CN108498568A - Chinese patent drug, medical food and the preparation method of autoimmune and immune related diseases are treated with Goat Placenta or embryo - Google Patents
Chinese patent drug, medical food and the preparation method of autoimmune and immune related diseases are treated with Goat Placenta or embryo Download PDFInfo
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- CN108498568A CN108498568A CN201810563588.XA CN201810563588A CN108498568A CN 108498568 A CN108498568 A CN 108498568A CN 201810563588 A CN201810563588 A CN 201810563588A CN 108498568 A CN108498568 A CN 108498568A
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- A—HUMAN NECESSITIES
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Abstract
The invention discloses the Chinese patent drugs that autoimmune and immune related diseases are treated with Goat Placenta or embryo, including 10 50 parts of Goat Placenta or sheep embryo, 5 50 parts of carrot, 1 39 parts of the root of Dahurain angelica, 10-50 parts of Radix Glycyrrhizae, after being pulverized and mixed, suitable application form is made in 20-50 parts of honeysuckle, the extracted active principle of above raw material.After digestion（Or nutrition component is added）Medical food is made（Medical food includes special diet food, health food and various types of other food fed through alimentary canal for human body.）；And the preparation method of Chinese patent drug and medical food.Prescription of the present invention is simple, primary raw material is medicine-food two-purpose, resourceful to be easy to get, Goat Placenta replaces Human plactnta, breaches Human plactnta applied to the realistic problems such as the bio-safety problem of human body, ethics problem, resource-constrained, solve the Current Situation that Goat Placenta is unable to entrance, clinical trial has notable curative effect to autoimmune and immune related diseases, compares traditional therapy, and total effective rate is substantially improved, it is the major contribution to human health, there is special meaning.
Description
Technical field
The present invention relates to medical Chinese patent drug or medical food medical foods（Including special diet food, health food and
Various types of other food fed through alimentary canal for human body.Special medicine purposes formula food, referred to as：Spy doctor's food, below
Together）Field, and in particular to Chinese patent drug, the medical food of autoimmune and immune related diseases are treated with Goat Placenta or embryo
And preparation method.
Background technology
Currently, pulmonary fibrosis（Obstructive lung disease）, systemic loupus erythematosus, ankylosing spondylitis, chorionitis, cachexia,
Alimentary canal（Such as ulcerative colitis, canker sore）, rheumatoid arthritis, hypoplastic anemia, easily catch a cold and its
His infectious diseases, the autoimmunities such as fatiguability or easy allergy and immunity function（State）It is diseases related；The diseases such as Epstein-Barr virus
Autoimmunities and the immune related diseases such as poison infection：And cancerous swelling（Such as lung cancer, liver cancer, malignant tumor of digestive tract（Including food
Road, stomach, intestines, intestinal mucosa system））In China, incidence has into increased trend year by year, and autoimmune is related to being immunized
Property disease there is no the clear effective therapy of ideal both at home and abroad at present, Chinese medicine multi-purpose greatly（Or Chinese patent drug）, Western medicine and Chinese and Western
In conjunction with.And such Chinese medicine（Or Chinese patent drug）It is most of there is composition complexity, have to human body so as to cause product multiple multiple
It the shortcomings that miscellaneous effect or even many side effects, is impatient at by patient；Or price is too high, cannot receive for patient；Or
Too greatly patient cannot bear toxic side effect；Or it is too many to patient's restrictive requirement during medication, influence the normal of patient
Work and life etc..Western medicine again mostly based on hormone or immunosuppressor, to injury of human（Side effect）It is larger.
Applicant has applied treating the Chinese patent drug of autoimmune and immune related diseases, special doctor's food and preparation before
Method（Application number：2017107599686）, using placenta, cordyceps sinensis powder as major ingredient, curative effect is preferable, but placenta, worm winter, worm summer or worm
Grass volvatus powder all has bad smell, and palatability is very poor, based on the Human plactnta that wherein placenta also mainly selects peculiar smell weaker.Human plactnta
Donor suffers from certain viral disease, or is certain virus carrier, and also or some bases are bad in hiding human gene or even dislike
The gene-code of property.In mass production, even an only placenta is with virus, or hiding pernicious gene-code, production
Product are extremely fearful to the harm caused by people.Therefore new edition in 2015《Chinese Pharmacopoeia》Human plactnta is no longer included, is deferred to
The problem of international practice, Human plactnta is used for the bio-safety of human body, has been subjected to the great attention of compatriots, while ethics problem, money
The realistic problems such as source is limited so that product is difficult to volume production.Subsequently take the Goat Placenta closest with human placenta's trophic structure
Prescription, Goat Placenta have formed after distinctive smell of mutton, with worm winter, worm summer or cordyceps prescription make one it is unacceptable stench and
Pessimal stimulation taste, so that preparation is unable to the present situation of entrance.
Invention content
The technical problem to be solved in the present invention is to provide it is a kind of treat in autoimmune and immune related diseases at
Medicine, medical food, with Goat Placenta or embryo's prescription, safely, without taboo；The root of Dahurain angelica, carrot compatibility improve peculiar smell, and palatability is good, faces
Bed test has notable curative effect to autoimmune and immune related diseases, and total effective rate is substantially improved, and cost is relatively low.
The invention is realized by the following technical scheme：
The Chinese patent drug of autoimmune and immune related diseases, clean Goat Placenta or sheep embryo are treated with Goat Placenta or embryo
10-50 parts, 5-50 parts of carrot, 1-39 parts of the root of Dahurain angelica, 10-50 parts of Radix Glycyrrhizae, 20-50 parts of honeysuckle, the above raw material is through carrying
After taking active principle, being pulverized and mixed, capsule or pulvis or tablet or granule or powder is made（It dissipates）Agent or suspension or
Solution or other suitable application forms.
The present invention is further preferred that, 19-30 parts of clean Goat Placenta or sheep embryo, 5-15 parts, root of Dahurain angelica 3-29 of carrot,
20-25 parts of Radix Glycyrrhizae, 10-25 parts of honeysuckle.
