CN103690457B - A kind of toothpaste and preparation method thereof - Google Patents

A kind of toothpaste and preparation method thereof Download PDF

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CN103690457B
CN103690457B CN201310642527.XA CN201310642527A CN103690457B CN 103690457 B CN103690457 B CN 103690457B CN 201310642527 A CN201310642527 A CN 201310642527A CN 103690457 B CN103690457 B CN 103690457B
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extract
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cockroach
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american
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CN103690457A (en
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耿福能
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Abstract

The invention discloses a kind of toothpaste containing American-cockroach-extract and preparation method thereof; toothpaste is by adding the American-cockroach-extract using specific process conditions to make wherein as the effective ingredient playing auxiliary therapeutic action; this extract protects the special biological activity of periplaneta americana to greatest extent; such as alanine etc.; make this toothpaste not only have oral cavity, tooth and gingiva and synchronize effect of nursing; and in terms for the treatment of oral ulcer, also there is significant curative effect; therefore, there is huge using value.

Description

A kind of toothpaste and preparation method thereof
Technical field
The invention belongs to oral cleaning nursing article technical field, be specifically related to a kind of containing periplaneta americana extraction Toothpaste of thing and preparation method thereof.
Background technology
Toothpaste is indispensable oral cavity cleaning hygienic article in people's daily life, and its basic function is clearly Clean one's teeth tooth, fresh breath, reaches to keep the purpose of oral cavity cleaning.In the past few years, realize due to consumer healthcare Constantly strengthen, toothpaste is proposed more requirement, also add some auxiliary prevention oral cavity diseases except cleaning the teeth Disease, has the function of nursing health effect to oral cavity;Therefore, domestic and international toothpaste has the product of various functional type Product become the market mainstream.In recent years, along with the development of modernization of Chinese medicine technology, to Chinese medicine study of active components The method utilized have also been obtained well development, and this utilizes active ingredient of Chinese herbs to assist prevention oral cavity for toothpaste Disease provides good technical support.
At present, prior art also has the various active ingredient of Chinese herbs of employing as toothpaste ancillary drug.These In medicated toothpaste, some toothpaste has plurality of Chinese composition, and producing process is complicated;Some toothpaste is processed Although production technology is simple, but effect is had nothing in common with each other, and is difficult to accomplish to synchronize oral cavity, tooth, gingiva simultaneously Effect of nursing health, especially for oral ulcer problem, is difficult to play remarkable result especially.
Periplaneta americana is Insecta wing subclass Blattaria Blattidae Periplaneta insecticide, is commonly called as " Blatta seu periplaneta ", in China Widely distributed, the beginning of being used as medicine is loaded in Shennong's Herbal, has antiinflammatory, subsides a swelling, promotes wound healing, promotion Angiogenesis, heart tonifying, expansion Pulmonary Vascular, improve microcirculation, arrhythmia, cardioprotection, antiviral, Improve immunity of organisms and repair the effects such as damage hepatocyte function.The applicant is May 25 in 2010 Patent in terms of the American cockroach medicament composition of day application treatment oral ulcer, Authorization Notice No. is CN101837019B;
It is one of common oral cavity chronic disease that tooth makes inflammation, and its sickness rate is up to 70%~90%, prevents and treats tooth ophthalmia It is crucial that control bacterial plaque, brush teeth be remove bacterial plaque Main Means.The mechanism of action of toothpaste antiplaque is main The pharmacological action of the antiplaque medicine for adding in toothpaste.It is badly in need of on market can effectively treating oral ulcer also And the toothpaste of the problem of oral cavity, tooth, gingiva synchronization nursing health can be solved.The object of the invention seeks to Research a kind of with American-cockroach-extract for active component prepare medicated toothpaste for effectively treatment oral ulcer and Solve oral cavity, tooth, the problem of gingiva synchronization nursing health.
Summary of the invention
Present invention aims to the deficiencies in the prior art, it is provided that one can be to oral cavity, tooth and gingiva Carry out synchronizing nursing and the toothpaste containing American-cockroach-extract of energy efficient solution breach chamber ulcer.
