11 | 11 | 3.5 | 3.5 | 11 |
| 14 | 12 | 4.5 | 12 | 12 | 4.5 | 4.5 | 12 |
| 15 | 13 | 5.5 | 13 | 13 | 5.5 | 5.5 | 13 |
| 16 | 14 | 6.5 | 14 | 14 | 6.5 | 6.5 | 14 |
| 17 | 15 | 7.5 | 15 | 15 | 7.5 | 7.5 | 15 |
Embodiment 18: the method for preparing of described nourishing yin and promoting granulation film, and its main feature is may further comprise the steps:
(1) pulverize: the weight portion proportioning of press embodiment 10 to 15 with Realgar, Calculus Bovis, Indigo Naturalis medicine pulverize separately after mistake 100～120 mesh sieves, subsequent use;
(2) extract, be condensed into extractum: Cortex Phellodendri, Radix Gentianae, Radix Glycyrrhizae are added 8～12 times of water gagings respectively or ethanol decocts 2～3 times by the weight portion proportioning of embodiment 12 to 17; Each 1～2 hour, merge extractive liquid, filtered; Filtrating concentrates; Obtaining concentration is liquor capacity: it is 1.10～1.12 that filtrating is concentrated into relative density, and temperature is 50 ℃ clear paste, and is subsequent use;
(3) enclose: Borneolum Syntheticum is being used beta-cyclodextrin inclusion compound with anhydrous alcohol solution, and inclusion method is a Borneolum Syntheticum and the ratio of beta cyclodextrin is 0.5～1:3～6, beta-schardinger dextrin-: H
2O (g:mL) is 0.5～1:6～12, and the enclose temperature is 45～50 ℃, enclose 30～35 minutes;
(4) film material preparation: press the weight portion proportioning weighing polyvinyl alcohol of embodiment 112 to 17, sodium carboxymethyl cellulose, gelatin add 10～15 times of amount distilled water swellings respectively and spend the night, and heating is dissolved fully in 90～95 ℃ of water-baths, and is subsequent use;
(5) film-forming method: the weight portion proportioning of pressing embodiment 12 to 17 is with Cortex Phellodendri, Radix Gentianae, Radix Glycyrrhizae extract clear paste and Realgar, Calculus Bovis, Indigo Naturalis, Borneolum Syntheticum clathrate by the weight portion proportioning of claim, and sodium benzoate, glycerol, tween 80 mix homogeneously mix with film material liquid; Leave standstill; Liquid to be mixed does not have bubble, bed board, and room temperature is dried; Cut into 1cm * 10cm film bar, packing.
Radix Glycyrrhizae: nature and flavor are sweet, and are flat, GUIXIN, lung, spleen, stomach warp.The invigorating middle warmer of ability QI invigorating, coordinating the actions of various ingredients in a prescription.Flavone compound is the main component of Radix Glycyrrhizae spasmolytic, antiulcer action.
Experimental example 1: pharmacodynamic study
1. animal
50 of Wistar rats, male, body weight 300 ± 30g, available from Gansu college of traditional Chinese medicine scientific experiment animal center, the quality certification number: SCXK (sweet) 2004-0006, the drinking-water of freely ingesting, room temperature is controlled at 20 ℃～25 ℃, the well-ventilated.90 of Kunming mouses, male, body weight 20 ± 2g, available from Gansu college of traditional Chinese medicine scientific experiment animal center, the quality certification number: SCXK (sweet) 2004-0006, the drinking-water of freely ingesting, room temperature is controlled at 20 ℃～25 ℃, the well-ventilated.
2 methods and result
2.1 the influence of rat oral ulcer due to the nourishing yin and promoting granulation film Dichlorodiphenyl Acetate
Get 50 of Wistar rats, by buccal left-external side inserting needle, 10% acetic acid 0.05mL is accurately injected under the cheek mucosa, behind the 24h, separate the rat lip, visible surface is canescence, circular or oval-shaped ulcer.Measure the ulcer diameter with divider, each animal ulcer diameter is at 4.5～5.5mm.Animal is divided into the high, medium and low dose groups of nourishing yin and promoting granulation film at random, positive drug contrast (watermelon crystal spray) group and blank group, totally 5 groups, 10 every group.By above-mentioned conversion dosage gastric infusion, every day 1 time, 21d observes the ulcer size simultaneously every day continuously, the record ulcer healing time, 21d do not heal by 21d.Carry out the t check between experimental data set, the result sees table 1.
