CN105327287A - Pharmaceutical composition for treating psychosis and preparation technology thereof - Google Patents
Pharmaceutical composition for treating psychosis and preparation technology thereof Download PDFInfo
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Abstract
The invention relates to a pharmaceutical composition for treating a psychosis. The pharmaceutical composition for treating the psychosis is prepared from 25 kg of clozapine, 28 kg of starch, 22 kg of dextrin, 2 kg of microcrystalline cellulose, 30 kg of ethyl alcohol of 50% (volume ratio) and 0.77 kg of magnesium stearate, the raw materials are taken, granulation is conducted according to a conventional method, and one million tablets are prepared. The pharmaceutical composition is significant in curative effect, treatment of the symptoms and the causes is achieved, and wide application prospect is achieved.
Description
Technical field
The invention belongs to medical art, be specifically related to be used for the treatment of psychotic Chinese-western medicine preparation, particularly based on the application of pharmaceutical composition in treatment psychosis that Western medicine clozapine and Chinese medicine are made.
Background technology
Psychosis refers to cerebral function activity incidence rate disorderly, causes the general name of the ergasias such as understanding, emotion, behavior and the will disease of obstacle in various degree.Paathogenic factor has many-side: congenital heredity, personal characteristics and physical factors, device quality factor, social environmental factors etc.Many mental patients have vain hope, hallucination, illusion, affective disorder, cry and laugh by turns, without any apparent reason, murmur to oneself, behavior is strange, hypobulia, and most humans lacks insight, does not admit that oneself is ill, does not initiatively seek the help of doctor.Ordinary people also exists and does not admit oneself ill phenomenon, so using shortage insight and can not admit that oneself is ill as determining psychotic foundation.Common psychosis has: the psychosis etc. that schizophrenia, manic depressive psychosis, involutional psychosis, paranoid psychosis and various organic disease occur together.Patient and family members actively should coordinate with psychiatrist, hospital treatment early.Psychotic often shows as mental excitation, and disposition is impetuous, insomnia headache, and suffering from losing one's temper, exceedes smooth upper room, shout abuses in the street and call out the numbers, do not keep away close and distant, hurting people or smashing objects or spiritual frightened or neurolysis, fidgety, shape is thin, flushing, susceptible to fright and polylogia, the few tongue of red tongue with yellow fur or red tongue or no fur, pulse condition stringy and rolling pulse or count accurately.Diagnosis is with red tongue, and oral mucosa, the thrifty mucous hyperemia of lower eye, rapid pulse is as the criterion effectively, sick visible red and uncoated tongue for a long time, thready and rapid pulse.
Existing Therapeutic Method is that master adds complementary therapy mainly with doctor trained in Western medicine, Western medicine diagnose is complicated, and the Western medicine of conventional treatment has: Ziprasidone, clozapine, perphenazine, chlorpromazine, risperidone, haloperidol, quetiapine fumarate, sulpiride, trimetozine, olanzapine etc.Because western medicine impairing the liver injures one's stomach, weak curative effect, some needs of patients is taken medicine for a long time even all the life, and most of patient can not adhere to treatment; Complementary therapy is as electrotherapy, and side effect is large, large to human injury.
Psychosis, in motherland's medical science, belongs to the category of mental diseases.The cause of disease of primary disease early has discussion in classical Chinese medicine works, as " a vital QI of the body connecting with natural QI opinion section " is said: YIN can’t match excessive YANG, the then thin disease of arteries and veins stream, and is mad." Plain Questions declares five gas opinion sections " is said: disturbance of YANG by pathogen leading to mania, and disturbance of YIN by pathogen leading to obstruction of QI-blood, sun of fighting is then insane disease." difficult difficult through 20 " is said: the Double Ninth Festival, person was mad, and overabundant yin person is insane." the mad disease of all cause of disease marquis opinion wind is waited " is said: gas sun then mad.Primary disease " insane ", " mad " name, be because of its " positivity insane fall; madly fail to see people ", also namely modern medicine " manic type " and " inhibitable type " are all caused by direct stimulation, so that the control that loses one's marbles, can not carry out correctly thinking, speaking incoherently, Mental Subnormality, hysteria, manic, going to a high place and singing, abandon clothing and the clinical manifestation such as to run.Motherland's medical science is thought, it has day, the moon, star, and people has essence, gas, god, " patient with vitality being easy to be cured; inverse refreshing person dies ", the general name of god and human life activity is also spirit and consciousness, the high level overview of the outward manifestation of thinking activities and internal organs, vital essence, blood and body fluid functional activity. in other words, the circulation law of the QI and blood of people, body fluid, thinking activities, come from the adjustment of self, and self-regulation function long-run disturbance, then can cause the exception of spirit.
