CN1453031A - Externally-applied medicine composition for treating mastoproliferation and its prepn - Google Patents
Externally-applied medicine composition for treating mastoproliferation and its prepn Download PDFInfo
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- CN1453031A CN1453031A CN 03126133 CN03126133A CN1453031A CN 1453031 A CN1453031 A CN 1453031A CN 03126133 CN03126133 CN 03126133 CN 03126133 A CN03126133 A CN 03126133A CN 1453031 A CN1453031 A CN 1453031A
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Abstract
The externally applied medicine compositino for treating mastoproliferation is prepared with angelica, zedoary, burreed rhizome and menthol. The medicine contains the effective components of the medicine materials prepared through different extracting processes and transdermal agent and is prepared into the skin administrated preparation form, which acts directly on the pathological change parts to result in fast cure of mastoproliferation and less side effects.
Description
Technical field the present invention relates to a kind of Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic, Mentholum of comprising as externally-applied medicine composite of active ingredient and preparation method thereof, and said composition is used for the treatment of cyclomastopathy.
Background technology cyclomastopathy, the traditional Chinese medical science are called " nodules of the breast ", are a class commonly encountered diseases, frequently-occurring disease.The sickness rate of cyclomastopathy accounts for the first place of cystic hyperplasia of breast, has 10%～15% people that this disease may take place before menopause in the women of city.Among the cyclomastopathy patient, some may cancerate and form breast carcinoma.Its sickness rate is higher 1.4～1.5 times than healthy women.Particularly in recent years, the morbidity of breast carcinoma raises year by year, has become first of women's malignant tumor.Paying close attention to cystic hyperplasia of breast has become various countries medicine worker's important topic.
As everyone knows, Chinese medicine external curing cyclomastopathy is the therapy that traditional traditional Chinese medical science shows unique characteristics, and has good effect, rapid-action, characteristics that side effect is little.The Chinese medicine exterior-applied prescription of existing treatment cyclomastopathy is a lot of, but the following problem of ubiquity:
(1) big prescription.It is more to choose the flavor medicine in the Chinese medicine external prescription of existing treatment cyclomastopathy, 6～15 kinds of medical material prescriptions commonly used, nearly 27 kinds of having.The drug effect and the biological activity of many medical materials are close in the big prescription, reuse comparatively generally, and whether scientific and reasonable medication is worth discussing.The application of big prescription in addition not only has many invalid elements to be absorbed, and the chance of the toxic and side effects generation of more Chinese crude drugs is increased.Therefore, the selected flavor medicine of science is given full play to drug effect, reduces toxic and side effects, and changing big prescription is that little prescription is the important topic that Chinese medicine continues development.
(2) do not extract.Because historical reasons are not understood the active ingredient of Chinese medicine, in using, tradition often directly is used as medicine with medical material.External Chinese medicine particularly all is to cooperate oil or honey or wine or glue or vinegar to stick the affected part pulverizing medicinal materials powdered to use.This usage is not only used inconvenience, and influences the Transdermal absorption of active ingredient in the medical material.The active ingredient of present many Chinese crude drugs is illustrated, and uses crude drug in contemporary Chinese medicine research less as far as possible, and using and extracting active ingredient is to improve Chinese medicine quality, improves curative effect, reduces one of key technology of toxic and side effects.
(3) dosage form is old.The Chinese medicine exterior-applied formulation is old, is plaster, paste mostly, sticks agent etc.Treatment cyclomastopathy administration time is longer, generally about three months, in addition longer.Therefore, the Chinese medicine exterior-applied formulation is taken like a shot keeping should making the patient easy to use under the eutherapeutic prerequisite.
Summary of the invention finder of the present invention imagines the few new compositions of a kind of medication assortment class of development, and under prerequisite evident in efficacy, the toxic and side effects of long-term prescription is little, and easy to use is maximum feature of the present invention.
