CN112618624A - Traditional Chinese medicine composition for treating digestive system diseases and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating digestive system diseases and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating digestive system diseases, which comprises the following components in parts by weight: 5-435 parts of coptis chinensis, 1-87 parts of cinnamon, 2-217 parts of fructus evodiae and 3-261 parts of semen brassicae. Compared with the prior art, the plaster of the invention adopts the external application of traditional Chinese medicines to stimulate the acupuncture points, and has important effect on treating digestive diseases. The medicinal plaster can be used for synergistically treating digestive diseases or symptoms caused by the obstruction of middle-jiao qi and the abnormal ascending and descending of the spleen and stomach, and has the advantages of simplicity, convenience, easiness, practicability, obvious curative effect, safety, reliability, accurate administration and strong applicability. The medicinal plaster can effectively regulate qi activity, channels and collaterals and yin and yang, can keep qi activity smooth after no medicine is taken or injection is not taken, and other oral medicines are reduced or stopped taking, can improve digestive tract symptoms such as fullness and distension, regurgitation, hiccup, vomiting and the like, can calm the nerves and calm the heart of a patient, and can improve the sleep quality.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition for treating digestive system diseases, a preparation method and application thereof, belonging to the technical field of traditional Chinese medicines.
Background
Digestive diseases such as functional dyspepsia, gastroesophageal reflux disease, gastroduodenal ulcer, chronic gastritis (erosive and atrophic), gastric polyp, irritable bowel syndrome, chronic colitis, constipation, intestinal polyp, hepatitis, hepatic fibrosis, liver cirrhosis, fatty liver, cholecystitis, gastrointestinal hemorrhage, intestinal obstruction, acute pancreatitis and the like are common diseases and frequently encountered diseases in clinic. Because the traditional Chinese medicine is mostly chronic disease, the recurrence rate of the disease is high, the disease is lingering and difficult to heal, and the disease can be progressively developed, the treatment and the medicine taking time of the disease are long, the physical and mental health and the life quality of a patient are seriously affected, and complications such as insomnia, anxiety and the like are often generated. At present, two treatment schemes of traditional Chinese medicine and western medicine are available, the western medicine mainly aims at the symptomatic treatment of acid inhibition and stomach protection, gastrointestinal function regulation, gastrointestinal motility promotion, gastrointestinal mucosa protection, intestinal flora regulation, liver protection and the like, the traditional Chinese medicine establishes an oral traditional Chinese medicine scheme according to the treatment based on syndrome differentiation, and simultaneously is assisted with the traditional Chinese medicine characteristic therapies of acupoint application, ear acupoint pressing, acupoint catgut embedding, acupoint injection, acupuncture, encapsulation, intermediate frequency treatment and the like, so that the traditional Chinese medicine has better curative effect on the treatment of the diseases.
The acupoint sticking therapy is based on the theory of Chinese medicine channels and collaterals, and includes grinding the Chinese medicinal materials into fine powder, mixing with water, vinegar, wine, egg white, honey, cooling oil, vegetable oil, etc. to obtain paste, or mixing with solidified oil, yellow vinegar, rice, date paste, etc. to obtain ointment, pill or cake, or decocting the decoction of Chinese medicinal materials to obtain ointment, or spreading the medicinal powder on plaster, and directly sticking on acupoints or affected parts.
Patients with chronic digestive system diseases such as functional dyspepsia, gastroesophageal reflux disease, chronic gastritis (erosive, atrophic), irritable bowel syndrome, chronic colitis, constipation, etc., and complications such as insomnia, anxiety, etc., often require long-term treatment. For the patients with the disease, western medicines have poor treatment effect, are easy to relapse, and have certain toxic and side effects, such as dizziness, sleepiness, dyspepsia and the like. The common sedative hypnotic can only be used for short-term treatment, has the defects of drug resistance, addiction and the like when being used for a long time, is easy to generate physiological and psychological dependence, can cause adverse reactions such as gait instability, memory impairment and the like, is easy to relapse after drug withdrawal, and is limited in clinical use to a certain extent. The traditional Chinese medicine has a certain curative effect when being taken orally, but the traditional Chinese medicine is inconvenient to decoct, the taste of the traditional Chinese medicine is poor, the patient in remission stage is not easy to adhere to the treatment, and the medical cost is higher.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a traditional Chinese medicine composition for treating digestive system diseases and a preparation method and application thereof.