Motherland's medical science thinks that psychotic etiology and pathogenesis mainly contains: 1. six climate exopathogens invasion and attack.Six climate exopathogens and wind, cold, summer-heat, wet, dry, fiery, be the abiogenous phenomenon of nature weather, general and not pathogenic, be called six gas.Only when weather is not normal, event of just can causing a disease is also known as six climate exopathogens.Mainly wind summer-heat fire three kinds relevant with mental sickness in the middle of six climate exopathogens." Plain Questions " has: the theory of " hinder in wind person, upper first by it, " and " all dry fanaticisms all belong to fiery ".But no matter be " wind, summer-heat ", or " dryness-fire " is always when human body weak, just can takes advantage of a weak point in opponent's defence and people is caused a disease.But " burning hot excessively high " is still regarded as the importance of etiology and pathogenesis at present.2. internal injury caused by excess of seven emotions.Namely seven emotions are liked, anger, melancholy, think of, compassion, probably, frightened, it is the Normal appearances of people's ergasia, if but exceeded normal limit or be subject to unexpected and permanent stimulation, and lack psychological stress ability and disposal skill, physiology and visceral dysfunction will be caused, meridian function is disorderly and mental sickness occurs.In addition, also have mental confusion due to phlegm, coagulation of QI-blood, negative and positive become estranged, heredity, consanguineous marriage, cerebral trauma, brain organic disease, poisoning etc.
At present, constantly have new antipsychotic medicine (comprising Western medicine and Chinese medicine) to occur clinically, but these all fail to reach real gratifying effect.Develop a kind of high-efficiency low-toxicity, the Chinese medicine and western medicine compound drug for the treatment of both the principal and secondary aspects of a disease is still clinical eager needs.
Summary of the invention
The object of this invention is to provide that a kind for the treatment of both the principal and secondary aspects of a disease, side effect are little, the compound medicinal formulation of safe ready.Its objective is to solve treatment psychosis, overcoming Western medicine side effect, drug withdrawal problem repeatedly, reaching the object for the treatment of both the principal and secondary aspects of a disease.
Present inventor according to forefathers' experience and oneself medical practice for many years, by the research to Chinese medicine, from entirety, primary disease mainly due to feelings will hindered, dredging mechanism of qi is fundamental law, and the network focusing on zang-fu differentiation belongs to, adjoin, the treatment of change of disease relation.From motherland's medical treasure-house, filtering out clears away heart-fire locates tired, YIN nourishing and the production of body fluid promoting, effect nourished heart of calming the nerves natural Chinese medicine, by theory of Chinese medical science prescription, be meticulously mixed with the antipsychotic pharmaceutical composition of one of the present invention in conjunction with Traditional Chinese Medicine technology, remarkable to psychotic therapeutic effect.
For achieving the above object, the technical solution used in the present invention is as follows:
A kind of antipsychotic pharmaceutical composition, it is prepared by following raw material and obtains:
Clozapine 25kg, starch 28kg, dextrin 22kg, microcrystalline Cellulose 2kg, 50%(volume ratio) ethanol 30kg, magnesium stearate 0.77kg.
Get above-mentioned raw materials, conventionally pelletize, prepare 1,000,000, tablet.
Preferably, the antipsychotic pharmaceutical composition of described one, it is prepared by following raw material and obtains:
Clozapine 18kg, starch 28kg, active ingredient of Chinese herbs 8kg, dextrin 22kg, microcrystalline Cellulose 2kg, 50%(volume ratio) ethanol 30kg, magnesium stearate 0.77kg.
