CN115779041A - Traditional Chinese medicine concentrated pill for treating colorectal inflammation and preparation method and application thereof - Google Patents
Traditional Chinese medicine concentrated pill for treating colorectal inflammation and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine concentrated pill for treating colorectal inflammation, which is prepared from the following raw material medicines in parts by weight: 2-10 parts of pseudo-ginseng powder, 2-10 parts of coptis chinensis, 8-16 parts of rhizoma bletillae, 11-19 parts of carbonized sanguisorba root, 5-13 parts of fried bighead atractylodes rhizome, 8-16 parts of white poria, 6-14 parts of fried chicken's gizzard-membrane and 2-10 parts of liquorice. The invention also provides a preparation method and application of the traditional Chinese medicine concentrated pill for treating the colorectal inflammation. Meanwhile, the concentrated pill has the effects of astringing to arrest bleeding, strengthening the spleen, tonifying qi, clearing away heat and toxic materials, eliminating dampness, stopping diarrhea, relieving swelling, expelling pus, regulating qi and blood and the like, is convenient to use clinically, is used for improving the symptoms of abdominal pain, diarrhea and hematochezia of patients with colorectal inflammation, delays the development of the disease and achieves the purpose of treating both symptoms and root causes.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine concentrated pill for treating colorectal inflammation and a preparation method and application thereof.
Background
The colorectal inflammation is a chronic, repeated and multiple disease, the intestinal tract has symptoms such as inflammatory edema, ulcer, bleeding lesion and the like due to various pathogenic reasons, the incidence rate of the colorectal inflammation is higher and higher, the common parts of the colorectal inflammation in the clinical narrow sense of the colorectal inflammation are rectum and sigmoid colon, the colorectal inflammation is characterized by long course of disease, chronic and repeated attack, the pathogenic reasons are not clear, the lesion is limited to mucous membrane and submucosa, and the initial part is the upward retrograde infection of the rectal part. It is mostly seen in the young and strong years of 20-30 years old. Colorectal inflammation is classified into the following categories, acute colorectal inflammation: the clinical data show that most patients with acute colorectal inflammation have the symptoms of diarrhea, fever, abdominal pain and the like. When the diarrhea is serious, patients can have the dehydration symptoms of listlessness, dry skin, deep sockets and the like; chronic colitis: chronic colorectal inflammation is not excluded from being caused by simple gastrointestinal dysfunction, and is manifested by irregular stool, abdominal distension, diarrhea and the like; ulcerative colitis: ulcerative colitis is a special disease, belonging to autoimmune diseases, and its main symptoms include mucous bloody stool, diarrhea, abdominal pain, etc.
At present, the treatment of the colorectal inflammation is mainly started from the following aspects that firstly, diet adjustment is carried out, light foods such as porridge and noodles are suitable to be eaten at ordinary times, excessively spicy foods such as hot pepper and spicy strips cannot be eaten, alcoholic beverages cannot be drunk, and foods which are difficult to digest and easily form hard stool such as dried vegetables, dried mushrooms and dried kidney beans are not required to be eaten. Secondly, if bacterial infections are considered to be the result, oral antibiotics are required for treatment, such as metronidazole, ornidazole, tinidazole, levofloxacin, norfloxacin, or cefalexin capsules, which are administered under the direction of the physician. Thirdly, some medicines for regulating the intestinal flora, such as befeuda, siliankang and the like, can be orally taken. Fourthly, doctors of traditional Chinese medicine department can take oral traditional Chinese medicines for treatment if necessary, and sometimes the traditional Chinese medicines are used for enema, so that the traditional Chinese medicines have good effects, for example, patients are caused by ulcerative colitis or proctitis, hormone medicines are mainly required to be taken, for example, the enteritis is serious, perforation and the like are caused, and even surgery is required for treatment. In the traditional Chinese medicine, the treatment of chronic colorectal inflammation is based on the treatment of invigorating spleen and tonifying kidney, tonifying qi and removing dampness, the treatment of the symptoms and root causes of clearing heat and removing toxicity, and activating blood and dissolving stasis, the treatment is carried out based on syndrome differentiation, the long-term application of a bitter and cold preparation is most forbidden, and the traditional Chinese medicine needle can be matched with a traditional Chinese medicine needle such as Shenmai injection, astragalus mongholicus injection and the like for intravenous drip to strengthen the body resistance.