Another object of the present invention is to for the deficiencies in the prior art, it is provided that a kind of technique is simply prepared The method of the toothpaste containing American-cockroach-extract stated.
In order to reach first purpose of foregoing invention, the technical solution used in the present invention is: provide a kind of tooth Cream, it is characterised in that: containing American-cockroach-extract in the mastic of described toothpaste.
Preferably, described mastic includes the component of following weight portion: American-cockroach-extract 2-10 part, mountain Pears alcohol 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, preservative 0.3-0.7 part, Edible glue 0.1-0.3 part and water 2-20 part.
Preferably, described mastic includes the component of following weight portion: American-cockroach-extract 3 parts, Pyrusussuriensis Alcohol 55.5 parts, Polyethylene Glycol 4 parts, 2.3 parts of surfactant, silicon dioxide 23.5 parts, 1.05 parts of essence, Cyclodextrin 0.27 part, Carboxymethyl cellulose sodium 0.55 part, preservative 0.5 part, edible glue 0.1 part and water 9.23 Part.
Preferably, described Polyethylene Glycol is PEG400;Described surfactant is sodium lauryl sulphate And sodium lauroyl sarcosine, sodium lauroyl sarcosine is 1:1-1:10 with the mass ratio of sodium lauryl sulphate; Described preservative is sodium benzoate;Described essence is Flos Chrysanthemi Mint Essence;Described edible glue is carrageenan.
Preferably, described American-cockroach-extract is prepared as follows:
1) extract
Periplaneta americana is dried polypide and is crushed to 10-40 mesh coarse powder, be placed in multi-function extractor, add 4-6 The volume fraction of times amount is 80-90% ethanol merceration 6-8 hour, and the volume fraction adding 3-7 times amount is 70% Alcohol reflux 3-6 hour, extracts 3 times, and during reflux, extract, control temperature is between 70-80 DEG C, steam Pressure is at below 0.02Mpa;Then extracting solution is crossed 100 eye mesh screens, collects filtrate.
2) concentrate
After above-mentioned filtrate recycling ethanol, it is concentrated into relative density at 50-70 DEG C and is by unlatching vacuum 1.20-1.25, prepares extractum A;
3) defat
In degreasing tank, first add the water of extractum A weight 8-10 times, open steam heating, opening after boiling It is slowly added to extractum A in the case of stirring, at 75-85 DEG C, is incubated 3-6 hour, stands 15-40 hour, When liquid level isolated by oils and fats, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, prepare American-cockroach-extract, wherein, containing total amino acids with alanine in the dry product of American-cockroach-extract (C3H7NO2) be calculated as 7.2-7.8%(mass percent).
Wherein, the American-cockroach-extract of the present invention preferably employs above-mentioned process to be prepared, however, it is possible to To use the periplaneta americana of supply on market to extract goods, as periplaneta americana extracting solution, periplaneta americana extractum and Periplaneta americana extract powder etc.;When using the periplaneta americana goods of supply on market, extract according to periplaneta americana Goods are equivalent to former dose and are converted into periplaneta americana according to the former dose of periplaneta americana required in above-mentioned toothpaste finished product Extract the addition of goods.
In order to reach another purpose of foregoing invention, the technical solution used in the present invention is: provide one system The method of the standby above-mentioned toothpaste containing American-cockroach-extract, it is characterised in that comprise the following steps:
A, by after American-cockroach-extract, sorbitol, Polyethylene Glycol, cyclodextrin water dissolution, join true In empty Manufacturing medicine extract machine, open vacuum pump, open agitator and colloid mill, stir 15-50 minute, mixing;
B, silicon dioxide, Carboxymethyl cellulose sodium and edible glue are mixed in advance after, join in vacuum Manufacturing medicine extract machine, After stirring 15-50 minute, add preservative, stir 15-50 minute;
C, add surfactant, stir 20-30 minute;It is eventually adding essence, stirs 15-50 minute; Vacuum under pressure at more than-700mmHg deaerates 20-65 minute again, prepares mastic, after testing, after fill, Make the toothpaste containing American-cockroach-extract.
