CN103690457A - Toothpaste and preparation method thereof - Google Patents
Toothpaste and preparation method thereof Download PDFInfo
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Abstract
The invention discloses toothpaste containing periplaneta americana extract and preparation method thereof. The toothpaste is characterized in that periplaneta americana extract which is prepared under specific process conditions is used as an effective component to take an assistant treatment effect, wherein the specific bioactivity of periplaneta americana is retained in the extract to the greatest extent, such as alanine, so that the toothpaste not only has the effect of synchronously protecting oral cavity, teeth and gum, but also has a remarkable curative effect in the field of dental ulcer treatment. Therefore, the toothpaste has a huge application value.
Description
Technical field
The invention belongs to oral cleaning nursing article technical field, be specifically related to a kind of toothpaste that contains American-cockroach-extract and preparation method thereof.
Background technology
Toothpaste is indispensable oral cavity cleaning hygienic article in people's daily life, and its basic function is cleaning teeth, fresh breath, reaches the object that keeps oral cavity cleaning.In the past few years, because consumer healthcare realizes continuous enhancing, toothpaste has been proposed to more requirement, except cleaning the teeth, also increased some auxiliary prevention oral diseases, oral cavity has been had to the function of nursing health effect; Therefore the product that, has both at home and abroad various functional types in toothpaste becomes the market mainstream.In recent years, along with the development of modernization of Chinese medicine technology, the method for Chinese medicine study of active components utilization has also been obtained to good development, this assists prevention oral disease that good technical support is provided for toothpaste utilizes active ingredient of Chinese herbs.
At present, in prior art, also have and adopt various active ingredient of Chinese herbs as toothpaste ancillary drug.In these medicated toothpaste, some toothpaste has plurality of Chinese composition, and producing process is complicated; Although some toothpaste producing process is simple, effect is had nothing in common with each other, and is difficult to accomplish the effect to oral cavity, tooth, the synchronous nursing health of gingiva especially for oral ulcer problem, to be difficult to especially play remarkable result simultaneously.
Periplaneta americana is Insecta wing subclass Blattaria Blattidae Periplaneta insecticide; be commonly called as " Blatta seu periplaneta "; widely distributed in China; be used as medicine and begin to be loaded in < < Sheng Nong's herbal classic > >, there is antiinflammatory, detumescence, promotion wound healing, promotion angiogenesis, heart tonifying, expansion lung blood vessel, improve microcirculation, arrhythmia, cardioprotection, antiviral, raising immunity of organisms and repair the effects such as damage hepatocyte function.The applicant has applied for the patent of the American cockroach medicament composition aspect for the treatment of oral ulcer on May 25th, 2010, Granted publication number is CN101837019B;
It is one of common oral cavity chronic disease that tooth is made inflammation, and its sickness rate is up to 70%～90%, and the key of control tooth ophthalmia is to control bacterial plaque, and brushing teeth is the Main Means of removing bacterial plaque.The mechanism of action of toothpaste antiplaque is mainly the pharmacological action of the antiplaque medicine adding in toothpaste.On market, be badly in need of the toothpaste that can effectively treat oral ulcer and can solve the problem of oral cavity, tooth, the synchronous nursing health of gingiva.The object of the invention is exactly will study a kind ofly to take American-cockroach-extract and be used for effectively treating oral ulcer and solve the problem of oral cavity, tooth, the synchronous nursing health of gingiva as active fraction preparation medicated toothpaste.
Summary of the invention
The object of the invention is to for the deficiencies in the prior art, provide a kind of can to oral cavity, tooth and gingiva synchronously nurse and can efficient solution breach chamber the toothpaste that contains American-cockroach-extract of ulcer.
Another object of the present invention is to for the deficiencies in the prior art, the method for the above-mentioned toothpaste that contains American-cockroach-extract of the simple preparation of a kind of technique is provided.
In order to reach first object of foregoing invention, the technical solution used in the present invention is: a kind of toothpaste is provided, it is characterized in that: in the mastic of described toothpaste, contain American-cockroach-extract.
Preferably, described mastic comprises the component of following weight portion: American-cockroach-extract 2-10 part, sorbitol 40-60 part, Polyethylene Glycol 2-10 part, surfactant 1.3-3.7 part, silicon dioxide 20-40 part, essence 0.8-2 part, cyclodextrin 0.1-0.3 part, Carboxymethyl cellulose sodium 0.3-0.7 part, antiseptic 0.3-0.7 part, edible glue 0.1-0.3 part and water 2-20 part.