The traditional Chinese medical science thinks that nodules of the breast is a deficiency of kidney-QI, and Chong and Ren channel disorder is to fall ill originally, depression of liver-QI, and the expectorant stasis of blood stagnates and is the mark of morbidity, the blood stasis internal resistance, long-pending lump is ached bitterly.The rule of treatment is with depressed liver-energy dispersing and QI regulating, and regulating thoroughfare and controlling vessel is main, and assistant is with blood circulation promoting and blood stasis dispelling, dissipating phlegm and resolving masses method.Finder of the present invention selects Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic, Mentholum prescription for use according to Chinese medical theory and clinical practice.Chinese angelica blood supplementing is invigorated blood circulation in the side, kind again pain relieving.Rhizoma Curcumae is gone into the Liver Channel blood system, and the blood in the dispelling the stagnated QI is with the dispelling the stagnated QI removing food stagnancy.Rhizoma sparganic is gone into liver spleen blood system, and the gas in the removing blood stasis stimulates the menstrual flow with removing blood stasis, and Mentholum is gone into Liver Channel, dispersing the stagnated live-QI to relieve the stagnation of QI, nice and cool pain relieving.Quan Fangsi flavor drug matching QI and blood is taken into account, kind blood circulation promoting and blood stasis dispelling, and promoting the circulation of QI to relieve pain have the power of eliminate indigestion repercussive, reach the effect of removing obstruction for relieving pain, make newborn network mediation, and the capable then blood of gas is capable, and natural heap soil or fertilizer over and around the roots person is easily logical, Yu Zheyi reaches, and the knot person easily looses, and hard person is easily soft, plays the merit of nodules of the breast recovery from illness altogether.
It is active ingredient that the finder successfully prepares with group side's Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic, 4 kinds of flavors of Mentholum medicine through pharmacy test, suitable enepidermic compositions.The finder shows that through toxicology test this compositions is to skin avirulence, nonirritant, no sensitization, safe in utilization.The finder shows that through the clinical observation test this compositions has significant curative effect through skin drug treatment cyclomastopathy, little untoward reaction.The present invention is based on and above-mentioned everyly discover and a kind of new compositions for the treatment of cyclomastopathy is provided, realized absorbing, directly act on diseased region, rapid-action, good effect, the predeterminated target that the life-time service toxic and side effects is little through transdermal administration.
Specific embodiment the present invention realizes in the following manner:
The present invention treats the cyclomastopathy externally-applied medicine composite and comprises that containing Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic, Mentholum forms as active ingredient and short cutaneous permeable agent and enepidermic excipient.
The Chinese crude drug consumption that the present invention treats the described active ingredient of cyclomastopathy externally-applied medicine composite prescription table routinely is shown Radix Angelicae Sinensis 100g～600g, is preferably 300g; Rhizoma Curcumae 100g～400g is preferably 200g; Rhizoma sparganic 100g～400g is preferably 200g; Mentholum 5g～40g is preferably 20g.These medical materials can directly be ground into fine powder and prepare the dermatologic dosage form, and perhaps medical material prepares the dermatologic dosage form behind decocting method, the way of distillation, percolation effective component extracting.Preferred for preparation technology is that Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic extract the acquisition distillate with the way of distillation earlier, extracts with decocting method then and obtains concentrated solution.With distillate that extracts and concentrated solution preparation application forms.
The present invention treats the cyclomastopathy externally-applied medicine composite and prepared by following weight percentages: distillate and concentrated solution that Chinese crude drug or Chinese crude drug extract, its consumption adds by the acquisition amount of extracting.The consumption of short cutaneous permeable agent can be 1%～10%, is preferably 2%～4%.Enepidermic excipient, its consumption can enepidermic routinely amount ranges be determined.
The present invention treats the described dermatologic dosage form of cyclomastopathy externally-applied medicine composite and comprises: solution, tincture, lotion, liniment, spray, suspension, Emulsion, ointment, cream, liniment, gel, transdermal patch.
The present invention treats the described short cutaneous permeable agent of cyclomastopathy externally-applied medicine composite: laurocapram, dimethyl sulfoxine.