Chinese patent CN114028322A, published Japanese 2022.02.11, discloses a Chinese medicinal suppository for treating ulcerative colitis, which comprises the following medicinal raw materials in parts by weight: 30-40 parts of matrix, 5-10 parts of angelica sinensis, 5-6 parts of safflower, 5-10 parts of cordyceps sinensis, 2-3 parts of beeswax, 10-15 parts of rhizoma bletillae, 4-5 parts of gardenia, 3-5 parts of Hainan sediment, 4-6 parts of rhizoma sparganii, 7-9 parts of schisandra chinensis, 15-20 parts of dandelion, 16-18 parts of coix seed, 10-15 parts of salvia miltiorrhiza, 15-18 parts of Chinese pulsatilla root and 20-30 parts of immature bitter orange. Chinese patent CN111773342A, published as 2020.10.16, discloses a traditional Chinese medicine formula for treating chronic colorectal inflammation and auxiliary treatment of colorectal cancer, which comprises the following traditional Chinese medicine raw materials in parts by weight: 25-30 parts of kudzuvine root, 4-6 parts of costus root, 9-12 parts of garden burnet root, 6-9 parts of Chinese gall, 4-6 parts of myrobalan fruit, 9-12 parts of Chinese magnoliavine fruit, 10-12 parts of wrinkled gianthyssop herb, 9-12 parts of prepared rehmannia root, 4-6 parts of Chinese date, 9-12 parts of summer heat clearing, 9-12 parts of poria, 6-8 parts of honey-fried licorice root, 15-20 parts of katsumade galangal seed, 9-12 parts of long pepper, 10-20 parts of hairyvein agrimonia herb and bud, 12-20 parts of paniculate swallowwort root, 18-25 parts of seaweed, 10-15 parts of panax notoginseng and 25-35 parts of astragalus root. The traditional Chinese medicine composition has more medicinal ingredients, increases the preparation procedures of the medicine, is more complicated, and has the defects of difficult material taking, high price, insignificant medicine effect and the like. Therefore, the traditional Chinese medicine composition is required to have more medicinal ingredients, the preparation process of the medicine is increased, the preparation process is complicated, the defects of difficult material obtaining, high price, insignificant efficacy and the like exist, and therefore, the development of the medicine for treating the colorectal inflammation, which has the advantages of obvious effect, moderate medicinal ingredient number, proper price and convenient use, is necessary.
However, no report is found on the treatment of colorectal inflammation by using the concentrated pill prepared from the traditional Chinese medicine composition at present.
Disclosure of Invention
The first purpose of the invention is to provide a traditional Chinese medicine concentrated pill for treating colorectal inflammation aiming at the defects in the prior art.
The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine concentrated pill
The third purpose of the invention is to provide the application of the traditional Chinese medicine concentrated pill.
In order to achieve the first purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine concentrated pill for treating colorectal inflammation is prepared from the following raw material medicines in parts by weight: 2-10 parts of pseudo-ginseng powder, 2-10 parts of coptis chinensis, 8-16 parts of rhizoma bletillae, 11-19 parts of carbonized sanguisorba root, 5-13 parts of fried bighead atractylodes rhizome, 8-16 parts of white poria, 6-14 parts of fried chicken's gizzard-membrane and 2-10 parts of liquorice.
More preferably, the traditional Chinese medicine concentrated pill is prepared from the following raw material medicines in parts by weight: 4-8 parts of pseudo-ginseng powder, 4-8 parts of coptis chinensis, 10-14 parts of rhizoma bletillae, 13-17 parts of carbonized sanguisorba root, 7-11 parts of fried bighead atractylodes rhizome, 10-14 parts of white poria, 8-12 parts of fried chicken's gizzard-membrane and 4-8 parts of liquorice.
More preferably, the traditional Chinese medicine concentrated pill is prepared from the following raw material medicines in parts by weight: 6 parts of pseudo-ginseng powder, 6 parts of coptis chinensis, 12 parts of rhizoma bletillae, 15 parts of carbonized sanguisorba root, 9 parts of fried bighead atractylodes rhizome, 12 parts of white poria, 10 parts of fried chicken's gizzard-membrane and 6 parts of liquorice.
In order to achieve the second object, the invention adopts the technical scheme that:
the preparation method of the traditional Chinese medicine concentrated pill comprises the following steps:
a) A decocting person takes the decoction pieces soaked for 40 minutes in a medicine moistening area, puts the soaked decoction pieces and the medicine moistening water into a medicine decocting machine, controls the decocting time to be 35 minutes after boiling, and butt joints a medicine moistening barrel and a liquid discharge hose of the medicine decocting machine for collecting decoction;
b) Vacuumizing to-0.005-0.007 MPa, vacuumizing the liquid medicine to be concentrated into a vacuum concentrator, starting steam to keep the steam pressure at 0.02-0.03 MPa, stopping the vacuum system after the concentration is finished, closing a steam valve, opening an emptying valve, starting a discharge valve, and removing the extract.
