CN107184701B - Traditional Chinese medicine composition for treating schizophrenia, preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating schizophrenia, preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating schizophrenia, which comprises the following raw materials in parts by weight: 15-25 parts of dark plum, 10-20 parts of clove, 10-20 parts of costus root, 10-20 parts of green tangerine peel, 10-20 parts of dried orange peel, 5-10 parts of pepper and 1-5 parts of croton cream. In addition, the invention also provides a preparation method and application of the traditional Chinese medicine composition for treating schizophrenia. The traditional Chinese medicine composition for treating schizophrenia can obviously improve the symptoms of schizophrenia, and particularly can improve the symptoms of schizophrenia in early and acute stages with positive symptoms as prominent clinical manifestations. In addition, the invention can treat schizophrenia which is induced by factors such as seven emotions, loss of appetite, insufficient endowment and the like and mainly characterized by hyperactivity of spirit, mania, noise, upset, the main unit of the stomach, movement and anger.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating schizophrenia, a preparation method and application thereof.
Background
Schizophrenia is a group of serious psychosis with unknown etiology, which is usually caused slowly or subacute in young and strong years, and is clinically manifested as syndromes with different symptoms, and involves various disorders such as sensory perception, thinking, emotion and behavior, and uncoordinated mental activities. The patient is generally conscious, the intelligence is basically normal, and the symptoms mainly comprise positive symptoms, negative symptoms and cognitive impairment, and are accompanied by persistent social function impairment, which accounts for more than half of the patients who are hospitalized in the psychiatric department. The course of the disease generally extends, and the disease is repeatedly attacked, aggravated or worsened, and some patients finally suffer from decline and mental disability, but some patients can keep a healing or basically healing state after treatment. Modern TCM generally holds that schizophrenia generally belongs to the category of mental and pathological mania in TCM.
According to the 2001 statistics of the world health organization, schizophrenia accounts for about 2.8% of the global disease total burden. At the Chinese symposium of disease burden, mental diseases have been listed as the first place of disease burden, and schizophrenia has been listed as the first place of mental disease burden. Due to various reasons, most rural schizophrenia patients cannot be treated systematically and effectively, and due to untimely diagnosis and treatment, the number of mental disability patients is increased, the deterioration of the illness state is accelerated, and heavy burden is brought to the patients, families and the society. Although 2/3 patients need hospitalization, only 1/6 patients with schizophrenia get hospitalization, and schizophrenia accounts for about 50% of hospitalized mental patients and about 60% of chronic mental disease hospitalization patients. Among untreated patients, mental handicapped accounts for 82.7%, schizophrenia accounts for 14.7% of severe patients, and 53.5% of very severe patients. Currently, there is still a rising trend in the lifetime prevalence of schizophrenia.
Schizophrenia is a typical complex mental disease, and the cause of the disease is not clarified at present. Multiple studies show that the genetic factors play an important role in the occurrence of schizophrenia, and the inheritance degree is as high as more than 80 percent, like other serious diseases. In addition to genetic factors, environmental factors play a role in the pathogenesis of schizophrenia, i.e., schizophrenia occurs on the basis of gene-environmental interactions. The etiology of schizophrenia is complex, with various hypotheses, such as genetic variation, neuronal pathology, and dysfunction of neurotransmitter-receptors. Among them, the results of studies on dysfunction of neurotransmitter-receptor are the most abundant, and some important contents of the cause of schizophrenia are elucidated.
The cause of schizophrenia is unknown, so that the treatment is difficult, which becomes a big problem in the medical field. The main goal of treating schizophrenia is to improve the positive, negative, emotional and cognitive symptoms. In the 50 s of the 20 th century, the use of chlorpromazine, a typical antipsychotic, clearly defines that the basis of the curative effect of the antipsychotic is the blocking effect on dopamine. Experience shows that the medicines can only control the positive symptoms of 2/3 of patients, but have almost no curative effect on the negative symptoms and cognitive symptoms, and have serious side effects, so that the compliance of the patients is reduced, and the curative effect is poor. Its side effects include constipation and blurred vision due to choline action, sexual dysfunction and menstrual disorder due to persistent hyperprolactinemia, and more commonly extrapyramidal symptoms. In 1959, clozapine, the first atypical antipsychotic, which acts by modulating the binding between 5-HT and DA receptors, was found to block D2 receptors at a low rate without inducing extrapyramidal side effects. After the extensive use of clozapine, it was found to cause agranulocytosis and has not been used in the first line clinically. The three atypical antipsychotics that are currently used clinically are risperidone, olanzapine and quetiapine fumarate, which do not cause agranulocytosis and are now widely used in the first line of the clinic. These three drugs are more effective in improving negative symptoms and cognitive function than typical antipsychotics. The risk of inducing extrapyramidal side effects, tardive dyskinesia and hyperprolactinemia is lower than with typical antipsychotics.