Table 1 is respectively organized oral ulcer healing time relatively
Annotate: compare * * p＜0.01, * p＜0.05 with the blank group.
2.2 the nourishing yin and promoting granulation film causes the influence of mice ear to 2% compound Oleum Tiglii
Get 75 of healthy mices, be divided into high, medium and low dose groups at random, blank group and watermelon crystal spray group, totally 5 groups; Every group 15, according to 0.02mL/g capacity gastric infusion, every day 1 time; 3d behind last 1 filling stomach 90min, is coated with 2% compound Oleum Tiglii proinflammatory agent 20 μ L in mouse right ear continuously; Mice takes off neck execution behind the 4h, cuts two ears along the auricle baseline, weighs.Calculate swelling degree and swelling rate with following formula, and experimental data is organized a t check, swelling degree=auris dextra weight-left ear weight; Swelling rate=(auris dextra weight-left ear weight) ÷ left side ear weight * 100%; Inhibitory rate of intumesce=(blank control group swelling rate-drug group swelling rate) ÷ blank control group swelling rate * 100%.The result sees table 2.
Table 2 is respectively organized ear swelling relatively
Annotate: compare * * p＜0.01, * p＜0.05 with the blank group.
2.3 the nourishing yin and promoting granulation film is to the granulomatous influence of rat due to the agar
Get 50 of Wistar rats,, 2% agar gel 0.5mL is accurately injected right oxter, behind the 24h animal is divided into the high, medium and low dose groups of nourishing yin and promoting granulation film at random, watermelon crystal spray group and blank group, totally 5 groups, 10 every group by the right outer side needling of rat.According to 0.01mL/g capacity gastric infusion, every day 1 time, continuous 14d, 90min puts to death rat after the last administration, cuts open and gets right oxter granuloma, weighs, and experimental data is organized a t check, and the result sees table 3.
Table 3 is respectively organized granuloma weight ratio
Annotate: compare * * p＜0.01, * p＜0.05 with the blank group.
2.4 the nourishing yin and promoting granulation film is to the influence of mice hot plate analgesic experiment
Get 90 of healthy mices, screen, will surpass removing of 30s incubation period, be divided into the high, medium and low dose groups of nourishing yin and promoting granulation film at random, watermelon crystal spray group and blank group, totally 5 groups, 15 every group with 55 ± 0.5 ℃ of hot-plate instruments.According to 0.02mL/g capacity gastric infusion, every day 1 time, 3d carries out hot plate test behind last 1 filling stomach 90min continuously, writes down incubation period, and experimental data is organized a t check, and the result sees table 4.
Table 4 is respectively organized the hot plate analgesic experiment, and compare
incubation period
Annotate: compare * * p＜0.01, * p＜0.05 with the blank group.
This research has been manufactured rat oral ulcer model with acetic acid; The result shows; The nourishing yin and promoting granulation film can obviously shorten the ulcer healing time; And can significantly alleviate by 2% compound Oleum Tiglii induced mice ear swelling and obviously alleviate rat granuloma quality due to 2% agar, more than experiment shows that all the nourishing yin and promoting granulation film has good antiinflammatory action.Secondly, the incubation period of nourishing yin and promoting granulation film ability significant prolongation mice hot plate experiment, show that the nourishing yin and promoting granulation film has good analgesic activity.In sum, the nourishing yin and promoting granulation film can promote the ulcer surface healing, improve tolerance, the while enhancing body defense function of body to the threshold of pain, and the treatment recurrent oral ulceration has been reached " mark ", " basis " double purpose of controlling.
