CN111789917A - Traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder and a preparation method and application thereof, and relates to the field of traditional Chinese medicine compositions for improving intestinal microenvironment and preparation methods thereof. The invention aims to solve the technical problem of unbalanced flora in the intestinal ecosystem of patients with autism spectrum disorder. The Chinese medicinal composition comprises JIANSHENQU, rhizoma Pinelliae QU, Red Rice and lignum Aquilariae Resinatum QU. The preparation method comprises the following steps: weighing raw materials, parching Massa Medicata Fermentata, rhizoma Pinelliae Fermentata and Red Rice, pulverizing, and mixing with lignum Aquilariae Resinatum Fermentata. The traditional Chinese medicine composition is applied to preparation of medicines for improving intestinal microenvironment. The traditional Chinese medicine composition is a unique traditional Chinese medicine composition consisting of Jianshenqu, pinellia ternate koji, red yeast rice and agilawood koji which are fermentation products, and the intestinal microenvironment of patients with autism spectrum disorder is improved and the autism symptom is obviously relieved by utilizing the fact that the traditional Chinese medicine composition contains a large amount of active ingredients such as yeast, vitamin B group and the like. The Chinese medicinal composition is used for improving intestinal microenvironment of patients with autism spectrum disorder.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition for improving intestinal microenvironment and a preparation method thereof.
Background
Autism spectrum disorders (autism) are a general term used to describe a large and diverse complex family of brain developments. These diseases have three common characteristic features: social interaction difficulties, verbal and non-verbal communication impairment, repetitive behaviors. According to the american centers for disease prevention and control, patients with autism in children or adults have the following characteristics: do not point at the object to represent interest; others cannot look at the object when pointing at the object; interpersonal difficulties or lack of interest in others; avoid contact with eyes, and like to be independent; the feeling of others cannot be understood or the feeling of oneself is hardly expressed; do not like a handshake or hug, or accept a hug only when one wants to; slow to respond when talking to others, but notice other sounds; are very interesting to others, but do not know how to talk, play or interact with them; repeating words or phrases spoken by others, or replacing normal language with repeated words or phrases; it is difficult to express own needs using typical words or actions; not playing a typical "fake" game; repeating the action again and again; difficulty in adapting to changes in daily activities; abnormal reactions in smell, taste, vision, perception or sound; losing the ability once possessed.
The etiology of autism spectrum disorders is unknown. The currently accepted cause is the occurrence of lesions in brain structure or function. The published data from the U.S. center for disease control and prevention indicate that there are a variety of factors that contribute to the etiology of autism, including environmental and genetic factors. Most scientists agree that susceptibility factors for genetic genes dominate.
At present, behavioral correction is mainly adopted to treat autism, and no effective medicine is found.
In recent years, various studies have shown that gastrointestinal diseases are one of the features of autism. Studies at the national institutes of health have evaluated autistic pediatric patients and found that 85% of the patients had constipation and 92% had gastrointestinal pain. They further indicated a "strong relationship between constipation and language disorder". It is also predicted by the U.S. centers for disease prevention and control that autistic children experience 3.5 times higher risk of chronic diarrhea and constipation than normal children. Further studies have shown that the intestinal ecosystem of autistic patients is very different from that of non-autistic patients: some pattern of intestinal bacterial composition in autistic children is shown that is lacking in normal children, and autistic patients often have higher levels of clostridia, which can disrupt the balance of other intestinal flora, resulting in lower levels of beneficial bacteria; in addition, many autistic patients also have problems with intestinal leakage. Thus, there is scientific evidence that changes in the intestinal microenvironment are an important contributor to autism, and therefore, improvement of its symptoms should be made to alleviate the symptoms of autism.
Disclosure of Invention
The invention provides a traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder and a preparation method and application thereof, aiming at solving the technical problem of unbalanced flora in the intestinal ecosystem of the patients with autism spectrum disorder.
A traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder comprises, by weight, 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate koji, 6-15 parts of red yeast rice and 6-15 parts of agilawood koji.
The preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder specifically comprises the following steps:
weighing 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate yeast, 6-15 parts of red yeast and 6-15 parts of agilawood yeast according to parts by weight;
secondly, the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one are respectively fried to obtain fried medicated leaven, fried pinellia ternate koji and fried red yeast rice;
and thirdly, coarsely crushing the fried medicated leaven, the fried pinellia leaven, the fried red yeast rice and the agilawood leaven respectively, and then fully mixing the materials uniformly to obtain a mixed material, namely the traditional Chinese medicine composition, thereby completing the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
Or, the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder specifically comprises the following steps:
weighing 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate yeast, 6-15 parts of red yeast and 6-15 parts of agilawood yeast according to parts by weight;
secondly, coarsely crushing the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one, uniformly mixing, and then frying to obtain a fried mixture;
and thirdly, coarsely crushing the agarwood koji weighed in the first step, and then uniformly mixing the crushed agarwood koji with the stir-fried mixture obtained in the second step to obtain a mixed material, namely the traditional Chinese medicine composition, so as to finish the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
The invention has the beneficial effects that:
the traditional Chinese medicine composition is few, is a fermented product and has easily obtained raw materials. The preparation process is simple, the forming is easy, and no auxiliary material is added.
Based on the fact that gastrointestinal diseases are one of clinical characteristics of autism and the change of intestinal microenvironment is an important factor of autism, the invention selects the unique traditional Chinese medicine composition consisting of the Jianshenqu, the pinellia ternate koji, the red yeast rice and the agilawood koji which are fermented products according to the traditional Chinese medicine theory, and realizes the effects of improving the intestinal microenvironment of autism spectrum disorder patients and obviously relieving autism symptoms by utilizing the fact that the composition contains a large amount of active ingredients of yeast, vitamin B group and the like.
The medicated leaven contains yeast, amylase, vitamin B complex, ergosterol, protein, fat, volatile oil, etc., and has vitamin B-like effect, and has effects of stimulating appetite and maintaining normal digestive function. The pinellia ternate fermented mass has remarkable effects of reducing phlegm and relieving cough; the pinellia ternate koji water extract is perfused into normal mice and mice with spleen deficiency and dyspepsia, after administration, the intestinal propulsion rate and the gastric emptying rate of the mice can be promoted, meanwhile, the secretion of gastrointestinal hormone gastrin and the secretion of neurotransmitter cholinesterase of the mice with spleen deficiency and dyspepsia can be promoted, and the secretion of nitric oxide is reduced. Red yeast is a natural food discovered so far and has the functions of reducing blood fat, blood pressure and blood sugar 3. Also has wide pharmacological effects of resisting tumor, relieving fatigue, preventing osteoporosis, enhancing immunity, protecting cardiac muscle and endothelial cells, resisting inflammation, promoting digestion, etc. The lignum Aquilariae Resinatum koji contains Notopterygii rhizoma alcohol, isoimperatorin, costunolide and dehydrocostuslactone.
Clinical observation results show that after the traditional Chinese medicine composition is used for treatment, the number of bifidobacteria and lactobacilli in the excrement of a patient is obviously increased compared with that before the treatment, the determination (x +/-s) of the bifidobacteria in the excrement reaches 14.34 +/-9.33, the determination (x +/-s) of the lactobacilli reaches 1.78 +/-0.86, and the number of the bifidobacteria and the lactobacilli is closer to a normal value than that of a control group. However, the observed group is inferior to the control group in terms of the total effective rate, and analysis of the results probably depends on factors such as short administration time of the observed group and slow onset of the traditional Chinese medicine. The traditional Chinese medicine composition provided by the invention is proved to improve the intestinal microenvironment of patients with autism spectrum disorder.
The traditional Chinese medicine composition is used for improving the intestinal microenvironment of patients with autism spectrum disorder.
Detailed Description
The technical solution of the present invention is not limited to the specific embodiments listed below, and includes any combination of the specific embodiments.
The first embodiment is as follows: the embodiment provides a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder, which comprises, by weight, 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate koji, 6-15 parts of red yeast rice and 6-15 parts of agilawood koji.
The traditional Chinese medicine composition for improving the gastrointestinal microenvironment of patients with autism spectrum comprises the components of Jianshenqu, pinellia ternate koji, red yeast rice and agilawood koji.
The medicated leaven in the embodiment has the functions of tonifying spleen to promote digestion, regulating qi to eliminate dampness and relieving exterior syndrome; the pinellia tuber leaven has the functions of eliminating phlegm and relieving cough, relieving asthma and lowering adverse qi, harmonizing stomach, relieving vomit, relieving stuffiness and eliminating stagnation; the red yeast rice has the functions of invigorating spleen to promote digestion, and promoting blood circulation to remove blood stasis; the agilawood koji has the functions of regulating spleen and invigorating stomach, relieving pain and stopping diarrhea and eliminating fullness.