The traditional Chinese medicine composition has the unique advantages of multiple components, multiple targets, small side effect and the like, and in recent years, under the common efforts of Chinese medical scholars, the traditional Chinese medicine makes great progress and great progress on the treatment and research of schizophrenia. It has strict thinking and differentiation process and strong persuasion in both the treatment of syndrome differentiation and the medication of selected prescription. The disease process of schizophrenia is a complex and long-term process in which multiple visceral diseases affect and transmit each other, so that treatment based on syndrome differentiation and regulation and tonifying of five internal organs are both applied in the aspect of treatment, and the development direction of the traditional Chinese medicine for treating schizophrenia is pointed out. Therefore, a traditional Chinese medicine composition for effectively treating schizophrenia is searched, the identification and treatment thought of the traditional Chinese medicine for treating schizophrenia can be greatly expanded, and the clinical treatment effective rate of schizophrenia is improved.
Disclosure of Invention
The invention provides a traditional Chinese medicine composition for treating schizophrenia, and solves the problem that a medicine which is safe, effective, relatively accepted in clinical treatment application, capable of remarkably improving schizophrenia with positive symptoms as prominent clinical manifestations and in early and acute stages is not available in the prior art.
The invention aims to provide a traditional Chinese medicine composition for treating schizophrenia, which comprises the following raw materials in parts by weight: 15-25 parts of dark plum, 10-20 parts of clove, 10-20 parts of costus root, 10-20 parts of green tangerine peel, 10-20 parts of dried orange peel, 5-10 parts of pepper and 1-5 parts of croton cream.
Preferably, the traditional Chinese medicine composition for treating schizophrenia comprises the following raw materials in parts by weight: 20 parts of dark plum fruit, 15 parts of clove, 15 parts of costustoot, 15 parts of green tangerine peel, 15 parts of dried orange peel, 8 parts of pepper and 3 parts of croton cream.
The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition for treating schizophrenia, which is implemented according to the following steps:
step 1, weighing 15-25 parts of dark plum, 10-20 parts of clove, 10-20 parts of costus root, 10-20 parts of green tangerine peel, 10-20 parts of dried orange peel, 5-10 parts of pepper and 1-5 parts of croton cream for later use;
step 2, mixing the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder weighed in the step 1 together, adding water which is 8-12 times of the total weight of the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder, soaking for 20-40 min, decocting for 0.5-1 h after soaking, and filtering to obtain a first filtrate and filter residues; adding water which is 8-12 times of the weight of the filter residue into the filter residue, decocting for 30-60 min, filtering to obtain a second filtrate, combining the first filtrate and the second filtrate, uniformly mixing, concentrating to a concentration of 2g/mL to obtain the traditional Chinese medicine composition, and refrigerating the traditional Chinese medicine composition at 4 ℃ for later use.
Preferably, the traditional Chinese medicine composition can be prepared into a pharmaceutically acceptable traditional Chinese medicine preparation according to a conventional method.
Preferably, the medicinal dosage form of the traditional Chinese medicine preparation is tablets, capsules, granules or pills.
The third purpose of the invention is to provide the application of the traditional Chinese medicine composition for treating schizophrenia in the preparation of medicines for treating schizophrenia.
The pharmacological action and the drug effect of the traditional Chinese medicine of the invention are as follows:
1. dark plum: sour, astringent and neutral in nature. It enters liver, spleen, lung and large intestine meridians. Has the effects of astringing lung, astringing intestine, promoting fluid production and calming ascaris. Can be used for treating chronic cough due to lung deficiency, chronic diarrhea and dysentery, asthenia heat, diabetes, ascariasis, emesis, and abdominal pain. The records in Ben Cao Jing Shu (herbal Jing Shu): "plum fruit, the so-called dark plum, is the most sour. "the internal classic" records: dark plum, fructus mume, due to heat damaging qi, pathogenic factors in the chest, makes qi adverse-rising and restless, and heart is restless. Dark plum is sour in flavor, can astringe floating heat and can inhale qi to enter original, so it is also indicated for descending qi, removing heat and restlessness. Diarrhea, diarrhea and collapse of large intestine; in the case of a dry mouth due to saliva, the deficient fire will cause inflammation and insufficient body fluid; sour can astringe deficiency fire, transform body fluids, strengthen intestine and collapse, so it is also indicated. For those with pain of limbs and partially withered limbs, the meridians and collaterals are affected by dampness, so the tendons and vessels are flaccid or painful; the liver governs tendons, sour entering liver to nourish tendons, and liver nourishment, it is excluded from for syndrome of bone, tendon and soft, passing through the organ and relieving the syndrome of the former. The vitro test shows that the dark plum has the function of resisting pathogenic microorganisms, and the bacteriostatic action of the dark plum has a certain relation with the acidity of the preparation. Proved by experimental research, the dark plum soup has the effects of promoting the contraction and benefiting gallbladder, is beneficial to draining bile in a biliary tract, reduces and prevents infection of the biliary tract, and has the function of increasing appetite of dark plum; and promoting digestion, stimulating salivary gland and gastric gland to secrete digestive juice; also has remarkable intestine regulating effect, and can promote enterokinesia and eliminate inflammation; and also has the function of contracting the intestinal wall.
