CN109157541A - Application of the kaolin in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament - Google Patents
Application of the kaolin in preparation prevention and treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance disease medicament Download PDFInfo
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Abstract
The present invention relates to new effect of kaolin single medicinal material, the present invention is had found by lot of experiments, and kaolin can be improved the diversity of enteric microorganism and promote a variety of growth of probiotics, improves immunity of organisms；And kaolin has effects that prevent and/or treat anaphylactia, mental disorder, metabolism class disease and endocrine disturbance related disease, it is highly-safe.
Description
Technical field
The present invention relates to kaolinic new applications, and in particular to kaolin prevents and treats anaphylactia, mental disease in preparation
Application in disease, metabolism class disease and endocrine disturbance disease medicament.
Background technique
Each age level of the anaphylactia from newborn to the elderly may all occur.Anaphylactia main Types
There are cutaneous anaphylaxis, respiratory tract anaphylaxis reaction, alimentary canal allergic reaction and anaphylactic shock etc., common disease has following several
Kind: allergic dermatitis, allergic rhinitis, allergic asthma, anaphylactoid purpura, anaphylactic shock, irritable bowel disorder, anaphylaxis first
Shape adenositis, allergic nephritis, interstitial cystitis etc..Wherein allergic dermatitis includes drug rash, contact dermatitis, eczema, nettle
Rash, dermographism, food hypersenstivity and environmental factor cause allergy.Irritable bowel disorder is primarily referred to as allergic colitis, ulcer
Property colitis and Crohn disease.
In recent years, the disease incidence of anaphylactia increases year by year, such as infantile eczema disease incidence Tianjin Dagang District women and children
Health care institute shows that disease incidence is 75.6% to neonatal investigation in 2007；The investigation knot of hospital of Chongqing City one in 2013
Fruit is 64.8%；The investigation 42 age in days childhood eczema disease incidence of discovery of Beijing's outpatient service in 2011 are up to 57.3%.It is complete at present
There are about 300,000,000 asthmatic patients for ball, wherein China is current, and oneself has every year there are about 1,005 million peoples because of the disease and disability
20000000 asthmatic patient.The disease incidence of China big city resident's allergic rhinitis has had increased to 10-19%.Other allergy
The disease incidence of property disease (such as allergic dermatitis, food irritability) also increases year by year.Therefore, heavy economy is brought to society
Huge economic loss is born and caused, serious public health problem is had become.
The treatment of anaphylactia mainly uses Loratadine and hormone medicine, and Loratadine such as flutters you
Quick, Astemizole, quick gram, Clarityne etc..Antihistamine drug has side effect, and long-time service can make one drowsiness, tired, mental slow
It is blunt.Hormone medicine such as mainly has cortex hormone of aadrenaline, such as prednisone, dexamethasone and cyclophosphamide, imuran
Deng, conventional Hormone can the internals such as serious liver injury, kidney, also will affect the growth and development of children.
In addition, as people's lifestyle changes, a variety of mental disorders, metabolism class disease and endocrine disorder
Increase year by year, there is great influence to the health of the mankind.
Summary of the invention
Goal of the invention: the purpose of the present invention is being screened by many experiments, kaolinic effect is furtherd investigate, it is new to develop it
Clinical efficacy.
In order to solve the above technical problems, the technical solution adopted by the present invention is that:
Kaolin is in preparation prevention and/or treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance
Application in related disease drug.
The anaphylactia includes allergic dermatitis, allergic rhinitis, allergic asthma, anaphylactoid purpura, allergy
Property shock, anaphylaxis thyroiditis, allergic nephritis, interstitial cystitis, irritable bowel disorder etc..
The allergic dermatitis include drug rash, contact dermatitis, eczema, nettle rash, dermographism, food hypersenstivity with
Environmental factor causes allergy dermatitis；Irritable bowel disorder includes allergic colitis, ulcerative colitis and Crohn disease.
The mental disorder includes depression, autism or senile dementia disease.
The metabolism class disease includes high blood pressure, diabetes or obesity.
The endocrine disturbance related disease include whelk, female irregular menstruation disease, sleep disturbance, be hard and dry and
Constipation.
Kaolin improves immunity of organisms, improves the diversity of enteric microorganism and promotes a variety of growth of probiotics in preparation
Drug in application.