The second embodiment is as follows: the first difference between the present embodiment and the specific embodiment is: a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder comprises, by weight, 8-10 parts of Jianshenqu, 8-10 parts of pinellia ternate koji, 8-10 parts of red yeast rice and 8-10 parts of agilawood koji. The rest is the same as the first embodiment.
The third concrete implementation mode: the embodiment provides a preparation method of a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder, which comprises the following steps:
weighing 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate yeast, 6-15 parts of red yeast and 6-15 parts of agilawood yeast according to parts by weight;
secondly, the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one are respectively fried to obtain fried medicated leaven, fried pinellia ternate koji and fried red yeast rice;
and thirdly, coarsely crushing the fried medicated leaven, the fried pinellia leaven, the fried red yeast rice and the agilawood leaven respectively, and then fully mixing the materials uniformly to obtain a mixed material, namely the traditional Chinese medicine composition, thereby completing the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
The fourth concrete implementation mode: the third difference between the present embodiment and the specific embodiment is that: the second step of stir-frying the medicated leaven comprises the following steps: putting the medicated leaven into a hot pot, frying to yellow, taking out, and cooling; the method for stir-frying the red yeast rice comprises the following steps: putting the red yeast rice into a hot pot, and frying until the exterior is black and the interior is dark yellow; the method for stir-frying the pinellia ternata koji comprises the following steps: putting the pinellia ternate koji into a hot pot, frying until the pinellia ternate koji develops fire color, taking out and cooling. The rest is the same as the third embodiment.
The fifth concrete implementation mode: the embodiment provides a preparation method of a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder, which comprises the following steps:
weighing 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate yeast, 6-15 parts of red yeast and 6-15 parts of agilawood yeast according to parts by weight;
secondly, coarsely crushing the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one, uniformly mixing, and then frying to obtain a fried mixture;
and thirdly, coarsely crushing the agarwood koji weighed in the first step, and then uniformly mixing the crushed agarwood koji with the stir-fried mixture obtained in the second step to obtain a mixed material, namely the traditional Chinese medicine composition, so as to finish the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
The sixth specific implementation mode: the fifth embodiment is different from the fifth embodiment in that: and step two, after the stir-frying, the medicated leaven is yellow, the red yeast rice is black on the outside and old yellow on the inside, and the pinellia ternate leaven is in fire color. The rest is the same as the fifth embodiment.
The seventh embodiment: the embodiment provides application of a traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder, and is characterized in that the traditional Chinese medicine composition is applied to preparation of a medicine for improving the intestinal microenvironment.
The specific implementation mode is eight: the seventh embodiment is different from the seventh embodiment in that: adding adjuvants into the Chinese medicinal composition, and making into tablet, capsule, pill, medicated tea, granule or dripping pill; wherein the auxiliary materials required for preparing the tablet are dextrin, microcrystalline cellulose, superfine silica gel powder, sodium carboxymethyl starch, magnesium stearate and talcum powder; the adjuvants for preparing capsule are starch and dextrin; the auxiliary material for preparing pills is starch; the auxiliary material required for preparing the tea is tea; the auxiliary materials required for preparing the granules are dextrin and sucrose; the adjuvants required for preparing the dripping pill are polyethylene glycol, stearic acid, glycerogelatin, sodium stearate, glyceryl monostearate and beeswax. The rest is the same as the seventh embodiment.
The following examples were used to demonstrate the beneficial effects of the present invention:
the first embodiment is as follows:
the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder specifically comprises the following steps:
weighing 10 parts of Jianshenqu, 10 parts of pinellia ternate koji, 10 parts of red yeast and 10 parts of agilawood koji according to parts by weight;
secondly, the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one are respectively fried to obtain fried medicated leaven, fried pinellia ternate koji and fried red yeast rice;
and thirdly, coarsely crushing the fried medicated leaven, the fried pinellia leaven, the fried red yeast rice and the agilawood leaven respectively, and then fully mixing the materials uniformly to obtain a mixed material, namely the traditional Chinese medicine composition, thereby completing the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
Example two:
the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder specifically comprises the following steps:
weighing 10 parts of Jianshenqu, 10 parts of pinellia ternate koji, 10 parts of red yeast and 10 parts of agilawood koji according to parts by weight;
secondly, coarsely crushing the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one, uniformly mixing, and then frying to obtain a fried mixture;
and thirdly, coarsely crushing the agarwood koji weighed in the first step, and then uniformly mixing the crushed agarwood koji with the stir-fried mixture obtained in the second step to obtain a mixed material, namely the traditional Chinese medicine composition, so as to finish the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
The Chinese medicinal compositions prepared in example one and example two were tested:
animal experimental study:
