CN103127388B - A kind of biological controlled-released film formulation and biological controlled-released film production process thereof - Google Patents
A kind of biological controlled-released film formulation and biological controlled-released film production process thereof Download PDFInfo
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- CN103127388B CN103127388B CN201210533026.3A CN201210533026A CN103127388B CN 103127388 B CN103127388 B CN 103127388B CN 201210533026 A CN201210533026 A CN 201210533026A CN 103127388 B CN103127388 B CN 103127388B
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Abstract
The invention provides a kind of biological controlled-released film formulation and biological controlled-released film production process thereof, adopt the Pseudobulbus Bletillae (Rhizoma Bletillae), the leachate of Rhizoma Dioscoreae adds the biological controlled-released film that processing that the pigskin collagen that obtains after oligochitosan enzyme enzymolysis Corii Sus domestica and sodium carboxymethyl cellulose raw material carry out patented technology prepares, a kind of brand-new, efficiently, safety, nontoxic, localized sustained administration, therapeutic effect is good, no pain, in tract, adhesion is strong, environmental protection, the biological controlled-released film for the treatment of both the principal and secondary aspects of a disease, for treatment female cervical erosion, can be used for substituting all kinds of dosage forms of curing the symptoms, not the disease in the past, also may be used for the prevention and restoration that human oral cavity mucosa is festered, the isolation of human body skin wound, hemostasis, granulation promoting infection, and tinea, Wen Chong Cheng stings, the many aspects such as antipruritic infection.Have internally, external environment is pollution-free, there is environmental protection, safety non-toxic, carry medicine after ingredient stability, meet water or body transudate combines more closely, the feature of continuous controlled delivery administration.
Description
Technical field
The present invention relates to medical accessory biological technical field, especially a kind of biological controlled-released film formulation and biological controlled-released film production process thereof.
Technical background
Show through medical statistics data, the cervical erosion of women, namely usually described chronic cervicitis, it is the commonly encountered diseases of numerous women, frequently-occurring disease, its prevalence accounts for about 70% of adult female's sum, if ill women is after ill, disease cannot obtain rationally, effective treatment, the state of an illness then can by mild-moderate-severe, even cervical atypical hyperplasia can be developed into, finally cause the generation of cervical cancer, the cause of disease of cervical erosion is caused mostly to be caused by pathogenic microorganism, by its be virus, and sanitation Ministry tissue's whole nation birth defects monitoring in Beijing area shows: because cervical erosion causes pathogenic microorganism up, causing the total incidence of the infection of fetus by birth canal is 13.7%, the baby of the various defect of 760,000 trouble of namely just having an appointment in annual birth 7,000 ten thousand babies, all cause because parent suffers from cervical erosion, therefore actively effectively cervical erosion is treated, be not only the health for women self, also be the normal development ensureing fetus simultaneously, the major issue that prenatal and postnatal care is improved the overall quality of the population.In prior art, treatment cervical erosion not yet finds desirable Therapeutic Method both at home and abroad at present, though have hundreds and thousands of kinds of gynecological lotions, irrigation, bolt, gel, comprise oral formulations, but finally can not solve more this problem, especially the cervical erosion of more than moderate is treated, or traditional laser to be adopted, freezing, electricity irons or the method such as LEEP cutter, but these methods can cause damage in various degree in womb local, scar, if some cicatrix generation contractures, may make cervix uteri be out of shape, affect the fertility of Women of childbearing age; And some cicatrixes come off and may cause massive hemorrhage, bring greatest misery to female patient.Meanwhile, traditional Therapeutic Method cannot be applicable to use intrauterine contraceptive loop and the women of generation cervical erosion cures disease.
Summary of the invention
The object of this invention is to provide to be formed on wound and continue isolation, protection, controlled release drug administration, sterilization, sterilization, the biological controlled-released film formulation of one of reparation wound and biological controlled-released film production process thereof.
In order to achieve the above object, the invention provides following technical scheme: a kind of biological controlled-released film formulation, by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 50%-70%, Rhizoma Dioscoreae leachate 3%-10%, the pigskin collagen 15%-25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 10%-20% forms.
A kind of biological controlled-released film is planar monolayer structure, biological controlled-released film thickness: 0.01mm-1mm, preferred thickness: 0.1mm-0.5mm.