Preferably, described mastic comprises the component of following weight portion: 9.23 parts, 3 parts of American-cockroach-extracts, 55.5 parts of sorbitol, 4 parts of Polyethylene Glycol, 2.3 parts, surfactant, 23.5 parts of silicon dioxide, 1.05 parts, essence, 0.27 part of cyclodextrin, 0.55 part of Carboxymethyl cellulose sodium, 0.5 part of antiseptic, 0.1 part of edible glue and water.
Preferably, described Polyethylene Glycol is PEG400; Described surfactant is sodium lauryl sulphate and sodium lauroyl sarcosine, and the mass ratio of sodium lauroyl sarcosine and sodium lauryl sulphate is 1:1-1:10; Described antiseptic is sodium benzoate; Described essence is Flos Chrysanthemi Mint Essence; Described edible glue is carrageenan.
Preferably, described American-cockroach-extract is prepared by the following method:
1) extract
The dry polypide of periplaneta americana is crushed to 10-40 order coarse powder, be placed in multi-function extractor, adding the volume fraction that 4-6 doubly measures is 80-90% ethanol merceration 6-8 hour, adding the volume fraction that 3-7 doubly measures is 70% alcohol reflux 3-6 hour again, extract 3 times, during reflux, extract,, control temperature between 70-80 ℃, steam pressure is below 0.02Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate.
2) concentrated
By after above-mentioned filtrate recycling ethanol, it is 1.20-1.25 that unlatching vacuum is concentrated into relative density by it at 50-70 ℃, makes extractum A;
3) defat
First in degreasing tank, add extractum A weight 8-10 water doubly, open Steam Heating, after boiling, in the situation that opening stirring, slowly add extractum A, at 75-85 ℃, be incubated 3-6 hour, standing 15-40 hour, when oils and fats is isolated liquid level, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, make American-cockroach-extract, wherein, in the dry product of American-cockroach-extract, contain total amino acids with alanine (C
3h
7nO
2) count 7.2-7.8%(mass percent).
Wherein, American-cockroach-extract of the present invention preferably adopts above-mentioned process preparation, still, also can adopt the periplaneta americana of supplying on market to extract goods, as periplaneta americana extracting solution, periplaneta americana extractum and periplaneta americana extract powder etc.; On adopting market, supply periplaneta americana goods time, according to periplaneta americana, extract goods and be equivalent to former dose and convert out according to the former dose of periplaneta americana required in above-mentioned toothpaste finished product the addition that periplaneta americana is extracted goods.
In order to reach another object of foregoing invention, the technical solution used in the present invention is: a kind of method of preparing the above-mentioned toothpaste that contains American-cockroach-extract is provided, it is characterized in that, comprise the following steps:
A, by American-cockroach-extract, sorbitol, Polyethylene Glycol, cyclodextrin with after water dissolution, join in vacuum Manufacturing medicine extract machine, open vacuum pump, open agitator and colloid mill, stir 15-50 minute, mix;
B, silicon dioxide, Carboxymethyl cellulose sodium and edible glue are mixed in advance after, join in vacuum Manufacturing medicine extract machine, stir after 15-50 minute, then add antiseptic, stir 15-50 minute;
C, add surfactant again, stir 20-30 minute; Finally add essence, stir 15-50 minute; At-more than 700mmHg degassed the 20-65 minute of vacuum under pressure, make mastic again, after testing, after fill, make the toothpaste that contains American-cockroach-extract.
In sum; toothpaste provided by the invention adopts American-cockroach-extract that specific process conditions make as the effective ingredient that plays auxiliary therapeutic action by adding therein; this extract is protected the special biological activity of periplaneta americana to greatest extent; as alanine etc.; make this toothpaste not only there is the effect of the synchronous nursing of oral cavity, tooth and gingiva; and also thering is significant curative effect aspect treatment oral ulcer, therefore, there is huge using value.