The present invention treats the described enepidermic excipient of cyclomastopathy externally-applied medicine composite: vaseline, paraffin, liquid paraffin, silicone oil, stearic acid, Cera Flava, lanoline, glyceryl monostearate, high-carbon fatty alcohol, Polyethylene Glycol, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic resin, cellulose and derivant thereof, Rhizoma Bletillae gel, gelatin, alginate, Pa Luoshamu, agar, carbomer, triethanolamine, cyclodextrin, polyoxyethylene, fatty oil, colloid silicon; Ethanol, propylene glycol, acetone, isopropyl alcohol, 1,3 butanediol; Glycerol, mannitol, sorbitol; Polysorbate, sorbitan ester; Benzyl chloride alkanamine, Benzalkonium Bromide, chlorobutanol, ethyl hydroxybenzoate, chlorhexidine, benzoic acid, sorbic acid, sodium benzoate; Sodium hydroxide, hydrochloric acid, acetic acid; Ethylene-acetate ethylene copolymer, acrylic acid or Polyisobutylene PSA, aluminium foil-polyethylene composite film, silicone rubber.
The present invention treats the cyclomastopathy externally-applied medicine composite can further comprise an amount of Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic, Mentholum therapeutic component in addition, as long as advantage of the present invention is not destroyed.
It is to give by local skin that the present invention treats the cyclomastopathy externally-applied medicine composite, is used for the treatment of cyclomastopathy, medication every day 1～3 time.
Below experiment will further specify the present invention.
Test 1 Chinese crude drug and extract experiment
Get Radix Angelicae Sinensis 300g, Rhizoma Curcumae 200g, rhizoma sparganic 200g is ground into coarse powder, soaks, and distills with steam distillation, collects distillate 2000ml, and distillate is carried out redistillation, collects distillate 300ml, and is standby.Medicinal residues after the distillation are added water and decoct secondary in right amount, decocted 1 hour for the first time, decocted 45 minutes for the second time, merge decoction liquor twice, filter, add ethanol and make that to contain the alcohol amount be 65%, cold preservation 24 hours filters, and behind the filtrate recycling ethanol, is concentrated into 50ml, and is standby.
More than distillate of Ti Quing and concentrated solution are used to prepare the dermatologic dosage form.
Test 2 skin acute toxicity testings
By to the animal intact skin with after damaged skin once contacts composition gels, the toxic reaction that observation post produces.Get 12 rabbit, male and female half and half are divided into 3 groups at random, 4 every group, are respectively vehicle group, composition gels low dose group (being clinical working concentration) and composition gels high dose group (for 4 times of clinical working concentration).24h before the administration, at back, rabbit right side with the 20% sodium sulfide 150cm that loses hair or feathers
2, being coated with respectively and being tried each 1g of thing, behind the effect 24h, flush away is tried thing, observes continuously poisoning symptoms such as going to be tried the behavior to the 7th day rabbit in 1,24,48,72 hour behind the thing, activity, fur gloss, diet and body weight, if any dead animal, postmortem in time.When test shows non-toxic reaction as intact skin, at the depilation 150cm of rabbit left dorsal portion
2, draw # shape scar with sterile needle behind the preserved skin, do not stab corium to stab wound epidermis, slight oozing of blood is advisable, coating immediately, observation index is the same, and with the excipient matched group relatively.
Result of the test shows: the behavior of intact skin group and damaged skin treated animal, activity, fur gloss, diet and body weight are all acted normally, and not seeing has any poisoning symptom, observe in 14 days and do not have animal dead, see the following form 2.
The acute toxicity test of table 2 composition gels skin (g, X ± SD, n=4)
| The group project | Before the administration | The intact skin group | The damaged skin group |
| Excipient matched group body weight has a net increase of the body weight poisoning symptom | 1900 ± 61 do not have | 1983 ± 74 83 do not have | 2096 ± 62 113 do not have |
| Composition gels low dose group body weight has a net increase of the body weight poisoning symptom | 1879 ± 58 do not have | 1964 ± 61 85 do not have | 2098 ± 65 134 do not have |
| Composition gels high dose group body weight has a net increase of the body weight poisoning symptom | 1900 ± 66 do not have | 1960 ± 72 60 do not have | 2056 ± 88 96 do not have |
Compare with matched group, be P＞0.05
Conclusion (of pressure testing): composition gels clinical dosage and its 4 times of clinical dosages are used in outward on the complete sum damaged skin of white rabbit, all do not cause acute toxic reaction.