In sum, the toothpaste that the present invention provides uses specific process conditions to make by adding wherein American-cockroach-extract is as the effective ingredient of an auxiliary therapeutic action, and this extract protects U.S. to greatest extent The special biological activity of the big Lian in continent, such as alanine etc., makes this toothpaste not only have oral cavity, tooth and gingiva same Effect of step nursing, and in terms for the treatment of oral ulcer, also there is significant curative effect, therefore, have huge Using value.
Detailed description of the invention
Below in conjunction with specific embodiment, the detailed description of the invention of the present invention is described in detail:
Embodiment 1
Make double centner lotion of toothpaste raw materials used as follows: American-cockroach-extract 3 kilograms, sorbitol 55.5 Kilogram, 4 kilograms of PEG400s, sodium lauryl sulphate 1.8 kilograms, silicon dioxide 23.5 kilograms, chrysanthemums Flower Mint Essence 1.05 kilograms, cyclodextrin 0.27 kilogram, Carboxymethyl cellulose sodium 0.55 kilogram, lauroyl flesh 0.5 kilogram of propylhomoserin sodium, sodium benzoate 0.5 kilogram, carrageenan 0.1 kilogram and pure water 9.23 kilograms;
Wherein, American-cockroach-extract is to use following methods to prepare: 20 kilograms of periplaneta americanaes are dried polypide Being crushed to 10 mesh coarse powder, be placed in multi-function extractor, the volume fraction adding 4 times amount is 80-90% ethanol Merceration 6 hours, the volume fraction adding 3 times amount is 70% alcohol reflux 3 hours, extracts 3 times, During reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then by extracting solution Cross 100 eye mesh screens, collect filtrate;After filtrate recycling ethanol, open vacuum and it is concentrated into phase at 50 DEG C It is 1.20 to density, prepares extractum A;In degreasing tank, first add the water of extractum A weight 8 times, open and steam Vapour heats, and is slowly added to extractum A after boiling in the case of opening stirring, is incubated 3 hours at 75 DEG C, Stand 20 hours again, when liquid level isolated by oils and fats, filter, collect filtrate, and be concentrated into relative density and be 1.06-1.10, prepares 3 kilograms of American-cockroach-extracts, wherein, contains in the dry product of this American-cockroach-extract Total amino acids is with alanine (C3H7NO2) be calculated as 7.5%(mass percent).
Embodiment 2
Make double centner lotion of toothpaste raw materials used as follows: American-cockroach-extract 5 kilograms, sorbitol 50 Kilogram, 2 kilograms of PEG400s, sodium lauryl sulphate 3 kilograms, silicon dioxide 20 kilograms, Flos Chrysanthemis Mint Essence 0.8 kilogram, cyclodextrin 0.1 kilogram, Carboxymethyl cellulose sodium 0.3 kilogram, Hamposyl L 0.3 kilogram of sodium, sodium benzoate 0.3 kilogram, carrageenan 0.1 kilogram and pure water 18.1 kilograms;
Wherein, American-cockroach-extract is to use following methods to prepare: 25 kilograms of periplaneta americanaes are dried polypide Being crushed to 20 mesh coarse powder, be placed in multi-function extractor, the volume fraction adding 5 times amount is 80-90% ethanol Merceration 7 hours, the volume fraction adding 5 times amount is 70% alcohol reflux 4 hours, extracts 3 times, During reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then by extracting solution Cross 100 eye mesh screens, collect filtrate;After filtrate recycling ethanol, open vacuum and it is concentrated into phase at 60 DEG C It is 1.22 to density, prepares extractum A;Then, in degreasing tank, first add the water of extractum A weight 9 times, Unlatching steam heats, and is slowly added to extractum A after boiling in the case of opening stirring, is incubated 4 at 80 DEG C Hour, then stand 15 hours, when liquid level isolated by oils and fats, filter, collect filtrate, and be concentrated into relatively Density is 1.06-1.10, prepares 5 kilograms of American-cockroach-extracts, contains in the dry product of American-cockroach-extract Total amino acids is with alanine (C3H7NO2) be calculated as 7.8%(mass percent).
