CN1278673C - Spray agent of dried powder in use for diminishing inflammation of mucous membrane and preparation method - Google Patents
Spray agent of dried powder in use for diminishing inflammation of mucous membrane and preparation method Download PDFInfo
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- CN1278673C CN1278673C CN 200310104025 CN200310104025A CN1278673C CN 1278673 C CN1278673 C CN 1278673C CN 200310104025 CN200310104025 CN 200310104025 CN 200310104025 A CN200310104025 A CN 200310104025A CN 1278673 C CN1278673 C CN 1278673C
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- yunnan baiyao
- mucous membrane
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Abstract
The present invention provides a powder spraying agent for relieving inflammation on mucous membranes. The present invention has the content medicine of yunnan baiyao with the hemostasis function and the antiphlogosis function. The present invention is characterized in that each spraying agent has 0.01 to 0.2g of yunnan baiyao extracts and auxiliary materials (with high biological mucous membrane compatibility and film forming capability) as the rest; the materials are made into the spraying agent which is acceptable in medicine. The present invention has the comprehensive functions of resisting bacteria, stopping bleeding, alleviating pain, relieving inflammation, improving the microcirculation, etc., and has other effects of fast stopping mucous membrane bleeding, relieving mucous membrane inflammation, promoting the mucous membrane concrescence and avoiding the scar generation. After sprayed on the mucous membranes, the powder spraying agent absorbs partial moisture, is dispersed to form a layer of protective film, and assists the mucous membrane recovery in the mucous membrane repairing process. The products of the present invention have the advantages of convenient use, stable performance and no stimulation.
Description
Technical field
The present invention relates to a kind of antibiotic mucosa antiinflammatory dry powder spray and production method that reaches the mucosa inflammation, swells and ache and have protective effect that have.
Background technology
Have more than 100 year historical YUNNAN BAIYAO, in the traumatology medication, have many original places, but the application aspect mucosa uses seldom, uses also inconvenient because of being subjected to the limitation of its dosage form and medicine built-in problem so far.The disease incidence of mucosa is still higher now, brings more misery to patient, as intractable oral cavity ulcer, be more common in recurrent aphtha, be oral mucosa limitation infringement with intermittence characteristics, the sickness rate height, general crowd's prevalence is not less than 10%.Nasal mucosa, vaginal mucosa sickness rate are also higher.YUNNAN BAIYAO has anti-inflammation, blood circulation promoting and blood stasis dispelling, to effects such as wound healing, Scar eliminating medicine remove, comprehensive healing of wound is had comprehensive therapeutical effect.Therefore, be necessary according to the analysis of existing medicine and the research of existing therapy,, develop a kind of YUNNAN BAIYAO dry powder spray that antiinflammatory is used at mucosa specially in conjunction with the development of the advantage and the modern biomedical of Chinese and western medicine.
Summary of the invention
The present invention proposes a kind of mucosa antiinflammatory dry powder spray and production method for addressing the above problem exactly.
The principle of the invention is: have comprehensive effects such as antibiotic, hemostasis, pain relieving, antiinflammatory, microcirculation improvement at YUNNAN BAIYAO or its extract, and can make mucosa hemostasis, antiinflammatory rapidly, heal, avoid producing on the basis of cicatrix, allocate into and have mucosa bioaffinity height, wound healing is had assosting effect, makes the natural or synthesis auxiliary material of self absorbed macromolecule with wound healing, make acceptable preparation.After making it to be sprayed on the mucosa with medicine, absorption portion moisture disperses, spreads out and forms layer protecting film, so that auxiliary mucosa recovers in the mucosa repair process, is organized again at last and assimilates.
Technical scheme of the present invention is: a kind of mucosa antiinflammatory dry powder spray, the medicine of its content is the YUNNAN BAIYAO with hemostasis, antiinflammatory, it is characterized in that containing YUNNAN BAIYAO extract 0.01～0.2g with every spray, surplus is biological mucosa affinity height, the film forming adjuvant of energy, makes pharmaceutically acceptable spray.
Described medicine is YUNNAN BAIYAO or its effective site or monomer.
Described adjuvant is selected for use to have mucosa bioaffinity height, wound healing is had assosting effect, makes the natural or synthesis auxiliary material of one or more macromolecules in self absorbed chitin (chitin), plant gum, cellulose and derivant thereof, the polyacrylic acid with wound healing.