2. Pepper: pungent and hot in nature. It enters stomach and large intestine meridians. Has the effects of warming spleen and stomach, dispelling cold, descending qi, and eliminating phlegm. Can be used for treating emesis due to stomach cold, abdominal pain, diarrhea, anorexia, epilepsy, and excessive phlegm. The records in Ben Cao Yan Yi (augmented materia Medica): pepper, fructus Piperis, for removing phlegm and spitting water in stomach, even though it is taken with food, it is proved that the excessive dose will cause qi to go. For cold and slippery large intestine, other herbs should be used. The compendium of materia Medica states: "Piper nigrum. Large pungent and hot property, pure yang property, it is suitable for cold-dampness of stomach and intestine. When a patient with heat eats, fire will damage qi and yin will be damaged. The record in "Ben Cao Jing Shu" (herbal Jing Shu) is: "Piper nigrum" is pungent in flavor, strong in smell, non-toxic in nature, pungent and warm in nature, and not harmful after taking, but thick in smell, and also yang in yang. It is mainly used for descending qi, warming middle energizer, removing phlegm, and removing wind-cold in zang-fu organs, so it is usually caused by the cold of stomach and intestine, resulting in the disorder of zang-fu organs. "
Experimental study shows that fructus Piperis has anticonvulsive pharmacological effect, and also has sedative effect and central inhibitory effect on other central nervous system drugs.
3. Clove: pungent and warm in nature. It enters spleen, stomach, lung and kidney meridians. Has effects of warming middle-jiao, lowering adverse qi, invigorating kidney, and tonifying yang. Can be used for treating deficiency-cold of spleen and stomach, singultus emesis, anorexia vomiting and diarrhea, psychroalgia of heart and abdomen, and sexual impotence due to kidney deficiency. The records in the book "materia medica new edition" are: "clove" is classified into male and female, and its therapeutic effects are not classified into each other. The disease of the direct yin channel is most suitable for the use, but not applicable to the transmission of exogenous febrile disease. The book of drug property treatise: clove is indicated for cold abdominal pain. "Rihuazi materia Medica" records: clove treats halitosis, regurgitation, kidney qi, galloping, yin pain, Yang strengthening, waist and knee warming, Jiujin, Xuanxiao and Duoliao removing. The "materia medica zheng" records: clove warms middle and fast qi. For hiccup due to upper energizer, it can remove stomach cold and dysentery, seven emotions and five depression. The experimental research shows that the clove has pharmacological action of resisting pathogenic microorganisms, and also has the effects of relieving abdominal flatulence, enhancing digestion capacity and relieving nausea and vomiting.
4. Costustoot: pungent, bitter and warm in nature. It enters spleen, stomach, large intestine, triple energizer and gallbladder meridians. Has effects of activating qi-flowing, relieving pain, invigorating spleen and promoting digestion. Can be used for treating chest and hypochondrium, abdominal distention and pain, dysentery with diarrhea, tenesmus, dyspepsia, anorexia, etc. The Chinese medicine is recorded in the book of the medical science elephant: mu Xiang is used for removing qi stagnation in lung, and Bing Lang is used for middle energizer and lower energizer and accumulation. The record in the Shen nong Ben Cao Jing (Shen nong's herbal): mu Xiang is mainly used for pathogenic qi, removing toxic plague, strengthening the mind and treating stranguria. The compendium of materia Medica states: mu Xiang is a herb of triple energizer qi system and can ascend and descend all qi. stagnation of qi belongs to the lung, so it is also the case of qi stagnation of the upper energizer that is relieved by the stagnation of the vital energy; the spleen-qi pertains to the spleen, so the middle energizer should be qi-stagnation, and the spleen and stomach should be fragrant; the latter is the case of qi stagnation in the large intestine, the retention of bladder qi is the case of stranguria due to urine retention, and the liver qi is the pain, so it is indicated for qi stagnation in the lower energizer, and it is indicated for obstruction of qi in the lower energizer. In vitro tests show that radix aucklandiae has the effects of promoting gastric emptying and promoting gastric digestive juice secretion, and has different effects on heart due to different components. Experimental research proves that the costus root water-soluble component has obvious inhibition effect on rabbit platelet aggregation and has certain depolymerization effect on aggregated platelets.
5. Green tangerine peel: bitter, pungent and warm in nature. It enters liver, gallbladder and stomach meridians. Has the effects of soothing liver, breaking qi, removing food retention and resolving stagnation. Can be used for treating chest and hypochondrium distending pain, hernia pain, food stagnation, qi stagnation, and abdominal distention and pain. The compendium of materia Medica records: mu Xiang is indicated for adverse qi of chest and diaphragm, hypochondriac pain, hernia in lower abdomen, swollen breast, soothing liver and gallbladder and purging lung qi. The "herbal literature" records: mu Xiang is mainly indicated for qi stagnation, downward eating, accumulation and diaphragm qi. "Pearl sacs" records: qing Pi is also indicated for the treatment of shaoyang meridian due to qi stagnation, accumulation and accumulation. Chen Pi treats high disease, while Qing Pi treats low disease. Experimental research shows that the green tangerine peel has the strongest effect of relaxing gastrointestinal smooth muscle, and the mechanism is to block M receptor, excite alpha receptor and directly inhibit the gastrointestinal smooth muscle. In addition, pericarpium Citri Reticulatae viride has long maintenance time for increasing blood pressure, can stimulate respiration, and has antishock and heart stimulating effects.