The invention mainly solves the technical problem of providing a traditional Chinese medicine composition and a preparation method and application thereof, and the traditional Chinese medicine composition is used for synergistically treating digestive diseases or symptoms caused by the blockage of middle-jiao qi activity and the abnormal ascending and descending of spleen and stomach, such as functional dyspepsia, gastroesophageal reflux disease and insomnia, and can also be used for assisting in treating digestive diseases such as gastroduodenal ulcer, chronic gastritis (erosive and atrophic), gastric polyp, irritable bowel syndrome, chronic colitis, constipation, intestinal polyp, hepatitis, hepatic fibrosis, cirrhosis, fatty liver, cholecystitis, gastrointestinal hemorrhage, intestinal obstruction, acute pancreatitis and the like, and diseases related to stomachache, fullness, regurgitation, hiccup, vomiting, jaundice, tympanites, abdominal pain, diarrhea, dysentery, constipation and the like.
In order to achieve the purpose, the invention adopts the technical scheme that: a traditional Chinese medicine composition for treating digestive system diseases comprises the following components in parts by weight: 5-435 parts of coptis chinensis, 1-87 parts of cinnamon, 2-217 parts of fructus evodiae and 3-261 parts of semen brassicae.
In the traditional Chinese medicine composition, the adopted traditional Chinese medicinal materials have the following effects and effects:
huang Lian is bitter and cold in flavor, and enters heart, liver, stomach and large intestine meridians. The efficacy is as follows: clear heat and dry dampness, purge fire and remove toxicity. Can be used for treating damp-heat stagnation, abdominal distention, emesis, dysentery, abdominal pain, fever, insomnia, emesis, liver-stomach disharmony, acid regurgitation, and hemorrhage due to blood heat. The product mainly contains alkaloids, and its main ingredients are berberine, coptisine, methyl coptisine, tetrandrine, etc., and has strong inhibitory effect on Shigella, Shigella flexneri, Vibrio cholerae, etc., and direct inhibitory effect on various influenza viruses, and has antipyretic, antiinflammatory, antitumor, cholagogue, and gastric ulcer resisting effects.
Cinnamon, pungent and sweet in flavor and hot in nature, enters kidney, spleen, heart and liver meridians. The efficacy is as follows: tonify fire and strengthen yang, dispel cold to alleviate pain, warm meridians and unblock collaterals. Can be used for treating kidney yang deficiency syndrome, abdominal psychroalgia due to cold accumulation and blood stagnation, cold-dampness arthralgia, thoracic obstruction, hernia with cold abdominal pain, dysmenorrhea due to cold accumulation and blood stagnation, and amenorrhea. The product mainly contains 1% -2% of volatile oil (oleum Cinnamomi), the main component of the oil is cinnamaldehyde, and other materials also contain cinnamyl alcohol, cinnamyl alcohol acetate, cinnamic acid, phenylpropyl acetate, cinnamyl glycoside, araboxylan, etc. The water extract and ether extract of cortex Cinnamomi have effects of protecting gastric mucosa, resisting ulcer, and relieving gastrointestinal spasm pain. Oleum Cinnamomi, cinnamaldehyde, and sodium cinnamate have tranquilizing, analgesic, antipyretic, and anticonvulsive effects. The cassia oil has strong bactericidal action, is better than negative bacteria for gram-positive bacteria, and has the function of promoting bile secretion.
Evodia rutaecarpa, fructus evodiae, pungent, bitter and hot in flavor, with little toxicity, enters liver, spleen, stomach and kidney meridians. The efficacy is as follows: dispel cold to alleviate pain, soothe the liver to check adverse rise of qi, strengthen yang to check diarrhea. Can be used for treating cold stagnation in liver meridian, abdominal cold pain, emesis, acid regurgitation, and diarrhea due to deficiency cold. The product mainly contains volatile oil, wherein the oil mainly contains evodiamine, ocimene, myrcene, evodia rutaecarpa lactone alcohol and the like. And alkaloids such as evodiamine and rutaecarpine. It has the actions of stopping vomiting, anti-ulcer and protecting liver. Evodiamine and volatile oil have stomach invigorating effect, and evodiamine, isoevodiamine and evodiamine lactone have analgesic effect, and also have antibacterial and antiviral effects.