1. material
1.1 AD rat of experimental animal, male, with the weight of 200-250 g.
1.2 test drugs: the invention relates to two technical extracts of a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder: the preparation method of the embodiment I obtains a process set No. 1, and the preparation method of the embodiment II obtains a process set No. 2;
preparation of test drug samples: respectively weighing 10g of the traditional Chinese medicine compositions prepared by the process groups No. 1 and No. 2, putting into a mortar, adding 10 times of water, and uniformly mixing to prepare a medicine suspension;
administration dose: calculating by pressing an object surface area folding algorithm: the dosage of rats is equal to the dosage of human use x 0.018.
1.3 culture medium and diluent intestinal flora detection culture medium (EC, BV1B, LBS, BS and BDB culture medium, all provided by Tianjin gold medal medical new technology research institute), 0.05% sterilized yeast powder aqueous solution is used as the intestinal flora detection diluent.
1.4 Experimental reagents: propionic Acid (PPA) (Ji nan Xin Bo chemical Co., Ltd., batch No.: 180614D7)
1.2 Experimental methods
1.2.1 replication of PPA (propionic acid) autism animal model: reference (Shultz, 2009) laboratory animals were housed in standard acrylic cages (experimental conditions: temperature controlled around 21 ℃, light/dark cycle 12:12 cycle, lit from 7:00 to 19:00 h) in the laboratory for 14 days, during which the experimental animals had ad libitum access to food and water. The experimental animals were implanted under anaesthesia and stereotactic and sterile conditions with a 23 gauge guide cannula (coordinates: anterior/posterior 1.4 mm; medial/lateral 1.8 mm; dorsal/ventral 3.0 mm), four small stainless steel screws were inserted into the skull around the cannula to provide an anchor for the dental cement which attached the cannula to the skull, sealing the guide cannula with a removable plug. After 4 days of recovery, PPA (4ml of 0.26M solution) was injected directly into the ventricle 1 time a day for 2 consecutive days by connecting to a Sage syringe pump through PE10 tubing.
1.2.2 animal grouping and handling: the weight of the Chinese medicinal composition is randomly divided into a normal control group (18), a model control group (18), a No. 1 technical Chinese medicinal composition group and a No. 2 technical Chinese medicinal composition group (12 in each group). Except for the normal control group, the other groups of experimental animals were replicated according to the replication method of the 2.1PPA (propionic acid) autism animal model. The experimental animals of the No. 1 technical traditional Chinese medicine composition group and the No. 2 technical traditional Chinese medicine composition group are administered with corresponding medicines 1 time a day through the approach of intragastric administration. The normal control group and the model control group were given the same volume of water.
1.2.3 detection of intestinal flora
Before the administration on the same day after grouping, 6 animals in each group of normal and model experimental animals are randomly selected for intestinal flora detection and colon histopathological observation. On days 6 and 12 after the administration, 6 mice were randomly selected from each group, and then subjected to intestinal flora detection and colon histopathological observation. The intestinal flora detection method comprises collecting feces to be discharged in a container without glass beadsWeighing in a small bacteria bottle, diluting 10 times the weight of the specimen with diluent, shaking and mixing for 200 times/min, and performing 10 times-3、10-5、10-6And (6) diluting. 3 drops of the 3 dilutions were dispensed into each coliform test medium, 20. mu.l each. Colon contents were also diluted and aliquoted. After inoculation, aerobic bacteria are placed in an aerobic bacteria incubator for culturing for 18 to 24 hours at 37 ℃, and anaerobic bacteria are placed in an anaerobic tank for culturing for 24 to 72 hours at 37 ℃. The bacterial content per gram of specimen (CFU/g specimen) was calculated by counting the number of colonies in the plate culture, and the CFU/g specimen was 50 × dilution × 1/specimen weight. The results were analyzed for variance (test F) using the common log values LgCFU/g.