Can add one or more surfactants in dodecyl sodium sulfate, span, the tween in the described adjuvant; perhaps cholate such as Bile Salts; perhaps fatty acid such as oleic acid; perhaps cyclodextrin such as α, β, gamma-cyclodextrin; perhaps chelating agen such as disodium edetate, sodium citrate; perhaps gather cationic polymers such as L-arginine, perhaps mucosa such as hyaluronic acid, Azone absorption enhancer.
Can add one or more spice in Radix Angelicae Sinensis oil, mugwort oil, Herba Artemisiae Annuae oil, Costusroot oil, nutgrass galingale oil, citron oil, cardamom oil, coumarin, the vanillin in the described adjuvant.
Preparation provided by the invention makes by following technology: with the processing of medicinal raw material process ultramicronising, packing, wherein the super-refinement process is: under 10,000 grades of conditions, the medicine material of intending usefulness is added in the adjuvant of intending usefulness, and mixing carries out air-flowing type or other ultramicronisings and pulverizes.
Preparation provided by the invention our experiments show that:
1, stability: can place at normal temperatures 1 year, product is reliable and stable, and every index is all qualified, meets the requirements fully;
2, zest: do irritant experiment with rabbit, zest is 0 grade, does not promptly have significant change.
YUNNAN BAIYAO effective site or monomeric general separation and Extraction:
Get YUNNAN BAIYAO powder, 8,6,6 times of calorimetric reflux, extract, of ethanol with 65% ~ 80% 1 hour three times, merge extractive liquid, concentrates and causes 50% amount, with the activated carbon decolorizing of 0.1% solution amount, filtrate is too short, and (10 ~ 15cm) silicagel column remove impurity once, concentrate and cause 15% ~ 25% amount, ultra-filtration filters is spent the night in 5 ~ 10 ℃ of placements, vacuum concentration causes dried, can get effective site (yield is generally 6～10%).
Separating monomer: effective site, with dry method or wet method upper prop, on silicagel column, separate, use following solvent: mixture eluting stream part of chloroform-methanol different proportion, receipts connect stream part, and bioanalysis is followed the trail of active, and the active part vacuum concentration causes dried, dry thing corresponding solvent recrystallization gets monomer (as baicalin, pennogenin etc.).
According to the physicochemical property of effective ingredient, can select supercritical (SC-CO for use
2) the extracting method extraction.Solvent can be selected CO for use
2, CO
2Carry ethanol, CO secretly
2Carry methanol etc. secretly, 45～65 ℃ of extraction temperature, extracting pressure 30～50Mpa resolves pressure 8～14Mpa, 42～67 ℃ of resolution temperatures.Advantage is that method belongs to clean and produces, and residual solvent is few in the extract.The amount of strict controlled condition and entrapment solvent can obtain different effective site until monomer.
Embodiment 1
The preparation of YUNNAN BAIYAO dry powder spray
The separation of step 1, YUNNAN BAIYAO effective ingredient:
Getting YUNNAN BAIYAO looses 1 kilogram, 8,6,6 times of calorimetric reflux, extract, of ethanol with 70% 1 hour three times, merge extractive liquid, concentrates and causes 50% amount, with the activated carbon decolorizing of 0.1% solution amount, the silicagel column remove impurity of short (10cm) once, concentrate and cause 20% amount, ultra-filtration filters is spent the night in 5 ~ 10 ℃ of placements, vacuum concentration causes dried, can get the about 70g of effective site (yield～7%) of YUNNAN BAIYAO antibacterial anti hemorrhagic antiinflammatory;
The preparation of step 2, YUNNAN BAIYAO extract micropowder:
Under 10,000 grades condition, the effective site 50g of the YUNNAN BAIYAO antibacterial anti hemorrhagic antiinflammatory of said extracted is added adjuvant chitin 250g, the porphyrize mixing carries out air-flowing type (or other) ultramicronising and pulverizes.Can make required uniform ultra-fine semi-finished product 285g;
The preparation of step 3, YUNNAN BAIYAO extract dry powder spray:
Under 10,000 grades of conditions, with above-mentioned YUNNAN BAIYAO extract micropowder, in every is encapsulated in capsule (or bubble ocular form/or bar bar type) by 0.2g the spray medicament reservoir, get final product 1425 sprays of YUNNAN BAIYAO extract dry powder spray, each spray (contains effective extract～0.035g).