Bai Jie Zi, pungent and warm in flavor, enters lung meridian. The efficacy is as follows: warm lung and resolve phlegm, promote qi and resolve masses, dredge collaterals and alleviate pain. The product is pungent in flavor and warm in nature and has effects of activating qi-flowing, dredging channels and collaterals, contains sinapiside, sinapine, myrosinase, etc., and its water extract has effects of inhibiting skin, and product after sinapiside hydrolysis has strong stimulation effect.
The several medicines are applied on the skin surface of the acupuncture points to play the roles of regulating qi activity of middle jiao and yin and yang of channels and collaterals. The Yongquan point is the lowest part of all acupoints, and is the essential point of the kidney meridian and the well meridian of foot Shaoyin, which connects the yang meridian with the yin meridian, and has the function of harmonizing yin and yang. The book Huangdi's classic on medicine (Huangdi's classic on medicine) says: the kidney is in the spring, so the spring is also in the arch of the foot. Shuishengmu, kidney yin can nourish liver yin and help to lower liver fire. Huang Lian excels in clearing heart-stomach fire and clearing liver-heat, and is often combined with Rou Gui to treat imbalance between heart-kidney and insomnia. The combination of the coptis and the cinnamon in the medicinal plaster strengthens the functions of communicating heart and kidney, clearing fire and lowering adverse qi, and inducing fire to return to the original.
Coptis root, rhizoma Coptidis, being bitter in taste and cold in nature, also can clear stomach and stop vomiting, evodia fruit, being pungent in flavor, dispel bitter in flavor, dispel heat and warm in flavor, dry in bitter heat, disperse cold pathogen of liver meridian to relieve pain, sooth liver and descend qi to check adverse rise of qi, is often combined with Coptis root, to dispel stagnation and dissipate stagnation of fire, to treat vomiting and acid regurgitation due to liver-fire attacking stomach, hypochondrium distending pain, disharmony between liver and stomach, etc. The evodia rutaecarpa is pungent and hot and is reversely assisted by the cold of the prepared coptis root, the two medicines are skillfully pungent and bitter, cold and heat are used for relieving fire without cooling and obstructing qi movement, stagnation is released to enable the fire and heat to be easily cleared, and the liver and stomach fire is cleared to descend the adverse flow of qi and dissipate stagnation.
Cinnamon is pure yang warming powder, good at nourishing fire of Mingmen, benefiting yang and eliminating yin, and can guide fire to the origin, and is often used with cold-dispelling and pain-relieving herbs such as Wu Zhu Yu to treat hernia of cold and abdominal pain. The semen Sinapis Albae has warm and hot stimulation to skin, belongs to a channel-guiding drug with strong pungent and fragrant smell and strong fleeing, and can stimulate acupuncture points. The Chinese medicinal materials are applied to acupoints to balance yin and yang, so as to treat digestive diseases.
The traditional Chinese medicine composition can effectively regulate the qi movement of the middle-jiao, calm the nerves, calm the heart, harmonize yin and yang, mutually harmonize yin and yang of viscera, regulate the qi movement of the three-jiao and improve the sleep quality of patients.
As a preferred embodiment of the traditional Chinese medicine composition, the traditional Chinese medicine composition comprises the following components in parts by weight: 435 parts of coptis root, 87 parts of cinnamon, 217 parts of fructus evodiae and 261 parts of semen brassicae.
As a preferred embodiment of the Chinese medicinal composition of the present invention, the digestive system diseases include digestive system diseases with insomnia complications and digestive system diseases with oral ulcer complications.
In a second aspect, the invention provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: mixing the raw materials at a certain proportion, grinding into fine powder, mixing, and sieving to obtain the Chinese medicinal composition.
As a preferred embodiment of the preparation method of the present invention, the mesh number of the sieve is 100 meshes.
In a third aspect, the invention provides a pharmaceutical preparation, which is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
As a preferable embodiment of the pharmaceutical preparation, the pharmaceutical preparation is in the form of tablets, granules, capsules, mixtures, pills, dripping pills, solid dispersants or patches.