c) Peeling the extract, weighing, binding a drying plate and an extract barrel after weighing, and dispensing to a pill making station according to a first-in first-out principle;
d) Mixing dextrin with the extract to obtain soft material with appropriate hardness, tabletting and rubbing with a small pill making machine to obtain small pills, spreading dextrin on the surface of the wet pills to make the surface dry and non-adhesive, screening with a screen, removing unqualified wet pills, mixing the unqualified wet pills, making pills again, placing the qualified pills into a drying tray, placing the drying tray into a conveying belt after finishing, and placing into a drying area;
e) Putting the qualified crude pills into a drying tray in an oven, determining that the crude pills are in a state to be dried, closing the oven, and drying according to a two-step drying curve;
f) Spreading the coating liquid on the surface of the dry hair pill, rapidly stirring to make it uniform, spreading talcum powder to make the surface complete, repeating the action for 2-3 times to ensure that the pill shape is qualified, and spreading insect white wax to make the surface smooth after the surface is dried.
As an example, the evacuation condition in the step b) is preferably-0.006 MPa, and the vapor pressure is maintained at 0.02MPa.
In order to achieve the second purpose, the invention adopts the technical scheme that:
the application of the traditional Chinese medicine concentrated pill in preparing a medicine for treating colorectal inflammation is provided.
The invention has the advantages that:
in the formula, the pseudo-ginseng powder has the effects of dissipating blood stasis, stopping bleeding, reducing swelling and relieving pain, and the coptis root has the effects of clearing heat, eliminating dampness, purging fire and removing toxicity, and is used as a monarch drug together. The proportion of the pseudo-ginseng and the coptis root is 1, so that the effect of stopping bleeding of the pseudo-ginseng is emphasized, and the effect of purging fire of the coptis root is achieved lightly. And when the proportion is adopted, the dissolution rates of the three effective components of the notoginsenoside R1, the ginsenoside Rg1 and the ginsenoside Rb1 are generally higher. In the formula, the rhizoma bletillae has the effects of astringing and stopping bleeding, reducing swelling and promoting granulation, and the garden burnet root is charred to cool blood and stop bleeding, detoxify and heal wound, and is used as a ministerial drug together. Wherein the rhizoma bletilla polysaccharide has hemostatic, immunity regulating, wound healing promoting and antiinflammatory effects. The tannin component and sanguisorbin I in radix Sangusorbae charcoal have hemostatic effect, acidic polysaccharide has antiinflammatory and protective effects, and radix Sangusorbae polyphenol extract has antibacterial effect. The fried white atractylodes rhizome and the white poria are used for assisting in strengthening the spleen and promoting diuresis, and the fried chicken's gizzard-membrane is used for promoting digestion and invigorating the stomach. And the liquorice is added to regulate the effects of the medicines, so as to achieve the effects of removing blood stasis, stopping bleeding, removing dampness and stopping diarrhea.
Drawings
FIG. 1 is a tongue picture A before and after a patient takes a traditional Chinese medicine once; B. the first day of taking the traditional Chinese medicine; C. taking the Chinese medicine for the seventh day; D. the fourteenth day after taking the Chinese medicine.
FIG. 2 is a tongue picture A before and after the patient takes the second traditional Chinese medicine, the day before the patient takes the second traditional Chinese medicine; B. the first day of taking the traditional Chinese medicine; C. taking the Chinese medicinal composition for the seventh day; D. taking the Chinese medicine on the fourteenth day.
Detailed Description
The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications can be made to the present invention by those skilled in the art after reading the present specification, and these equivalents also fall within the scope of the invention defined by the appended claims.
Example 1 concentrated pill of Chinese traditional medicine for treating colorectal inflammation
6 parts of pseudo-ginseng powder, 6 parts of coptis chinensis, 12 parts of rhizoma bletillae, 15 parts of carbonized sanguisorba root, 9 parts of fried bighead atractylodes rhizome, 12 parts of white poria, 10 parts of fried chicken's gizzard-membrane and 6 parts of liquorice.
Example 2 concentrated pill of Chinese traditional medicine for treating colitis
6 parts of pseudo-ginseng powder, 4 parts of coptis chinensis, 14 parts of rhizoma bletillae, 11 parts of carbonized sanguisorba root, 13 parts of fried bighead atractylodes rhizome, 12 parts of white poria, 8 parts of fried chicken's gizzard-membrane and 8 parts of liquorice.