Embodiment 3
Make double centner lotion of toothpaste raw materials used as follows: American-cockroach-extract 8 kilograms, sorbitol 40 Kilogram, 10 kilograms of PEG400s, sodium lauryl sulphate 2 kilograms, silicon dioxide 30 kilograms, Flos Chrysanthemis Mint Essence 1 kilogram, cyclodextrin 0.2 kilogram, Carboxymethyl cellulose sodium 0.2 kilogram, sodium lauroyl sarcosine 0.2 kilogram, sodium benzoate 0.2 kilogram, carrageenan 0.2 kilogram and pure water 8 kilograms;
Wherein, American-cockroach-extract is to use following methods to prepare: 40 kilograms of periplaneta americanaes are dried polypide Being crushed to 40 mesh coarse powder, be placed in multi-function extractor, the volume fraction adding 6 times amount is 80-90% ethanol Merceration 8 hours, the volume fraction adding 7 times amount is 70% alcohol reflux 6 hours, extracts 3 times, During reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then by extracting solution Cross 100 eye mesh screens, collect filtrate;After filtrate recycling ethanol, open vacuum and it is concentrated into phase at 70 DEG C It is 1.25 to density, prepares extractum A;Then, in degreasing tank, first add the water of extractum A weight 10 times, Unlatching steam heats, and is slowly added to extractum A after boiling in the case of opening stirring, is incubated 6 at 85 DEG C Hour, then stand 40 hours, when liquid level isolated by oils and fats, filter, collect filtrate, and be concentrated into relatively Density is 1.06-1.10, prepares 8 kilograms of American-cockroach-extracts, contains in the dry product of American-cockroach-extract Total amino acids is with alanine (C3H7NO2) be calculated as 7.6%(mass percent).
Embodiment 4
Make double centner lotion of toothpaste raw materials used as follows: American-cockroach-extract 10 kilograms, sorbitol 42 Kilogram, 3 kilograms of PEG400s, sodium lauryl sulphate 1 kilogram, silicon dioxide 25 kilograms, Flos Chrysanthemis Mint Essence 2 kilograms, cyclodextrin 0.3 kilogram, Carboxymethyl cellulose sodium 0.5 kilogram, sodium lauroyl sarcosine 0.5 kilogram, sodium benzoate 0.5 kilogram, carrageenan 0.5 kilogram and pure water 14.7 kilograms;
Wherein, American-cockroach-extract is to use following methods to prepare: 50 kilograms of periplaneta americanaes are dried polypide Being crushed to 30 mesh coarse powder, be placed in multi-function extractor, the volume fraction adding 5 times amount is 80-90% ethanol Merceration 7 hours, the volume fraction adding 5 times amount is 70% alcohol reflux 4.5 hours, extracts 3 Secondary, during reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then will carry Take liquid and cross 100 eye mesh screens, collect filtrate;After filtrate recycling ethanol, open vacuum and it is concentrated at 60 DEG C It is 1.23 to relative density, prepares extractum A;Then, in degreasing tank, extractum A weight 9 times is first added Water, opens steam heating, is slowly added to extractum A after boiling in the case of opening stirring, protect at 80 DEG C Temperature 4.5 hours, then stand 25 hours, when liquid level isolated by oils and fats, filter, collect filtrate, and concentrate It is 1.06-1.10 to relative density, prepares 10 kilograms of American-cockroach-extracts, being dried of American-cockroach-extract Containing total amino acids with alanine (C in product3H7NO2) be calculated as 7.2%(mass percent).
Described in above-described embodiment 1-4, the preparation method of lotion of toothpaste is as follows:
After American-cockroach-extract, sorbitol, Polyethylene Glycol, cyclodextrin dissolved in purified water, join In the main frame of vacuum Manufacturing medicine extract machine, open vacuum pump, open agitator and colloid mill, stir 15-50 minute, mixed Even;After silicon dioxide, Carboxymethyl cellulose sodium and carrageenan being mixed in advance, join the master of vacuum Manufacturing medicine extract machine In machine, after stirring 15-50 minute, add sodium benzoate, stir 15-50 minute;Add lauroyl flesh Propylhomoserin sodium and sodium lauryl sulphate, stir 20-30 minute;It is eventually adding Flos Chrysanthemi Mint Essence, stirs 15-50 Minute;Vacuum under pressure at more than-700mmHg deaerates 20-65 minute again, prepared mastic, after testing, After fill, make the toothpaste containing American-cockroach-extract.