The specific embodiment
Below in conjunction with specific embodiment, the specific embodiment of the present invention is described in detail:
Embodiment 1
Make double centner lotion of toothpaste raw materials used as follows: 9.23 kilograms of 3 kilograms of American-cockroach-extracts, 55.5 kilograms, 4 kilograms PEG400s of sorbitol, 1.8 kilograms of sodium lauryl sulphates, 23.5 kilograms of silicon dioxide, 1.05 kilograms of Flos Chrysanthemi Mint Essences, 0.27 kilogram of cyclodextrin, 0.55 kilogram of Carboxymethyl cellulose sodium, 0.5 kilogram of sodium lauroyl sarcosine, 0.5 kilogram of sodium benzoate, 0.1 kilogram of carrageenan and pure water;
Wherein, American-cockroach-extract is to adopt following methods preparation: the dry polypide of 20 kilograms of periplaneta americanaes is crushed to 10 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 4 times of amounts is 80-90% ethanol merceration 6 hours, the volume fraction that adds again 3 times of amounts is 70% alcohol reflux 3 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.20 that unlatching vacuum is concentrated into relative density by it at 50 ℃, makes extractum A; The water that first adds 8 times of extractum A weight in degreasing tank, open Steam Heating, after boiling, in the situation that opening stirring, slowly add extractum A, at 75 ℃, be incubated 3 hours, standing 20 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, make 3 kilograms of American-cockroach-extracts, wherein, in the dry product of this American-cockroach-extract, contain total amino acids with alanine (C
3h
7nO
2) count 7.5%(mass percent).
Embodiment 2
Make double centner lotion of toothpaste raw materials used as follows: 18.1 kilograms of 5 kilograms of American-cockroach-extracts, 50 kilograms, 2 kilograms PEG400s of sorbitol, 3 kilograms of sodium lauryl sulphates, 20 kilograms of silicon dioxide, 0.8 kilogram of Flos Chrysanthemi Mint Essence, 0.1 kilogram of cyclodextrin, 0.3 kilogram of Carboxymethyl cellulose sodium, 0.3 kilogram of sodium lauroyl sarcosine, 0.3 kilogram of sodium benzoate, 0.1 kilogram of carrageenan and pure water;
Wherein, American-cockroach-extract is to adopt following methods preparation: the dry polypide of 25 kilograms of periplaneta americanaes is crushed to 20 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 5 times of amounts is 80-90% ethanol merceration 7 hours, the volume fraction that adds again 5 times of amounts is 70% alcohol reflux 4 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.22 that unlatching vacuum is concentrated into relative density by it at 60 ℃, makes extractum A; Then, the water that first adds 9 times of extractum A weight in degreasing tank, opens Steam Heating, slowly adds extractum A after boiling in the situation that opening stirring, at 80 ℃, be incubated 4 hours, standing 15 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, make 5 kilograms of American-cockroach-extracts, in the dry product of American-cockroach-extract containing total amino acids with alanine (C
3h
7nO
2) count 7.8%(mass percent).
Embodiment 3
Make double centner lotion of toothpaste raw materials used as follows: 8 kilograms of 8 kilograms of American-cockroach-extracts, 40 kilograms, 10 kilograms PEG400s of sorbitol, 2 kilograms of sodium lauryl sulphates, 30 kilograms of silicon dioxide, 1 kilogram of Flos Chrysanthemi Mint Essence, 0.2 kilogram of cyclodextrin, 0.2 kilogram of Carboxymethyl cellulose sodium, 0.2 kilogram of sodium lauroyl sarcosine, 0.2 kilogram of sodium benzoate, 0.2 kilogram of carrageenan and pure water;
Wherein, American-cockroach-extract is to adopt following methods preparation: the dry polypide of 40 kilograms of periplaneta americanaes is crushed to 40 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 6 times of amounts is 80-90% ethanol merceration 8 hours, the volume fraction that adds again 7 times of amounts is 70% alcohol reflux 6 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.25 that unlatching vacuum is concentrated into relative density by it at 70 ℃, makes extractum A; Then, the water that first adds 10 times of extractum A weight in degreasing tank, opens Steam Heating, slowly adds extractum A after boiling in the situation that opening stirring, at 85 ℃, be incubated 6 hours, standing 40 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, make 8 kilograms of American-cockroach-extracts, in the dry product of American-cockroach-extract containing total amino acids with alanine (C
3h
7nO
2) count 7.6%(mass percent).