The present invention provides the preparation for the Chinese patent drug that autoimmune and immune related diseases are treated with Goat Placenta or embryo
Method,
（1）Extract volatile oil：Extracting honeysuckle, the root of Dahurain angelica are put into distillation container, add 6 times of weight of water, are impregnated 40-70 minutes, and water steams
Steam distillation 2.5-3.5h obtains oil water mixture, then is distilled to obtain volatile oil to oil water mixture, then with 10 times of weight
Beta-cyclodextrin inclusion compound volatile oil includes 2 hours at 60 ± 5 DEG C, obtains inclusion compound；Liquid is carried out to the surplus material after distillation admittedly to divide
From obtaining the dregs of a decoction and liquid；
（2）Carry fat：By step（1）The gained dregs of a decoction are extracted 2 times with alcohol reflux, and for the first time plus 10 times of weight concentrations are 60%-
85% ethyl alcohol, refluxing extraction 1.5-2.5 hours, the filtered dregs of a decoction add 8 times of weight concentrations to be 60%-85% ethyl alcohol again, and reflux carries
It takes 1.5-2.5 hours, merges extracting solution twice, and ethyl alcohol is recycled under negative pressure state, until extracting solution obtains containing fat without alcohol taste
The liquid of soluble substance；The remaining dregs of a decoction after reflux are continued to employ；
（3）Extract water soluble ingredient：Extracting liquorice is put into the decoction container of preprepared cleaning, soaks 40-70 points
Clock, with step（2）The gained dregs of a decoction decoct together it is secondary, it is 40-70 minutes each, for the first time plus 9.5 times of weight waters, second plus 6
Times weight water, detaches decoction liquor, and waste merges the liquid after decoction filtering twice, step（1）Isolated liquid is added
Carrot, clean Goat Placenta or embryo keep liquid submergence placenta or embryo 3-5cm, impregnate 40-70 minutes, use water vapour
Boiling, holding are boiled 70-90 minutes, and the Goat Placenta after decocting or embryo are taken, and merge the liquid after taking out Goat Placenta or embryo,
Negative pressure, which is concentrated into after relative density is 1.10-1.15, must extract concentrate, spare；
（4）By step（3）Placenta or embryo after decoction are successively through ultramicro grinding, multigelation, centrifugation, ultrafiltration technology, then pass through
It is spare that enzyme incision technology is digested into 500-3000Da >=97%；Or by step（3）Placenta or embryo after decoction is in 80-85 DEG C
Drying 1.5-2.5 hour, crushed after drying 70 mesh medicines sieve, drying after through ultramicro grinding or be micronized after it is spare；
（5）Take step（3）Step is added in extraction concentrate obtained（1）Inclusion compound, step（2）Contg fat-soluble substances
Liquid and step（4）Manufactured medicinal powder or digestion object, after mixing, spray drying or freezing negative pressure drying are at water content
≤ 5% powdery is made into capsule or tablet, granule, powder（It dissipates）Agent, tablet, suspension or other suitable applications
Form.
The present invention is further preferred that, step（3）The described negative pressure concentration be fluid temperature in container 50-60 DEG C it
Between concentration；Step（5）The spray drying, the drying pressure in drying tower are 100-150Pa, the import temperature of drying tower
Degree is 180 ± 5 DEG C, and outlet temperature is 80 ± 5 DEG C；The negative pressure drying is that the solid in container is between 75-80 DEG C
It is dry, or be dried under reduced pressure after -40 ± 2 DEG C of freezings.
The present invention provides the medical food that autoimmune and immune related diseases are treated with Goat Placenta or sheep embryo, clean
10-30 parts net of Goat Placenta or sheep embryo, 5-50 parts, root of Dahurain angelica 3-29 of carrot, 10-50 parts of Radix Glycyrrhizae, 20-50 parts of honeysuckle, battalion
Foster component, that is, 0.9-60 parts of maltodextrin, 0.5-30 parts of dietary fiber, 0.1-45 parts of medium chain triglyceride, micro- 0.1-19
Part, 0.1-27 parts of water soluble vitamin, 0.1-5 parts of liposoluble vitamin, 0.9-15 parts of milk taste flavoring agent, the above raw material
After being pulverized and mixed, capsule or pulvis or tablet or granule or powder is made in extracted active principle（It dissipates）Agent is suspended
Agent or solution or other suitable application forms.
The present invention is further preferred that, 19-30 parts of clean Goat Placenta or sheep embryo, 5-15 parts, root of Dahurain angelica 3-19 of carrot,
20-25 parts of Radix Glycyrrhizae, 10-25 parts of honeysuckle, nutrition component, that is, 9-20 parts of maltodextrin, 1-15 parts of dietary fiber, medium chain triglyceride
Three 0.1-9 parts of esters, 0.1-9 parts micro-, 0.2-17 parts of water soluble vitamin, 0.1-5 parts of liposoluble vitamin, the seasoning of milk taste
0.9-10 parts of agent.
The present invention provides the medical food preparation that autoimmune and immune related diseases are treated with Goat Placenta or embryo
Method,
（1）Extract volatile oil：Extracting honeysuckle, the root of Dahurain angelica are put into distillation container, add 6 times of weight of water, are impregnated 40-70 minutes, and water steams
Steam distillation 2.5-3.5h obtains oil water mixture, then is distilled to obtain volatile oil to oil water mixture, then with 10 times of weight
Beta-cyclodextrin inclusion compound volatile oil includes 2 hours at 60 ± 5 DEG C, obtains inclusion compound；Liquid is carried out to the surplus material after distillation admittedly to divide
From obtaining the dregs of a decoction and liquid；
（2）Carry fat：By step（1）The gained dregs of a decoction are extracted 2 times with alcohol reflux, and for the first time plus 10 times of weight concentrations are 60%-
85% ethyl alcohol, refluxing extraction 1.5-2.5 hours, the filtered dregs of a decoction add 8 times of weight concentrations to be 60%-85% ethyl alcohol again, and reflux carries
It takes 1.5-2.5 hours, merges extracting solution twice, and ethyl alcohol is recycled under negative pressure state, until extracting solution obtains containing fat without alcohol taste
The liquid of soluble substance；The remaining dregs of a decoction after reflux are continued to employ；
（3）Extract water soluble ingredient：Extracting liquorice is put into the decoction container of preprepared cleaning, soaks 40-70 points
Clock, with step（2）The gained dregs of a decoction decoct together it is secondary, it is 40-70 minutes each, for the first time plus 9.5 times of weight waters, second plus 6
Times weight water, detaches decoction liquor, and waste merges the liquid after decoction filtering twice, step（1）Isolated liquid is added
Carrot, clean Goat Placenta or embryo keep liquid submergence placenta or embryo 3-5cm, impregnate 40-70 minutes, use water vapour
Boiling, holding are boiled 70-90 minute, and the Goat Placenta after decocting or embryo are taken, merge the liquid after taking out Goat Placenta or embryo with
Step（1）Obtained liquid, negative pressure, which is concentrated into after relative density is 1.10-1.15, must extract concentrate, spare；
（4）By step（3）Placenta or embryo after decoction are successively through ultramicro grinding, multigelation, centrifugation, ultrafiltration technology, then pass through
It is spare that enzyme incision technology is digested into 500-3000Da >=97%；Or by step（3）Placenta or embryo after decoction is in 80-85 DEG C
Drying 1.5-2.5 hour, crushed after drying 70 mesh medicines sieve, drying after through ultramicro grinding or be micronized after it is spare；
（5）Take step（3）Step is added in extraction concentrate obtained（1）Inclusion compound, step（2）Contg fat-soluble substances
Liquid and step（4）Nutrition component is added in manufactured medicinal powder or digestion object, after mixing, negative pressure drying to water content≤
5%, it is made into medical food.
