CN1084080A - The pharmaceutical composition that contains collagen - Google Patents
The pharmaceutical composition that contains collagen Download PDFInfo
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- CN1084080A CN1084080A CN92110754A CN92110754A CN1084080A CN 1084080 A CN1084080 A CN 1084080A CN 92110754 A CN92110754 A CN 92110754A CN 92110754 A CN92110754 A CN 92110754A CN 1084080 A CN1084080 A CN 1084080A
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- collagen
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- mikaxin
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Abstract
This paper has introduced powder or the medicine film that contains collagen, and these powder or medicine film are made up of insoluble collagen fiber or powdered natural collagen, and carries active is at topical.
Description
The present invention is the utilization of relevant fibroid or soluble collagen, and this collagen can carry medicine with the drug powder that contains collagen or the form of thin film.
As everyone knows, in technical field especially pharmaceutical field, collagen is widely used.In fact, collagen has been used to the drug world of people and beasts as up-to-date biocompatible polymer.
Because the structure of molecular weight distribution and polymer chain widely, collagen has a lot of characteristics.In calf-skin (the 3-4 month) both can obtain the collagen (300,000 dalton) of water-soluble low molecular wt, also can obtain water-fast high-molecular weight collagen (300,000 to millions of), and can form colloid form structure.Method by various chemistry and physics can obtain different collagen parts, sees French patent application number 1,568,829,1967.12.1.
Extract high molecular collagen, can obtain a kind of product of fibers form, this product is had many uses, and for example its thin film is used as the adjuvant treatment damage, and it can promote healing, quickens the recovery of epidermis function.
Recently, use the collagen formulations that has other holder, make thin film, thin netted and/or surperficial use product, these products can be avoided the formation of decubitus ulcer and can promote its healing.
Especially recently the spongy collagen that utilizes that proposes is treated skin injury due to the different reasons as a kind of pharmaceutical dosage form, for example contingency or surgery damage, venostasis ulcer, decubitus ulcer and exodontia or the like.
In fact, collagen can promote the hypertrophy of granulation tissue and scar tissue, and to be the structure that contains collagen soaked into by blood and in-house leukocyte and phagocyte its mechanism of action, by cytophagous protease digestion, thereby causes the reparative regeneration of damaged tissues.
Collagen is not absorbed, so finish its effect in position, does not change systemic structure, and it promotes the generation of the necessary endogenous collagen of wound healing by fibroblast.
Have now found that it is that main its curative effect of medicine may be better that collagen fiber or soluble collagen carry local action.Therefore, the present invention provides the powder that contains collagen or the pharmaceutical composition of thin film.
The present invention can be contained the active substance that form of collagen carries to be had:
-aminoglycosides antibiotics (A Mikaxin, kanamycin, neomycin, paromomycin, tobramycin, rickamicin, netilmicin, dibekacin, clindamycin, lincomycin)
-erythromycin derive antibiotic and other antibiotic
-promotion wound healing medicine: dermatan sulfate, heparin sulfate, benzoyl peroxide, glycosamine glucosan, sulfo-mucopolysaccharide, chitin, chitosan, meso polysaccharide, O-(beta-hydroxyethyl) rutin
-hyaluronic acid, and salt and derivant
-steroidal anti-inflammatory drugs (beclomethasone dipropionate, hydrocortisone)
-nonsteroidal antiinflammatory drug (ketoprofen, pyrroles's former times health, ibuprofen, Ibuproben-Lysiante, ketoprofen lysinate, the acid of sulfo-ibuprofen, tenoxicam indometacin, nimesulide)
-chemotherapeutant (sulfanilamide, sulfadiazine silver colloid, ofloxacin)
-epidermal growth factor, Semen Tritici aestivi and other plant source extraction of active ingredients thing
-antiseptic and disinfectant (methylene blue, mercurochrome, alkaline fuchsin, chlorhexidine gluconate)
-antiviral agent (acyclovir, iodouracil desoxyriboside, inosine, pranobex, interferon, ribavirin, vidarabine phosphate etc.)