The toothpaste described in embodiment 1 to 4 utilizing said method to prepare is pioneering oral cavity, tooth and gingiva Synchronize nursing health toothpaste, have cleaning-nursing oral cavity, improve gingiva problem (mainly oral ulcer), Reduce dental plaque and effect of nutrition gingiva periodontal.
Test example 1:
It is used for treating facing of oral ulcer patient with the toothpaste containing American-cockroach-extract of embodiment 1 preparation Bed test data:
One, patient's classified data:
Oral ulcer patient 200 example, meets diagnostic criteria.It is divided into treatment group and matched group, treatment group immediately 100 examples, male 62 example, women 38 example, age 16~40 years old;Matched group 100 example, male 60 example, Women 40 example, age 16~40 years old.Two groups of patient ages, sex and the course of disease through statistical procedures, difference without Significant, has comparability.
Two, Therapeutic Method:
Treatment group: take the toothpaste containing American-cockroach-extract prepared according to preparation method in test example, often It is brushed teeth 1-2 time, and consumption is 1g/ time, brushes teeth 1-3 minute every time, allows toothpaste during brushing teeth in oral cavity Rinsing the mouth 2-3 minute, used for 1 week continuously;
Matched group: mica filled polypropylene, brushes teeth 1-2 time every day, and consumption is 1g/ time, and the 1-3 that every time brushes teeth divides Clock, used for 1 week continuously.
Three, comparitive study result:
Table 1 show two groups of comparitive study, wherein treatment group 100 example, and total effective rate is 98%;Matched group 100 examples, total effective rate is 88%.Table 2 show comparitive study in two groups of 3 days and 1 weeks;Treatment group In treating 3 days, cure rate is 60%, and treatment of control group is in 3 days, and cure rate is 46%;Treatment group treatment 1 In individual week, cure rate is 98.0%, and in 1 week for the treatment of of control group, cure rate is 88%;(table 1 He N number of delegates in table 2)
Table 1:
Table 2:
Four, conclusion (of pressure testing):
Comprehensive conclusion: from above-mentioned clinical data, treatment group curative effect is substantially better than matched group.
Oral ulcer is clinical common oral disease, can occur, at any age, have the feature of recurrent exerbation. The generation of oral ulcer is relevant with many factors, common are infection, zinc deficiency etc.;Periplaneta americana is a kind of elder brother Worm, internal containing various active composition, its extract main component is polyalcohols and peptides active substance, Confirm through pharmacological research: the toothpaste of the present invention has promotion epithelial cell, granulation tissue growth, promotes ulcer The function of tissue repair;The toothpaste using the present invention to contain American-cockroach-extract can reach raising ulcer healing Rate, the purpose of shortening healing.
Test example 2:
One, patient's classified data:
150 experimenters carry out whole body and oral cavity hard and soft tissue evaluation, and record history of past illness, general oral hygiene Custom.
Use PI to evaluate plaque index, include PI in the experimenter of 1.5.
Use Sulcus Bleeding Index (SBI) to evaluate instruction gingival hemorrhage situation, include SBI in=1 be subject to Examination person.
1, inclusive criteria
A) whole body health in order, without whole body system disease, have the intact tooth of more than 20;
B) age is in 18~70 one full year of life;
C) if women, must not be in 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 suitable degree of gingivitis;Preliminary screening process includes oral soft tissue and hard group Knitting inspection, gingivitis determines whether being selected in of experimental subject.Plaque index (PI) >=1.5 and the hemorrhage finger of gingival sulcus The object of study of number >=1.0 participates in research.