The present invention is further preferred that, step（3）The described negative pressure concentration be fluid temperature in container 75-80 DEG C it
Between concentration；Step（5）The spray drying, the drying pressure in drying tower are 100-150Pa, the import temperature of drying tower
Degree is 180 ± 5 DEG C, and outlet temperature is 80 ± 5 DEG C；The negative pressure drying is that the solid in container is between 75-80 DEG C
It is dry, or be dried under reduced pressure after -40 ± 2 DEG C of freezings.
Compared with prior art, the present invention having following obvious advantage：
1, primary raw material according to the present invention is medicine-food two-purpose, resourceful to be easy to get, safe without toxic side effect；
2, reasonable recipe of the present invention, gears to actual circumstances, and with the root of Dahurain angelica, Radix Glycyrrhizae, carrot, reconciles Goat Placenta or strong stench of sheep embryo
Taste can rectify the bad taste of Goat Placenta, improve mouthfeel to the sense of taste of people and the pessimal stimulation of stomach and intestine, the aroma of the root of Dahurain angelica, and carrot makes
With helping to eliminate the distinctive smell of mutton of Goat Placenta, this prescription breaches cordyceps sinensis（Or cordyceps）It is formed with after Goat Placenta prescription
Make one unacceptable stench and pessimal stimulation taste so that preparation is unable to the present situation of entrance；
3, of the invention by Goat Placenta short peptide molecules amount（Granularity）It is set as being digested into 500-3000Da >=97% with enzyme incision technology
The effect of human body is more excellent, and Goat Placenta reality is more suited compared with " being digested into 300-400Da >=85% with enzyme incision technology ", right
This is also one of the principal element that its curative effect is better than Human plactnta；
4, the present invention replaces Human plactnta using Goat Placenta or sheep embryo, and the bio-safety for breaching Human plactnta applied to human body is asked
The realistic problems such as topic, ethics problem, resource-constrained, and its trophic component and human placenta are almost the same, trophic structure is closest
Human plactnta, rational natural structure, very rich nutrient composition content become the preferred type of animal placenta；And Goat Placenta
The viruses such as human hepatitis will not be infected, cross-infection will not be generated with the mankind.Other animal placentas（Including Human plactnta）It is likely to
With one or more Causative virus, especially significantly, it is hidden in the base that some bases are bad or even pernicious in human gene
Because password will thoroughly be prevented.In mass production, even an only placenta is close with virus, or hiding pernicious gene
Code, product is extremely fearful to the harm caused by people, and uses Goat Placenta, then has evaded problems, safer.
Specific implementation mode
Chinese patent drug or medical food the treatment autoimmune and immune related diseases of the following clinical test present invention, with
The effect of traditional therapy and Human plactnta prescription Comparative Analysis：
One, the treatment of pulmonary fibrosis is more acted on
The traditional therapy of pulmonary fibrosis is to give oxygen uptake, hormone, antibiotic, to autoimmune and immune related diseases
It is therefore one of the method for being clinically usually used in pulmonary fibrosis disposition selects conventional therapy means with certain mitigation
As a control group.Increase in Primary Care and takes Human plactnta prescription as treatment A groups.Increase in Primary Care and takes this hair
Bright prescription is as treatment B groups.To the serum such as clinical cardinal symptom, lung function, pulmonary fibrosis, CT images under conditions of " double blind "
Etc. indexs carry out observation comparison, analysis.
1. object and method
1.1 object.Object 225 is observed, is patients with liver fibrosis, wherein man 120, female 105；45-79 years old ages,
Average age is 55 years old.
1.2 grouping：225 are randomly divided into control group 75, wherein man 40, female 35, age 45-78 Sui.Treat A groups
75, wherein man 40, female 35, age 46-79 Sui.B groups 75 are treated, wherein man 40, female 35, age 45-78 Sui.
Three groups of genders, age distribution and the state of an illness are almost the same, and three groups receive Primary Care, including (1) controlling oxygen therapy（Control
Property oxygen uptake）；(2) (3) (4) oral acetylcysteine uses antibiotic (5) basic to the ill when necessary for ambroxol hydrochloride injection intravenous infusion
Treatment；
Treat A groups：On the basis of Primary Care, Human plactnta preparation prescription composition (20-50 parts of honeysuckle, placenta are taken in increase
10-30 parts, 10-50 parts of Radix Glycyrrhizae, 0.5-50 parts of ginger, after being pulverized and mixed, glue is made in above raw material extraction active principle
Capsule).3 times a day, 3-6 each（Every 0.5 gram of capsule powder charge powder）（Or 10-30 grams of medical food nutritional preparation powder）
Treat B groups:On the basis of Primary Care, increase the preparation for taking the present invention, 3 times a day, each medical special food
Product（Short peptide type）10-29 grams of nutritional preparation powder（Or capsule is 3-6 each, every 0.5 gram of capsule）；.
Three groups of clinic symptomatic treatments are consistent, the course for the treatment of 3 months, follow-up half a year.
1.3 observation item.（1）Symptom：It coughs, pant（Asthma）, uncomfortable in chest, lung's Velcro rales, complexion shortness of breath, abundant expectoration
（2）Lung function；（3）Arterial blood gas analysis：（4）Sero-immunity index:Serum prealbumin（PA）, albumin（ALB）It is content, white
Protein spheres protein ratio（A/G）；（5）Chest HRCT etc.