Kaolin and pharmaceutically acceptable carrier can be prepared into oral preparation or external preparation by the present invention.The medicine
The solid or liquid form that object can take orally can also be made external application and smear ointment preparation or powder.
Kaolin provided by the invention can increase the type and quantity of probiotics, the especially kind of increase actinomyces door bacterium
Class and quantity.
Kaolin provided by the invention can reduce influence of the antibiotic for intestinal microecology, promote intestinal microecology used
It restores balance as early as possible after antibiotic.
As an improvement of the present invention, kaolin provided by the invention can individually be taken, can also be with any food
With integration of drinking and medicinal herbs food, and mixes and take without antergic Chinese medicine or Western medicine.
The present invention compared with the prior art, has the advantage that as follows:
1) kaolin provided by the invention is a kind of silicate mineral containing aluminium, the oxide contained and it is a variety of it is inorganic from
Son has and adjusts micro-ecological in intestines and anabolic action；It is a variety of in contained oxide and the micro- state of inorganic ion-pair enteron aisle
Probiotics plays trophism.
2) for kaolin provided by the invention by adjusting intestinal microecology, having further stimulates panimmunity cell development
Effect；Required nutrients of many oxide and ion that kaolin contains as a variety of probiotics, supports the growth of probiotics,
Probiotics can further stimulate the development of immunocyte, further maintain immunologic balance, reach prevention and treatment anaphylaxis disease
The effect of disease.
3) a variety of probiotics of nutrition of the present invention generate immune factor by the development of stimulation immunocyte, these are immune
The factor further adjusts the development of children's brain and nerve, therefore has the function of adjusting neurodevelopment.
4) a variety of probiotics metabolites of nutrition of the present invention, adjustable human endocrine activity, reach prevention and control
Treat a variety of diseases caused by endocrine disturbance.
Specific embodiment
The preferred embodiments of the present invention will be described in detail below so that advantages and features of the invention can be easier to by
It will be appreciated by those skilled in the art that so as to make a clearer definition of the protection scope of the present invention.
Embodiment 1:
Treat autism
(1) prepared by preparation: kaolin crushes, and high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour and wheat bran, kaolin
Powder: corn flour: celery powder is 4:12:1 (mass ratio), capsule is made, 0.55 gram of drug containing in each capsule makes rear spare.
(2) autism research object: Autism children 52 are recruited as research subject, patient passes through Americanism obstacle
The diagnostic criteria of diagnostic and statistical manual (DSM- IV) childhood autism is made a definite diagnosis, the age less than 3.0 years old, wherein boy 36,
Girl 16.In these subjects, slight self-closing disease infant 18, moderate self-closing disease infant 18, severe self-closing disease infant 16
Example.Experimental subjects is randomly divided into two groups, treatment group and control group, every group of 26 people, wherein patients with mild 9, moderate patient 9,
Severe patient 8.
(3) treatment method: treatment group takes orally kaolin capsule, 1 time a day, 5 tablets each time.It is treated after medication 3 months
Effect evaluation and test.Control group takes placebo made of the auxiliary material of same ratio, the same treatment group of dosage.During medication, patient is normal
Participate in rehabilitation and normal diet.Variation pretherapy and post-treatment using high-flux sequence instrument detection enteric microorganism simultaneously.
(4) treatment effectiveness evaluation: CARS scale, ABC scale, Gesell developmental scale (social adaptation are used before and after treatment
DQ, personal social activity DQ, language DQ), it is evaluated and tested using items of the questionnaire form to autism children.The data of acquisition use
18.0 software of SPSS is for statistical analysis.
(5) result: the pretherapy and post-treatment CARS scale for the treatment of group, ABC scale numerical value significant difference (P ﹤ 0.05) as the result is shown, and
Control group scores no significant change before and after treatment.Compared with the control group, CARS, ABC scale score are obvious for treatment group after treatment
It reduces, significant difference (P ﹤ 0.05) the results are shown in Table 1.Treatment group's infant social adaptation DQ, language DQ, personal social activity DQ after treatment
Value is significantly raised compared with the control group, significant difference (P ﹤ 0.05).It the results are shown in Table 1 and table 2.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 3), actinomyces door
Bacterial species and quantity dramatically increase (P ﹤ 0.01).