1.2.4 Colon histopathology observations gross pathology of colon tissue and tissue sampling were performed simultaneously with colon content collection. Observing with a light microscope, taking colon tissues, fixing, slicing and HE staining; observing by an electron microscope, taking colon tissues of 1mm multiplied by 1mm, and fixing 2.5 percent glutaraldehyde phosphate buffer for 2 hours at the temperature of 4 ℃; 1% osmic acid fixation for 1 h; and (5) dehydrating the acetone. Embedding resin, trimming, slicing and dyeing lead and uranium.
1.3 results of the experiment
1.3.1 number of intestinal flora in mice in the feces and colon contents of normal control and model groups before administration. The results are shown in Table 1.
TABLE 1 number of intestinal flora (LgCFU/g) in feces and colon contents of normal control and model control groups
Note that P <0.05, P <0.01, compared with normal control group
The experimental result shows that compared with the normal control group, the numbers of the enterobacteria and the enterococcus of the contents in the feces and the colon of the experimental animals of the model group are obviously increased, and the numbers of the lactobacilli, the bifidobacteria and the bacteroides are obviously reduced (P is less than or equal to 0.05 or P is less than or equal to 0.01).
1.3.2 intestinal flora numbers in faeces and colon contents of the experimental animals of each group on day 6 after administration. The results are shown in Table 2.
TABLE 2 number of intestinal flora (LgCFU/g) in feces and colon contents of experimental animals of each group on day 6 after administration
Note P <0.0 compared to normal control group
The experimental result shows that compared with the normal control group, the numbers of the enterobacteria and the enterococcus in the excrement and the colon contents of the experimental animals of the model control group are obviously increased, and the numbers of the lactobacillus, the bifidobacterium and the bacteroides are obviously reduced (P is less than or equal to 0.05); compared with the model group, the numbers of enterobacteria and enterococcus in the excrement and colon contents of the experimental animals grouped by the traditional Chinese medicine in the No. 1 process are reduced, the numbers of lactobacillus, bifidobacterium and bacteroides are increased, but no obvious difference exists; compared with the traditional Chinese medicine component group in the No. 1 process, the change of the flora of the excrement and colon contents of the experimental animals of the traditional Chinese medicine component group in the No. 2 process is not obviously different (P is less than or equal to 0.05).
1.3.3 intestinal flora number in faeces and colon contents of the experimental animals of each group on day 12 after administration. The results are shown in Table 3.
Table 3 intestinal flora number in faeces and colon contents of each group of experimental animals on day 12 after dosing. (LgCFU/g)
Note P <0.05 compared to normal control group; # P <0.05 compared to model group; # P <0.01
The experimental result shows that compared with the normal control group, the numbers of enterobacteria and enterococci in the excrement and colon contents of the experimental animals of the model control group are obviously increased, and the numbers of bifidobacteria and bacteroides are obviously reduced (P is less than or equal to 0.05); compared with the model control group, the numbers of the feces of the experimental animals of the No. 1 process traditional Chinese medicine component group, intestinal bacilli and enterococci in colon are obviously reduced (P is less than or equal to 0.01), and the numbers of bifidobacteria and bacteroides are obviously increased (P is less than or equal to 0.01); compared with the group of the traditional Chinese medicine for the No. 1 process, the group of the traditional Chinese medicine for the No. 1 process has no significant difference in the change of the flora of the contents in the feces and colon (P is less than or equal to 0.05).