EXAMPLE 3 concentrated pill of Chinese traditional medicine for treating colitis
4 parts of pseudo-ginseng powder, 8 parts of coptis chinensis, 8 parts of rhizoma bletillae, 19 parts of carbonized sanguisorba root, 9 parts of fried bighead atractylodes rhizome, 10 parts of white poria, 12 parts of fried chicken's gizzard-membrane and 2 parts of liquorice.
EXAMPLE 4 traditional Chinese medicine concentrated pill prescription (IV) for treating colonic inflammation
8 parts of pseudo-ginseng powder, 2 parts of coptis chinensis, 16 parts of rhizoma bletillae, 15 parts of carbonized sanguisorba root, 7 parts of fried bighead atractylodes rhizome, 14 parts of white poria, 6 parts of fried chicken's gizzard-membrane and 10 parts of liquorice.
EXAMPLE 5 concentrated pill of Chinese herbs prescription for treating colitis
2 parts of pseudo-ginseng powder, 10 parts of coptis chinensis, 12 parts of rhizoma bletillae, 13 parts of carbonized sanguisorba root, 11 parts of fried bighead atractylodes rhizome, 8 parts of white poria, 14 parts of fried chicken's gizzard-skin and 6 parts of liquorice.
EXAMPLE 6 concentrated pill of Chinese traditional medicine for treating colitis
10 parts of pseudo-ginseng powder, 6 parts of coptis chinensis, 10 parts of rhizoma bletillae, 17 parts of carbonized sanguisorba root, 5 parts of fried bighead atractylodes rhizome, 16 parts of white poria, 10 parts of fried chicken's gizzard-membrane and 4 parts of liquorice.
EXAMPLE 7 concentrated pill of Chinese traditional medicine for treating colitis
6 parts of pseudo-ginseng powder, 8 parts of coptis chinensis, 8 parts of rhizoma bletillae, 19 parts of carbonized sanguisorba root, 9 parts of fried bighead atractylodes rhizome, 10 parts of white poria, 12 parts of fried chicken's gizzard-membrane and 2 parts of liquorice.
EXAMPLE 8 condensed pill of Chinese herbs prescription (eight) for treating colonic inflammation
4 parts of pseudo-ginseng powder, 2 parts of coptis chinensis, 16 parts of rhizoma bletillae, 15 parts of carbonized sanguisorba root, 7 parts of fried bighead atractylodes rhizome, 14 parts of white poria, 6 parts of fried chicken's gizzard-membrane and 10 parts of liquorice.
EXAMPLE 9 concentrated pill of Chinese traditional medicine for treating colitis
8 parts of pseudo-ginseng powder, 10 parts of coptis chinensis, 12 parts of rhizoma bletillae, 13 parts of carbonized garden burnet root, 11 parts of fried bighead atractylodes rhizome, 8 parts of white poria, 14 parts of fried chicken's gizzard-membrane and 6 parts of liquorice.
Example 10 concentrated pill of Chinese traditional medicine for treating colorectal inflammation
2 parts of pseudo-ginseng powder, 6 parts of coptis chinensis, 10 parts of rhizoma bletillae, 17 parts of carbonized garden burnet root, 5 parts of fried bighead atractylodes rhizome, 16 parts of white poria, 10 parts of fried chicken's gizzard-membrane and 4 parts of liquorice.
EXAMPLE 11 concentrated pill of Chinese traditional medicine for treating colitis
10 parts of pseudo-ginseng powder, 4 parts of coptis chinensis, 14 parts of rhizoma bletillae, 11 parts of carbonized sanguisorba root, 13 parts of fried bighead atractylodes rhizome, 12 parts of white poria, 8 parts of fried chicken's gizzard-membrane and 8 parts of liquorice.
EXAMPLE 12 preparation of concentrated pill of Chinese medicine for treating colitis (twelve)
The traditional Chinese medicine concentrated pill is prepared by the following method:
a) A decocting person takes the decoction pieces soaked for 40 minutes (taking the concentrated pill prescription in any embodiment 1-11) in a medicine moistening area, puts the soaked decoction pieces and the moistening liquid into a medicine decocting machine, controls the decocting time to be 30-40 minutes after boiling, and butt joints a medicine moistening barrel with a liquid discharge hose of the medicine decocting machine for collecting the decoction; b) Opening a vacuum pump, vacuumizing to-0.006 MPa, pumping the liquid medicine to be concentrated into a vacuum concentrator in vacuum, starting steam to keep the steam pressure at 0.02MPa, stopping a vacuum system after the concentration is finished, closing a steam valve, opening an emptying valve, starting a discharge valve, and removing the extract; c) Peeling the extract, weighing, binding a drying plate and an extract barrel after weighing, and dispensing to a pill making station according to a first-in first-out principle; d) Mixing dextrin with the extract to obtain soft material with appropriate hardness, tabletting and rubbing with a small pill making machine to obtain small pills, spreading a proper amount of dextrin on the surface of the wet pills to make the surface dry and non-adhesive, screening with a screen, removing unqualified wet pills, mixing the unqualified wet pills, re-making pills, putting the qualified pills into a drying tray, putting the drying tray into a conveying belt after finishing, and putting the pills into a drying area; e) Putting the qualified crude pills into a drying tray in an oven by a drying person, confirming that the crude pills are in a state to be dried, closing the oven, and drying according to a two-step drying curve; f) Spreading a proper amount of coating liquid on the surface of the dry hair pills, quickly stirring to ensure the dry hair pills to be uniform, then spreading a proper amount of talcum powder to ensure the surface to be complete, repeating the action for 2-3 times to ensure that the pills are qualified, and spreading a proper amount of insect white wax to ensure the surface to be smooth and clean after the surface is dried.