6. Dried orange peel: bitter, pungent and warm in nature. It enters lung and spleen meridians. Has the effects of regulating qi, strengthening spleen, eliminating dampness and phlegm. Can be used for treating abdominal distention, anorexia, vomiting, diarrhea, cough, and excessive phlegm. The records in the famous physicians bibliography are as follows: chen Pi can direct qi downward and stop vomiting. The compendium of materia Medica states: tangerine peel can vomit and regurgitate stomach and upset stomach, and clear water is vomited in time. Years of experimental researches show that the dried orange peel has a plurality of pharmacological effects, the volatile oil contained in the dried orange peel has mild stimulation effect on gastrointestinal tracts, can promote the secretion of digestive juice and eliminate pneumatosis in intestinal tracts, and shows the effects of aromatizing, invigorating stomach and dispelling wind and descending qi. In addition, pericarpium Citri Tangerinae has antiinflammatory effect, and its decoction can be used together with vitamin C and vitamin K to enhance antiinflammatory effect.
7. The croton cream comprises the following components: pungent and hot in property and with strong toxicity. It enters stomach and large intestine meridians. Has the effects of drastically purging cold accumulation, eliminating water retention, relieving swelling, eliminating phlegm and relieving sore throat. Can be used for treating constipation due to cold accumulation, stagnation of milk and food, ascites tympanites, and constipation. The records in Lei Gong processing drug property are as follows: the croton cream enters spleen, stomach and large intestine meridians. The record in the pearl sac tonic drug property endowment is as follows: bashu Shuang is floating and yang within yang is also involved. The record in "Ben Cao Jing Shu" (herbal Jing Shu) is: croton cream is thin in smell and thick in taste, and can descend and nourish yang and yin. The experimental research shows that the croton cream has strong stimulation effect on skin mucosa and digestive tract and has excitation effect on intestinal muscles. In addition, semen crotonis Pulveratum has analgesic and antibacterial effects, and can inhibit protein synthesis, and PMA in semen crotonis Pulveratum is a potent platelet aggregation agent.
Schizophrenia generally belongs to the category of 'mania' of psychology in traditional Chinese medicine, congenital deficiency, six exogenous pathogenic factors, seven-emotion internal injury and the like are important factors of the pathogenesis of mania, emotional distress, qi movement disorder, imbalance of qi, blood, yin and yang and viscera function imbalance of human bodies cause pathological products of qi, blood, phlegm, fire, stasis and the like in vivo, the pathological products cause brain spirit to be disturbed, the mental retardation destroys the coordination between the spirit of five zang organs and the brain spirit, and is the main etiology and pathogenesis of mania. The traditional Chinese medicine researches believe that schizophrenia with positive symptoms as prominent clinical manifestations or in early and acute stages can approximately correspond to mania of mania. Schizophrenia is related to the dysfunction of the liver, spleen and heart, which are the main reasons of the zang-fu organs, and the liver governs smoothing flow of qi, and the failure of the liver to smooth flow of qi leads to the obstruction of qi movement, and the obstruction of qi leads to the obstruction of the fluid into phlegm; spleen governs transportation and transformation, failure of spleen to transport and transform body fluids is unable to transform body fluids, and retention of body fluids results in phlegm; heart stores blood to nourish mind, and heart blood deficiency leads to the failure of spirit, thus forming the etiology and pathogenesis of phlegm-qi stagnation. Just as recorded in Bing Zhi Jue: for epilepsy as the disease, phlegm-accumulation in the liver is depressive psychosis and qi stagnation is phlegm. Recorded in Jingyue quan Shu & dakang dementia, dao Dian is because it is most advanced when checking phlegm and checking qi. Therefore, the invention takes the dried orange peel and the green tangerine peel as monarch drugs, has the functions of soothing liver, breaking qi, regulating qi, strengthening spleen, eliminating dampness and reducing phlegm; the pepper and the croton cream are ministerial drugs, warm the middle and eliminate phlegm, and strengthen the phlegm dissolving power of monarch drugs, and the costustoot is also ministerial drug and helps the monarch drugs to play the role of promoting qi; clove and dark plum are adjuvant drugs, clove has the function of warming middle-jiao to make qi move in a mild way, and dark plum is sour in taste and can astringe floating heat, inhale qi to return to original, remove heat and relieve restlessness and calm mind. The traditional Chinese medicine composition disclosed by the invention is mild in medicine property, and can regulate the liver and the spleen, so that the qi activity can be dredged and the emotion can be regulated.
Compared with the prior art, the invention has the beneficial effects that:
1) the traditional Chinese medicine composition for treating schizophrenia has a reasonable raw material formula, and has the effects of mild medicine property, soothing the liver, promoting the circulation of qi, strengthening the spleen, reducing phlegm, regulating the liver, regulating the spleen, dredging the qi activity and regulating the emotion.