Get above-mentioned raw materials, conventionally pelletize, prepare 1,000,000, tablet.
Described active ingredient of Chinese herbs, prepared by the raw material of following weight and obtain:
Folium Nerviliae fordii 40 parts, Rhizoma Acori Graminei 40 parts, Herba Nicandrae Physaloidis 40 parts, gray gum 35 parts, Olibanum 35 parts,
Fructus Ligustri Lucidi 35 parts, Rhodobryum roseum Limpr. 35 parts, Radix Curcumae 30 parts, 30 parts, Rhizoma Gastrodiae, Radix Rhodiolae 30 parts,
Radix Inulae 28 parts, Fructus Arctii 28 parts, Herba Taraxaci 28 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, the Radix Astragali 25 parts,
Lignum Aquilariae Resinatum 25 parts, Radix Polygalae 20 parts, Myrrha 20 parts, Massa Medicata Fermentata 20 parts, 20 parts, Poria,
15 parts, Radix Glycyrrhizae, Semen Ziziphi Spinosae 15 parts, Radix Polygoni Multiflori 10 parts, Fructus Schisandrae Chinensis 10 parts, Radix Codonopsis 10 parts,
Rhizoma Dioscoreae 10 parts, 10 parts, Semen Persicae.
The preparation method of described active ingredient of Chinese herbs is:
(1) above-mentioned raw materials is taken for subsequent use;
(2) get Radix Curcumae, Radix Glycyrrhizae, Rhizoma Dioscoreae, Semen Persicae pulverized 100 mesh sieves, mix homogeneously, prepare complex A;
(3) get Folium Nerviliae fordii, Herba Nicandrae Physaloidis, gray gum, Radix Rhodiolae, Fructus Arctii, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Poria decoct with water, first time adds 5 times of weight water, decoct 1 hour, obtain filtrate and medicinal residues after filtration, medicinal residues are added 4 times of weight water and decoct half an hour, after filtration, obtain filtrate, merge twice filtrate, filtrate after merging is condensed into the extractum that density is 1.2g/ml, after 60 DEG C of dryings, pulverizes and obtain complex B;
(4) get surplus stock and add 2 times of weight 75%(volume ratios) ethanol, reflux, extract, 2 times, each 1 hour, extracting solution merged, and is concentrated into the extractum that density is 1.2g/ml, after 60 DEG C of dryings, pulverized and obtained complex C;
(5) namely Homogeneous phase mixing complex A, B, C obtain active ingredient of Chinese herbs.
Pharmaceutical composition of the present invention can add one or more pharmaceutically acceptable carriers and be mixed and made into any one clinically or pharmaceutically acceptable dosage form, preferred oral preparation.When being applied in the mode of oral administration the patient needing this treatment, conventional solid preparation can be made into, as tablet, capsule, soft capsule etc.
Pharmaceutical composition of the present invention is not only effective to psychosis positive symptom, also has certain effect to negative symptoms.Be applicable to each hypotype that is acute and chronic schizophrenia, effective to hallucinatory paranoid form, hebephrenictype.Also the affective symptom (as: depression, sense of guilt, anxiety) relevant with schizophrenia can be alleviated.To fail to respond to any medical treatment with traditional antipsychotics to some or patient that curative effect is bad, using this product instead may be effectively.This product is also used for the treatment of the restless and hallucination vain hope of the excitement of mania or other psychotic disorders.
Usage and dosage: oral from low dose, initial dose is a 25mg(1 sheet), 2 ~ 3 times on the one, be slowly increased to conventional therapeutic dose 200 ~ 400mg(8 ~ 16 slice on the one gradually), a large amount can reach 600mg(24 sheet on the one).Maintenance dose is 100 ~ 200mg(4 ~ 8 slice on the one).