Example 13 clinical efficacy analysis
1 research data and methods
1.1 case data
40 patients were selected from 6 months to 2022 months from 8 months out-patient and ward for treatment of colorectal inflammation, and were divided into two groups at random. 20 cases of the traditional Chinese medicine, 20 cases of the control group and the age of 39.5 +/-8.3 years. The two general data are compared, and the difference is not statistically significant (P > 0.05) and is comparable. All patients are confirmed and diagnosed by routine examination of enteroscope and feces, and gastrointestinal malignant lesions and other gastrointestinal diseases influenced by liver, pancreas and the like are eliminated.
1.2 diagnostic criteria
(1) Western diagnostic criteria: the standard for diagnosing mild and moderate ulcerative colitis refers to "consensus opinion on diagnosis and treatment of inflammatory bowel disease (2018, beijing)". The ulcerative colitis is divided into an active period and a remission period, an improved Mayo scoring standard (table 1) is adopted, the total score is less than or equal to 2, no single subentry score is greater than 1, the remission period is divided, and the total score is greater than or equal to 3, the active period is divided. The active disease was classified into mild, moderate and severe according to severity, and the severity classification standard of Truelove and Witts disease was adopted (Table 2).
TABLE 1 improved Mayo scoring system for assessing ulcerative colitis Activity
Note: a each subject served as a self-control, thereby evaluating the degree of abnormality in the number of times of defecation; b daily bleeding score represents the most severe bleeding in 1 d; c the physician global assessment includes 3 criteria: subject review of abdominal discomfort, overall well-being and other performance, such as physical examination findings and subject performance status, scored ≦ 2 and no individual scoring>1 is divided into clinical remissionThe score of 3-5 is mild activity, the score of 6-10 is moderate activity, and the score of 11-12 is severe activity.
TABLE 2 improved Truelove and Witts disease severity typing
Note: moderate degree is between light and severe degree
(2) The traditional Chinese medicine syndrome differentiation standard is as follows: the syndrome of damp-heat in large intestine with diarrhea refers to the consensus of Chinese and Western combined diagnosis and treatment of ulcerative colitis (2017). The main symptoms are: (1) diarrhea, mucus, purulent bloody stool; (2) abdominal pain; (3) tenesmus after tenesmus. The secondary symptoms are as follows: (1) burning of the anus; (2) body heat is not raised; (3) dry mouth and bitter taste; (4) scanty and brownish urine. Tongue pulse: the tongue is red and yellow with greasy coating; the pulse is smooth and rapid. Has 2 main symptoms and 1 or more secondary symptoms.
1.3 inclusion criteria
(1) The above-mentioned Western diagnosis standard and Chinese medicine dialectical standard are met;
(2) The age is 18-65 years old;
(3) Those who have not received other treatments within 2 months;
(4) Signing the informed consent.
1.4 exclusion criteria
(1) Those who do not meet the Western diagnosis standard or the Chinese dialectical standard;
(2) Pregnant or lactating women, allergic constitutions and those involved in this study;
(3) Patients with serious primary diseases and mental diseases such as cardiovascular disease, cerebrovascular disease, hepatic disease, renal disease, hemopoietic system, etc.;
(4) Disabled as prescribed by law;
(5) Complications such as intestinal local stenosis, intestinal obstruction, intestinal perforation, rectal polyp, toxic colonic dilatation, and colorectal cancer;
(6) If the treatment effect is not judged according to the prescription of the study, the treatment effect cannot be judged or the data are not complete, which affects the judgment of the treatment effect.
1.5 rejection Standard
(1) Those who do not comply with the prescribed study protocol;
(2) Those who are included without meeting the inclusion criteria;
(3) Those who meet the inclusion criteria and are not conducted according to the study plan after inclusion.
