CN101543658B - Cervical cap for preventing and treating cervical erosion and preparation method thereof - Google Patents
Cervical cap for preventing and treating cervical erosion and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a cervical cap which is placed on a cervical orifice and prevents and treats cervical erosion and a preparation method thereof. The cervical cap for preventing and treating cervical erosion consists of an implanting part which extends into the cervical orifice and a coating part which is connected with the bottom of the implanting part, wherein the coating part is coated on the outside of the cervical orifice, takes biocompatible materials as substrate materials, and is mixed with medicaments for preventing and treating cervical erosion. The invention is characterized in that the effective composition of the medicines is chito-oligosaccharide/iodine complex to ensure that the iodine content in the cervical cap is between 80 and 90 milligrams of iodine per gram of the cervical cap; and the chito-oligosaccharide/iodine complex comprises the following compositions in percentage by weight: 0.5 to 1 percent of citric acid, 6 to 8 percent of gelatin, 0.2 to 0.5 percent of sodium hyaluronate, 6 to 8 percent of carboxymethyl chitosan, 0.1 to 0.3 percent of emulsifier, 25 to 35 percent of iodine-chitosan solution, and the balance of deionized water. The invention also provides the preparation method. The cervical cap directly contacts the external cervical orifice and not only protects cervical mucosa from being invaded by foreign viral microorganisms but also has the functions of virus killing, antibacterium and sterilization.
Description
Technical field
The present invention relates to a kind of diaphragm, especially a kind of place cervix uteri mouth place prevent and treat diaphragm of cervical erosion and preparation method thereof.
Background technology
A kind of diaphragm is now arranged on the market, be made of with the coating section that is connected bottom inserting section the section of inserting that stretches into from the cervix uteri mouth, as for cervix uteri mouth place, the muscle tone location by cervix uteri mouth place can prevent and treat cervical erosion effectively with this diaphragm.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of bactericidal effect good, the diaphragm of preventing and treating cervical erosion of sterilization longer duration.
Another technical problem to be solved by this invention is to provide above-mentioned preparation method of preventing and treating the diaphragm of cervical erosion.
The present invention solves the problems of the technologies described above the technical scheme of taking: a kind of diaphragm of preventing and treating cervical erosion, consisted of with the coating section that bottom inserting section, is connected by the section of inserting that stretches into from the cervix uteri mouth, coating section is coated on the outside of cervix uteri mouth, it is take biocompatible materials as matrix material, mixed to prevent and treat the medicine of cervical erosion, wherein, the effective ingredient of described medicine is chitin oligosaccharide/iodine coordination compound, making the interior amount of iodine of diaphragm is 80～90mg iodine/g diaphragm, comprises by weight percentage following component:
Citric acid 0.5%～1%
Gelatin 6%～8%
Hyaluronate sodium 0.2%～0.5%
Carboxymethyl chitosan 6%～8%
Emulsifying agent 0.1%～0.3%
Chitosan iodine solution 25%～35%
Other are deionized water or other solvents etc.
In the each component, arbitrary value between the citric acid 0.5%, 0.6%, 0.7%, 0.8%, 0.9% or 1%; Arbitrary value between the gelatin 6%, 7% or 8%; Arbitrary value between the hyaluronate sodium 0.2%, 0.3%, 0.4% or 0.5%; Arbitrary value between the carboxymethyl chitosan 6%, 7% or 8%; Arbitrary value between the emulsifying agent 0.1%, 0.2% or 0.3%; Arbitrary value between the chitosan iodine solution 25%, 30% or 35%.
Should illustrate: product iodine allergy person of the present invention avoids usefulness.
On the basis of such scheme, the saturated suction ratio of described diaphragm is 1: 10～12.
On the basis of such scheme, the coating section of described diaphragm is spherical shape, and fits tightly with the cervix uteri mouth, guarantees that under the tension force of cervix uteri, diaphragm can not come off, and the contact area that strengthens simultaneously can improve the effect of preventing and treating cervical erosion.
On the basis of such scheme, for the applying effect of coating section further is provided, described coating section and to insert the angle that consists of between the section be 45 °～85 °.