Embodiment 2
The preparation of YUNNAN BAIYAO dry powder spray
Step 1, with embodiment 1;
The preparation of step 2, YUNNAN BAIYAO extract micropowder:
Under 10,000 grades condition, the effective site 50g of the YUNNAN BAIYAO antibacterial anti hemorrhagic antiinflammatory of said extracted is added adjuvant polyacrylic carbomer (CP) 100g, beta-schardinger dextrin-150g, Herba Artemisiae Annuae oil 0.05g, porphyrize mixing carry out air-flowing type (or other) ultramicronising and pulverize.Can make required uniform ultra-fine semi-finished product 290g;
The preparation of step 3, YUNNAN BAIYAO extract dry powder spray:
Under 10,000 grades of conditions, with above-mentioned YUNNAN BAIYAO extract micropowder, in every is encapsulated in capsule (or bubble ocular form/or bar bar type) by 0.1g the spray medicament reservoir, get final product 2900 sprays of YUNNAN BAIYAO extract dry powder spray, each spray (contains effective extract～0.016g).
Embodiment 3
The preparation of YUNNAN BAIYAO dry powder spray
Step 1, with embodiment 1;
The preparation of step 2, YUNNAN BAIYAO extract micropowder:
Under 10,000 grades condition, the effective site 50g of the YUNNAN BAIYAO antibacterial anti hemorrhagic antiinflammatory of said extracted is added hypromellose 70g, NaGC 1g, Radix Aucklandiae oil 0.2ml, the porphyrize mixing carries out air-flowing type (or other) ultramicronising and pulverizes.Can make required uniform ultra-fine semi-finished product 110g.
The preparation of step 3, YUNNAN BAIYAO extract dry powder spray:
Under 10,000 grades of conditions, with above-mentioned YUNNAN BAIYAO extract micropowder, in every is encapsulated in capsule (or bubble ocular form/or bar bar type) by 0.3g the spray medicament reservoir, get final product 366 sprays of YUNNAN BAIYAO extract dry powder spray, each spray (contains effective extract～0.14g).
Embodiment 4
The preparation of YUNNAN BAIYAO dry powder spray
Step 1, with embodiment 1;
The preparation of step 2, YUNNAN BAIYAO extract micropowder:
Under 10,000 grades condition, the effective site 50g of the YUNNAN BAIYAO antibacterial anti hemorrhagic antiinflammatory of said extracted is added chitosan 150g, tween 0.3g, alpha-cyclodextrin 35g, disodium edetate 0.2g porphyrize mixing carry out air-flowing type (or other) ultramicronising and pulverize.Can make required uniform ultra-fine semi-finished product 223g;
The preparation of step 3, YUNNAN BAIYAO extract dry powder spray:
Under 10,000 grades of conditions, with above-mentioned YUNNAN BAIYAO extract micropowder, in every is encapsulated in capsule (or bubble ocular form/or bar bar type) by 0.2g the spray medicament reservoir, get final product 1116 sprays of YUNNAN BAIYAO extract dry powder spray, each spray (contains effective extract～0.045g).
Product study of pharmacy and effect:
1, the stability of agent
The lucifuge keeping at room temperature of 1,2,3,4 four samples of embodiment was placed 1,2,3,6 month, and through trial inspection, the spray volume of every spray is constant substantially, and effective ingredient does not change through check yet.Therefore, think that tentatively the various prescriptions of this inhalant all can reach the shelf-life about 1 year.
2, the antiinflammatory action of spray
Use the Whttle method, 30 of mices are divided into 3 groups at random, and 10 every group, the about 4cm of mouse back both sides unhairing
2Be administered twice at the unhairing position continuously, midfeather 30min, each spray (embodiment 1) intact (～0.052g), behind the administration 1h, the blue 0.2ml/ of mouse tail vein injection 0.5% ivens is the timely lumbar injection 0.7% acetic acid 0.2ml/10g in back only, puts to death mice behind the 15min, and intraperitoneal injection of saline 5ml gently rubs the back and extracts peritoneal fluid, centrifugal, supernatant is measured optical density value in the 620nm place, calculate and comparable group differences significance, the results are shown in following table:
| Group | Body weight | Dosage (mg/Kg) | Optical density value | Suppression ratio |
| Blank group aspirin spray group | 20±1.1 20±1.3 20±1.2 | Equal-volume 200 52 | 0.28±0.04 0.11±0.03 0.10±0.01 | 61.0％ 73.1％ |
Conclusion: this spray has antiinflammatory action preferably, with the blank group difference of highly significant is arranged relatively.