2. curative effect compares：
2.1 pretherapy and post-treatment symptom variations：Cardinal symptom after three groups of patient's treatments（Cough, expectoration, asthma, uncomfortable in chest, lung Velcro hello
Sound pants, is thirsty on foot, receives difference）It is obviously improved, is as a result seen（Table 1）.
1 pretherapy and post-treatment symptom of table changes（Number of cases）
The result shows that in comprehensive cardinal symptom（Cough, expectoration, asthma, uncomfortable in chest, lung Velcro rales pant, are thirsty, receiving on foot
Difference）Etc. three groups improved before and after treatment, and treat B groups be significantly better than control group（P ＜ 0.05）, with treatment A groups
It is close；B group curative effects are treated better than treatment A groups.
2.2 pretherapy and post-treatment lung function variations：
2 pretherapy and post-treatment lung function situation of change comparison sheet of table
Treat first three groups patient's total lung capacity（TLC）, lung capacity（VC）Account for predicted value percentage（%）, carbon monoxide diffusion capacity
（DLCO）Account for predicted value percentage（%）Without significant difference（P ＞ 0.05）, have comparativity.After three groups of lung function index of correlation treatments
It is improved in varying degrees, the pretherapy and post-treatment significant difference for the treatment of A, B group（P ＜ 0.05）, the pretherapy and post-treatment difference of control group is without aobvious
Work property（P ＞ 0.05）.B groups are treated in terms of lung function improvement is significantly better than control group（P ＜ 0.05）；It is excellent to treat B group curative effects
In treatment A groups.
The pretherapy and post-treatment arterial blood oxygen of 2.3 3 groups of patients, carbon dioxide divide situation of change
3. 3 groups of pretherapy and post-treatment arterial blood oxygens of table, carbon dioxide partial pressure compare（MmHg) comparison sheet
Treat first three groups patient arterial blood oxygen, carbon dioxide partial pressure there are no significant difference（P＞ 0.05）, have comparativity.Treatment
Three groups of patient's arterial blood oxygens, carbon dioxide partial pressure obtain different degrees of improvement afterwards, and treatment group changes tool conspicuousness before and after treatment
Difference, treatment B groups are significantly better than control group, have statistical significance（P ＜ 0.05）；B group curative effects are treated better than treatment A groups.
2.4 pretherapy and post-treatment serum prealbumins（PA）, albumin（ALB）Content, Archon ratio（A/G）Situation
4. 3 groups of pretherapy and post-treatment serum prealbumins of table（PA）, albumin（ALB）Content, Archon ratio（A/G）Situation contrast table
Before three groups of treatments, patients serum's prealbumin（PA）, albumin (ALB), albumin globulin ratio value（A/G）Contrast difference
Not statistically significant, after treatment, These parameters value is obviously improved, and is treated B groups and be substantially better than control group, is compared between group, poor
It is different statistically significant（P ＜ 0.05）.Especially it is noted that the improvement of A/G, prompts the preparation of the invention to changing body
Immunity function, improving body itself repair ability has especially important meaning.B group curative effects are treated better than treatment A groups.
2.5 pretherapy and post-treatment three groups of patient chests HRCT situations of change
2.5.1.HRCT pulmonary interstitial fibrosis is shown：Lesion is under pleura, grid shadow, honeycomb based on base part distribution, companion
Or not with stretching bronchiectasis.
2.5.2. pulmonary fibrosis extent of disease scores
Using 4 point-scores, to the scoring of pulmonary fibrosis extent of disease, (x ± s divides）, the model of entire lungs is accounted for according to grid and honeycomb lesion
It encloses：(1) 0 point：It is not involved；(2) 1 point：Extent of disease≤25%；(3) 2 points：Extent of disease >=26% ,≤50%（26%~50%）；(4) 3 points：
Extent of disease 51% ~ 75%（>=51% extent of disease≤75%）；(5) 4 points：Extent of disease 76%--100%（76% >=extent of disease≤
100%）；
HRCT iconographies are shown, are expanded in stretching branch before treatment first three groups patient treatment（Example）, grid shadow（Example）, honeycomb（Example）、
Mediastinal lymph node enlargement（Example）(x ± s divides with pulmonary fibrosis scoring）Etc. without statistical significant difference（P ＞ 0.05）,
Has comparativity；Has statistical significant difference in terms of the above-mentioned performance assessment criteria of three groups of patients after treatment（P ＜ 0.05）.
The pretherapy and post-treatment chest HRCT iconographies index of correlation contrast table of 5. 3 groups of patients of table
2.5.3. pretherapy and post-treatment three groups of patient chests HRCT situations compare
6. pretherapy and post-treatment three groups of patient's curative effect comparison sheets of table
The pulmonary interstitial fibrosis course of disease different in iconography, different times have different performances：The pulmonary alveolitis phase shows as pathology
The still inverse ground glass shadow of variation；The pulmonary fibrosis phase shows as net and knits structure；And pulmonary fibrosis later stage Radiologic imaging is honeycomb
Shape can knit structure with a small amount of ground glass shadow, net.Chest HRCT can have found initial stage lesion, such as appear under pleura, relatively early to find
There is irregular linear mesh-like and changes in intrapulmonary, and is often accompanied by the small air cavity of capsule and is formed, and interconnection can be formed under pleura
Line is one of the important means of diagnosis early stage pulmonary interstitial fibrosis.
Result of study is shown：There is the big portion of 0 patient chest HRCT lesion shadow to absorb or disappear after control group treatment；10 patients
Chest HRCT improves, 32 stabilizations, 33 exacerbations, total effective rate 56.0%.There are 14 patient chest HRCT after treatment A groups treatment
The big portion of lesion shadow absorbs or disappears；27 patient chest HRCT improve, 32 stabilizations, 2 exacerbations, total effective rate 97.3%.Treatment
There is the big portion of 15 patient chest HRCT lesion shadows to absorb or disappear after the treatment of B groups；30 patient chest HRCT improve, and 29 are in
Stable state, doubtful before 1 relatively treatment to have progressed, effective percentage 98.7%.It is equal on statistical significance and clinical meaning to treat B groups
It is significantly better than treatment A groups（P ＜ 0.05）.
Two, the treatment of systemic loupus erythematosus is more acted on
1. object and method
1.1 object.Object 225 is observed, is Lupus Nephritis Patients, wherein man 80, female 145；18-69 years old ages,
Average age is 39.1 years old.