In a fourth aspect, the present invention provides a patch for treating digestive system diseases, which comprises the above-mentioned Chinese medicinal composition.
As a preferred embodiment of the patch of the present invention, the patch further comprises a pharmaceutically acceptable adjuvant.
In a fifth aspect, the present invention provides a method for preparing the above patch, comprising the steps of: adding pharmaceutically acceptable adjuvants into the Chinese medicinal composition, concocting into paste, taking 20g each time, making into ointment with size of about 2.5cm × 2.5cm and thickness of about 0.3cm, making into medicine core, and fixing the medicine core with medical adhesive plaster to obtain the patch.
Preferably, the pharmaceutically acceptable adjuvant is water or honey.
The application method of the medicine patch of the invention comprises the following steps: the acupoint application treatment is carried out on the Yongquan acupoint of a patient, 1 time per day, the treatment time is more than 6 hours each time, and the treatment is continuously carried out for 4 weeks.
Compared with the prior art, the invention has the beneficial effects that: compared with the prior art, the plaster of the invention adopts the external application of traditional Chinese medicines to stimulate the acupuncture points, and has important effect on treating digestive diseases. The medicine is rapidly dispersed into blood circulation from extracellular fluid through stratum corneum and epidermis of skin surface structure, and sweat gland, hair follicle and sebaceous gland of skin appendage are channels for medicine absorption. The medicinal plaster can be used for synergistically treating digestive diseases or symptoms caused by the obstruction of middle-jiao qi and the abnormal ascending and descending of the spleen and stomach, and has the advantages of simplicity, convenience, easiness, practicability, obvious curative effect, safety, reliability, accurate administration and strong applicability. The medicinal plaster can effectively regulate qi activity, channels and collaterals and yin and yang, can keep qi activity smooth after no medicine is taken or injection is not taken, and other oral medicines are reduced or stopped taking, can improve digestive tract symptoms such as fullness and distension, regurgitation, hiccup, vomiting and the like, can calm the nerves and calm the heart of a patient, and can improve the sleep quality. The invention is beneficial to supplementing a clinical treatment method, improving the clinical cure rate and avoiding generating toxic and side effects of long-term administration of western medicines, thereby improving the life quality and medication compliance of patients.
Detailed Description
To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.
Example 1
A traditional Chinese medicine composition for treating digestive system diseases comprises the following components in parts by weight: 435 parts of coptis root, 87 parts of cinnamon, 217 parts of fructus evodiae and 261 parts of semen brassicae.
A patch for treating digestive system diseases comprises the above Chinese medicinal composition.
The preparation method of the patch of the embodiment comprises the following steps:
s1, mixing the raw material medicaments, and grinding the mixture into fine powder;
s2, uniformly mixing the treated mixture, and sieving the mixture by a 100-mesh sieve;
s3, adding feasible auxiliary materials such as water and honey in proper amount, and blending into paste;
s4, taking 20g each time, making into ointment with size of about 2.5cm × 2.5cm and thickness of about 0.3cm, making into medicated core, and fixing the medicated core with medical adhesive plaster to obtain the final product.
The patches prepared in example 1 of the present invention were used clinically, and the usage for about 5 years is shown in Table 1.
TABLE 1
Example 2
A traditional Chinese medicine composition for treating digestive system diseases comprises the following components in parts by weight: 5 parts of coptis root, 1 part of cinnamon, 2 parts of evodia rutaecarpa and 3 parts of semen brassicae.
A patch for treating digestive system diseases comprises the above Chinese medicinal composition.
The preparation method of the patch of this example is the same as that of example 1.
Example 3
A traditional Chinese medicine composition for treating digestive system diseases comprises the following components in parts by weight: 200 parts of coptis chinensis, 50 parts of cinnamon, 100 parts of fructus evodiae and 100 parts of semen brassicae.
A patch for treating digestive system diseases comprises the above Chinese medicinal composition.
The preparation method of the patch of this example is the same as that of example 1.
EXAMPLE 4 clinical study for the treatment of non-erosive gastroesophageal reflux disease
1. Clinical data
1.1 general data
Dividing 40 inpatients or outpatients of a first affiliated hospital of Guangzhou Chinese medicinal university from 1 month to 2013 month in 2012 into a control group and a treatment group randomly, wherein each group comprises 20 patients, the control group comprises 7 men and 13 women, and the average age of the patients is 40.2 years old; treatment groups, 8 men and 12 women, mean age 38.5 years.