-have the peptide and a polypeptide (insulin, calcitonin) of pharmacological action
-beta-Blocking agent (metoprolol, atenolol)
-calcium antagonist (nifedipine, two nifedipines, sulfur nitrogen
Ketone)
-antifungal medicine (econazole, miconazole and derivant thereof)
-antihistamine drug (terfenadine, color polysaccharide sodium)
-heparin and low molecular weight part thereof.
According to its activity, the amount of these active component is between 0.001% and 90%.
The collagen of carrying active material not only can be treated skin injury, also can be used for vagina, eyes, nasal cavity, oral cavity, periodontal or gums.
Collagen fiber can be prepared into the thin film that contains collagen, and non-collagen fiber (as powder or solution) can be used for concrete prescription to meet the requirements of technical performance (intensity, hydrophilic, adhesiveness etc.).
For example, in the preparation of nasal cavity applied medicine, can use soluble collagen (low-molecular-weight), it can generate water-base cement previous status suspension or solution, and they not only contain collagen, also contains the active component (heparin of various molecular weight, calcitonin, polysaccharide sodium, beclomethasone dipropionate etc.).
Resulting solution or suspension carry out drying by atomization drying or lyophilization or other method, and dry back powder particle should use suitable gageable applicator to pass through nasal delivery less than 20 μ m.
Because the above-mentioned material that contains collagen is arranged, resulting drug powder has good adhesiveness, if before drying, adds the biocompatible substance that other has height mucosal adhesive method in solution or suspension, also can increase the bioadhesion power of mucosa.
In addition, according to general standard, on prescription, also can use other can increase the material (as antiseptic, buffer agent, antioxidant, stabilizing agent etc.) of active substance absorption or stability.
As for the collagen fiber thin film that local skin uses, its active component is distributed in the refrigerated collagen fiber film.Usually the aqueous solution of active component is to be added in the aqueous suspension of collagen fiber.
Active component is directly disperse in the collagen suspension, and its uniform suspension product is easy to carry out lyophilization and other drying according to a conventional method.
Be used for form of film of the present invention pharmaceutical composition contain Collagen material by: have certain technical characteristic and particle size distribution and form so that in water, form the collagen fiber (water insoluble) of gel; Is best to have described characteristic of front French Patent (FRP) and molecular weight above 285,000 daltonian collagens.
Yet the powder that is used to prepare medicine is the natural collagen powder, and it is water-soluble, and molecular weight is lower than 300,000 dalton.
In the pharmaceutical preparation of the collagen film of local usefulness, before drying, the percentage ratio of original glue thing should be between 0.1 to 10% in the solution, but is preferably between the 0.2-5%.
Remove the part and take, the collagen formulations that other approach is taken (can contain various active ingredients), fiber no matter, still powder type also can be used Collagen material in a large number, and according to the purpose for preparing, its content should be between 20 to 90%.
Collagen film medicine of the present invention also can contain relatively large active component; This collagen film can also can be made into the form of plural layers as method for preparing, and every layer can contain special active component as requested.Can use continuous or discrete lyophilization operation or calendering procedure in the preparation.
In order to make it that characteristics such as certain adhesion and intensity be arranged, when preparation collagen powder or medicine film, can add some other material, as cellulosic derivant: methylcellulose, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose and derivant thereof, CVP Carbopol ETD2050, the propylene of biocompatibility and methyl acryloyl derivative, under any circumstance, other material in the biomedical sector also can use.
Not only eye is taken the preparation of medicine, and the preparation of epidermis injury medicine also must be aseptic, and has biology and the Microbiological Characteristics that meets pharmacopeia and reference manual standard.
The present invention's prescription can be used for medicine, veterinary drug or cosmetic field.The latter's medicine film can be made into the facial film form, has the effect of anti-acne as erythromycin and other active component.
Following relevant details of the present invention of example explanation and range of application thereof.