2) The traditional Chinese medicine composition for treating schizophrenia can obviously improve the symptoms of schizophrenia, and particularly can improve the symptoms of schizophrenia in early and acute stages with positive symptoms as prominent clinical manifestations. In addition, the invention can treat schizophrenia which is induced by factors such as seven emotions, loss of appetite, insufficient endowment and the like and mainly characterized by hyperactivity of spirit, mania, noise, upset, the main unit of the stomach, movement and anger.
Detailed Description
In order to make the technical solutions of the present invention better understood and enable those skilled in the art to practice the present invention, the following embodiments are further described, but the present invention is not limited to the following embodiments.
Dark plum, clove, costustoot, green tangerine orange peel, tangerine peel, pepper and defatted croton seed powder used in the embodiments of the invention are all sold in the market, and the test methods are all conventional methods unless otherwise specified.
Example 1
A traditional Chinese medicine composition for treating schizophrenia comprises the following raw materials in parts by weight: 15g of dark plum fruit, 20g of clove, 20g of costustoot, 10g of green tangerine peel, 10g of pepper and 1g of croton cream.
The method is implemented according to the following steps:
step 1, weighing 15g of dark plum, 20g of clove, 20g of costus root, 10g of green tangerine peel, 10g of dried orange peel, 10g of pepper and 1g of croton cream for later use;
step 2, mixing the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder weighed in the step 1, adding 700g of water into the mixture, soaking for 40min, decocting for 1h after soaking is finished, and filtering to obtain a first filtrate and filter residues; adding 700g of water into the filter residue, decocting for 60min, filtering to obtain a second filtrate, mixing the first filtrate and the second filtrate, mixing, concentrating to a concentration of 2g/mL to obtain a Chinese medicinal composition, and refrigerating the Chinese medicinal composition at 4 deg.C for later use;
pulverizing the above Chinese medicinal composition, adding appropriate amount of adjuvants, mixing, granulating, sieving, drying, further tabletting the obtained granules, and drying to obtain tablet for treating schizophrenia.
Example 2
A traditional Chinese medicine composition for treating schizophrenia comprises the following raw materials in parts by weight: 20g of dark plum fruit, 15g of clove, 15g of costustoot, 15g of green tangerine peel, 15g of tangerine peel, 8g of pepper and 3g of croton cream.
The method is implemented according to the following steps:
step 1, weighing 20g of dark plum, 15g of clove, 15g of costus root, 15g of green tangerine peel, 15g of dried orange peel, 8g of pepper and 3g of croton cream for later use;
step 2, mixing the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder weighed in the step 1, adding 900g of water into the mixture, soaking for 30min, decocting for 1h after soaking is finished, and filtering to obtain a first filtrate and filter residues; adding 900g of water into the filter residue, decocting for 45min, filtering to obtain a second filtrate, mixing the first filtrate and the second filtrate, mixing, concentrating to a concentration of 2g/mL to obtain a Chinese medicinal composition, and refrigerating the Chinese medicinal composition at 4 deg.C for use;
pulverizing the above Chinese medicinal composition, adding appropriate amount of adjuvants, mixing, sieving, granulating, and drying to obtain pill for treating schizophrenia.
Example 3
A traditional Chinese medicine composition for treating schizophrenia comprises the following raw materials in parts by weight: 25g of dark plum fruit, 10g of clove, 10g of costustoot, 20g of green tangerine peel, 20g of tangerine peel, 5g of pepper and 5g of croton cream.
The method is implemented according to the following steps:
step 1, weighing 25g of dark plum, 10g of clove, 10g of costus root, 20g of green tangerine peel, 20g of dried orange peel, 5g of pepper and 5g of croton cream for later use;
step 2, mixing the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder weighed in the step 1, adding 1100g of water into the mixture, soaking for 20min, decocting for 0.5h after soaking is finished, and filtering to obtain a first filtrate and filter residues; adding 1100g of water into the filter residue, decocting for 30min, filtering to obtain a second filtrate, mixing the first filtrate and the second filtrate, mixing, concentrating to a concentration of 2g/mL to obtain a Chinese medicinal composition, and refrigerating the Chinese medicinal composition at 4 deg.C for use;
pulverizing the above Chinese medicinal composition, adding appropriate amount of adjuvants, mixing, granulating, sieving, drying, encapsulating the obtained granules in capsule shell, and making into capsule.
The traditional Chinese medicine compositions for treating schizophrenia prepared in the examples 1 to 3 have good effects, and the effects of the present invention are described only by using the traditional Chinese medicine composition prepared in the example 2 because the effects of the traditional Chinese medicine compositions for treating schizophrenia prepared in the examples 1 to 3 are substantially parallel.
The effects of the present invention will be further described below using animal tests and clinical tests.
First, animal experiment
1. Purpose of the experiment
The acute toxicity of the traditional Chinese medicine composition for treating schizophrenia is evaluated, and a test basis is provided for clinical safe medication.
2. Test materials and methods
2.1 test animals
The clean-grade Kunming mouse is half a female mouse and half a male mouse, has the body mass of 18-22 g, and is provided by the animal test center of Heilongjiang Chinese medicine university.