1 CARS scale of table, ABC scale score compare (point,)
The scoring of 2 Gesell developmental scale of table (point,)
The type that 3. random forest of table analysis treatment group enteric bacteria content dramatically increases
2 kaolin of embodiment treats the experimental study that allergic asthma merges Allergic Rhinitis
(1) prepared by preparation: kaolin being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry pearling cone meal and wheat flour, kaolinite
Native powder, pearling cone meal and wheat flour mixed proportion are kaolin powder: corn flour: red bean powder is 3:4:1 (mass ratio), and capsule is made,
0.5-0.55 grams of drug containing in each capsule makes rear spare.
(2) allergic asthma merges allergic rhinitis subject selection: 100 sensitive asthmatics merge Allergic Rhinitis with
Machine is divided into treatment group and control group.Treatment group 50, male 26 are female 24, the age 5~64 years old, 35.6 ± 14.5 years old average.Disease
Journey 1~21 year, average (8 ± 7.3) year；Control group 50, male 28, female 22, the age 5~64 years old, average (35.1 ±
11.6) year；The course of disease 1~21 year, average (7 ± 8.5) year.Two groups of subject Genders, age, course of disease no difference of science of statistics.Enter
Case is selected to meet allergic asthma and allergia nose's inflammation diagnostic criteria (allergic asthma diagnostic criteria: with reference to Chinese Medical Association
" prevention and control of bronchial asthma guide (2008) " that respirology branch asthma group is formulated).
(3) treatment method: kaolin capsule is taken by treatment group, 1 time a day, 5 tablets/time of dosage.It is controlled after medication 3 months
Therapeutic effect evaluation and test.Control group takes placebo made of the auxiliary material of same ratio, the same treatment group of dosage.It is measured simultaneously using high pass
The detection of sequence instrument progress enteric microorganism variation.
(4) treatment effectiveness evaluation: after treatment 3 months, therapeutic effect is observed.
1. Asthma control standards of grading: it is 25 points that asthma, which fully controls scoring, and it is 20~24 points that Asthma control, which well scores,
It is that < 20 divides that asthma, which does not control scoring,.
2. Rhinitis Symptoms standards of grading: A. is commented referring to the allergic rhinitis in " allergic rhinitis processing is pocket to refer to 2009 "
The symptom of minute mark quasi- evaluation patient.Pretherapy and post-treatment Rhinitis Symptoms scoring is completed by the same veteran doctor.
B.RQLQ marking scales: it scores before and after treatment.
3. serum total Ig E detects: limosis vein blood, kit detect IgE content.
4. allergic rhinitis index of assessment of curative effect: improvement rate is by [(total score after total score-treatment before treating)/treatment is preceding total
Point] * 100% calculating, wherein Xian Xiao≤51%；,≤21% of You Xiao≤50%；Wu Xiao≤20%.
5. total effective rate: effectively: asthma scoring is 25 points, meanwhile, allergic rhinitis therapeutic evaluation Zhi Biao≤51%；It is good
Turn: asthma scoring is 20~24 points, while allergic rhinitis therapeutic evaluation Zhi ,≤21% of Biao≤50%；It is invalid: asthma < 20
Point, while allergic rhinitis therapeutic evaluation Zhi Biao≤20%.
(5) result: the data of acquisition are for statistical analysis using 18.0 software of SPSS.The results show that kaolin capsule system
The effective percentage of agent treatment is significantly higher than control (16.0%), the results are shown in Table 4 and table 5 up to 92.0%.
(6) variation of enteric microorganism: high-flux sequence instrument sequencing analysis 16s rRNA is used, as the result is shown treatment group's intestines
The diversity of road microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 6), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
4. pretherapy and post-treatment two groups of patient view's Indexes Comparisons of table (point,)
5. two groups of patients of table treat total effect and compare (example)
| Group | Number of cases | Effectively | It improves | In vain | Total effective rate |
| Treatment group | 50 | 39 | 7 | 4 | 92.0% |
| Control group | 50 | 3 | 5 | 42 | 16.0% |
| P value | <0.001 |
Note: through Chi-square Test: df=1, X2=58.132, P < 0.001.