Example 1
A Mikaxin collagen medicine film
Preparation contains A Mikaxin collagen medicine film, and its composition is as follows:
Sulphuric acid A Mikaxin is A Mikaxin 2.5g
Collagen fiber 2.5g
A Mikaxin is dissolved in about 100ml distilled water in the conical flask, adds dilution heat of sulfuric acid (0.1N) and make pH value to 4.5.In second conical flask, suspendible in the distilled water of the about 100ml of collagen fiber (Gattefosse batch no.78-I) adding.With magnetization agitator stir about 15 minutes, obtain PH and be 2.9 uniform suspension, add diluted alkaline and make PH to 4.5.
Under agitation, in the collagen suspension, slowly add sulphuric acid A Mika new soln, its uniform suspension is poured in the tray of freeze dryer.
Suspension thickness is about 1.4mm.
Carry out lyophilization according to known technology and can get exsiccant product, it is the spongy solid of rubber-like, is easy to cut into littler part.
Exsiccant product thickness is uniformly, is about 1.3mm.
This desciccate is cut into the diaphragm that size is 5 * 10Cm, and every square centimeter of component content is as follows:
Sulphuric acid A Mikaxin is A Mikaxin 6.7mg
Collagen fiber 2.9mg
These diaphragms are packed in a certain size transparent Polythene Bag, and by hot melt bag mouth are sealed.This kind packing is easy to carry out aseptic process (illuminating method of gamma-radiation) according to known technology.So far obtain the sterile preparation of A Mikaxin collagen, can be used for the treatment of skin ulcer and decubitus ulcer.
Example 2
A Mikaxin collagen medicine film
Preparation A Mikaxin collagen medicine film, its composition is as follows:
Sulphuric acid A Mikaxin is A Mikaxin 2.5g
Collagen fiber 1.0g
Sulphuric acid A Mikaxin is dissolved in the distilled water of about 100ml in the conical flask, and PH is transferred to 4.5 with dilution heat of sulfuric acid (0.1N).In second conical flask, collagen fiber (Gattefosse batch no.78 I) are suspended in the distilled water of about 100ml.With magnetization agitator stir about 15 minutes, obtain uniform suspension, add diluted acid or alkali transfers to 4.5 with pH value.
Under agitation, in the collagen suspension, slowly add sulphuric acid A Mika new soln, obtain uniform suspension, be poured in the tray of freeze dryer.
The about 1.4mm of suspension thickness.
Carry out lyophilization by known technology, obtain rubber-like, spongiform solid drying product, it is easy to be cut into less part.
The product thickness that is dried is even, is about 1.3mm.
Product is cut into the diaphragm of 5 * 10Cm size.Every square centimeter of composition is as follows:
Sulphuric acid A Mikaxin is A Mikaxin 6.7mg
Collagen fiber 1.1mg
In packing diaphragm into a certain size Polythene Bag transparent, bag mouth is sealed by hot melt.This kind packing is easy to carry out aseptic process (with the method for gamma-radiation irradiation) according to known technology.So far obtain containing the aseptic collagen formulations of A Mikaxin.
Example 3
A Mikaxin collagen medicine film
Preparation A Mikaxin collagen medicine film, its composition is as follows:
Sulphuric acid A Mikaxin is A Mikaxin 5.0g
Collagen fiber (Gattefosse) 1.0g
In conical flask, A Mikaxin is dissolved in the distilled water of about 150ml, add dilute hydrochloric acid (0.1N) pH value is transferred to 4.5.In second conical flask, collagen fiber (Gattefosse batch no.78-I) are suspended in the distilled water of about 150ml, to magnetize the agitator stir about 15 minutes, obtain uniform suspension, and pH value is transferred to 4.5.
Under agitation, sulphuric acid A Mika new soln is slowly added in the collagen suspension.The even suspension that obtains is poured in the tray of freeze dryer.
Make suspension thickness be about 1.4mm.
Carry out lyophilization according to known technology, obtain rubber-like, spongiform drying solid product, it is easy to take out from tray.
The thickness of dry products is uniformly, about 1.3mm.