Test repeatedly irritant experiment of 3 skins
Observe animal skin and repeatedly contact the local excitation reaction that is produced after the composition gels.Consubstantiality left and right sides self matching type is adopted in test, and 6 rabbit are divided into 2 groups at random, 3 every group, with the 20% sodium sulfide rabbit back spinal column both sides unhairing of being in, distinguishes 2 of unhairing, every 150cm
2The intact skin experimental animal is checked unhairing district skin zero damage; The damaged skin experimental animal is drawn # shape scar with sterile needle after unhairing, do not stab wound corium to stab epidermis, and slight oozing of blood is advisable.In 1 times and 4 times each 1g of medicine of animal left side depilation district difference coating combination gel; Depilation district, right side is coated with excipient 1g.Every kind is tried the thing area of filming is 50cm
2Contact with depilation district, every interval is every keeping at a distance, and uses water proof paper and immobilization with adhesive tape respectively.Every animal sub-cage rearing, medicine is coated with once every day, behind the effect 24h, the flush away medicine is with warm water cleaning coating again, continuous 7 days, flush away medicine behind the last coating 24h is used warm water cleaning, observes to smear the position 1 week and have or not situations such as erythema and edema, write down score value and recovery situation and time in each in time, skin irritation intensity is estimated.Composition gels sees Table 3 to rabbit skin irritant test result repeatedly.
Table 3 composition gels is to rabbit skin irritation reaction appraisal result repeatedly
| The test group | The intact skin test group | The damaged skin test group | ||||
| Test period | 1 day | 3 days | 7 days | 1 day | 3 days | 7 days |
| The compositions small dose group | ?0.00 | ????0.00 | ????0.00 | ???0.00 | ???0.00 | ????0.00 |
| The heavy dose of group of compositions | ?0.66 | ????0.00 | ????0.00 | ???1.00 | ???0.33 | ????0.00 |
| Vehicle group | ?0.00 | ????0.00 | ????0.00 | ???0.00 | ???0.00 | ????0.00 |
Skin repeatedly irritant test result shows, composition gels tried thing and excipient contrast to intact skin and the 7th day average response value of damaged skin all less than 0.4, apparent nonirritant.
The therapeutic test of 4 pairs of cyclomastopathies of experiment
By composition gels is carried out clinical observation, its clinical efficacy and safety are estimated.This test MethodsThe cases enrolled 110 examples are because the patient unites the use other medicines, 4 examples that come off, effective 106 examples voluntarily.The oldest 48 years old, minimum 21 years old of age, 36 years old mean age.The shortest 2 weeks of the course of disease, the longest about 5 years.All cases all have the distending pain of the breast symptom, and part patient has dysmenorrhea history, more or less mensis in amount.During treatment medicine is spread upon on the breast lesion skin, every day sooner or later each once, be a course of treatment January, 1～3 course of treatment of medication.
The observe the curative effect standard: fully recover for mastalgia disappears, lump disappears; Produce effects is that mastalgia disappears, and the lump maximum gauge dwindles more than 1/2; Progressive for mastalgia alleviates, the lump maximum gauge dwindles less than 1/2; Or mastalgia do not alleviate, and the lump maximum gauge dwindles more than 1/2.Invalidly do not dwindle or increase, hardening for lump; Or simple mastalgia is alleviated and lump does not dwindle.Result of the test sees Table 4.
The therapeutic evaluation of table 4 composition gels clinical trial
Curative effect recovery from illness produce effects enabledisable total effective rate
Example several 36 43 17 10 106
Percentage ratio % 34.0 40.6 16.0 9.4 90.6
After 1 routine medication, have the burning sensation in this test, do not see that other untoward reaction take place, carry out routine blood test, routine urinalysis, liver function test before and after the medication, all no abnormal.Clinical observation result shows that composition gels has clear improvement to the clinical symptoms and the sign of cyclomastopathy, and effective percentage is 90.6%.