The type that 6. random forest of table analysis treatment group enteric bacteria content dramatically increases
The experimental study of 3 kaolin of embodiment treatment eczema
(1) prepared by preparation: kaolin being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour and soybean powder, kaolinite
Native traditional Chinese medicine powder, corn flour and soybean powder mixed proportion are kaolin powder: wheat bran: mung bean flour is 2:5:1 (mass ratio), and tabletting is made
Tablet, each tablet weight are 0.5 gram, are made rear spare.
(2) adult eczema subject selection: 108 patients are randomly divided into treatment group and control group.Treatment group 54, male 27
Example, female 27, the age 13~70 years old, average (41.5 ± 10.7) year.The course of disease 1~23 year, average (12.4 ± 8.6) year；Control
Group 54, male 27, female 27, the age 14~69 years old, average (39.2 ± 11.2) year；The course of disease 1~22 year, average (13.4 ±
7.9) year.Two groups of subject Genders, age, course of disease no difference of science of statistics.Selected case meets eczema diagnostic criteria.
(3) treatment method: treatment group's above-mentioned kaolin tablet orally three times a day, 2 times a day, 5 tablets once.Control group clothes
With the auxiliary material of same ratio, the same treatment group of dosage.Therapeutic effect evaluation and test is carried out after medication 6 months.
(4) treatment effectiveness evaluation: after treatment 6 months, 9 months after drug withdrawal, therapeutic effect is observed.Criterion of therapeutical effect is cured: skin
Rash all subsides, and pruritis disappears；Effective: 80% or more deflorescence, pruritis is substantially reduced；Improve: skin subsides
50%, pruritis does not mitigate；Invalid: deflorescence is unobvious, and pruritis does not mitigate or in vain.With healing, effective case
Number is total to calculate effective percentage.
(5) result: treated effect as the result is shown is shown in Table 7.According to statistical analysis, treatment group and the clinical of control group are treated
There were significant differences (P < 0.001) for effect.It has no adverse reaction.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 8), actinomyces door
Bacterial species and quantity dramatically increase (P ﹤ 0.01).
7 two groups of patients of table treat total effect and compare (example)
| Group | N | It cures | It is effective | It improves | In vain | Effective number of cases | It is efficient |
| Treatment group | 54 | 40 | 10 | 1 | 3 | 50 | 92.6% |
| Control group | 54 | 3 | 6 | 6 | 39 | 9 | 16.7% |
| P value | P < 0.001 |
Note: through Chi-square Test: df=1, X2=62.798, P < 0.001.
The type that 8 random forest of table analysis treatment group enteric bacteria content dramatically increases
4 kaolin antihypertensive function experimental study of embodiment
(1) prepared by preparation: kaolin being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry pearling cone meal and soybean powder, kaolinite
Native powder, corn flour and soybean powder mixed proportion are kaolin powder: wheat flour: soybean powder is 1:5:1 (mass ratio), and tablet is made,
Each tabletting weight is 0.5 gram, is made rear spare.
(2) hypertensive patient selects: 90 meet I grades of hypertensive patients, are randomly divided into treatment group and control group.Treatment group
45, male 23, female 22, the age 38~63 years old, average (47.5 ± 8.8) year.Control group 45, male 22, female 23, year
Age 39~63 years old, average (48.2 ± 8.1) year.Two groups of subject Genders, age, course of disease no difference of science of statistics.It is tested unused
Drug or after deactivated depressor 1 week signs informed consent form.
Selected case meet TCM syndrome diagnostic criteria (drug surveilance office of the People's Republic of China (PRC) (2002) it is specified " in
Medicine Clinical Researches of New Drugs guideline " type of deficiency of YIN leading to hyper activity of YANG primary symptom), and meet the tetra- Hypertension Guideline diagnosis marks of WHO/SH in 1999
It is quasi-: the non-drug state lower 2 times or 2 times or more non-blood pressure determination averaging of income values that repeat on the same day: systolic pressure 140mmHg and/or easypro
Pressure 90mmHg is opened, level-one hypertension 140~159/90~99 requires to need drug therapy according to Hypertension Guideline.
Exclusion criteria: 1. acute coronary syndrome (ACS)；2. in acute apoplexy event 1 month；3. secondary high blood
Pressure, hypertensive crisis；4. secondary patients with dyslipidemia；5. II grades and II grades or more hypertensive patient；6. type-1 diabetes mellitus and II
Patients with type Ⅰ DM merges the acute metablize confusion；7. wound was performed the operation in 3 months；8. in acute infectious diseases 1 month；9. patient has
Obvious reason, is not able to cooperate the person of completion.