Pharmaceutical composition of the present invention has depressed liver-energy dispersing and QI regulating, suppressing the hyperactive liver and subsiding YANG, support that brain is calmed the nerves, intestinal stasis relieving of invigorating blood circulation, inducing diuresis to remove edema, causing resuscitation with aromatic drugs, clearing away heat-fire, benefiting qi and nourishing blood, benefit essence mend effect of marrow, clinical practice proves, evident in efficacy to psychosis especially schizophrenia, manic depressive psychosis, paranoid psychosis, effective percentage is high.
The excellent results of pharmaceutical composition of the present invention is:
1. Chinese medicine preparation compatibility of the present invention meets Chinese medicine " monarch " principle, is made up of pure Chinese medicine, and each component meets pharmaceutical control law regulation, utilize the comprehensive function of each taste Chinese medicine, not containing chemical components, not containing hormone, treating both the exterior and interior, reaches and better supports that brain is calmed the nerves, function of soothing liver to regulate;
2. this medicament short treating period, total effective rate is high, not easily recurs more.
3. technique of the present invention is simple, reduces production cost, alleviates the financial burden of patient.
Detailed description of the invention
Embodiment 1
A kind of antipsychotic pharmaceutical composition, it is prepared by following raw material and obtains:
Clozapine 25kg, starch 28kg, dextrin 22kg, microcrystalline Cellulose 2kg, 50%(volume ratio) ethanol 30kg, magnesium stearate 0.77kg.
Get above-mentioned raw materials, conventionally pelletize, prepare 1,000,000, tablet.
Embodiment 2
A kind of antipsychotic pharmaceutical composition, it is prepared by following raw material and obtains:
Clozapine 18kg, starch 28kg, active ingredient of Chinese herbs 8kg, dextrin 22kg, microcrystalline Cellulose 2kg, 50%(volume ratio) ethanol 30kg, magnesium stearate 0.77kg.
Get above-mentioned raw materials, conventionally pelletize, prepare 1,000,000, tablet.
Described active ingredient of Chinese herbs, prepared by the raw material of following weight and obtain:
Folium Nerviliae fordii 40 parts, Rhizoma Acori Graminei 40 parts, Herba Nicandrae Physaloidis 40 parts, gray gum 35 parts, Olibanum 35 parts,
Fructus Ligustri Lucidi 35 parts, Rhodobryum roseum Limpr. 35 parts, Radix Curcumae 30 parts, 30 parts, Rhizoma Gastrodiae, Radix Rhodiolae 30 parts,
Radix Inulae 28 parts, Fructus Arctii 28 parts, Herba Taraxaci 28 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, the Radix Astragali 25 parts,
Lignum Aquilariae Resinatum 25 parts, Radix Polygalae 20 parts, Myrrha 20 parts, Massa Medicata Fermentata 20 parts, 20 parts, Poria,
15 parts, Radix Glycyrrhizae, Semen Ziziphi Spinosae 15 parts, Radix Polygoni Multiflori 10 parts, Fructus Schisandrae Chinensis 10 parts, Radix Codonopsis 10 parts,
Rhizoma Dioscoreae 10 parts, 10 parts, Semen Persicae.
The preparation method of described active ingredient of Chinese herbs is:
(1) above-mentioned raw materials is taken for subsequent use;
(2) get Radix Curcumae, Radix Glycyrrhizae, Rhizoma Dioscoreae, Semen Persicae pulverized 100 mesh sieves, mix homogeneously, prepare complex A;
(3) get Folium Nerviliae fordii, Herba Nicandrae Physaloidis, gray gum, Radix Rhodiolae, Fructus Arctii, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Poria decoct with water, first time adds 5 times of weight water, decoct 1 hour, obtain filtrate and medicinal residues after filtration, medicinal residues are added 4 times of weight water and decoct half an hour, after filtration, obtain filtrate, merge twice filtrate, filtrate after merging is condensed into the extractum that density is 1.2g/ml, after 60 DEG C of dryings, pulverizes and obtain complex B;
(4) get surplus stock and add 2 times of weight 75%(volume ratios) ethanol, reflux, extract, 2 times, each 1 hour, extracting solution merged, and is concentrated into the extractum that density is 1.2g/ml, after 60 DEG C of dryings, pulverized and obtained complex C;
(5) namely Homogeneous phase mixing complex A, B, C obtain active ingredient of Chinese herbs.