2.2 preparation of the test drug
The tested drugs are: example 2 the prepared Chinese medicinal composition
The application and dosage are as follows: the clinical recommended dose (crude drug) for adults is 91 g/d. According to the technical guidance principle of acute toxicity research of traditional Chinese medicines and natural medicines issued by the State food and drug administration at 7 months in 2005, the administration dose is designed according to the maximum administration concentration and the maximum administration volume of the mouse ig, and the traditional Chinese medicine composition of 2g/mL (crude drugs) is prepared according to the proportion of 1: the dilution at a ratio of 0.8 was performed in 5 dose groups, and the maximum dose volume was administered in a dose volume (40mL/kg) acceptable to mice, and the mice were individually subjected to intragastric administration.
2.3 test methods
After adaptive feeding of 60 male mice for 3 days, the mice were randomly divided into groups according to body weight, and the administration groups were divided into groups according to the results of preliminary experiments, each group being 1: the 0.8 dilution ratio was divided into 5 dose groups for 6 groups of 10 individuals each. The test mice were administered by gavage at a dose of 0.4mL/10g body weight 1 time per day at a fixed time point (AM 9: 00-AM 10: 00). The animals were dosed for 21d, and the weight change and death count of the animals were observed during dosing, and the number of days in which half of the animal death occurred was observed in the test group.
60 female mice were tested in exactly the same manner as described above.
2.4 statistical methods
Data processing all data to
Shown, the data analysis was performed using SPSS17.0 using a t-test for group comparisons.
3. Test results and analysis
3.1 Effect on mouse body weight
The body mass of each group of mice is shown in table 1 and table 2.
TABLE 1 Effect on body weight in Male mice
TABLE 2 Effect on female mouse body weight
As can be seen from tables 1 and 2, there was no statistical difference in body weight (P >0.05) between the groups of mice before administration, and there was no statistical difference in body weight (P >0.05) between the groups of mice at days 1, 7, 14, and 21 of administration, and there was a certain increase in body weight, indicating that the drugs in each group had no significant effect on the body weight of the mice.
3.2 toxic reaction
From the day of administration until the end of the test, the mice were in good condition, normal activity and diet, smooth and bright hair, formed feces, and no animal death occurred. The maximum total administration dose in 24 hours is calculated to be 80g/kg, the clinical daily dose (crude drug) of an adult (calculated by 70 kg) is 91g/70kg (namely 1.3g/kg), and the multiple (80/1.3-62 times) corresponding to the clinical daily dose is calculated to be more than 50 times, so that the preparation has low toxicity and a large safety range.
3.3 Effect on mouse histopathology
The day after the end of the experiment, all animals were subjected to gross anatomical observation, and no changes in organ volume, color, texture, etc. were observed with the naked eye. The major organs such as brain, heart, liver, spleen, lung and kidney are observed, bleeding, congestion, exudation, ulcer, perforation and inflammation are not seen, and no hydrops exists in the chest cavity, abdominal cavity and pericardial cavity.
Second, clinical trial
1. Data and method
1.1 general data
All tested cases in the test are from inpatients 5 months to 5 months in 2012 to 2014 in China national center of traditional Chinese medicine (department of mental diseases) of Heilongjiang Shenzhi hospital, and 60 patients meeting the inclusion standard are selected according to the sequence of the patients, wherein 27 men and 33 women are selected. The random grouping method is adopted to divide the treatment groups into 30 cases, wherein 14 cases of men and 16 cases of women have the average age of 43.47 +/-9.99 years and the average course of disease of 9.16 +/-5.832 years; control group 30, 13 of men and 17 of women; the average age is 42.50 +/-9.74 years, and the average course of disease is 7.76 +/-4.44 years.
The patients in the two groups have no statistical difference in sex, age and disease course (P >0.05) and are comparable.
1.2 selection criteria for study subjects
1.2.1 inclusion criteria: a schizophrenia patient who meets the following criteria:
(1) the diagnosis standard of the western medicine schizophrenia is met, and the Chinese mental disorder classification system and the 3 rd edition (CCMD-3) of the diagnosis standard are taken as the standard;
(2) the simple psychosis scale (BPRS) is rated more than 35 points, and the total negative symptom scale (SANS) is rated more than or equal to 60 points;
(3) the vital signs are stable, the mind is clear, and certain expression capacity is realized;
(4) in the schizophrenia patients, the main symptoms of mania in traditional Chinese medicine are characterized by irritability, mania, noise, and distressing, and the patients with schizophrenia are abused and irritative.
1.2.2, exclusion criteria:
(1) systemic diseases and external environmental interference factors or craniocerebral trauma;
(2) pregnant or lactating women;
(3) if the drug is not administered according to the prescription, the curative effect or the safety judgment is not affected by the incompleteness of the data or the curative effect;
(4) patients under 18 or over 65 years of age, without mental retardation (intelligence >70), without severe speech or hearing impairment;
(5) those who have received a new drug trial in the past 12 weeks;
(6) excitement and non-cooperation (score of No. 14 or No. 17 on BPRS scale is more than 6).
Any item 1 above is excluded.