(3) treatment method: treatment group takes orally 3 kaolin tablets daily, 5 tablets each time.Control group is using same ratio
Auxiliary material, the same treatment group of dosage.Therapeutic effect evaluation and test is carried out after medication 12 weeks.
(4) treatment effectiveness evaluation: treatment time is 12 weeks, 4 weeks after drug withdrawal, evaluates therapeutic effect.Sign observation: before treatment
1,4,7d after ld and treatment start, later 2 times/week, set time (morning 8:00-10:00；Afternoon 15:00-17:00) monitoring
Blood pressure is surveyed be averaged twice weekly, and measured's peace and quiet are rested 10 minutes, takes seat right upper extremity blood pressure.
Symptom Observation: observation dizziness, headache, palpitaition, insomnia, tinnitus.
Criterion of therapeutical effect is effective: diastole drops 10mmHg and dropping to normal or decline 20mmHg or more after treatment, shrinks
Pressure drop is to normally.Effective: diastole drops are not up to 10mmHg after treatment, but oneself drops to normal range (NR), or decline 10-
19mmHg, for example systolic hypertension shrink drops 30mmHg.Invalid: blood pressure decline is not up to effective standard after treatment.
Symptom curative effect determinate standard: 1. effective: clinical symptoms are obviously improved integral Jian Shao≤70%；2. effectively: clinic has
It is improved, symptom integral subtracts few≤30%；3. invalid: clinical symptoms are not improved, even it aggravates, symptom integral Jian Shao≤
30%.
(5) result: treated effect as the result is shown is shown in Table 9.According to statistical analysis, treatment group and the clinical of control group are treated
There were significant differences (P < 0.001) for effect.It has no adverse reaction.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 10), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
Curative effect compares (n, %) after 9 two groups of patients of table treat 1 month
| Group | N | It is effective | Effectively | In vain | Effective number of cases | It is efficient |
| Treatment group | 45 | 29 | 12 | 4 | 41 | 91.1% |
| Control group | 45 | 4 | 4 | 37 | 8 | 17.8% |
Note: through Chi-square Test: df=1, X2=48.785, P < 0.001.
The type that 10 random forest of table analysis treatment group enteric bacteria content dramatically increases
The research of 5 kaolin function of blood sugar reduction of embodiment
(1) prepared by preparation: kaolin being crushed, high pressure sterilization is spare.Auxiliary material is high-grade maize powder, soybean powder and wheat
Powder, mixed proportion are kaolin powder: corn flour: pearling cone meal is 2:3:4 (mass ratio), and tablet is made, and each tabletting weight is 0.5
Gram, it makes rear spare.
(2) type-2 diabetes mellitus subject selection: 120 patients are randomly divided into treatment group and control group.Treatment group 60, male 30
Example, female 30, the age 42~69 years old, average (50.7 ± 9.7) year.The course of disease 1~15 year, average (9.1 ± 7.1) year；Control group
60, male 30, female 30, the age 43~68 years old, average (49.1 ± 10.8) year；The course of disease 1~15 year, average (10.2 ±
7.4) year.Two groups of subject Genders, age, course of disease no difference of science of statistics.Selected case meets the standard of diabetes diagnosis
(standard referring to ADA in 1998 about diabetes diagnosis), is diagnosed as diabetes B department of traditional Chinese medicine out-patient.
Chinese medical discrimination has in following real example in 3 and asthenic symptoms 2.
Real example: addiction delicious food, gastral cavilty turgor, hiccup is rotten, ozostomia, dirty smelly of defecating, side of body rib turgor pain, and irritability is burnt
Worry, rapid digestion of food and polyorexia, constipation, extreme thirst, irregular menstruation, limbs are heavy, and the swollen limb of greasy or hand is sticked in mouth and is swollen, indigestion and loss of appetite just to stick, irritable
Irritability, vexed bitter taste, dry and hard excrement.Asthenic symptoms: dry, polydipsia, polyorexia, dysphoria in chestpalms-soles, soreness and weakness of waist and knees, dizziness ear
Ring.