Embodiment 3
Acute toxicity testing: application mice 60, male and female half and half, body weight 30 ~ 40g, carries out acute toxicity test.Mice is divided into two groups at random, i.e. matched group and embodiment 1 group, embodiment 2 groups, often organizes 20, fasting 12 hours before experiment, the pharmaceutical composition that administration group gives embodiments of the invention 1 respectively, prepared by embodiment 2 is dissolved in gastric infusion in water, matched group gives normal saline, administration in a day 2 times, delivery time 6 hours, Continuous Observation fortnight after administration, and the toxic reaction and the death toll that record mice.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation two weeks, mouse systemic situation, diet, drinking-water, body weight increase all normal.Therefore pharmaceutical composition toxicity of the present invention is lower, and clinical application is comparatively safe.
Long term toxicity test: the pharmaceutical preparation embodiment of the present invention 2 prepared is to mice continuous use 15 weeks and drug withdrawal after 3 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and drug withdrawal are after 3 weeks, and Organs of Mice is all without obviously changing.Illustrate that Chinese medicine of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.
Embodiment 4
Clinical data
130 routine clinical patients chosen by clinical data, wherein male 66 people, women 64 people, age reckling 17 years old, the maximum 65 years old, the shortest person of the course of disease three months, most elder 16 years.Wherein, suffer from schizophrenia 97 example, suffer from mania 33 examples.Be divided into two groups at random, embodiment 1 group and embodiment 2 groups, two groups of Genders, age, courses of disease, through statistical procedures, without significant difference (P > 0.05), there is comparability.
Diagnostic criteria: acute stage: mental excitation, lies awake all night, and has a headache manic, and two orders are glared at, flushed face with red ears, mania is many not to be kept away close and distant, does not frenziedly make, swear at people and ruin thing, exceed smooth upper room, sing heartily and scream aloud, the prolonged illness then positive symptom is slightly slow, and god is slow-witted, speaking incoherently, loquacity, moves more, uneasy in terror, fidgety insomnia, red tongue with yellow fur or red and uncoated tongue or flower tongue, the strong or thready and rapid pulse of the sliding number of pulse condition.
Curative effect determinate standard:
Recovery from illness: language, manner, look all recover normal, can normal process routine matter.
Effective: transference cure, language, manner are normal, and can do simple housework, life can take care of oneself.
Effective: look is stabilized, and language, manner is normal or make moderate progress, when spiritedness stimulates, look unstable.
Invalid: language, manner, look are all without improvement.
Therapeutic Method: embodiment 1 group gives pharmaceutical composition prepared by embodiment 1, initial dose be one time 1,2 ~ 3 times on the one, gradually slowly to conventional therapeutic dose 4-8 sheet on the one, one month is a course for the treatment of;
Embodiment 2 groups gives pharmaceutical composition prepared by embodiment 2, initial dose be one time 1,2 ~ 3 times on the one, gradually slowly to conventional therapeutic dose 4-8 sheet on the one, one month is a course for the treatment of;
Two groups of patients all coordinate body acupuncture, terrible Men Shisan pin, wrist-ankle acupuncture for treatment to treat.Before and after two groups of treatments, effectiveness comparison is in table 1:
Table 1
| Group | Example time | Recovery from illness | Effective | Effectively | Invalid | Total effective rate (%) |
| Embodiment 1 group | 65 | 29 | 15 | 12 | 9 | 86.2 |
| Embodiment 2 groups | 65 | 37 | 10 | 15 | 3 | 95.4 |
Embodiment 5
Model case
Chen, female, because of marriage failure, take things too hard consequently coma after divorced and put upside down, being happy and angry uncertainly, be schizophrenia after diagnosing, through Multiple Hospitalization, and repeatedly galvanic shock joins Western medicine, puts forth energy to wait unsatisfactory curative effect quietly.Disease is seen, shallow complexion, emaciated physique, Hypomenorrhea, color purple has clot, spirit depressing, mind is dull, anxious, murmurs to oneself, red tongue greasy fur, wiry and frequent pulse, gives pharmaceutical composition prepared by embodiment 2, takes a course for the treatment of, coordinate terrible Men Shisan pin, patient mental takes a turn for the better, and language increases, and can talk the state of an illness, diet strengthens, body of the tongue, pulse condition relax, and advise and continue to take a course for the treatment of with consolidate curative effect, and patient's look is stabilized, language, manner, to take a favorable turn, through fully recovering with square disease after continuing again to take a course for the treatment of.