1.3.4 intestinal histopathological observations:
the experimental results show that compared with the normal control group, the experimental animals of the model control group can be seen to have enlarged ileocecal part, congestion and edema of colon wall, adhesion of intestinal mucosa and obvious reduction of intestinal contents. The colon and intestinal cavity is dilated by a light microscope, the muscle layer becomes thin, the number of goblet cells is obviously reduced, and the intestinal mucosa is damaged, and villi becomes short, small and sparse. The electron microscope shows that intestinal mucosa microvilli are disorganized, broken or lost, mitochondria swell, mitochondria membranes are incomplete, and mitochondria domains are reduced; on the 6 th day after administration, the pathological changes of the intestinal tissues and cells of the model control group, the technical traditional Chinese medicine component No. 1 and the technical traditional Chinese medicine component No. 1 are not obviously recovered. On the 12 th day after administration, intestinal tissue and cell pathological changes of experimental animals of the model control group, the No. 1 technical traditional Chinese medicine component group and the No. 1 technical traditional Chinese medicine component group are obviously recovered, so that the ileocecal part is recovered to be normal in size, congestion and edema of the intestinal wall are eliminated or basically eliminated, and intestinal contents are obviously increased. The colon cavity is dilated and disappeared or basically disappears by a light microscope, the villi on the surface of the intestinal mucosa tend to be normal, the number of goblet cells is increased to different degrees, but the number is still obviously less than that of a normal control group. The intestinal mucosa microvilli are regularly arranged or tend to be regularly arranged as seen by an electron microscope, the mitochondrial membrane is complete, the mitochondrial swelling disappears or basically disappears, and the form returns to normal.
Clinical trial studies:
2 general data and methods:
2.1 general data 30 infants from autism were selected for outpatient clinic and randomized into control and observation groups. Each group had 15, 8 men and 7 women in the group were observed; mean age 6.2 ± 2.5; the mean course of disease is 3.7 + -1.6 years. 9 men and 6 women in the control group; mean age 6.1 ± 2.1; the average course of disease is 2.2 + -2.0 years. The comparison of the general data of sex, age, course of disease and the like of two groups of children patients has no statistical significance (P is less than or equal to 0.05).
Bringing in the standard, the children patients all accord with the related diagnosis standard of the autism of children in the manual of mental disorder diagnosis and statistics; stool is water-like or pasty, has much foam and is in acidic reaction, and is accompanied by fermentation dyspepsia such as borborygmus, increased exhaust, abdominal distension and the like for several times or more than ten times every day; ③ the feces flora is cultured to show the excessive bacteria to be obviously propagated, while the physiological dominant bacteria are reduced. And fourthly, the family members of the children patient agree to participate in the research.
The elimination standard is that firstly, people can not be matched with the traditional Chinese medicine treatment; ② those who receive other treatments and do not cooperate with family members.
2.2 methods
2.2.1 the control group was orally administered 0.5g per time 3 times a day by growth-promoting (manufacturer: first biological pharmaceutical industry, llc, of Anyang, Henan province: batch 20010603, batch number: national drug Standard number S10980014).
2.2.2 the observation group adopts No. 1 technical traditional Chinese medicine components, 0.25g/kg body weight is taken with warm water for 2 times each day.
The above two groups take 15 days as a treatment course.
2.2.3 Observation index and judgment standard (I) cure: the stool turns to be normal, the symptoms of indigestion and malabsorption such as borborygmus, abdominal distension, appetite reduction and the like disappear, and the stool flora is cultured normally; secondly, the method is effective: diarrhea is relieved, symptoms of dyspepsia are improved, the culture of excrement floras shows that physiological bacteria are increased, and putrefying bacteria are reduced; ③ invalid: diarrhea and other symptoms are not reduced or aggravated, and stool culture surplus bacteria still obviously propagate.
2.3 results
The test results are shown in tables 4-6.
TABLE 4 comparison of the clinical effects of the two groups
Note that the two groups of total effective rates are tested by the radius analysis, and P is less than 0.01.
TABLE 5 measurement of bifidobacteria in stool before and after treatment (x. + -. s)
| Group of | Before treatment | After treatment | Normal reference value |
| Observation group | 4.62±2.57 | 14.34±9.33 | 15.7±7.82 |
| Control group | 4.84±2.46 | 11.63±7.52 | 15.68±6.62 |
Note that after treatment, the P is less than 0.05 by t-test statistics.
TABLE 6 determination of Lactobacillus faecalis before and after two groups of treatments (x. + -. s)
| Group of | Before treatment | After treatment | Normal reference value |
| Observation group | 0.89±0.41 | 1.78±0.86 | 1.83+0.87 |
| Control group | 0.87±0.42 | 1.34±0.66 | 1.83±0.87 |
Note that after treatment, the P is less than 0.05 by t-test statistics.
The clinical observation result shows that the number of bifidobacteria and lactobacilli in the observed group of excrement is obviously increased compared with that before treatment; the numbers of bifidobacteria and lactobacilli in the stools of the control group were also increased compared to those before treatment, and the numbers of bifidobacteria and lactobacilli in the stools of the observed group after treatment were closer to normal values than those of the control group. However, the observed group is inferior to the control group in terms of the total effective rate, and analysis of the results probably depends on factors such as short administration time of the observed group and slow onset of the traditional Chinese medicine.