It is as follows that every square centimeter in preparation contains composition:
Sulphuric acid A Mikaxin is A Mikaxin 13.4mg
Collagen fiber 1.1mg
Each thin film is packed in a certain size the transparent Polythene Bag, by hot melt bag mouth is sealed.This kind packing is easy to carry out aseptic process (with the method for gamma-radiation irradiation) according to known technology.So far can obtain the aseptic collagen formulations that contains A Mikaxin.
Example 4
A Mikaxin and hyaluronic acid collagen medicine film
Preparation A Mikaxin collagen medicine film, its composition is as follows:
Sulphuric acid A Mikaxin is A Mikaxin 2.5g
Hyaluroni 0.1g
Collagen fiber (Gattefosse) 2.5g
In conical flask, sulphuric acid A Mikaxin is dissolved in the distilled water of about 150ml, add dilute sulfuric acid (0.1N) pH value is transferred to 4.5.In second conical flask, collagen fiber are suspended in the distilled water of about 150ml.To magnetize the agitator stir about 15 minutes, obtain uniform suspension, and make its pH value transfer to 4.5.
Hyaluroni is dissolved in the other 20ml distilled water.
Under agitation, sulphuric acid A Mika new soln is slowly added in the collagen suspension, add hyaluronic acid solution subsequently.The even suspension that obtains is poured in the tray of freeze dryer.
The thickness of suspension is about 1.4mm.
Carry out lyophilization according to known technology, obtain rubber-like, spongiform, the solid product that is dried, it is easy to take out in tray.
Exsiccant product thickness is even, is about 1.3mm.
It is as follows that every square centimeter in preparation contains composition:
Sulphuric acid A Mikaxin is A Mikaxin 6.7mg
Hyaluroni 0.26mg
Collagen fiber 1.1mg
Diaphragm is made 5 * 10Cm size, and with in its a certain size transparent Polythene Bag of packing into, bag mouth seals by hot melt.This packing is easy to carry out aseptic process (using the gamma-radiation irradiation) according to known technology.So far obtain the aseptic collagen formulations that contains A Mikaxin.
Example 5
Erythromycin collagen medicine film
Preparation erythromycin lactobionate medicine film, its composition is as follows:
Erythromycin lactobionate is erythromycin 1.0g
Collagen fiber (Gattefosse) 1.5g
As ejection preparation, erythromycin salt is dissolved in the water of about 100ml, obtain limpid transparent solution.
According to the step of example 1,, collagen fiber are suspended in the water of about 150ml as ejection preparation.
Antibiotic is added in the collagen suspension, and the mixture that obtains carries out lyophilization and handles by example 1 is described.
The resilient fiber product that obtains being dried, its thickness is about 1.6mm.
Use puncher, cut out the diaphragm of facial film shape, in its transparent Polythene Bag of packing into, and heat sealing.This packing of product also is easy to carry out aseptic process with known technology.The product that obtains is with the form of therapy facial acne of facial film.
Above-mentioned explanation is not restriction, just explains, can use other form (as medicated strip) treatment to be confined to the acne at facial and/or other position of health yet.
Example 6
Clindamycin collagen medicine film
Preparation p chloromethylbenzoic acid lincomycin collagen medicine film, it is composed as follows:
The p chloromethylbenzoic acid lincomycin is clindamycin 1.0g
Collagen fiber (Gattefosse) 1.5g
As ejection preparation, clindamycin salt is dissolved in the water of about 100ml, obtains limpid transparent solution.
Press example 1 described step,, collagen fiber are suspended in the 150ml water as ejection preparation.
Antibiotic solution is added in the collagen suspension, and as described in example 1, the mixture that obtains carries out lyophilization to be handled.
Obtain being dried resilient fiber product, the about 1.6mm of thickness.
Use puncher, be cut into the facial film form, in its transparent Polythene Bag of packing into, and pass through heat sealing.This packing is easy to carry out gamma-radiation according to known technology and disinfects.The sterile product of the medicine form membrane of gained can be treated facial acne.
The said goods also can be made into different form (medicine film) treatment than the face of limitation and the acne at other position of health.