2 method of treatment
The traditional Chinese medicine group takes orally the traditional Chinese medicine concentrated pills (6 g of pseudo-ginseng powder, 6g of coptis chinensis, 12g of common bletilla pseudobulb, 15g of carbonized sanguisorba root, 9g of fried bighead atractylodes rhizome, 12g of white poria, 10g of fried chicken gizzard membrane and 6g of liquorice which are prepared into pills and then are divided into 2 parts) after being taken with warm water for half an hour after breakfast and supper every day, 1 part is taken each time, and the total treatment period is 14 days. The control group was orally administered sulfasalazine salicylate SASP 4 times daily, 1g each time, for 14 days.
3 Observation of therapeutic effects
3.1 comparison of baseline data
Evaluation criteria for baseline data are shown in tables 3-5:
baseline data were compared to general data on age, gender, body Mass Index (BMI), fever, number of bowel movements, bristol Stool Classification (BSC), chronic constipation severity score (CCS), cleveland hospital incontinence score (CCF-IS), anal stenosis, quality of life (NRS) score, etc. for both groups of patients.
The results of the baseline data comparisons for both groups of patients are shown in Table 6, and show no statistical difference between the two groups, indicating that both groups are comparable.
TABLE 3 Bristol stool Classification
Table 4 severity score for chronic constipation
TABLE 5 extent of anal stenosis
TABLE 6 Baseline data comparison of two groups of patients
Note: a quality of life NRS score: minimum 0, maximum 10, 0 being unsatisfactory, 10 being satisfactory.
3.2 serum inflammatory factor level comparison
The results of the comparison of serum inflammatory factor levels before and after administration of the two groups of patients are shown in Table 7, the differences of IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10 and TNF-alpha between the traditional Chinese medicine group after administration and the control group after administration have statistical significance (the mean P is less than 0.05), and the differences of the traditional Chinese medicine group after administration are lower than those of the control group after administration; the difference of IL-5 between the traditional Chinese medicine before administration and the traditional Chinese medicine after administration has statistical significance (P = 0.031), and the traditional Chinese medicine after administration is lower than that before administration; the differences of IL-10, IL-12P70 and IFN-gamma before and after the control group is taken have statistical significance (the average P is less than 0.05), and the difference of the control group before and after the control group is taken is lower than that of the control group after the control group is taken. The results show that the Lianqi pill can effectively control the serum inflammatory factor level of enteritis patients and has obvious curative effect.
TABLE 7 comparison of serum inflammatory factor levels before and after dosing in two groups of patients [ ng/L, M (P) 25 ，P 75 )]
Note: a the data does not conform to normal distribution, and the rank sum test is adopted; b the data accords with normal distribution and homogeneity of variance, and an independent sample T test is adopted; p 1 : chinese medicine for treating chronic hepatitisComparing before administration with that of control group; p 2 : comparing the traditional Chinese medicine after being taken with a control group after being taken; p 3 : comparing the Chinese medicine before taking with the Chinese medicine after taking; p 4 : the control group was compared before and after administration.
3.3 tongue changes
The tongue changes are shown in figure 1 and figure 2, and the two photographs of the tongue pictures of the patients show that the tongue coating of the patients is thick and greasy and the tongue body is fat and large before the patients take the medicine, the tongue coating is obviously thinned after the patients take the medicine, the tooth marks are obviously disappeared, and the damp-heat symptom is obviously improved compared with that before the patients take the medicine.
Example 14 animal experiments
1 materials and methods
1.1 drugs and reagents
The traditional Chinese medicine concentrated pill of the invention is prepared by the following steps: the raw materials were weighed in parts by weight as described in example 1, and concentrated pills were prepared according to the preparation method of example 12.
The traditional Chinese medicine concentrated pill (II) is prepared: the raw materials were weighed out in parts by weight as described in example 1, and concentrated pills were prepared according to the preparation method of example 12.
Preparing a traditional Chinese medicine concentrated pill I of a control group: weighing 6 parts of pseudo-ginseng powder, 6 parts of coptis chinensis, 12 parts of rhizoma bletillae, 15 parts of carbonized sanguisorba root, 9 parts of fried bighead atractylodes rhizome, 12 parts of plantain seed, 10 parts of fried chicken's gizzard-membrane and 6 parts of honeysuckle according to the weight part ratio, and preparing the concentrated pills according to the preparation method of the embodiment 12. .