1.2 diagnostic criteria
1.2.1 Western diagnostic criteria: firstly, the symptoms of GERD such as heartburn, acid regurgitation, poststernal pain and the like for not less than 3 months exist; secondly, examining the normal esophageal mucosa by a gastroscope, and detecting no pathological changes such as esophageal mucosa erosion, ulcer, Barrett esophagus and the like; ③ 24 hours esophagus pH monitoring has reflux phenomenon and is related to patient symptoms.
1.2.2 Chinese medicine dialectical standard: the syndrome differentiation conforms to the traditional Chinese medicine syndrome diagnostic standard of the liver-stomach stagnated heat syndrome (the guidelines for clinical research of new Chinese medicines 2002 edition), and the main symptoms are abdominal distention and hypochondrium, acid regurgitation, heart burn, red tongue with red fur
Yellow, wiry and rapid pulse. The secondary symptoms are depression or irritability, dry mouth and bitter taste, gastric cavity upset, constipation, and the above main symptoms 3, or the main symptoms 2 plus the secondary symptoms 2 can be diagnosed.
1.3 case inclusion criteria: patients who accord with the Western medicine diagnosis standard and the traditional Chinese medicine syndrome differentiation standard.
1.4 case exclusion criteria 1 cardiogenic chest pain; ② history of esophagus, cardia or abdomen operation; ③ medicinal esophagitis, or combined gastric ulcer, duodenal bulbar ulcer, liver, gall and pancreas diseases; patients with other systemic and systemic diseases; pregnant or lactating women; sixthly, patients with psychosis are suffered from the diseases.
2 research methods
2.1 methods of treatment
The control group is treated with oral esomeprazole 20mg each time, 1 time per day, and taken immediately in the morning for 4 weeks. The treatment groups were treated with the patch of example 1 for external use, 1 time per day for > 6 hours for 4 weeks of treatment (bilateral Yongquan acupoints).
2.2 therapeutic efficacy criteria
2.2.1 esophageal ManoScan360 High-Resolution Manometry Model A120 esophageal pressure detector is adopted for esophageal ManoScan pressure measurement, and data such as esophageal sphincter tension, esophageal distal amplitude and the like are collected.
The esophagus pH monitoring is carried out for 2.2.224 hours by adopting a ManoScan-Zhigh-Resolution Impedance Model A200 pH Impedance monitor, fixing a miniature pH probe at the position 5cm above the lower esophageal sphincter through the nose, collecting reflux times, calculating the data of DeMeester score and the like.
2.2.3 reflux symptom integral acid regurgitation, heartburn were recorded separately for degree and frequency. Degree 0, no symptom; 1 point, mild, patients need to pay attention to the feeling; 2 points, moderate, symptomatic but not affecting day
The life is long; 3 points, severe with symptoms and affecting daily life. ② the frequency is 0 minutes, and the attack is avoided; 1 minute, attack 1-3 times per week; attack 4-6 times per week for 2 min; attack every day for 3 minutes. Reflux symptom score-degree + frequency.
3. Results
3.1 integral comparison of reflux symptoms before and after treatment in two groups of patients
TABLE 2 comparison of reflux symptom scores before and after treatment in two groups of patients: (
Minute)
Note that compared with the group before treatment, the delta P is less than 0.05; p > 0.05 compared to control after treatment.
3.2 comparison of esophageal manometry before and after treatment of two groups of patients
TABLE 3 comparison of esophageal manometry before and after treatment of two groups of patients: (
mmHg)
Note that compared with the same group before treatment, the delta P is less than 0.05, and the # P is more than 0.05; p > 0.05 compared to control after treatment.
3.3 esophagus acid ratio before and after treatment of two groups of patients
TABLE 4 esophagus acid ratio before and after treatment of two groups of patients
Compared with the same group before treatment, the delta P is less than 0.05; compared with the control group after treatment, # P <0.05.