Example 7
Intacellin collagen medicine film
Preparation collagen medicine film, it is composed as follows:
Total intacellin aqueous solution 2.5g
Collagen fiber (Gattefesse-batch
no.78-1） 1.5g
Use is dissolved in it in water of 25ml with the titrating human placental extract's aqueous solution of poly deoxynucleosides (PDRN) and anticomplementary unit (ACU).
Press example 1 described step, collagen fiber are suspended in the water of about 150ml,, aqueous solution is added in the suspension mixing and lyophilization by the described step of preceding example.
The product that will contain aseptic placental collagen fiber is made the band of 10 * 10Cm.
Example 8
Aseptic epidermal growth factor collagen medicine film
The preparation collagen film, it is composed as follows:
Epidermal growth factor (EGF) 50IU
Collagen fiber (Gattefosse) 2.0mg
Described by preceding example, collagen fiber are suspended in the water, stir, make it into uniform suspension.
In other conical flask, epidermal growth factor is water-soluble rapidly, and temperature is no more than 20 ℃ during operation.
Gained solution adds in the suspension rapidly, and stirs; Mixture is poured in the tray of freeze dryer, and is freezing rapidly, and lyophilization.
Exsiccant product is cut into required size, as stated above packing.
Example 9
Semen Tritici aestivi extract collagen medicine film
Preparation collagen medicine film, its composition is as follows:
Total Semen Tritici aestivi extract aqueous solution 1.0g
Collagen fiber (Gattefosse) 0.8g
The aqueous solution of Semen Tritici aestivi extract is added in the collagen suspension of 20ml water.
Suspension is easy to the lyophilization processing uniformly, obtains the collagen medicine film of 10 * 5Cm, but packs with the Polythene Bag of hot melt sealing subsequently.
This packaging product is easy to sterilization.
Example 10
Naproxen sodium collagen medicine film
Preparation collagen medicine film, its composition is as follows:
Naproxen sodium 1.0g
Collagen fiber (Gattefosse) 1.0g
Naproxen sodium is dissolved in the distilled water of 200ml, adds a small amount of collagen fiber again, continue to stir with the magnetization agitator.
With uniform suspension lyophilization, the collagen medicine film of gained is cut into a certain size also sterilization wrap as stated above.
Example 11
Polygynax collagen medicine film
Preparation 150ml contains the collagen powder aqueous solution of 10.0g, and the polygynax of 5.0g is dissolved in this solution.
The faint yellow clear solution of gained is carried out atomization drying with atomizing dryer (B ü chi Mod.190 mini Spray Dryer) and is handled.Make temperature at 80 ℃, obtain exsiccant flowable powder, this powder is easy to pack in the bottle, and with radiation sterilization, it can be as treatment damage of spray medication powder or excoriation.
Example 12
What be used for vagina contains Acycloguanosine sodium collagen medicine film
Preparation vagina administration medicine film, its composition is as follows:
Acyclovir 5.0g
Collagen fiber (Gattefosse) 2.2g
Collagen is suspended in about 40ml water, the 5g Acycloguanosine sodium is dissolved in about 15ml water.
Solution is added above-mentioned suspension.
Pour solution into brass die (bolt shape), and make its size become diameter 12mm length 55mm.The solution amount that each mould contains is equivalent to the 500mg active component.
Suspension is refrigerated to-40 ℃ rapidly.Open mould,, make it be easy to lyophilization and handle the cooling once more immediately (-50 ℃ approximately) in the lyostat box of resulting column suppository.This collagen medicine film treatment gynaecopathia toxicity illness (genitals herpes simplex etc.) is very convenient.This preparation is step packing, sterilization routinely also.
Example 13
The Acycloguanosine sodium collagen that contains that is used for eye embeds film
The preparation eye is with embedding film, and its composition is as follows:
Acycloguanosine sodium 4.0mg
Collagen 0.5mg
Prepare this and embed film, the aqueous solution of the collagen suspension of elder generation's preparation 0.6%, 5 minutes 2500rpm are mixed suspension even with Ultra-Turrax device (JKA-Germany).