Following examples will be described further compositions of the present invention, but it should be considered as limitation of the present invention.
Embodiment 1 presses the compositions of a kind of gel form of prescription preparation:
The composition consumption
Chinese medicine distillate 300g
Chinese medicine concentrated solution 50g
Laurocapram 20g
Carbomer 10g
Triethanolamine 10g
Propylene glycol 200g
Ethanol 250g
Glycerol 100g
Mentholum 20g
Benzyl chloride alkanamine 0.1g
Sodium hydroxide is an amount of
Water adds to 1000g
Getting carbomer adds water and soaks in right amount, adding propylene glycol, ethanol, glycerol, benzyl chloride alkanamine, Chinese medicine distillate, Chinese medicine concentrated solution, laurocapram then stirs, adding triethanolamine again stirs, moisturizing is to full dose, with sodium hydroxide pH value to 6.0～7.0, stir, after the degassing, packing promptly.
Embodiment 2 presses the compositions of a kind of ointment form of prescription preparation:
Get Radix Angelicae Sinensis 200g, Rhizoma Curcumae 150g, rhizoma sparganic 150g is ground into fine powder, Mentholum 2g, ethyl hydroxybenzoate 0.3g add vaseline in right amount to full dose, stir, packing promptly.
Embodiment 3 presses the compositions of a kind of transdermal patch form of prescription preparation:
The composition consumption
Chinese medicine distillate 300g
Chinese medicine concentrated solution 50g
Laurocapram 10g
Polyacrylic acid resin 40g
Stearic acid 120g
Lanoline 140g
Ethanol 120g
Mentholum 20g
Ethyl hydroxybenzoate 2g
Get Chinese medicine distillate, Chinese medicine concentrated solution, the polyacrylic acid resin adds soak with ethanol, get stearic acid, that lanoline adds hot melt is molten, mixing and stirring after adding Mentholum, laurocapram, ethyl hydroxybenzoate then and stirring, is coated in and mounts on the backing material, dry below 80 ℃, topped film, cutting, packing is promptly.
Embodiment 5 presses the compositions of a kind of liniment form of prescription preparation:
The composition consumption
Chinese medicine distillate 300g
Chinese medicine concentrated solution 50g
Dimethyl sulfoxine 40g
Propylene glycol 250g
Polyvinyl alcohol 65g
Glycerol 50g
Mentholum 20g
Tween 80 5g
Ethanol 300g
Sodium hydroxide is an amount of
Water adds to 1000g
Get Chinese medicine distillate, Chinese medicine concentrated solution, polyvinyl alcohol and add water and soak in right amount, add propylene glycol, ethanol, glycerol, Mentholum, dimethyl sulfoxine, Tween 80 then, stir, moisturizing is to full dose, with sodium hydroxide pH value to 6.0～7.0, stir, packing is promptly.
Claims (8)
1, a kind of topical composition for the treatment of cyclomastopathy, it is characterized in that comprising Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic, Mentholum as active ingredient and short cutaneous permeable agent make a kind of for the dermatologic dosage form.
2, according to the topical composition of the treatment cyclomastopathy of claim 1, the Chinese crude drug consumption that it is characterized in that described active ingredient prescription table routinely is shown Radix Angelicae Sinensis 100g～600g, is preferably 300g; Rhizoma Curcumae 100g～400g is preferably 200g; Rhizoma sparganic 100g～400g is preferably 200g; Mentholum 5g～40g is preferably 20g.
3, according to the topical composition of the treatment cyclomastopathy of claim 1, it is characterized in that described Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic can directly be ground into fine powder and prepare the dermatologic dosage form, perhaps preparation dermatologic dosage form behind decocting method, the way of distillation, percolation effective component extracting.Preferred for preparation technology is that Radix Angelicae Sinensis, Rhizoma Curcumae, rhizoma sparganic extract the acquisition distillate with the way of distillation earlier, extracts with decocting method then and obtains concentrated solution.With distillate that extracts and concentrated solution preparation application forms.