F) participate in other similar experimental studies the most simultaneously;
2, exclusion standard
A) test toothpaste component there are allergies;
B) medicine influential on result of the test is taken now;
C) antibiotic is used in the previous moon participating in research;
Two, Index for examination and method
1, oral cavity hard and soft tissue checks
Inspection socket transmucosal includes lip, tongue, soft or hard palatine mucosa, salivary gland, tonsil and pharyngeal etc., Carry out record.
2, plaque index (PI)
The Turesky plaque index using Quigley-Hein improvement evaluates tooth supragingival plaque.To tooth supragingival plaque Dye and according to following standard recording:
0=is without bacterial plaque
The bacterial plaque that 1=neck portion marginal existence is dispersed in
Continuous print thin bacterial plaque band (reaching lmm width) seen from 2=neck edge
3=neck portion bacterial plaque band is more than lmm but less than the 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, be 10 for the numeration of each tooth maximum.Except third molar, artificial tooth with have The tooth of cervical region dummy, remaining tooth is all at the row of numeration.The mean of each experimenter's plaque index is by individual All tooth detection gained counting sum (each tooth 2 record) divided by total measurement number, (take advantage of by teeth number With 2) obtain.
3, sulcular bleeding index (SBI)
Gingivitis and gingival hemorrhage situation use sulcular bleeding index (Sulcus Bleeding Index, SBI), Gingival sulcus is hemorrhage is the performance of gingivitis, and it is thinner that this index indexes relatively gingival index, it is adaptable to the experiment of gingivitis Epidemiological study.
Scoring criteria
0=gum edge and gum nipple healthy appearance are the most hemorrhage after light spy gingival sulcus
1=gum edge and gum nipple healthy appearance are hemorrhage after light spy gingival sulcus
2=gingiva is because of inflammation color change, without swelling or edema, visits after examining hemorrhage (petechial hemorrhage)
3=gingiva color change is slight, edema, visits hemorrhage after examining (hemorrhage along the extension of gum edge)
4=gingiva color change, hence it is evident that swelling, visits after examining hemorrhage (hemorrhage spilling gum edge)
5=gingiva color change, hence it is evident that swelling, has ulcer sometimes, visits hemorrhage after examining or has the most hemorrhage
As the inspection of plaque index, each tooth inspection record buccal surface and lingual surface, except third molar, vacation Tooth and the tooth having cervical region dummy, remaining tooth is included in the row of numeration.Each experimenter's gingivitis indices Mean by individual's whole tooth detection gained counting sum (each tooth 2 record) divided by total measurement number (teeth number is multiplied by 2) obtains.
Three, research process
This research design research time limit is April, including screening and January eluting phase and 3 months experimental periods.
1, (screening) is checked for the first time
According to entering group standard, screen experimenter.About 150 experimenters are carried out whole body and oral cavity soft or hard group Knit evaluation, and record history of past illness, general oral sanitary habit.Distribution toothpaste toothbrush articles for use, field surveillance brush Tooth.The dosage (using one cun of long toothpaste) of demonstration toothpaste, and it is familiar with brushing time.It addition, to experimenter In illustrating to use (1 week) time of requirement, experimenter uses the tooth of the eluting phase of unified distribution as requested every day Cream and toothbrush).
The reservation second time review time.
2, second time checks (baseline inspection)
Require that experimenter checks that the morning on the same day carries out baseline inspection;Check before 12(+2) hour in do not brush teeth, Lived on air before 2 hours.Check oral cavity hard and soft tissue, check full mouth plaque index and gingivitis indices, meet First 150 of the experimenter of inclusive criteria participates in test, and every Eligible subjects will obtain a random number, For distributing test products at random;Experimenter will use test toothpaste and comparison toothpaste respectively.Special messenger refers to Lead experimenter's product using method.
3, third time checks (1.5 months)
Check before 12(+2) hour in do not brush teeth, lived on air before 2 hours.Check OST, check PI, SBI.Reclaim toothpaste, distribute experiment toothpaste and the toothbrush of 3 months subsequently.
4, (3 months) are checked the 4th time
Check before 12(+2) hour in do not brush teeth, lived on air before 2 hours.Check oral cavity hard and soft tissue feelings Condition.Check PI, SBI index.Questionnaire assessment experimenter uses the subjective effect of product, service condition etc..