Preparing a control group traditional Chinese medicine concentrated pill (II): 6 parts of pseudo-ginseng powder, 6 parts of coptis root, 12 parts of bletilla, 15 parts of carbonized sanguisorba root, 9 parts of fried bighead atractylodes rhizome, 12 parts of grifola, 10 parts of fried chicken's gizzard-membrane and 6 parts of scutellaria baicalensis are weighed according to the weight part ratio, and concentrated pills are prepared according to the preparation method of the example 12. .
Reagent: azoxymethane (AOM) at a final concentration of 0.5mg/mL, available from Sigma-Aldrich; sodium glucose sulfate (DSS) available from MP Biomedicals at a final concentration of 2.5% (mass/volume); mouse Interleukin-6 (Interleukin-6, 1L-6) ELISA kit, mouse Interleukin 1 beta (Interleukin-1 beta, IL-1 beta) ELISA kit, purchased from Sigma-Aldrich company.
1.2 animals
Healthy male 5-6 week-old C57BL/6 mice, 80 mice, 24-26g in body mass, were purchased from Spbefu laboratory animal science and technology, inc.
1.3 Main instruments
Electronic balances (mettleltoreq, switzerland); centrifuge (medical centrifuge factory, beijing); ultra-low temperature refrigerator (Thereto Corp., USA).
2 methods and results
2.1 animal modelling (colitis-associated colorectal cancer model)
80 mice were taken, and on day 1, mice were given regular water for 5 days after intraperitoneal injection of AOM (10 mg/kg); adding dextran sodium sulfate DSS (2.5%) into drinking water on day 6 for 5 days; regular water diet was given on day 11 for 14 days; thereafter, 2 DSS cycle periods were passed for 9 weeks. Mice with emerging rectocele were selected as model success mice.
2.2 protocol
Randomly selecting 50 mice successfully modeled, wherein 10 mice are randomly selected as one group, namely a first group of the invention, a second group of the invention, a first control group, a second control group and a model group; normal 10 mice were then selected as a blank group and administered for 30 consecutive days as follows:
the invention comprises the following components: the concentrated pill prepared by the above group one of the present invention is ground into powder every day, 10g/kg, and the powder is administered by intragastric administration with distilled water, once in the morning and at night.
The invention has the following group two: grinding the concentrated pills prepared by the group II of the invention into powder every day, and feeding the powder by filling distilled water into the stomach, wherein the powder is taken in the morning and at night.
Control group one: grinding the concentrated pill prepared by the above control group one daily into powder, 10g/kg, and administrating by intragastric administration with distilled water, once in the morning and evening.
Control group two: the concentrated pill prepared by the control group II is used for intragastric administration and ground into powder at a dose of 10g/kg, and is administrated by intragastric administration with distilled water once in the morning and at night.
Model group: the stomach is irrigated with 10mL/kg of distilled water once a day in the morning and at night.
Blank group: the stomach is irrigated with 10mL/kg of distilled water once a day in the morning and at night.
2.3 detection of indicators
2.3.1 evaluation of mouse body quality
The body mass before and after the model making of the mouse and after the drug administration, the influence of the reaction model making on the body mass of the mouse and the influence of the traditional Chinese medicine concentrated pill on the body mass of the mouse are measured.
2.3.2 measurement of the levels of 1L-6 and IL-1. Beta. In the sera of groups of mice
Before sacrifice, blood was collected from the retroorbital vein, a sufficient amount of blood sample was collected, the sample kept clean, and the blood was stored in a 1.5ml lep tube and left overnight at 4 ℃. Centrifuging at low temperature, 4000r/min for 10min to completely separate light yellow serum from blood cells, transferring the serum to an EP tube by using a liquid transfer device, packaging, labeling, and storing in a refrigerator at-20 ℃. The detection of serum 1L-6 and IL-1. Beta. Concentrations was performed strictly according to the ELISA kit instructions.
2.4 statistical methods
The results are expressed as mean ± sd, and the data are statistically different when P <0.05 is determined by SPSS23.0 for t-test. Comparing every two groups by adopting LSD (local Stroke detection); when variance is irregular, dunnett's T3 test is used. If the distribution does not satisfy normal distribution, a nonparametric Kruskul-wullas test is adopted. P <0.05 indicates that the difference is statistically significant.
2.5 results
2.5.1 Effect of concentrated pill of Chinese medicinal composition on mouse body quality
After modeling, the body mass of each group of mice is obviously lower than that of the blank group (P < 0.05); after administration, the body weight of the mice in the model group is obviously lower than that of normal mice (P < 0.01), and the body mass of the mice in other groups is obviously higher than that of the model group (P <0.05, P < -0.01); see table 8.