(3) treatment method: 120 out-patients keep former therapeutic scheme and diet motion scheme constant.From the day of observation
It rises, treatment group takes orally 3 kaolin tablets daily, 4 tablets each time.Control group uses the auxiliary material of same ratio, the same treatment group of dosage.
It is deactivated after medication 90 days 10 days, then carries out therapeutic effect evaluation and test.
(4) hypoglycemic efficacy evaluation: after treatment 90 days, 10 days observation therapeutic effects after drug withdrawal.Criterion of therapeutical effect is effective: treatment
30% or more decline before fasting blood-glucose < 7.0mmol/L or 2h-plasma glucose < 7.8mmol/L or hypoglycemic amplitude are relatively treated afterwards；Have
Effect: decline before fasting blood-glucose < 8.3mmol/L or 2h-plasma glucose < 11.0mmol/L or hypoglycemic amplitude are relatively treated after treatment
10%~30%；Invalid: blood glucose decline does not reach above-mentioned standard person after treatment.Effective percentage is calculated so that effective, effective case load is total.
(5) result: treated effect as the result is shown is shown in Table 11.According to statistical analysis, treatment group and the clinical of control group are treated
There were significant differences (P < 0.001) for effect.It has no adverse reaction.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 12), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
Curative effect compares (n, %) after 11 two groups of patients of table treat 9 months
| Group | N | It is effective | Effectively | In vain | Effective number of cases | It is efficient |
| Treatment group | 60 | 33 | 22 | 5 | 55 | 91.7% |
| Control group | 60 | 4 | 3 | 53 | 7 | 11.7% |
Note: through Chi-square Test: df=1, X2=76.885, P < 0.001.
The type that 12 random forest of table analysis treatment group enteric bacteria content dramatically increases
6 kaolin of embodiment treats whelk functional study
(1) prepared by preparation: kaolin being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour and soybean powder, kaolinite
Native powder, corn flour and soybean powder mixed proportion are kaolin powder: corn flour: soybean powder is 2:3:1 (mass ratio), and tablet is made,
Each tabletting weight is 0.5 gram, is made rear spare.
(2) whelk patient is tested selection: 70 patients are randomly divided into treatment group and control group.Treatment group 35, male 18
Example, female 17, the age 11~21 years old, average (15.3 ± 4.6) year.The course of disease 1~5 year；Control group 35, male 19, female 16,
Age 11~20 years old, average (14.3 ± 4.5) year；The course of disease 1~5 year.Two groups of subject Genders, age, courses of disease are without statistics
Difference.Selected case is that experienced dermatologist is diagnosed as whelk.
(3) treatment method: treatment group daily take orally kaolin preparation, daily 6.Control group is auxiliary using same ratio
Material.The same treatment group of dosage.Therapeutic effect evaluation and test is carried out after medication 4 weeks.
(4) it treatment effectiveness evaluation: is drafted according to " disease of tcm Standardization of diagnosis and curative effect " in conjunction with clinic.It cures: skin lesion
Subside, subjective symptoms, which disappears, to improve；Improve: subjective symptoms is substantially reduced, 30% or more skin lesion recession；It is not cured: skin lesion and symptom
Unchanged or recession is not as good as 30%.To cure, improvement case load it is total calculate it is efficient.
(5) result: treated effect as the result is shown is shown in Table 13.According to statistical analysis, treatment group and the clinical of control group are treated
There were significant differences (P < 0.001) for effect.It has no adverse reaction.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 14), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
Curative effect compares (n, %) after 13 two groups of patients of table treat 4 weeks
| Group | N | It cures | It improves | In vain | Effective number of cases | It is efficient |
| Treatment group | 35 | 21 | 10 | 4 | 31 | 88.6% |
| Control group | 35 | 4 | 4 | 27 | 8 | 22.9% |
Note: through Chi-square Test: df=1, X2=30.629, P < 0.001.
The type that 14. random forest of table analysis treatment group enteric bacteria content dramatically increases
7 kaolin adjuvant therapy of depression functional study of embodiment
(1) prepared by preparation: kaolin being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry wheat bran, corn flour and soya bean
Powder, kaolin powder, wheat bran, corn flour and soybean powder mixed proportion are kaolin powder: corn flour: soybean powder is 1:2:1 (quality
Than), tablet is made, each tabletting weight is 0.5 gram, is made rear spare.