1.2.3, case shedding criteria:
(1) the observer was withdrawn or discontinued for medical reasons related to the drug (allergic or intolerant adverse events), and the case was taken into adverse event statistics;
(2) patients who were actively withdrawn from the study or were out of visit for various reasons.
1.3 methods of treatment
The traditional Chinese medicine pills prepared in the embodiment 2 of the invention are taken by a treatment group once in the morning and at night every day, 1 pill is taken each time, 9g is taken each time, and the treatment course is 6 weeks. The control group was administered risperidone tablet (Jiangsu Enhua pharmaceutical industry, Ltd., national Standard H20050160) at a dose of 2mg/d for 2 times, which was increased to 6mg/d within 7 days, and the treatment course was 6 weeks.
2. Observation index and evaluation of therapeutic effect
2.1, safety observations
(1) General physical examination items (body temperature, pulse, respiration, blood pressure);
(2) routine examination of blood and urine, and liver function examination;
(3) adverse reactions possibly occurring in the clinical use process of the medicine.
Note: the indexes (1) and (2) are examined before and after treatment, and the observation and recording are carried out at any time if adverse reaction occurs in item (3).
2.2 therapeutic Effect Observation
(1) Brief Psychiatric Rating Scale (BPRS);
(2) negative symptoms scale (SANS);
(3) adverse reactions scale (TESS).
2.3 Observation methods
The test patients are evaluated and recorded with BPRS and SANS scales before and after the treatment, namely the eighth week; safety evaluation and related item examination are carried out before treatment and after treatment is finished.
2.4 therapeutic evaluation criteria (taking SANS score as standard)
Treatment improvement rate P ═ [ (pre-treatment score-post-treatment score)/pre-treatment score ] × 100%;
the clinical cure is as follows: clinical symptoms disappear, the emotion is basically normal, and P is more than or equal to 75 percent;
the clinical effect is shown: the clinical symptoms are obviously improved, the emotion is basically normal, and P is more than or equal to 50% and less than 75%;
the clinical effect is as follows: the clinical symptoms are relieved, the emotion is basically stable, and P is more than or equal to 25% and less than 50%;
clinical ineffectiveness: the symptoms and mood are not obviously improved, and P is less than 25 percent.
2.5 statistical methods
Analyzing by SPSS17.0 statistical software, performing paired t-test for the front and back comparison of the measurement data, performing independent sample t-test for the inter-group comparison of the measurement data, and performing x-test for the inter-group comparison of the count data2And (6) checking.
3. Test results
3.1, comparison of the BPRS scale scores before and after treatment in the two groups, see Table 3.
TABLE 3 comparison of BPRS Scale scores before and after treatment in two groups
| Group of | Number of examples | Before treatment | After treatment |
| Treatment group | 30 | 54.07±11.26 | 28.72±4.22*▲ |
| Control group | 30 | 52.71±9.21 | 29.13±4.28△ |
Note: p <0.05 after treatment compared to before treatment in treatment groups; (ii) a Δ P <0.05 after treatment compared to before treatment in the control group; after treatment the P is greater than 0.05 compared with the P after treatment of the control group.
As can be seen from table 3, the difference was statistically significant (P <0.05) when compared between the two groups before and after treatment; the differences were not statistically significant after treatment compared to after treatment of the control group (P > 0.05).
3.2, comparison of SANS Scale scores before and after treatment in both groups, see Table 4.
TABLE 4 comparison of SANS Scale scores before and after treatment in two groups
| Group of | Number of examples | Before treatment | After treatment |
| Treatment group | 30 | 68.21±5.95 | 25.65±4.53*▲ |
| Control group | 30 | 67.14±6.06 | 47.55±4.71△ |
Note: p <0.05 after treatment compared to before treatment in treatment groups; (ii) a Δ P <0.05 after treatment compared to before treatment in the control group; after the treatment group is compared with the control group after the treatment, the P is less than 0.05.
As can be seen from table 4, the difference was statistically significant (P <0.05) when compared between the two groups before and after treatment;
the differences after treatment in the treatment group were statistically significant (P <0.05) compared to after treatment in the control group; after the two groups of medicaments are treated, the SANS scale score is obviously reduced, the clinical symptoms are obviously relieved, and the treated group is superior to the control group.
3.3, the overall curative effect rates of the two groups are compared, and the specific results are shown in Table 5.
TABLE 5 comparison of Total effective rates after treatment (%)
| Group of | Total number of cases | Recovery (case) | Obvious effect (example) | Improvement (example) | Invalid (example) | Total effective rate |
| Treatment group | 30 | 6 | 12 | 8 | 4 | 86.67％* |
| Control group | 30 | 2 | 10 | 7 | 11 | 63.33％ |
Note: p <0.05 in the treated group compared to the control group.
As can be seen from Table 5, the total curative effect rates of the treatment group and the control group are 86.67 percent and 63.33 percent respectively,
by x2Inspection, P<0.05, the difference has statistical significance, which indicates that the total curative effect of the treatment group is better than that of the control group.
3.4, comparing the occurrence conditions of the two groups of side reactions, and concretely referring to the table 6.