4, according to the topical composition of the treatment cyclomastopathy of claim 1, it is characterized in that described compositions is prepared by following weight percentages: distillate and concentrated solution that Chinese crude drug or Chinese crude drug extract, its consumption adds by the acquisition amount of extracting.The consumption of short cutaneous permeable agent can be 1%～10%, is preferably 2%～4%.Enepidermic excipient, its consumption can enepidermic routinely amount ranges be determined.
5, according to the topical composition of the treatment cyclomastopathy of claim 1, it is characterized in that described dermatologic dosage form comprises: solution, tincture, lotion, liniment, spray, suspension, Emulsion, ointment, cream, liniment, gel.
6, according to the topical composition of the treatment cyclomastopathy of claim 1, it is characterized in that described short cutaneous permeable agent is laurocapram, dimethyl sulfoxine.
7, according to the topical composition of the treatment cyclomastopathy of claim 4, it is characterized in that described enepidermic excipient is: vaseline, paraffin, liquid paraffin, silicone oil, stearic acid, Cera Flava, lanoline, glyceryl monostearate, high-carbon fatty alcohol, Polyethylene Glycol, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic resin, cellulose and derivant thereof, Rhizoma Bletillae gel, gelatin, alginate, Pa Luoshamu, agar, carbomer, triethanolamine, cyclodextrin, polyoxyethylene, fatty oil, colloid silicon; Ethanol, propylene glycol, acetone, isopropyl alcohol, 1,3 butanediol; Glycerol, mannitol, sorbitol; Polysorbate, sorbitan ester; Benzyl chloride alkanamine, Benzalkonium Bromide, chlorobutanol, ethyl hydroxybenzoate, chlorhexidine, benzoic acid, sorbic acid, sodium benzoate; Sodium hydroxide, hydrochloric acid, acetic acid; Ethylene-acetate ethylene copolymer, acrylic acid or Polyisobutylene PSA, aluminium foil-polyethylene composite film, silicone rubber.
8, according to the topical composition of the treatment cyclomastopathy of claim 1, it is characterized in that giving, be used for the treatment of cyclomastopathy, medication every day 1～3 time by local skin.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258568A (en) * | 2010-05-27 | 2011-11-30 | 迪特克(济源)绿色生物科技有限公司 | Method for preparing external rabdosia rubescens antibacterial cream |
| CN105749129A (en) * | 2014-12-16 | 2016-07-13 | 江海涛 | Breast hyperplasia dissipating paster |
| CN108079246A (en) * | 2017-12-20 | 2018-05-29 | 广州傲雅威代生物科技有限公司 | A kind of medium-height grass medicinal gel and preparation method thereof |
| CN110711214A (en) * | 2019-11-15 | 2020-01-21 | 广州蓝丝乳葆投资管理咨询有限公司 | Traditional Chinese medicine composition spray for treating hyperplasia of mammary glands and preparation method thereof |
-
2003
- 2003-04-25 CN CN 03126133 patent/CN1251753C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258568A (en) * | 2010-05-27 | 2011-11-30 | 迪特克(济源)绿色生物科技有限公司 | Method for preparing external rabdosia rubescens antibacterial cream |
| CN102258568B (en) * | 2010-05-27 | 2012-11-21 | 迪特克(济源)绿色生物科技有限公司 | Method for preparing external rabdosia rubescens antibacterial cream |
| CN105749129A (en) * | 2014-12-16 | 2016-07-13 | 江海涛 | Breast hyperplasia dissipating paster |
| CN108079246A (en) * | 2017-12-20 | 2018-05-29 | 广州傲雅威代生物科技有限公司 | A kind of medium-height grass medicinal gel and preparation method thereof |
| CN110711214A (en) * | 2019-11-15 | 2020-01-21 | 广州蓝丝乳葆投资管理咨询有限公司 | Traditional Chinese medicine composition spray for treating hyperplasia of mammary glands and preparation method thereof |
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| Publication number | Publication date |
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| CN1251753C (en) | 2006-04-19 |
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