On the basis of such scheme, described coating section and insert the angle that consists of between the section and be preferably 65 °～75 °
On the basis of such scheme, in order to reduce this diaphragm in use to twinge and the wearing and tearing of cervix uteri mouth, the outer of described coating section is that circular arc is excessive.
The invention provides a kind of preparation method for the above-mentioned diaphragm of preventing and treating cervical erosion, citric acid, gelatin, hyaluronate sodium, carboxymethyl chitosan, emulsifying agent, chitosan iodine solution are mixed by above-mentioned prescription, in the mould of tool diaphragm shaped inner chamber, adopt the lyophilization molding to make.
The invention has the beneficial effects as follows:
Chitosan can be very fast in the vagina weak acid environment well dissolving, diaphragm directly contacts the external os of vervix, has both protected cervical mucosa not to be subjected to the infringement of adventitious viruses microorganism, kills again the viral micro-organisms of mucomembranous surface, realizes thorough antibiotic and sterilizing function;
And the external form of diaphragm is well in conjunction with women's cervix uteri construction features.
Description of drawings
Fig. 1 diaphragm of the present invention is at the structural representation of in-mold molding.
Attached number in the figure explanation
The 1-mould
2-diaphragm diaphragm 21-inserts section
22-coating section 221-outer
The specific embodiment
A kind of diaphragm of preventing and treating cervical erosion, consisted of with the coating section that bottom inserting section, is connected by the section of inserting that stretches into from the cervix uteri mouth, coating section is coated on the outside of cervix uteri mouth, it is take biocompatible materials as matrix material, mixed to prevent and treat the medicine of cervical erosion, wherein, the effective ingredient of described medicine is chitin oligosaccharide/iodine coordination compound, making the interior amount of iodine of diaphragm is 80～90mg iodine/g diaphragm, comprises by weight percentage following component:
Citric acid 0.5%
Gelatin 6%
Hyaluronate sodium 0.25%
Carboxymethyl chitosan 6%
Emulsifying agent 0.1%
Chitosan iodine solution 30%
Other are deionized water.
Preparation method is: citric acid, gelatin, hyaluronate sodium, carboxymethyl chitosan, emulsifying agent, chitosan iodine solution are mixed by above-mentioned prescription, adopt lyophilization to make in the mould of tool diaphragm shaped inner chamber.
See also Fig. 1 and be diaphragm of the present invention at the structural representation of in-mold molding, diaphragm 2 is made of with the coating section 22 that is connected with the section of inserting 21 bottoms the section of inserting 21 that stretches into from the cervix uteri mouth.Described coating section 22 and to insert the angle that consists of between the section 21 be 68 °, the coating section 22 that is spherical shape is coated on the outside of cervix uteri mouth, and fits tightly with the cervix uteri mouth, and the outer 221 of described coating section 22 is that circular arc is excessive.
Diaphragm 2 molding in the mould 1 of form fit with it, the section of inserting 21 inboard form porose.
It is yellow or white that the product diaphragm is, and without obvious impurity, build is complete, and diameter is 25～35mm, highly is not more than 20mm, and weight is not less than 150mg, and saturated suction ratio is not less than 1: 8.
Below be to experimental study of the present invention: lot number of the present invention is 2005042001.
1. prevent and treat the diaphragm extracorporeal disinfecting experimental study of cervical erosion
1.1 research purpose
Mensuration is prevented and treated effective ingredient minimum bactericidal concentration (MBC) and the persistent period bactericidal effect of cervical erosion diaphragm.
1.2 materials and methods
1.2.1 material
1.2.1.1 tested medicine
Preventing and treating cervical erosion diaphragm effective ingredient is chitin oligosaccharide/iodine coordination compound, and the brownish red soft solid contains available iodine 85mg iodine/g diaphragm, and lot number 20050321 is provided by Jiaxing City Shu Fute bio tech ltd.Dissolved in distilled water is used in test.
1.2.1.2 test strain
Staphylococcus aureus, escherichia coli, bacillus pyocyaneus, enterococcus faecalis, Klebsiella Pneumoniae, Candida albicans, each 10 strain clinical isolates of gonococcus 7 strain strains are by clinical laboratory of Hangzhou Chinese Medicinal Hospital isolation identification from patient.