As can be seen from tables 2-4, the reflux symptom scores and the DeMeester scores of the two groups of patients before and after treatment are both obviously reduced, the difference has statistical significance (P is less than 0.05), but the difference does not have statistical significance (P is more than 0.05) when the two groups are compared. The tension of the lower esophageal sphincter and the amplitude of the distal esophageal sphincter in the treatment group are obviously increased compared with the tension before treatment, and the difference has statistical significance (P is less than 0.05), but the difference has no obvious change before and after the treatment of the two indexes in the control group and has no statistical significance (P is more than 0.05). Reflux times before and after treatment of the two groups are obviously reduced, and the difference has statistical significance (P is less than 0.05); the difference was statistically significant (P <0.05) in both groups.
4. Conclusion
The patch of example 1 was shown to be effective in the synergistic treatment of non-erosive gastroesophageal reflux disease, and may be associated with increased lower esophageal sphincter pressure, increased distal esophageal amplitude, and decreased reflux frequency.
Example 5 clinical study on treatment of functional dyspepsia with insomnia
1. Clinical data
1.1 general data
80 inpatients or outpatients of a first affiliated hospital of Guangzhou Chinese medicine university from 6 months to 2014 in 2012 are treated, wherein the average age of the patients is 43.2 years in 40 cases, 19 cases of men and 21 cases of women in the comprehensive treatment group of the traditional Chinese medicine; the control group had 40 cases, 17 men and 23 women, and the average age was 42.6 years.
1.2 inclusion criteria
1.2.1 diagnosis of functional dyspepsia complies with the diagnostic criteria of Roman III: 1 or more of postprandial satiety, early satiety, epigastric pain or epigastric burning sensation are mainly expressed; no organic disease that could explain the above symptoms; ③ symptoms appear for at least 6 months.
1.2.2 diagnostic criteria for insomnia: the first is to complain about the difficulty of falling asleep, the difficulty of maintaining sleep or the poor sleep quality; ② the sleep disorder occurs at least 3 times per week and lasts more than 1 month; ③ being concentrated on insomnia day and night, worrying about the consequences of insomnia too much; dissatisfaction with quality and/or quantity of sleep causes significant distress or affects social and occupational functioning.
1.3 exclusion criteria
Age < 18 years or > 60 years; ② accompanied with other digestive system organic lesions such as stomach, intestine, liver, gallbladder, pancreas, etc., irritable bowel syndrome and gastroesophageal reflux disease; the skull MRI or CT examination has intracranial organic lesion; patients with other systemic and systemic diseases; pregnant or lactating women; sixthly, patients with psychosis are suffered from the diseases.
2 research methods
2.1 methods of treatment
The control group is treated with domperidone 30min before meal, 10 mg/time, 3 times daily, and 4 weeks as the treatment course. The traditional Chinese medicine comprehensive treatment group adopts oral traditional Chinese medicine decoction and external patch treatment of the embodiment 1, the patch (bilateral Yongquan acupoints) of the embodiment 1 is used for 1 time every day, each time is more than 6 hours, and the treatment course is 4 weeks.
2.2 therapeutic efficacy criteria
2.2.1 functional dyspepsia symptom score: the degree and frequency of postprandial fullness, early satiety, epigastric pain, and burning sensation of the upper abdomen are recorded. Degree of: 0, no symptoms; 1, mild, which the patient needs to pay attention to feel; 2, moderate, with symptoms but without affecting daily life; severe, symptomatic and affecting daily life. Frequency: 0, no attack; 1, attack 1-3 times per week; attack 4-6 times per week and 3 times per day. Score-degree + frequency, total score was 24.
2.2.2 functional dyspepsia curative effect standard: and (3) healing: the symptoms and physical signs disappear or basically disappear, and the curative effect index is more than or equal to 95 percent; the effect is shown: the symptoms and physical signs are obviously improved, and the curative effect index is more than or equal to 70 percent; the method has the following advantages: symptoms and physical signs are improved, and the curative effect index is more than or equal to 30 percent; and (4) invalidation: failing to meet the above-mentioned criteria of effectiveness or aggravation. Efficacy index (pre-treatment score-post-treatment score)/pre-treatment score 100%.
2.2.3 sleep score: pittsburgh Sleep Quality Index (PSQI) was used.