1.2 grouping：225 are pressed into group # and are divided into control group 75 using random data table, wherein man 28, female 47
Example, 19-69 Sui average course of disease of age 7.2 years.A groups 75 are treated, wherein man 26, female 49, age 18-68 Sui, average disease
Journey 7.3 years.B groups 75 are treated, wherein man 26, female 49, age 18-68 Sui, average course of disease 7.5 years.Three groups of genders, ages
Distribution and the state of an illness are almost the same, are comparable（The equal ＞ of P values 0.05）
1.3. case collects standard：(1) inclusion criteria：The system that selected case meets the revision of American society of rheumatism in 2009
Property lupus erythematosus（SLE）Diagnostic criteria, while having the performance of different degrees of kidney damage（Albuminuria, cylindruria, slight kidney function
Can decline etc.）(2) exclusion criteria：There are severe cardiac, brain, pulmonary lesions and nephrarctia patient.
1.4. administering mode and the course for the treatment of：Treat A groups：Give Human plactnta prescription（20-50 parts of honeysuckle, 10-30 parts of placenta,
After being pulverized and mixed, capsule is made in 10-50 parts of Radix Glycyrrhizae, 0.5-50 parts of ginger, the above raw material extraction active principle）In preparation
Each 2-5 grams of patent medicine（Or 5-15 grams of medical food nutritional preparation powder）, 2 times a day；Oral prednisone is given according to the state of an illness simultaneously
The systemic loupus erythematosuses basic treatment drug such as 20~30 mg/d or hydroxychloroquine successively decreases after obtaining effect；Control group, according to the state of an illness
The systemic loupus erythematosuses basic treatment drugs such as 20~30 mg/d of oral prednisone or hydroxychloroquine are given, that successively decreases after imitating is obtained
Treat B groups：Give each 2-5 grams of invention formulation Chinese patent drug（Or medical Special food nutritional preparation powder 5-15
Gram）, 2 times a day；The systemic loupus erythematosuses such as oral prednisone 20~30 mg/d, or hydroxychloroquine basis is given according to the state of an illness simultaneously
Property medicine, obtain effect after successively decrease.
Treat A groups, smelting treats the B group courses for the treatment of equal 6 months.
1.5. observation index and method:1. Clinical Activity symptom and sign:Fever, fash, scrositis, oedema, myalgia,
Not aggressive arthritis etc..2. subjective observation index (TCM syndrome):Dim complexion, soreness and weakness of waist and knees, spiritlessness and weakness, lower limb are floating
It swells, the fat matter of tongue is light, small and weak pulse.3. biochemical indicator:Erythrocyte sedimentation rate (ESR) (ESR), creatinine clearance rate, for 24 hours quantity of proteinuria.
1.6. immune indexes:Complement C_3, C4 are measured using immunoquantitation；Indirect immunofluorescence detects T cell subgroup,
Including CD3, CD4, CD8 and natural kill (NK) cell.
1.7. criterion of therapeutical effect:
(1) effective:Clinical Activity symptom integral≤1, Urine proteins decline for 24 hours >=70%, activity lab index (ESR, C3,
SIL-2R) at least 1 switchs to normally, remaining index has improvement.(2) effectively:Clinical Activity symptom integral≤3, urinate for 24 hours
Protein decreased 20-69%, ((ESR, C3, sIL-2R) has decline to activity experimental index, remaining index makes moderate progress.Without
Effect:Effective standard person is not achieved.
1.8. statistical procedures:Measurement data data fit normal distribution is indicated using x ± s, is examined using t, p<
0.05 is statistically significant.
Safety indexes:
(1) general inspection project:Blood routine, routine urinalysis, stool routine examination+OB, liver function, renal function, the heart
Electrograph, rabat.
(2) it is accordingly checked according to related symptoms row.As occurred person's row chest CT uncomfortable in chest, out of breath, heart in the course of disease
The inspections such as color ultrasound;There are cough, expectoration person to give Sputum culturing, phlegm acid-fast stain etc..
(3) adverse reaction being likely to occur, main detection infection conditions are observed.
2. curative effect compares
2.1 clinical event symptom integrals change：Treatment group：Prior treatment integral is 3.56 ± 1.28, is 2.01 ± 0.23 after treatment.
Control group：Prior treatment integral is 3.82 ± 1.34, is 2.97 ± 0. 61 after treatment.Preceding two group difference for the treatment of is anticipated without statistics
Justice；After treatment two groups relatively treat before and comparison among groups difference it is significant (P values equal ＜ 0.05).
2.2 subjective observation target improvement situations：Treatment group and control group significantly improve (P values equal ＜ 0.05).It is shown in Table 7.
7. treatment group of table and control group subjectivity disease improve situation
Table 7. is shown, significant improvement (P ＜ 0.01) is obtained before relatively being treated after treatment group's indices treatment；Except dim complexion
Outside, remaining subjective observation index treatment group have compared with control group pole significant difference (PEqual ＜ 0.01), B group indices are treated in smelting
Effect is better than treatment A groups after treatment.
2.3. clinical efficacy:Effective 30 of B groups for the treatment of, effective 40, invalid 5, total effective rate 93.3%.Treat A
Effective 29 of group, effective 40, invalid 6, total effective rate 92.0%.Effective 5 of control group, effective 49, invalid 21,
Total effective rate is 72.0%.Two groups of obvious effective rates, total effective rate difference it is significant (P＜ 0.01).
2.4 clinical biochemistry indications are shown in Table 8.
The variation ((x ± s) of 8. clinical biochemistry indications of table
Compared with before treatment:aP ＜ 0.05bP ＜ 0.01
Table 8. is the results show that treatment first three groups patient's biochemical indicator:Erythrocyte sedimentation rate (ESR) (ESR), urinates egg at creatinine clearance rate for 24 hours
The differences such as quantitative are not statistically significant in vain, have comparativity；Before treating the relatively treatment of A, treatment B groups These parameters after treatment, and
Three groups have notable or pole significant difference（P ＜ 0.05 or ＜ 0.01）, poor before relatively being treated after the treatment of control group creatinine clearance rate
Different no significant difference（P ＞ 0.05）, erythrocyte sedimentation rate (ESR) (ESR), for 24 hours significant difference of Urine proteins（P ＜ 0.05）
2.5 amynologic index
2.5.1 the variation of complement:Treat A, treatment B groups：Change of serum C 3, C4 obviously increase after treatment, as a result significant difference (P
＜ 0.01, orP＜ 0.05) and the pretherapy and post-treatment no significant difference (P ＞ 0.05) of control group.It is shown in Table 9.