A production technology for biological controlled-released film, comprises the steps:
1) Pseudobulbus Bletillae (Rhizoma Bletillae) leachate preparation section, soaks the Pseudobulbus Bletillae (Rhizoma Bletillae) with deionized water, preparation Pseudobulbus Bletillae (Rhizoma Bletillae) leachate;
2) Rhizoma Dioscoreae leachate preparation section, soaks Rhizoma Dioscoreae with deionized water, preparation Rhizoma Dioscoreae leachate;
3) enzymolysis pigskin collagen preparation section, decocts with water with fresh unhairing fat raw pig skin, adds oligochitosan enzymology;
4) sodium carboxymethyl cellulose manufacturing procedure, dissolves sodium carboxymethyl cellulose completely with deionized water for subsequent use.
5) formula material mixed processes, by step 1) to step 4) prepared by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate, Rhizoma Dioscoreae leachate, the pigskin collagen obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose liquid, takes according to formula ratio, stirs after mixing;
6) gel leaches agent preparation section, by step 5) the formula material mixed liquor that obtains be placed on flat smooth flat board on request thickness pave, at 30 DEG C--in 35 DEG C of gnotobasiss, be dried to gel and leach agent.
Described step 1) Pseudobulbus Bletillae (Rhizoma Bletillae) leachate preparation section and step 2) in Rhizoma Dioscoreae leachate preparation section, the Pseudobulbus Bletillae (Rhizoma Bletillae) or Rhizoma Dioscoreae soak 72 hours in deionized water.
Described step 3) enzymolysis pigskin collagen preparation section in, slow fire boiling Corii Sus domestica 5 hours, stops decoction being cooled to after room temperature until pigskin collagen and adding 1% oligochitosan enzyme again.
Above-mentioned steps 3) enzymolysis pigskin collagen preparation section in, add oligochitosan enzyme, enzymology 12 hours.
The present invention is that a kind of brand-new, efficient, safe, nontoxic, localized sustained administration, therapeutic effect are good, no pain, in tract, adhesion is strong, environmental protection, the biological controlled-released film for the treatment of both the principal and secondary aspects of a disease, for treatment female cervical erosion, can be used for substituting all kinds of dosage forms of curing the symptoms, not the disease in the past, the prevention and restoration that the present invention also may be used for festering to human oral cavity mucosa, the isolation of human body skin wound, hemostasis, granulation promoting infection, and the many aspects such as tinea, Wen Chong Cheng sting, antipruritic infection.
The present invention is internal, external environment is pollution-free, has environmental protection, safety non-toxic, carries ingredient stability after medicine, meets water or body transudate combines more closely, the feature of continuous controlled delivery administration.
Detailed description of the invention
Below in conjunction with the present invention, be clearly and completely described technical scheme of the present invention, obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art, not making the every other embodiment obtained under creative work prerequisite, belong to the scope of protection of the invention.
Embodiment 1: a kind of biological controlled-released film formulation, its formula is: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 60%, Rhizoma Dioscoreae leachate 5%, and the pigskin collagen 20% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 15% forms.
Embodiment 2: a kind of biological controlled-released film formulation, its formula is: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 50%, Rhizoma Dioscoreae leachate 10%, and the pigskin collagen 25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 15% forms.
Embodiment 3: a kind of biological controlled-released film formulation, its formula is: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 55%, Rhizoma Dioscoreae leachate 7%, and the pigskin collagen 25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 13% forms.
Embodiment 4: a kind of biological controlled-released film formulation, its formula is: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 67%, Rhizoma Dioscoreae leachate 3%, and the pigskin collagen 15% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 15% forms.
Embodiment 5: a kind of biological controlled-released film formulation, its formula is: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 50%, Rhizoma Dioscoreae leachate 5%, and the pigskin collagen 25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 20% forms.
The biological controlled-released film of the one obtained by formula of the present invention is planar monolayer structure, biological controlled-released film thickness: 0.01mm-1mm, preferred thickness: 0.1mm-0.5mm, and shape is not limit, as long as be suitable for using.
A production technology for biological controlled-released film, comprises the steps:
1) Pseudobulbus Bletillae (Rhizoma Bletillae) leachate preparation section, soaks the Pseudobulbus Bletillae (Rhizoma Bletillae) with deionized water and soaks 72 hours, preparation Pseudobulbus Bletillae (Rhizoma Bletillae) leachate;
2) Rhizoma Dioscoreae leachate preparation section, soaks Rhizoma Dioscoreae with deionized water and soaks 72 hours, preparation Rhizoma Dioscoreae leachate;
3) preparation section of enzymolysis pigskin collagen, decocts with water slow fire boiling after 5 hours with fresh unhairing fat raw pig skin, adds 1% oligochitosan enzyme, enzymology 12 hours;
4) sodium carboxymethyl cellulose manufacturing procedure, dissolves sodium carboxymethyl cellulose completely with deionized water for subsequent use.