TABLE 8 influence of concentrated pill of Chinese medicinal composition on mouse body quality (X + -SD, g)
Note: in comparison to the blank set, the data is, a P<0.05； b P<0.01 comparison with model set c P<0.05， d P<0.01。
2.5.2 serum levels of 1L-6 and IL-1 β in groups of mice
The serum levels of 1L-6 and IL-1 beta in each group of mice are shown in Table 9, wherein compared with the blank group, the IL-6 and IL-1 beta levels in the model group of mice are significantly higher than those in the blank group (P < 0.01), and the IL-6 and IL-1 beta levels in the other groups of mice are significantly lower than those in the model group (P < 0.05; wherein the IL-1 beta of the first group of the invention is also obviously higher than that of the first and second control groups of the control group and the second group of the invention (P < 0.05).
TABLE 9 serum levels of 1L-6 and IL-1 β (X + -SEM, pg/mL) in groups of mice
Note: in comparison to the blank set, the data was, a p<0.01; compared with model group b p<0.05， c p<0.01; comparison with control group 1,2 d p<0.05, in comparison with group one of the present invention e p<0.05。
In conclusion, the group of the invention and the control group can improve the symptoms of the colorectal cancer-related mice suffering from colitis to different degrees, wherein the first group of the invention has the most prominent improvement effect.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.
Claims (6)
1. The traditional Chinese medicine concentrated pill for treating colorectal inflammation is characterized by being prepared from the following raw material medicines in parts by weight: 2-10 parts of pseudo-ginseng powder, 2-10 parts of coptis chinensis, 8-16 parts of rhizoma bletillae, 11-19 parts of carbonized sanguisorba root, 5-13 parts of fried bighead atractylodes rhizome, 8-16 parts of white poria, 6-14 parts of fried chicken's gizzard-membrane and 2-10 parts of liquorice.
2. The traditional Chinese medicine concentrated pill according to claim 1, which is prepared from the following raw materials in parts by weight: 4-8 parts of pseudo-ginseng powder, 4-8 parts of coptis chinensis, 10-14 parts of rhizoma bletillae, 13-17 parts of carbonized sanguisorba root, 7-11 parts of fried bighead atractylodes rhizome, 10-14 parts of white poria, 8-12 parts of fried chicken's gizzard-membrane and 4-8 parts of liquorice.
3. The traditional Chinese medicine concentrated pill according to claim 1, which is prepared from the following raw material medicines in parts by weight: 6 parts of pseudo-ginseng powder, 6 parts of coptis chinensis, 12 parts of rhizoma bletillae, 15 parts of carbonized sanguisorba root, 9 parts of fried bighead atractylodes rhizome, 12 parts of white poria, 10 parts of fried chicken's gizzard-membrane and 6 parts of liquorice.
4. The method for preparing the traditional Chinese medicine concentrated pill as claimed in any one of claims 1 to 3, which is characterized by comprising the following steps:
a) Putting the decoction pieces soaked for 40 minutes and the moistening liquid into a decocting machine, boiling for 35 minutes, butting a moistening barrel with a liquid discharge hose of the decocting machine, and collecting decoction;
b) Vacuumizing to-0.005-0.007 MPa, vacuumizing the liquid medicine to be concentrated into a vacuum concentrator, starting steam to keep the steam pressure at 0.02-0.03 MPa, stopping a vacuum system after concentration is finished, closing a steam valve, opening an emptying valve, starting a discharge valve, and removing the extract;
c) Peeling the extract, weighing, binding a drying plate and an extract barrel after weighing the materials, and distributing to a pill making station according to a first-in first-out principle;
d) Mixing dextrin with the extract to obtain soft material with appropriate hardness, tabletting and rubbing with a small pill making machine to obtain small pills, spreading dextrin on the surfaces of the wet pills to make the surfaces dry and not sticky, screening with a screen, removing unqualified wet pills, mixing the unqualified wet pills, re-making pills, putting the qualified pills into a drying tray, putting the drying tray into a conveying belt after completion, and putting the pills into a drying area;
e) Putting the qualified crude pills into a drying tray in an oven, determining that the crude pills are in a state to be dried, closing the oven, and drying according to a two-step drying curve;
f) Spreading the coating liquid on the surface of the dry hair pill, rapidly stirring to make it uniform, spreading talcum powder to make the surface complete, repeating the action for 2 times to ensure that the pill shape is qualified, and spreading insect white wax to make the surface smooth after the surface is dried.
5. The method of claim 4, wherein the evacuation in step b) is performed under a condition of-0.006 MPa and a vapor pressure is maintained at 0.02MPa.
6. Use of the concentrated pill of any one of claims 1-3 in the preparation of a medicament for the treatment of colorectal inflammation.
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