Embodiment 4
Make double centner lotion of toothpaste raw materials used as follows: 14.7 kilograms of 10 kilograms of American-cockroach-extracts, 42 kilograms, 3 kilograms PEG400s of sorbitol, 1 kilogram of sodium lauryl sulphate, 25 kilograms of silicon dioxide, 2 kilograms of Flos Chrysanthemi Mint Essences, 0.3 kilogram of cyclodextrin, 0.5 kilogram of Carboxymethyl cellulose sodium, 0.5 kilogram of sodium lauroyl sarcosine, 0.5 kilogram of sodium benzoate, 0.5 kilogram of carrageenan and pure water;
Wherein, American-cockroach-extract is to adopt following methods preparation: the dry polypide of 50 kilograms of periplaneta americanaes is crushed to 30 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 5 times of amounts is 80-90% ethanol merceration 7 hours, the volume fraction that adds again 5 times of amounts is 70% alcohol reflux 4.5 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.23 that unlatching vacuum is concentrated into relative density by it at 60 ℃, makes extractum A; Then, the water that first adds 9 times of extractum A weight in degreasing tank, opens Steam Heating, slowly adds extractum A after boiling in the situation that opening stirring, at 80 ℃, be incubated 4.5 hours, standing 25 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, make 10 kilograms of American-cockroach-extracts, in the dry product of American-cockroach-extract containing total amino acids with alanine (C
3h
7nO
2) count 7.2%(mass percent).
Described in above-described embodiment 1-4, the preparation method of lotion of toothpaste is as follows:
American-cockroach-extract, sorbitol, Polyethylene Glycol, cyclodextrin, with after dissolved in purified water, are joined in the main frame of vacuum Manufacturing medicine extract machine, open vacuum pump, open agitator and colloid mill, stir 15-50 minute, mix; After silicon dioxide, Carboxymethyl cellulose sodium and carrageenan are mixed in advance, join in the main frame of vacuum Manufacturing medicine extract machine, stir after 15-50 minute, then add sodium benzoate, stir 15-50 minute; Add again sodium lauroyl sarcosine and sodium lauryl sulphate, stir 20-30 minute; Finally add Flos Chrysanthemi Mint Essence, stir 15-50 minute; At-more than 700mmHg degassed the 20-65 minute of vacuum under pressure, make mastic again, after testing, after fill, make the toothpaste that contains American-cockroach-extract.
Utilizing toothpaste described in embodiment 1 to 4 prepared by said method is the health toothpaste of the pioneering synchronous nursing of oral cavity, tooth and gingiva, there is cleaning-nursing oral cavity, improve gingiva problem (being mainly oral ulcer), reduce the effect of dental plaque and nutrition gingiva periodontal.
Test example 1:
The clinical testing data that is used for the treatment of oral ulcer patient with the toothpaste that contains American-cockroach-extract of embodiment 1 preparation:
One, patient's classified data:
Oral ulcer patient's 200 examples, meet diagnostic criteria.Be divided into immediately treatment group and matched group, treatment group 100 examples, male's 62 examples, women's 38 examples, 16～40 years old age; Matched group 100 examples, male's 60 examples, women's 40 examples, 16～40 years old age.Two groups of patient ages, sex and courses of disease are learned processing by statistics, and no significant difference, has comparability.
Two, Therapeutic Method:
Treatment group: get the toothpaste that contains American-cockroach-extract making according to preparation method in test example, brush teeth 1-2 every day, consumption is 1g/ time, the 1-3 minute that at every turn brushes teeth allows toothpaste rinsing the mouth 2-3 minute in oral cavity in the process of brushing teeth, used continuously for 1 week;
Matched group: YUNNAN BAIYAO toothpaste, brush teeth 1-2 every day, and consumption is 1g/ time, and the 1-3 minute that at every turn brushes teeth was used for 1 week continuously.
Three, curative effect comparative result:
Table 1 is depicted as two groups of curative effect comparisons, treatment group 100 examples wherein, and total effective rate is 98%; Matched group 100 examples, total effective rate is 88%.Table 2 is depicted as curative effect comparison in two groups of 3 days and 1 weeks; In treatment group treatment 3 days, cure rate is 60%, and in treatment of control group 3 days, cure rate is 46%; Treatment group is in 1 week for the treatment of, and cure rate is 98.0%, and treatment of control group is in 1 week, and cure rate is 88%; (n number of delegates in table 1 and table 2)
Table 1:
Table 2:
Four, conclusion (of pressure testing):
Comprehensive conclusion: from above-mentioned clinical data, treatment group curative effect is obviously better than matched group.