5) formula material mixed processes, by step 1) to step 4) prepared by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate, Rhizoma Dioscoreae leachate, the pigskin collagen obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose liquid, takes according to formula ratio, stirs after mixing;
6) gel leaches agent preparation section, by step 5) the formula material mixed liquor that obtains be placed on flat smooth flat board on request thickness pave, as glass plate etc., at 30 DEG C--in 35 DEG C of gnotobasiss, be dried to gel and leach agent.
The present invention be adopt the Pseudobulbus Bletillae (Rhizoma Bletillae) of integration of edible and medicinal herbs, Rhizoma Dioscoreae leachate is equipped with the pigskin collagen after " oligochitosan enzyme " enzymolysis, and the biological controlled-released film that the mutual proportioning of the sodium carboxymethyl cellulose of control degradation speed is combined into.
The present invention adopts bletilla, cold nature, bitter in the mouth, sweet, puckery, return lung, liver, stomach warp, modern study shows, Pseudobulbus Bletillae (Rhizoma Bletillae) leachate has hemostasis, protection mucosa, antibacterial, antifungal, anticancer and protective effect on cancer risk, Pseudobulbus Bletillae (Rhizoma Bletillae) leachate, in hemostasis, can strengthen platelet factor III active, significantly shortens clotting time and thrombinogen formation time, suppress plasmin enzymatic activity, have anastalsis to local hemorrhage; Antibiosis, has very strong inhibitory action to staphylococcus aureus, bacillus subtilis, Bacillus tuberculosis, microsporon audouini, Candida albicans ATCC1057 and Trichophyton QM248.
The present invention adopts traditional Chinese medicine Chinese yam, property is put down, sweet in the mouth, returns spleen, lung, kidney channel, through modern medicine study, Rhizoma Dioscoreae Aqueous extracts significantly can suppress Cu2+, to the Denaturation of gamma Globulin, have antiinflammation, Rhizoma Dioscoreae Aqueous extracts can eliminate urine protein, mutant cell is had to the effect suppressing to produce, the copper ion in medicine and connective tissue have very big help to human development.
The present invention uses enzymolysis pigskin collagen, the Pseudobulbus Bletillae (Rhizoma Bletillae) leachate that former combination viscosity is not given prominence to and the leachate of Rhizoma Dioscoreae be combined with each other tightr, simultaneously after being applicable to human body, with human body transudate rapidly in conjunction with the film of formation, more outstanding to the adhesiveness of skin, tract mucosa, the feature such as degraded and absorbed and breathability.
The present invention uses sodium carboxymethyl cellulose to control the degradation rate of prescription drug, and the prescription drug of use reaches rational degradation speed.
Membrane matrix of the present invention enters after tract leaches; can be combined with body tract transudate; and form a kind of Global Macros film and be attached in whole tract; and do not come off; thus the effect such as lasting isolation, protection, controlled release drug administration, sterilization, sterilization, reparation really reached wound; sticked on the uterine erosion face of women by this biological controlled-released film, uterine erosion face is well isolated, sterilization, antiinflammatory make the rotten to the corn fast treating in palace and reparation.
According to the physical characteristic of biological controlled-released film, by extending for this technology in the prevention and restoration festered to human oral cavity mucosa, the isolation of human body skin wound, hemostasis, granulation promoting infection, and the many aspects such as tinea, Wen Chong Cheng sting, antipruritic infection, therefore can this biological controlled-released film be applied on bandage, bandage is upgraded, there is stronger protection buffer action, make wound sterilization, antiinflammatory, reparation fast.
The results showed, water absorption of the present invention is 20%-30%; Thickness its pulling force Strong degree when 0.1mm-0.5mm is 20MP; Conventional and accelerated test result shows: this biological controlled-released film is stable and test this biological controlled-released film of proof to human non-toxic, harmless through Wuhan Tongji Medical Univ.'s long_term toxcity experiment, acute toxicological experiment, skin hypersensitivity experiment, mucous membrane irritation experiment etc.
The above; be only the specific embodiment of the present invention, but protection scope of the present invention is not limited thereto, is anyly familiar with those skilled in the art in the technical scope that the present invention discloses; change can be expected easily or replace, all should be encompassed within protection scope of the present invention.Therefore, protection scope of the present invention should described be as the criterion with the protection domain of claim.
Claims (10)
1. a biological controlled-released film, is characterized in that: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 50%-70%, Rhizoma Dioscoreae leachate 3%-10%, and the pigskin collagen 15%-25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 10%-20% forms.
2. biological controlled-released film according to claim 1, is characterized in that: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 60%, Rhizoma Dioscoreae leachate 5%, and the pigskin collagen 20% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 15% forms.