3, the irritation test of spray
Get 4 of healthy rabbits, W:2.0～2.2kg, female, be divided into two groups, vagina administration 1 time (～0.1mg), contrast spray primary blank.After the administration, write down the situation of the erythema of 1h, 24h, the appearance of 48h medicine-feeding part respectively, the stimulation degree is also estimated in the according to the form below scoring:
Table 1 mucosa irritation reaction standards of grading
| Erythema | Integration | Edema | Integration |
| The visible reluctantly obviously erythema moderate of no erythema is to serious erythema | 0 1 2 3 | The slight edema cutaneous protuberance of no edema profile is known edema protuberance 1mm and expanded range | 0 1 2 3 |
Table 2 mucosa irritation intensity standards of grading
| Mean scores | Estimate |
| 0～0.49 0.5～2.99 3.0～5.99 6.0～8.0 | Zest moderate zest intense stimulus that nonirritant is slight |
Table 3 spray is to the average response value of mucosa irritation
| Group | Number of animals | The integration summation | The average response value | ||||
| 1h | 24h | 48h | 1h | 24h | 48h | ||
| The blank experiment group | 2 2 | 1 1 | 0 0 | 0 0 | 1 0.8 | 0 0 | 0 0 |
The result: as can be seen from Table 3 spray to the stimulation and the blank no significant difference of mucosa, be non-stimulated.
Claims (1)
1, a kind of mucosa antiinflammatory dry powder spray, it is characterized in that it contains YUNNAN BAIYAO extract 0.01～0.2g, surplus is chitin, carbomer, beta-schardinger dextrin-, Herba Artemisiae Annuae oil, hypromellose, NaGC, Radix Aucklandiae oil, chitosan, one or more adjuvants in tween, alpha-cyclodextrin, the disodium edetate, and the following method of process makes:
YUNNAN BAIYAO effective site or monomeric general separation and Extraction:
Get YUNNAN BAIYAO powder, 8,6,6 times of calorimetric reflux, extract, of ethanol with 65%～80% 1 hour three times, merge extractive liquid, concentrates and causes 50% amount, with the activated carbon decolorizing of 0.1% solution amount, the short silicagel column remove impurity that filtrate is crossed 10～15cm once, concentrate and cause 15%～25% amount, ultra-filtration filters is spent the night in 5～10 ℃ of placements, vacuum concentration causes dried, gets effective site;
The preparation of YUNNAN BAIYAO extract micropowder:
Under 10,000 grades condition, the YUNNAN BAIYAO effective site of extracting is added adjuvant, the porphyrize mixing carries out the air-flowing type ultramicronising and pulverizes, and gets ultra-fine semi-finished product;
The preparation of YUNNAN BAIYAO extract dry powder spray:
Under 10,000 grades of conditions, with the YUNNAN BAIYAO extract micropowder, be encapsulated in the capsular spray medicament reservoir, promptly get YUNNAN BAIYAO extract dry powder spray.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310104025 CN1278673C (en) | 2003-12-13 | 2003-12-13 | Spray agent of dried powder in use for diminishing inflammation of mucous membrane and preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310104025 CN1278673C (en) | 2003-12-13 | 2003-12-13 | Spray agent of dried powder in use for diminishing inflammation of mucous membrane and preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1626114A CN1626114A (en) | 2005-06-15 |
| CN1278673C true CN1278673C (en) | 2006-10-11 |
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| CN 200310104025 Expired - Fee Related CN1278673C (en) | 2003-12-13 | 2003-12-13 | Spray agent of dried powder in use for diminishing inflammation of mucous membrane and preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1319541C (en) * | 2003-12-13 | 2007-06-06 | 昆明紫健生物技术有限公司 | Spray agent of dried powder in use for treating hemorrhoid and preparation method |
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| CN1626114A (en) | 2005-06-15 |
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