1.2.1.3 reference culture
Large intestine Erichsen bacterium ATCC25922, staphylococcus aureus ATCC25923, Pseudomonas aeruginosa ATCC27853, Candida albicans ATCC10231 are preserved by this laboratory.
1.2.1.4 culture medium
MH agar, broth bouillon, gonococcus culture medium, husky Bao Luoshi agar, broth bouillon are provided by sky, Hangzhou and microorganism reagent company limited.
1.2.2 method
Adopt tube dilution method.With reference to the People's Health Publisher, the 1647th～1661 page of correlation technique of " pharmacological experimental methodology " third edition of the chief editors such as Xu Shuyun carries out.
1.2.2.1 minimum bactericidal concentration (MBC) is measured
The lawn that takes a morsel respectively from each strain inclined plane of preserving before the test, escherichia coli, bacillus pyocyaneus, Klebsiella Pneumoniae are seeded in respectively in the MH broth bouillon; Staphylococcus aureus, enterococcus faecalis and gonococcus are seeded in respectively in 0.5% glucose broth; Candida albicans is seeded in the husky Bao Luoshi broth bouillon.Below all in 37 ℃ of cultivation 16～18h, as test organisms stock solution, then with corresponding broth bouillon that the antibacterial dilution is for subsequent use into about 107CFU/mL.In containing the meat soup culture tube (control tube adds the 1.8mL broth bouillon) of variable concentrations (100,200,300,400,500,600,700 and 800) chitosan derivatives, 1.8mL inoculates respectively above-mentioned each bacterium liquid 0.2mL for subsequent use, observed result behind 37 ℃ of cultivation 18h～24h, draw 0.1mL in the culture tube with asepsis growth, be inoculated in the corresponding broth bouillon, cultivate 18h～24h observed result in 37 ℃ again.Take the minimum tested drug level of asepsis growth as minimum bactericidal concentration (MBC).
1.2.2.2 the time meta-disinfecting effect observing
According to time-kill curve method (KCs); the accurate staphylococcus aureus ATCC25923 of label taking, large intestine Erichsen bacterium ATCC25922, Pseudomonas aeruginosa ATCC27853, each strain of Candida albicans ATCC10231 bacterial strain; cultivate 16～18h for 37 ℃ in MH broth bouillon and husky Bao Luoshi broth bouillon, it is for subsequent use then with corresponding broth bouillon antibacterial to be diluted to 107CFU/mL.Get sterile test tube, mark test pipe and control tube add respectively the broth bouillon that 1.8mL contains the variable concentrations chitosan derivatives in the developmental tube respectively, and control tube adds the 1.8ml broth bouillon, inoculates respectively above-mentioned each bacterium liquid 0.2ml (final concentration about 10 for subsequent use
6CFU/ml), behind 37 ℃ of cultivations 0,4h, 8h and 24h, respectively get 0.1ml, through suitably being inoculated on MH and the husky Bao Luoshi agar plate after the dilution, evenly be coated with inoculation with the L-type glass rod.Cultivate 18h～24h for 37 ℃ and calculate clump count.
1.3 result of study
Chitosan derivatives is through the Minimum bactericidal concentration to 7 strain strains (70 strain clinical isolates), and the result is respectively: Candida albicans and gonococcus (MBC
90Be 200mg/L), staphylococcus aureus and enterococcus faecalis (MBC
90Be 400mg/L), Klebsiella Pneumoniae (MBC
90Be 600mg/L), escherichia coli and bacillus pyocyaneus (MBC
90Be 700mg/L), see table 1 for details.
Chitosan derivatives shows that to the bactericidal effect of 4 strain standard bacterium different times (0,4h, 8h, 24h) chitosan derivatives is 8 hours to the maximum sterilizing time of staphylococcus aureus and Pseudomonas aeruginosa; Maximum sterilizing time to large intestine Erichsen bacterium and Candida albicans is 4 hours.
Table 1, prevent and treat the cervical erosion diaphragm to the minimal bactericidal concentration (MBC) of each bacterial strain
1.4 research conclusion
According to above result of the test, lot number is that 20050321 " preventing and treating the cervical erosion diaphragm " has stronger bactericidal effect, and its sterilizing time is in 4～8 hours.