2.2.4 Insomnia curative effect standard: and judging the insomnia curative effect according to the reduction rate of the Pittsburgh sleep quality index. And (3) healing: the reduction rate is more than 75 percent; the effect is shown: the reduction rate is 50% -75%; the method has the following advantages: the reduction rate is 25-49%; and (4) invalidation: the reduction rate is less than 25%. Score reduction ═ (pre-treatment score-post-treatment score)/pre-treatment score 100%.
3. Results
3.12 comparison of functional dyspepsia symptom scores before and after treatment
The scores of the functional dyspepsia symptoms of the traditional Chinese medicine comprehensive treatment group and the control group are reduced (P is less than 0.05) after treatment compared with the scores before treatment, but the traditional Chinese medicine comprehensive treatment group is better than the control group (P is less than 0.05).
TABLE 5 comparison of scores of functional dyspepsia before and after treatment of the TCM combination treatment group and the control group
Note: Δ P <0.05 compared to pre-treatment; p <0.05 compared to control group.
3.22 comparison of therapeutic effects of functional dyspepsia
The total effective rates of the traditional Chinese medicine comprehensive treatment group and the control group are respectively 95.0 percent and 82.5 percent, and Ridit is adopted to analyze that the difference P between the 2 groups is less than 0.05.
TABLE 6 comparison of the curative effects of the Chinese medicine comprehensive treatment group and the control group on the treatment of functional dyspepsia
Note: p <0.05 compared to control group.
Comparison of Pittsburgh sleep quality indices before and after 3.32 treatment groups
The sleep quality index of Pittsburgh after treatment in the traditional Chinese medicine comprehensive treatment group and the control group is reduced (P <0.05), but the sleep quality index of Pittsburgh before treatment in the traditional Chinese medicine comprehensive treatment group is better than that in the control group (P < 0.05).
TABLE 7 comparison of Pittsburgh sleep quality index before and after treatment in TCM comprehensive treatment group and control group
Note: Δ P <0.05 compared to pre-treatment; p <0.05 compared to control group.
Comparison of therapeutic effects on insomnia in 3.42 groups
The total effective rates of the traditional Chinese medicine comprehensive treatment group and the control group are respectively 87.5 percent and 55.0 percent, and Ridit is adopted to analyze that the difference P between the 2 groups is less than 0.05.
TABLE 8 comparison of the curative effects of the Chinese medicine combination treatment group and the control group on insomnia treatment
Note: p <0.05 compared to control group.
As can be seen from tables 5-8, the scores of functional dyspepsia symptoms and Pittsburgh sleep quality index are reduced (P <0.05) after the treatment of the 2 groups, but the traditional Chinese medicine comprehensive treatment group is more obvious, and the curative effect of treating insomnia and functional dyspepsia is better than that of the control group (P < 0.05).
4. Conclusion
The patch of example 1 was found to be effective in synergistically treating patients with functional dyspepsia complicated by insomnia.
EXAMPLE 6 clinical cases
Name: certain plum, sex: male, age: in the 44-year-old patient, the patient is hospitalized in the first subsidiary hospital of Guangzhou university of traditional Chinese medicine from 31 days in 31 months in 2018 to 05 months in 2018 after repeated right-side abdominal pain for more than 1 month, and is examined for eight infections: 711.41IU/ml of hepatitis B virus surface antigen, 3.168S/C0 of hepatitis B virus e antigen and 7.77S/C0 of hepatitis B virus core antibody. Gastroscopy: 1. chronic superficial gastritis with erosions 2 reflux esophagitis (grade a) 3 duodenal bulbar ulcer (stage S2), diagnosed as: 1. chronic superficial gastritis with erosion 2, reflux esophagitis (grade a), 3, duodenal bulbar ulcer (stage S2) 4, chronic viral hepatitis b. For antiviral treatment, the oral administration of the traditional Chinese medicine takes the effects of tonifying qi and spleen, clearing heat and promoting diuresis, and the formula is modified by taking the four monarch drugs, the epimedium, the magnolia bark and the poria cocos decoction as the main formula. And the treatment is carried out by matching with the plaster (bilateral Yongquan acupoints) of the external example 1, 1 time per day, and each time is more than 6 hours. After treatment, the right upper abdominal pain symptoms of the patients are obviously improved compared with the former symptoms.