The variation ((x ± s, n=75, pg/ml) of 9. pretherapy and post-treatment serum complement of table
Compared with before treatment:aP ＜ 0.O5,bP ＜ 0.O1
2.5.2 the variation of NK cells:NK cells are 10.63 ± 4.32 before treatment group's treatment, are 13.01 ± 4.62 after treatment.It is right
Before group treatment：NK cells are 10.13 ± 4.90, are 9.08 ± 4.74 after treatment.Two groups of pretherapy and post-treatment differences have significantly
Property (P values are divided into ＜ 0.O1 and ＜ 0.05).
2.5.3 the variation of T cell subgroup:CD4 obviously rises (P ＜ 0.05) after treatment group's treatment.It is shown in Table 10.
The variation (x ± s) of 10. pretherapy and post-treatment T cell subgroup of table
Compared with before treatment:bP ＜ 0.01
3. discussion of results
Lupus nephritis causes renal failure to be one of SLE major causes of death, after SLE makes a definite diagnosis 4 years, the incidence of ephritis
Up to 92.3%.At present mainly using treatments such as glucocorticoid, immunosuppressor.It is total effective that A groups, treatment B groups are treated in this research
Rate is 92%, is significantly higher than control group 72%.Nutritional preparation of the present invention can be substantially reduced the clinical event disease of Lupus Nephritis Patients
Shape integral, for 24 hours urine albumen amount and ESR, and subjective observation index (TCM syndrome can be improved）, improve creatinine clearance rate, to lupus
Property nephritis patient imbalance Immunologic function have preferable adjusting, restitution.
Three, design considerations of the present invention and therapy mechanism to autoimmune and the diseases such as immune-related.
The autoimmunities such as pulmonary fibrosis, systemic loupus erythematosus and immune related diseases pathogenic factor, the state of an illness are complicated, and one
After denier is formed, both at home and abroad without clearly effective remedy measures.It is considered that blood stasis and deficient（It is mainly shown as that immune function lacks
Damage（Or it is low）, body itself repair ability, treat be cured inferior capabilities）It plays an important role in the evolution process of disease.Therefore it controls
Advocate in treatment with promoting blood circulation and removing blood stasis, strengthen the body resistance to consolidate the constitution based on.
The present invention is made of the supporting vital QI and dispersing blood stasis drug such as Goat Placenta, the root of Dahurain angelica, honeysuckle, carrot, Radix Glycyrrhizae.
Goat Placenta is the tissue for being responsible for parent and fetal blood and nutrient exchange when ewe breeds fetus, can be generated non-
Normal more active materials.According to《Compendium of Materia Medica》It records：" sheep placenta, the tire beast in ewe abdomen is sweet in flavor and warm in property, has QI invigorating qi-restoratives, middle benefit gas
Under warm, the effect of adjusting kidney tonifying empty, thin thin ... ".Scientist confirms that Goat Placenta also has nourishing blood and tranquilization, rich by many experiments
Flesh pool skin is promoted longevity and other effects, is the strengthening by means of tonics medicine to reinforce vital energy.Human plactnta is also known as dried human placenta, and magical effect is more next
More understood and received by people, but human placenta is limited after all, and the problems such as there are biological safety, ethics, common people can not
It can often eat, be largely unpractical using Human plactnta as processing raw material.Pig, cattle and sheep be all three big herding food of compatriots it
One, but only sheep is only unique pure plant-eating animal therein, so Goat Placenta is the cleanest, it is that the medicine food of replenishing the vital essence and the blood is good
Product.The trophic component of Goat Placenta and human placenta are almost the same, and trophic structure is the tissue closest to human placenta in nature,
The very rich nutritional ingredient of its rational natural structure, wherein containing abundant protein, 17 kinds of amino acid, 14 kinds of micro members
Element, phosphatide, lipopolysaccharides, vitamin, also run well with immune function and body relevant various active polypeptide, nutrition at
Demand of the ratio point naturally arranged in pairs or groups closest to human body.Another major reason is that Goat Placenta will not infect the viruses such as hepatitis, will not
Cross-infection is generated with the mankind.Other animal placentas（Including Human plactnta）It is likely to carry this virus, in mass production,
As long as there is a placenta with virus, the harm of product is conceivable, and uses Goat Placenta, opposite to want much more secure.
The root of Dahurain angelica, acrid flavour temperature is nontoxic, and fragrance is strong, also fragrant grass, the uplink head, lower to support stomach, in reach limbs, all over logical flesh
Skin is down to hair key, and profit lets out perverse trend.The aroma of the root of Dahurain angelica can rectify the bad taste of Goat Placenta, improve mouthfeel, conducive to taking, increase and comply with
Property, unique pharmacological action increases prescription and promotes the immune effect with body repair function of patient.
Radix Glycyrrhizae, root and root-like stock hyoscine are a kind of help Chinese herbal medicines, and gas is micro-, sweet and special, can reconcile some drugs
It is strong.It such as seasons CHENGQI TANG this product and mitigates rheum officinale, the discharge function of saltcake and its stimulation to gastrointestinal tract；Contained by Radix Glycyrrhizae
Hypo acid can block the effect of Induced by Carcinogen tumour growth.
Honeysuckle is known as clearing heat and detoxicating good medicine from ancient times.The sweet cold air fragrance of its property, clear heat with drugs of sweet flavour and cold nature is without injuring one's stomach, fragrance
Thoroughly up to again can eliminating evil, enter lung, the heart, stomach, have effects that clearing heat and detoxicating, anti-inflammatory, qi-restoratives treatment wind, cure mainly disease under turgor, warm disease
Fever, the diseases such as heat toxin large carbuncle and tumour.Modern study proves that honeysuckle contain the pharmacological activity such as chlorogenic acid, cyanidenon glycosides at
Point, there is stronger suppression to the various pathogens such as hemolytic streptococcus, Staphylococcus aureus and infection of the upper respiratory tract Causative virus etc.