2. prevent and treat cervical erosion diaphragm guinea pig skin sensitivity test
2.1 test objective
Observe animal skin and repeat to contact the performance of collective's immune system response on skin after the tested material.
2.2 experimental animal
Healthy Hartley Cavia porcellus, the whole white hair, 50, body weight is 300～400g, ♀ ♂ dual-purpose is by the supply of Shin Wong, Shanghai laboratory animal plant, the animal quality quality certification: SCHK (Shanghai) 2002-0011.
2.3 feeding and management
Raising is bright with cleaning, 22～24 ℃ of temperature, and relative humidity 50～60%, natural lighting, high zoopery is indoor with dividing.Feed full nutrition pellet is supplied by Zhejiang Province's laboratory animal Feed Manufacturing supply base.Drinking-water is packed into after with Water purifier filter for city tap-water and is allowed it freely drink in the Water drinking basin of sterilizing.
2.4 tested material
2.4.1 prevent and treat the cervical erosion diaphragm
The brownish red paste, water-soluble, available iodine content: 80mg iodine/g diaphragm, drying at room temperature is preserved, lot number: 2005042001, provided by Jiaxing City Shu Fute bio tech ltd, the time spent is mixed with desired concn with deionized water.
2.4.2 deionized water
Standby with RO-MB-20D type reverse osmosis high purity water mechanism, made by oneself by this laboratory temporarily.
2.4.3 DNFB
Buff powder, lot number 2000-01-01 is produced by Shanghai reagent one factory, faces the time spent and prepares with 70% alcoholic solution.
2.5 dosage grouping
High dose group sensitization 3.00% tested material solution 0.2ml/ (only. inferior) * 3 times
Excite 0.30% tested material solution 0.2ml/ (only. inferior) * 1 time
Middle dosage group sensitization 1.00% tested material solution 0.2ml/ (only. inferior) * 3 times
Excite 0.10% tested material solution 0.2ml/ (only. inferior) * 1 time
Low dose group sensitization 0.30% tested material solution 0.2ml/ (only. inferior) * 3 times
Excite 0.03% tested material solution 0.2ml/ (only. inferior) * 1 time
Positive control sensitization 1.00%2,4-dinitrochlorobenzene 0.2ml/ (only. inferior) * 3 times
Excite 0.10%2,4-dinitrochlorobenzene 0.2ml/ (only. inferior) * 1 time
Negative control sensitization deionized water 0.2ml/ (only. inferior) * 3 times
Excite deionized water 0.2ml/ (only. inferior) * 1 time
2.6 dose determination
Be that available iodine content is 0.3% aqueous solution according to tested material clinic trial preparation maximum concentration.
2.7 test method
The method requirement of " skin anaphylactic test standard operating procedure (SOP-NLDSERZJ-CZ19-01) " that formulate " GLP ", " chemicals zest, anaphylaxis and hemolytic investigative technique guideline " and this chamber of promulgating by State Food and Drug Administration is carried out.
Get that healthy the male and female dual-purpose is divided into five groups at random by body weight without hindering 50 of Cavia porcelluss, i.e. tested material high dose test group, middle dosetest group, low dosage test group, DNFB positive controls and deionized water negative control group, 10 every group.24h shaves only scope about 3cm * 3cm in unhairing district with the holysword shaver with guinea pig back left side hair before the test.During sensitization, get tested material solution 0.2ml and be applied in depilation district, tested group of Cavia porcellus left side, (2.5cm * 2.5cm) and one deck cellophane cover the administration district and fix with non-stimulated adhesive tape rear usefulness two floor gauze, stick to remove behind the 6h to stick thing, use warm water flush away left drug.7d and 14d in kind repeat respectively after the sensitization first, amount to three times.After each sensitization 1 and 24h observe the abnormal response situations such as skin erythema, edema.Positive controls and negative control treated animal in kind carry out sensitization.