Oral ulcer is clinical common oral disease, can occur in any age, has the feature of outbreak repeatedly.The generation of oral ulcer is relevant with many factors, common are infection, zinc deficiency etc.; Periplaneta americana is a kind of insecticide, body contains various active composition, its extract main component is polyalcohols and peptide class active substance, through pharmacological research, confirms: toothpaste of the present invention has the epithelial cell of promotion, granulation tissue growth, promotes the function that chronic ulcer tissue is repaired; The toothpaste that uses the present invention to contain American-cockroach-extract can reach the object that improves ulcer healing rate, shortens healing.
Test example 2:
One, patient's classified data:
150 experimenters carry out whole body and oral cavity soft or hard tissue-estimating, and record history of past illness, general oral sanitary habit.
Use PI to evaluate plaque index, include the experimenter of PI>1.5 in.
Use Sulcus Bleeding Index (SBI) to evaluate indication gingival hemorrhage situation, include the experimenter of SBI>=1 in.
1, inclusive criteria
A) whole body health in order, without whole body systemic disease, have 20 above intact teeth;
B) age is in 18～70 one full year of life;
C) women if, must not be within trimester of pregnancy and age of sucking;
D) signature Informed Consent Form, can observe test code and requirement can complete clinical trial on request.
E) experimenter should have the gingivitis of suitable degree; Preliminary screening process comprises that oral soft tissue and sclerous tissues check, gingivitis determines the whether selected of experimental subject.The object of study of plaque index (PI) >=1.5 and gingival sulcus bleeding index >=1.0 is participated in research.
F) do not participate in other similar experimental studies simultaneously;
2, exclusion standard
A) test toothpaste component is had to allergies;
B) take now the influential medicine of result of the test;
C) at previous month that participates in research, use antibiotic;
Two, Index for examination and method
1, oral cavity soft or hard tissue examination
Inspection socket transmucosal comprises lip, tongue, soft or hard palatine mucosa, salivary gland, tonsil and pharyngeal etc., carries out record.
2, plaque index (PI)
Adopt the Turesky plaque index of Quigley-Hein improvement to evaluate tooth supragingival plaque.To plaque stain on gingiva and according to following standard recording:
0=is without bacterial plaque
The bacterial plaque that 1=neck portion marginal existence is dispersed in
The visible continuous thin bacterial plaque band (reaching lmm wide) in 2=neck edge
3=neck portion bacterial plaque band is greater than lmm but is less than 1/3 of facing
4=bacterial plaque covers the 1/3-2/3 of facing
5=bacterial plaque covers facing more than 2/3
Tooth detection buccal surface and lingual surface, for each tooth, maximum numeration is 10.Except third molar, artificial tooth with there is the tooth of cervical region dummy, remaining tooth is all at the row of numeration.The mean of each experimenter's plaque index is obtained divided by total measurement number (teeth number is multiplied by 2) by the whole tooth detection gained counting sums of individual (2 records of each tooth).
3, sulcular bleeding index (SBI)
Gingivitis and gingival hemorrhage situation adopt sulcular bleeding index (Sulcus Bleeding Index, SBI), and gingival sulcus is hemorrhage is the performance of gingivitis, and this index calibration is thinner compared with gingival index, are applicable to the experimental epidemiology research of gingivitis.
Scoring criteria
0=gum edge and gum nipple healthy appearance, gently visit after gingival sulcus not hemorrhage
1=gum edge and gum nipple healthy appearance, gently visit after gingival sulcus hemorrhage
2=gingiva, because of inflammation color change, without swelling or edema, is visited and is examined rear hemorrhage (petechial hemorrhage)
3=gingiva color change is slight, and edema is visited and examined rear hemorrhage (hemorrhage along the expansion of gum edge)
4=gingiva color change, obvious tumefaction, visits and examines rear hemorrhage (the hemorrhage gum edge that overflows)
5=gingiva color change, obvious tumefaction, has ulcer sometimes, visit examine rear hemorrhage or have automatically hemorrhage
As the inspection of plaque index, each tooth inspection record buccal surface and lingual surface, except third molar, artificial tooth with there is the tooth of cervical region dummy, remaining tooth includes the row in numeration.The mean of each experimenter's gingivitis indices is obtained divided by total measurement number (teeth number is multiplied by 2) by the whole tooth detection gained counting sums of individual (2 records of each tooth).
Three, research process
This research design research time limit is April, comprises screening and January eluting phase and 3 months experimental periods.