Power processed, in addition can also strengthen immunity, Robust speaker feature, protect liver, antitumor, anti-inflammatory, antipyretic, hemostasis（Blood coagulation）, inhibit intestinal absorption
Cholesterol etc., honeysuckle have enhancing immunity of organism, enhance body disease-resistant poison function, clinical application is very extensive, can be with it
Its compatibility of drugs plants illness for treating respiratory tract infection, bacillary dysentery, acute urinary, hypertension etc. more than 40.
Carrot, homely vegetables full of nutrition, is known as the title of " glabrousleaf asiabell root ".Carrot rich in carbohydrate, fat, carrotene,
Vitamin A, vitamin B1, vitamin B2, anthocyanidin, calcium, nutritional ingredients, the warming middle-JIAO for easing the stomach having such as iron mitigate all bad smells
The effects that bad fishy smell of medicinal material is to the pessimal stimulation of human body.
The present invention replaces Human plactnta using Goat Placenta, breaches bio-safety problem, ethics that Human plactnta is applied to human body
The realistic problems such as problem, resource-constrained, Goat Placenta will not infect the viruses such as human hepatitis, will not generate cross-infection with the mankind.
This prescription root of Dahurain angelica, Radix Glycyrrhizae, honeysuckle, carrot reconcile the strong bad smell of Goat Placenta to the bad of the sense of taste of people and stomach and intestine
The aroma of stimulation, the root of Dahurain angelica can rectify the bad taste of Goat Placenta, improve mouthfeel, and the use of carrot contributes to elimination Goat Placenta distinctive
Smell of mutton, this prescription solve cordyceps sinensis（Or cordyceps）Make one unacceptable stench and bad with what is formed after Goat Placenta prescription
Pungent taste, so that preparation is unable to the present situation of entrance.Slightly it is better than cordyceps sinensis from clinical test curative effect simultaneously（Cordyceps）With people's tire
The formula of disk, while subtracting expensive grass-and-insect painting（Cordyceps）, effectively reduce product cost.
In conclusion sorting of the present invention is superior, prescription is scientific and reasonable, and primary raw material is medicine-food two-purpose, resourceful easy
, it is curative for effect, it can especially treat more such as systemic loupus erythematosus, pulmonary fibrosis（Obstructive lung disease）, systemic loupus erythematosus,
Ankylosing spondylitis, chorionitis, cachexia, alimentary canal（Such as ulcerative colitis, canker sore）, rheumatoid arthritis,
Hypoplastic anemia is easily caught a cold and other infectious diseases, the autoimmune diseases such as fatiguability or easy allergy with it is immune
It is diseases related；Immune and immune related diseases and the cancerous swellings such as the virus infection such as Epstein-Barr virus（Lung cancer, liver cancer, alimentary canal
（Including esophagus, stomach, intestines, intestinal mucosa system）Malignant tumour）Etc. generally believing that world's sex medicine refractory disease starts history
Meaning, be the invention of great significance to human health and contribution, there is special meaning.
Claims (9)
1. treating the Chinese patent drug of autoimmune and immune related diseases with Goat Placenta or embryo, it is characterised in that：Clean
10-50 parts of Goat Placenta or sheep embryo, 5-50 parts of carrot, 1-39 parts of the root of Dahurain angelica, 10-50 parts of Radix Glycyrrhizae, 20-50 parts of honeysuckle are above
After being pulverized and mixed, capsule or pulvis or tablet or granule or powder is made in the extracted active principle of raw material（It dissipates）
Agent or suspension or solution or other suitable application forms.
2. it is according to claim 1 with Goat Placenta or embryo treat in autoimmune and immune related diseases at
Medicine, it is characterised in that：19-30 parts clean of Goat Placenta or sheep embryo, 5-15 parts, root of Dahurain angelica 3-29 of carrot, 20-25 parts of Radix Glycyrrhizae,
10-25 parts of honeysuckle.
3. treating the preparation method of the Chinese patent drug of autoimmune and immune related diseases with Goat Placenta or embryo, feature exists
In：
（1）Extract volatile oil：Extracting honeysuckle, the root of Dahurain angelica are put into distillation container, add 6 times of weight of water, are impregnated 40-70 minutes, and water steams
Steam distillation 2.5-3.5h obtains oil water mixture, then is distilled to obtain volatile oil to oil water mixture, then with 10 times of weight
Beta-cyclodextrin inclusion compound volatile oil includes 2 hours at 60 ± 5 DEG C, obtains inclusion compound；Liquid is carried out to the surplus material after distillation admittedly to divide
From obtaining the dregs of a decoction and liquid；
（2）Carry fat：By step（1）The gained dregs of a decoction are extracted 2 times with alcohol reflux, and for the first time plus 10 times of weight concentrations are 60%-
85% ethyl alcohol, refluxing extraction 1.5-2.5 hours, the filtered dregs of a decoction add 8 times of weight concentrations to be 60%-85% ethyl alcohol again, and reflux carries
It takes 1.5-2.5 hours, merges extracting solution twice, and ethyl alcohol is recycled under negative pressure state, until extracting solution obtains containing fat without alcohol taste
The liquid of soluble substance；The remaining dregs of a decoction after reflux are continued to employ；
（3）Extract water soluble ingredient：Extracting liquorice is put into the decoction container of preprepared cleaning, soaks 40-70 points
Clock, with step（2）The gained dregs of a decoction decoct together it is secondary, it is 40-70 minutes each, for the first time plus 9.5 times of weight waters, second plus 6
Times weight water, detaches decoction liquor, and waste merges the liquid after decoction filtering twice, step（1）Isolated liquid is added
Carrot, clean Goat Placenta or embryo keep liquid submergence placenta or embryo 3-5cm, impregnate 40-70 minutes, use water vapour
Boiling, holding are boiled 70-90 minutes, and the Goat Placenta after decocting or embryo are taken, and merge the liquid after taking out Goat Placenta or embryo,
Negative pressure, which is concentrated into after relative density is 1.10-1.15, must extract concentrate, spare；
（4）By step（3）Placenta or embryo after decoction are successively through ultramicro grinding, multigelation, centrifugation, ultrafiltration technology, then pass through
It is spare that enzyme incision technology is digested into 500-3000Da >=97%；Or by step（3）Placenta or embryo after decoction is in 80-85 DEG C
Drying 1.5-2.5 hour, crushed after drying 70 mesh medicines sieve, drying after through ultramicro grinding or be micronized after it is spare；
（5）Take step（3）Step is added in extraction concentrate obtained（1）Inclusion compound, step（2）Contg fat-soluble substances
Liquid and step（4）Manufactured medicinal powder or digestion object, after mixing, spray drying or freezing negative pressure drying are at water content
≤ 5% powdery is made into capsule or tablet, granule, powder（It dissipates）Agent, tablet, suspension or other suitable applications
Form.