14d after the last administration sensitization, more than respectively organize Cavia porcellus and carry out respectively unhairing on the right side, the about 3cm * 3cm of unhairing district scope.And smear respectively above corresponding exciting agent in the unhairing district, namely get tested material solution, 0.1%2, removal sticked thing after the 4-dinitro-chloro-benzene positive and deionized water, gauze sticked 6h, with warm water flush away left drug, respectively at after cleaning 24 and 48h observe the skin allergy situation.And mark by table 2 pair erythema and edema, calculate the reaction meansigma methods, reaction meansigma methods=(erythema forms total points+edema and forms total points)/add up to number of animals.Judge the anaphylaxis occurrence degree of tested material according to the national incidence rate of table 3, wherein the animal example number of skin erythema or edema (no matter degree weight) will occur divided by the tested material sum during calculating of irritated incidence rate.The body weight change of simultaneously observing animal in first sensitization, last sensitization with when exciting.
Table 2 skin hypersensitivity reaction standards of grading
Table 3 skin hypersensitivity evaluation criterion
2.8 result of the test
Depilation district, healthy guinea pig left side every 7 days once, continuous smear respectively for 3 times 3%, 1%, 0.3% tested material solution, 1% 2,4-chloronitrobenzene and deionized water 0.2ml (only. inferior) sensitization, each note is removed the tested material observation after applying 6h, except positive control 2.4-dinitrochlorobenzene dosage group Cavia porcellus all has 2 Mus the slight erythema phenomenon to occur after the 2nd time and the 3rd sensitization, any abnormal phenomena all appearred in guinea pig skin after all the other respectively organized each administration, and also other abnormal responses appear in the end.Smeared respectively 0.3% in depilation district, the right side of Cavia porcellus in 14 days after the last sensitization, 0.1%, 0.03% tested material solution, 0.1% 2,4-dinitrochlorobenzene and deionized water (0.2ml/ only) excite, 24h and 48h observe after removing tested material, each dosetest group of tested material and negative control group Cavia porcellus pilot region skin are showed no the phenomenons such as erythema and edema, mark by table 1 pair erythema and edema, calculate above four groups of each time point skin allergy meansigma methodss and be 0. and 2.4-dinitrochlorobenzene positive controls 24h and 48h after exciting have 5 guinea pig skin test blocks in various degree erythema to occur, wherein there are 3 Mild edema to occur, press the scoring of table 1 standard, 24h erythema total points is that (1 is divided into 2 to 7 excrement, 2 are divided into 3), the edema total points is 3 minutes (3 are 1 minute), the skin allergy meansigma methods of its each time period is respectively 1.1 and 1.3, and for details see attached table 4.
Three dosage groups of tested material and 2,4-dinitrochlorobenzene positive controls all has no significant effect at the body weight gain of whole duration of test to Cavia porcellus, its body weight all increases with the prolongation of test period, and first sensitization, last sensitization and average weight and the deionized water negative control group Mus of corresponding time similar (P＞0.05) of each group when exciting.For details see attached table 5.
Table 4, tested material skin allergy result of the test table
The as a result table that table 5, tested material skin allergy affect the Cavia porcellus body weight
| Group | Irritated first | Last sensitization | Excite |
| High dose group | 325±18 | 338±19 | 369±22 |
| Middle dosage group | 319±13 | 331±15 | 357±26 |
| Low dose group | 321±21 | 337±25 | 369±35 |
| Positive control | 317±11 | 334±15 | 368±22 |
| Negative control | 319±12 | 321±17 | 370±22 |
2.9 result of the test
Above result of the test shows: under this test dose condition, the tested material of lot number 2005042001 is reacted without allergy guinea pig skin.
Claims (7)
1. diaphragm of preventing and treating cervical erosion, consisted of with the coating section that bottom inserting section, is connected by the section of inserting that stretches into from the cervix uteri mouth, coating section is coated on the outside of cervix uteri mouth, it is take biocompatible materials as matrix material, mixed to prevent and treat the medicine of cervical erosion, it is characterized in that: the effective ingredient of described medicine is chitin oligosaccharide/iodine coordination compound, and making the interior amount of iodine of diaphragm is 80～90mg iodine/g diaphragm, and described diaphragm comprises following component by weight percentage:
Citric acid 0.5%～1%
Gelatin 6%～8%
Hyaluronate sodium 0.2%～0.5%
Carboxymethyl chitosan 6%～8%
Emulsifying agent 0.1%～0.3%
Chitosan iodine solution 25%～35%
All the other are deionized water.