In conclusion, according to the traditional Chinese medicine theory, the Jianshenqu, the pinellia ternate koji, the red yeast rice and the agilawood koji which are fermented products are selected to form the unique traditional Chinese medicine composition, and the intestinal microenvironment of the autism spectrum disorder patient is improved and the autism symptom is obviously relieved by utilizing the fact that the traditional Chinese medicine composition contains a large amount of active ingredients such as yeast, vitamin B group and the like.
Claims (8)
1. A traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder is characterized by comprising 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate koji, 6-15 parts of red yeast rice and 6-15 parts of agilawood koji according to parts by weight.
2. The traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder according to claim 1, which is characterized by comprising, by weight, 8-10 parts of Jianshenqu, 8-10 parts of pinellia ternate koji, 8-10 parts of red yeast rice and 8-10 parts of agilawood koji.
3. The method for preparing a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder according to claim 1, which is specifically carried out according to the following steps:
weighing 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate yeast, 6-15 parts of red yeast and 6-15 parts of agilawood yeast according to parts by weight;
secondly, the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one are respectively fried to obtain fried medicated leaven, fried pinellia ternate koji and fried red yeast rice;
and thirdly, coarsely crushing the fried medicated leaven, the fried pinellia leaven, the fried red yeast rice and the agilawood leaven respectively, and then fully mixing the materials uniformly to obtain a mixed material, namely the traditional Chinese medicine composition, thereby completing the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
4. The preparation method of the traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder according to claim 3, wherein the method for stir-frying the medicated leaven in the second step comprises the following steps: putting the medicated leaven into a hot pot, frying to yellow, taking out, and cooling; the method for stir-frying the red yeast rice comprises the following steps: putting the red yeast rice into a hot pot, and frying until the exterior is black and the interior is dark yellow; the method for stir-frying the pinellia ternata koji comprises the following steps: putting the pinellia ternate koji into a hot pot, frying until the pinellia ternate koji develops fire color, taking out and cooling.
5. The method for preparing a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder according to claim 1, which is specifically carried out according to the following steps:
weighing 6-15 parts of Jianshenqu, 6-15 parts of pinellia ternate yeast, 6-15 parts of red yeast and 6-15 parts of agilawood yeast according to parts by weight;
secondly, coarsely crushing the medicated leaven, the pinellia ternate koji and the red yeast rice weighed in the step one, uniformly mixing, and then frying to obtain a fried mixture;
and thirdly, coarsely crushing the agarwood koji weighed in the first step, and then uniformly mixing the crushed agarwood koji with the stir-fried mixture obtained in the second step to obtain a mixed material, namely the traditional Chinese medicine composition, so as to finish the preparation method of the traditional Chinese medicine composition for improving the intestinal microenvironment of patients with autism spectrum disorder.
6. The method for preparing a Chinese medicinal composition for improving intestinal microenvironment of patients with autism spectrum disorder according to claim 5, wherein the medicated leaven is yellow after parching in step two, the red yeast rice is black at the outside and old yellow at the inside, and the pinellia leaven is dark.
7. An application of a traditional Chinese medicine composition for improving intestinal microenvironment of patients with autism spectrum disorder is characterized in that the traditional Chinese medicine composition is applied to preparation of a medicine for improving the intestinal microenvironment.
8. The use of the Chinese medicinal composition for improving the intestinal microenvironment of patients with autism spectrum disorder according to claim 7, wherein the Chinese medicinal composition is added with adjuvants to be made into tablets, capsules, pills, teas, granules or dropping pills; wherein the auxiliary materials required for preparing the tablet are dextrin, microcrystalline cellulose, superfine silica gel powder, sodium carboxymethyl starch, magnesium stearate and talcum powder; the adjuvants for preparing capsule are starch and dextrin; the auxiliary material for preparing pills is starch; the auxiliary material required for preparing the tea is tea; the auxiliary materials required for preparing the granules are dextrin and sucrose; the adjuvants required for preparing the dripping pill are polyethylene glycol, stearic acid, glycerogelatin, sodium stearate, glyceryl monostearate and beeswax.
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