3. biological controlled-released film according to claim 1, is characterized in that: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 50%, Rhizoma Dioscoreae leachate 5%, and the pigskin collagen 25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 20% forms.
4. biological controlled-released film according to claim 1, is characterized in that: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 50%, Rhizoma Dioscoreae leachate 10%, and the pigskin collagen 25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 15% forms.
5. biological controlled-released film according to claim 1, is characterized in that: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 55%, Rhizoma Dioscoreae leachate 7%, and the pigskin collagen 25% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 13% forms.
6. biological controlled-released film according to claim 1, is characterized in that: by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate 67%, Rhizoma Dioscoreae leachate 3%, and the pigskin collagen 15% obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose 15% forms.
7. a production technology for the arbitrary described biological controlled-released film of claim 1 to 6, is characterized in that:
Comprise the steps:
1) Pseudobulbus Bletillae (Rhizoma Bletillae) leachate preparation section, soaks the Pseudobulbus Bletillae (Rhizoma Bletillae) with deionized water, preparation Pseudobulbus Bletillae (Rhizoma Bletillae) leachate;
2) Rhizoma Dioscoreae leachate preparation section, soaks Rhizoma Dioscoreae with deionized water, preparation Rhizoma Dioscoreae leachate;
3) enzymolysis pigskin collagen operation, decocts with water with fresh unhairing fat raw pig skin, add oligochitosan enzyme enzymology obtain enzymolysis after pigskin collagen;
4) sodium carboxymethyl cellulose manufacturing procedure, dissolves sodium carboxymethyl cellulose completely with deionized water for subsequent use;
5) formula material mixed processes, by step 1) to step 4) prepared by Pseudobulbus Bletillae (Rhizoma Bletillae) leachate, Rhizoma Dioscoreae leachate, the pigskin collagen obtained after oligochitosan enzyme enzymolysis Corii Sus domestica, sodium carboxymethyl cellulose liquid, takes according to formula ratio, stirs after mixing;
6) gel leaches agent preparation section, by step 5) the formula material mixed liquor that obtains be placed on flat smooth flat board on request thickness pave, at 30 DEG C--in 35 DEG C of gnotobasiss, be dried to gel and leach agent.
8. the production technology of a kind of biological controlled-released film according to claim 7, is characterized in that: described step 1) Pseudobulbus Bletillae (Rhizoma Bletillae) leachate preparation section and step 2) in Rhizoma Dioscoreae leachate preparation section, the Pseudobulbus Bletillae (Rhizoma Bletillae) or Rhizoma Dioscoreae soak 72 hours in deionized water.
9. the production technology of a kind of biological controlled-released film according to claim 7, it is characterized in that: described step 3) in the preparation section of enzymolysis pigskin collagen, slow fire boiling Corii Sus domestica 5 hours, stops decoction being cooled to after room temperature until pigskin collagen and adds 1% oligochitosan enzyme again.
10. the production technology of a kind of biological controlled-released film according to claim 7, is characterized in that: described step 3) in enzymolysis pigskin collagen preparation section, add oligochitosan enzyme, enzymology 12 hours.
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| CN104984359A (en) * | 2015-05-28 | 2015-10-21 | 杭州优玛达生物科技有限公司 | Biological membrane and application of close structure or cellular compartment with biological membrane performance serving as vaccine carrier or immunomodulator |
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| CN1321475A (en) * | 2000-04-29 | 2001-11-14 | 翁维健 | Chinese medicine gel powder |
| CN101224277A (en) * | 2008-01-24 | 2008-07-23 | 陶谦 | Sticking membrane for mucous membrane after septoplasty |
| CN101524544A (en) * | 2008-03-07 | 2009-09-09 | 大连永兴生物医药孵化器有限公司 | Composite gel film agent |
| CN101648003A (en) * | 2008-08-13 | 2010-02-17 | 北京和润创新医药科技发展有限公司 | Medicinal composition for treating gynecological inflammation and application thereof |
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Address after: 430040 Hubei province Wuhan City Qiaokou District Jixian Village No. 162-1 Applicant after: Ren Xin Address before: 430040 Wu Guang office building, 688 Jiefang Avenue, Jianghan District, Hubei, Wuhan, 43A-11 Applicant before: Ren Xin |
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Effective date of registration: 20181218 Address after: 332000 Jiujiang City Jiujiang Economic and Technological Development Zone Comprehensive Industrial Park Jiujiang Sapphire Technology Co., Ltd. No. 3 Workshop Patentee after: Jiangxi Yuanshengji Health Technology Co., Ltd. Address before: 430040 Jixian Village No. 162-1, Qiekou District, Wuhan City, Hubei Province Patentee before: Ren Xin |