TABLE 6 comparison of incidence of adverse side effects after treatment (%)
| Group of | Total number of cases | Has no adverse side effect | Has little influence | The influence is large | Incidence of side reactions |
| Treatment group | 30 | 28 | 2 | 0 | 6.67％* |
| Control group | 30 | 14 | 13 | 3 | 53.33％ |
Note: p <0.05 in the treated group compared to the control group.
As can be seen from Table 6, the incidence of side effects was 6.67% and 53.33% in the treatment group and the control group, respectively, using x2Inspection, P<0.05, the difference was statistically significant, indicating that the side effects were lower in the treated group than in the control group.
It should be noted that when the following claims refer to numerical ranges, it should be understood that two endpoints of each numerical range and any numerical value between the two endpoints can be selected, and since the steps and methods adopted are the same as those in embodiments 1 to 3, the preferred embodiments are described in the present invention for preventing redundancy, but once a person skilled in the art knows the basic inventive concept, other changes and modifications can be made to the embodiments. Therefore, it is intended that the appended claims be interpreted as including preferred embodiments and all such alterations and modifications as fall within the scope of the invention.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (6)
1. The traditional Chinese medicine composition for treating schizophrenia is characterized by comprising the following raw materials in parts by weight: 15-25 parts of dark plum, 10-20 parts of clove, 10-20 parts of costus root, 10-20 parts of green tangerine peel, 10-20 parts of dried orange peel, 5-10 parts of pepper and 1-5 parts of croton cream;
the traditional Chinese medicine composition is prepared according to the following steps:
step 1, weighing 15-25 parts of dark plum, 10-20 parts of clove, 10-20 parts of costus root, 10-20 parts of green tangerine peel, 10-20 parts of dried orange peel, 5-10 parts of pepper and 1-5 parts of croton cream for later use;
step 2, mixing the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder weighed in the step 1 together, adding water which is 8-12 times of the total weight of the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder, soaking for 20-40 min, decocting for 0.5-1 h after soaking, and filtering to obtain a first filtrate and filter residues; adding water which is 8-12 times of the weight of the filter residue into the filter residue, decocting for 30-60 min, filtering to obtain a second filtrate, combining the first filtrate and the second filtrate, uniformly mixing, concentrating to a concentration of 2g/mL to obtain the traditional Chinese medicine composition, and refrigerating the traditional Chinese medicine composition at 4 ℃ for later use.
2. The traditional Chinese medicine composition for treating schizophrenia according to claim 1, wherein the raw materials comprise the following components in parts by weight: 20 parts of dark plum fruit, 15 parts of clove, 15 parts of costustoot, 15 parts of green tangerine peel, 15 parts of dried orange peel, 8 parts of pepper and 3 parts of croton cream.
3. The preparation method of the traditional Chinese medicine composition for treating schizophrenia according to claim 1, which is implemented by the following steps:
step 1, weighing 15-25 parts of dark plum, 10-20 parts of clove, 10-20 parts of costus root, 10-20 parts of green tangerine peel, 10-20 parts of dried orange peel, 5-10 parts of pepper and 1-5 parts of croton cream for later use;
step 2, mixing the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder weighed in the step 1 together, adding water which is 8-12 times of the total weight of the dark plum, clove, costus root, green tangerine peel, dried orange peel, pepper and defatted croton seed powder, soaking for 20-40 min, decocting for 0.5-1 h after soaking, and filtering to obtain a first filtrate and filter residues; adding water which is 8-12 times of the weight of the filter residue into the filter residue, decocting for 30-60 min, filtering to obtain a second filtrate, combining the first filtrate and the second filtrate, uniformly mixing, concentrating to a concentration of 2g/mL to obtain the traditional Chinese medicine composition, and refrigerating the traditional Chinese medicine composition at 4 ℃ for later use.
4. The preparation method of the traditional Chinese medicine composition for treating schizophrenia according to claim 3, wherein the traditional Chinese medicine composition can be prepared into a pharmaceutically acceptable traditional Chinese medicine preparation according to a conventional method.
5. The preparation method of the traditional Chinese medicine composition for treating schizophrenia according to claim 4, wherein the pharmaceutical dosage form of the traditional Chinese medicine preparation is tablets, capsules, granules or pills.
6. The use of the Chinese medicinal composition for treating schizophrenia according to any one of claims 1-2 in the preparation of a medicament for treating schizophrenia.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1059102A (en) * | 1991-05-04 | 1992-03-04 | 张雁 | A kind of compound method of curing the schizophrenia Chinese medicine pill |
| CN1615948A (en) * | 2004-09-16 | 2005-05-18 | 唐玉厚 | Medicine for treating mental disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1059102A (en) * | 1991-05-04 | 1992-03-04 | 张雁 | A kind of compound method of curing the schizophrenia Chinese medicine pill |
| CN1615948A (en) * | 2004-09-16 | 2005-05-18 | 唐玉厚 | Medicine for treating mental disease |
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| Title |
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| 中西医结合治疗精神障碍54例;白晓英等;《陕西中医》;20021231;第23卷(第02期);第118-120页 * |
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