Also can use the low-molecular-weight natural collagen to obtain solubility or biological absorbable preparation.
With the no long fibre chain collagen of gained or the even suspension of low-molecular-weight collagen, add in the acyclovir sodium solution in the distilled water.
The gained mixture is at about 600Cm
2Tray in lyophilization handle.Operating procedure obtains exsiccant glued membrane routinely, with puncher glued membrane is made fourth of the twelve Earthly Branches shape diaphragm, size 3 * 8mm.
To embed film and pack into by (bubble type) in the box, step carries out disinfection to obtain aseptic pharmaceutical preparation routinely.
Claims (8)
1, preparation contains the method for the drug powder or the medicine film of collagen, and wherein, collagen is that insoluble fibre collagen or powdery natural collagen are formed, and this method comprises: with insoluble collagen or powdery natural collagen and active ingredient and mixed with excipients.
2, the process of claim 1 wherein that containing collagen medicine film is to form by having the water-fast fiber collagen that surpasses 285,000 Dalton molecular weights.
3, the process of claim 1 wherein that containing the collagen drug powder is to be lower than 300,000 daltonian solubility natural collagens compositions by having molecular weight.
4, the method for claim 1 is characterized by: the content of Collagen material is 20～99% in the medicament.
5, the process of claim 1 wherein that active ingredient is selected from:
-aminoglycosides antibiotics (A Mikaxin, kanamycin, neomycin, paromomycin, rickamicin, tobramycin, netilmicin, dibekacin, clindamycin, lincomycin)
-erythromycin derive antibiotic and other antibiotic
-promotion medicine: dermatan sulfate, heparin sulfate, benzoyl peroxide, glycosamine glucosan, sulfo-mucopolysaccharide, chitin, chitosan, meso polysaccharide, O-(beta-hydroxyethyl) rutin
-hyaluronic acid, and salt and derivant
Steroidal anti-inflammatory drugs (beclomethasone dipropionate, hydrocortisone)
-nonsteroidal antiinflammatory drug (ketoprofen, pyrroles's former times health, ibuprofen, Ibuproben-Lysiante, ketoprofen lysinate, the acid of sulfo-ibuprofen, tenoxicam, indometacin, nimesulide)
-chemotherapeutant (sulfanilamide, sulfadiazine silver colloid, ofloxacin)
-epidermal growth factor, Semen Tritici aestivi and other plant source extraction of active ingredients thing
-antiseptic and disinfectant (methylene blue, mercurochrome, alkaline fuchsin, chlorhexidine gluconate)
-antiviral agent (acyclovir, iodouracil desoxyriboside, inosine, pranobex, interferon, ribavirin, arabinose gland former times phosphate etc.)
-have the peptide and a polypeptide (insulin, calcitonin) of pharmacological action
-beta-Blocking agent (metoprolol, atenolol)
-calcium antagonist (nifedipine, two nifedipines, sulfur nitrogen
Ketone)
-antifungal medicine (econazole, dioxygen benzene imidazoles and derivant thereof)
-antihistamine drug (terfenadine, color polysaccharide sodium)
-heparin and low molecular weight part thereof.
6, the process of claim 1 wherein that active component content is 0.001% to 90%.
7, the process of claim 1 wherein and contain the collagen powder or the medicine film contains the active component that can mutually combine.
8, the process of claim 1 wherein and contain collagen powder or medicine film contain high adherence to mucosa or skin surface reagent or excipient.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN92110754A CN1084080A (en) | 1992-09-17 | 1992-09-17 | The pharmaceutical composition that contains collagen |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN92110754A CN1084080A (en) | 1992-09-17 | 1992-09-17 | The pharmaceutical composition that contains collagen |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1084080A true CN1084080A (en) | 1994-03-23 |
Family
ID=4944964
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN92110754A Pending CN1084080A (en) | 1992-09-17 | 1992-09-17 | The pharmaceutical composition that contains collagen |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1084080A (en) |
-
1992
- 1992-09-17 CN CN92110754A patent/CN1084080A/en active Pending
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