(2) depression subject selection: 56 patient volunteers meet the diagnostic criteria (" Chinese Spirit of depressive illness
Obstacles classification and diagnostic criteria ", the 3rd edition).Subject is randomly divided into observation group, totally 28, male patient 13, female patient
15, the age 15~66 years old, average (34.8 ± 10.3) year, average course of disease (18.7 ± 10.7) moon；Control group 28, male suffers from
Person 14, female patient 14, the age 15~65 years old, average (33.9 ± 9.8) year, average course of disease (17.8 ± 9.1) moon.Two groups
Patient is in the indexs such as age, gender, the course of disease, no difference of science of statistics.
(3) treatment method: before administration, observation group and control group subject are all provided with the cleaning phase 2 weeks, avoid other depressed drugs pair
The influence of this research.Observation group takes orally 2 kaolin preparations, 5 tablets each time in addition to using effect of paroxetine in treating daily.Control group
Using effect of paroxetine in treating.Therapeutic effect evaluation and test is carried out after 12 week of medication.
(4) treatment effectiveness evaluation: treatment different periods, using Hamilton Depression Scale (Hamilton Depression
Scale, HAMD) scoring and comparative analysis, before treatment, substantially quite, group difference is without statistics for the HAMD scoring of two groups of patients
Learn meaning.And being obviously improved occur in 4 weeks, 6 weeks, 10 weeks, 12 weeks after treating, HAMD scoring of the observation group compared with control group patient,
Group difference has statistical significance (P < 0.05), is shown in Table 15.
15 two groups of patients of table HAMD index scoring situation ()
| Group | It is tested quantity | Before treatment | Treatment 4 weeks | Treatment 6 weeks | Treatment 10 weeks | Treatment 12 weeks |
| Observation group | 28 | 28.55±6.91 | 17.63±7.56 | 12.36±6.31 | 11.42±5.63 | 10.22±4.63 |
| Control group | 28 | 28.37±7.15 | 24.56±8.64 | 20.14±6.91 | 17.22±4.86 | 14.32±5.34 |
| t | 0.098 | -3.194 | -4.399 | -4.126 | -3.070 | |
| P | 0.924 | 0.002 | <0.001 | <0.001 | 0.003 |
A situation arises compares for the adverse reaction of (5) two groups of patients: during treatment, two groups of patients occur dry, perspiration,
The adverse reactions such as Nausea and vomiting, weight gain, food is fuzzy, still, observation group's adverse reaction rate is significantly lower than control
Group patient, wherein have between the incidence group of the adverse reactions such as perspiration, dry, nausea and vomiting, weight gain, blurred vision, headache
There is statistical difference, is shown in Table 16.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 17), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
The comparison of adverse reaction situation occurs during 16 two groups of patient's treatments of table
| Group | It perspires | Dry | Nausea and vomiting | Weight gain | Blurred vision | It is dizzy | Constipation/diarrhea | Headache |
| Observation group | 1 | 4 | 4 | 1 | 1 | 0 | 1 | 1 |
| Control group | 7 | 14 | 10 | 8 | 5 | 3 | 3 | 6 |
| P | 0.056 | 0.004 | 0.064 | 0.029 | 0.195 | 0.235 | 0.604 | 0.106 |
The type that 17. random forest of table analysis treatment group enteric bacteria content dramatically increases
8 kaolin of embodiment treats functional consitipation research
(1) prepared by preparation: kaolin being crushed, high pressure sterilization is spare.Auxiliary material is high-quality dry corn flour, kaolin Chinese medicine
Powder and corn flour mixed proportion are kaolin powder: wheat bran: millet flour is 1:3:1 (mass ratio), and tablet, each tabletting weight is made
Amount is 0.5 gram, is made rear spare.
(2) functional consitipation subject selection: 80 patients are randomly divided into treatment group and control group.Treatment group 40, male 20
Example, female 20, the age 36~68 years old, average (43.8 ± 8.8) year.The course of disease 1~10 year, average (6.1 ± 4.3) year；Control group
40, male 20, female 20, the age 36~70 years old, average (42.2 ± 7.9) year；The course of disease 1~10 year, average (7.1 ± 5.2)
Year.Two groups of subject Genders, age, course of disease no difference of science of statistics.Selected case meets functional consitipation diagnostic criteria (sieve
Horse II standard).