2. the diaphragm of preventing and treating cervical erosion according to claim 1 is characterized in that: the saturated suction of described diaphragm is than being 1:8～12.
3. the diaphragm of preventing and treating cervical erosion according to claim 1 and 2, it is characterized in that: the coating section of described diaphragm is spherical shape, and fits tightly with the cervix uteri mouth.
4. the diaphragm of preventing and treating cervical erosion according to claim 3 is characterized in that: described coating section and to insert the angle that consists of between the section be 45 °～85 °.
5. the diaphragm of preventing and treating cervical erosion according to claim 4 is characterized in that: described coating section and to insert the angle that consists of between the section be 65 °～75 °.
6. the diaphragm of preventing and treating cervical erosion according to claim 3 is characterized in that: the outer of described coating section is arc transition.
7. according to claim 1 to the described preparation method of preventing and treating the diaphragm of cervical erosion of 6 any one, it is characterized in that in the steps below: citric acid, gelatin, hyaluronate sodium, carboxymethyl chitosan, emulsifying agent, chitosan iodine solution are weighed by following percentage by weight:
Citric acid 0.5%～1%
Gelatin 6%～8%
Hyaluronate sodium 0.2%～0.5%
Carboxymethyl chitosan 6%～8%
Emulsifying agent 0.1%～0.3%
Chitosan iodine solution 25%～35%
All the other are deionized water, and above-mentioned each component is mixed, and adopt the lyophilization molding to make in the mould of tool diaphragm shaped inner chamber.
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058876A (en) * | 2010-12-18 | 2011-05-18 | 甘少磊 | Cervix antibacterial repair complex and preparation method thereof |
| CN102309778A (en) * | 2010-12-19 | 2012-01-11 | 甘少磊 | Iodine-contained cervix antibiosis repair material and preparation method thereof |
| CN102258829A (en) * | 2011-04-19 | 2011-11-30 | 魏鹏飞 | Product for preventing and treating cervical diseases and wounds |
| CN102886062A (en) * | 2011-07-21 | 2013-01-23 | 武汉市三鼎医用生物制品有限公司 | Iodinated chitosan biological antibacterial gel |
| CN102886061B (en) * | 2011-07-21 | 2018-02-06 | 武汉市三鼎医用生物制品有限公司 | Chitosan-iodide biological antibacterial film |
| CN107019841A (en) * | 2016-01-29 | 2017-08-08 | 嘉兴市舒福特生物科技有限公司 | A kind of anti-treating cervicitis film forming powder and its propeller |
| CN105727348A (en) * | 2016-04-11 | 2016-07-06 | 上海济国医疗科技有限公司 | Antibacterial film, preparing method and antibacterial repairing dressing |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2143124Y (en) * | 1992-12-25 | 1993-10-06 | 马德泉 | Cervix cap for cervicovginal erosion |
| CN2741569Y (en) * | 2004-08-16 | 2005-11-23 | 嘉兴市润和医用科贸有限公司 | Antiseptic biological film for uterine neck |
| CN1868553A (en) * | 2006-04-04 | 2006-11-29 | 杨玉民 | Cervical skin tissue engineering stent and its making method |
-
2009
- 2009-04-29 CN CN 200910050261 patent/CN101543658B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2143124Y (en) * | 1992-12-25 | 1993-10-06 | 马德泉 | Cervix cap for cervicovginal erosion |
| CN2741569Y (en) * | 2004-08-16 | 2005-11-23 | 嘉兴市润和医用科贸有限公司 | Antiseptic biological film for uterine neck |
| CN1868553A (en) * | 2006-04-04 | 2006-11-29 | 杨玉民 | Cervical skin tissue engineering stent and its making method |
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Effective date of registration: 20150318 Address after: 200030 Shanghai Xietu Road No. 2140 Patentee after: SHANGHAI INSTITUTE OF PLANNED PARENTHOOD RESEARCH Patentee after: Jiaxing Western European Biological Products Co.,Ltd. Address before: 200030 Shanghai Xietu Road No. 2140 Patentee before: Shanghai Institute of Planned Parenthood Research Patentee before: JIAXING SOFTTER BIOTECHNOLOGY Co.,Ltd. |