Four, test specimen and using method
Treatment group: toothpaste prepared by embodiment 1 method
Matched group: mica filled polypropylene
Experimenter uses soft toothbrush and uses according to regulations toothpaste, it is desirable within 1st, brush teeth 2 times (early, evening), often Secondary 1 minute.Consumption is 1g/ time
Require in experimentation without any other dental care product such 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.Sieve Looking into the method that patient is just used when checking product by doctor with baseline, the item such as time is handed in detail, The most periodically supervision patient is carried out.Every 1.5 months exchange toothpaste, every three months exchange toothbrush.And understand right As using toothpaste brushing condition.
Five, experimental stage product uses:
Be responsible for clinical indices inspection doctor do not know about experimenter's random packet situation (can not identification test group or Matched group experimenter).It is responsible for packet, distribution trial target and the work such as reference product, registration by special messenger.Tested It is product to be measured or reference product that person also must not understand it used.
Six, data statistics analyse:
By data input computer, use SPSS statistical package that data is analyzed statistics.Data typing Complete by specialty statistician with statistical analysis.
Seven, effect assessment and standard
By medical statistics means, equal to the full mouth of indices before and after treatment group and matched group statistical test respectively Value situation of change;And carry out between two groups each time period, the statistical analysis of each index change.Effective evaluation Should compare between Change in Mean based on every clinical indices and group and determine.
Eight, result of the test
150 subjects enter research, male 70, women 80, age 18~65 years old, smoker 30, wherein treatment group 75, matched group 75, sex ratio, age and smoker's ratio of two groups Having carried out statistical analysis, two groups of baselines are consistent.Process of the test is followed up a case by regular visits to patient without coming off.Process of the test, nothing Allergy and untoward reaction thereof occur.
Baseline checks
To two clinical indices: plaque index (PI) and sulcular bleeding index (SBI) carry out baseline and compare, knot Equal no difference of science of statistics between fruit two inspection values of display, is shown in Table 1:
The baseline of 1 two clinical indices of table compares (x ± s)
P > 0.05
The change 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 clinic refers to Mark is obviously improved and is shown in Table 2.As can be seen from Table 2, the clinical indices for the treatment of group and matched group is entered along with treatment Declining all occurs in row, and the clinical indices for the treatment of group declines degree and is higher than treatment group, and between two groups, difference has statistics Meaning (P < 0.05).
The comparison (x ± s) of 2 two clinical indices of table
Treatment group is with matched group compared with baseline values, and all there were significant differences, * P < 0.01;Treatment group and comparison Group is compared, and difference is statistically significant, #P < 0.05.
In research, matched group compares with test group, and the minimizing of indices meets following condition: [(compare-examination Test)/comparison] >=15%;Or by reducing bacterial plaque amount or to change bacterial plaque pathogenic and control the product of gingivitis Product should measure the minimizing of bacterial plaque amount or pathogenic attenuating, and has significant difference.
Test shows that the toothpaste that the present invention comprises periplaneta americana has reasonable treatment for gingivitis and dental plaque Effect.
Although in conjunction with specific embodiments the detailed description of the invention of the present invention is described in detail, but not It it is the restriction to this patent protection domain.In claims limited range, those skilled in the art Various amendments or adjustment that member can make without creative work are still protected by this patent.

Claims (4)

1. an American-cockroach-extract, it is characterized in that using following methods to prepare: periplaneta americana is dried polypide and is crushed to 10 mesh coarse powder, it is placed in multi-function extractor, the volume fraction adding 4 times amount is 80-90% ethanol merceration 6 hours, the volume fraction adding 3 times amount is 70% alcohol reflux 3 hours, extracting 3 times, during reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then extracting solution is crossed 100 eye mesh screens, collects filtrate;After filtrate recycling ethanol, opening vacuum and it is concentrated at 50 DEG C relative density is 1.20, prepares extractum A;In degreasing tank, first add the water of extractum A weight 8 times, unlatching steam heats, in the case of opening stirring, it is slowly added to extractum A after boiling, at 75 DEG C, it is incubated 3 hours, then stands 20 hours, when liquid level isolated by oils and fats, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, obtain American-cockroach-extract.