EXAMPLE 7 clinical cases
Name: somebody of yellow, sex: female, age: the patient is hospitalized in the first subsidiary hospital of the traditional Chinese medicine university in Guangzhou in 2017 from 29 th in 11 th to 07 th in 12 th in 2017 after the age of 78 years, and the symptoms are shown in admission: sometimes, the patient feels dull pain and discomfort due to abdominal pain, and physical examination: the abdomen is soft, and the upper abdomen and the left lower abdomen are lightly painful. The diagnosis is as follows: 1. chronic superficial gastritis (with erosion) 2 rectal polyp 3 hepatic cyst (left lobe) 4 gall bladder calculus (multiple). Rectal polypectomy is performed under an enteroscope during hospitalization, the treatment is performed on the aspects of acid inhibition, stomach protection, intestinal flora adjustment and the like, the traditional Chinese medicine is taken orally by strengthening the spleen and replenishing qi, and moving qi and reducing phlegm, the formula is modified by Xiangsha Liujunzi decoction, and the traditional Chinese medicine is matched with the external application patch (bilateral Yongquan acupoint) of the embodiment 1 for treatment, 1 time per day and more than 6 hours each time. After treatment, the abdominal pain symptoms of the patients are obviously improved compared with the prior one. No abdominal pain was present at discharge on the day 07 of 12/2017.
EXAMPLE 8 clinical cases
Name: certain of Zhu, sex: male, age: gastroscopy at age 44, 05 and 12 months in 2017: 1. stomach polyp (shantian type II) 2, chronic superficial gastritis with erosion, enteroscopy shows: chronic colitis. The patients are hospitalized in the first subsidiary hospital of the traditional Chinese medicine university in Guangzhou in 2017, from 03 th at 07 month to 05 th at 2017, and the symptoms at the time of admission are shown as follows: repeated steganache under xiphoid process, aggravation during hunger, no abdominal distension, acid regurgitation and warm air, and diarrhea after eating unclean food. The diagnosis is as follows: 1. stomach polyp 2, chronic superficial gastritis (with erosion) 3, chronic colitis, gastric polypectomy under gastroscope during hospitalization, acid suppression and stomach protection for symptomatic treatment, traditional Chinese medicine is used for tonifying qi and spleen, soothing liver and relieving depression, and is matched with the external patch (bilateral Yongquan acupoint) of the embodiment 1 for treatment, 1 time per day, and each time is more than 6 hours. After treatment, the patient has no obvious symptoms of cryptomelalgia, acid regurgitation, eructation, diarrhea and the like.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Claims (10)
1. The traditional Chinese medicine composition for treating digestive system diseases is characterized by comprising the following components in parts by weight: 5-435 parts of coptis chinensis, 1-87 parts of cinnamon, 2-217 parts of fructus evodiae and 3-261 parts of semen brassicae.
2. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 435 parts of coptis root, 87 parts of cinnamon, 217 parts of fructus evodiae and 261 parts of semen brassicae.
3. The Chinese medicinal composition of claim 1, wherein the digestive system diseases include digestive system diseases with insomnia complications and digestive system diseases with oral ulcer complications.
4. The method for preparing a Chinese medicinal composition according to any one of claims 1 to 3, comprising the following steps: mixing the raw materials at a certain proportion, grinding into fine powder, mixing, and sieving to obtain the Chinese medicinal composition.
5. The method of claim 4, wherein the screen has a mesh size of 100 mesh.
6. A pharmaceutical preparation, which is characterized by being prepared from the traditional Chinese medicine composition of any one of claims 1-3 and pharmaceutically acceptable auxiliary materials.
7. The pharmaceutical preparation of claim 6, wherein the pharmaceutical preparation is in the form of tablets, granules, capsules, mixtures, pills, drops, solid dispersions or patches.
8. A patch for treating digestive system diseases, which comprises the Chinese medicinal composition according to any one of claims 1 to 3.
9. The patch of claim 8, further comprising a pharmaceutically acceptable excipient.
10. A method of manufacturing a patch according to claim 8 or 9, comprising the steps of: adding pharmaceutically acceptable adjuvants into the Chinese medicinal composition, concocting into paste, making into unguent as medicine core, and fixing the medicine core with medical adhesive plaster to obtain the patch.
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