(3) treatment method: treatment group takes orally 2 above-mentioned kaolin tablets daily, and 5 tablets once.Control group is using mutually year-on-year
The auxiliary material of example, the same treatment group of dosage.Therapeutic effect evaluation and test is carried out after medication 1 month.
(4) it treatment effectiveness evaluation: is formulated referring to the adult constipation criterion of therapeutical effect in " disease of tcm Standardization of diagnosis and curative effect ".
(1) cure: defecation 1 time in 1 day, just matter is normal, and defecation is unobstructed, without recurrence in 1 month；(2) effective: defecation 1 time in 2 days, just
Matter tends to normally, and defecation is unobstructed, without recurrence in 1 month；(3) effectively: defecation 1 time in 3 days, just matter turns profit, and defecation owes smooth；(4)
Invalid: clinical symptoms are not improved.It is efficient with healing, the total calculating of effective case load.
(5) result: treated effect as the result is shown is shown in Table 18.According to statistical analysis, treatment group and the clinical of control group are treated
There were significant differences (P < 0.001) for effect.It has no adverse reaction.
(6) enteric microorganism changes: using high-flux sequence instrument sequencing analysis 16s rRNA, as the result is shown treatment group's enteron aisle
The diversity of microorganism dramatically increases (P ﹤ 0.01), and random forest (Random Forests) is analysis shows that (table 19), actinomyces
Door bacterial species and quantity dramatically increase (P ﹤ 0.01).
Curative effect compares (n, %) after 18 two groups of patients of table treat 1 month
| Group | N | It cures | It is effective | Effectively | In vain | Effective number of cases | It is efficient |
| Treatment group | 40 | 24 | 8 | 4 | 4 | 36 | 90% |
| Control group | 40 | 5 | 2 | 8 | 25 | 15 | 37.5% |
Note: through Chi-square Test: df=1, X2=23.854, P < 0.001.
The type that 19. random forest of table analysis treatment group enteric bacteria content dramatically increases
Above-described embodiment is only the preferred technical solution of the present invention, and is not construed as limitation of the invention, the present invention
Protection scope should with claim record technical solution, including claim record technical solution in technical characteristic etc.
It is protection scope with alternative, i.e., equivalent replacement within this range is improved, also within protection scope of the present invention.
Claims (10)
1. kaolin is in preparation prevention and/or treatment anaphylactia, mental disorder, metabolism class disease and endocrine disturbance phase
Application in related disorders drug.
2. kaolin improves immunity of organisms, improves the diversity of enteric microorganism and promotes a variety of growth of probiotics in preparation
Application in drug.
3. application according to claim 1, which is characterized in that the anaphylactia includes allergic dermatitis, allergy
Property rhinitis, allergic asthma, anaphylactoid purpura, anaphylactic shock, irritable bowel disorder, allergic nephritis, anaphylaxis thyroiditis
And interstitial cystitis.
4. application according to claim 3, which is characterized in that the allergic dermatitis include drug rash, contact dermatitis,
Eczema, nettle rash, dermographism, food hypersenstivity and environmental factor cause allergy dermatitis；Irritable bowel disorder includes anaphylaxis knot
Enteritis, ulcerative colitis and Crohn disease.
5. application according to claim 1, which is characterized in that the mental disorder include depression, autism or
Senile dementia disease.
6. application according to claim 1, which is characterized in that the metabolism class disease include hypertension, diabetes or
Obesity.
7. application according to claim 1, which is characterized in that the endocrine disturbance related disease include whelk,
Female irregular menstruation disease, sleep disturbance are hard and dry and constipation.
8. application according to claim 1, which is characterized in that kaolin and pharmaceutically acceptable carrier are prepared into mouth
Formulation or external preparation.
9. application according to claim 2, which is characterized in that kaolin can increase the type sum number of actinomyces door bacterium
Amount.
10. application according to claim 2, which is characterized in that kaolin can reduce antibiotic for intestinal microecology
It influences, restores balance as early as possible after promoting the used antibiotic of intestinal microecology.
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| CN110420220A (en) * | 2019-08-19 | 2019-11-08 | 东南大学 | Application containing soil material in preparation prevention and/or treatment endocrine disturbance disease medicament or health care product |
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Application publication date: 20190108 |