1, check for the first time (screening)
According to entering group standard, screening experimenter.About 150 experimenters are carried out to whole body and oral cavity soft or hard tissue-estimating, and record history of past illness, general oral sanitary habit.Distribution toothpaste toothbrush articles for use, on-the-spot supervision is brushed teeth.The dosage (using one cun of long toothpaste) of demonstration toothpaste, and be familiar with brushing time.In addition, to experimenter, illustrate in instructions for use every day (1 week) time, experimenter uses toothpaste and the toothbrush of the eluting phase of unified distribution to brush teeth as requested).
Preengage the review time for the second time.
2, check for the second time (baseline inspection)
Require experimenter to check and carried out baseline inspection the morning on the same day; Check before 12(+2) hour in do not brush teeth, before 2 hours, lived on air.Check oral cavity soft or hard tissue, check complete mouthful plaque index and gingivitis indices, first 150 of the experimenter who meets inclusive criteria participates in test, and every qualified experimenter will obtain a random number, for random distribution test products; Experimenter will distinguish service test toothpaste and contrast toothpaste.Special messenger instructs experimenter's product using method.
3, check for the third time (1.5 months)
Check before 12(+2) hour in do not brush teeth, before 2 hours, lived on air.Check OST, check PI, SBI.Reclaim toothpaste, distribute toothpaste and the toothbrush for experiment of 3 months subsequently.
4, check (3 months) the 4th time
Check before 12(+2) hour in do not brush teeth, before 2 hours, lived on air.Inspection oral cavity soft or hard is organized situation.Check PI, SBI index.Questionnaire assessment experimenter uses the subjective effect of product, service condition etc.
Four, test specimen and using method
Toothpaste prepared by treatment group: embodiment 1 method
Matched group: YUNNAN BAIYAO toothpaste
Experimenter adopts soft toothbrush use in accordance with regulations toothpaste, requires to brush teeth for 1st 2 times (early, evening), and each 1 minute.Consumption is 1g/ time
Require in experimentation without any other dental care product as other toothpaste or toothbrush, collutory, dental floss etc.Diet and smoking are not restricted.Toothpaste and toothbrush at interval of regular replenishment experiment in 6 weeks.Examination and baseline are just used the method for product while checking to patient by doctor, the items such as time are handed in detail, regularly supervise in test patient and carry out.Every 1.5 months exchange toothpaste, every three months exchange toothbrush.And understand object and use the toothpaste situation of brushing teeth.
Five, experimental stage product is used:
The doctor who is responsible for clinical indices inspection does not understand experimenter's random packet situation (can not identification test group or matched group experimenter).By special messenger, be responsible for the work such as grouping, distribution trial target and reference product, registration.It is product to be measured or reference product that experimenter also must not understand it used.
Six, data statistics analyse:
By data input computer, adopt SPSS statistical package to carry out analytic statistics to data.Data typing and statistical analysis are completed by professional statistician.
Seven, effect assessment and standard
Press medical statistics means, the complete mouthful of Change in Mean situation to indices before and after treatment group and matched group difference statistical test; And the statistical analysis that carries out each time period between two groups, each index variation.Effective evaluation should be based on every clinical indices Change in Mean and group between more definite.
Eight, result of the test
150 subjects enter research, 70 of male, and 80 of women, 18～65 years old age, 30 of smokers, wherein treatment group is 75,75 of matched groups, the sex ratio of two groups, age and smoker's ratio have been carried out statistical analysis, and two groups of baselines are consistent.In process of the test, follow up a case by regular visits to patient without coming off.Process of the test, occurs without allergy and untoward reaction thereof.
Baseline checks
To two clinical indices: plaque index (PI) and sulcular bleeding index (SBI) are carried out baseline comparison, result shows between two check the values all no difference of science of statistics, in Table 1:
The baseline comparison (x ± s) of two clinical indices of table 1
P＞0.05
The variation of clinical indices
Along with the carrying out for the treatment of, after treatment group and matched group patient treatment, cardinal symptom is obviously improved, and clinical indices is obviously improved in Table 2.As can be seen from Table 2, the clinical indices for the treatment of group and matched group is along with declining all appears in the carrying out for the treatment of, and the clinical indices decline degree for the treatment of group is higher than treatment group, and between two groups, difference has statistical significance (P < 0.05).