4. the Chinese patent drug according to claim 3 for treating autoimmune and immune related diseases with Goat Placenta or embryo
Preparation method, it is characterised in that：Step（3）The described negative pressure concentration is fluid temperature in container between 50-60 DEG C
Concentration；Step（5）The spray drying, the drying pressure in drying tower is 100-150Pa, and the inlet temperature of drying tower is
180 ± 5 DEG C, outlet temperature is 80 ± 5 DEG C；The negative pressure drying is the drying that the solid in container is between 75-80 DEG C,
Or it is dried under reduced pressure after -40 ± 2 DEG C of freezings.
5. treating the medical food of autoimmune and immune related diseases with Goat Placenta or embryo（It is eaten including special diet
Product, health food and various types of other food fed through alimentary canal for human body.
6. special medicine purposes formula food, referred to as：Spy doctor's food, it is the same below）, it is characterised in that：Clean Goat Placenta or sheep
10-30 parts of embryo, 5-50 parts, root of Dahurain angelica 3-29 of carrot, 10-50 parts of Radix Glycyrrhizae, 20-50 parts of honeysuckle, nutrition component, that is, malt paste
0.9-60 parts smart, 0.5-30 parts of dietary fiber, 0.1-45 parts of medium chain triglyceride is 0.1-19 parts micro-, water soluble vitamin life
It is 0.1-27 parts plain, 0.1-5 parts of liposoluble vitamin, 0.9-15 parts of milk taste flavoring agent, the above extracted working substance of raw material
After being pulverized and mixed, capsule or pulvis or tablet or granule or powder is made in matter（It dissipates）Agent or suspension or solution, or
Other suitable application forms.
7. the medical food according to claim 5 for treating autoimmune and immune related diseases with Goat Placenta or embryo
Product, it is characterised in that：19-30 parts clean of Goat Placenta or sheep embryo, 5-15 parts, root of Dahurain angelica 3-19 of carrot, 20-25 parts of Radix Glycyrrhizae,
10-25 parts of honeysuckle, nutrition component, that is, 9-20 parts of maltodextrin, 1-15 parts of dietary fiber, 0.1-9 parts of medium chain triglyceride are micro-
0.1-9 parts of secondary element, 0.2-17 parts of water soluble vitamin, 0.1-5 parts of liposoluble vitamin, 0.9-10 parts of milk taste flavoring agent.
8. treating the medical food preparation method of autoimmune and immune related diseases with Goat Placenta or embryo, feature exists
In：
（1）Extract volatile oil：Extracting honeysuckle, the root of Dahurain angelica are put into distillation container, add 6 times of weight of water, are impregnated 40-70 minutes, and water steams
Steam distillation 2.5-3.5h obtains oil water mixture, then is distilled to obtain volatile oil to oil water mixture, then with 10 times of weight
Beta-cyclodextrin inclusion compound volatile oil includes 2 hours at 60 ± 5 DEG C, obtains inclusion compound；Liquid is carried out to the surplus material after distillation admittedly to divide
From obtaining the dregs of a decoction and liquid；
（2）Carry fat：By step（1）The gained dregs of a decoction are extracted 2 times with alcohol reflux, and for the first time plus 10 times of weight concentrations are 60%-
85% ethyl alcohol, refluxing extraction 1.5-2.5 hours, the filtered dregs of a decoction add 8 times of weight concentrations to be 60%-85% ethyl alcohol again, and reflux carries
It takes 1.5-2.5 hours, merges extracting solution twice, and ethyl alcohol is recycled under negative pressure state, until extracting solution obtains containing fat without alcohol taste
The liquid of soluble substance；The remaining dregs of a decoction after reflux are continued to employ；
（3）Extract water soluble ingredient：Extracting liquorice is put into the decoction container of preprepared cleaning, soaks 40-70 points
Clock, with step（2）The gained dregs of a decoction decoct together it is secondary, it is 40-70 minutes each, for the first time plus 9.5 times of weight waters, second plus 6
Times weight water, detaches decoction liquor, and waste merges the liquid after decoction filtering twice, step（1）Isolated liquid is added
Carrot, clean Goat Placenta or embryo keep liquid submergence placenta or embryo 3-5cm, impregnate 40-70 minutes, use water vapour
Boiling, holding are boiled 70-90 minute, and the Goat Placenta after decocting or embryo are taken, merge the liquid after taking out Goat Placenta or embryo with
Step（1）Obtained liquid, negative pressure, which is concentrated into after relative density is 1.10-1.15, must extract concentrate, spare；
（4）By step（3）Placenta or embryo after decoction are successively through ultramicro grinding, multigelation, centrifugation, ultrafiltration technology, then pass through
It is spare that enzyme incision technology is digested into 500-3000Da >=97%；Or by step（3）Placenta or embryo after decoction is in 80-85 DEG C
Drying 1.5-2.5 hour, crushed after drying 70 mesh medicines sieve, drying after through ultramicro grinding or be micronized after it is spare；
（5）Take step（3）Step is added in extraction concentrate obtained（1）Inclusion compound, step（2）Contg fat-soluble substances
Liquid and step（4）Nutrition component is added in manufactured medicinal powder or digestion object, after mixing, negative pressure drying to water content≤
5%, it is made into medical food.
9. the medical food according to claim 3 for treating autoimmune and immune related diseases with Goat Placenta or embryo
Product preparation method, it is characterised in that：Step（3）The described negative pressure concentration is fluid temperature in container between 75-80 DEG C
Concentration；Step（5）The spray drying, the drying pressure in drying tower is 100-150Pa, and the inlet temperature of drying tower is
180 ± 5 DEG C, outlet temperature is 80 ± 5 DEG C；The negative pressure drying is the drying that the solid in container is between 75-80 DEG C,
Or it is dried under reduced pressure after -40 ± 2 DEG C of freezings.
Priority Applications (1)
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| CN111084878A (en) * | 2020-02-21 | 2020-05-01 | 曹正雨 | Biological medicine and medical total nutrient food for lung and respiratory system diseases and preparation method thereof |
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Application publication date: 20180907 |