2. an American-cockroach-extract, it is characterized in that using following methods to prepare: periplaneta americana is dried polypide and is crushed to 20 mesh coarse powder, it is placed in multi-function extractor, the volume fraction adding 5 times amount is 80-90% ethanol merceration 7 hours, the volume fraction adding 5 times amount is 70% alcohol reflux 4 hours, extracting 3 times, during reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then extracting solution is crossed 100 eye mesh screens, collects filtrate;After filtrate recycling ethanol, opening vacuum and it is concentrated at 60 DEG C relative density is 1.22, prepares extractum A;Then, in degreasing tank, first add the water of extractum A weight 9 times, unlatching steam heats, and is slowly added to extractum A after boiling in the case of opening stirring, is incubated 4 hours at 80 DEG C, stand 15 hours again, when liquid level isolated by oils and fats, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, prepare American-cockroach-extract.
3. an American-cockroach-extract, it is characterized in that using following methods to prepare: periplaneta americana is dried polypide and is crushed to 40 mesh coarse powder, it is placed in multi-function extractor, the volume fraction adding 6 times amount is 80-90% ethanol merceration 8 hours, the volume fraction adding 7 times amount is 70% alcohol reflux 6 hours, extracting 3 times, during reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then extracting solution is crossed 100 eye mesh screens, collects filtrate;After filtrate recycling ethanol, opening vacuum and it is concentrated at 70 DEG C relative density is 1.25, prepares extractum A;Then, in degreasing tank, first add the water of extractum A weight 10 times, unlatching steam heats, and is slowly added to extractum A after boiling in the case of opening stirring, is incubated 6 hours at 85 DEG C, stand 40 hours again, when liquid level isolated by oils and fats, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, prepare American-cockroach-extract.
4. an American-cockroach-extract, it is characterized in that using following methods to prepare: periplaneta americana is dried polypide and is crushed to 30 mesh coarse powder, it is placed in multi-function extractor, the volume fraction adding 5 times amount is 80-90% ethanol merceration 7 hours, the volume fraction adding 5 times amount is 70% alcohol reflux 4.5 hours, extracting 3 times, during reflux, extract, control temperature is between 70-80 DEG C, and steam pressure is at below 0.02Mpa;Then extracting solution is crossed 100 eye mesh screens, collects filtrate;After filtrate recycling ethanol, opening vacuum and it is concentrated at 60 DEG C relative density is 1.23, prepares extractum A;Then, in degreasing tank, first add the water of extractum A weight 9 times, unlatching steam heats, and is slowly added to extractum A after boiling in the case of opening stirring, is incubated 4.5 hours at 80 DEG C, stand 25 hours again, when liquid level isolated by oils and fats, filter, collect filtrate, and to be concentrated into relative density be 1.06-1.10, prepare American-cockroach-extract.
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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
CN104983806B (en) * 2015-07-01 2018-03-23 重庆登康口腔护理用品股份有限公司 A kind of Chinese medicine composition for treating mouth disease, preparation method and applications
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
CN109966319B (en) * 2017-12-22 2022-11-22 四川好医生攀西药业有限责任公司 Raw material of novel rehabilitation liquid and preparation method and application thereof
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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CN1961893A (en) * 2005-11-08 2007-05-16 肖小芹 Method for preparing extract of adult bombay canary
CN102416023A (en) * 2011-12-09 2012-04-18 浙江京新药业股份有限公司 Periplaneta Americana L. and gel externally applied medicinal composition and preparation method and use thereof in preparation of externally applied medicines for treating scalding

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CN1961893A (en) * 2005-11-08 2007-05-16 肖小芹 Method for preparing extract of adult bombay canary
CN102416023A (en) * 2011-12-09 2012-04-18 浙江京新药业股份有限公司 Periplaneta Americana L. and gel externally applied medicinal composition and preparation method and use thereof in preparation of externally applied medicines for treating scalding

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