The above is merely preferred embodiment of the present invention, in order to restriction the present invention, all any modifications of within spirit of the present invention and principle, being done, is not equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (6)
1. nourishing yin and promoting granulation film pharmaceutical composition is characterized in that including following raw materials in weight portion:
Realgar 10～15 weight portions, artificial Calculus Bovis's 2.5～7.5 weight portions, Borneolum Syntheticum 10～15 weight portions;
Polyvinyl alcohol 35～40 weight portions, sodium carboxymethyl cellulose 5～10 weight portions, gelatin 95～100 weight portions, sodium benzoate 1.5～2 weight portions, glycerol 150～200 weight portions, tween 80 35～40 weight portions.
2. nourishing yin and promoting granulation film pharmaceutical composition as claimed in claim 1 is characterized in that also including following raw materials in weight portion:
Indigo Naturalis 10～15 weight portions.
3. nourishing yin and promoting granulation film pharmaceutical composition as claimed in claim 2 is characterized in that also including following raw materials in weight portion:
Cortex Phellodendri 2.5～7.5 weight portions, Radix Gentianae 2.5～7.5 weight portions.
4. nourishing yin and promoting granulation film pharmaceutical composition as claimed in claim 3 is characterized in that also including following raw materials in weight portion:
Radix Glycyrrhizae 10～15 weight portions.
5. the method for preparing of a nourishing yin and promoting granulation film is characterized in that may further comprise the steps:
(1) pulverize: cross 100～120 mesh sieves by the weight portion proportioning of claim 1 to 4 after with Realgar, Calculus Bovis, Indigo Naturalis medicine pulverize separately, subsequent use;
(3) enclose: Borneolum Syntheticum is used anhydrous alcohol solution, carrying out beta-cyclodextrin inclusion compound, inclusion method is a Borneolum Syntheticum and the ratio of beta-schardinger dextrin-is 0.5～1:3～6, beta-schardinger dextrin-: H
2O (g:mL) is 0.5～1:6～12, and the enclose temperature is 45～50 ℃, enclose 30～35 minutes;
(4) film material preparation: by the weight portion proportioning weighing polyvinyl alcohol of claim 1 to 4, sodium carboxymethyl cellulose, gelatin add 10～15 times of amount distilled water swellings respectively and spend the night, and heating dissolving fully in 90～95 ℃ of water-baths is subsequent use;
(5) film-forming method: with Cortex Phellodendri, Radix Gentianae, Radix Glycyrrhizae extract clear paste and Realgar, Calculus Bovis, Indigo Naturalis, Borneolum Syntheticum clathrate by the weight portion proportioning of claim, sodium benzoate, glycerol, tween 80 mix homogeneously mix with film material liquid by the weight portion proportioning of claim; Leave standstill; Liquid to be mixed does not have bubble, bed board, and room temperature is dried; Cutting film forming bar, packing.
6. the method for preparing of nourishing yin and promoting granulation film as claimed in claim 5 is characterized in that further comprising the steps of:
(2) extract, be condensed into extractum: Cortex Phellodendri, Radix Gentianae, Radix Glycyrrhizae are added 8～12 times of water gagings respectively or ethanol decocts 2～3 times by the weight portion proportioning of claim 1 to 4; Each 1～2 hour, merge extractive liquid, filtered; Filtrating concentrates; Obtaining concentration is liquor capacity: medical material weight be medicine clear paste or the filtrating of 1:1 to be concentrated into relative density be 1.10～1.12, temperature is 50 ℃ clear paste, and is subsequent use.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113952376A (en) * | 2017-01-19 | 2022-01-21 | 祝勇 | Composition for treating ulcer and preparation method thereof |
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2012
- 2012-08-19 CN CN2012102946023A patent/CN102824367A/en active Pending
Non-Patent Citations (2)
| Title |
|---|
| 林其盛: "《中医儿科歌括》", 31 July 2001, 上海中医药大学出版社 * |
| 田燕 等: "《药剂学》", 30 September 2011, 清华大学出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113952376A (en) * | 2017-01-19 | 2022-01-21 | 祝勇 | Composition for treating ulcer and preparation method thereof |
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Application publication date: 20121219 |