The comparison (x ± s) of two clinical indices of table 2
Treatment group is compared with baseline values with matched group, and all there were significant differences, * P < 0.01; Treatment group is compared with matched group, and difference has statistical significance, #P < 0.05.
Matched group and test group comparison in research, the minimizing of indices meets following condition: [(contrast-test)/contrast] >=15%; Or by reducing bacterial plaque amount or changing the pathogenic product of controlling gingivitis of bacterial plaque, should measure the minimizing of bacterial plaque amount or pathogenic attenuating, and there is significant difference.
Test shows that the toothpaste that the present invention comprises periplaneta americana has reasonable curative effect for gingivitis and dental plaque.
Although in conjunction with specific embodiments the specific embodiment of the present invention is described in detail, it is not the restriction to this patent protection domain.In claims limited range, the various modifications that those skilled in the art can make without creative work or adjustment are still subject to the protection of this patent.
Claims (7)
1. an American-cockroach-extract, it is characterized in that preparing by the following method: the dry worm of periplaneta americana is crushed to 10-40 order coarse powder, be placed in extraction pot, adding the volume fraction that 4-6 doubly measures is 80-90% ethanol merceration 6-8 hour, adding the volume fraction that 3-7 doubly measures is 70% ethanol reflux, extract, 3-6 hour at 70-80 ℃ again, extract 3 times, then extracting solution is crossed to 100 eye mesh screens, collect filtrate, and at 50-70 ℃, to be concentrated into relative density be 1.20-1.25, make extractum, add again extractum weight 8-10 water doubly, at 75-85 ℃, be incubated 3-6 hour, standing 15-40 hour, when oils and fats is isolated liquid level, filter, collect filtrate, being concentrated into relative density is 1.06-1.10, make American-cockroach-extract.
2. the preparation method of an American-cockroach-extract, its feature is prepared as follows: the dry worm of periplaneta americana is crushed to 10-40 order coarse powder, be placed in extraction pot, adding the volume fraction that 4-6 doubly measures is 80-90% ethanol merceration 6-8 hour, adding the volume fraction that 3-7 doubly measures is 70% ethanol reflux, extract, 3-6 hour at 70-80 ℃ again, extract 3 times, then extracting solution is crossed to 100 eye mesh screens, collect filtrate, and at 50-70 ℃, to be concentrated into relative density be 1.20-1.25, make extractum, add again extractum weight 8-10 water doubly, at 75-85 ℃, be incubated 3-6 hour, standing 15-40 hour, when oils and fats is isolated liquid level, filter, collect filtrate, being concentrated into relative density is 1.06-1.10, make American-cockroach-extract.
3. American-cockroach-extract according to claim 1, is characterised in that the mass content of its total amino acids is counted 7.2-7.8% with alanine.
4. American-cockroach-extract according to claim 1, it is characterized in that adopting following methods preparation: the dry polypide of periplaneta americana is crushed to 10 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 4 times of amounts is 80-90% ethanol merceration 6 hours, the volume fraction that adds again 3 times of amounts is 70% alcohol reflux 3 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02 Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.20 that unlatching vacuum is concentrated into relative density by it at 50 ℃, makes extractum A; The water that first adds 8 times of extractum A weight in degreasing tank, opens Steam Heating, after boiling, in the situation that opening stirring, slowly adds extractum A, at 75 ℃, is incubated 3 hours, standing 20 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and concentrated, obtain American-cockroach-extract.
5. American-cockroach-extract according to claim 1, it is characterized in that adopting following methods preparation: the dry polypide of periplaneta americana is crushed to 20 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 5 times of amounts is 80-90% ethanol merceration 7 hours, the volume fraction that adds again 5 times of amounts is 70% alcohol reflux 4 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02 Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.22 that unlatching vacuum is concentrated into relative density by it at 60 ℃, makes extractum A; Then, the water that first adds 9 times of extractum A weight in degreasing tank, open Steam Heating, after boiling, in the situation that opening stirring, slowly add extractum A, at 80 ℃, be incubated 4 hours, standing 15 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and concentrated, make American-cockroach-extract.