The antipsychotic pharmaceutical composition of the application is with low cost, evident in efficacy, has broad application prospects.
Claims (5)
1. an antipsychotic pharmaceutical composition, is characterized in that, it is prepared by following raw material and obtains:
Clozapine 25kg, starch 28kg, dextrin 22kg, microcrystalline Cellulose 2kg, 50%(volume ratio) ethanol 30kg, magnesium stearate 0.77kg, get above-mentioned raw materials, conventionally pelletize, prepare 1,000,000, tablet.
2. an antipsychotic pharmaceutical composition, is characterized in that, it is prepared by following raw material and obtains:
Clozapine 18kg, starch 28kg, active ingredient of Chinese herbs 8kg, dextrin 22kg, microcrystalline Cellulose 2kg, 50%(volume ratio) ethanol 30kg, magnesium stearate 0.77kg, get above-mentioned raw materials, conventionally pelletize, prepare 1,000,000, tablet.
3. pharmaceutical composition according to claim 2, is characterized in that, described active ingredient of Chinese herbs is prepared by the raw material of following weight and obtains:
Folium Nerviliae fordii 40 parts, Rhizoma Acori Graminei 40 parts, Herba Nicandrae Physaloidis 40 parts, gray gum 35 parts, Olibanum 35 parts,
Fructus Ligustri Lucidi 35 parts, Rhodobryum roseum Limpr. 35 parts, Radix Curcumae 30 parts, 30 parts, Rhizoma Gastrodiae, Radix Rhodiolae 30 parts,
Radix Inulae 28 parts, Fructus Arctii 28 parts, Herba Taraxaci 28 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, the Radix Astragali 25 parts,
Lignum Aquilariae Resinatum 25 parts, Radix Polygalae 20 parts, Myrrha 20 parts, Massa Medicata Fermentata 20 parts, 20 parts, Poria,
15 parts, Radix Glycyrrhizae, Semen Ziziphi Spinosae 15 parts, Radix Polygoni Multiflori 10 parts, Fructus Schisandrae Chinensis 10 parts, Radix Codonopsis 10 parts,
Rhizoma Dioscoreae 10 parts, 10 parts, Semen Persicae.
4. the pharmaceutical composition according to claim 2-3, is characterized in that, the preparation method of described active ingredient of Chinese herbs is:
(1) above-mentioned raw materials is taken for subsequent use;
(2) get Radix Curcumae, Radix Glycyrrhizae, Rhizoma Dioscoreae, Semen Persicae, pulverized 100 mesh sieves, mix homogeneously, prepare complex A;
(3) Folium Nerviliae fordii, Herba Nicandrae Physaloidis, gray gum, Radix Rhodiolae, Fructus Arctii, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Poria is got, mixing, decocts with water, and first time adds 5 times of weight water, decoct 1 hour, obtain filtrate and medicinal residues after filtration, medicinal residues are added 4 times of weight water and decoct half an hour, after filtration, obtain filtrate, merge twice filtrate, filtrate after merging is condensed into the extractum that density is 1.2g/ml, after 60 DEG C of dryings, pulverizes and obtain complex B;
(4) get surplus stock, mixing, add the ethanol of 2 times of weight 75%, reflux, extract, 2 times, each 1 hour, extracting solution merges, and is concentrated into the extractum that density is 1.2g/ml, after 60 DEG C of dryings, pulverizes and obtains complex C;
(5) namely Homogeneous phase mixing complex A, B, C obtain active ingredient of Chinese herbs.
5. the purposes of pharmaceutical composition described in claim 1-4.
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