6. American-cockroach-extract according to claim 1, it is characterized in that adopting following methods preparation: the dry polypide of periplaneta americana is crushed to 40 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 6 times of amounts is 80-90% ethanol merceration 8 hours, the volume fraction that adds again 7 times of amounts is 70% alcohol reflux 6 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02 Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.25 that unlatching vacuum is concentrated into relative density by it at 70 ℃, makes extractum A; Then, the water that first adds 10 times of extractum A weight in degreasing tank, open Steam Heating, after boiling, in the situation that opening stirring, slowly add extractum A, at 85 ℃, be incubated 6 hours, standing 40 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, make American-cockroach-extract.
7. American-cockroach-extract according to claim 1, it is characterized in that adopting following methods preparation: the dry polypide of periplaneta americana is crushed to 30 order coarse powder, be placed in multi-function extractor, the volume fraction that adds 5 times of amounts is 80-90% ethanol merceration 7 hours, the volume fraction that adds again 5 times of amounts is 70% alcohol reflux 4.5 hours, extract 3 times, control temperature during reflux, extract, between 70-80 ℃, steam pressure is below 0.02 Mpa; Then extracting solution is crossed to 100 eye mesh screens, collected filtrate; After filtrate recycling ethanol, it is 1.23 that unlatching vacuum is concentrated into relative density by it at 60 ℃, makes extractum A; Then, the water that first adds 9 times of extractum A weight in degreasing tank, open Steam Heating, after boiling, in the situation that opening stirring, slowly add extractum A, at 80 ℃, be incubated 4.5 hours, standing 25 hours again, when oils and fats is isolated liquid level, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, make American-cockroach-extract.
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| CN104983806A (en) * | 2015-07-01 | 2015-10-21 | 重庆登康口腔护理用品股份有限公司 | Traditional Chinese medicine composition for treating oral diseases, preparation method, and application of traditional Chinese medicine composition |
| CN104997707A (en) * | 2014-07-31 | 2015-10-28 | 耿福能 | Preparation method of opaque toothpaste containing periplaneta americana and application of opaque toothpaste |
| CN105434310A (en) * | 2015-12-22 | 2016-03-30 | 广州市娇兰化妆品有限公司 | Application of periplaneta americana active ingredient extract in cosmetic preparation |
| CN105476947A (en) * | 2015-12-28 | 2016-04-13 | 昆明东特农业科技有限公司 | Toothpaste containing periplaneta Americana and preparation method thereof |
| CN107375168A (en) * | 2017-07-22 | 2017-11-24 | 李映波 | A kind of anti-caries toothpaste of American-cockroach-extract-containing |
| CN107970199A (en) * | 2018-01-03 | 2018-05-01 | 昆明赛诺制药股份有限公司 | A kind of toothpaste of the extract containing American cockroach |
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| CN104997707A (en) * | 2014-07-31 | 2015-10-28 | 耿福能 | Preparation method of opaque toothpaste containing periplaneta americana and application of opaque toothpaste |
| CN104997707B (en) * | 2014-07-31 | 2018-07-03 | 耿福能 | A kind of preparation method and applications of the opaque toothpaste containing American-cockroach-extract |
| CN104983806A (en) * | 2015-07-01 | 2015-10-21 | 重庆登康口腔护理用品股份有限公司 | Traditional Chinese medicine composition for treating oral diseases, preparation method, and application of traditional Chinese medicine composition |
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| CN105434310A (en) * | 2015-12-22 | 2016-03-30 | 广州市娇兰化妆品有限公司 | Application of periplaneta americana active ingredient extract in cosmetic preparation |
| CN105434310B (en) * | 2015-12-22 | 2021-02-19 | 广州市娇兰化妆品有限公司 | Application of periplaneta americana active ingredient extract in preparation of cosmetics |
| CN105476947A (en) * | 2015-12-28 | 2016-04-13 | 昆明东特农业科技有限公司 | Toothpaste containing periplaneta Americana and preparation method thereof |
| CN107375168A (en) * | 2017-07-22 | 2017-11-24 | 李映波 | A kind of anti-caries toothpaste of American-cockroach-extract-containing |
| CN109966319A (en) * | 2017-12-22 | 2019-07-05 | 四川好医生攀西药业有限责任公司 | A kind of raw material of Kangfuxin Liquid and its preparation method and application |
| CN107970199A (en) * | 2018-01-03 | 2018-05-01 | 昆明赛诺制药股份有限公司 | A kind of toothpaste of the extract containing American cockroach |
| CN107970199B (en) * | 2018-01-03 | 2021-05-07 | 昆明赛诺制药股份有限公司 | Toothpaste containing periplaneta americana refined extract |
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